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| Rule |
Rule 3701-22-01 | Definitions.
Effective:
September 14, 2024
As used in this chapter: (A) "Administrator" means the
person responsible for the overall daily management of the hospital and
decisions regarding the hospital license. (B) "Adult open heart surgery service" or
"pediatric cardiovascular surgery service" means the combination of
staff, equipment, physical space and support services which are used to perform
open-heart surgeries. (C) "Advanced practice registered nurse" means an
individual who holds a valid license under Chapter 4723. of the Revised Code to
practice nursing as a certified registered nurse anesthetist, clinical nurse
specialist, certified nurse-midwife, or certified nurse
practitioner. (D) "Alcohol and drug hospital" means a hospital
engaged primarily in providing specialized care to inpatients with alcoholism
or chemical dependency rehabilitative service needs. (E) "Alcohol or drug abuse rehabilitation bed"
means a hospital bed that is staffed and equipped for care of inpatients whose
primary diagnosis is alcoholism or other chemical dependency. (F) "Anesthesiologist" means a physician who has
completed a residency training program in anesthesiology accredited by the
accreditation council for graduate medical education or the American
osteopathic association. (G) "Anesthesiologist assistant" means an
individual who holds a valid certificate of registration under Chapter 4760. of
the Revised Code to practice as a anesthesiologist assistant. (H) "Autologous/syngeneic bone marrow
transplantation" means autologous, peripheral blood stem cell or syngeneic
transplants. (I) "Average daily census" means total patient
days for a given calendar year divided by the number of days in the
year. (J) "Blood and bone marrow
transplantation service" also known as "hematopoietic stem cell
transplantation" or "(HSCT)" means the replacement or
supplementation of a patient's bone marrow with autologous or allogeneic
hematopoietic stem cells when the patient's own bone marrow has been
ablated or partially ablated by disease or therapy for the purpose of achieving
long-term management of certain hematologic, immunologic, oncologic or genetic
conditions, or enzymatic deficiency disease. A bone marrow transplantation
service includes a service in stem cell harvesting and reinfusion. (K) "Burn care bed" means a
hospital bed that is staffed and equipped for care of inpatients whose primary
diagnosis is burn-related. (L) "Burn care hospital" means
a hospital engaged primarily in providing inpatient care to patients requiring
specialized burn-related diagnostic or therapeutic services. (M) "Cancer hospital" means a
hospital that is classified as a cancer hospital under 42 C.F.R. 412.23(f)
(1985) and is organized primarily for treatment and research on
cancer. (N) "Cardiac catheterization" means a procedure
used to diagnose and treat various cardiac and circulatory diseases that
involves inserting a thin, pliable catheter into a major blood vessel and
manipulating the tip of the catheter through veins or arteries to the
heart. (O) "Cardiac catheterization
service" means the staff, equipment, physical space, and support services
required to perform cardiac catheterization and percutaneous coronary
interventions. (P) "Certified nurse-midwife" means a registered
nurse who holds a valid license issued under Chapter 4723. of the Revised Code
to practice as a certified nurse-midwife in accordance with section 4723.43 of
the Revised Code and rules adopted by the board of nursing. (Q) "Certified nurse practitioner" means a
registered nurse who holds a valid license issued under Chapter 4723. of the
Revised Code to practice as a certified nurse practitioner in accordance with
section 4723.43 of the Revised Code and rules adopted by the board of
nursing. (R) "Certified registered nurse anesthetist" or
"CRNA" means an RN who meets the qualifications specified in section
4723.41 of the Revised Code and is credentialed and privileged by the provider
of a health care service to administer anesthetics to patients within his or
her scope of practice. (S) "Children's hospital" means either of
the following: (1) A hospital that
provides general pediatric medical and surgical care in which at least
seventy-five per cent of annual inpatient discharges for the preceding two
calendar years were individuals less than eighteen years of age; (2) A distinct portion of
a hospital that provides general pediatric medical and surgical care, has a
total of at least one hundred fifty pediatric special care and pediatric acute
care beds, and in which at least seventy-five per cent of annual inpatient
discharges for the preceding two calendar years were individuals less than
eighteen years of age. (T) "Chiropractor" means a person licensed under
Chapter 4734. of the Revised Code to practice chiropractic care. (U) "Cobalt service" means the structural unit of
a hospital which provides radiation therapy using a cobalt teletherapy
machine. (V) "Cobalt teletherapy machine" means a machine
that provides a collimated beam of gamma rays from a sealed cobalt-60 source
for the purposes of radiation therapy treatment. (W) "Consultation" means an individual is capable
of rendering advice, opinions, recommendations, suggestions, and counsel in
evaluating a patient upon notice by the requesting licensed health care
provider and in accordance with the medical needs of the patient. This may be
done by telemedicine or e-medicine in accordance with accepted professional
standards. (X) "Critical access hospital" means a hospital
that is certified by the federal government as meeting the conditions of
participation in the medicare program under 42 C.F.R. part 485, subpart F
(1993). (Y) "Deceased patient" means a human body or part
of a human body from the condition of which it reasonably may be concluded that
death recently occurred. (Z) "Department" means the Ohio department of
health. (AA) "Director" means the director of health or
his duly authorized representative. (BB) "Direct care services" means any in-person
patient contact where health care or personal care is provided in the
hospital. (CC) "Discharge" means a patient who is formally
released from a hospital, including deaths. Discharge does not include
temporary transfers to other settings. (DD) "Donor human milk" means milk from a
lactating mother or lactating mothers, other than the milk of the mother of the
newborn, that has been screened pursuant to the guidelines issued by the
"Human milk bank association of North America." (EE) "Dose" means energy imparted per unit mass of
absorber at a specific site under certain conditions. (FF) "Feeding preparation area" means a designated
clean area within the newborn care nursery that is specifically for the storage
and preparation of human milk, donor human milk, or commercial infant
formula. (GG) "Electrophysiology study" means a test
performed to assess the heart's electrical system or activity and is used
to diagnose abnormal heartbeats or arrhythmias. For the purpose of this
chapter, the term also includes the implantation of permanent pacemakers and
implantable cardioverter-defibrillator (ICD) devices and other
electrophysiology procedures within the scope of procedures authorized at each
level of a cardiac catheterization service. (HH) "Emergency department" means a distinct
portion of a hospital or a freestanding building that provides care to
individuals with emergency medical conditions. (II) "Fetal death" means death prior to the
complete expulsion or extraction from its mother of a product of conception,
which after such expulsion or extraction, does not breathe or show any other
evidence of life such as beating of the heart, pulsation of the umbilical cord,
or definite movement of voluntary muscles. (JJ) "Final disposition" means the interment,
cremation, removal from the state, donation, or other authorized disposition of
a dead body or a fetal death. (KK) "Freestanding
emergency department" means a facility that provides emergency care and is
structurally separate and distinct from a hospital. (LL) "Full-time equivalent" means at least one
thousand eight hundred twenty hours per calendar year. (MM) "Gamma knife" means a dedicated device for
stereotactic radiosurgery which employs multiple cobalt-60 sealed radiation
sources aimed at a single isocenter. The gamma knife may also be used to
perform stereotactic radiotherapy. (NN) "Gamma knife service" means the structural
unit of a hospital which provides stereotactic radiosurgery or stereotactic
radiotherapy using a gamma knife. (OO) "Guidelines for perinatal care" means the
eighth edition of the "Guidelines for Perinatal Care" issued by the
American academy of pediatrics and the American congress of obstetricians and
gynecologists. (PP) "Gynecologic patient" means a woman with or
suspected of having a disorder related to her reproductive organs. (QQ) "Health care service" or "HCS"
means any of the following: (1) Pediatric intensive
care; (2) Solid organ and bone
marrow transplantation; (3) Stem cell harvesting
and reinfusion; (4) Cardiac
catheterization; (5) Open heart
surgery; (6) Operation of linear
accelerators; (7) Operation of cobalt
radiation therapy units; (8) Operation of gamma
knives. (RR) "Heart hospital" means a hospital primarily
engaged in providing inpatient care to patients requiring specialized cardiac
diagnostic or therapeutic services. (SS) "High-risk allogeneic bone marrow
transplantation" is determined according to the combination of:
hematopoietic cell transplant comorbidity index (HCT-CI), performance status of
recipient, and disease-risk index (DRI) as defined by established criteria.
(TT) "Hospice beds" means the inpatient beds of a
hospice care program as defined in division (A) of section 3712.01 of the
Revised Code. (UU) "Hospital" means an institution or facility
that provides inpatient medical or surgical services for a continuous period
longer than twenty-four hours. "Hospital" includes a children's
hospital. "Hospital" does not include: (1) A hospital operated
by the federal government; (2) An ambulatory
surgical facility or other health care facility licensed as described in
section 3702.30 of the Revised Code; (3) A nursing home or
residential care facility licensed under Chapter 3721. of the Revised
Code; (4) A hospital or
inpatient unit licensed under section 5119.33 of the Revised Code; (5) A residential
facility as defined in section 5119.34 of the Revised Code; (6) A residential
facility as defined in section 5123.19 of the Revised Code; (7) A community addiction
services provider as defined in section 5119.01 of the Revised
Code; (8) A facility providing
services under a contract with the department of developmental disabilities
under section 5123.18 of the Revised Code; (9) A facility operated
by a hospice care program licensed under section 3712.04 of the Revised Code
and that is used exclusively for the care of hospice patients; (10) A facility operated
by a pediatric respite care program licensed under section 3712.041 of the
Revised Code and that is used exclusively for the care of pediatric respite
care patients; (11) The site where a
health care practice is operated, regardless of whether the practice is
organized as an individual or group practice; (12) A clinic providing
ambulatory patient services where patients are not regularly admitted as
inpatients; (13) A facility
registered to provide a pediatric transition care program under section
3712.042 of the Revised Code that is used exclusively for pediatric transition
care patients. (14) An institution for the sick that is
operated exclusively for patients who use spiritual means for healing and for
whom the acceptance of medical care is inconsistent with their religious
beliefs, accredited by a national accrediting organization, exempt from federal
income taxation under section 501 of the Internal Revenue Code of 1986, 26
U.S.C. 1, and providing twenty-four-hour nursing care pursuant to the exemption
from the licensing requirements of Chapter 4723. of the Revised Code described
in division (E) of section 4723.32 of the Revised Code. (VV) "Hospital bed" or "bed" means a bed
in a hospital, with the attendant physical space, fixtures, and equipment for
use in caring primarily for inpatients, including those beds used in caring for
patients who stay for less than twenty-four hours, but the primary use of such
beds is for care of inpatients. (WW) "Human milk" means the milk produced by a
mother to feed her newborn. (XX) "Inpatient" means a patient who is admitted
to the hospital. (YY) "Inpatient surgical operating room" means a
room in a hospital used to perform any operative or manual procedure undertaken
for the diagnosis or treatment of a disease or other disorder. (ZZ) "Ionizing radiation" means gamma rays and
x-rays, alpha and beta particles, high-speed electrons, neutrons, protons, and
other atomic or nuclear particles or rays. (AAA) "Lactation consultant" means an individual
who holds credentials as an "International board certified lactation
consultant." (BBB) "Level classification" means the level
designation of the maternity unit and newborn care nursery that determines the
services that may be provided. (CCC) "Licensed dietitian" means an individual
licensed under Chapter 4759. of the Revised Code to practice as a licensed
dietitian. (DDD) "Licensed practical nurse" means an
individual licensed under Chapter 4723. of the Revised Code to practice nursing
as a licensed practical nurse. (EEE) "Linear accelerator" means a medical linear
accelerator which provides a collimated beam of electrons or electronically
produced x-rays used for radiation therapy treatment. (FFF) "Linear accelerator service" means the
structural unit of a hospital which provides radiation therapy or stereotactic
radiosurgery using a linear accelerator. (GGG) "Long term acute care hospital", or LTACH,
means a hospital that is classified as a long-term care hospital under 42
C.F.R. 412.23(e) (1985), that is engaged primarily in providing medically
necessary specialized acute hospital care for medically complex patients who
are critically ill or have multi-system complications or failures, and that has
an average length of stay of forty-five days or less. (HHH) "Long term acute care hospital bed" means a
bed in a long term acute care hospital. (III) "Low-risk allogeneic bone marrow
transplantation" means fully matched allogeneic sibling donor transplants
without any of the high-risk features listed under paragraph (SS) of this rule.
(JJJ) "Maternity unit" means a distinct portion of
a hospital in which inpatient care is provided to women during all or part of
the maternity cycle. (KKK) "Medical
director" means the physician who is responsible for managing and
directing the provision of medical services at the maternity unit or newborn
care nursery or health care service. (LLL) "Medical/surgical bed" means a hospital bed
in a medical or surgical unit where general medical/surgical services are
provided. (MMM) "Neonate" or "neonatal" means a
newborn up to thirty days old. (NNN) "Neonatal care service" also known as a
"newborn care nursery," means a distinct portion of a hospital in
which inpatient care is provided to infants and may include a distinct portion
of a hospital in which intensive care is provided to infants. (OOO) "Neonatal resuscitation program" means the
neonatal resuscitation program developed by the American heart association and
American academy of pediatrics, or an equivalent program approved by the
director. (PPP) "Number of admissions" means the number of
patients accepted for inpatient service of twenty-four hours or
more. (QQQ) "Nurse" means either a licensed practical
nurse or a registered nurse. (RRR) "Nursing staff" means registered nurses,
licensed practical nurses, and other staff that render care under the direction
or delegation of a registered nurse. (SSS) "Obstetric and newborn care service" means
the staff, equipment, physical space, and support services required to care for
pregnant women, fetuses, women who have recently delivered a child, and
newborns. (TTT) "Obstetric service" means a maternity
unit. (UUU) "Occupational therapist" means a person
licensed to practice occupational therapy pursuant to section 4755.07 of the
Revised Code. (VVV) "On-call" means an individual is capable of
being reached by telephone or other electronic device and able to return to the
unit in accordance with facility policies. (WWW) "On-duty" means in the unit alert and
responsive to patient needs. (XXX) "On-site" means in the building.
(YYY) "On-staff" means a member of the formal
organization of physicians and other health professionals approved by the
governing body with the delegated responsibility to provide for the quality of
all medical care, and other health care as appropriate, provided to
patients. (ZZZ) "Owner" means the legal entity that holds the
hospital license and seeks reimbursement for hospital services from patients
and/or third party payors. A change of owner is evidenced by a change in the
federal tax identification number (FEIN) of such entity. (AAAA) "Outpatient" means a patient who receives
medical treatment and is not admitted to the hospital as an
inpatient. (BBBB) "Outpatient surgical operating room" means a
room in a hospital designed to perform an operative or manual procedure
undertaken for the diagnosis or treatment of a disease or other disorder on
non-inpatients. (CCCC) "Patient" means any individual who receives
care in a hospital. (DDDD) "Patient days of care" means annual total
number of inpatients in a hospital on a daily count at a specific uniform time
of day. (EEEE) "Patient representative" means either a
person acting on behalf of a patient with the consent of the patient or the
patient's legal guardian. (FFFF) "Pediatric intensive care unit" or
"PICU" or "pediatric intensive care service" means a
separate and distinct unit in a hospital where pediatric patients, suffering
from critical illness, receive care. "PICU" does not include a
neonatal intensive care unit. (GGGG) "Pediatric intensive care beds" means beds
located in a separate and distinct pediatric intensive care unit where
pediatric patients suffering from critical illness receive care; (HHHH) "Pediatric intensivist" means a physician who
is board eligible or board certified in pediatric critical care medicine after
training in an ACGME-accredited program and participates in training to meet
ongoing education and certification requirements for pediatric critical care
medicine. (IIII) "Pediatric patient" means any patient less
than twenty-two years of age, unless otherwise specified in this chapter.
(JJJJ) "Percutaneous coronary interventions" or
"PCI," commonly known as coronary angioplasty or simply angioplasty,
is a non-surgical procedure used to treat the stenotic (narrowed) coronary
arteries of the heart found in coronary heart disease. (KKKK) "Percutaneous transluminal coronary
angioplasty" or "PTCA" means the inflation of a balloon-tipped
catheter at the site of a coronary artery stenosis to attempt to enlarge the
diameter of the lumen. (LLLL) "Pharmacist" means an individual registered
under Chapter 4729. of the Revised Code to practice pharmacy. (MMMM) "Physical rehabilitation bed" means a
hospital bed that is staffed and equipped for care of inpatients requiring
intensive, multi-disciplinary physical restorative services. (NNNN) "Physical rehabilitation hospital" means a
hospital engaged primarily in providing specialized care to inpatients with
intensive, multi-disciplinary physical restorative service needs. (OOOO) "Physical therapist" means a person licensed
to practice physical therapy pursuant to section 4755.44 of the Revised
Code. (PPPP) "Physician" means an individual who is
licensed under Chapter 4731. of the Revised Code to practice medicine and
surgery, or osteopathic medicine and surgery. (QQQQ) "Physician assistant" means a individual who
holds a valid certificate to practice issued under Chapter 4730. of the Revised
Code to provide services to patients as a physician assistant under the
supervision, control, and direction of one or more physicians who are
responsible for the physician assistant's performance. (RRRR) "Political subdivision" means a county,
township, municipal corporation, or other body corporate and politic
responsible for governmental activities in a geographic area smaller than that
of the state. (SSSS) "Primary agent" means a person granted
authority to act for a principal under a power of attorney, whether denominated
an agent, attorney in fact, or otherwise. (TTTT) "Proof of accreditation" means the written
proof of compliance with the Conditions of Participation by a CMS-approved
accreditation organization. (UUUU) "Psychiatric care bed" means a hospital bed
that is staffed and equipped for care of inpatients whose primary diagnosis in
mental illness not licensed by the Ohio department of mental health and
addiction services. (VVVV) "Psychiatric hospital" means a hospital
engaged primarily in providing specialized care to inpatients diagnosed with
mental illness licensed by the Ohio department of mental health and addition
services. (WWWW) "Psychologist" means a person licensed to
practice psychology pursuant to Chapter 4732. of the Revised Code. (XXXX) "Psychosocial health" means the combined
influence of psychological factors and the surrounding social environment on an
individual's physical, emotional, and/or mental wellness. (YYYY) "Radiation oncologist" means a physician who:
(1) Has satisfactorily
completed a radiation oncology residency in an accreditation council for
graduate medical education or American osteopathic association approved
program; (2) Is certified in
radiology by the American board of radiology or the American osteopathic board
of radiology and who has had a practice limited to radiation oncology for the
ten year period prior to May 1, 1996; or (3) Is certified in
radiation oncology or therapeutic radiology by the American board of radiology,
the American osteopathic board of radiology, the royal college of physicians
and surgeons of Canada. (ZZZZ) "Radiation therapy" means the use of ionizing
radiation, including external beam radiation therapy (teletherapy), or
intraoperative radiation therapy and radioactive materials for therapeutic
administration as authorized on a radioactive materials license issued by the
director pursuant to Chapter 3701:1-58 of the Administrative Code in the
treatment of human illness. (AAAAA) "Radiation therapy service" means the
structural unit of a hospital which provides radiation therapy. (BBBBB) "Registered dietitian" means a person
registered pursuant to Chapter 4759. of the Revised Code to practice
dietetics. (CCCCC) "Registered nurse" means an individual who is
licensed under section 4723.09 of the Revised Code to practice as a licensed
registered nurse. (DDDDD) "Rural emergency hospital" means an entity
that is certified by the federal government as meeting the conditions of
participation in the medicare program under 42 C.F.R. part 485, subpart E
(2023). (EEEEE) "Serious harm" means an adverse outcome that
results in or is likely to result in any of the following: (1) Death; (2) A significant decline
in physical, mental, or psychosocial health that is not solely due to the
normal progression of a disease or aging process; (3) A loss of limb, or
disfigurement; (4) Avoidable pain that
is excruciating, and more than transient; or (5) Other serious harm
that creates life-threatening complications/conditions. (FFFFF) "Social worker" means an individual licensed
to practice social work under Chapter 4757. of the Revised Code. (GGGGG) "Special care bed" means a hospital bed in
which special medical/surgical services, beyond general medical/surgical care
and including intensive care or coronary care, are provided. (HHHHH) "Special delivery services" means services
provided by a freestanding children's hospital that does not offer typical
obstetric services as a level I obstetric service, level II obstetric service,
or level III obstetric service, but is licensed as a level III or level IV
neonatal care service, and is designed and equipped to provide delivery
services to pregnant women as part of a comprehensive multidisciplinary program
of fetal and neonatal care when it is determined that the fetus, once
delivered, will require immediate highly subspecialty neonatal intensive care
or neonatal surgery typically provided by a level III or level IV neonatal care
service. (IIIII) "Solid organ transplant service" means the
transplantation of heart, lung, liver, kidney, pancreas, small bowel, islet
cells, excluding autologous islet cell transplantation, and any and all
combinations of such transplanted organs. (JJJJJ) "Staff member" or "staff" means the
administrator and individuals providing direct care to patients on a full-time,
part-time, temporary, contract, or voluntary basis. Staff member or staff does
not include volunteers who are family members of a patient. (KKKKK) "State university" has the same meaning as in
section 3345.12 of the Revised Code. (LLLLL) "Stereotactic radiosurgery" means the
closed-skull destruction of a precisely defined intracranial or extracranial
target by beam(s) of ionizing radiation in which the total dose is administered
during a single treatment session. (MMMMM) "Stereotactic radiosurgery service" means the
structural unit of a hospital which provides stereotactic radiosurgery.
(NNNNN) "Stereotactic radiotherapy" means the
closed-skull destruction of a precisely defined intracranial target by beam(s)
of ionizing radiation in which the total dose of radiation is administered as
fractions during multiple treatment sessions. (OOOOO) "Stillbirth" means that an infant of at least
twenty weeks of gestation suffered a fetal death. (PPPPP) "Temporary license" means a license issued by
the director of health to a new hospital applying for licensure under Chapter
3722. of the Revised Code, authorizing the new hospital to see patients for
accreditation or certification purposes as part of the completion of the final
licensing process.
Last updated September 16, 2024 at 8:35 AM
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Rule 3701-22-02 | Applicability of rules.
Effective:
September 14, 2024
Until September 30, 2024, each hospital will comply
with the following: (A) With a maternity unit, newborn care
nursery, or both, complies with Chapter 3701-7 of the Administrative
Code; (B) With a pediatric intensive care unit
complies with the applicable requirements of Chapter 3701-84 of the
Administrative Code; (C) With a solid organ and bone marrow
transplantation service complies with the applicable requirements of Chapter
3701-84 of the Administrative Code; (D) With a stem cell harvesting and
reinfusion complies with the applicable requirements of Chapter 3701-84 of the
Administrative Code; (E) With a cardiac catheterization
service complies with the applicable requirements of Chapter 3701-84 of the
Administrative Code; (F) With a open heart surgery service
complies with the applicable requirements of Chapter 3701-84 of the
Administrative Code; (G) That operates linear accelerators
complies with the applicable requirements of Chapter 3701-84 of the
Administrative Code; (H) With a cobalt radiation therapy unit
complies with the applicable requirements of Chapter 3701-84 of the
Administrative Code; (I) That operates gamma knives complies
with the applicable requirements of Chapter 3701-84 of the Administrative
Code;
Last updated September 16, 2024 at 8:35 AM
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Rule 3701-22-03 | Application for initial, renewal, or transfer licensure; notice to the director; sales, assignments, or transfers.
Effective:
September 14, 2024
(A) Application for a license to operate
a hospital, renewal of an existing license may be made either in writing on a
form provided by the director and signed by the applicant or the
applicant's primary agent, or using an electronic system prescribed by the
director and affirmed by the applicant or the applicant's agent. A
completed application includes the following: (1) A nonrefundable
license application or renewal fee based on the number of beds within the
hospital as follows: (a) One to fifty beds, four thousand four hundred
twenty-five dollars; (b) Fifty-one to one hundred beds, eight thousand eight
hundred fifty dollars; (c) One hundred one to one hundred fifty beds, thirteen
thousand two hundred fifty dollars; (d) One hundred fifty-one to three hundred beds, seventeen
thousand six hundred seventy-five dollars; (e) Three hundred one to five hundred beds, twenty-six
thousand five hundred dollars; (f) Five hundred one to seven hundred fifty beds,
thirty-five thousand three hundred fifty dollars, (g) Seven hundred fifty-one to one thousand beds, forty
four thousand one hundred seventy-five dollars; (h) One thousand one to one thousand five hundred beds,
fifty-three thousand dollars; or (i) More than one thousand five hundred beds, sixty-one
thousand eight hundred fifty dollars; Any fee paid pursuant to this section may be
paid either in full at the time of application, renewal, or transfer, or in
increments of one-third of the total amount annually. (2) A nonrefundable
service fee in the form of a check or money order made payable to the
"treasurer, state of Ohio" or as payment submitted through an
electronic system prescribed by the director as follows: (a) For each maternity unit, three thousand
dollars; (b) For each newborn care nursery, three thousand dollars;
and (c) For each health care service, three thousand
dollars; Any fee paid pursuant to this section may be
paid either in full at the time of application, renewal, or transfer, or in
increments of one-third of the total amount annually. (3) The name to appear on the
license; (4) The address of the main hospital
location and an attestation signed by the hospital administrator as defined in
paragraph (A) of rule 3701-22-01 of the Administrative Code, that includes the
address(es) of each "department of a provider," remote location of a
hospital," "satellite facility," and "provider based
location" as those terms are defined in 42 CFR 413.65. (a) Locations listed pursuant to this section are operated
under the license issued under Chapter 3722. to the hospital that is the
"main provider" as that term is defined in 42 CFR 413.65. Only those
locations are permitted to be operated under the main hospital's license;
and (b) Hospitals are to maintain a current list of all
provider-based locations and notify the director within thirty days of the
removal or addition of a provider based location. Failure to provide notice to
the director may result in compliance actions set forth in rule 3701-22-05 of
the Administrative Code. (5) A copy of the proof of certification
or accreditation, if applicable. For a newly-constructed hospital seeking
licensure after October 1, 2024, a copy of the hospital's proof of
temporary accreditation. (6) A listing of the beds within the
hospital, under the following categories: (a) Adult medical/surgical; (b) Adult special care (ICU/CCU); (c) Alcohol or drug abuse rehabilitation; (d) Burn care; (e) Hospice; (f) Long term acute care; (g) Long term, reported in the following
categories: (i) Skilled nursing
facility beds certified under Title XVIII of the Social Security Act, 49 Stat.
620 (1935), 42 U.S.C. 301, as amended (1981) and which are not licensed under
Chapter 3721. of the Revised Code; (ii) Nursing facility
beds certified under Title XIX of the Social Security Act, 49 Stat. 620 (1935),
42 U.S.C. 301, as amended (1981) and which are not licensed under Chapter 3721.
of the Revised Code; (iii) Nursing facility
beds certified under Title XVIII of the Social Security Act, 49 Stat. 620
(1935), 42 U.S.C. 301, as amended (1981) and Title XIX of the Social Security
Act, 49 Stat. 620 (1935), 42 U.S.C. 301, as amended (1981) and which are not
licensed under Chapter 3721. of the Revised Code; or (iv) Special skilled
nursing beds certified as skilled nursing facility beds under Title XVIII of
the Social Security Act, 49 Stat. 620 (1935), 42 U.S.C. 301, as amended (1981)
that were originally authorized by and are operated in accordance with section
3702.521 of the Revised Code or its predecessor; (h) Neonatal, reported in the following
categories: (i) Level I; (ii) Level
II; (iii) Level
III; (iv) Level
IV; (i) Obstetric, reported in the following
categories: (i) Level I; (ii) Level
II; (iii) Level III,
including special delivery beds; (iv) Level IV, including
special delivery beds; (j) Pediatric intensive care (beds in a separate and
distinct pediatric intensive care unit where pediatric patients suffering from
critical illness receive care); (k) Pediatric - general (services for patients less than
twenty-two years of age are provided); (l) Physical rehabilitation; (m) Psychiatric care (beds not licensed by the Ohio
department of mental health and addiction services); and (n) Emergency service. (B) If the applicant satisfies the
requirements described in paragraph (A) of this rule, the director will, as
applicable, issue to the applicant a license to operate a hospital, or renew an
applicant's license unless the applicant to renew is barred from renewing
in accordance with rule 3701-22-05 of the Administrative Code. (C) The license is valid only for the
hospital and any department(s) of a provider, remote location(s) of the
hospital, satellite facility(ies), and provider based locations. (D) If a hospital licensed under this
chapter is to be assigned, sold, or transferred to a new owner, the prospective
new owner will, at least thirty days prior to the effective date of the
assignment, sale, or transfer, apply, on an application provided by the
director, for a change of owner and provide the information required by
paragraphs (A)(3) to (A)(6) of this rule. (1) Once the license
transfer is approved, the new owner will be responsible for compliance with any
action taken or proposed by the director under sections 3722.07 or 3722.08 of
the Revised Code, or rule 3701-22-05 of the Administrative Code. If a notice
has been issued under section 119.07 of the Revised Code, the new owner becomes
party to the notice. (E) The license holder will post a copy of the license in a
conspicuous place in the main hospital and all locations listed pursuant to
paragraph (A)(4) of this rule. (F) Each license issued under this rule is valid for a
three-year period unless revoked or suspended. A license expires on the date
that is three years from the date of issuance and may be renewed for additional
three-year periods. (G) The license renewal fee, including fees paid as
one-third increments annually, specified in paragraph (A) of this rule will be
paid not later than ninety days after the director of health mails an invoice
for the fee to the license holder. A penalty of ten per cent of the amount of
the renewal fee will be assessed for each month the fee is
overdue. (H) Application for a temporary license to operate a new
hospital after October 1, 2024 may be made either in writing on a form provided
by the director and signed by the applicant or the applicant's agent, or
using an electronic system prescribed by the director and affirmed by the
applicant or the applicant's agent. A completed application for a
temporary licensure will include the following: (1) The information
required under paragraphs (A)(3) to (A)(6) of this rule; (2) A copy of the
applicant's occupancy permit; and (3) A copy of the current
state fire marshal inspection report documenting that the applicant is in
compliance with the state fire code. (I) If an applicant satisfies the requirements described in
paragraph (H) of this rule, the director will issue to the applicant a
temporary license to allow the applicant to operate as a hospital for up to six
months for the purposes of completing a certification or accreditation process.
Once the applicant receives proof of certification or accreditation, the
applicant will apply for full licensure under paragraph (A) of this
rule. (1) The applicant may
apply for one extension of a temporary license for up to an additional six
months; (2) If an applicant fails
to apply to the department for full licensure by the date of expiration of a
temporary license to operate as a hospital, the applicant will cease operating
as a hospital. (J) The licensee will notify the director, in
writing: (1) Within seven days of
a change in administrator or name of the hospital. (2) Seven days prior to
the voluntary suspension of operation or closing of the hospital. In the event
of involuntary closure, the licensee will provide written notice as soon as
possible after learning of the closure. (3) Ninety days prior to
any change to the owner of the entity holding the license. For purposes of this
section, such change is not a change of ownership. (K) Except in the event of emergencies, the licensee will
notify the director, in writing, at least fifteen days prior to any
construction, modernization, major acquisition, or significant alteration
that: (1) Will result in an
interruption of patient care services in any department(s) of a provider,
remote location(s) of the hospital, or satellite facility(ies). (2) Adds a department(s)
of a provider, remote location(s) of the hospital, or satellite
facility(ies). (3) Adds hospital building(s), replaces
hospital building(s), or expands hospital building(s) patient care
areas; (4) Changes the layout of a patient care
area of the hospital that involves removing or replacing walls, adding new or
extending existing plumbing or electric service, adding new or extending
existing heating, ventilation, or air conditioning service; or adding vacuum or
gases; or (5) Converts non-patient care area(s) to
patient care area(s) that involves removing or replacing walls, adding new or
extending existing plumbing or electric service, adding new or extending
existing heating, ventilation, or air conditioning service; or adding vacuum or
gases. Emergencies resulting in an interruption of
hospital services are to be reported as soon as possible, no later than within
twenty-four hours, to the director by phone or electronic mail. For purposes of
this rule, emergency means an unexpected serious event restricting patient
access to hospital services or represents the potential for harm to patients.
This may include events involving emergency evacuations, fire suppression,
disaster response, law enforcement, and other forms of hazard control and
mitigation of an ongoing event. (L) Failure to provide notice to the director required by
paragraph (K) of this rule may result in compliance actions set forth in rule
3701-22-05 of the Administrative Code. (M) The director may inspect a hospital prior to issuing or
denying a license to operate a hospital, or when renewing a license. An
applicant may avoid this inspection if the applicant submits with the
application a copy of the hospital's most recent final on-site survey
report from the federal centers for medicare and medicaid services or an
accrediting organization approved under 42 U.S.C. 1395bb(a) demonstrating that
the hospital is certified or accredited.
Last updated September 16, 2024 at 8:35 AM
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Rule 3701-22-04 | Prohibitions.
Effective:
September 14, 2024
(A) Upon licensure or temporary licensure
as a hospital by the director of health or September 30, 2024, whichever is
sooner, no person and no political subdivision, agency, or instrumentality of
this state may operate a hospital without holding a license or a temporary
license issued by the director of health under section 3722.03 of the Revised
Code. (B) If the director of health determines that a hospital is
operating without a license or temporary license in violation of Chapter 3722.
of the Revised Code or this chapter, the director may do any of the
following: (1) Notify the hospital that it is operating without a
license or a temporary license and provide it with an opportunity to apply for
licensure, but only within the thirty-day period beginning on the date the
hospital received the director's notice; (2) Direct the hospital to cease operations; (3) Impose a civil penalty of not more than two hundred
fifty thousand dollars; (4) In addition to the imposition of a civil money penalty,
impose a penalty of not less than one thousand dollars and not more than ten
thousand dollars for each day the hospital operates without a license or
temporary license. (C) If the hospital described in paragraph (B) of this rule
continues to operate without a license or a temporary license, the director may
petition the court of common pleas of the county in which the hospital is
located for an order enjoining the hospital from operating. (D) No person and no political subdivision, agency, or
instrumentality of this state may: (1) Interfere with an inspection or investigation of a
hospital, maternity unit, or health care service. As used in this paragraph,
"interfere" means to obstruct directly or indirectly any individual
conducting an authorized inspection or investigation from carrying out his or
her duties, including: (a) Harassment; (b) Intimidation; (c) Refusal to permit the
director upon presentation of official department identification, to inspect or
investigate the operation of a hospital, maternity unit, or health care
service; or (d) Refusal to permit the
director upon presentation of official department identification to enter and
inspect records that are kept concerning the operations of the hospital,
maternity unit, or health care service, for information necessary to determine
compliance with the applicable rules of this chapter. (2) Materially misrepresent any information provided to the
director pursuant to Chapter 3722. of the Revised Code and this
chapter. (E) Nothing in this chapter is to be construed as
authorizing individuals to provide services outside their licensed scope of
practice.
Last updated September 16, 2024 at 8:35 AM
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Rule 3701-22-05 | Inspections; compliance actions.
Effective:
September 14, 2024
(A) The director of health monitors
compliance with Chapter 3722. of the Revised Code and Chapter 3701-22 of the
Administrative Code. The director may at any time inspect a licensed hospital
in order to address an incident that may impact public health, respond to a
complaint submitted to the director, or otherwise ensure the safety of patients
cared for by the hospital. Inspections may be scheduled and announced or random
and unannounced. (B) If the director determines the existence of a violation
of any provision of Chapter 3722. of the Revised Code or Chapter 3701-59 of the
Administrative Code, the director may do any of the following: (1) Request the licensee
to submit an acceptable plan of correction to the director stating the actions
being taken or to be taken to correct a violation, the time frame for
completion and the means by which continuing compliance will be monitored;
and (2) In accordance with
Chapter 119. of the Revised Code: (a) Impose a civil penalty based on the severity of the
violation as follows: (i) For violations that
present an imminent threat of serious physical or life threatening danger, or
an immediate serious threat to the health, safety or security of one or more
patients, a civil penalty of not less than one hundred thousand dollars and not
more than two hundred thousand dollars, not including per day civil penalties
for ongoing violations; (ii) For violations that
directly threaten the health, safety, or security of one or more patients, a
civil penalty of not less than ten thousand dollars and not more than one
hundred thousand dollars, not including per day civil penalties for ongoing
violations; or (iii) For violations that
indirectly threaten or potentially threaten the health, safety, or security of
one or more patients, a civil penalty of not less than one thousand dollars and
not more than ten thousand dollars, not including per day civil penalties for
ongoing violations; In addition to the civil monetary penalties
set forth in this rule, the director may impose a civil penalty of one thousand
dollars per day for each day the director determines a violation is
ongoing. (b) Suspend a health care service or revoke the
hospital's license, in accordance with paragraph (D)(3) of this rule, if
the director believes that there is clear and convincing evidence that the
continued operation of the hospital, maternity unit, newborn care nursery, or
health care service unit present a danger of immediate and serious harm to
patients or residents. The director will provide the hospital with written
notice of the proposed action to the hospital that specifies the: (i) Nature of the
conditions giving rise to the director's judgment; (ii) Measures that the
director determines the hospital needs to take to respond to the
conditions; (iii) Date, which will be
not later than thirty days after the notice is delivered, on which the director
intends to suspend the health care service or revoke the hospital's
license if the conditions are not corrected and the director determines that
the license holder has not come into substantial compliance; (C) In determining whether a violation
warrants a civil money penalty, the director may consider all of the
following: (1) The danger of serious physical or life-threatening harm
to one or more patients or residents, including a determination whether the
harm presents an: (a) Imminent threat of
serious physical or life threatening danger, or an immediate serious threat to
the emotional health, safety, or security one or more patients; (b) Direct threat to the
physical or emotional health, safety, or security of one or more patients;
or (c) Indirect threat or
potential threat to the physical or emotional health, safety, or security of
one or more patients; (2) The number of patients directly
affected by the violation; (3) The number of hospital staff involved
in the violation; (4) Any actions taken by the hospital to
correct or mitigate the violation, including the timeliness and sufficiency of
the hospital's response to the violation and the outcome of that response;
and (5) The hospital's history of
compliance. (D) If the director determines the need
for a civil money penalty under this rule, the director may enter into
settlement negotiations with the affected hospital. Settlements may include any
or all of the following: (1) A lesser civil money
penalty than initially proposed; (2) Allowing the hospital
to invest an amount equal to the proposed civil penalty on remedial measures
designed to reduce the likelihood of similar violations occurring in the
future. Unless authorized by the director, such remedial measures are to be
conducted or undertaken by a third party; or (3) Alternative remedies
warranted by the deficient practice and negotiations. (E) If the director suspends a health
care service or revokes the license of a hospital under paragraph (B)(2)(b) of
this rule, the director will issue a written order of suspension or a
revocation, as applicable, and cause it to be delivered by certified mail or in
person in accordance with section 119.07 of the Revised Code. The order is not
subject to suspension by the court while an appeal filed under section 119.12
of the Revised Code is pending. If the license holder subject to the suspension
or revocation requests an adjudication, the date set for the adjudication will
be within seven days after the license holder makes the request, unless another
date is agreed to by both the license holder and the director. The suspension
of the health care service or revocation of a hospital's license will
remain in effect, unless reversed by the director, until a final adjudication
order issued by the director pursuant to this chapter and Chapter 119. of the
Revised Code becomes effective. The director will issue a final adjudication
order not later than fourteen days after completion of the adjudication. If the
director does not issue a final order within the fourteen-day period, the
suspension or revocation is void, but any final adjudication order issued
subsequent to the fourteen-day period is not affected. (F) During the period specified in
paragraph (B)(2)(b)(iii) of this rule, the hospital may, without staying the
proceedings, notify the director that the conditions giving rise to the
director's determination have been corrected and that the hospital is in
substantial compliance with Chapter 3722. of the Revised Code and this chapter,
the director shall conduct an inspection. Based on this inspection, if the
director determines that the conditions have not been corrected and the license
holder has not come into substantial compliance, the director may suspend the
health care service or revoke the license. (G) If the licensed hospital fails to
notify the director, within the period of time specified in paragraph
(B)(2)(b)(iii) of this rule, that the conditions giving rise to the
director's determination have been corrected and that the hospital is in
substantial compliance with this chapter and shall not be affected, the
director may suspend the health care service or revoke the
license. (H) If the director issues a final
adjudication order suspending a health care service or suspending or revoking a
license issued under this chapter and the license holder continues to operate a
hospital, the director may ask the attorney general to apply to the court of
common pleas of the county in which the hospital is located for an order
enjoining the license holder from operating the hospital.
Last updated September 16, 2024 at 8:35 AM
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Rule 3701-22-06 | Administration.
Effective:
September 14, 2024
Each hospital, other than a critical access
hospital or a rural emergency hospital, is to provide effective administration
responsible for the following areas: (A) Compliance with federal, state, and
local laws, in accordance with 42 CFR 482.11, including cooperation with any
public health investigation; (B) Governing body, in accordance with 42
CFR 482.12; (C) Patient's rights, in accordance
with 42 CFR 482.13; (D) Emergency preparedness, in accordance
with 42 CFR 482.15.
Last updated June 25, 2025 at 6:23 PM
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Rule 3701-22-07 | Basic hospital functions.
Effective:
September 14, 2024
Each hospital, other than a critical access
hospital or a rural emergency hospital, is to provide for the following: (A) A quality assessment and performance
improvement program, in accordance with 42 CFR 482.21. In addition, the
hospital will participate in quality assessment and performance improvement
projects identified by the director in consultation with the representatives of
the regulated industry. Such projects may include those: (1) Required by the
United States centers for medicare and medicaid services or the hospital's
accrediting organization; or (2) For a hospital with a
maternity unit and newborn care nursery, implementation of one or more maternal
safety bundle(s) developed by the alliance for innovation in maternal
health. (B) Medical staff, in accordance with 42
CFR 482.22; (C) Nursing services, in accordance with
42 CFR 482.23; (D) Medical records services, in
accordance with 42 CFR 482.24; (E) Pharmaceutical services, in
accordance with 42 CFR 482.25; (F) Radiologic services, in accordance
with 42 CFR 482.26; (G) Laboratory services, in accordance
with 42 CFR 482.27; (H) Food and dietetic services, in
accordance with 42 CFR 482.28; (I) Utilization review, in accordance
with 42 CFR 482.30; (J) Physical environment, in accordance
with 42 CFR 482.41; (K) Infection prevention and control and
antibiotic stewardship programs, in accordance with 42 CFR 482.42. In addition,
the hospital will: (1) Maintain a
tuberculosis control plan that meets the standards set forth in rule 3701-15-03
of the Administrative Code; (2) Implement a written
surveillance plan outlining the activities for monitoring/tracking infections
based on nationally-recognized surveillance criteria such as the CDC's
national healthcare safety network (NHSN) criteria to define infections or
other nationally recognized system for hospitals and: (a) Includes a surveillance system that includes a data
collection tool; and (b) Uses surveillance data to implement timely corrective
actions when: (i) A greater than
expected number healthcare-associated infections are detected; (ii) Transmission of
targeted multi-drug resistant organisms (e.g., cre, candida auris) are
detected; (3) Establish and implement an effective
water management program to identify hazardous conditions, and take steps to
manage the risk of occurrence and transmission of waterborne pathogens,
including but not limited to legionella, in building water systems in
accordance with guidance from the United States centers for disease control and
prevention (available at
https://www.cdc.gov/control-legionella/php/toolkit/wmp-toolkit.html) and
recommendations of the United States centers for disease control and prevention
healthcare infection control practices advisory committee, "Environmental
Infection Control Guidelines" (2019) or its successors. (a) Within the first twelve months, two sets of validation
testing in the building water system of each building that provides inpatient
medical or surgical services, taken no fewer than four months apart and more
than eight months apart, is to occur. Each set of water samples will be
representative of all hot potable water loops and water sources based upon the
risk assessment and conditions identified in the water management program,
including but not limited to cooling towers, therapy spas, decorative fountains
or water features where exposure to aerosols may occur in order to evaluate the
performance of the water management program in controlling legionella risk or
other waterborne pathogens. A hospital that has demonstrated detections of less
than one cfu/ml of legionella through at least two prior validation test sets
collected over a one year period may conduct annual validation testing in lieu
of twice-yearly testing. Validation testing includes all of the
following: (i) At least one cold
water sample obtained from the incoming water mains from the public water
system or the water source; (ii) At minimum,
representative samples obtained from distal and proximal locations on each hot
water loop on the hot water distribution system; and (iii) Measurement of
total or free chlorine residual, as appropriate, at the time of sample
collection, and the observed sustained maximum temperatures for cold and hot
water samples. (b) Collection of water samples under this paragraph will
conform to the United States centers for disease control and prevention's
guidelines for water testing for legionella available at
https://www.cdc.gov/control-legionella/php/toolkit/routine-testing-module.html
and
https://www.cdc.gov/investigate-legionella/media/pdfs/cdc-sampling-procedure.pdf.
Samples collected may be less than one liter in volume. Collected samples are
to be analyzed at a laboratory that has been accredited by a national or
international accrediting body according to national or international
recognized standards, that has legionella culture testing included in the
laboratory's scope of accreditation. (4) As it relates to waterborne
pathogens, coordinate with the Ohio department of health and the local health
district having jurisdiction when there is a legionellosis presumptive
healthcare-associated case, there are two or more legionellosis possible
healthcare-associated cases in a twelve-month period, or when a legionellosis
outbreak occurs. When an investigation is required, investigation activities
are coordinated with the disease surveillance and recommendations in the Ohio
department of health's "Infectious Disease Control Manual,"
available online at
https://odh.ohio.gov/know-our-programs/infectious-disease-control-manual, the
CDC guidance on defining healthcare-associated cases available at
https://www.cdc.gov/investigate-legionella/php/healthcare-resources/healthcare-facilities.html,
and CDC guidance on conducting investigations available at
https://www.cdc.gov/investigate-legionella/php/healthcare-resources/testing-collecting-specimens.html,
and includes any or all of the following: (a) Implementing water use restrictions and/or installation
of absolute 0.2 micron biological United States food and drug
administration-approved point of use filters on potable hot water fixtures
throughout the facility as appropriate or where separate water loops are
present and can be isolated within the facility, in locations where the
legionellosis case or cases resided, or received treatment or services while in
the facility, or otherwise may have been exposed to aerosols from the hot water
system or other water features. A hospital with a continuous secondary
disinfection system that has demonstrated detections of less than one cfu/ml of
legionella through validation testing and control measures specified in the
water management plan, may, after consultation of the Ohio department of health
and the local health district having jurisdiction, avoid installation of point
of use water filters; (b) Conducting or updating an environmental facility
assessment using the United States centers for disease control and
prevention's "Legionella Environmental Assessment Form,"
available online at
https://www.cdc.gov/legionella/downloads/legionella-environmental-assessment-p.pdf,
or equivalent assessment, for the facility to identify risk conditions that may
promote the growth of Legionella or other waterborne pathogens; (c) Providing a copy of the water management program and at
least one year of prior validation testing results to the Ohio department of
health and the health district having jurisdiction; (d) Identification and collection of a set of water samples
that is representative of all potable water loops and water sources associated
with the investigation, including but not limited to cooling towers, therapy
spas, decorative fountains or water features where exposure to aerosols may
occur. Water sample testing includes: (i) At least one cold
water sample will be obtained from the incoming water mains from the public
water system or the water source; (ii) Representative
samples obtained from a minimum of distal and proximal locations on each floor
of each hot water loop on the hot water distribution system, including hot
water storage tanks or storage units when present, both a swab or first draw
sample, and a bulk water sample from the fixture or location; (iii) A sample or samples
from locations in the hot water system or water features where the
legionellosis case or cases resided, or received treatment or services while in
the facility, or otherwise may have been exposed to aerosols from the hot water
system or other water features; (iv) Measurement of total
and free chlorine residual, as appropriate, at the time of sample collection,
and the observed sustained maximum temperatures for cold and hot water samples.
(v) Preservation and
provision of all cultured water and swab samples with observed Legionella
cultures that were collected during an investigation of a case or outbreak to
the Ohio department of health's public health laboratory for potential
comparison against clinically cultured samples. (e) Collection of water samples under this paragraph will
conform to the United States centers for disease control and prevention's
"Sampling Procedure and Potential Sampling Sites for Investigation"
available at
https://www.cdc.gov/legionella/downloads/cdc-sampling-procedure.pdf, to include
collection of one liter samples, and "CDC Laboratory Guidance for
Processing Environmental Samples" (2005), respectively, with collected
samples to be analyzed at a laboratory that has been accredited by a national
or international accrediting body according to national or international
recognized standards, that has legionella culture testing included in the
laboratory's scope of accreditation, and that has demonstrated proficiency
in the detection of legionella culture in accordance with the United States
centers for disease control and prevention environmental legionella isolation
techniques evaluation program. (f) Implementation of identified actions to correct the
risk conditions identified as part of the environmental facility assessment,
and environmental water testing results, which may include but not be limited
to: (i) Adjustments to hot
water temperatures in storage tanks or circulation systems; (ii) Correction of areas
of poor water flow or stagnation; (iii) Conducting
short-term remediation; or (iv) Installing permanent
disinfection systems; (g) Provision of appropriate communications to patients,
employees, and visitors regarding the investigative and corrective actions to
help reduce risk of further exposures; (h) After remediation actions are completed, or permanent
disinfection is installed, collection of the same sample locations and types as
set forth in paragraph (K)(4)(d) of this rule as follows: (i) The first sample set,
no earlier than forty-eight hours after remediation actions have ceased;
and (ii) For the second and
subsequent sample sets, no earlier than ten days having elapsed since the last
sample collection date; All sample results collected under this
paragraph are to be reported to both the Ohio department of health and the
local health district having jurisdiction. (i) Obtaining the concurrence of the Ohio department of
health and the local health district having jurisdiction, before lifting of
water restrictions or removal of point of use water filters from fixtures when
all water or swab samples have legionella detections of less than one colony
forming unit per milliliter for potable water (j) Flushing of all hot water distribution systems and
fixtures after water restrictions are lifted and/or point of use water filters
are removed; and (k) An investigation conducted under this paragraph
includes revising the hospital's water management program based on the
full investigations results and the recommendations of the Ohio department of
health and the local health district. (L) Discharge planning, in accordance
with 42 CFR 482.43; and (M) Organ, tissue, and eye procurement,
in accordance with 42 CFR 482.45.
Last updated September 16, 2024 at 8:36 AM
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Rule 3701-22-08 | Optional hospital functions.
Effective:
September 14, 2024
Each hospital, other than a critical access
hospital or rural emergency hospital may provide for any or all the
following: (A) Surgical services, in accordance with
42 CFR 482.51; (B) Anesthesia services, in accordance
with 42 CFR 482.52; (C) Nuclear medicine services, in
accordance with 42 CFR 482.53; (D) Outpatient services, in accordance
with 42 CFR 482.54; (E) Emergency services, in accordance
with 42 CFR 482.55; (F) Rehabilitation services, in
accordance with 42 CFR 482.56; (G) Respiratory services, in accordance
with 42 CFR 482.57; or (H) Special requirements for hospital
providers of long-term care services ("swing-beds"), in accordance
with 42 CFR 482.58.
Last updated June 25, 2025 at 7:15 PM
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Rule 3701-22-09 | Critical access hospitals.
Effective:
September 14, 2024
Each critical access hospital is to comply with 42
CFR 485 subpart F. In addition, each critical access hospital will: (A) Participate in quality assessment and
performance improvement projects identified by the director in consultation
with the representatives of the regulated industry. Such projects may include
those required by the United States centers for medicare and medicaid services
or the hospital's accrediting organization. (B) Meet the infection control and
waterborne pathogen provisions sets forth in paragraphs (K)(1) to (K)(5) of
rule 3701-22-07 of the Administrative Code. (C) Cooperate with any public health
investigation.
Last updated June 25, 2025 at 6:23 PM
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Rule 3701-22-10 | Rural emergency hospitals.
Effective:
September 14, 2024
Each rural emergency hospital is to comply with 42
CFR 485 subpart E. In addition, each rural emergency hospital will: (A) Submit: (1) A complete
application for a license to operate a rural emergency hospital or renewal of
an existing license may be made either in writing on a form provided by the
director and signed by the applicant or the applicant's agent, or using an
electronic system prescribed by the director and affirmed by the applicant or
the applicant's agent. A complete application includes: (a) The name to appear on the license; (b) The address of the main hospital location and an
attestation signed by the hospital administrator as defined in paragraph (B) of
rule 3701-22-01 of the Administrative Code, that includes the
following: (i) The address(es) of
each "provider based location" as those terms are defined in 42 CFR
413.65; (ii) Locations listed
pursuant to this section are operated under the license issued under Chapter
3722. of the Revised Code to the hospital that is the "main provider"
as that term is defined in 42 CFR 413.65. Only those locations are permitted to
be operated under the main hospital's license; and (iii) Rural emergency
hospitals are to maintain a current list of all provider-based locations and
notify the director within thirty days of the removal or addition of a provider
based location. Failure to provide notice to the director may result in
compliance actions set forth in rule 3701-22-05 of the Administrative
Code. (2) A nonrefundable
license application or renewal fee in the form of a check or money order for
three thousand dollars made payable to the "treasurer, state of Ohio"
or as payment submitted through an electronic system prescribed by the
director. The fee paid pursuant to this section may be paid either in full at
the time of application, renewal, or transfer, or in increments of one-third of
the total amount annually; and (3) Documents as
prescribed on the application for a license to operate a rural emergency
hospital, including, but not limited to, an attestation signed by the
administrator, that the facility will follow the process for conversion to a
rural emergency hospital as prescribed by CMS and comply with the conditions of
participation set forth in 42 CFR 485 subpart E during the conversion
process. (B) Participate in quality assessment and performance
improvement projects identified by the director in consultation with the
representatives of the regulated industry. Such projects may include those
required by the United States centers for medicare and medicaid services or the
hospital's accrediting organization. (C) Meet the infection control and waterborne pathogen
provisions sets forth in paragraphs (K)(1) to (K)(5) of rule 3701-22-07 of the
Administrative Code. (D) Cooperate with any public health
investigation. (E) If the applicant satisfies the
requirements set forth in paragraph (A) of this rule, the director will, as
appropriate, issue to the applicant a license to operate a rural emergency
hospital or renew an applicant's license unless the applicant is barred
from renewal for failure to comply with the applicable requirements to operate
as a rural emergency hospital.
Last updated September 16, 2024 at 8:36 AM
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Rule 3701-22-11 | Quality assurance and patient health and safety.
Effective:
September 14, 2024
The director will work with representatives of the
regulated industry to determine reporting requirements that help to assure
quality and patient health and safety within the hospital. Reporting
requirements for quality and patient health and safety are subject to any state
or federal privacy laws or regulations.
Last updated September 16, 2024 at 8:36 AM
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Rule 3701-22-12 | Annual report.
Effective:
September 14, 2024
(A) Until September 30, 2024, each
hospital is obligated to continue reporting information annually to the
director in accordance with chapter 3701-59 of the Administrative
Code. (B) The Ohio department of health will
work with the regulated industry to determine what, if any, new annual
reporting requirements for hospitals to report to the department after
September 30, 2024.
Last updated September 16, 2024 at 8:37 AM
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Rule 3701-22-13 | Data collection.
Effective:
September 14, 2024
After consultation with representatives of the
regulated industry, the director may require hospitals to submit data in areas
including performance, quality, or other agreed upon areas. (A) Any information reported under this section that
reveals the identity or that could be used to lead to the identity of any
individual is considered protected health information in accordance with
section 3701.17 of the Revised Code. Information that does not identify nor
lead to the identity of an individual may be released in summary, statistical
or aggregate form. (B) A third-party organization may report as described in
this division on behalf of the hospital.
Last updated September 16, 2024 at 8:37 AM
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Rule 3701-22-14 | Hospital Zones.
Effective:
September 14, 2024
The director may establish regional hospital zones
to respond to public health events, outbreaks of disease, or similar incidents,
as well as ongoing public health considerations resulting from those events.
Such zones may include health care providers, including but not limited to,
hospitals, nursing homes, residential care facilities, home health agencies,
and hospice care programs.
Last updated September 16, 2024 at 8:37 AM
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Rule 3701-22-19 | Variances; waivers.
Effective:
September 14, 2024
(A) The director may grant a variance or
waiver from any requirement established by Chapter 3701- 22 of the
Administrative Code, unless the requirement is mandated by
statute. (B) Written requests by a hospital
seeking a variance or waiver should include the following
information: (1) The specific nature
of the request and the rationale for the request; (2) The specific building
or safety requirement in question, with a reference to the relevant
administrative code provision; (3) The time period for
which the variance or waiver is requested; (4) If the request is for
a variance, a statement of how the hospital will meet the intent of the
requirement in an alternative manner; and (5) If the request is for
a waiver, a statement regarding why application of the requirement will cause
undue hardship to the hospital and why granting the waiver will not jeopardize
the health and safety of any patient. (C) Upon written request of the hospital the director
may: (1) Request additional
information from the hospital seeking a variance or waiver; (2) Grant a variance if
the director determines that the requirement has been met in an alternative
manner; or (3) Grant a waiver if the director
determines that the strict application of the license requirement would cause
an undue hardship to the hospital and that granting the waiver would not
jeopardize the health and safety of any patient. (D) The director may stipulate a time period for which a
variance or a waiver is to be effective and may establish conditions that the
hospital must meet for the variance or waiver to be operative. Such time period
may be different than the time period sought by the hospital in the written
variance or waiver request. (E) The director may establish conditions that the hospital
must meet for the variance or waiver to be operative. The director may, in the
director's discretion, rescind the waiver or variance at any time upon
determining that the hospital is not meeting such conditions. (F) The refusal of the director to grant a variance or
waiver, in whole or in part, shall be final and shall not be construed as
creating any rights to a hearing under Chapter 119. of the Revised
Code. (G) The granting of a variance or waiver by the director
does not constitute a precedent for the granting of any other variance or
waiver. All variance and waiver requests will be considered on a case-by-case
basis.
Last updated September 16, 2024 at 8:37 AM
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Rule 3701-22-20 | Maternity unit and newborn care nursery general facilities and equipment requirements.
Effective:
August 31, 2025
(A) This rule is not to be construed to
require any maternity unit licensed on or before March 20, 1997, to alter,
upgrade, or otherwise improve the structure or fixtures of the maternity unit
in order to comply with the requirements of this rule, unless one of the
following applies: (1) The maternity unit
initiates or has, after March 20, 1997, initiated a construction, renovation,
or a reconstruction project that involves a capital expenditure of at least
five hundred thousand dollars, not including expenditures for equipment or
staffing or operational costs, and that directly involves the area in which the
existing maternity unit is located; (2) The maternity unit
initiates or has, after March 20, 1997, initiated a service level designation
change under rule 3701-07-01 of the Administrative Code as it existed prior to
the effective date of this rule, or prior versions of Chapter 3701-84 of the
Administrative Code; (3) On or after the
effective date of this rule, the maternity unit or newborn care nursery
initiates a change of the unit's level classification for which it is
licensed; or (4) The director
determines or has determined, by clear and convincing evidence, that failure to
comply would create an imminent risk to the health and welfare of any
patient. (B) Each maternity unit or newborn care
nursery will ensure that the building or structure where the maternity unit or
newborn care nursery is located: (1) Has a certificate of
use from a local, certified building department or from the Ohio department of
commerce as meeting applicable requirements of Chapters 3781. and 3791. of the
Revised Code and the rules adopted thereunder; (2) Complies with the
state fire code; and (3) Complies with the
applicable provisions of Chapter 3737. of the Revised Code and the rules
adopted under it. (C) The maternity unit or newborn care
nursery will develop and follow a disaster preparedness plan including
evacuation in the event of a fire. Evacuation procedures will be reviewed at
least annually, and practice drills will be conducted quarterly on each
shift. (D) The maternity unit or newborn care
nursery will develop and follow policies for ensuring the safety and security
of all patients, including infant hospital-wide security drills for locating
missing newborns. The policies will be reviewed at least annually, and practice
infant security drills will be conducted hospital-wide on each shift at least
once every six months. (E) Each maternity unit or newborn care
nursery will label, store and dispose all poisons, hazardous wastes and
flammable materials in a safe manner that does not jeopardize patient or
resident health or safety, and in accordance with state and federal laws and
regulations. (F) Minimum space or square footage
requirements specified in this chapter are of clear floor space and exclusive
of fixed or wall mounted cabinets, desks, wardrobes, and closets that are floor
based. (G) Each maternity unit constructed on
or after January 1, 2012, that utilizes separate antepartum areas will provide
space for the provision of services and provide: (1) Single occupancy
rooms with a minimum of one hundred twenty square feet of open floor space.
Each room will provide space for the mother and a support person; (2) A private toilet and
shower or tub for each room; and (3) Two medical gas,
medical air, and vacuum outlets available in each room. (H) Each maternity unit's
labor-delivery-recovery or labor-delivery-recovery-postpartum area will provide
space for the provision of services and the following: (1) Single occupancy
rooms with a minimum of two hundred fifty square feet of open floor space and a
minimum room width or length of thirteen feet. Each room will provide space for
the mother, newborn and a support person; (2) A private toilet and
shower or tub for each room; (3) A distinct area
within the room for newborn resuscitation and stabilization. The distinct area
will be equipped with one medical gas, medical air, and vacuum outlet available
to each mother and one medical gas, medical air, and vacuum outlet available to
each newborn; (4) A minimum of six
total air changes per hour with the ability to provide fifteen air changes per
hour during the performance of a cesarean delivery where that room is
designated as such. Maternity units constructed on or after January 1, 2012,
will provide a minimum of six total air changes per hour with the ability to
provide twenty air changes per hour during the performance of a cesarean
delivery where that room is designated as such; and (5) Immediately
accessible examination lights. (I) Each maternity unit that utilizes
separate labor rooms will provide space for the provision of services and
provide: (1) Maternity units
constructed on or after January 1, 2012, will provide a minimum area of two
hundred square feet per bed; (2) One medical gas, one
medical air and one vacuum outlet accessible to each mother's bed;
and (3) A minimum of two
total air changes per hour with the ability to provide twenty air changes per
hour during the performance of a cesarean delivery where that room is
designated as such. Maternity units constructed on or after January 1, 2012,
will provide a minimum of six total air changes per hour with the ability to
provide twenty air changes per hour during the performance of a cesarean
delivery where that room is designated as such. (J) Each maternity unit that utilizes
separate recovery rooms will provide space for the provision of services and
shall provide: (1) A minimum of two
recovery room beds; (2) Space for the
newborn, mother and support person; and (3) A minimum of six
total air changes per hour per recovery room. (K) Each maternity unit that utilizes
separate postpartum areas will provide space for the provision of services and
provide: (1) A minimum of one
hundred square feet of clear floor space per bed in semiprivate rooms and one
hundred and twenty square feet of clear floor space in private rooms.
Postpartum rooms existing on or before March 20,1997 will provide at least
eighty square feet of clear space per bed in semiprivate rooms and one hundred
square feet in private rooms; and (2) Patient access to a
bathroom with toilet and shower or tub, without entering the main corridor.
Bathrooms in postpartum rooms existing before January 1, 2012, may serve no
more than two postpartum beds. Postpartum rooms constructed on or after January
1, 2012, will have one bathroom with toilet and shower or tub for each patient
in that room. (L) Each maternity unit will provide at
least one cesarean delivery room in every obstetrical area. Each cesarean
delivery room will provide space for services and provide: (1) Cesarean delivery
rooms with a minimum of three hundred and sixty square feet of open floor space
and a minimum room width or length of sixteen feet. Any additional delivery
rooms without cesarean delivery capability will have a minimum open floor area
of three hundred square feet; (2) Space for newborn
resuscitation that meets one of the following: (a) A minimum of an additional forty square feet of open
floor space within the cesarean delivery room. Cesarean delivery rooms
constructed on or after January 1, 2012, will provide a minimum of an
additional eighty square feet of open floor space within the cesarean delivery
room; or (b) An area of one hundred and fifty square feet in a
separate room immediately accessible to the cesarean delivery room;
and (3) A minimum of fifteen
air changes per hour per cesarean delivery room. Cesarean delivery rooms
constructed on or after January 1, 2012, will provide a minimum of twenty air
changes per hour. (M) Each maternity unit will provide the
necessary equipment and supplies for the complete care of the newborn in the
location where the physiologic transition period occurs. Equipment will
include: (1) Heat source
equipment; (2) Oxygen, suction, and
air outlets; (3) Oxygen blender
available for delivery; (4) Resuscitation
equipment; (5) Equipment necessary
for physiologic monitoring; and (6) Transport
conveyance. (N) Each maternity unit will provide at
least one airborne infection isolation room in or near at least one nursery.
The room will be enclosed and separated from the nursery with the ability to
observe the infant from adjacent nurseries or control area and will be
consistent with current infection control guidelines, issued by the United
States centers for disease control and prevention. (O) The maternity unit will provide
separate areas as necessary to support the services provided
including: (1) The consultation, or
demonstration of breast feeding or breast pumping; and (2) Family
waiting. (P) Each newborn nursery room will
provide a floor area of twenty-four square feet for each newborn station with a
minimum of two feet between newborn stations. Maternity units providing care to
newborns requiring close observation will conform to the requirements for the
level designation of that neonatal care service and, at a minimum, provide a
floor area of fifty square feet with a distance of four feet between and at all
sides of newborn stations. Maternity units constructed on or after January 1,
2012, that provide care to newborns requiring close observation will conform to
the requirements for the level designation and classification of that newborn
service and provide a minimum of one hundred twenty square feet of open floor
space for each newborn station with additional space based on the acuity level
of the newborn. (Q) Each newborn nursery room or newborn
care nursery will conform to the requirements for the level designation of that
neonatal care service and provide space for procedures, equipment, and staff
functions and provide: (1) Medical gas, medical
air, and vacuum outlets accessible to each newborn; (2) Every door in each
newborn nursery room that exits to the main corridor is capable of being
locked; (3) At least one sink,
capable of hands free operation, for each eight newborn stations; (4) Observation windows
to permit the viewing of newborns from public areas, workrooms and adjacent
nursery rooms; (5) A system for storage
and distribution of emergency drugs and routine medications; (6) A minimum of six
total air changes per hour in all newborn nursery rooms or newborn care units;
and (7) Lighting capable of
varying from indirect to high intensity. (R) Maternity units may replace newborn
nursery rooms with baby holding nurseries in postpartum and
labor-delivery-recovery-postpartum areas. The holding nursery will meet the
requirements of paragraphs (P) and (Q) of this rule. (S) In addition to the requirements of
paragraphs (N) and (P) of this rule, each maternity unit or newborn care
nursery licensed as a level II, level III, or level IV neonatal care service
will provide: (1) A group patient or
open bay area with a clearly identified entrance large enough to accommodate
portable x-ray equipment, and a reception area for families. The reception area
will permit visual observation and contact by the staff of all individuals
entering the unit. A hand washing area will be provided at each family entrance
to the newborn care area; (2) At least one door to
each nursery room that is large enough to accommodate portable x-ray
equipment; (3) A system to provide
efficient and controlled access to the nursery from the labor and delivery
area, the emergency room, and other referral entry points as may be
applicable; (4) Work areas, in
addition to newborn care space; (5) Newborn care
nurseries constructed prior to January 1, 2012 will provide: (a) A minimum of one hundred square feet of open floor
space for each newborn station. Additional space is obligated to be provided
based on acuity level of the newborn; and (b) An aisle adjacent to each newborn station with a
minimum width of three feet to accommodate movement through the nursery without
disturbing newborn care. (6) Newborn care
nurseries constructed on or after January 1, 2012 will provide: (a) A minimum of one hundred twenty square feet of open
floor space for each newborn station with additional space based on the acuity
level of the newborn; and (b) An aisle adjacent to each newborn station with a
minimum width of four feet to accommodate movement through the nursery without
disturbing newborn care. (7) Newborn care
nurseries constructed prior to January 1, 2012 will provide a minimum of three
medical gas, three medical air, three vacuum outlets, and seven duplex-grounded
electrical receptacles organized in an accessible and safe manner for each
newborn station, with fifty per cent of electrical outlets connected to the
emergency system power and be so labeled. (8) Newborn care
nurseries constructed on or after January 1, 2012 will provide a minimum of
three medical gas, three medical air, three vacuum outlets, and sixteen single
or duplex-grounded electrical receptacles organized in an accessible and safe
manner for each newborn station, with fifty per cent of electrical outlets
connected to the emergency system power and be so labeled; (9) A respiratory therapy
work area and storage area within the newborn care area or in close
proximity; (10) A transition room
that allows parents and the infant extended private time together in close
proximity to the nursery. The room will have a sink and toilet fixtures, a bed
for parents, sufficient space for an infant bed and equipment, communication
linkage with newborn intensive care nursery staff, and electric, air, vacuum,
and medical gas outlets. The transition room may be used for other purposes
when not required for use by parents and infant or infants; and (11) Newborn care
nurseries that utilize single patient private or semi-private rooms within the
nursery will meet the requirements of paragraphs (S)(5) and (S)(6) of this
rule. (T) Equipment and technology required
under this rule may be replaced by newer technology and equipment with
equivalent or superior capability. In assessing new equipment and technology,
consideration will be given to the recommendations of recognized professional
societies and accrediting bodies. (U) Each maternity unit or newborn care
nursery will provide hands-free hand washing fixtures in all areas for staff
use where patient care is provided. (V) Each maternity unit or newborn care
nursery will provide a system of communication that interconnects all areas in
which patient care is provided and that effectively alerts staff members of
emergencies or patient needs. Each toilet, or shower, or both, used by patients
will have an emergency communications system capable of alerting staff of
emergencies or patient needs. (W) Each maternity unit or newborn care
nursery will provide appropriate safety features including handrails, emergency
power, and electrical outlets for the services provided.
Last updated September 2, 2025 at 8:35 AM
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Rule 3701-22-21 | Level I service standards.
Effective:
August 31, 2025
(A) Obstetric license. A level I
obstetric service will provide antepartum, intrapartum and postpartum care for
obstetrical patients, including: (1) Low-risk patients,
such as patients with: (a) Term deliveries; (b) Singleton deliveries; and (c) Deliveries with vertex presentation; (2) Selected
uncomplicated patients with higher-risk conditions, such as patients
with: (a) Term twin gestation; (b) Trial of labor after cesarean delivery; (c) Uncomplicated cesarean delivery; or (d) Preeclampsia with severe features at term: A level I
obstetrical service may provide care to patients with preeclampsia with severe
features at term in the service if the service has appropriate staff,
equipment, and training to care for both the mother and the
neonate; (3) The management of
unanticipated complications of labor and delivery; and (4) The management of
emergencies. (B) Obstetric transfers. A level I
obstetric service will transfer to a level II, level III, or level IV obstetric
service, as appropriate, any pregnant woman for intrapartum care: (1) With a complicated
condition beyond those designated by the service; or (2) At less than
thirty-five weeks of her pregnancy. Exception: A level I obstetric service may
provide care where an emergency medical condition exists as defined by the
Emergency Medical Treatment and Labor Act, 42 U.S.C. 1395dd (2012), and
evidenced by the following: (a) The mother is having contractions; and (b) In the clinical judgment of a qualified obstetrical
practitioner working under that practitioner's scope of
practice: (i) There is inadequate
time to effect a safe transfer of the mother to an appropriate higher level
hospital before delivery; or (ii) The transfer will
pose a threat to the health or safety of either the mother or the
fetus. (C) When considering a woman's
condition and the likelihood of pregnancy-related complications, paragraphs (A)
and (B) of this rule do not preclude the admission of: (1) A less than
thirty-five weeks gestation pregnant woman to the maternity unit for care or
services for a non-obstetrical issue, but that may require monitoring of the
health of the mother, the fetus, or both; (2) Women with
uncomplicated and complicated conditions for antepartum care where labor is not
imminent; (3) Non-infectious
gynecologic patients; or (4) Non-infectious female
surgical patients in accordance with policies and procedures approved by the
service's director. (D) Neonatal license. A level I neonatal
care service will provide care to newborns, including: (1) All low-risk
newborns; (2) Newborns with
selected complicated conditions as identified by the service, such as newborns
who are: (a) Moderately ill with problems that are expected to
resolve rapidly and are not anticipated to need specialty or subspecialty
services on an urgent basis; and (b) Convalescing that can be appropriately transferred from
another service provider; and (3) Newborns requiring
emergency resuscitation or stabilization for transport. (E) Newborn transfers. When a level I
obstetrical service cannot timely transfer a pregnant woman pursuant to
paragraph (B)(2) of this rule, the level I neonatal care service will transfer
a newborn that is less than thirty-five weeks gestation to a neonatal care
service or freestanding children's hospital licensed to provide the needed
care, unless all of the following conditions are met: (1) The level I neonatal
care service has identified a neonatal transport program to facilitate the
transport of the newborn to a higher level neonatal facility; (2) The level I neonatal care service has
in place a valid memorandum of agreement with one or more neonatal care
services licensed to provide the needed care, providing for consultation on the
retention of the infant between the level I neonatal care service attending
physician and a neonatologist on the staff of the neonatal care service
licensed to provide the needed care; (3) The consultation with, and the
concurrence of, the neonatologist on the staff of the neonatal care service
licensed to provide the needed care is documented by the level I neonatal care
service in the patient medical record and as otherwise may be determined by the
service. Such documentation will be made available to the director upon
request; and (4) The risks and benefits to the newborn
for both retention at the level I neonatal care service and transfer of the
newborn to a neonatal care service licensed to provide the needed care, are
discussed with the parent, parents, or legal guardian of the newborn and
appropriately documented. Such documentation will be made available to the
director upon request. (F) Informed consent. When discussing
transfer of a pregnant woman or a newborn to another facility in accordance
with this rule, the transferring service will document and provide the patient
or patient's legal guardian with: (1) The recommendations
from any consultations with a higher-level service; (2) The risks and
benefits associated with the patient's transfer or retention;
and (3) Any other information
required by the hospital's policies and procedures. (G) In the event the patient or
patient's legal guardian refuses transfer to a recommended hospital, the
service will document the refusal of transfer and provide treatment to the
patient or patients in accordance with hospital policies and procedures. The
service will update the patient or patient's legal guardian as the
patient's condition warrants. (H) Written service plan. Each provider
will, using licensed health care professionals acting within their scopes of
practice, develop a written service plan for the care and services to be
provided by the service. The written service plan will be based on the
"Guidelines for perinatal care" or other applicable professional
standard and address, at minimum: (1) The selected
uncomplicated conditions for which care will be provided based on
the: (a) Patient population; (b) Acuity of patients; (c) Volume of patients; and (d) Competency of staff. (2) Criteria for
determining those conditions that can be routinely managed by the
service; (3) Admission to the
service; (4) Discharge from the
service; (5) Patient care in
accordance with accepted professional standards; (6) Referrals for
obtaining public health, dietetic, genetic, and toxicology services not
available in-house; (7) Minimum competency
requirements for staff in accordance with recognized national standards and
ensure that all staff are competent to perform services based on education,
experience and demonstrated ability; (8) Administration of
blood and blood products; (9) Provision of
phototherapy; (10) Provision of
respiratory therapy; (11) Unit-based surgeries
and surgical suite-based surgeries; (12) Post-mortem
care; (13) A formal education
program for staff, including, at minimum: (a) A nursing orientation that incorporates didactic
education, simulation, skills verification, and competency and is tailored to
the individual needs of each nurse based on clinical experience; (b) The neonatal resuscitation program. The service will
ensure all labor and delivery registered nurses and any other practitioner
likely to attend to a neonate at a high risk delivery receive training in the
neonatal resuscitation program; and (c) A post resuscitation program. The service will ensure
individuals caring for newborns receive training in a post resuscitation
program to include, at minimum: (i) The identification
and treatment of signs and symptoms related to hypoglycemia, hypothermia, and
pneumothorax; (ii) Blood pressure
(normal ranges, factors that can impair cardiac output); (iii) Lab work, including
perinatal and postnatal risk factors and clinical signs of sepsis; (iv) Emotional support to
parents with sick infants; and (v) Quality improvement
to identify problems and the importance of debriefing to evaluate care in the
post-resuscitation period; and (d) Ongoing continuing education that
includes: (i) An annual educational
needs assessment to determine the educational needs of the clinical nursing
staff and ancillary team members; (ii) Annual nursing
education that addresses the annual needs assessment and incorporates
simulation and skills verification of the types of care provided in the
obstetric and neonatal care service and includes education related to serious
safety events; and (iii) Nursing staff
participation in annual simulation and skills verification of the types of care
provided in the obstetric and neonatal care services. (14) Provision of care by
direct care staff to individuals in other areas of the hospital, including, but
not limited to the emergency department and the intensive care
unit; (15) Risk assessment of
obstetric and newborn patients to ensure identification of appropriate
consultation requirements for or referral of high-risk patients; (16) A formal process for
the on-site provision of services or the referral of patients to follow-up
services, as appropriate, for the following: (a) Developmental screening; (b) Ophthalmology; (c) Audiology; (d) Child life specialist; (e) Lactation education and support; (f) Neonatal therapists to address the six core practice
domains of environment, family or psychosocial health support, sensory system,
neurobehavioral system, neuromotor and musculoskeletal systems, and oral
feeding and swallowing by providers with neonatal experience,
including: (i) Physical
therapy; (ii) Occupational
therapy; and (iii) Speech
therapy. (17) Education for
mothers regarding personal care and nutrition, newborn care and nutrition, and
newborn feeding; (18) Infection control,
consistent with current infection control guidelines issued by the United
States centers for disease control and prevention; (19) Consultation for and
referral of both obstetric and neonatal transports; (20) Criteria for the
acceptance of both obstetric and neonatal transports from other services, which
may include the reverse transport of newborns who otherwise do not meet the
level I gestational age restriction, based on demonstrated capability to
provide the appropriate services; and (21) Developmental
follow-up of at-risk newborns in the service or referral of such newborns to
appropriate programs. (I) Each provider will, in accordance
with accepted professional standards, develop and follow written policies and
procedures to implement the written service plan required by paragraph (H) of
this rule. (J) Each provider will have the ability
to perform all of the following: (1) An emergency cesarean
delivery in accordance with facility policy, but no later than thirty minutes
from the time that the decision is made to perform the procedure; (2) Fetal monitoring;
and (3) Resuscitation and
stabilization of newborns and emergency care for the mother and newborn in each
delivery room. (K) Support services (on-site). Each
provider will have the staff and support services to meet the needs of patients
and have the following staff and services on-site on a twenty-four hour
basis: (1) Clinical laboratory
capable of providing any necessary testing; and (2) Blood, blood products
and substitutes. (L) Support services (on-call). Each
provider will have the following services on-site on a twenty-four hour basis,
with staff necessary to provide the services on-call: (1) Diagnostic x-ray
capable of providing portable x-ray services; (2) Portable ultrasound
visualization equipment for diagnosis and evaluation; (3) Pharmacy;
and (4) Anesthesia, except
that when a patient or patients are receiving a labor epidural, an
anesthesiologist or certified registered nurse anesthetist acting within their
scope of practice and under the supervision of a physician, will remain in
attendance with a patient until it is determined the patient is stable, but for
at least thirty minutes. After it is determined the patient is stable, an
anesthesiologist or certified registered nurse anesthetist may be on-call, but
is obligated to remain available to return in accordance with facility policy,
but no longer than thirty minutes. (M) Unit management. Each provider will
have qualified individuals on-staff appropriate for the services provided
including: (1) Co-directors of the
obstetric and neonatal care service responsible for the overall operation of
the respective care service; (a) One co-director will be a board certified obstetrician
or board certified family physician with experience in obstetrics;
and (b) One co-director will be a board certified pediatrician
or a board certified family physician with experience in
pediatrics. (2) Nurse leader: A
single, designated registered nurse with a bachelor's degree in nursing
(Individuals employed in this position prior to October 1, 2019, who remain in
this position do not need to comply with the degree requirement) with
demonstrated expertise in obstetric care, responsible for leading the
organization and supervision of nursing services in the obstetric and newborn
care services to: (a) Coordinate with respective newborn care, pediatric, and
obstetric care services, as appropriate; (b) Provide oversight of annual obstetric and newborn care
specific education; (c) Collaborate with multidisciplinary team members,
facility leadership, and higher-level facilities to create a diverse,
equitable, and inclusive environment focused on the quality of care and patient
care outcomes; and (d) If the nurse leader is involved with providing care to
the neonatal patient, the nurse leader must be current on neonatal
resuscitation. (N) For every anticipated low risk
delivery or uncomplicated delivery with higher-risk condition, each provider
will have an: (1) Obstetrician,
physician, or certified nurse midwife acting within their scope of practice and
under a standard care arrangement with a collaborating physician, in
attendance; and (2) Individual who has
successfully completed the neonatal resuscitation program and who can initiate
and complete full resuscitation on-site. This requirement may be met by a team
of individuals who have successfully completed the neonatal resuscitation
program, one of whom can initiate resuscitation, and one of whom can complete
full resuscitation. (O) For every anticipated high-risk
delivery as that term is used in paragraph (A)(3) of rule 3701-22-22 of the
Administrative Code, each provider will have in attendance: (1) An obstetrician or
physician; (2) A second physician, a
certified nurse practitioner acting within their scope of practice and under a
standard care arrangement with a collaborating physician, or a physician
assistant acting within their scope of practice and under a supervisory
agreement with a physician, to care for the neonate; and (3) An individual who has
successfully completed the neonatal resuscitation program and who can initiate
and complete full resuscitation. This requirement may be met by a team of
individuals who have successfully completed the neonatal resuscitation program,
one of whom can initiate resuscitation, and one of whom can complete full
resuscitation. For an unanticipated delivery of a high-risk
delivery, every attempt shall be made to secure a second physician, a certified
nurse practitioner acting within their scope of practice and under a standard
care arrangement with a collaborating physician, or a physician assistant
acting within their scope of practice and under a supervisory agreement with a
physician, to care for the neonate. (P) Each provider will have qualified
staff on-duty appropriate for the services provided including, at
minimum: (1) Registered nurse
staffing to include: (a) At least two registered nurses competent in obstetric
and neonatal care for labor and delivery; (b) A registered nurse with obstetric and neonatal
experience for each patient in the second stage of labor; (c) A registered nurse to circulate for the cesarean birth
deliveries; (d) Additional registered nurses with the appropriate
education and demonstrated competence, commensurate with the acuity and volume
of patients served, to provide direct supervision of obstetric patients;
and (e) Additional registered nurses with the appropriate
education and demonstrated competence, commensurate with the acuity and volume
of patients served, to provide direct supervision of newborns; and (2) At least one member
of the nursing staff to attend to newborns when they are not with the mother or
her designee. (Q) Other disciplines. Each provider will
have the following practitioners on-staff: (1) A licensed social
worker with knowledge of obstetric and neonatal psychosocial and family support
services; (2) A licensed dietitian;
and (3) Personnel with the
knowledge and skills to support lactation including: (a) A certified lactation consultant, as defined in rule
3701-22-01 of the Administrative Code, available for on-site consultation on
weekdays and certified lactation consultant services will be accessible by
telehealth or telephone twenty-four hours a day, seven days a week. After-hours
and weekend consultation can be provided by free services available to
healthcare providers and their patients through other avenues such as a
hotline. Individuals employed in this position on the effective date of these
rules who do not meet the qualifications of this rule shall have five years
from the effective date of this rule to come into compliance with the
certification requirement; (b) Lactation support may be provided under the direction
of the certified lactation consultant by lactation counselor/educator staff or
registered nurse staff educated and trained on how to provide lactation support
to the mother and neonate; and (c) The provider will ensure that lactation support staff
maintain continuing education and certification requirements, as applicable,
and ensure adequately trained lactation coverage is available based on the
specific need and volume of the neonatal population served. (R) If the provider utilizes licensed
practical nurses (LPNs) or nonlicensed direct care providers to support the
clinical nursing staff, the facility will: (1) Have written criteria
that define the LPN's or nonlicensed direct care provider's scope of
obstetric or neonatal care; (2) Provide annual
education specific to the care of the obstetric and neonatal population served;
and (3) Have a written
staffing plan that establishes collaborative work assignments in accordance
with the facility's policies and procedures. (S) If the provider utilizes physician
assistants (PA): (1) Physician supervision
for the PA will be provided by a neonatologist or a board-certified
pediatrician with special interest and experience in neonatal
medicine; (2) The PA will have
appropriate education and demonstrated competence, commensurate with the acuity
and volume of patients served, to provide direct supervision of newborns;
(3) The PA is responsible for maintaining
clinical expertise and knowledge of current therapy by participating in
continuing medical education and scholarly activities; (4) The PA will maintain national
certification, including one hundred hours of continuing medical education
every two years and a recertification exam given by the "National
Commission on Certification of Physician Assistants" every ten years;
and (5) The level I service will maintain
written criteria that define the PA's scope of obstetric or neonatal
care.
Last updated September 2, 2025 at 8:36 AM
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Rule 3701-22-22 | Level II service standards.
Effective:
August 31, 2025
(A) Obstetric license. A level II
obstetrical service will provide antepartum, intrapartum and postpartum care
for obstetrical patients, including: (1) All low-risk
patients; (2) All uncomplicated
patients with higher-risk conditions; (3) Selected high-risk
patients as identified by the service, such as patients with: (a) Severe preeclampsia; or (b) Placenta previa with prior uterine surgery in which a
placenta accreta has been ruled out by ultrasound or magnetic resonance
imaging; (4) The management of
unanticipated complications of labor and delivery; and (5) The management of
emergencies. (B) Obstetric transfer. A level II
obstetric service will transfer to a level III or level IV obstetric service,
as appropriate, any pregnant woman for intrapartum care: (1) With a high-risk
condition beyond those designated by the service; or (2) At less than
thirty-two weeks gestation or with a fetus expected to weigh less than one
thousand five hundred grams. Exception: A level II obstetric service may
provide care where an emergency medical condition exists as defined by the
Emergency Medical Treatment and Labor Act, 42 U.S.C. 1395dd (2012), and is
evidenced by the following: (a) The mother is having contractions; and (b) When, in the clinical judgment of a qualified obstetric
practitioner working under that practitioner's scope of
practice: (i) There is inadequate
time to effect a safe transfer of the mother to an appropriate higher level
hospital before delivery; or (ii) The transfer will
pose a threat to the health or safety of either the mother or the
fetus. (C) When considering a woman's
condition and the likelihood of pregnancy-related complications, paragraphs (A)
and (B) of this rule do not preclude the admission of: (1) A less than thirty
two weeks gestation pregnant woman to the maternity unit for care or services
for a non-obstetrical issue, but that may require monitoring of the health of
the mother, the fetus, or both; (2) Women with
uncomplicated, complicated, and high-risk conditions for antepartum care where
labor is not imminent; (3) Non-infectious
gynecologic patients; or (4) Non-infectious female
surgical patients in accordance with policies and procedures approved by the
service's director. (D) Neonatal license. A level II neonatal
care service will provide intermediate and routine care to newborns, including
to: (1) All low-risk
newborns; (2) All uncomplicated
newborns; (3) Newborns with
selected complicated conditions as identified by the service, such as
newborns: (a) With physiologic immaturity such as apnea of
prematurity; (b) With an inability to maintain body
temperature; (c) With an inability to take oral feedings; (d) Who are moderately ill with problems that are expected
to resolve rapidly and are not anticipated to need sub-specialty services on an
urgent basis; and (e) Who are convalescing from intensive care. (4) Newborns requiring
mechanical ventilation for brief durations of less than twenty-four hours or
continuous positive airway pressure, except the twenty-four hour period may be
extended if the newborn is stable and improving, and the newborn does not
require numerous interventions for time periods nearing twenty-four hours over
the course of days; and (5) Newborns requiring
emergency resuscitation or stabilization for transport. (E) Newborn transfer. When a level II
obstetric service cannot effect a timely transfer of a pregnant woman pursuant
to paragraph (B)(2) of this rule, the level II neonatal care service will
transfer a newborn that is less than thirty-two weeks gestation or weighs less
than one thousand five hundred grams to a neonatal care service licensed to
provide the needed care unless all of the following conditions are
met: (1) The level II neonatal
care service has identified a neonatal transport program to facilitate the
transport of the newborn to a higher level neonatal facility; (2) The level II neonatal
care service has in place, a valid memorandum of agreement with one or more
neonatal care services licensed to provide the needed care, providing for
consultation on the retention of the infant between the level II neonatal care
service attending physician and a neonatologist on the staff of that neonatal
care service licensed to provide the needed care; (3) The consultation
with, and the concurrence of, the neonatologist on the staff of the neonatal
care service licensed to provide the needed care is documented by the level II
neonatal care service in the patient medical record and as otherwise may be
determined by the service. Such documentation will be made available to the
director upon request; and (4) The risks and
benefits to the newborn for both retention at the level II neonatal care
service and transfer of the newborn to a neonatal care service licensed to
provide the needed care are discussed with the parent, parents, or legal
guardian of the newborn and appropriately documented. Such documentation will
be made available to the director upon request. (F) Informed consent. When discussing
transfer of a pregnant woman or a newborn to another facility in accordance
with this rule, the transferring service will document and provide the patient
or patient's legal guardian with: (1) The recommendations
from any consultations with a higher-level service; (2) The risks and
benefits associated with the patient's transfer or retention;
and (3) Any other information
required by the hospital's policies and procedures. (G) In the event the patient or
patient's legal guardian refuses transfer to a recommended hospital, the
service will document the refusal of transfer and provide treatment to the
patient or patients in accordance with hospital policies and procedures. The
service will update the patient or patient's legal guardian as the
patient's condition warrants. (H) Written service plan. Each provider
will, using licensed health care professionals acting within their scopes of
practice, develop a written service plan for the care and services to be
provided by the service. The written service plan will be based on the
"Guidelines for perinatal care" or other applicable professional
standard and address, at minimum: (1) The selected
high-risk conditions for which care will be provided based on the: (a) Patient population; (b) Acuity of patients; (c) Volume of patients; and (d) Competency of staff; (2) Criteria for
determining those conditions that can be routinely managed by the
service; (3) Admission to the
service; (4) Discharge from the
service; (5) Patient care in
accordance with accepted professional standards; (6) Referrals for
obtaining public health, dietetic, genetic, and toxicology services not
available in-house; (7) Minimum competency
requirements for staff in accordance with recognized national standards and
ensure that all staff are competent to perform services based on education,
experience and demonstrated ability; (8) Administration of
blood and blood products; (9) Provision of
phototherapy; (10) Provision of
respiratory therapy; (11) Unit-based surgeries
and surgical suite-based surgeries; (12) Post-mortem
care; (13) A formal education
program for staff, including, at minimum: (a) A nursing orientation that incorporates didactic
education, simulation, skills verification, and competency and is tailored to
the individual needs of each nurse based on clinical experience; (b) Ensures all labor and delivery registered nurses and
any other practitioner likely to attend to a neonate at a high risk delivery
receive training in the neonatal resuscitation program; (c) A post resuscitation program that ensures that all
individuals caring for newborns receive training in a post resuscitation
program to include, at minimum: (i) The identification
and treatment of signs and symptoms related to hypoglycemia, hypothermia, and
pneumothorax; (ii) Blood pressure
(normal ranges, factors that can impair cardiac output); (iii) Lab work, including
perinatal and postnatal risks factors and clinical signs of
sepsis; (iv) Principles of
assisted ventilation, continuous positive airway pressure, positive pressure
ventilation, assisting and securing endo-tracheal tube insertion, and chest
x-rays; (v) Emotional support to
parents with sick infants; and (vi) Quality improvement
to identify problems and the importance of debriefing to evaluate care in the
post-resuscitation period. (d) Ongoing continuing education that
includes: (i) An annual educational
needs assessment to determine the educational needs of the clinical nursing
staff and ancillary team members; (ii) Annual nursing
education that addresses the annual needs assessment and incorporates
simulation and skills verification of low-volume, high-risk procedures
consistent with the types of care provided in the obstetric and neonatal care
services and includes education related to serious safety events;
and (iii) Nursing staff
participation in annual simulation and skills verification, including
low-volume, high-risk procedures consistent with the types of care provided in
the obstetric and neonatal care services. (14) Provision of care by
direct care staff to individuals in other areas of the hospital, including, but
not limited to the emergency department and the intensive care
unit; (15) Risk assessment of
obstetric and neonatal patients to ensure identification of appropriate
consultation requirements for referral of high-risk patients; (16) A formal process for
the on-site provision of services or the referral of patients to follow-up
services, as appropriate, for the following: (a) Developmental screening; (b) Ophthalmology; (c) Audiology; (d) Child life specialist; (e) Lactation clinical care, education, and
support; (f) Neonatal therapists to address the six core practice
domains of environment, family or psychosocial health support, sensory system,
neurobehavioral system, neuromotor and musculoskeletal systems, and oral
feeding and swallowing by providers with neonatal experience,
including: (i) Physical
therapy; (ii) Occupational
therapy; and (iii) Speech
therapy. (17) Education for
mothers regarding personal care and nutrition, newborn care and nutrition, and
newborn feeding; (18) Infection control,
consistent with current infection control guidelines issued by the United
States centers for disease control and prevention; (19) Consultation for or
referral of both obstetric and neonatal transports; (20) Criteria for the
acceptance of both obstetric and neonatal transports from other services, which
may include the reverse transport of newborns who otherwise do not meet the
level II gestational age and weight restrictions, based on demonstrated
capability to provide the appropriate services; (21) Consultation for
maternal-fetal medicine on a twenty-four hour basis; (22) Developmental
follow-up of at-risk newborns in the service or referral of such newborns to
appropriate programs; and (23) If the facility back
transfers infants for convalescent care, the facility must have a process in
place to appropriately identify infants at risk for retinopathy of prematurity
to guarantee timely examination and treatment by having: (a) Documented policies and procedures for the monitoring,
treatment, and follow-up of retinopathy of prematurity; and (b) The ability to perform, either on-site or by
arrangement and referral, retinal examinations, or off-site interpretation of
digital photographic retinal images, by a pediatric ophthalmologist or retinal
specialist with expertise in retinopathy of prematurity, if
needed. (I) Each provider will, in accordance
with accepted professional standards, develop and follow written policies and
procedures to implement the written service plan required by paragraph (H) of
this rule. (J) Each provider will have the ability
to perform all of the following: (1) An emergency cesarean
delivery in accordance with facility policy, but no later than thirty minutes
from the time that the decision is made to perform the procedure; (2) Fetal monitoring;
and (3) Resuscitation and
stabilization of newborns and emergency care for the mother and newborn in each
delivery room. (K) Support services (on-site). Each
provider will have the staff and support services to meet the needs of patients
and have the following staff and services on-site on a twenty-four hour
basis: (1) Clinical laboratory,
capable of providing any necessary testing, including; (a) Blood typing, crossmatch, and antibody
testing; (b) Neonatal blood gas monitoring; and (c) Analysis of small volume samples. (2) Low-volume specialty
laboratory services may be provided by an outside laboratory, but the facility
will have policies and procedures in place to verify timely and direct
communication of all critical value results. (3) A blood bank capable of providing
blood, blood products, substitutes, blood component therapy and irradiated,
leukoreduced or cytomegalovirus (CMV)-negative blood; (4) Diagnostic imaging limited to
x-ray; (5) Portable ultrasound visualization
equipment for diagnosis and evaluation; and (6) Respiratory therapy and pulmonary.
The respiratory therapy service will: (a) Have a full-time credentialed respiratory care
practitioner, with education, training, or experience in neonatal and pediatric
respiratory care who: (i) Has sufficient time
allocated to provide direction and guidance as needed, of the respiratory
therapists who provide care in the level II neonatal care service;
and (ii) Provide oversight of
an annual simulation and skills verification of staff, including neonatal
respiratory care modalities and low-volume, high-risk neonatal respiratory
procedures. (b) Develop a written staffing plan for respiratory
therapists that establishes flexibility for variable census and acuity. This
plan and actual staffing will be based on allocating the appropriate number of
respiratory therapy staff to a care situation, attend to a safe and
high-quality work environment, and be operationally reviewed annually for
adherence and to verify respiratory therapy staffing is adequate for patient
care need; (c) Maintain appropriate staffing ratios for infants
receiving supplemental oxygen and positive pressure ventilation;
and (d) Ensure that respiratory therapy
practitioners: (i) Have documented
education, training, or experience in the respiratory support of newborns and
infants; (ii) Will be on-site, in
the same hospital building, twenty-four hours a day, seven days a week and
remain available to supervise assisted ventilation, assist in resuscitation,
and attend deliveries; (iii) Are able to attend
deliveries and assist with resuscitation as requested; (iv) Are current on
neonatal resuscitation program training; (v) Have their
credentials reviewed by the respiratory care leader annually; and (vi) Participate in
annual simulation and respiratory skills verification, including low-volume,
high-risk procedures consistent with the types of respiratory care provided in
the obstetric and neonatal care services. (L) Support services (on-call). On a
twenty four hour basis, each provider will have the following services on-site,
with staff necessary to provide the services on-call: (1) Diagnostic imaging,
including: (a) Computed tomography; (b) Magnetic resonance imaging; (c) Fluoroscopy; (d) Personnel appropriately trained in ultrasonography to
perform advanced imaging as requested; and (e) The ability to provide timely imaging interpretation by
radiologists with pediatric expertise as requested. Cranial ultrasonography may be provided
on-site or by arrangement. (2) Pharmacy: (a) Each provider will have at least one registered
pharmacist with experience in neonatal and/or pediatric pharmacology who
will: (i) Complete continuing
education requirements specific to pediatric and neonatal pharmacology;
and (ii) Participate in
multidisciplinary care, as needed. (b) Have policies and procedures in place to address drug
shortages and to verify medications are appropriately allocated to the neonatal
care service; and (c) Have policies and procedures in place to verify
neonatal competency for pharmacy staff supporting and preparing medications for
neonatal patients. (3) A pediatric/neonatal
trained hospital pharmacist available by telephone or telehealth on a
twenty-four-hour day basis. This requirement can be provided directly or by an
agreement with a children's hospital. (4) Anesthesia, except that when a
patient or patients are receiving a labor epidural, an anesthesiologist or
certified registered nurse anesthetist acting within their scope of practice
and under the supervision of a physician, will remain in attendance with a
patient until it is determined the patient is stable, but for at least thirty
minutes. After it is determined the patient is stable, an anesthesiologist or
certified registered nurse anesthetist may be on-call, but is obligated to
remain available to return in accordance with facility policy, but no longer
than thirty minutes; and (5) Biomedical engineering. (M) Unit management. Each provider will
have qualified individuals on-staff appropriate for the services provided
including: (1) A board-certified
obstetrician and a board-certified pediatrician as co-directors of the
obstetric and neonatal care service. The co-directors will establish procedures
for patients and integrate and coordinate a system for consultation, in-service
education and communication with referring obstetric and neonatal care
services; (2) A neonatologist or a
pediatrician in consultation with an on-staff neonatologist, to manage the care
of newborns and to provide for: (a) A system for consultation and referral; (b) Continuing education programs; (c) Communication and coordination with the obstetrical
service; and (d) Defining and establishing appropriate policies,
protocols, and procedures for the unit nursery or nurseries and neonatal
follow-up as may be indicated; (3) A director of
anesthesia services who is a board eligible or board certified
anesthesiologist; (4) Nurse leader: A
single, designated, full-time registered nurse with at least a bachelor's
degree in nursing, with demonstrated expertise in obstetric care, or neonatal
care, or both responsible for leading the organization and supervision of
nursing services in the neonatal care service and the obstetrical service
to: (a) Coordinate with respective neonatal, pediatric, and
obstetric care services, as appropriate; (b) Provide oversight of annual obstetric and
neonatal-specific education, which includes low-volume, high-risk procedures
consistent with the care provided in the obstetric and neonatal care services;
(c) Collaborate with multidisciplinary team members,
facility leadership, and higher-level facilities to create a diverse,
equitable, and inclusive environment focused on the quality of care and patient
care outcomes; and (d) If the nurse leader is involved with providing care to
the neonatal patient, the nurse leader must be current on neonatal
resuscitation. (5) Nurse educator: A registered nurse
with at least a bachelor's degree in nursing and are current on neonatal
resuscitation, to act as the clinical nurse educator or perinatal nurse
educator with the experience and expertise to: (a) Evaluate the educational needs of the clinical staff,
develop didactic and skill-based educational tools, oversee education and
skills verification, and evaluate retention of content, critical thinking
skills, and competency relevant to the obstetric and neonatal care
services; (b) Collaborate with the obstetrical nurse leader, neonatal
nurse leader, and facility leadership to improve the quality of care and
patient care outcomes; (c) If the nurse educator is involved with providing care
to the neonatal patient, the nurse educator must be current on neonatal
resuscitation; and (d) The nurse educator may be performed by a single
designated registered nurse in addition to their other duties. (N) Specialists. Each provider will have
medical, surgical, radiological and pathology specialists on-call based upon
the medical needs of the patients and policies and procedures will be in place
for referral to a higher level of neonatal care when pediatric medical
subspecialty or pediatric surgical specialty consultation and/or intervention
is needed. (O) Sub-specialists. Each provider will
have a maternal-fetal medicine sub-specialist available for
consultation. (P) Deliveries: (1) For every low risk
delivery or uncomplicated delivery with higher-risk conditions, each provider
will have an obstetrician, physician, or certified nurse midwife acting within
their scope of practice and under a standard care arrangement with a
collaborating physician, in attendance; or (2) For an unanticipated
high-risk delivery, every attempt will be made to secure a second physician,
certified nurse practitioner acting within their scope of practice and under a
standard care arrangement with a collaborating physician to care for the
neonate, or a physician assistant acting within their scope of practice and
under a supervisory agreement with a physician, to care for the
neonate. (Q) For every anticipated high-risk
delivery, each provider will have in attendance: (1) An obstetrician or
physician; (2) A second physician,
certified nurse practitioner acting within their scope of practice and under a
standard care arrangement with a collaborating physician to care for the
neonate, or a physician assistant acting within their scope of practice and
under a supervisory agreement with a physician, to care for the neonate;
and (3) Members of the
multi-disciplinary team required by paragraph (S) of this rule, one of whom can
initiate resuscitation, and one of whom can complete full resuscitation. This
can be the same individual. (R) Each provider will ensure every
newborn requiring mechanical ventilation or continuous positive airway pressure
has an initial evaluation by a physician, certified nurse practitioner, or
physician assistant acting within their scope of practice. If stable, qualified
staff with experience in newborn airway management and diagnosis and management
of air leaks will be on-site to care for such newborns. (S) Each provider will have qualified
staff on-duty appropriate for the services provided, including at
minimum: (1) Registered nurse
staffing, including: (a) At least two registered nurses competent in obstetric
and neonatal care for labor and delivery; (b) A registered nurse with obstetric and neonatal
experience for each patient in the second stage of labor; (c) A registered nurse to circulate for the cesarean
section deliveries; (d) Additional registered nurses with the appropriate
education and demonstrated competence, commensurate with the acuity and volume
of patients served, to provide direct supervision of newborns; and (e) Additional registered nurses with the appropriate
education and demonstrated competence, commensurate with the acuity and volume
of patients served, to provide direct supervision of obstetric
patients. (2) At least one member
of the nursing staff to attend to newborns when they are not with the mother or
her designee; and (3) A multi-disciplinary
team, each of whom have successfully completed the neonatal resuscitation
program and can initiate resuscitation. One member of the multi-disciplinary
team shall be capable of completing full resuscitation. (T) Other disciplines. Each provider will
have the following practitioners on-staff: (1) A licensed social
worker to provide psychosocial assessments and family support services.
Additional social workers will be provided based upon the size and needs of the
patient population; (2) A licensed dietitian
with knowledge of maternal and newborn nutrition and knowledge of
parenteral/enteral nutrition management of at-risk newborns; and (3) Personnel with the
knowledge and skills to support lactation including: (a) A certified lactation consultant, as defined in rule
3701-22-01 of the Administrative Code, available for on-site consultation on
weekdays and certified lactation consultant services will be accessible by
telehealth or telephone twenty-four hours a day, seven days a week. After-hours
and weekend consultation can be provided by free services available to
healthcare providers and their patients through other avenues such as a
hotline. Individuals employed in this position on the effective date of these
rules who do not meet the qualifications of this rule shall have five years
from the effective date of this rule to come into compliance with the
certification requirement; (b) Lactation support may be provided under the direction
of the certified lactation consultant by lactation counselor/ educator staff or
registered nurse staff educated and trained on how to provide lactation support
to the mother and neonate; and (c) The provider will ensure that certified lactation
consultant staff maintain continuing education and certification requirements,
as applicable, and ensure adequately trained lactation coverage is available
based on the specific need and volume of the neonatal population
served. (U) If the provider utilizes licensed
practical nurses (LPNs) or nonlicensed direct care providers to support the
clinical nursing staff, the facility will: (1) Have written criteria
that define the LPN's or nonlicensed direct care provider's scope of
obstetric or neonatal care; (2) Provide annual
education specific to the care of the obstetric and neonatal population served;
and (3) Have a written
staffing plan that establishes collaborative work assignments in accordance
with the facility's policies and procedures. (V) If the provider utilizes physician
assistants (PA): (1) Physician supervision
for the PA will be provided by a neonatologist or a board-certified
pediatrician with special interest and experience in neonatal
medicine; (2) The PA will have
appropriate education and demonstrated competence, commensurate with the acuity
and volume of patients served, to provide direct supervision of newborns;
(3) The PA is responsible for maintaining
clinical expertise and knowledge of current therapy by participating in
continuing medical education and scholarly activities; (4) The PA will maintain national
certification , including one hundred hours of continuing medical education
every two years and a recertification exam given by the "National
Commission on Certification of Physician Assistants" every ten years;
(5) The level II service will maintain
written criteria that define the PA's scope of obstetric or neonatal care;
and (6) If the PA is involved
with providing care to the neonatal patient, the PA must be current on neonatal
resuscitation.
Last updated September 2, 2025 at 8:36 AM
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Rule 3701-22-23 | Level III service standards.
Effective:
August 31, 2025
(A) Obstetric license. A level III
obstetrical service will provide antepartum, intrapartum and postpartum care
for obstetrical patients, including: (1) All low-risk
patients; (2) All uncomplicated
patients with higher-risk conditions; (3) All high-risk
patients; (4) Patients with more
complex maternal or fetal conditions as identified by the service, such as
patients: (a) With suspected placenta accreta or placenta previa with
prior uterine surgery; (b) With suspected placenta percreta; (c) With adult respiratory syndrome; or (d) Requiring expectant management of early severe
preeclampsia at less than thirty-four weeks of gestation. (5) Intensive care
through an on-site intensive care unit that is equipped to: (a) Provide labor and delivery in the intensive care
unit; (b) Provide medical and surgical care of complex
obstetrical conditions; and (c) Bring intensive care unit services to the obstetrical
unit. (6) The management of
unanticipated complications of labor and delivery; and (7) The management of
emergencies. (B) Obstetric transfer. A level III
obstetrical service will transfer to a level IV obstetric service care any
pregnant woman for intrapartum care: (1) With a complex
medical condition that requires critical care or intensive care beyond that
which the facility can provide; or (2) If the newborn is
anticipated to need advanced medical and surgical care beyond that which the
transferring service is licensed to provide. (a) The mother is having contractions; and (b) When, in the clinical judgment of a qualified
obstetrical practitioner working under that practitioner's scope of
practice: (i) There is inadequate
time to effect a safe transfer of the mother to an appropriate higher level
hospital before delivery; or (ii) The transfer will
pose a threat to the health or safety of either the mother or the
fetus. (3) Exception: A level
III obstetric service may provide care where an emergency medical condition
exists as defined by the Emergency Medical Treatment and Labor Act, 42 U.S.C.
1395dd (2012), and is evidenced by the following: (C) When considering a woman's
condition and the likelihood of pregnancy-related complications, paragraphs (A)
and (B) of this rule do not preclude the admission of: (1) A pregnant woman to
the maternity unit for care or services for a non-obstetrical issue, but that
may require monitoring of the health of the mother, the fetus, or
both; (2) Women for antepartum
care at any stage of the maternity cycle where labor is not
imminent; (3) Non-infectious
gynecologic patients; or (4) Non-infectious female
surgical patients in accordance with policies and procedures approved by the
service's director. (D) Neonatal license. A level III
neonatal care service will provide intensive, intermediate and routine care to
newborns, including to: (1) All low risk
newborns; (2) All complicated
newborns; (3) Extremely low birth
weight infants; (4) Newborns requiring
advanced respiratory care, other than extracorporeal membrane oxygenation,
including high-frequency ventilation and inhaled nitric oxide and/or
therapeutic hypothermia or the provider will have policies and procedures in
place to facilitate neonatal transfer to a higher level of care. This paragraph
notwithstanding, a level III neonatal care service that was providing pulmonary
extracorporeal membrane oxygenation that did not require cardiac intervention
under rule 3701-22-24 of the Administrative Code, may continue to provide
extracorporeal membrane oxygenation that does not require cardiac
intervention; (5) Newborns requiring
major surgery as identified by the service, other than newborns requiring
immediate surgical repair of serious congenital cardiac malformations that
require cardiopulmonary bypass, as designated by the service, either on-site or
at a nearby, closely-related institution; and (6) Newborns that require
emergency resuscitation or stabilization for transport. (E) Newborn transfers. When a level III
obstetric service cannot timely transfer a pregnant woman pursuant to paragraph
(B)(2) of this rule, the level III neonatal care service will transfer a
newborn to a level IV neonatal care service if the newborn is anticipated to
need advanced medical or surgical care beyond that which the transferring
service is licensed to provide, unless all of the following are
met: (1) The level III
neonatal care service has identified a neonatal transport program to facilitate
the transport of the newborn to a higher level neonatal facility; (2) The level III
neonatal care service has in place a valid memorandum of agreement with one or
more level IV neonatal care services, providing for consultation on the
retention of the infant between the level III neonatal care service attending
physician and the neonatologist on the staff of the level IV neonatal care
service; (3) The consultation
with, and the concurrence of, the neonatologist on the staff of the level IV
neonatal care service is documented by the level III neonatal care service in
the patient medical record and as otherwise may be determined by the service;
and (4) The risks and
benefits to the newborn for both retention at the level III neonatal care
service and transfer of the newborn to a level IV neonatal care service are
discussed with the parent, parents, or legal guardian of the newborn and
appropriately documented. (F) Informed consent. When discussing
transfer of a pregnant woman or a newborn to another facility in accordance
with this rule, the transferring service will document and provide the patient
or patient's legal guardian with: (1) The recommendations
from any consultations with a level IV service; (2) The risks and
benefits associated with the patient's transfer or retention;
and (3) Any other information
required by the hospital's policies and procedures. (G) In the event the patient or
patient's legal guardian refuses transfer to a recommended hospital, the
service will document the refusal of transfer and provide treatment to the
patient or patients in accordance with hospital policies and procedures. The
service will update the patient or patient's legal guardian as the
patient's condition warrants. (H) Written service plan. Each provider
will, using licensed health care professionals acting within their scopes of
practice, develop a written service plan for the care and services to be
provided by the service. The written service plan will be in accordance with
the "Guidelines for perinatal care" or other applicable professional
standard and address, at minimum: (1) The more complex
maternal or fetal conditions for which the care will be provided based on
the: (a) Patient population; (b) Acuity of patients; (c) Volume of patients; and (d) Competency of staff. (2) Criteria for
determining those conditions that can be routinely managed by the
service; (3) Admission to the
service; (4) Discharge from the
service; (5) Patient care in
accordance with accepted professional standards; (6) Referrals for
obtaining public health, dietetic, genetic, and toxicology services not
available in-house; (7) Minimum competency
standards for staff in accordance with recognized national standards and ensure
that all staff are competent to perform services based on education, experience
and demonstrated ability; (8) Administration of
blood and blood products; (9) Provision of
phototherapy; (10) Provision of
respiratory therapy; (11) Unit-based surgeries
and surgical suite-based surgeries; (12) Post-mortem
care; (13) A formal education
program for staff including, at minimum: (a) A nursing orientation that incorporates didactic
education, simulation, skills verification, and competency and is tailored to
the individual needs of each nurse based on clinical experience; (b) The neonatal resuscitation program. The service will
ensure all labor and delivery registered nurses and any other practitioner
likely to attend to a neonate at a high risk of a more complicated delivery
will receive training in the neonatal resuscitation program; (c) A post- resuscitation program. The service will ensure
individuals caring for newborns receive training in a post resuscitation
program to include, at minimum: (i) The identification
and treatment of signs and symptoms related to hypoglycemia, hypothermia, and
pneumothorax; (ii) Blood pressure
(normal ranges, factors that can impair cardiac output); (iii) Lab work, including
perinatal and postnatal risks factors and clinical signs of
sepsis; (iv) Principles of
assisted ventilation, continuous positive airway pressure, positive pressure
ventilation, assisting and securing endo-tracheal tube insertion, and chest
x-rays; (v) Emotional support to
parents with sick infants; and (vi) Quality improvement
to identify problems and the importance of debriefing to evaluate care in the
post-resuscitation period. (d) Ongoing continuing education that
includes: (i) An annual educational
needs assessment to determine the educational needs of the clinical nursing
staff and ancillary team members; (ii) Annual nursing
education that addresses the annual needs assessment and incorporates
simulation and skills verification of low-volume, high-risk procedures
consistent with the types of care provided in the obstetric and neonatal care
services and includes education related to serious safety events;
and (iii) Nursing staff
participation in annual simulation and skills verification, including
low-volume, high-risk procedures consistent with the types of care provided in
the obstetric and neonatal care services. (14) Provision of care by
direct care staff to individuals in other areas of the hospital, including, but
not limited to the emergency department and the intensive care
unit; (15) Risk assessment of
obstetric and neonatal patients to ensure identification of appropriate
consultation requirements for or referral of high-risk patients; (16) A formal process for
the on-site provision of services or the referral of patients to follow-up
services, as appropriate, for the following: (a) Developmental screening; (b) Ophthalmology; (c) Audiology; (d) Child life specialist; (e) Lactation clinical care, education, and support;
and (f) Neonatal therapists to address the six core practice
domains of environment, family or psychosocial health support, sensory system,
neurobehavioral system, neuromotor and musculoskeletal systems, and oral
feeding and swallowing by providers with neonatal experience,
including: (i) Physical
therapy, (ii) Occupational
therapy; and (iii) Speech
therapy. (17) Education for
mothers regarding personal care and nutrition, newborn care and nutrition, and
newborn feeding; (18) Infection control,
consistent with current infection control guidelines issued by the United
States centers for disease control and prevention; (19) Consultation for and
referral of both obstetric and neonatal transports; (20) The coordination and
facilitation, on a twenty-four hour basis, of both obstetric and neonatal
transports, which may include the reverse transport of newborns; (21) Consultation for
maternal-fetal medicine on a twenty-four hour basis; (22) Developmental
follow-up of at-risk newborns in the service or referral of such newborns to
appropriate programs; (23) Provision of ongoing
education for referring hospitals; (24) Provision of
opportunities for graduate medical education such as pediatric residencies or
obstetrics-gynecology residencies, neonatal fellowships or maternal-fetal
medicine fellowships, provided either directly or through an agreement with a
hospital providing co-located newborn services; (25) Provision of
opportunities for clinical experience for purposes of graduate nursing
education, or continuing education, or both; (26) Participation, on an
ongoing basis, in basic or clinical obstetrics or neonatology research;
(27) Provision of
multi-disciplinary planning relating to management and therapy through the
postpartum period; and (28) A process to
appropriately identify infants at risk for retinopathy of prematurity to
guarantee timely examination and treatment by having: (a) Documented policies and procedures for the monitoring,
treatment, and follow-up of retinopathy of prematurity; and (b) The ability to perform on-site retinal examinations, or
off-site interpretation of digital photographic retinal images, by a pediatric
ophthalmologist or retinal specialist with expertise in retinopathy of
prematurity. (I) Each provider will, in accordance
with accepted professional standards, develop and follow written policies and
procedures to implement the written service plan set forth in paragraph (H) of
this rule. (J) Each provider will have the ability
to perform all of the following: (1) An emergency cesarean
delivery in accordance with facility policy, but no later than thirty minutes
from the time that the decision is made to perform the procedure; (2) Fetal monitoring;
and (3) Resuscitation and
stabilization of newborns and emergency care for the mother and newborn in each
delivery room. (K) Support services (on-site). Each
provider will have the following staff and services on-site on a twenty-four
hour basis: (1) Clinical laboratory,
capable of providing any necessary testing, including: (a) Blood typing, crossmatch, and antibody
testing; (b) Neonatal blood gas monitoring; and (c) Analysis of small volume samples; (i) Low-volume specialty
laboratory services may be provided by an outside laboratory, but the facility
will have policies and procedures in place to verify timely and direct
communication of all critical value results; and (d) Access to perinatal pathology services, if applicable,
may be provided on-site or by arrangement. (2) A blood bank capable
of providing blood, blood products, substitutes, blood component therapy and
irradiated, leukoreduced or cytomegalovirus (CMV)-negative blood; (3) Diagnostic imaging,
including: (a) X-ray; and (b) Computed tomography; (4) Portable ultrasound
visualization equipment for diagnosis and evaluation; (5) Each provider will
have at least one registered pharmacist with experience in neonatal and/or
pediatric pharmacology who will: (a) Complete continuing education requirements specific to
pediatric and neonatal pharmacology; (b) Participate in multidisciplinary care, including
participation in patient care rounds; (c) Ensure that neonatal appropriate total parenteral
nutrition (TPN) is available twenty-four hours a day and that written policies
and procedures for the proper preparation and delivery of TPN are in
place; (d) Have policies and procedures in place to address drug
shortages and to verify medications are appropriately allocated to the neonatal
care service; and (e) Have policies and procedures in place to verify
neonatal competency for pharmacy staff supporting and preparing medications for
neonatal patients. (f) A pediatric/neonatal trained hospital pharmacist
available by telephone or telehealth on a twenty-four-hour day basis. This
requirement can be provided directly or by an agreement with a children's
hospital. (6) Respiratory therapy
and pulmonary. The respiratory therapy service will: (a) Have a full-time credentialed respiratory care
practitioner, with education, training, or experience in neonatal respiratory
care who: (i) Has sufficient time
allocated to provide direction and guidance as needed, of the respiratory
therapists who provide care in the level III neonatal care service;
and (ii) Provide oversight of
an annual simulation and skills verification of staff, including neonatal
respiratory care modalities and low-volume, high-risk neonatal respiratory
procedures. (b) Develop a written staffing plan for respiratory
therapists that establishes flexibility for variable census and acuity. This
plan and actual staffing will be based on allocating the appropriate number of
respiratory therapy staff to a care situation, attend to a safe and
high-quality work environment, and be operationally reviewed annually for
adherence and to verify respiratory therapy staffing is adequate for patient
care need; (c) Maintain appropriate staffing ratios for infants
receiving supplemental oxygen and positive pressure ventilation;
and (d) Ensure that respiratory therapy
practitioners: (i) Have documented
education, training, or experience in the respiratory support of newborns and
infants; (ii) Will be on-site, in
the same hospital building, twenty-four hours a day, seven days a week and
remain available to supervise assisted ventilation, assist in resuscitation,
and attend deliveries; (iii) Are current on
neonatal resuscitation program training; (iv) Have their
credentials reviewed by the respiratory care leader annually; and (v) Participate in annual
simulation and respiratory skills verification, including low-volume, high-risk
procedures consistent with the types of respiratory care provided in the
neonatal care service. (7) Anesthesia, including
an anesthesiologist with the ability to: (a) Respond to the bedside within one hour of request or
identified need; (b) Act as the primary responsible anesthesia provider for
all infants; and (c) Be physically present for all neonatal surgical
procedures for which they serve as the primary responsible anesthesia
provider. (8) Neonatal
nutrition: (a) Provide a specialized area or room, with limited access
and away from the bedside, to accommodate mixing of formula or additives to
human milk; (b) Develop standardized feeding protocols for the
advancement of feedings based on the availability of, and family preference for
human milk, donor human milk, fortification of human milk and formula;
and (c) Have policies and procedures in place for accurate
verification and administration of human milk and formula, and to avoid
misappropriation. (L) Support services (on-call). On a
twenty-four hour basis, each provider will have the following services on-site,
with staff necessary to provide the services on-call: (1) Magnetic resonance
imaging; (2) Fluoroscopy: If
fluoroscopy is not offered on-site at the facility, policies and procedures
will be in place to facilitate transfer of an infant to a higher level of care;
(3) The ability to
provide timely imaging interpretation by radiologists with pediatric expertise
as requested; (4) Personnel
appropriately trained in ultrasonography, including cranial ultrasonography, to
perform advanced imaging as requested; (5) Echocardiography,
including the ability to consult with a pediatric cardiologist for timely
echocardiography interpretation as requested; and (6) Biomedical
engineering. (M) Unit management: Each provider will
have qualified individuals on-staff appropriate for the services provided,
including: (1) A board-certified
obstetrician and a board-certified neonatologist as co-directors for the
obstetric and neonatal care service. The co-directors will coordinate and
integrate the following: (a) A system for consultation; (b) In-service education programs; (c) Coordination and communication with support services
and other obstetrical services; (d) Defining and establishing, in collaboration with other
members of the obstetric team, appropriate protocols and procedures for
obstetric patients; and (e) Treatment of patients in the neonatal intensive care
unit who are not under the care of other physicians. (2) A board-certified
maternal-fetal medicine subspecialist to serve as director of the
maternal-fetal medicine service; (3) Obstetric nurse
leader: A single, designated registered nurse with a bachelor's degree in
nursing and a master's degree responsible for leading the organization and
supervising the nursing services in the obstetrical service; (4) Neonatal nurse
leader: A single, designated registered nurse with a bachelor's degree in
nursing and a master's degree, who has experience and expertise in
neonatal nursing and conditions, responsible for leading the organization and
supervising the nursing services of a level III neonatal care service, who
will: (a) Be responsible for inpatient activities in the neonatal
care service and, as appropriate, obstetrical, well newborn, and/or pediatric
units; (b) Coordinate with respective neonatal, pediatric, and
obstetric care services, as appropriate; (c) Provide oversight of annual neonatal-specific education
which includes low-volume, high-risk procedures consistent with the care
provided in the level III neonatal care service; (d) Foster collaborative relationships with
multidisciplinary team members, facility leadership, and higher-level
facilities to create a diverse, equitable, and inclusive environment to improve
the quality of care and patient care outcomes; and (e) If the neonatal nurse leader is involved with providing
care to the neonatal patient, the neonatal nurse leader must be current on
neonatal resuscitation. (5) Neonatal nurse specialist: A
registered nurse with bachelor's degree in nursing and a master's
degree, who has current neonatal nursing certification and demonstrated
expertise in neonatal care to: (a) Foster continuous quality improvement in nursing
care; (b) Develop and educate staff to provide evidence-based
nursing care; (c) Be responsible for mentoring new staff and developing
team building skills; (d) Provide leadership to multidisciplinary
teams; (e) Facilitate case management of high-risk neonatal
patients; (f) Cultivate collaborative relationships with
multidisciplinary team members and facility leadership to improve the quality
of care and patient care outcomes; (g) If the neonatal nurse
specialist is involved with providing care to the neonatal patient, the
neonatal nurse specialist must be current on neonatal resuscitation;
and (h) The roles and responsibilities of the nurse specialist
can be allocated to multiple individuals or provided by a co-located hospital
to perform this role. (6) Nurse educator: A registered nurse
with a bachelor's degree in nursing and a master's degree, who has
sufficient time allocated to perform the roles and responsibilities of the role
who is responsible for: (a) Cultivating collaborative relationships with the
obstetric nurse leader and the neonatal nurse leader and facility leadership to
improve the quality of care and patient care outcomes; (b) Evaluating the educational needs of the clinical staff,
developing didactic and skill-based educational tools, overseeing education and
skills verification, and evaluating retention of content, critical thinking
skills, and competency relevant to obstetric and neonatal care services;
and (c) A registered nurse employed as a nurse educator as of
October 1, 2024, who has not obtained a master's degree will have five
years from that date to complete a master's degree program. (7) A director of
obstetric anesthesia services who is a board-eligible or board-certified
anesthesiologist; (8) A geneticist or
genetics counselor who is certified by the American college of medical genetics
or eligible for such certification to: (a) Identify families at risk for genetic
abnormalities; (b) Obtain family genetic history; (c) Provide genetic counseling in complicated cases;
and (d) If necessary, refer complicated cases to an on-staff
medical geneticist. (N) Specialists. Each provider will have
medical, surgical, radiological and pathology specialists either on-site or
on-call based on the medical needs of the patients. (O) Sub-specialists. Each provider will
have qualified sub-specialists available for consultation, and, if necessary,
patient care either on-site or at a nearby closely related hospital or
institution, appropriate for the services provided and based upon the medical
needs of the patient, that may include: (1) Medical-surgical: (a) Maternal-fetal medicine; (b) Critical care; (c) General surgery; (d) Infectious disease; (e) Hematology; (f) Cardiology; (g) Nephrology; and (h) Neurology. (2) Pediatric: (a) Hematology; (b) Nephrology; (c) Metabolic; (d) Endocrinology; (e) Gastroenterology; (f) Nutrition; (g) Immunology; (h) Ophthalmology; and (i) Pharmacology. (3) Pediatric
surgical: (a) Orthopedic surgeons; (b) Urologic surgeons; and (c) Otolaryngologic surgeons. (P) Deliveries: (1) For every anticipated
low-risk delivery or uncomplicated delivery with higher-risk conditions, each
provider will have an obstetrician, physician, or certified nurse midwife
acting within their scope of practice and under a standard care arrangement
with a collaborating physician, in attendance; or (2) For an unanticipated
high-risk delivery, every attempt will be made to secure a second physician,
certified nurse practitioner acting within their scope of practice and under a
standard care arrangement with a collaborating physician to care for the
neonate, or a physician assistant acting within their scope of practice and
under a supervisory agreement with a physician, to care for the
neonate. (Q) For every anticipated high-risk
delivery, each provider will have in attendance: (1) An obstetrician or
physician; (2) A second physician,
certified nurse practitioner acting within their scope of practice and under a
standard care arrangement with a collaborating physician to care for the
neonate, or a physician assistant acting within their scope of practice and
under a supervisory agreement with a physician, to care for the neonate;
and (3) Members of the
multi-disciplinary team set forth in paragraph (T) of this rule, one of whom
can initiate resuscitation, and one of whom can complete full resuscitation.
This can be the same individual. (R) For every delivery with more complex
maternal or fetal conditions, each provider will have in
attendance: (1) An obstetrician or
maternal fetal medicine specialist capable of performing a cesarean
section; (2) A neonatologist or
physician to attend to the neonate; (3) A maternal-fetal
medicine or fetal surgeon, as appropriate, during operative procedures;
and (4) Members of the
multi-disciplinary team set forth in paragraph (T) of this rule, one of whom
can initiate resuscitation, and one of whom can complete full resuscitation.
This can be the same individual. (S) Each provider will ensure every
newborn requiring mechanical ventilation or continuous positive airway pressure
has an initial evaluation by a physician, certified nurse practitioner, or
physician assistant acting within their scope of practice. If stable, qualified
staff with experience in newborn airway management and diagnosis and management
of air leaks will be on-site to care for such newborns. (T) Each provider will have on-duty,
qualified staff appropriate for the services provided including at
minimum: (1) Registered nurse
staffing, including: (a) At least two registered nurses competent in obstetric
and neonatal care for labor and delivery; (b) A registered nurse with obstetric and neonatal
experience for each patient in the second stage of labor; (c) A registered nurse to circulate for the cesarean
section deliveries; (d) Additional registered nurses with the appropriate
education and demonstrated competence, commensurate with the acuity and volume
of patients served, to provide direct supervision of newborns; and (e) Additional registered nurses with the appropriate
education and demonstrated competence, commensurate with the acuity and volume
of patients served, to provide direct supervision of obstetric patients.
(2) At least one member
of the nursing staff to attend to newborns when they are not with the mother or
her designee; and (3) A multi-disciplinary
team, each of whom have successfully completed the neonatal resuscitation and
can initiate resuscitation. One member of the multi-disciplinary team is
obligated to be capable of completing full resuscitation. (U) Other disciplines. Each provider will
have: (1) A master's
prepared social worker. Individuals employed in this position on the effective
date of these rules who do not meet the qualifications of this rule shall have
five years from the effective date of this rule to come into compliance with
the certification requirement. Additional social workers will be provided based
upon the size and needs of the patient population. Social workers
will: (a) Provide assessments, family support services, and
medical social work; (b) Have a written description that clearly identifies the
responsibilities and functions of the obstetric and neonatal care services
social worker; (c) Have social services available for each family with an
infant in the neonatal care service as needed. (2) A licensed dietitian
with knowledge of maternal and newborn nutrition and knowledge of
parenteral/enteral nutrition management of at-risk newborns who
will: (a) Collaborate with the medical team to establish feeding
protocols, develop patient-specific feeding plans, and help determine
nutritional needs at discharge; (b) Establish policies and procedures to verify proper
preparation and storage of human milk and formula; (c) Participate in multidisciplinary care, including
participation in patient care rounds; and (d) Ensure that policies and procedures are in place for
dietary consultation for infants in the neonatal care service. (3) Personnel with the
knowledge and skills to support lactation including: (a) A certified lactation consultant, as defined in rule
3701-22-01 of the Administrative Code, available for on-site consultation on
weekdays and certified lactation consultant services will be accessible by
telehealth or telephone twenty-four hours a day, seven days a week. After-hours
and weekend consultation can be provided by free services available to
healthcare providers and their patients through other avenues such as a
hotline. Individuals employed in this position on the effective date of these
rules who do not meet the qualifications of this rule shall have five years
from the effective date of this rule to come into compliance with the
certification requirement; (b) Lactation support may be provided under the direction
of the certified lactation consultant by lactation counselor/education staff or
registered nurse staff educated and trained on how to provide lactation support
to the mother; and (c) The provider will ensure that certified lactation
consultant staff maintain continuing education and certification requirements,
as applicable, and ensure adequately trained lactation coverage is available
based on the specific need and volume of the neonatal population
served. (V) If the provider utilizes licensed
practical nurses (LPNs) or nonlicensed direct care providers to support the
clinical nursing staff, the facility will: (1) Have written criteria
that define the LPN's or nonlicensed direct care provider's scope of
obstetric and neonatal care; (2) Provide annual
education specific to the care of the obstetric and neonatal population served;
and (3) Have a written
staffing plan that establishes collaborative work assignments in accordance
with the facility's policies and procedures. (W) If the provider utilizes physician
assistants (PA): (1) Physician supervision
for the PA will be provided by: (a) A neonatologist or a board certified pediatrician when
the PA is providing care to a neonate; or (b) An obstetrician or maternal-fetal medicine physician
when the PA is providing care to the obstetric patient. (2) The PA will have
appropriate education and demonstrated competence, commensurate with the acuity
and volume of patients served, to provide direct supervision of newborns and/or
obstetric patients; (3) The PA is responsible for maintaining
clinical expertise and knowledge of current therapy by participating in
continuing medical education and scholarly activities; (4) The PA will maintain national
certification, including one hundred hours of continuing medical education
every two years and a recertification exam given by the "National
Commission on Certification of Physician Assistants" every ten years;
(5) The level III service will maintain
written criteria that define the PA's scope of obstetric or neonatal care;
and (6) If the PA is involved
with providing care to the neonatal patient, the PA must be current on neonatal
resuscitation.
Last updated September 2, 2025 at 8:36 AM
|
Rule 3701-22-24 | Level IV service standards.
Effective:
August 31, 2025
(A) Obstetric license. A level IV
obstetric service will provide antepartum, intrapartum and postpartum care for
obstetrical patients, including: (1) All low-risk
patients; (2) All uncomplicated
patients with higher-risk conditions; (3) All high-risk
patients; (4) Patients with more
complex maternal or fetal conditions; (5) Patients with the
most complex medical conditions as identified by the service, or patients who
are critically ill, including patients with: (a) Severe maternal cardiac conditions; (b) Severe pulmonary hypertension or liver
failure; (c) Pregnant women requiring neurosurgery or cardiac
surgery; and (d) Pregnant women in unstable condition and in need of an
organ transplant. (6) Intensive care
through an on-site intensive care unit that is equipped to: (a) Provide labor and delivery in the intensive care
unit; (b) Provide medical and surgical care of complex
obstetrical conditions; and (c) Bring intensive care unit services to the obstetrical
unit. (7) The management of
unanticipated complications of labor and delivery; and (8) The management of
emergencies. (B) A level IV neonatal care service will
be located in a hospital or other institution and will provide intensive,
intermediate and routine care to newborns, including to: (1) All low risk
newborns; (2) All complicated
newborns; (3) Extremely low birth
weight newborns; (4) Newborns requiring
advanced respiratory care, including extracorporeal membrane oxygenation;
and (5) Newborns requiring
major newborn surgery, including surgical repair of serious congenital
malformations that require cardiac bypass. (C) A level IV obstetrical service may
admit: (1) A pregnant woman to
the maternity unit for care or services for a non-obstetrical issue, but that
may require monitoring of the health of the mother, the fetus, or
both; (2) Women for antepartum
care at any stage of the maternity cycle; (3) Non-infectious
gynecologic patients; or (4) Non-infectious female
surgical patients in accordance with policies and procedures approved by the
service's director. (D) Written service plan. Each provider
will, using licensed health care professionals acting within their scopes of
practice, develop a written service plan for the care and services to be
provided by the service. The written service plan will be based on the
"Guidelines for perinatal care" or other applicable professional
standard and address, at minimum: (1) The complex medical
conditions and critical illnesses for which the care will be provided based on
the: (a) Patient population; (b) Acuity of patients; (c) Volume of patients; and (d) Competency of staff. (2) Competency of
staff; (3) Admission to the
service; (4) Discharge from the
service; (5) Patient care in
accordance with accepted professional standards; (6) Referrals for
obtaining public health, dietetic, genetic, and toxicology services not
available in-house; (7) Minimum competency
standards for staff in accordance with recognized national standards and ensure
that all staff are competent to perform services based on education, experience
and demonstrated ability; (8) Administration of
blood and blood products; (9) Provision of
phototherapy; (10) Provision of
respiratory therapy; (11) Unit-based surgeries
and surgical suite-based surgeries; (12) Post-mortem
care; (13) A formal education
program for staff including, at minimum: (a) A nursing orientation that incorporates didactic
education, simulation, skills verification, and competency and is tailored to
the individual needs of each nurse based on clinical experience; (b) The neonatal resuscitation program. The service will
ensure all labor and delivery registered nurses and any other practitioner
likely to attend to a neonate at a high-risk or complex delivery receive
training in the neonatal resuscitation program; (c) A post-resuscitation program. The service will ensure
individuals caring for newborns receive training in a post resuscitation
program to include, at minimum: (i) The identification
and treatment of signs and symptoms related to hypoglycemia, hypothermia, and
pneumothorax; (ii) Blood pressure
(normal ranges, factors that can impair cardiac output); (iii) Lab work, including
perinatal and postnatal risks factors and clinical signs of
sepsis; (iv) Principles of
assisted ventilation, continuous positive airway pressure, positive pressure
ventilation, assisting and securing endo-tracheal tube insertion, and chest
x-rays; (v) Emotional support to
parents with sick infants; and (vi) Quality improvement
to identify problems and the importance of debriefing to evaluate care in the
post-resuscitation period. (d) Ongoing continuing education that
includes: (i) An annual educational
needs assessment to determine the educational needs of the clinical nursing
staff and ancillary team members; (ii) Annual nursing
education that addresses the annual needs assessment and incorporates
simulation and skills verification of low-volume, high-risk procedures
consistent with the types of care provided in the obstetric and neonatal care
services and includes education related to serious safety events;
and (iii) Nursing staff
participation in annual simulation and skills verification, including
low-volume, high-risk procedures consistent with the types of care provided in
the obstetric and neonatal care services. (14) Provision of care by
direct care staff to individuals in other areas of the hospital, including, but
not limited to the emergency department and the intensive care
unit; (15) Risk assessment of
obstetric and neonatal patients to ensure identification of appropriate
consultation requirements or referral for high-risk patients; (16) A formal process for
the on-site provision of services or the referral of patients to follow-up
services, as appropriate, for the following: (a) Developmental screening; (b) Ophthalmology; (c) Audiology; (d) Child life specialist; (e) Lactation clinical care, education, and
support; (f) Neonatal therapists to address the six core practice
domains of environment, family or psychosocial health support, sensory system,
neurobehavioral system, neuromotor and musculoskeletal systems, and oral
feeding and swallowing by providers with neonatal experience,
including: (i) Physical
therapy; (ii) Occupational
therapy; and (iii) Speech
therapy. (17) Education for
mothers regarding personal care and nutrition, newborn care and nutrition, and
newborn feeding; (18) Infection control,
consistent with current infection control guidelines issued by the United
States centers for disease control and prevention; (19) Consultation or
referral of both obstetric and neonatal transports; (20) The coordination and
facilitation, on a twenty-four hour basis, of both obstetric and neonatal
transports, which may include the reverse transport of newborns; (21) Consultation for
maternal-fetal medicine on a twenty-four hour basis; (22) Developmental
follow-up of at-risk newborns in the service or refer such newborns to
appropriate programs; (23) Provision of ongoing
education for referring hospitals; (24) Provision of
opportunities for graduate medical education such as pediatric residencies or
obstetrics-gynecology residencies, neonatal fellowships or maternal-fetal
medicine fellowships, provided either directly or through an agreement with a
hospital providing co-located newborn services; (25) Provision of
opportunities for clinical experience for purposes of graduate nursing
education, or continuing education, or both; (26) Participation, on an
ongoing basis, in basic or clinical obstetrics or neonatology research;
(27) Provision of
multi-disciplinary planning relating to management and therapy through the
postpartum period; and (28) A process to
appropriately identify infants at risk for retinopathy of prematurity to
guarantee timely examination and treatment by having: (a) Documented policies and procedures for the monitoring,
treatment, and follow-up of retinopathy of prematurity; and (b) The ability to perform on-site retinal examinations, or
off-site interpretation of digital photographic retinal images, by a pediatric
ophthalmologist or retinal specialist with expertise in retinopathy of
prematurity. (E) Each provider will, in accordance
with accepted professional standards, develop and follow written policies and
procedures to implement the written service plan set forth in paragraph (D) of
this rule. (F) Each provider will have the ability
to perform all of the following: (1) An emergency cesarean
delivery in accordance with facility policy, but no later than thirty minutes
from the time that the decision is made to perform the procedure; (2) Fetal monitoring;
and (3) Resuscitation and
stabilization of newborns and emergency care for the mother and newborn in each
delivery room. (G) Support services (on-site). Each
provider will have the following staff and services on-site on a twenty-four
hour basis: (1) Clinical laboratory,
capable of providing any necessary testing, including: (a) Blood typing, crossmatch, and antibody
testing; (b) Neonatal blood gas monitoring; (c) Analysis of small volume samples. Low-volume specialty laboratory services may
be provided by an outside laboratory, but the facility will have policies and
procedures in place to verify timely and direct communication of all critical
value results. (d) The capability to process biopsies and perform
autopsies; and (e) Access to perinatal pathology services, if
applicable. (2) A blood bank capable
of providing blood, blood products, substitutes, blood component therapy and
irradiated, leukoreduced or cytomegalovirus (CMV)-negative blood with policies
and procedures in place to facilitate emergent access to blood and blood
component therapy so that the neonatal care service can provide a full range of
hematologic interventions; (3) Diagnostic imaging,
including: (a) X-ray; and (b) Computed tomography. (4) Portable ultrasound
visualization equipment for diagnosis and evaluation; (5) Each provider will
have at least one registered pharmacist with experience in neonatal and/or
pediatric pharmacology who will: (a) Complete continuing education requirements specific to
pediatric and neonatal pharmacology; (b) Participate in multidisciplinary care, including
participation in patient care rounds; (c) Ensure that neonatal appropriate total parenteral
nutrition (TPN) is available twenty-four hours a day and that written policies
and procedures for the proper preparation and delivery of TPN are in
place; (d) Have policies and procedures in place to address drug
shortages and to verify medications are appropriately allocated to the neonatal
care service; and (e) Have policies and procedures in place to verify
neonatal competency for pharmacy staff supporting and preparing medications for
neonatal patients. (f) A pediatric/neonatal trained hospital pharmacist
available by telephone or telehealth on a twenty-four-hour day basis. This
requirement can be provided directly or by an agreement with a children's
hospital. (6) Respiratory therapy
and pulmonary. The respiratory therapy service will: (a) Have a full-time credentialed respiratory care
practitioner, with education, training, or experience in neonatal respiratory
care who: (i) Has sufficient time
allocated to provide direction and guidance as needed, of the respiratory
therapists who provide care in the level IV neonatal care service;
and (ii) Provide oversight of
an annual simulation and skills verification of staff, including neonatal
respiratory care modalities and low-volume, high-risk neonatal respiratory
procedures. (b) Develop a written staffing plan for respiratory
therapists that establishes flexibility for variable census and acuity. This
plan and actual staffing will be based on allocating the appropriate number of
respiratory therapy staff to a care situation, attend to a safe and
high-quality work environment, and be operationally reviewed annually for
adherence and to verify respiratory therapy staffing is adequate for patient
care need; (c) Maintain appropriate staffing ratios for infants
receiving supplemental oxygen and positive pressure ventilation;
and (d) Ensure that respiratory therapy
practitioners: (i) Have documented
education, training, or experience in the respiratory support of newborns and
infants; (ii) Will be on-site, in
the same hospital building, twenty-four hours a day, seven days a week and
remain available to supervise assisted ventilation, assist in resuscitation,
and attend deliveries; (iii) Are current on
neonatal resuscitation program training; (iv) Have their
credentials reviewed by the respiratory care leader annually; and (v) Participate in annual
simulation and respiratory skills verification, including low-volume, high-risk
procedures consistent with the types of respiratory care provided in the
neonatal care service. (7) Anesthesia, including
an anesthesiologist with the ability to: (a) Respond to the bedside within one hour of request of
identified need; (b) Act as the primary responsible anesthesia provider for
all infants; and (c) Be physically present for all neonatal surgical
procedures for which they serve as the primary responsible anesthesia
provider. (8) Neonatal
nutrition: (a) Provide a specialized area or room, with limited access
and away from the bedside, to accommodate mixing of formula for two or more or
additives to human milk; (b) Develop standardized feeding protocols for the
advancement of feedings based on the availability of, and family preference for
human milk, donor human milk, fortification of human milk and formula;
and (c) Have policies and procedures in place for accurate
verification and administration of human milk and formula, and to avoid
misappropriation. (H) Support services (on-call). On a
twenty-four hour basis, each provider will have the following services on-site,
with staff necessary to provide the services on-call: (1) Magnetic resonance
imaging; (2) Fluoroscopy; (3) The ability to
provide timely imaging interpretation by radiologists with pediatric expertise
as requested; (4) Personnel
appropriately trained in ultrasonography, including cranial ultrasonography, to
perform advanced imaging as requested; and (5) Echocardiography,
including the ability to consult with a pediatric cardiologist for timely
echocardiography interpretation as requested. (I) Unit management: Each provider will
have qualified individuals on-staff appropriate for the services provided,
including: (1) A board-certified
maternal-fetal medicine subspecialist or a board-certified obstetrician and a
board-certified neonatologist as co-directors for the obstetric and neonatal
care service. The co-directors will coordinate and integrate the
following: (a) A system for consultation; (b) In-service education programs; (c) Coordination and communication with support services
and other obstetric care services; (d) Foster collaborative relationships with
multidisciplinary team members, facility leadership, and higher-level
facilities to create a diverse, equitable, and inclusive environment to improve
the quality of care and patient care outcomes; and (e) Treatment of patients in the neonatal intensive care
unit who are not under the care of other physicians. (2) A board-certified
maternal-fetal medicine subspecialist to serve as director of the
maternal-fetal medicine service; (3) Obstetric nurse
leader: A single, designated, full-time registered nurse with a bachelor's
degree in nursing and a master's degree responsible for leading the
organization and supervising the nursing services in the obstetrical care
service; (4) Neonatal nurse
leader: A single, designated registered nurse with a bachelor's degree in
nursing and a master's degree with experience and expertise in neonatal
nursing and conditions, responsible for leading the organization and
supervising the nursing services of a level IV neonatal care service, who
will: (a) Be responsible for inpatient activities in the neonatal
care service and, as appropriate, obstetrical, well newborn, and/or pediatric
units; (b) Coordinate with respective neonatal, pediatric, and
obstetric care services, as appropriate; (c) Provide oversight of annual neonatal-specific education
which includes low-volume, high-risk procedures consistent with the care
provided in the level IV neonatal care service; (d) Foster collaborative relationships with
multidisciplinary team members, facility leadership, and higher-level
facilities to create a diverse, equitable, and inclusive environment to improve
the quality of care and patient care outcomes; and (e) If the neonatal nurse leader is involved with providing
care to the neonatal patient, the neonatal nurse leader must be current on
neonatal resuscitation. (5) Neonatal nurse
specialist: A registered nurse with master's degree in nursing, who has
demonstrated expertise in neonatal health to provide clinical nursing expertise
commensurate with the patient acuity and services provided, who
will: (a) Foster continuous quality improvement in nursing
care; (b) Develop and educate staff to provide evidence-based
nursing care; (c) Be responsible for mentoring new staff and developing
team building skills; (d) Provide leadership to multidisciplinary
teams; (e) Facilitate case management of high-risk neonatal
patients; (f) Cultivate collaborative relationships with
multidisciplinary team members and facility leadership to improve the quality
of care and patient care outcomes; (g) If the neonatal nurse specialist is involved with
providing care to the neonatal patient, the neonatal nurse specialist must be
current on neonatal resuscitation; and (h) The roles and responsibilities of the nurse specialist
can be allocated to multiple individuals or provided by a co-located hospital
to perform this role. (6) Nurse educator: A
registered nurse with a bachelor's degree in nursing and a master's
degree, who has sufficient time allocated to perform the roles and
responsibilities of the role who is responsible for: (a) Cultivating collaborative relationships with the
obstetric nurse leader and the neonatal nurse leader and facility leadership to
improve the quality of care and patient care outcomes; (b) Evaluating the educational needs of the clinical staff,
developing didactic and skill-based educational tools, overseeing education and
skills verification, and evaluating retention of content, critical thinking
skills, and competency relevant to obstetric and neonatal care services;
and (c) A registered nurse employed as a nurse educator as of
October 1, 2024, who has not obtained a master's degree will have five
years from that date to complete a master's degree program. (7) A director of
obstetric anesthesia services who is a board-eligible or board-certified
anesthesiologist; (8) A geneticist or
genetics counselor certified by the American college of medical genetics or
eligible for such certification to: (a) Identify families at risk for genetic
abnormalities; (b) Obtain family genetic history; (c) Provide genetic counseling in complicated cases;
and (d) If necessary, refer complicated cases to an on-staff
medical geneticist. (J) Specialists. Each provider will have
medical, surgical, radiological and pathology specialists either on-site or
on-call based on the medical needs of the patients. (K) Sub-specialists. Each provider will
have, either on-site or at a nearby closely related hospital or institution
qualified subspecialists that may include: (1) Medical/surgical: (a) Maternal-fetal medicine; (b) Critical care; (c) General surgery; (d) Infectious disease; (e) Hematology; (f) Cardiology; (g) Nephrology; and (h) Neurology. (2) Pediatric: (a) Hematology; (b) Nephrology; (c) Metabolic; (d) Endocrinology; (e) Gastroenterology; (f) Nutrition; (g) Immunology; (h) Ophthalmology; and (i) Pharmacology. (3) Pediatric
surgical: (a) Orthopedic surgeons; (b) Urologic surgeons; and (c) Otolaryngologic surgeons. (L) Deliveries: (1) For every anticipated
low-risk delivery or uncomplicated delivery with higher-risk conditions, each
provider will have an obstetrician, physician, or certified nurse midwife
acting within their scope of practice and under a standard care arrangement
with a collaborating physician, in attendance. (2) For an unanticipated
high-risk delivery, every attempt will be made to secure a second physician, a
certified nurse practitioner acting within their scope of practice and under a
standard care arrangement with a collaborating physician, or a physician
assistant acting within their scope of practice and under a supervisory
agreement with a physician, to care for the neonate. (M) For every anticipated high-risk
delivery, each provider will have in attendance: (1) An obstetrician or
physician; (2) A second physician,
certified nurse practitioner acting within their scope of practice and under a
standard care arrangement with a collaborating physician to care for the
neonate, or a physician assistant acting within their scope of practice and
under a supervisory agreement with a physician to care for the neonate;
and (3) Members of the
multi-disciplinary team set forth in paragraph (P) of this rule, one of whom
can initiate resuscitation, and one of whom can complete full resuscitation.
This can be the same individual. (N) For every delivery with more complex
maternal or fetal conditions, delivery of the most complex medical conditions,
or delivery of critically ill patients, each provider will have in
attendance: (1) An obstetrician or
maternal fetal medicine specialist capable of performing a cesarean
section; (2) A neonatologist or
physician to attend to the neonate; (3) Maternal-fetal
medicine or fetal surgeon, as appropriate, during operative procedures;
and (4) Members of the
multi-disciplinary team set forth in paragraph (P) of this rule, one of whom
can initiate resuscitation, and one of whom can complete full resuscitation.
This can be the same individual. (O) Each provider will ensure every
newborn requiring mechanical ventilation or continuous positive airway pressure
has an initial evaluation by a physician, certified nurse practitioner, or
physician assistant acting within their scope of practice. If stable, qualified
staff with experience in newborn airway management and diagnosis and management
of air leaks will be on-site to care for such newborns. (P) Each provider will have qualified
staff on-duty for direct care of patients, including at minimum: (1) Registered nurse
staffing including: (a) At least two registered nurses competent in obstetric
and neonatal care for labor and delivery; (b) A registered nurse with obstetric and neonatal
experience for each patient in the second stage of labor; (c) A registered nurse to circulate for cesarean
deliveries; (d) Additional registered nurses with the appropriate
education and demonstrated competence, commensurate with the acuity and volume
of patients served, to provide direct supervision of newborns; and (e) Additional registered nurses with the appropriate
education and demonstrated competence, commensurate with the acuity and volume
of patients served, to provide direct supervision of obstetric
patients. (2) At least one member
of the nursing staff to attend to newborns when they are not with the mother or
her designee; and (3) A multi-disciplinary
team, each of whom have successfully completed the neonatal resuscitation
program and can initiate resuscitation. One member of the multi-disciplinary
team will be capable of completing full resuscitation. (Q) Other disciplines. Each provider will
have: (1) A master's
prepared social worker. Individuals employed in this position on the effective
date of these rules who do not meet the qualifications of this rule shall have
five years from the effective date of this rule to come into compliance with
the certification requirement. Additional social workers will be provided based
upon the size and needs of the patient population. Social workers
will: (a) Provide assessments, family support services, and
medical social work; (b) Have a written description that clearly identifies the
responsibilities and functions of the obstetric and neonatal care services
social worker; (c) Have social services available for each family with an
infant in the neonatal care service as needed. (2) A licensed dietitian
with knowledge of maternal and newborn nutrition and knowledge of
parenteral/enteral nutrition management of at-risk newborns who
will: (a) Collaborate with the medical team to establish feeding
protocols, develop patient-specific feeding plans, and help determine
nutritional needs at discharge; (b) Establish policies and procedures to verify proper
preparation and storage of human milk and formula; (c) Participate in multidisciplinary care, including
participation in patient care rounds; and (d) Ensure that policies and procedures are in place for
dietary consultation for infants in the neonatal care service. (3) Personnel with the
knowledge and skills to support lactation including: (a) A certified lactation consultant, as defined in rule
3701-22-01 of the Administrative Code, available for on-site consultation on
weekdays and certified lactation consultant services will be accessible by
telehealth or telephone twenty-four hours a day, seven days a week. After-hours
and weekend consultation can be provided by free services available to
healthcare providers and their patients through other avenues such as a
hotline. Individuals employed in this position on the effective date of these
rules who do not meet the qualifications of this rule shall have five years
from the effective date of this rule to come into compliance with the
certification requirement; (b) Lactation support may be provided under the direction
of the certified lactation consultant by lactation counselor/educator staff or
registered nurse staff educated and trained on how to provide lactation support
to the mother and neonate; (c) The provider will ensure that certified lactation
consultant staff maintain continuing education and certification requirements,
as applicable, and ensure adequately trained lactation coverage is available
based on the specific need and volume of the neonatal population
served. (4) Child life services
or the equivalent, will be available for on-site consultation to support
patient- and family-centered care by establishing and maintaining therapeutic
relationships between patients, family members, multidisciplinary team members,
and community resources. (R) If the provider utilizes licensed practical nurses
(LPNs) or nonlicensed direct care providers to support the clinical nursing
staff, the facility will: (1) Have written criteria
that define the LPN's or nonlicensed direct care provider's scope of
obstetric or neonatal care; (2) Provide annual
education specific to the care of the obstetric and neonatal population served;
and (3) Have a written
staffing plan that establishes collaborative work assignments in accordance
with the facility's policies and procedures. (S) If the provider utilizes physician
assistants (PA): (1) Physician supervision
for the PA will be provided by: (a) A neonatologist or a board certified pediatrician when
the PA is providing care to a neonate; or (b) An obstetrician or maternal-fetal medicine physician
when the PA is providing care to the obstetric patient. (2) The PA will have
appropriate education and demonstrated competence, commensurate with the acuity
and volume of patients served, to provide direct supervision of newborns and/or
obstetric patients; (3) The PA is responsible for maintaining
clinical expertise and knowledge of current therapy by participating in
continuing medical education and scholarly activities; (4) The PA will maintain national
certification, including one hundred hours of continuing medical education
every two years and a recertification exam given by the "National
Commission on Certification of Physician Assistants" every ten years;
(5) The level IV service will maintain
written criteria that define the PA's scope of obstetric or neonatal care;
and (6) If the PA is involved
with providing care to the neonatal patient, the PA must be current on neonatal
resuscitation.
Last updated September 2, 2025 at 8:36 AM
|
Rule 3701-22-25 | Freestanding children's hospitals with level III or level IV neonatal care services.
Effective:
August 31, 2025
(A) A freestanding children's
hospital with a level III neonatal care service will provide care for newborns,
including: (1) Low-risk
newborns; (2) Convalescing and
moderately ill newborns; (3) Extremely low birth
weight infants; (4) Newborns who require
advanced respiratory care, other than extracorporeal membrane oxygenation, such
as high-frequency ventilation and inhaled nitric oxide; and (5) Newborns who require
major surgery other than surgical repair of serious congenital cardiac
malformations that require cardiopulmonary bypass. (B) A freestanding children's
hospital with a level IV neonatal care service will provide care for newborns
and fetuses, including: (1) Low-risk
newborns; (2) Convalescing and
moderately ill newborns; (3) Extremely low birth
weight infants; (4) Newborns who require
advanced respiratory care, including extracorporeal membrane
oxygenation; (5) Newborns who require
major surgery, such as surgical repair of serious congenital cardiac
malformations that require cardiopulmonary bypass; (6) Newborns at extreme
high-risk; (7) Newborns receiving
specialized services such as: (a) Cardiac surgery; (b) Organ transplants; or (c) Treatments of rare inborn metabolic
errors. (C) Written service plan. Each
freestanding children's hospital with a level III or level IV neonatal
care service will, using licensed health care professionals acting within the
scopes of their practice, develop a written service plan for the care and
services to be provided. The written service plan will be based on the
"Guidelines for perinatal care" and address, at minimum: (1) The specialized
services provided by the service based on the: (a) Patient population; (b) Acuity of patients; (c) Volume of patients; and (d) Competency of staff. (2) Criteria for
determining those conditions that can be routinely managed by the service;
(3) Admission to the
unit; (4) Discharge from the
unit; (5) Patient care in
accordance with accepted professional standards; (6) Referrals for
obtaining public health, dietetic, genetic, and toxicology services not
available in-house; (7) Minimum competency
standards for staff in accordance with recognized national standards and ensure
that all staff are competent to perform services based on education, experience
and demonstrated ability; (8) Administration of
blood and blood products; (9) Provision of
phototherapy; (10) Provision of
respiratory therapy; (11) Unit-based surgeries
and surgical suite-based surgeries; (12) Post-mortem
care; (13) Provision of a
formal education program for staff that includes, at minimum: (a) A nursing orientation that incorporates didactic
education, simulation, skills verification, and competency and is tailored to
the individual needs of each nurse based on clinical experience; (b) The neonatal resuscitation program. The service will
ensure all labor and delivery registered nurses and any other practitioner
likely to attend a high risk delivery receive training in the neonatal
resuscitation program; (c) A post resuscitation program. The service will ensure
individuals caring for newborns receive training in a post resuscitation
program to include, at minimum: (i) The identification
and treatment of signs and symptoms related to hypoglycemia, hypothermia, and
pneumothorax; (ii) Blood pressure
(normal ranges, factors that can impair cardiac output); (iii) Lab work, including
perinatal and postnatal risks factors and clinical signs of
sepsis; (iv) Principles of
assisted ventilation, continuous positive airway pressure, positive pressure
ventilation, assisting and securing endo-tracheal tube insertion, and chest
x-rays; (v) Emotional support to
parents with sick infants; and (vi) Quality improvement
to identify problems and the importance of debriefing to evaluate care in the
post-resuscitation period. (d) Ongoing continuing education that
includes; (i) An annual educational
needs assessment to determine the educational needs of the clinical nursing
staff and ancillary team members; (ii) Annual nursing
education that addresses the annual needs assessment and incorporates
simulation and skills verification of low-volume, high-risk procedures
consistent with the types of care provided in the obstetric and neonatal care
services and includes education related to serious safety events;
and (iii) Nursing staff
participation in annual simulation and skills verification, including
low-volume, high-risk procedures consistent with the types of care provided in
the obstetric and neonatal care services. (14) Provision of direct
care staff to provide care to individuals in other areas of the hospital,
including, but not limited to the emergency department and the intensive care
unit; (15) Risk assessment of
neonatal patients to ensure identification of appropriate consultation
requirements or referral of high-risk patients; (16) A formal process for
the on-site provision of services or the referral of patients to follow-up
services, as appropriate, for the following: (a) Developmental screening; (b) Ophthalmology; (c) Audiology; (d) Child life specialist; (e) Lactation clinical care, education, and
support; (f) Neonatal therapists to address the six core practice
domains of environment, family or psychosocial health support, sensory system,
neurobehavioral system, neuromotor and musculoskeletal systems, and oral
feeding and swallowing by providers with neonatal experience,
including: (i) Physical
therapy; (ii) Occupational
therapy; and (iii) Speech
therapy. (17) Infection control,
consistent with current infection control guidelines issued by the United
States centers for disease control and prevention; (18) Consultation or
referral of neonatal transport; (19) Coordination and
facilitation of neonatal transports from referring hospitals on a twenty four
hour basis; (20) Consultation for
neonatal care services on a twenty-four hour basis; (21) Developmental
follow-up of at-risk newborns in the service or refer such newborns to
appropriate programs; (22) Provision of
developmental follow-up of at-risk newborns in the service or refer such
newborns to appropriate programs; (23) Provision of ongoing
education for referring hospitals; (24) Provision of
opportunities for graduate medical education such as pediatric residencies or
neonatal medicine fellowships; (25) Provision of
opportunities for clinical experience for purposes of graduate nursing
education, or continuing education, or both; (26) Participation in
basic or clinical neonatology research on an ongoing basis; (27) Provision of
multidisciplinary planning related to management and therapy for newborn care;
and (28) A process to
appropriately identify infants at risk for retinopathy of prematurity to
guarantee timely examination and treatment by having: (a) Documented policies and procedures for the monitoring,
treatment, and follow-up of retinopathy of prematurity; and (b) The ability to perform on-site retinal examinations, or
off-site interpretation of digital photographic retinal images, by a pediatric
ophthalmologist or retinal specialist with expertise in retinopathy of
prematurity. (D) Each provider will, in accordance
with accepted standards of practice, develop and follow written policies and
procedures to implement the written service plan set forth in paragraph (C) of
this rule. (E) Support services. Each provider will
have the following staff and services on-site on a twenty-four hour
basis: (1) Clinical laboratory,
capable of providing any necessary testing, including: (a) Blood typing, crossmatch, and antibody
testing; (b) Neonatal blood gas monitoring; (c) Analysis of small volume samples; Low-volume specialty laboratory services may
be provided by an outside laboratory, but the facility will have policies and
procedures in place to verify timely and direct communication of all critical
value results; (d) The capability to process biopsies and perform
autopsies; and (e) Access to perinatal pathology services, if
applicable. (2) A blood bank capable
of providing blood, blood products, substitutes, blood component therapy and
irradiated, leukoreduced or cytomegalovirus (CMV)-negative blood with policies
and procedures in place to facilitate emergent access to blood and blood
component therapy so that the neonatal care service can provide a full range of
hematologic interventions; (3) Diagnostic imaging,
including: (a) X-ray; and (b) Computed tomography. (4) Portable ultrasound
visualization equipment for diagnosis and evaluation; (5) Each provider will
have at least one registered pharmacist with experience in neonatal and/or
pediatric pharmacology who will: (a) Complete continuing education requirements specific to
pediatric and neonatal pharmacology; (b) Participate in multidisciplinary care, including
participation in patient care rounds; (c) Ensure that neonatal appropriate total parenteral
nutrition (TPN) is available twenty-four hours a day and that written policies
and procedures for the proper preparation and delivery of TPN are in
place; (d) Have policies and procedures in place to address drug
shortages and to verify medications are appropriately allocated to the neonatal
care service; and (e) Have policies and procedures in place to verify
neonatal competency for pharmacy staff supporting and preparing medications for
neonatal patients. (f) A pediatric/neonatal trained hospital pharmacist
available by telephone or telehealth on a twenty-four-hour day basis. This
requirement can be provided directly or by an agreement with a children's
hospital. (6) Respiratory therapy
and pulmonary. The respiratory therapy service will: (a) Have a full-time credentialed respiratory care
practitioner, with education, training, or experience in neonatal respiratory
care who: (i) Has sufficient time
allocated to provide direction and guidance as needed, of the respiratory
therapists who provide care in the level III or level IV neonatal care service;
and (ii) Provide oversight of
an annual simulation and skills verification of staff, including neonatal
respiratory care modalities and low-volume, obstetric and high-risk neonatal
respiratory procedures. (b) Develop a written staffing plan for respiratory
therapists that establishes flexibility for variable census and acuity. This
plan and actual staffing will be based on allocating the appropriate number of
respiratory therapy staff to a care situation, attend to a safe and
high-quality work environment, and be operationally reviewed annually for
adherence and to verify respiratory therapy staffing is adequate for patient
care need; (c) Maintain appropriate staffing ratios for infants
receiving supplemental oxygen and positive pressure ventilation;
and (d) Ensure that respiratory therapy
practitioners: (i) Have documented
education, training, or experience in the respiratory support of newborns and
infants; (ii) Will be on-site
twenty-four hours a day, seven days a week and immediately available to
supervise assisted ventilation, assist in resuscitation, and attend
deliveries; (iii) Are current on
neonatal resuscitation program training; (iv) Have their
credentials reviewed by the respiratory care leader annually; and (v) Participate in annual
simulation and respiratory skills verification, including low-volume, high-risk
procedures consistent with the types of respiratory care provided in the
obstetric and neonatal care services. (7) Anesthesia, including
an anesthesiologist with the ability to: (a) Respond to the bedside within one hour of request or
identified need; (b) Act as the primary responsible anesthesia provider for
all infants; and (c) Be physically present for all neonatal surgical
procedures for which they serve as the primary responsible anesthesia
provider. (8) Neonatal
nutrition: (a) Provide a specialized area or room, with limited access
and away from the bedside, to accommodate mixing of formula for two or more
additives to human milk; (b) Develop standardized feeding protocols for the
advancement of feedings based on the availability of, and family preference for
human milk, donor human milk, fortification of human milk and formula;
and (c) Have policies and procedures in place for accurate
verification and administration of human milk and formula, and to avoid
misappropriation. (F) On a twenty four hour basis, each
provider will have the following services on-site, with staff necessary to
provide the service on-call: (1) Diagnostic imaging,
including: (a) Magnetic resonance imaging; (b) Fluoroscopy; (c) The ability to provide timely imaging interpretation by
radiologists with pediatric expertise as requested; (d) Personnel appropriately trained in ultrasonography,
including cranial ultrasonography, to perform advanced imaging as requested;
and (e) Echocardiography, including the ability to consult with
a pediatric cardiologist for timely echocardiography interpretation as
requested. (2) Biomedical
engineering. (G) Unit management: Each provider will
have qualified individuals on-staff appropriate for the services provided,
including: (1) A board certified
neonatologist as director of the neonatal care service. The director will
coordinate and integrate the following, including: (a) A system for consultation; (b) In-service education programs; (c) Coordination and communication with support
services; (d) In collaboration with other members of the neonatal
team, define and establish appropriate protocols and procedures for newborn
patients; and (e) Treatment of patients in the neonatal intensive care
unit who are not under the care of other physicians. (2) Neonatal nurse
leader: A single, designated registered nurse with a bachelor's degree in
nursing and a master's degree with experience and expertise in neonatal
nursing and conditions, responsible for leading the organization and
supervising the nursing services of a level III or level IV neonatal care
service, who will: (a) Be responsible for inpatient activities in the neonatal
care service; (b) Coordinate with respective neonatal and peditatric care
services, as appropriate; (c) Provide oversight of annual neonatal-specific education
which includes low-volume, high-risk procedures consistent with the care
provided in the level III or level IV neonatal care service; (d) Foster collaborative relationships with
multidisciplinary team members, facility leadership, and higher-level
facilities to create a diverse, equitable, and inclusive environment to improve
the quality of care and patient care outcomes; and (e) If the neonatal nurse leader is involved with providing
care to the neonatal patient, the neonatal nurse leader must be current on
neonatal resuscitation. (3) Neonatal nurse
specialist: A registered nurse with master's degree in nursing, who has
demonstrated expertise in neonatal health to provide clinical nursing expertise
commensurate with the patient acuity and services provided, who
will: (a) Foster continuous quality improvement in nursing
care; (b) Develop and educate staff to provide evidence-based
nursing care; (c) Be responsible for mentoring new staff and developing
team building skills; (d) Provide leadership to multidisciplinary
teams; (e) Facilitate case management of high-risk neonatal
patients; (f) Cultivate collaborative relationships with
multidisciplinary team members and facility leadership to improve the quality
of care and patient care outcomes; (g) If the neonatal nurse specialist is involved with
providing care to the neonatal patient, the neonatal nurse specialist must be
current on neonatal resuscitation; and (h) The roles and responsibilities of the nurse specialist
can be allocated to multiple individuals to perform this role. (4) Nurse educator: A
registered nurse with a bachelor's degree in nursing and a master's
degree, who has sufficient time allocated to perform the roles and
responsibilities of the role who is responsible for: (a) Cultivating collaborative relationships with the
neonatal nurse leader and facility leadership to improve the quality of care
and patient care outcomes; (b) Evaluating the educational needs of the clinical staff,
developing didactic and skill-based educational tools, overseeing education and
skills verification, and evaluating retention of content, critical thinking
skills, and competency relevant to neonatal care services; and (c) A registered nurse employed as a nurse educator as of
October 1, 2024, who has not obtained a master's degree will have five
years from that date to complete a master's degree program. (5) A geneticist or
genetics counselor certified by the American college of medical genetics or
eligible for such certification to: (a) Identify families at risk for genetic
abnormalities; (b) Obtain family genetic history; (c) Provide genetic counseling in complicated cases;
and (d) If necessary, refer complicated cases to an on-staff
medical geneticist. (H) Specialists. Medical, surgical,
radiological and pathology specialists will be on-call based on the medical
needs of the patients. (I) Sub-specialists. Each freestanding
children's hospital with a level III or level IV neonatal care service
will have, either on-site or at a nearby closely related hospital or
institution, qualified sub-specialists that may include: (1) Pediatric: (a) Nephrologists; (b) Hematologists; (c) Metabologists; (d) Endocrinologists; (e) Gastroenterologists; (f) Nutritionists; (g) Infectious disease; (h) Pulmonologists; (i) Ophthalmologists; (j) Immunologists; (k) Pharmacologists; and (l) General surgery. (2) Pediatric
surgical: (a) Orthopedic surgeons; (b) Urologic surgeons; and (c) Otolaryngologic surgeons. (3) For a freestanding
children's hospital with a level IV neonatal care service, additional
pediatric surgical: (a) Cardiovascular surgeons; and (b) Neurosurgeons. (J) Each provider will have sufficient
registered nurses with the appropriate education and demonstrated competence,
commensurate with the acuity and volume of patients served, on-duty at all
times to provide direct supervision of newborns. (K) Other disciplines. Each provider will
have: (1) A master's
prepared social worker. Individuals employed in this position on the effective
date of these rules who do not meet the qualifications of this rule shall have
five years from the effective date of this rule to come into compliance with
the certification requirement. Additional social workers will be provided based
upon the size and needs of the patient population. Social workers
will: (a) Provide assessments, family support services, and
medical social work; (b) Have a written description that clearly identifies the
responsibilities and functions of the obstetric and neonatal care service
social worker; (c) Have social services available for each family with an
infant in the neonatal care service as needed; (2) A licensed dietitian
with knowledge of maternal and newborn nutrition and knowledge of
parenteral/enteral nutrition management of at-risk newborns who
will: (a) Collaborate with the medical team to establish feeding
protocols, develop patient-specific feeding plans, and help determine
nutritional needs at discharge; (b) Establish policies and procedures to verify proper
preparation and storage of human milk and formula; (c) Participate in multidisciplinary care, including
participation in patient care rounds; (d) Ensure that policies and procedures are in place for
dietary consultation for infants in the neonatal care service. (3) Personnel with the
knowledge and skills to support lactation including: (a) A certified lactation consultant, as defined in rule
3701-22-01 of the Administrative Code, available for on-site consultation on
weekdays and certified lactation consultant services will be accessible by
telehealth or telephone twenty-four hours a day, seven days a week. This can be
provided by free services available to healthcare providers and their patients
through other avenues such as a hotline. Individuals employed in this position
on the effective date of these rules who do not meet the qualifications of this
rule shall have five years from the effective date of this rule to come into
compliance with the certification requirement. (b) Lactation support may be provided under the direction
of the certified lactation consultant by lactation counselor/educator staff or
registered nurse staff educated and trained on how to provide lactation support
to the mother and neonate. (c) The provider will ensure that certified lactation
consultant staff maintain continuing education and certification requirements,
as applicable, and ensure adequately trained lactation coverage is available
based on the specific need and volume of the neonatal population
served. (4) Child life services
or the equivalent, will be available for on-site consultation to support
patient- and family-centered care by establishing and maintaining therapeutic
relationships between patients, family members, multidisciplinary team members,
and community resources. (L) If the provider utilizes licensed
practical nurses (LPNs) or nonlicensed direct care providers to support the
clinical nursing staff, the facility will: (1) Have written criteria
that define the LPN's or nonlicensed direct care provider's scope of
obstetric or neonatal care; (2) Provide annual
education specific to the care of the obstetric and neonatal population served;
and (3) Have a written
staffing plan that establishes collaborative work assignments in accordance
with the facility's policies and procedures. (M) If the provider utilizes physician
assistants (PA): (1) Physician supervision
for the PA will be provided by: (a) A neonatologist or a board certified pediatrician when
the PA is providing care to a neonate; or (b) An obstetrician or maternal-fetal medicine physician
when the PA is providing care to the obstetric patient. (2) The PA will have
appropriate education and demonstrated competence, commensurate with the acuity
and volume of patients served, to provide direct supervision of newborns;
(3) The PA is responsible for maintaining
clinical expertise and knowledge of current therapy by participating in
continuing medical education and scholarly activities; (4) The PA will maintain national
certification, including one hundred hours of continuing medical education
every two years and a recertification exam given by the "National
Commission on Certification of Physician Assistants" every ten years;
(5) The level III or Level IV service
will maintain written criteria that define the PA's scope of obstetric or
neonatal care; and (6) If the PA is involved
with providing care to the neonatal patient, the PA must be current on neonatal
resuscitation.
Last updated September 2, 2025 at 8:37 AM
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Rule 3701-22-26 | Freestanding children's hospitals with level III or level IV neonatal care services that provide special delivery services.
Effective:
August 31, 2025
(A) A freestanding children's
hospital licensed under this chapter may provide special delivery services to
pregnant women as part of a comprehensive multidisciplinary program of fetal
and neonatal care when it is determined that the fetus, once delivered, will
require immediate highly specialized neonatal intensive care or neonatal
surgery typically provided by a level III or level IV neonatal care service.
Special delivery services will only be available to pregnant women when it is
determined, after evaluation of the patient and review of their medical history
and other contributing factors leading up to labor and delivery by an
appropriately qualified obstetric provider, the woman is less likely to
experience intrapartum and postpartum medical and surgical
complications. (B) Each freestanding children's
hospital that provides special delivery services will, in conjunction with
contracted obstetric staff or a licensed obstetric service, develop and follow
a patient care plan for both the pregnant woman and the newborn for each
delivery. The comprehensive care plan will include, at minimum: (1) A delineation of
responsibilities for the provision of obstetric care and neonatal care,
including support personnel and services at all stages of labor; (2) Provision of
antepartum and postpartum care of the pregnant woman, to include supervision by
an obstetrician or maternal-fetal medicine specialist, and on-site nursing
services provided by at least two registered nurses competent in obstetric care
with additional registered nurses based on the acuity of the
patient; (3) Parameters for
transfer of the pregnant woman should risks present themselves before, during,
or after pregnancy; and (4) A staffing plan for
when actively providing special delivery services, in addition to the standards
set forth in paragraphs (C) to (M) of rule 3701-22-25 of the Administrative
Code, that includes, at minimum, the following qualified staff on-site to
attend each delivery: (a) An obstetrician or maternal fetal medicine specialist
capable of performing a cesarean section; (b) A neonatologist to attend to the newborn; (c) Maternal-fetal medicine or fetal surgeon during
operative procedures; (d) A neonatal multidisciplinary team of staff for
deliveries, headed by a neonatologist with additional registered nurse staff
competent in neonatal care based on the acuity of newborn; and (e) At least two registered nurses competent in obstetric
care with additional registered nurses based on the acuity of the
patient. (C) Each freestanding children's
hospital that provides special delivery services will meet the
following: (1) Rooms in which
special delivery services are provided will meet all standards for labor,
delivery, and recovery rooms as set forth in rule 3701-22-20 of the
Administrative Code; and (2) Perform cesarean
deliveries in an operating room that is in or nearby the area where special
delivery services are provided. (D) When being used for delivery, each
freestanding children's hospital that provides special delivery services
will have the ability to perform all the following: (1) An emergency cesarean
delivery in accordance with facility policy, but no later than thirty minutes
from the time that the decision is made to perform the procedure; (2) Fetal monitoring;
and (3) Resuscitation and
stabilization of newborns and emergency care for the mother and
newborn.
Last updated September 2, 2025 at 8:37 AM
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Rule 3701-22-27 | Freestanding children's hospitals with a level IV neonatal care services and a level III obstetrical service.
Effective:
August 31, 2025
(A) A freestanding children's
hospital with a level IV neonatal care service may also provide a level III
obstetrical service. In addition to the standards set forth in paragraphs (C)
to (H) of rule 3701-22-25 of the Administrative Code, a freestanding
children's hospital with a level IV neonatal care service and a level III
obstetric service will provide antepartum, intrapartum and postpartum care for
obstetric patients, including: (1) All low-risk
patients; (2) All uncomplicated
patients with higher-risk conditions; (3) All high-risk
patients; (4) Patients with more
complex maternal or fetal conditions as identified by the service, such as
patients: (a) With suspected placenta accreta or placenta previa with
prior uterine surgery; (b) With suspected placenta percreta; (c) With adult respiratory syndrome; or (d) Requiring expectant management of early severe
preeclampsia at less than thirty-four weeks of gestation. (5) Intensive care
through an on-site intensive care unit that is equipped to: (a) Provide labor and delivery in the intensive care
unit; (b) Provide medical and surgical care of complex
obstetrical conditions; and (c) Bring intensive care unit services to the obstetric
unit. (6) The management of
unanticipated complications of labor and delivery; and (7) The management of
emergencies. (B) Obstetric transfer. A freestanding
children's hospital with a level IV neonatal care service and a level III
obstetric service will transfer to a level IV obstetric service care for
pregnant woman for intrapartum care: (1) With a complex
medical condition that necessitates critical care or intensive care beyond that
which the facility can provide; or (2) If the newborn is
anticipated to need advanced medical and surgical care beyond that which the
transferring service is licensed to provide. Exception: A level III obstetric service may
provide care where an emergency medical condition exists as defined by the
Emergency Medical Treatment and Labor Act, 42 U.S.C. 1395dd (2012), and is
evidenced by the following: (a) The mother is having contractions; and (b) When, in the clinical judgment of a qualified
obstetrical practitioner working under that practitioners scope of
practice: (i) There is inadequate
time to effect a safe transfer of the mother to an appropriate higher level
hospital before delivery; or (ii) The transfer will
pose a threat to the health or safety of either the mother or the
fetus. (C) When considering a woman's
condition and the likelihood of pregnancy-related complications, paragraphs (A)
and (B) of this rule do not preclude the admission of: (1) A pregnant woman to
the maternity unit for care or services for a non-obstetrical issue, but that
may need monitoring of the health of the mother, the fetus, or
both; (2) Women for antepartum
care at any stage of the maternity cycle where labor is not
imminent; (3) Non-infectious
gynecologic patients; or (4) Non-infectious female
surgical patients in accordance with policies and procedures approved by the
service's director. (D) Informed consent. When discussing
transfer of a pregnant woman to another facility in accordance with this rule,
the transferring service will document and provide the patient or
patient's legal guardian with: (1) The recommendations
from any consultations with a level IV obstetric service; (2) The risks and
benefits associated with the patient's transfer or retention;
and (3) Any other information
required by the hospital's policies and procedures. (E) In the event the patient or
patient's legal guardian refuses transfer to a recommended hospital, the
service will document the refusal of transfer and provide treatment to the
patient or patients in accordance with hospital policies and procedures. The
service will update the patient or patient's legal guardian as the
patient's condition warrants. (F) Written service plan. Each
freestanding children's hospital with a level IV neonatal care service and
a level III obstetrical service will, using licensed health care professionals
acting within the scopes of their practice, include in the written service plan
set forth in paragraph (C) of rule 3701-22-25 of the Administrative
Code: (1) The more complex
maternal or fetal conditions for which the care will be provided based on
the: (a) Patient population; (b) Acuity of patients; (c) Volume of patients; and (d) Competency of staff. (2) Criteria for
determining those conditions that can be routinely managed by the
service; (3) Admission to the
service; (4) Discharge from the
service; (5) A risk assessment of
obstetric patients to ensure identification of appropriate consultation
criteria for or referral of high-risk patients; (6) Education for mothers
regarding personal care and nutrition, newborn care and nutrition, and newborn
feeding; (7) Consultation for and
referral of obstetric transports; (8) The coordination and
facilitation, on a twenty-four hour basis, of obstetric
transports; (9) Consultation for
maternal-fetal medicine on a twenty-four hour basis; (10) The provision of
opportunities for graduate medical education such as pediatric or
obstetrics-gynecology residencies; (11) Participation, on an
ongoing basis, in basic or clinical obstetrics research; and (12) The provision of
multi-disciplinary planning relating to management and therapy through the
postpartum period. (G) Each freestanding children's
hospital with a level IV neonatal care service and a level III obstetric
service will, in accordance with accepted standards of practice, develop and
follow written policies and procedures to implement the additional component of
the written service plan set forth in paragraph (F) of this rule. (H) Each provider will have the ability
to perform all of the following: (1) An emergency cesarean
delivery in accordance with facility policy, but no later than thirty minutes
from the time that the decision is made to perform the procedure; (2) Fetal monitoring;
and (3) Resuscitation and
stabilization of newborns and emergency care for the mother and newborn in each
delivery room. (I) Support services. Each freestanding
children's hospital with a level IV neonatal care service and a level III
obstetric service will have the support services set forth in paragraphs (E)
and (F) of rule 3701-22-25 of the Administrative Code available for adult
obstetric patients. (J) Unit management. In addition to the
standards set forth in paragraph (G) of rule 3701-22-25 of the Administrative
Code, each freestanding children's hospital with a level IV neonatal care
service and a level III obstetrical service will have qualified individuals
on-staff appropriate for the services provided, including: (1) A board-certified
obstetrician director for the obstetrical service. The director of the
obstetric service will work with the director of the neonatal care service set
forth in paragraph (G)(1) of rule 3701-22-25 of the Administrative Code to
coordinate and integrate the standards set forth in paragraph (G)(1) of rule
3701-22-21 of the Administrative Code, and to coordinate and integrate the
following: (a) Coordination and communication with support services
and other obstetrical services; and (b) Defining and establishing, in collaboration with other
members of the obstetric team, appropriate protocols and procedures for
obstetric patients. (2) A board-certified
maternal-fetal medicine subspecialist to serve as director of the
maternal-fetal medicine service; (3) Obstetric nurse
leader: A single, designated, full-time registered nurse with a bachelor's
degree in nursing and a master's of science in nursing degree responsible
for leading the organization and supervising the nursing services in the
obstetric service; (4) Neonatal nurse
specialist: A registered nurse with a master's of science in nursing
degree and an area of specialization in perinatal care to provide clinical
nursing expertise commensurate with the patient acuity and services provided.
The registered nurse required by paragraph (G)(3) of rule 3701-22-25 of the
Administrative Code may meet this standard with sufficient perinatal
expertise; (5) A director of
obstetric anesthesia services who is a board-eligible or board-certified
anesthesiologist; and (6) A geneticist or
genetics counselor who is certified by the American college of medical genetics
or eligible for such certification to: (a) Identify families at risk for genetic
abnormalities; (b) Obtain family genetic history; (c) Provide genetic counseling in complicated cases;
and (d) If necessary, refer complicated cases to an on-staff
medical geneticist. (K) Specialists. In addition to the
standards set forth in paragraph (H) of rule 3701-22-25 of the Administrative
Code, each freestanding children's hospital with a level IV neonatal care
service and a level III obstetrical service will have medical, surgical,
radiological and pathology specialists either on-site or on-call based on the
medical needs of adult obstetric patients. (L) Sub-specialists. In addition to the
standards set forth in paragraph (I) of rule 3701-22-25 of the Administrative
Code, each freestanding children's hospital with a level IV neonatal care
service and a level III obstetrical service will have qualified sub-specialists
available for consultation, and, if necessary, adult obstetric patient care
either on-site or at a nearby closely related hospital or institution,
appropriate for the services provided and based upon the medical needs of the
patient, that may include medical-surgical sub-specialists: (1) Maternal-fetal
medicine; (2) Critical
care; (3) General
surgery; (4) Infectious
disease; (5) Hematology; (6) Cardiology; (7) Nephrology;
and (8) Neurology. (M) For every anticipated low-risk
delivery or uncomplicated delivery with higher-risk conditions, each provider
will have an obstetrician, physician, or certified nurse midwife acting within
their scope of practice and under a standard care arrangement with a
collaborating physician, in attendance. (N) For an unanticipated high risk
delivery, every attempt will be made to secure a second physician or certified
nurse practitioner acting within their scope of practice and under a standard
care arrangement with a collaborating physician to care for the
neonate. (O) For every anticipated high-risk
delivery, each provider will have in attendance: (1) An obstetrician or
physician; (2) A second physician or
certified nurse practitioner acting within their scope of practice and under a
standard care arrangement with a collaborating physician to care for the
neonate; and (3) Members of the
multi-disciplinary team required by paragraph (R) of this rule, one of whom can
initiate resuscitation, and one of whom can complete full resuscitation. This
can be the same individual. (P) For every delivery with more complex
maternal or fetal conditions, each provider will have in
attendance: (1) An obstetrician or
maternal fetal medicine specialist capable of performing a cesarean
section; (2) A neonatologist or
physician to attend to the neonate; (3) Maternal-fetal
medicine or fetal surgeon, as appropriate, during operative procedures;
and (4) Members of the
multi-disciplinary team required by paragraph (R) of this rule, one of whom can
initiate resuscitation, and one of whom can complete full resuscitation. This
can be the same individual. (Q) Each freestanding children's
hospital with a level IV neonatal care service and a level III obstetric
service will ensure every newborn requiring mechanical ventilation or
continuous positive airway pressure has an initial evaluation done by a
physician, certified nurse practitioner, or physician assistant acting within
their scope of practice. If stable, qualified staff with experience in newborn
airway management and diagnosis and management of air leaks will be on-site to
care for such newborns. (R) In addition to the standards set
forth in paragraph (J) of rule 3701-22-25 of the Administrative Code, each
freestanding children's hospital with a level IV neonatal care service and
a level III obstetric service will have on-duty, qualified staff appropriate
for the services provided including at minimum: (1) Registered nurse
staffing, including: (a) At least two registered nurses competent in obstetric
and neonatal care for labor and delivery; (b) A registered nurse with obstetric and neonatal
experience for each patient in the second stage of labor; (c) A registered nurse to circulate for the cesarean
section deliveries; and (d) Additional registered nurses with the appropriate
education and demonstrated competence, commensurate with the acuity and volume
of patients served, to provide direct supervision of obstetric
patients. (2) At least one member
of the nursing staff to attend to newborns when they are not with the mother or
her designee; and (3) A multi-disciplinary
team, each of whom have successfully completed the neonatal resuscitation
program and can initiate resuscitation. One member of the multi-disciplinary
team will be able to complete full resuscitation. (S) If the provider utilizes licensed
practical nurses (LPNs) or nonlicensed direct care providers to support the
clinical nursing staff, the facility will: (1) Have written criteria
that define the LPN's or nonlicensed direct care provider's scope of
obstetric or neonatal care; (2) Provide annual
education specific to the care of the obstetric and neonatal population served;
and (3) Have a written
staffing plan that establishes collaborative work assignments in accordance
with the facility's policies and procedures. (T) If the provider utilizes physician
assistants (PA): (1) Physician supervision
for the PA will be provided by: (a) A neonatologist or pediatrician when the PA is
providing care to a neonate; or (b) An obstetrician or maternal-fetal medicine physician
when the PA is providing care to the obstetric patient. (2) The PA will have
appropriate education and demonstrated competence, commensurate with the acuity
and volume of patients served, to provide direct supervision of newborns;
(3) The PA is responsible
for maintaining clinical expertise and knowledge of current therapy by
participating in continuing medical education and scholarly
activities; (4) The PA will maintain
national certification, including one hundred hours of continuing medical
education every two years and a recertification exam given by the
"National Commission on Certification of Physician Assistants" every
ten years; (5) The level III or
level IV service will maintain written criteria that define the PA's scope
of obstetric or neonatal care; and (6) The PA is involved
with providing care to the neonatal patient, the PA must be current on neonatal
resuscitation.
Last updated September 2, 2025 at 8:37 AM
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Rule 3701-22-28 | Newborn nutrition.
Effective:
August 31, 2025
(A) Each maternity unit or newborn care
nursery will develop and follow written service plans for the
following: (1) Administration of
donor human milk and donor human milk products, if used, including protocols,
equipment, and supplies for the administration of donor milk and donor milk
products to newborns requiring intervention; and (2) Maintenance of
newborn nutrition services to ensure that newborn nutritional needs are
met. (B) Each maternity unit or newborn care
nursery that provides parenteral nutrition will develop and follow a written
service plan for the preparation and administration of parenteral nutrition,
including: (1) Appropriate
staff; (2) Equipment; (3) Supplies;
and (4) A laminar flow hood,
which need not be located in the newborn care nursery. (C) If the maternity unit or newborn care
nursery does not provide for on-site preparation of parenteral nutrition, the
maternity unit or newborn care nursery will develop and follow a written
service plan for the outsourcing of the preparation of parenteral
nutrition. (D) Each maternity unit or newborn care
nursery will provide the necessary support to assess and monitor patients
receiving parenteral nutrition. (E) Maternity units and newborn care
nurseries using commercial formula, human milk, donor human milk, or donor
human milk products, will provide for the storage and handling of the formula,
human milk, donor human milk, donor human milk products, or any combination
thereof. (F) Maternity units and newborn care
nurseries that prepare newborn formula on-site will provide an appropriately
equipped, designated feeding preparation area. If any formula or human milk
requires the addition of more than two measured ingredients, or requires the
addition of an ingredient not routinely available in a nursery, a separate
formula room will be provided and maintained in accordance with guidelines
issued by the American dietetic association. (1) The formula room may
be an area outside the maternity unit or newborn care nursery that is on-site
and has qualified staff and policies and procedures for the safe handling of
commercial formulas, human milk, donor human milk, and donor human milk
products for formula preparation. (2) The formula room may
include outsourcing from the facility that has an enteral formulary room and
has qualified staff and policies and procedures for the safe handling of
commercial formulas, human milk, donor human milk, and donor human milk
products for formula preparation.
Last updated September 2, 2025 at 8:38 AM
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Rule 3701-22-29 | Record keeping.
Effective:
August 31, 2025
(A) Medical record. Each maternity unit
or newborn care nursery will maintain a medical record for each patient that
documents, in a timely manner and in accordance with acceptable standards of
practice, the patient's needs and assessments, and services rendered. Each
medical record will be legible and readily accessible to staff for use in the
ordinary course of treatment. (B) Each maternity unit will maintain
delivery logs that includes the following, if known at the time of
delivery: (1) Maternal
name; (2) Admission
date; (3) Estimated date of
confinement; (4) Membrane rupture date
and time; (5) Type of anesthesia,
to include: (a) Epidural; (b) General; (c) Local; or (d) Spinal. (6) Type of delivery, to
include: (a) Cesarean section; (b) Forcep; (c) Trial of labor after cesarean; (d) Vaginal; or (e) Vacuum. (7) Delivery date and
time; (8) Newborn's
weight; (9) Apgars; (10) Gestational age;
and (11) Complications, if
any, to include: (a) Delivery and postpartum problems; (b) Diabetes (gestational); (c) Emergency cesarean section; (d) Hemorrhage; (e) Known fetal anomalies; (f) Placenta previa; (g) Placental abruption; (h) Preeclampsia; (i) Gestational hypertension; or (j) Uterine rupture. (C) A provider may keep the delivery log
set forth in paragraph (B) of this rule on an electronic system that makes the
necessary information readily accessible to the director. (D) Each maternity unit or newborn care
nursery will not disclose individual medical records except as authorized by
the patient, the parent or guardian of an infant or minor, or as allowed by
state and federal laws and regulations, including but not limited to the
provisions of this chapter of the Administrative Code. (E) Each maternity unit or newborn care
nursery will: (1) Systematically review
records for conformance with acceptable standards of practice and the standards
established by this chapter of the Administrative Code; (2) Maintain an adequate
medical record-keeping system and take appropriate measures to ensure the
confidentiality of patient medical records; (3) Maintain fetal
monitoring strips in a format that maintains the record for the period of time
mandated for medical record retention; and (4) Maintain medical
records as necessary to verify the information and reports obligated by statute
or regulation for five years from the date of discharge.
Last updated September 2, 2025 at 8:38 AM
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Rule 3701-22-30 | Health care service notification requirements.
Effective:
August 31, 2025
(A) At least thirty days prior to
initiating a new HCS or reactivating a discontinued or temporarily suspended
HCS the hospital will notify the director in writing, in a manner prescribed by
the director, of its intentions to initiate the service. This notice will
contain: (1) The name, address,
and telephone number of the hospital where the HCS is located; (2) The type of HCS which
the hospital is seeking to initiate including the scope of services to be
provided; and (3) The projected date of
initiation. (B) Prior to initiating a new HCS or
reactivating a discontinued or temporarily suspended HCS, the hospital will
file with the director: (1) An attestation of
compliance, with the applicable provisions of this chapter for the HCS to be
initiated or reinstated. The attestation will be signed by the medical director
of the HCS and the service manager of the HCS; and (2) An attestation that
to the best of the knowledge of the individual signing the attestation, the
information in the attestation and any accompanying material is true and
accurate. (C) The HCS will submit a revised
attestation within thirty days of the following: (1) Change of medical
director; or (2) Change of service
manager who previously signed an attestation. (D) If the director determines that the
HCS has failed to demonstrate compliance with the provisions of this chapter,
the director may take action under rule 3701-22-05 of the Administrative
Code. (E) At least thirty days prior to a
change in the scope of the HCS, the hospital will notify the director in
writing of its intentions to change the scope of service and the specific
changes to be implemented. (F) Within thirty days of recognizing
that a HCS is not in compliance with applicable criteria, standards or
provisions of this chapter, the hospital will notify the director in writing
of: (1) The criteria,
standard or requirement not met; (2) The reason for
failure to meet the criteria, standard or requirement; (3) The corrective action
that will be taken; and (4) The time table for
meeting the criteria, standard or requirement. (G) At least thirty days prior to
discontinuing a HCS, the hospital will notify the director in writing of its
intentions to discontinue the service. If the discontinuation is out of the
control of the hospital and the thirty day requirement in this paragraph cannot
be met, the written notice will be given prior to discontinuing the service and
include the projected date of discontinuance.
Last updated September 2, 2025 at 8:38 AM
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Rule 3701-22-31 | Solid organ transplant service standards.
Effective:
August 31, 2025
(A) Each solid organ transplant service
will provide services in a manner that meets or exceeds the conditions of
participation set forth in Title 42 CFR Part 482, 482.72 to
482.104. (B) Each solid organ transplant service
will be located in a transplant hospital that is a member of and abides by the
rules and requirements of the organ procurement and transplantation network
(OPTN) established and operated in accordance with section 372 of the Public
Health Service (PHS) Act, 42 U.S.C. 274, (November 21, 2013). (C) Each solid organ transplant service
will: (1) Demonstrate an
institutional commitment to graduate medical education and research
programs; (2) Execute letters of
agreement or contracts with an independent organ procurement organization which
can provide sufficient numbers of organs to support the applicable volume goals
consistent with Title 42 CFR 482.80 and 482.82; (3) Ensure that kidney
transplant services are a member of the appropriate end-stage renal disease
coordinating council designated for the medicare program under 42 C.F.R.
405.2110 (August 26, 1986); (4) Develop a procedure
to evaluate access for the uninsured or financially indigent patient;
and (5) Have written patient
management policies and protocols for organ transplantation,
including: (a) Detailed plans for the acute and long-term management
of each transplant patient by a multidisciplinary care team, including the
waiting period, in-hospital phase, and immediate post-discharge
period; (b) Transplant experienced social services available to the
patient and the patient's family at all times; (c) Appropriate and thorough education of the
patient; (d) Liaison with the patient's primary care physician
to provide timely notification of changes in the patient's condition;
and (e) If the solid organ transplant service performs living
donor transplants, detailed plans for the donor, that include the evaluation,
donation, and discharge phases of living organ donation.
Last updated September 2, 2025 at 8:38 AM
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Rule 3701-22-32 | Patient selection criteria.
Effective:
August 31, 2025
(A) An extra-renal, solid organ
transplant service will use written patient selection criteria in determining a
patients suitability for placement on the waiting list or a patient's
suitability for transplantation. (B) Patient selection criteria will
comply with the organ procurement and transplantation network (OPTN) organ
allocation priorities and be based on objective medical criteria. (C) Patient selection criteria will
include a psychosocial evaluation. (D) Patient selection criteria will
ensure a fair non-discriminatory distribution of organs and be in compliance
with centers for medicare and medicaid services (CMS) and OPTN
oversight. (E) Documentation of the patient
selection criteria utilized will be included in the patient's medical
record.
Last updated September 2, 2025 at 8:38 AM
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Rule 3701-22-33 | Utilization levels - solid organ transplant services.
Effective:
August 31, 2025
(A) Each solid organ transplant service
designated as an adult or combined adult/pediatric transplant service
performing surgeries in a single hospital or university multi-hospital
transplant service, should achieve volume goals consistent with Title 42 CFR
482.80 and 482.82 to ensure efficiency and a minimum floor of
competency. (B) Volume goals may be considered by the
director in conjunction with other indicators of quality, not as the sole
indicator of service performance. (C) The following solid organ transplant
services are not subject to volume goals: (1) Heart-lung; (2) Intestinal; (3) Pancreas;
and (4) Pediatric.
Last updated September 2, 2025 at 8:39 AM
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Rule 3701-22-34 | Bone marrow transplantation service standards.
Effective:
August 31, 2025
(A) The provisions of rules 3701-22-34 to
3701-22-37 of the Administrative Code are applicable to each blood and bone
marrow transplant service regardless of the date service was
initiated. (B) Each blood and bone marrow
transplantation service will be located in a hospital classified as a general
hospital, a children's hospital or as a specialty hospital that primarily
furnishes oncology services that meets all of the following
criteria: (1) Participates with
other hospitals nationally in cancer treatment research, such as national
cancer institute sponsored research. The hospital's research activities
should include all of the following: (a) Use of uniform patient treatment
protocols; (b) On-site audits at least every five years by a cancer
research organization or another hospital involved in national cancer treatment
research; and (c) Reporting of patient eligibility and treatment data to
the research organization in which the hospital participates. (2) Meets the following
administrative requirements: (a) Appropriate patient management plans and protocols
consistent with nationally accepted standards, including: (i) Patient selection
criteria; (ii) Plans for long-term
management; (iii) Protocols to
address the prevention of opportunistic infections among blood and bone marrow
transplant recipients; and (iv) Protocols for
liaising with the patient's family and primary care
physician. (b) Quality assurance standards for the procurement of
hematopoietic stem cells including the procurement of bone marrow via a bone
marrow harvest, as well as procurement of hematopoietic progenitor cells (stem
cells) by the use of leukapheresis or umbilical cord blood collection;
and (c) Has a documented
agreement to cooperate with other blood and bone marrow transplantation
services in Ohio relative to patient selection that is non-discriminatory as to
race, gender, and ability to pay. (C) Prior to initiating transplantation
services, the blood and bone marrow transplantation service will specify to the
director: (1) The type of patient
population to be served: (a) Pediatric patients aged seventeen years or
younger; (b) Adult patients aged eighteen or older; and
(c) A blood and bone marrow transplantation service may
serve patients greater than or equal to eighteen years of age as a pediatric or
an adult patient, whichever best serves the needs of the patient, as determined
by the transplant physician and transplant service's medical
director. (2) The type of
transplantation service: (a) Autologous; (b) Allogeneic; or (c) Both.
Last updated September 2, 2025 at 8:39 AM
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Rule 3701-22-35 | Personnel/staffing - bone marrow transplantation service.
Effective:
August 31, 2025
(A) A medical director responsible for
the oversight of the care provided on the unit who actively performs blood and
bone marrow transplant services as part of that transplant service and who
is: (1) Board-certified in
hematology, oncology, immunology, or pediatric hematology/oncology or have
documented experience in the field of hematopoietic progenitor cell (HPC)
transplantation extending over ten years; (a) In lieu of board certification: A physician who is
board-certified by a foreign board and is eligible to take the examination of
an American board of medical specialties recognized board or an American
osteopathic association board may serve as medical director of an HCS;
or (b) In accordance with rule 3701-22-19 of the
Administrative Code, an HCS may request a waiver from the department of health
for physicians who are board-certified by a foreign board who are not eligible
to take the examination of an American board of medical specialties recognized
board or an American osteopathic association board. (2) An active physician
on staff at the hospital providing the blood or bone marrow transplant who is
involved in direct patient care; and (3) Has a minimum of one
year in clinical blood and bone marrow transplantation training at a transplant
center in the United States formally recognized as a blood and bone marrow
transplant center by at least one of the following: (a) A national cooperative chemotherapy group; (b) The national bone marrow donor program; or (c) A national institute of health-supported blood and bone
marrow transplant research program. (B) At a minimum, one other primary
transplantation physician actively participating in the service. (C) A nursing team that, in order to
ensure adequate continuity of care, is committed to the transplant service on a
full-time basis and has the training and skills to commensurate with the
required tasks performed. (D) The care of blood and bone marrow
transplant patients will be coordinated by a multidisciplinary team whose
members have training and skills to commensurate with the required tasks
performed.
Last updated September 2, 2025 at 8:39 AM
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Rule 3701-22-36 | Facilities/safety standards - bone marrow transplantation service.
Effective:
August 31, 2025
(A) The hospital at which the blood and
bone marrow transplant service is located will provide all of the following on
site: (1) A designated blood
and bone marrow transplant unit with a sufficient number of beds to meet the
needs of the transplant service; (2) Active departments or
sections in hematology/oncology, immunology and infectious
diseases; (3) Laboratories; (4) Adequate intensive
care facilities; (5) Protective reverse
isolation rooms with appropriate air handling characteristics (i.e.,
hepa-filtered positive pressure patient rooms); (6) Radiologic services
including, but not limited to, tomography, computed tomography (CT) scans
and/or magnetic resonance imaging (MRI) scans; (7) Radionuclide scans
and ultrasonography; (8) Immunopathology and
hepatopathology; (9) Histopathology; (10) Microbiology
laboratory; (11) Blood banking
services capable of routinely providing irradiated blood products appropriate
for cytomegalovirus (CMV) seronegative patients; (12) Clinical
pharmacology services with a pharmacist familiar with antineoplastic
agents; (13) Modern radiotherapy
capabilities including the ability to provide total body irradiation either
on-site or through agreement or contract with another hospital; (14) Operating room
facilities; and (15) Echocardiography or
multigated blood-pool imaging (MUGA) scan capability. (B) Each blood and bone marrow
transplant service will have the following readily available: (1) Tissue-typing
laboratory; (2) Apheresis capability
with adequate blood cell component therapy and routine access to a blood
irradiator; and (3) Facilities to
cryopreserve hematopoietic stem cells for transplantation and which
additionally may be used to manipulate hematopoietic stem cells
ex-vivo.
Last updated September 2, 2025 at 8:39 AM
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Rule 3701-22-37 | Patient selection/utilization - blood and bone marrow transplantation service.
Effective:
August 31, 2025
(A) All candidates for blood and bone
marrow transplantation are subject to prospective patient selection criteria as
specified in appendix A to this rule. (B) If a transplantation service desires
to perform a transplant on a patient who does not meet the selection protocols
set forth in appendix A to this rule, the service is obligated to undertake a
thorough review of the case, conducted by a blood and bone marrow transplant
team comprised of members of the service's ethics, legal, and medical
staff, to determine that the transplant is appropriate and
include: (1) Preparation of a
detailed clinical summary of the patient that includes: (a) A brief medical history; (b) Complete laboratory data related to the
diagnosis; (c) A thorough psychosocial evaluation that
includes: (i) The identification of
the patient's support system, including potential caregivers; (ii) Identification of
psychosocial barriers; (iii) Identification of
potential barriers and challenges of the transplant; and (iv) The patient's
attitude toward the transplant, the patient's understanding of the
transplant, and the patients understanding of the treatment, including whether
the intention is to be palliative or curative. (d) A justification of the transplant despite failure to
meet the selection criteria; and (2) After sufficient
review time, an affirmative vote of a majority of the members of the team that
the transplant is appropriate. (C) Each blood and bone marrow
transplantation service should achieve the following volume goals per year to
ensure efficiency and a minimum floor of competency: (1) Adult blood and bone
marrow transplantation service performing transplants at a single clinical
site: (a) Autologous only transplantation services should perform
an average of at least five autologous transplants per year; or (b) Combined autologous and allogeneic services should
perform an average of at least ten allogeneic transplants per
year. (2) Adult blood and bone
marrow transplantation service performing transplants at multiple clinical
sites: (a) Autologous only transplantation services should perform
an average of at least five autologous transplants per year at each site;
or (b) Combined autologous and allogeneic transplantation
services should perform an average of at least five autologous and five
allogeneic transplants per year at each site. (3) Pediatric blood and
bone marrow transplantation service performing transplants at a single clinical
site: (a) Autologous only transplantation services should perform
an average of at least five autologous transplants per year; or (b) Combined autologous and allogeneic services should
perform an average of at least five allogeneic and five autologous transplants
per year. (4) Pediatric blood and
bone marrow transplantation service performing transplants at multiple clinical
sites: (a) Autologous only transplantation services should perform
an average of at least five autologous transplants per year at each site;
or (b) Combined autologous and allogeneic transplantation
services should perform an average of at least five autologous transplants per
year at each site. (5) Combined adult and
pediatric blood and bone marrow transplantation services performing transplants
at a single clinical site: (a) Autologous only transplantation services should perform
an average of at least five pediatric autologous transplants and five adult
autologous transplants per year; or (b) Combined autologous and allogeneic services should
perform an average of at least five pediatric allogeneic transplants and five
adult allogeneic transplants per year. (6) Combined adult and
pediatric blood and bone marrow transplantation services performing transplants
at multiple clinical sites: (a) Autologous only transplantation services should
perform an average of at least five autologous transplants per year at each
site; or (b) Combined autologous and allogeneic transplantation
services should perform an average of at least five pediatric and five adult
autologous transplants per year and and at least five pediatric allogeneic and
five adult allogeneic transplants per year at each site. (D) Volume goals may be considered by the
director in conjunction with other indicators of quality and not as the sole
indicator of service performance.
Last updated September 2, 2025 at 8:39 AM
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Rule 3701-22-38 | General adult cardiac catheterization service standards.
Effective:
August 31, 2025
(A) The provisions of rules 3701-22-38 to
3701-22-42.1 of the Administrative Code are applicable to each provider of
cardiac catheterization services performing procedures on adult patients
greater than or equal to eighteen years of age. An adult cardiac
catheterization service may serve a patient less than eighteen years of age if
the patient's attending physician and the adult service's medical
director determine that the adult service best serves the needs of the
patient. (B) Each provider of cardiac
catheterization services will: (1) Designate in writing
to the director the service level classification, as defined in this chapter,
it provides or intends to provide; (2) Designate in writing
to the director the scope of services, including the number of procedure and
control rooms, provided within the service level classification; (3) Meet the requirements
of this chapter for the service level classification designated;
and (4) Not hold itself out
to any person or government entity by means of signage, advertising, or other
promotional efforts as having a service level classification for which it is
not designated. (C) Each provider of cardiac
catheterization services will have an established written protocol for the
emergency transfer and care of patients who require emergency medical/surgical
management during or immediately after cardiac catheterization. (D) Each provider of cardiac
catheterization services will have immediate access to services for hematology
and coagulation disorders, electrocardiography, and diagnostic radiology.
Access to clinical pathology, nuclear medicine and nuclear cardiology,
doppler-echocardiography, pulmonary function testing, and microbiology will be
available within a reasonable amount of time to meet the needs of the
service. (E) Each provider of cardiac
catheterization services will establish and maintain a quality assessment
review process, including methodology, for reviewing the quality of cardiac
catheterization procedures performed by each physician credentialed to perform
such procedures. The review methodology will, at a minimum, assess the
following: (1) Appropriateness of
cardiac catheterization studies and interventions; (2) Technical quality of
cardiac catheterization studies; (3) Procedure
result; (4) Rate of therapeutic
success; and (5) Rate of procedural
complications. (F) Each provider of cardiac
catheterization services will have explicit criteria based upon current
recommendations of recognized professional societies and accrediting bodies,
specifying the number of times a year an appropriately privileged physician
will perform each catheterization procedure in order to retain privileges to
perform that procedure. (G) Each provider of cardiac
catheterization services will conduct an ongoing review of all cases with
mortality or significant morbidity within sixty days of the
procedure. (H) Each provider of cardiac
catheterization services will establish and maintain a database to support the
review process detailed in paragraph (E) of this rule. The results of analysis
and review will be documented and used to guide periodic random and selected
peer reviews of individual physicians with respect to maintaining their
credentials to perform specific cardiac catheterization
procedures. (I) Adult cardiac catheterization service
will only be provided in a fully permanent setting within the permanent frame
of the building of a licensed hospital that is classified as a general hospital
or a special hospital-cardiac that primarily furnishes limited services to
patients with cardiac conditions. The hospital will: (1) Operate inpatient
medical and surgical services in the same building and accessible by gurney
from the cardiac catheterization laboratory; (2) Operate an
intensive/critical care unit with licensed special care beds, that
is: (a) Reviewed and accredited or certified as such as part
of the hospital's accreditation or certification program in the same
building; (b) Accessible by gurney from the cardiac catheterization
laboratory; and (c) The unit will provide appropriate equipment and staff
to care for coronary patients and have twenty-four hour monitoring
capability. (3) Provide a setting in
the same building as the adult cardiac catheterization laboratory in which
ambulatory cardiac catheterization patients can be observed for at least two to
six hours after the procedure depending on the access site and the nursing
assessment of the patient; and (4) Provide adequate
physician coverage to manage post-procedure complications. (J) For the purpose of rules 3701-22-38
to 3701-22-42.1 of the Administrative Code the following references are defined
and all documents are available at www.acc.org: (1) "2012 expert
consensus document" means 2012 American college of cardiology
foundation/society for cardiovascular angiography and interventions expert
consensus document on cardiac catheterization laboratory standards update (June
12, 2012); (2) "2014 expert
consensus document" means the 2014 society for cardiovascular angiography
and interventions/American college of cardiology/American heart association
expert consensus document update on percutaneous coronary intervention without
on-site surgical backup (June 17, 2014); (3) "Table 2:
support services" means 2012 American college of cardiology
foundation/society for cardiovascular angiography and interventions expert
consensus document on cardiac catheterization laboratory standards update,
table 2: optimal (recommended) on-site support services for invasive cardiac
procedures (June 12, 2012). (4) "Table 3:
facility requirements" means 2014 society for cardiovascular angiography
and interventions/American college of cardiology/American heart association
expert consensus document update on percutaneous coronary intervention without
on-site surgical backup, table 3: facility requirements for percutaneous
coronary intervention programs without on-site surgery (June 17,
2014); (5) "Table 4:
personnel recommendations" means 2014 society for cardiovascular
angiography and interventions/American college of cardiology/American heart
association expert consensus document update on percutaneous coronary
intervention without on-site surgical backup, table 4: personnel
recommendations (June 17, 2014); (6) "Table 5:
general exclusion criteria" means the 2012 American college of cardiology
foundation/society for cardiovascular angiography and interventions expert
consensus document on cardiac catheterization laboratory standards update,
table 5: general exclusion criteria for invasive cardiac procedures in a
setting without cardiothoracic surgery (June 12, 2012); (7) "Table 5:
recommendations for off-site surgical backup and case selection" means the
2014 society for cardiovascular angiography and interventions/American college
of cardiology/American heart association expert consensus document update on
percutaneous coronary intervention without on-site surgical backup, table 5:
recommendations for off-site surgical backup and case selection (June 17,
2014); and (8) "Table 6:
patient and lesion characteristics" means the 2014 society for
cardiovascular angiography and interventions/American college of
cardiology/American heart association expert consensus document update on
percutaneous coronary intervention without on-site surgical backup, table 6:
patient and lesion characteristics that could be unsuitable for nonemergency
procedures at facilities without an on-site cardiac surgery (June 17,
2014); (K) For the purpose of rules 3701-22-38
to 3701-22-42.1 of the Administrative Code, major bleeding is defined
as: (1) Bleeding event within
seventy-two hours; (2) Hemorrhagic
stroke; (3) Tamponade; (4) Post-PCI transfusion
for patients with a pre-procedure hemoglobin >8 g/dL; or (5) Absolute hemoglobin
decrease from pre-PCI to post-PCI of >= 3 g/dl and pre- procedure
hemoglobin=<16 g/dL.
Last updated September 2, 2025 at 8:40 AM
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Rule 3701-22-38.1 | Level I cardiac catheterization service standards.
Effective:
August 31, 2025
(A) Level I cardiac catheterization
service or "level I service" means an adult cardiac catheterization
service located in a hospital without an on-site open-heart surgery service
that provides only diagnostic cardiac catheterization procedures on an
organized regular basis. (B) Each level I service will perform
only diagnostic cardiac catheterization procedures to diagnose anatomical
and/or physiological problems in the heart. Diagnostic cardiac catheterization
procedures include: (1) Intracoronary
administration of drugs; (2) Left heart
catheterization; (3) Right heart
catheterization; (4) Coronary
angiography; (5) Basic diagnostic
electrophysiology studies not involving transseptal puncture; (6) Intra-aortic balloon
pump or, if required for patient stabilization for transfer, placement of
percutaneous left ventricular assist device; and (7) Device implantation,
including, but not limited to defibrillators. (C) Each level I service will implement
patient exclusion criteria consistent with the 2012 table 5: general exclusion
criteria. (D) Each level I service will comply with
the personnel and staffing requirements set forth in rule 3701-22-39 of the
Administrative Code. (E) Each level I service will comply with
the facilities, equipment, and supplies requirements set forth in rule
3701-22-40 of the Administrative Code. (F) Each level I service will comply with
the safety standards set forth in rule 3701-22-41 of the Administrative
Code. (G) Each level I service will maintain a
formal written transfer protocol for emergency medical/surgical management with
a licensed hospital that provides open-heart surgery services, which can be
reached expeditiously from the level I service by available emergency vehicle
within a reasonable amount of time and that provides the greatest assurance for
patient safety. The open-heart surgery service that is party to a transfer
protocol is referred to as the receiving service. Each protocol will include,
but not be limited to: (1) Provisions addressing
indications, contraindications, and other criteria for the emergency transfer
of patients in a timely manner; (2) Assurance of the
initiation of appropriate medical/surgical management in a timely
manner; (3) Assurance that
surgical back-up is available for urgent cases at all hours; (4) Specification of
mechanisms for continued substantive communication between the services party
to the agreement and between their medical directors and
physicians; (5) Provisions for
collaborative training programs among staff of the services party to the
agreement, including the cardiologists from the level I service and the
cardiologist/cardiothoracic surgeon(s) from the receiving service; (6) Provisions for the
recommendation by the medical director of the receiving service, regarding the
cardiac catheterization service's credentialing criteria; and (7) Provisions for annual
drilling activities to review and test the components of the written transfer
protocol. An actual emergent patient transfer consistent with the written
transfer protocol within the calendar year meets the requirement for an annual
drill. (H) Major complications and emergency
transfers should be reviewed at least once every sixty days by the quality
assessment review process required in paragraph (E) of rule 3701-22-38 of the
Administrative Code and rule 3701-22-11 of the Administrative
Code. (I) Reporting: (1) Each level I service
will submit the following information to the department by June first of each
year that: (a) Maintains patient confidentiality; (b) Includes the numbers for the following: (i) Diagnostic cardiac
catheterization and electrophysiology studies as provided in paragraphs (B)(1)
to (B)(7) of this rule conducted in a cardiac catheterization procedure
room; (ii) Diagnostic
electrophysiology studies as provided in paragraphs (B)(1) to (B)(7) of this
rule conducted in an cardiac catheterization laboratory or an electrophysiology
procedure room; (iii) Post-procedure
in-hospital mortality number; (iv) Vascular access
injury requiring surgery or other intervention; (v) Major bleeding as
defined in paragraph (K) of rule 3701-22-38 of the Administrative
Code; (vi) Emergent transfers
to the receiving service for interventional medical management that became
necessary as a result of the cardiac catheterization or electrophysiology study
during or immediately after the cardiac catheterization or electrophysiology
study; and (vii) Emergency PCI
procedures performed when clinically indicated and reported to the department
in accordance with paragraph (K) of this rule. (J) Prior to performance of a diagnostic
procedure, each level I service will obtain a signed informed consent form that
includes an acknowledgment by the patient that the diagnostic procedure is
being performed in a cardiac catheterization service without an on-site
open-heart surgery service and an acknowledgment that, if necessary as the
result of an adverse event, the patient may be transferred to a receiving
service for medical/surgical management. (K) Nothing in this rule will prohibit
the provision of emergency care, including an emergent PCI, when clinically
indicated. The service will provide notice to the department within forty-eight
hours of any incident requiring action outside the scope of services authorized
to be performed at the level I designation and ensure the
notification: (1) Maintains patient
confidentiality; (2) Indicates when the
incident occurred; (3) Describes the nature
of the emergency and what actions were taken; and (4) Includes the
outcome.
Last updated September 2, 2025 at 8:40 AM
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Rule 3701-22-38.2 | Level II cardiac catheterization service standards.
Effective:
August 31, 2025
(A) Level II cardiac catheterization
service or "level II service" means an adult cardiac catheterization
service located in a hospital without an on-site open-heart surgery service
that provides only diagnostic and authorized therapeutic cardiac
catheterization procedures on an organized and regular basis. (B) Level II services are prohibited from
providing the following procedures: (1) Transcatheter aortic
valve replacement (TAVR); (2) Revascularization of
chronic total occlusion (CTO); (3) Rotational coronary
artherectomy; (4) Alcohol septal
ablation; (5) Cardiac
biopsy; (6) Mitral valve
clip; (7) Transcatheter mitral
valve (TMV) repair or replacement; (8) Laser lead
extraction; (9) Atrial septal defect
(ASD), patent foramen ovale (PFO), and ventricular septal defect (VSD)
closure; (10) Balloon aortic
valvuloplasty; (11) PCI of last
remaining coronary artery; (12) Left atrial
appendage closure; (13) Ventricular
tachycardia ablation; (14) Lead extractions;
and (15) Multivessel PCI in
the setting of severe left ventricular dysfunction. (C) Each level II service will have
provided at least one year of service performing diagnostic cardiac
catheterizations prior to providing notice to the director of their intent to
provide level II services. Accelerated designation may be granted to a service
on a case-by-case basis by the director and not be construed as constituting
precedent for the granting of an accelerated designation for any other service
provider. (D) Level II services will: (1) Implement patient
screening criteria consistent with the 2014 expert consensus
document: (a) Table 5: recommendations for off-site surgical backup
and case selection; and (b) Table 6: patient and lesion
characteristics. (2) Ensure that the
medical director for the level II service monitors and ensures strict adherence
to the patient selection criteria and treatment protocols. (E) In addition to the general personnel
and staffing requirements set forth in rule 3701-22-39 of the Administrative
Code, each level II service will: (1) Provide nursing and
laboratory staff consistent with the 2014 expert consensus document, table 4:
personnel recommendations; and (2) Maintain personnel
capable of endotracheal intubation and ventilator management within their scope
of practice, both on-site and during transfer of the patient if
necessary. (F) In addition to the general
facilities, equipment, and supplies requirements set forth in rule 3701-22-40
of the Administrative Code, each level II service will have, at a minimum,
equipment consistent with the 2014 expert consensus document, table 3: facility
requirements. (G) Each level II service will comply
with the safety standards set forth in rule 3701-22-41 of the Administrative
Code. (H) Each level II service will maintain a
formal written transfer protocol for emergency medical/surgical management with
a licensed hospital that provides open-heart surgery services, which can be
reached expeditiously from the level II service by available emergency vehicle
within a reasonable amount of time and that provides the greatest assurance for
patient safety. The open-heart surgery service that is party to a transfer
protocol is referred to as the receiving service. Each protocol will
include: (1) Provisions addressing
indications, contraindications, and other criteria for the emergency transfer
of patients in a timely manner; (2) Assurance of the
initiation of appropriate medical/surgical management in a timely
manner; (3) Assurance that
surgical back-up is available for urgent cases during all hours of
operation; (4) Specification of
mechanisms for continued substantive communication between the services party
to the agreement and between their medical directors and
physicians; (5) Provisions for a
collaborative training program among the staff of the services party to the
agreement, including the cardiologists from the level II service and the
cardiologist/cardiothoracic surgeon(s) from the receiving service; (6) Provisions for the
recommendation by the medical director of the receiving service, regarding the
cardiac catheterization service's credentialing criteria; and (7) Provisions for annual
drilling activities to review and test the components of the written transfer
protocol. An actual emergent patient transfer consistent with the written
transfer protocol within the calendar year meets the requirement for an annual
drill. (I) Each level II service will maintain a
formal written agreement with a ground and/or air ambulance service that can
commit to on-site availability within thirty minutes of notification and is
capable of advanced cardiac life support and intra-aortic balloon pump transfer
of a patient to the hospital party per the written transfer protocol required
by paragraph (H) of this rule. Ground and/or air ambulance service agreements
should be consistent with the recommendations set forth in the 2014 expert
consensus document, table 3: facility requirements. (J) Major complications and emergency
transfers should be reviewed at least once every sixty days by the quality
assessment review process required in paragraph (E) of rule 3701-22-38 of the
Administrative Code and rule 3701-22-11 of the Administrative
Code. (K) Each level II service will obtain
enrollment and maintain participation in a data registry to monitor operator
and institutional volumes and outcomes. (L) Reporting: Each level II service will
submit an annual report to the department by June first of each year
that: (1) Maintains patient
confidentiality; (2) Includes the numbers
for the following: (a) Cardiac catheterization procedures and
electrophysiology studies or procedures conducted in a cardiac catheterization
procedure room; (b) Electrophysiology studies or procedures conducted in an
a cardiac catheterization laboratory or an electrophysiology procedure
room; (c) Elective PCI; (d) Primary PCI; (e) Post-procedure in-hospital mortality
number; (f) Vascular access injury requiring surgery or other
intervention; (g) Major bleeding as defined in paragraph (K) of rule
3701-22-38 of the Administrative Code; (h) Emergent transfers to the receiving service for
interventional medical management, that became necessary as a result of the
cardiac catheterization procedure or electrophysiology study or procedure
during or immediately after a cardiac catheterization procedure or an
electrophysiology study or procedure; and (i) Emergency PCI procedures performed when clinically
indicated and reported to the department in accordance with paragraph (N) of
this rule. (M) Prior to the performance of any
procedure, each level II service will obtain a signed informed consent form
from each patient prior to performance of any procedure that includes an
acknowledgment by the patient that the procedure is being performed in a
cardiac catheterization service without an on-site open-heart surgery service
and an acknowledgment that, if necessary as the result of an adverse event, the
patient may be transferred to a receiving service for medical/surgical
management. (N) Nothing in this rule will prohibit
the provision of emergency care, including emergent PCI, when clinically
indicated. The service will provide notice to the department within forty-eight
hours of any incident requiring action outside the scope of services authorized
to be performed at the level II designation and ensure the
notification: (1) Maintains patient
confidentiality; (2) Indicates when the
incident occurred; (3) Describes the nature
of the emergency and what actions were taken; and (4) Includes the
outcome.
Last updated September 2, 2025 at 8:40 AM
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Rule 3701-22-38.3 | Level III adult cardiac catheterization service standards.
Effective:
August 31, 2025
(A) Level III cardiac catheterization
service or "level III service" means an adult cardiac catheterization
service located in a hospital with an on-site open-heart surgery service that
provides all levels of diagnostic and therapeutic cardiac catheterization
procedures. (B) Each level III service will operate
on an organized, regular, twenty-four hours a day, seven days a week basis to
perform primary PCI. (C) Each level III service will have
provided at least one year of service performing diagnostic cardiac
catheterizations prior to providing notice to the director of their intent to
provide level III services. Accelerated designation may be granted to a service
on a case-by-case basis by the director and not be construed as constituting
precedent for the granting of an accelerated designation for any other
service. (D) Each level III service will have the
following: (1) An on-site adult
open-heart surgery service available within the same hospital as the cardiac
catheterization laboratory and is immediately accessible from the cardiac
catheterization laboratory by gurney; (2) An experienced
cardiovascular surgical team that is readily available in less than sixty
minutes on a twenty-four hours a day basis in the event that emergency
open-heart surgery is required; and (3) Support services
consistent with the 2012 expert consensus document, table 2: support
services. (E) Each level III service will comply
with the personnel and staffing requirements set forth in rule 3701-22-39 of
the Administrative Code. (F) In addition to the general
facilities, equipment, and supplies requirements set forth in rule 3701-22-40
of the Administrative Code, each level III service will have: (1) One or more surgical
suites that are equipped to accommodate thoracic and cardiac surgical
procedures requiring cardiopulmonary bypass, with appropriate staff available
in less than sixty minutes; and (2) At a minimum,
equipment consistent with the 2014 expert consensus document, table: 3 facility
requirements. (G) Each level III service will comply
with the safety standards set forth in rule 3701-22-41 of the Administrative
Code. (H) Major complications and emergency
transfers should be reviewed at least once every sixty days by the quality
assessment review process required in paragraph (E) of rule 3701-22-38 of the
Administrative Code and rule 3701-22-11 of the Administrative
Code. (I) Each level III service will obtain
enrollment and maintain participation in a data registry to monitor operator
and institutional volumes, outcomes, and procedural
appropriateness. (J) Reporting: Each level III service
will submit an annual report to the department by June first of each year
that: (1) Maintains patient
confidentiality; (2) Includes the numbers
for the following: (a) Cardiac catheterization procedures and
electrophysiology studies or procedures conducted in a cardiac catheterization
procedure room; (b) Electrophysiology studies or procedures conducted in a
cardiac catheterization laboratory or an electrophysiology procedure
room; (c) Elective PCI; (d) Primary PCI; (e) Post-procedure in-hospital mortality
number; (f) Vascular access injury requiring surgery or other
intervention; and (g) Major bleeding as defined in paragraph (K) of rule
3701-22-38 of the Administrative Code. (K) Each level III service will obtain a
signed informed consent from each patient prior to the performance of any
procedure.
Last updated September 2, 2025 at 8:40 AM
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Rule 3701-22-38.4 | Adult electrophysiology procedure rooms.
Effective:
August 31, 2025
(A) Adult electrophysiology studies may
be conducted in any level adult cardiac catheterization laboratory or an
electrophysiology procedure room. (B) Procedure rooms where adult
electrophysiology studies are conducted will: (1) Have a minimum floor
area of three hundred fifty square feet; (2) Have the following
minimum clearances: (a) Sufficient footage on each side of the procedure table
to ensure that movement around and in the sterile field does not compromise or
contaminate the sterile field; and (b) Clearance at the head of the bed should be allocated
for anesthesia equipment on either side and sterile access to jugular vein
entry sites, if employed, while allowing for free range of movement of a
fluoroscopy C-arm. (3) Hybrid procedure
rooms where adult electrophysiology studies are conducted will meet the minimum
clear floor area and clearances of paragraphs (B)(1) and (B)(2) of this rule
and include at least the additional minimum clear floor area, clearances, and
storage requirements for the imaging equipment contained in the
room. (4) Provide the
following: (a) Positive airflow; (b) High flow oxygen and vacuum for
suctioning; (c) Medical gas availability; (d) Substerile scrub area; and (e) A patient post-procedural care area. (5) Provide adequate
utilities based upon the types of procedures and workload,
including: (a) Water taps; (b) Overhead and task lighting will be adequate to perform
electrophysiology procedures and for clinical evaluation and treatment of the
patient and include: (i) Overhead lighting
will be able to be dimmed during fluoroscopy; (ii) Lighting to flood
the main procedure area; and (iii) A dedicated
workspace light for the nursing/anesthesia area. (c) Electrical outlets; (d) Emergency power; (e) Telephones; (f) Heating and cooling; and (g) Ventilation. (C) The following equipment will be
available to each procedure room where adult electrophysiology studies are
conducted: (1) Electrogram
recording systems; (2) Programmed
stimulators; (3)
Defibrillator; (4) Electrocardiogram
and hemodynamic monitoring equipment; (5) Non-invasive blood
pressure monitor; (6) Supplies specific to
the procedure being performed; (7) Emergency equipment
and supplies; (8) If the procedure
requires fluoroscopy, radiation shielded barriers that meet state and federal
requirements are required; and (9) When determined
necessary, three-dimensional (3D) mapping systems may be provided by a service
onsite or through agreement or contract with another hospital. (D) Electrophysiology study numbers are
to be included in each adult cardiac catheterization service's annual
report of the number and type of procedures performed.
Last updated September 2, 2025 at 8:40 AM
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Rule 3701-22-39 | General personnel/staffing - adult cardiac catheterization service.
Effective:
August 31, 2025
(A) Each adult cardiac catheterization
service will designate a medical director. (B) The medical director of service
will: (1) Have at least five
years catheterization experience and recognized skills in the cardiac
catheterization laboratory; (2) Have performed at
least five hundred catheterizations; (3) Be an active
participant in the operation of the cardiac catheterization laboratory by
actively performing cardiac catheterization procedures in the cardiac
catheterization service where they are the medical director; and (4) Be responsible for
oversight of quality of care provided in the cardiac catheterization laboratory
and be an active participant in the cardiac catheterization laboratory's
quality assessment review process required by paragraph (E) of rule 3701-22-38
of the Administrative Code. (C) In addition to the requirements of
paragraph (B) of this rule, the medical director of a level II or level III
service will: (1) Be board-certified in
interventional cardiology or, in lieu of board-certification: (a) A physician who is board-certified by a foreign board
and is eligible to take the examination of an American board of medical
specialties recognized board or an American osteopathic association board may
serve as medical director of an HCS; or (b) In accordance with rule 3701-22-19 of the
Administrative Code, a HCS may request a waiver from the department of health
for physicians who are board-certified by a foreign board who are not eligible
to take the examination of an American board of medical specialties recognized
board or an American osteopathic association board. (2) Have at least five
years experience in interventional cardiology; or (3) Have performed, as
the primary operator, at least five hundred percutaneous coronary
interventions. (D) Each adult cardiac catheterization
service will have at least two licensed physicians credentialed to provide
cardiac catheterization services on staff who are knowledgeable of the
laboratory's protocols and equipment by providing cardiac catheterization
services at the hospital. Only physicians appropriately credentialed to provide
cardiac catheterization services may be the primary operator of a cardiac
catheterization procedure. (E) Each adult cardiac catheterization
service will consider the American college of cardiology/American heart
association/American college of physicians task force 2013 update of clinical
competence statement on coronary artery interventional procedures in assessing
clinical competency. At a minimum, all physicians who perform cardiac
catheterization procedures will: (1) Have training that
includes at least one year dedicated to cardiac catheterization
procedures; (2) Be a fully-accredited
member of the service's staff; and (3) Participate in the
cardiac catheterization laboratory's quality assurance programs, including
peer review. (F) In addition to requirements contained
in paragraph (E) of this rule, physicians performing percutaneous coronary
interventions (PCI) who have not performed PCI prior to March 20, 1997, will
have completed a fellowship training program in interventional
cardiology. (G) In addition to the requirements of
paragraphs (A), (B), and (D) of this rule, the adult cardiac catheterization
service will have available a sufficient number of qualified staff who are able
to supervise and conduct the service including the following: (1) Support staff, all of
whom are skilled in cardiac life support, comprised of individuals skilled in
the following: (a) Digital imaging; (b) Systematic quality control testing; (c) Patient observation; (d) Critical care; (e) Monitoring and recording electrocardiographic and
hemodynamic data; (f) Radiographic and angiographic imaging techniques and
safety principles; and (g) For catheterization laboratories where physiological
studies are performed: (i) Managing blood
samples; (ii) Performing blood gas
measurements and calculations; and (iii) Assisting with
indicator dilution studies. (2) Nursing
personnel: (a) May include nurse practitioners, registered nurses,
licensed practical nurses, and nursing assistants; (b) Nursing personnel involved in the provision of cardiac
catheterization services will: (i) Have knowledge of
operating room techniques; and (ii) Have experience in
critical care. The adult cardiac catheterization service will provide
nursing personnel with an orientation and training in critical care for the
adult cardiac catheterization patient and document the orientation and training
in the nurse's personnel record. (c) Nurse practitioners, registered nurses, and licensed
practical nurses involved in the provision of cardiac catheterization services
will: (i) Be advanced cardiac
life support certified; (ii) Have experience in
cardiovascular medications; and (iii) Have the ability to
begin administration of intravenous solutions. (d) Nurse practitioners may assume some of the duties of a
physician as permitted by law. However, ultimate responsibility for procedures
will always remain with the physician on record. (H) Respiratory therapists and critical
care staff will be immediately available at all times to care for
patients. (I) Biomedical, electronic, and radiation
safety experts will be involved in maintaining the equipment utilized by the
service. (J) Staffing requirements of this rule
may be met by individuals with equivalent or greater qualifications if the
replacement's scope of practice encompasses the duties of the required
staff.
Last updated September 2, 2025 at 8:41 AM
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Rule 3701-22-40 | General facilities, equipment, and supplies - adult cardiac catheterization service.
Effective:
August 31, 2025
(A) Each adult cardiac catheterization
service, or "service" will provide adequate, properly designed space
to perform cardiac catheterization procedures safely and effectively. The
amount of space may vary with the types of procedures performed and the nature
of the facility (e.g., interventional versus diagnostic, teaching versus
non-teaching). (B) Each service will utilize the
following: (1) Procedure rooms
will: (a) Have a minimum floor area of four hundred square
feet; (b) Have the following minimum clearances: (i) If anesthesia is
utilized, six feet at the head of the operating table. This dimension will
result in an anesthesia work zone with a clear floor area of six feet by eight
feet; and (ii) Sufficient footage
on each side of the procedure table to ensure that movement around and in the
sterile field does not compromise or contaminate the sterile
field. (c) Procedure rooms utilizing image-guided surgery or
procedures requiring more space for personnel or equipment will be sized to
accommodate the personnel and equipment planned to be in the room during
procedures and have a minimum floor area of six hundred square feet with a
minimum clear dimension of twenty feet; (d) Hybrid procedure rooms will meet the minimum floor area
and clearances of paragraphs (B)(1)(a) and (B)(1)(b) of this rule and include
at least the additional minimum floor area, clearances, and storage
requirements for the imaging equipment contained in the room; (e) Fixed encroachments into the minimum clear floor area
are permitted to be included when determining the minimum clear floor area for
a procedure room as long as: (i) There are no
encroachments into the sterile field; (ii) The encroachments do
not extend more than twelve inches into the minimum clear floor area outside
the sterile field; and (iii) The encroachment
width along each wall does not exceed ten percent of the length of that
wall. (2) Control rooms, if
utilized, will: (a) Accommodate the imaging system control
equipment; (b) Be sized and configured in compliance with manufacturer
recommendations for installation, service, and maintenance; (c) Have view panels that provide for a view of the patient
and the cardiac catheterization team; (d) Be permitted to serve more than one hybrid procedure
room, provided that manufacturer recommendations for installation, service, and
maintenance are accommodated for all rooms served; (e) Be physically separated from a hybrid procedure room
with walls and a door; and (f) A door is not required where a control room serves only
one procedure room and is built, maintained, and controlled the same as the
procedure room. (3) Clean utility rooms
that can sufficiently and efficiently supply the procedure rooms. (C) A general radiology room cannot be
used as a cardiac catheterization procedure room. (D) Equipment described in this paragraph
may be replaced by newer technology that has equivalent or superior capability
as determined by the provider of the service. In assessing these new
technologies, consideration should be given to recommendations of recognized
professional societies and accrediting bodies (e.g. the American college of
cardiology). All services will, at a minimum, have the following
equipment: (1) High quality x-ray
imaging with mutiaxial position capability; (2) A three-phase, twelve
pulse generator with an output of eighty to one hundred kilowatts or a constant
potential generator with an output of at least one hundred kilowatts at one
hundred kilovolts; (3) Multimode or cesium
iodide image intensifiers; (4) High-quality matched
optics; (5) Appropriate imaging
modality for review and storage of images; (6) Digital imaging
equipment; (7) Carbon-fiber table
tops; (8) A mechanism for
continuous monitoring of a patient's blood pressure and
electrocardiogram; (9) An adequate supply
and variety of catheters, guide wires, and sheaths; (10) A crash cart with
equipment for ventilatory support; (11) A
defibrillator; (12) A temporary
pacemaker; and (13) An intra-aortic
balloon pump or other percutaneous mechanical circulatory assistance device of
superior capability. (E) Each adult cardiac catheterization
service will provide and maintain radiation generating equipment in accordance
with applicable state and federal requirements as specified in Chapter 3748. of
the Revised Code and the rules adopted thereunder.
Last updated September 2, 2025 at 8:41 AM
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Rule 3701-22-41 | Safety standards - adult cardiac catheterization service.
Effective:
August 31, 2025
(A) Each adult cardiac catheterization
service, or "service," will establish and maintain safety guidelines,
and practices and policies in accordance with applicable United States nuclear
regulatory commission regulations, applicable provisions of Chapter 3748. of
the Revised Code, and the rules adopted pursuant to that chapter to assure a
safe environment for patients, visitors, and personnel. (B) Each service will establish, maintain
and follow electrical safety policies that, at a minimum, include: (1) A safe primary
electrical wiring system; (2) Electrical isolation
of all equipment attached to a patient; (3) Use of an
equipotential hardwired grounding system for all equipment; and (4) Periodic inspection
of the electrical system and measurement of interequipment current
leakage. (C) Each service will periodically survey
all of the equipment utilized by the service and perform preventive maintenance
on a schedule that, at a minimum, conforms to manufacturers'
recommendations. Results of surveillance and preventive maintenance activities
will be internally documented.
Last updated September 2, 2025 at 8:41 AM
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Rule 3701-22-42 | Adult cardiac catheterization service performance measures.
Effective:
August 31, 2025
(A) Each adult cardiac catheterization
service should maintain a volume of cardiac catheterization procedures
sufficient to ensure the safety and quality of procedures performed at the
service and individual cardiologist proficiency. (B) No minimum cardiologist volume is
recommended, however, the combination of high mortality and low volume will
trigger a thorough internal review of an individual physician by the adult
cardiac catheterization service. (C) Volume may be considered by the
director in conjunction with other indicators of quality and not as the sole
indicator of service performance. An adult cardiac catheterization service with
significant rates of in hospital complications, emergent transfers, or
mortality may be subject to an independent third party review, including
individual case review, by a third party approved by the director. The service
will be responsible for: (1) Providing a copy of
the review to the director; and (2) Payment of any fees
associated with the independent third party review to the provider of the
review.
Last updated September 2, 2025 at 8:41 AM
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Rule 3701-22-42.1 | Inspection and review of adult cardiac catheterization services.
Effective:
August 31, 2025
(A) In addition to the inspection and
audit requirements set forth in rule 3701-22-05 of the Administrative Code, the
director will conduct an inspection of each adult cardiac catheterization
service approximately once every three years. (B) The number of procedures performed by
the service may be considered by the director in conjunction with other
indicators of quality and not as the sole indicator of the service's
performance. (C) Failure to maintain a volume of
cardiac catheterization procedures sufficient to ensure the safety and quality
of procedures performed at the service and individual cardiologist proficiency
may result in any or all of the following: (1) An extended review of
the service by the director; (2) Mandatory peer review
of PCI procedures performed by the service; (3) Annual inspections
until such time as the service performs the established number of procedures
for a period of two consecutive years or the director determines that annual
inspection is no longer required; or (4) At the discretion of
the director, the establishment of a probationary period. If a probationary
period is imposed, at a minimum, the service will be notified of the
following: (a) The time period for which the probationary period is
effective; (b) The actions that may be taken by the director for a
service's failure to successfully complete the probationary
period.
Last updated September 2, 2025 at 9:06 AM
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Rule 3701-22-43 | Open-heart surgery service standards.
Effective:
August 31, 2025
(A) The provisions of rules 3701-22-43 to
3701-22-47 of the Administrative Code are applicable to open-heart surgery
services performing procedures on adult patients greater than or equal to
eighteen years of age. An adult open-heart surgery service may serve a patient
less than eighteen years of age if the patient's attending physician and
the adult service's medical director determine that the adult service best
serves the needs of the patient. (B) Each an open-heart surgery service
will have available at all times and accessible by gurney in the same building,
adequate facilities for the open-heart surgery service, including but not
limited to the following: (1) Cardiac operating
rooms; (2) A cardiac surgery
intensive care unit; (3) A post-intensive care
"step-down" unit; and (4) Cardiac
catheterization services. (C) Each open-heart surgery service will
have the capability, equipment, and personnel to perform emergency open-heart
procedures on a twenty four hours a day, seven days a week basis. A
cardiovascular surgical team will be available in less than sixty minutes on a
twenty-four hours a day basis. (D) Each open-heart surgery service will
have access to the following services: (1) Cardiology; (2) Hematology; (3) Nephrology; (4) Pulmonary
medicine; (5) Infectious
disease; (6) Radiology; (7) Neurology; (8) Emergency
care; (9) Electrocardiography; (10) Stress
testing; (11) Nuclear
medicine; (12) Pathology; (13) Blood banking
services; (14) Echocardiography; (15) Pulmonary function
testing; (16) Cardiac
rehabilitation; (17) Pre-admission
testing; and (18) Follow-up outpatient
nursing referral services. (E) An open-heart surgery service will
only be provided in a fully permanent setting within the permanent frame of the
building of a licensed hospital that is classified as a general hospital or as
a special hospital - cardiac that primarily furnishes limited services to
patients with cardiac conditions. The hospital will be fully equipped and have
all resources necessary to perform open-heart surgery. (F) Each adult open-heart surgery service
will obtain and maintain enrollment in a data registry to monitor operator and
institutional volumes and outcomes. (G) Reporting: Each adult open-heart
service will submit an annual report to the department by June first of each
year that: (1) Maintains patient
confidentiality; (2) Includes numbers for
the following: (a) The number of procedures performed by the adult
open-heart service; (b) Post procedure in-hospital mortality
number; (c) In hospital prolonged intubation (ventilation) for a
period of longer than seven days; (d) Deep sternal wound infection
(mediastinitis); (e) Post-operative renal insufficiency; (f) Surgical re-exploration; and (g) Stroke. (H) Each adult open-heart surgery service
will have a written policy requiring the documentation of any internal review
of surgeons with a combination of higher than expected risk adjusted mortality
and low individual surgeon volume. (I) Each adult open-heart surgery service
will utilize a coordinated and integrated multidisciplinary approach to patient
care, including meetings between cardiologists and cardiovascular surgeons as
necessary, to address the needs of patients with complex cardiovascular
disease. (J) Each adult open-heart surgery service
will have established criteria that cardiologists and surgeons will utilize for
the purposes of patient selection and appropriateness. (K) Each adult open-heart surgery will
have patient selection and appropriateness criteria: (1) Consistent with the
2021 American college of cardiology/American heart association (ACC/AHA)
guideline update for coronary artery bypass graft surgery, available at
www.acc.org; and (2) For patients with
adult congenital heart disease, consistent with the 2018 American college of
cardiology/American heart association guidelines for the management of adults
with congenital heart disease: executive summary, available at
www.acc.org.
Last updated September 2, 2025 at 9:06 AM
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Rule 3701-22-44 | Personnel/staffing - open-heart surgery service.
Effective:
August 31, 2025
(A) The medical director of the adult
open-heart surgery service will be board-certified in thoracic surgery. The
medical director will: (1) Be a physician
certified or eligible for certification by the American board of thoracic
surgery, the American board of surgery or, in lieu of board
certification: (a) A physician who is board-certified by a foreign board
and is eligible to take the examination of an American board of medical
specialties recognized board or an American osteopathic association board may
serve as medical director of an HCS; or (b) In accordance with rule 3701-22-19 of the
Administrative Code, an HCS may request a waiver from the department of health
for physicians who are board-certified by a foreign board who are not eligible
to take the examination of an American board of medical specialties recognized
board or an American osteopathic association board. (2) Be responsible for
oversight of care in the service; (3) Be credentialed to
provide adult open-heart surgery services at the hospital where the adult
open-heart surgery service is located; and (4) Actively perform
open-heart procedures at the open-heart surgery service where they are the
medical director. (B) Each open-heart surgery service will
have at least two thoracic surgeons on staff, credentialed to perform
open-heart procedures at the hospital who actively perform open-heart
procedures at the hospital. The medical director of the open- heart surgery
service may be counted as one of the two required thoracic
surgeons. (C) Each open-heart surgery service will
have competent and qualified staff available, including but not limited
to: (1) Surgical assistants
to assist the surgeon. A surgical assistant may be a resident, another
physician, or a specially trained surgical assistant; (2) Cardiac
anesthesiologists with special training in the anesthetic and supportive
requirements of open-heart surgery; (3) Nursing staff that
will include appropriate numbers of scrub nurses or technicians and a
circulating nurse based on the needs of the surgeons and the patient. A minimum
of two staff, including a circulating nurse and one scrub nurse or technician
will be present for each procedure. Nursing staff will be trained in cardiac
surgical operating room procedures; (4) A cardiac surgical
intensive care unit will be staffed at the appropriate nurse patient ratio to
commensurate with the acuity of the patients and the amount of time following
surgery that such care is necessary. Cardiac surgical intensive care nurses
will be advanced cardiac life support (ACLS) certified and have specialized
training to develop the theoretical knowledge and clinical skills required for
the care of cardiac surgical patients; and (5) A minimum of two
perfusionists who are graduates of an accredited cardiovascular perfusion or
perfusion technology program or have equivalent training and
experience. (D) In addition to the requirements of
paragraph (C) of this rule, an open-heart surgery service will have appropriate
staff available, including but not limited to: (1) Pharmacists; (2) Dietitians; (3) Respiratory
therapists; (4) Physical
therapists; (5) Cardiac
rehabilitation therapists; and (6) Social
workers. (E) Staffing requirements of this rule
may be met by individuals with equivalent or greater qualifications if the
replacement's scope of practice encompasses the duties of the required
staff.
Last updated September 2, 2025 at 9:06 AM
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Rule 3701-22-45 | Facilities, equipment, and supplies - open-heart surgery service.
Effective:
August 31, 2025
(A) Operating rooms used for open-heart
surgery: (1) Standard operating
rooms will: (a) Have a minimum floor area of four hundred fifty square
feet; (b) Have the following minimum clearances: (i) If anesthesia is
utilized, six feet at the head of the operating table. This dimension will
result in an anesthesia work zone with a clear floor area of six feet by eight
feet; and (ii) Sufficient footage
on each side of the procedure table to ensure that movement around and in the
sterile field does not compromise or contaminate the sterile
field. (2) Operating rooms
utilizing image-guided surgery or procedures requiring more space for personnel
or equipment will be sized to accommodate the personnel and equipment planned
to be in the room during procedures and have a minimum floor area of six
hundred square feet with a minimum clear dimension of twenty feet. (3) Hybrid operating
rooms will meet the minimum floor area and clearances of paragraphs (A)(1)(a)
and (A)(1)(b) of this rule and include at least the additional minimum clear
floor area, clearances, and storage requirements for the imaging equipment
contained in the room. (4) Fixed encroachments
into the minimum floor area are permitted to be included when determining the
minimum clear floor area for an operating room as long as: (a) There are no encroachments into the sterile
field; (b) The encroachments do not extend more than twelve inches
into the minimum clear floor area outside the sterile field; and (c) The encroachment width along each wall does not exceed
ten per cent of the length of that wall. (5) Control rooms if
utilized, will: (a) Accommodate the imaging system control
equipment; (b) Be sized and configured in compliance with manufacturer
recommendations for installation, service, and maintenance; (c) Have view panels that provide for a view of the patient
and the open-heart surgery team; (d) Be permitted to serve more than one hybrid operating
room, provided that manufacturer recommendations for installation, service, and
maintenance are accommodated for all rooms served; (e) Be physically separated from a hybrid operating room
with walls and a door; and (f) A door is not required where a control room serves only
one operating room and is built, maintained, and controlled the same as the
operating room. (B) Each operating room used for
open-heart surgery will have appropriate numbers of oxygen and vacuum outlets
and proper operating room lighting. Fiber optic headlights will be
provided. (C) Equipment and technology described in
this paragraph may be replaced by newer technology and equipment with
equivalent or superior capability. In assessing this new equipment and
technology, consideration should be given to the recommendations of recognized
professional societies and accrediting bodies. An open-heart surgery service
will have at least the following: (1) Two fully operational
cardiopulmonary bypass machines equipped with; (a) A time and temperature module; (b) An air bubble and level detector system; (c) A blender (air and oxygen mixer); (d) An oxygen analyzer; (e) A saturation monitor; (f) Two pressure monitors; (g) A back up pump head; and (h) A heater/cooler (one back up). (2) Appropriate patient
monitoring equipment with overhead slave, electrocardiogram, three pressure
reading, and cardiac output; (3) An
electrocauter; (4) A heat
exchanger; (5) Drug infusion
equipment; (6) Transportable
monitoring equipment including electrocardiogram, defibrillator, oxygen
saturation monitor, and pressure transducer; (7) An intra-aortic
balloon pump or other percutaneous mechanical circulatory assistance device of
superior capability; (8) The availability of a
transesophageal echo; (9) A cardiac
pacemaker; (10) Routine blood gas
analysis and chemistry including blood sugar analysis in the operating
room; (11) Defibrillators; (12) A heating
blanket; (13) An ice
bath; (14) An automated
coagulation timer (ACT) machine; and (15) A cell
saver. (D) Each open-heart surgery service will
ensure that a fully equipped and staffed cardiac surgical intensive care unit
that meets the needs of the cardiac surgery patient is available in the
building and accessible by gurney from where the open- heart surgery is
performed. The cardiac surgical intensive care unit will ensure that a
sufficient number of intensive care unit beds are available to meet the needs
of open-heart surgery patients each week, however, the beds are not required to
be dedicated only to cardiac surgery patients. (E) Each open-heart surgery service will
ensure that a post-intensive care "step-down" unit with telemetry is
available in the building and accessible by gurney from where the open-heart
surgery is performed. The number of "step-down" beds will be
sufficient to meet the needs of open-heart surgery patients each week, however,
the beds are not required to be dedicated only to cardiac surgery
patients.
Last updated September 2, 2025 at 9:07 AM
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Rule 3701-22-46 | Quality assessment and performance improvement - open-heart surgery service.
Effective:
August 31, 2025
(A) In addition to the general quality
assessment and performance improvement requirements set forth in rule
3701-22-07 of the Administrative Code, each open-heart surgery service
will: (1) As part of the
service's overall quality assessment and performance improvement
process: (a) Utilize the quality performance measures outcomes data
obtained from the service's participation in a data registry to monitor
operator and institutional volumes and outcomes; and (b) Include a periodic review and evaluation of the
multidisciplinary meetings required by paragraph (I) of rule 3701-22-43 of the
Administrative Code. (2) Have a regular formal
morbidity and mortality conference chaired by the medical director of the
open-heart surgery service or the medical director's designee. The
morbidity and mortality conferences will: (a) Be held at least once every sixty days or more
frequently depending on the need; and (b) Review all deaths and complications such as reoperation
for bleeding, deep sternal wound infection, stroke, and perioperative
myocardial infarction and any patterns that might indicate a problem will be
investigated and remedied if necessary. (B) Each open-heart surgery service will
maintain a clinical pathway for coronary bypass graft surgery and valve
replacements.
Last updated September 2, 2025 at 9:07 AM
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Rule 3701-22-47 | Adult open- heart surgery service performance measures.
Effective:
August 31, 2025
(A) Each adult open-heart surgery service
should maintain a volume of open-heart procedures per year sufficient to ensure
the safety and quality of procedures performed at the service and individual
surgeon proficiency. (B) Volume may be considered by the
director in conjunction with other indicators of quality and not as the sole
indicator of service performance. (C) No minimum volume is recommended,
however, the combination of high mortality and low individual surgeon volume
will trigger a thorough internal review of an individual surgeon by the
provider of the open-heart surgery service. (D) Failure to maintain the safety and
quality of the procedures performed at the service may result in any or all of
the following: (1) An extended review of
the service by the director; (2) Mandatory peer review
of procedures performed by the service; (3) Annual inspections
until such time as the director determines that annual inspection is no longer
required; or (4) At the discretion of
the director, the establishment of a probationary period. If a probationary
period is imposed, at a minimum, the service will be notified of the
following: (a) The time period for which the probationary period is
effective; (b) The actions that may be taken by the director for a
service's failure to successfully complete the probationary
period.
Last updated September 2, 2025 at 9:07 AM
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Rule 3701-22-48 | Pediatric intensive care service standards.
Effective:
August 31, 2025
(A) The provisions of rules 3701-22-48 to
3701-22-52 of the Administrative Code are applicable to each pediatric
intensive care service (PICU) regardless of the date service was
initiated. (B) Each PICU service will develop and
follow written comprehensive and effective patient care policies and procedures
that designate the severity of illnesses that may be treated and the types of
care that may be provided in the PICU. The PICU will operate within the scope
of this service plan. (C) A temporary expansion of PICU
services due to seasonal illness or outbreak necessitating an increase in the
number of PICU beds does not require notification to the director under the
change in the scope of the HCS requirement set forth in paragraph (E) of rule
3701-22-30 of the Administrative Code. Any expansion of PICU services for these
purposes will meet all established requirements for a PICU. (D) Each PICU service will ensure that a
pediatric intensivist is on-site and in-house twenty-four hours per day, seven
days a week. (E) The following physicians will be
available on-site to the PICU within sixty minutes on a twenty-four hour a day,
seven days a week basis: (1) An anesthesiologist
with demonstrated training and experience in pediatrics; (2) A pediatric surgeon
or a general surgeon with demonstrated training and experience in
pediatrics; (3) Pediatric
subspecialists to include: (a) A cardiologist; (b) A gastroenterologist; (c) A pulmonologist or other physician proficient in
pediatric flexible bronchoscopy; (d) A neurologist. (4) Surgeon
subspecialists with demonstrated training and experience in pediatrics, to
include: (a) A neurosurgeon; (b) An otolaryngologist; (c) A plastic surgeon; (d) An oral surgeon; and (e) An orthopedist. (F) The following services will be
available by phone or teleconference within sixty minutes on a twenty-four
hours a day, seven days a week basis: (1) A
nephrologist; (2) A
hematologist/oncologist; (3) An
endocrinologist; (4) An infectious
disease specialist; and (5) A pathologist with
demonstrated training and experience in pediatrics. (G) A psychiatrist or psychologist with
demonstrated training and experience in pediatrics will be available to the
PICU by phone or teleconference within twenty-four hours on a twenty-four hours
a day seven days a week basis. (H) Each PICU service will have access to
the following pediatric specialists for consultation and treatment as
necessary, either on staff or by arrangement or contract: (1) A
neonatologist; (2) An allergist or
immunologist; (3) A
geneticist; (4) A cardiovascular
surgeon; and (5) A radiologist with
demonstrated training and experience in pediatrics. (I) Each PICU service without an on-site
pediatric cardiac catheterization service and a pediatric cardiovascular
surgery service will maintain a written transfer agreement for emergency
pediatric cardiovascular surgery services with a provider of pediatric cardiac
catheterization services and pediatric cardiovascular surgery services that,
once the patient can safely be transported, can be reached expeditiously by
available emergency vehicle in less than sixty minutes on a twenty-four hours a
day, seven days a week basis and that provides the greatest assurance for
patient safety. (J) Each PICU service without an on-site
pediatric radiologist or radiologist with training and experience in pediatrics
will maintain a written transfer agreement for emergency pediatric radiologic
services with a provider of pediatric radiologic services that, once the
patient can safely be transported, can be reached and expeditiously available
by emergency vehicle in less than sixty minutes on a twenty-four hours a day,
seven days a week basis and that provides the greatest assurance for patient
safety. (K) Each PICU service will have available
at least two operating rooms with the capability, equipment and personnel to
perform emergency procedures in less than sixty minutes on a twenty-four hours
a day, seven days a week basis. (L) Each PICU service will have access to
a blood bank with all blood components available twenty-four hours a day, seven
days a week. Unless some unusual antibody is encountered, blood typing and
cross matching will allow for transfusion in less than sixty
minutes. (M) Each PICU service will have radiology
services available to the PICU at all times to meet the needs of the patient
and will include: (1) Portable
radiology; (2) Fluoroscopy; (3) Computerized
tomography scanning; (4) Ultrasonography; (5) Angiography; (6) Nuclear scanning;
and (7) Magnetic resonance
imaging; (N) Radiation therapy services will be
available on-site or through contract with another hospital. (O) Each PICU service will have the
following clinical laboratory capabilities: (1) Microspecimen
capability and one hour turnaround time for: (a) Clotting studies and measurements of complete blood
cell count; (b) Differential count; (c) Platelet count; (d) Urinalysis; (e) Electrolytes; (f) Blood urea nitrogen; (g) Creatinine; (h) Glucose; (i) Calcium; (j) Prothrombin time; (k) Partial thromboplastin time; and (l) Cerebrospinal fluid cell counts; (2) Blood gas values
available within fifteen minutes; (3) Within three hours,
results of: (a) Drug screening and levels of serum
ammonia; (b) Serum and urine osmolarity; (c) Phosphorus; and (d) Magnesium. (4) Preparation of gram
stains and bacteriological cultures available twenty-four hours a day, seven
days a week. (P) Each PICU service will have access to
the hospital's pharmacy service and personnel on-site capable of
dispensing all necessary medications for pediatric patients of all types and
ages, twenty-four hours a day, seven days a week. (Q) Diagnostic cardiac and neurological
services will be available twenty-four hours per day to the PICU service as
needed and technicians with special training in pediatrics should be available
to perform the following studies: (1) Electrocardiograms,
two-dimensional and echocardiograms and electroencephalograms; and (2) Doppler
ultrasonograph devices and evoked potential monitoring equipment. (R) Each PICU service will timely provide
hemodialysis equipment and competent and qualified staff experienced with
pediatric patients available twenty-four hours a day, seven days a week. Each
provider of a PICU service without an on-site hemodialysis service will
maintain a written transfer agreement for emergency hemodialysis services with
a provider of hemodialysis services that, once the patient can safely be
transported, can be reached expeditiously by an available emergency vehicle in
less than sixty minutes on a twenty-four hours a day, seven days a week basis
and that provides the greatest assurance for patient safety. (S) Each PICU service will have an
integrated communication system with a local emergency medical transport
system. (T) Each PICU service will have a
secondary emergency communication system available twenty-four hours a day,
seven days a week into the PICU. (U) Each PICU service will have an
internal transportation system and competent and qualified staff for effective
transport. (V) Each PICU service will maintain a
communication link to a federal, state, or local poison control
center. (W) A PICU will only be operated in a
fully permanent setting within the permanent frame of the building of a
hospital that is classified as a general hospital or a children's
hospital. The hospital will be fully equipped to meet the needs of the
PICU.
Last updated September 2, 2025 at 9:07 AM
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Rule 3701-22-49 | Personnel and staffing standards - pediatric intensive care service.
Effective:
August 31, 2025
(A) Each PICU service will have a medical
director whose appointment, acceptance and responsibilities will be in writing
and on file in the PICU. (B) The PICU medical director will
be: (1) An active service
provider in the PICU where he or she is the medical director; and (2) Be board-certified in
one of the following: (a) Pediatric critical care; (b) Anesthesiology with practice limited to infants and
children and with special qualifications in critical care medicine;
or (c) Pediatric surgery with added qualifications in surgical
critical care medicine. (C) The PICU medical director
will: (1) Participate in
development, review, and implementation of PICU policies; (2) Participate in budget
preparation; (3) Coordinate staff
education; (4) Maintain a data base
and/or vital statistics that describe unit experience and
performance; (5) Supervise
resuscitation techniques, including educational component; (6) Supervise quality
control, assessment and improvement activities, including morbidity and
mortality reviews; (7) Coordinate
research; (8) Have the authority to
consult on any PICU patient; and (9) Name qualified
designees to fulfill the medical director's duties during
absences. (D) Other individuals may supervise the
activities required in paragraph (C) of this rule, but the PICU director will
participate in each. (E) In addition to the pediatric
intensivist required in paragraph (D) of rule 3701-22-48 of the Administrative
Code, each PICU service will have a licensed physician assigned to the PICU
who: (1) Is available to
provide bedside care to the patients in the PICU; and (2) Is skilled in and has
the credentials to provide emergency care to critically ill
children. These responsibilities may be shared or
delegated to an advanced practice nurse with specialized training in pediatric
critical care and credentials and privileges to provide care in the
PICU. (F) Each PICU service will have a nurse
manager dedicated to the PICU who will be supervised by the director of
pediatric nursing or equivalent. The PICU nurse manager will have specific
training and experience in pediatric critical care. Pediatric critical care
registered nurse (CCRN) certification is recommended for the nurse manager, but
not required. (G) The PICU nurse manager will
participate in the following: (1) Development, review,
and implementation of written policies and procedures for the
PICU; (2) Coordination of
multidisciplinary staff education; (3) Quality
assurance; (4) Nurse
research; (5) Budget preparation
with the medical director; and (6) Name qualified
designees to fulfill their duties during absences. These responsibilities may be shared or
delegated to advanced practice nurses, but the PICU nurse manager will maintain
overall responsibility for these requirements. (H) Nursing to patient ratios in the PICU
service will be sufficient to accommodate the acuity level and volume of
patients, usually ranging from two nurses to one patient to one nurse to three
patients and adjusted as needed. (I) Required nursing skills for PICU
nurses will include: (1) Recognition,
interpretation and recording of various physiologic variables; (2) Drug and fluid
administration; (3) Cardio-pulmonary
resuscitation (CPR) certification; (4) Pediatric advanced
life support certification (PALS); (5) Respiratory care
techniques including chest physiotherapy, endotracheal suctioning and
management, and tracheostomy care; (6) Preparation and
maintenance of patient monitors; and (7) Psychosocial skills
to meet the needs of both patient and family. (J) Each PICU service will provide the
nursing staff and document in each nurse's personnel file the
following: (1) An orientation
performed by the PICU; (2) A clinical and
didactic orientation in pediatric critical care; and (3) On-going pediatric
critical care in-service education. (K) Each PICU service will have
respiratory therapy staff assigned to the unit in-house twenty-four hours a
day, seven days a week who: (1) Have clinical
experience managing pediatric patients with respiratory failure;
and (2) It is recommended
that all respiratory therapy staff have pediatric advanced life support (PALS)
training or an equivalent course. (L) Other PICU staff will
include: (1) Biomedical
technicians (in-house or available within one hour on a twenty-four hours a
day, seven day a week basis); (2) A social
worker; (3) A pharmacist in-house
twenty-four hours per day; (4) A radiology
technician; (5) A registered
dietitian; (6) A physical
therapist; (7) An occupational
therapist; (8) A child life
specialist; and (9) A unit
clerk. (M) As part of a continuing education
program, the PICU service will: (1) Have staff
participate in regional pediatric critical care education programs;
and (2) Provide regularly
scheduled resuscitation practice sessions. (N) Staffing requirements of this rule
may be met by individuals with equivalent or greater qualifications if the
replacement's scope of practice encompasses the duties of the required
staff.
Last updated September 2, 2025 at 9:07 AM
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Rule 3701-22-50 | Physical design and facilities - pediatric intensive care service.
Effective:
August 31, 2025
(A) Each PICU will have controlled access
with no through traffic. (B) The location of the
PICU: (1) Is recommended to be
in close proximity to the physician's on-call office. (2) Will be in close
proximity to a family waiting area; and (3) Will be available by
gurney to the emergency department, the surgical area, and the recovery
area. (C) Each PICU will contain the following
distinct areas: (1) Patient isolation
rooms; (2) A clean linen
room; (3) A soiled linen
room; (4) Equipment
storage; (5) Counseling; (6) A medication station
with a drug refrigerator and locked narcotic cabinet; (7) A nourishment
station; (8) Hand washing
facilities; (9) Staff and patient
toilets; and (10) Patient personal
effects storage. (D) All patient rooms will
have: (1) The capacity to
provide patient privacy, such as through the use of walls or
curtains; (2) Easy, rapid access to
the head of the bed; and (3) Adequate electrical
outlets, compressed air, oxygen, and vacuum outlets per bed sufficient in
number to supply all necessary equipment. (E) Each PICU will have a rapid and
reliable system that timely reports and receives laboratory
results.
Last updated September 2, 2025 at 9:07 AM
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Rule 3701-22-51 | Equipment and supplies - pediatric intensive care service.
Effective:
August 31, 2025
(A) Appropriate drugs for resuscitation and pediatric
advanced life support will be present and immediately available for use in the
treatment of any patient in the PICU. (B) The following life-saving, therapeutic and monitoring
equipment will be present or immediately available in the PICU: (1) Portable equipment including: (a) An emergency
("code" or "crash") cart; (b) A procedure
lamp; (c) Pediatric sized blood
pressure cuffs for systemic arterial pressure determination; (d) A doppler
ultrasound; (e) An
electrocardiograph; (f) A defibrillator or
cardioverter with pediatric paddles; (g) Thermometers with a
range sufficient to identify extremes of hypothermia and
hyperthermia; (h) Automated blood
pressure apparatus; (i) Transthoracic pacer
with pediatric pads; (j) Devices for
accurately measuring body weight; (k) Cribs and beds with
head pressure apparatus; (l) Infant
warmers; (m) Heating and cooling
blankets; (n) Bilirubin
lights; (o) Temporary
pacemakers; (p) A blood warming
apparatus; (q) A transport
monitor; (r) Infusion pumps with
microinfusion capability; (s) Oxygen tanks for
transport and backup; (t) Suction machines for
transport and backup; (u) Volumetric infusion
pumps; (v) Air-oxygen
blenders; (w) An air
compressor; (x) Gas
humidifiers; (y) Bag-valve mask
resuscitators; (z) An otoscope and
ophthalmoscope; (aa) Isolation carts; and (bb) A portable electro-encephalogram available in the
hospital for recordings. (2) Respiratory equipment appropriate to meet the needs of
all patients, including: (a) Mechanical
ventilators suitable for pediatric patients of all sizes; (b) Pulse oximeters and
transcutaneous oxygen monitors; (c) Cardon dioxide (CO2)
monitors; (d) Inhalation therapy
equipment; (e) Chest physiotherapy
and suctioning; (f) Spirometers;
and (g) Continuous oxygen
analyzers with alarms. (3) Small equipment including: (a) Tracheal intubation
equipment in adequate numbers and type to intubate patients of all
ages; (b) Endotracheal tubes of
all pediatric sizes; (c) Oral/nasal
airways; (d) Flexible
bronchoscope; (e) Suction
catheters; (f) Vascular access
equipment; and (g) Surgical trays for
the following: (i) Vascular cut-downs; (ii) Open chest procedures; (iii) Cricothyroidectomy; and (iv) Tracheostomy; (h) Intraosseous (IO)
needles. (4) Bedside monitors that are capable of providing
continuous, sufficient and appropriate monitoring that have visible and audible
alarms and are capable of producing a permanent hard copy of the rhythm
strip. (C) Each PICU service will have the capability to
continuously monitor a patient's: (1) Electrocardiogram and heart rate; (2) Respiration; (3) Temperature; (4) Systemic arterial pressure; (5) Oxygen; (6) Carbon dioxide; (7) Central venous pressure; (8) Intracranial pressure; and (9) Four pressures simultaneously.
Last updated September 2, 2025 at 9:35 AM
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Rule 3701-22-52 | Quality assessment and performance improvement program - pediatric intensive care service.
Effective:
August 31, 2025
Each PICU will have a multidisciplinary
collaborative quality assessment and performance improvement program. The
written quality assessment and performance improvement program plan required
under rule 3701-22-07 of the Administrative Code will, at a minimum, include a
review of: (A) All morbidity and mortality
instances; (B) Utilization; (C) Medical records; (D) Discharge criteria and discharge
planning; and (E) Patient safety.
Last updated September 2, 2025 at 9:35 AM
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Rule 3701-22-53 | Radiation therapy, stereotactic radiosurgery, and stereotactic radiotherapy service standards.
Effective:
August 31, 2025
(A) Each radiation therapy, stereotactic radiotherapy, or
stereotactic radiosurgery service will operate in accordance with Chapter 3748.
of the Revised Code and all rules adopted thereunder. (B) Each radiation therapy service, stereotactic
radiotherapy, and stereotactic radiosurgery service will comply with the
requirements pertaining to the Ohio cancer incidence surveillance system
established under sections 3701.261 and 3701.262 of the Revised Code and
Chapter 3701-4 of the Administrative Code.
Last updated September 2, 2025 at 9:35 AM
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Rule 3701-22-54 | Pediatric cardiac catheterization service standards.
Effective:
August 31, 2025
(A) The provisions of rules 3701-22-54 to
3701-22-59 of the Administrative Code are applicable on the effective date of
this rule to each pediatric cardiac catheterization service performing
procedures on patients less than eighteen years of age, regardless of the date
the service was initiated. A pediatric cardiac catheterization service may
serve a patient greater than eighteen years of age if the patient's
attending physician and the pediatric service's medical director determine
that the pediatric service best serves the needs of the patient. (B) All pediatric cardiac catheterization
services will: (1) Have on-site a
pediatric cardiovascular surgery service immediately accessible from the
pediatric cardiac catheterization laboratory by gurney; and (2) Have an experienced
pediatric cardiovascular surgical team available in less than sixty minutes on
a twenty-four hours a day, seven days a week basis in the event that emergency
open-heart surgery is required. (C) Each pediatric cardiac
catheterization service will have explicit criteria consistent with current
recommendations of recognized professional societies and accrediting bodies,
specifying the number of times a year an appropriately privileged physician
performs each catheterization procedure in order to retain privileges to
perform that procedure. (D) Each pediatric cardiac
catheterization service will have immediate access to services
for: (1) Hematology and
coagulation disorders; (2) Electrocardiography; (3) Diagnostic
radiology; (4) Clinical
pathology; (5) Doppler-electrocardiography; (6) Pulmonary function
testing; and (7) Microbiology. (E) Each pediatric cardiac
catheterization service will have established criteria for patient selection
and appropriateness that are specific to each procedure performed in the
service. (F) Each pediatric cardiac
catheterization service will have a written policy requiring the documentation
of any internal review of surgeons with a combination of high risk adjusted
mortality and low individual surgeon volume. (G) Each pediatric cardiac
catheterization service will enroll and be actively submitting data to a
pediatric cardiac catheterization data registry. (H) A cardiac catheterization service for
pediatric patients will only be provided in a fully permanent setting within
the permanent frame of the building of a licensed hospital that is classified
as a general hospital, a children's hospital or a special hospital -
cardiac, that primarily furnishes limited services to patients with cardiac
conditions. The hospital will: (1) Operate inpatient
pediatric medical and surgical services in the same building that are
accessible by gurney from the pediatric cardiac catheterization
laboratory; (2) Operate a pediatric
intensive/critical care unit with licensed special care beds that is reviewed
and accredited or certified as such as part of the hospital's
accreditation or certification program in the same building and accessible by
gurney from the pediatric cardiac catheterization laboratory. The unit will
provide appropriate equipment and staff to care for pediatric cardiac patients
and have twenty-four hour monitoring capability; (3) Provide a setting in
the same building as the pediatric cardiac catheterization laboratory in which
ambulatory pediatric cardiac catheterization patients can be observed for at
least four hours after the procedure; and (4) Provide adequate
physician coverage to manage postprocedure complications. (I) A pediatric cardiac catheterization
service that performs same-day pediatric cardiac catheterization will have
written criteria for same-day catheterization and discharge. (1) These written
criteria should establish discharge requirements such as: (a) Absence of bleeding; (b) Presence and adequacy of pulses and
perfusion; (c) Access to medical evaluation and care after discharge;
and (d) Parental understanding and ability to observe
overnight. (2) The written criteria
should account for the following when determining whether the patient is
eligible for discharge on the day of the cardiac catheterization: (a) Cardiac physiology; (b) Differences in procedure type; (c) Patient age; (d) Expected patient and parental compliance with discharge
instructions; (e) Travel distance; and (f) Duration of procedure and time of
completion.
Last updated September 2, 2025 at 9:35 AM
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Rule 3701-22-55 | Personnel/staffing - pediatric cardiac catheterization service.
Effective:
August 31, 2025
(A) Each pediatric cardiac
catheterization service will designate a medical director for the pediatric
cardiac catheterization service. The medical director will: (1) Possess the
experience and leadership qualities that are necessary to manage the laboratory
appropriately and to ensure safe and effective delivery of catheterization
services to pediatric patients; and (2) The medical director
will actively perform pediatric cardiac catheterization procedures at the
hospital where they are the medical director. (B) The medical director of the pediatric
cardiac catheterization service will be board-certified in pediatric cardiology
by the American board of pediatrics or the American osteopathic board of
pediatrics and have additional education or experience in pediatric cardiac
catheterization and intervention, or in lieu of the board certification
requirements specified in this chapter, will be: (1) A physician who is
board-certified by a foreign board and is eligible to take the examination of
an American board of medical specialties recognized board or an American
osteopathic association board may serve as medical director of an HCS;
or (2) In accordance with
rule 3701-22-19 of the Administrative Code, a HCS may request a waiver from the
department of health for physicians who are board-certified by a foreign board
who are not eligible to take the examination of an American board of medical
specialties recognized board or an American osteopathic association
board. (C) Each pediatric cardiac
catheterization service will have at least two licensed physicians credentialed
to provide pediatric cardiac catheterization services on staff who are
knowledgeable of the laboratory's protocols and equipment by providing
pediatric cardiac catheterization services at the hospital. Only physicians
appropriately credentialed to provide pediatric cardiac catheterization
services may be the primary operator of a pediatric cardiac catheterization
procedure. (D) At a minimum, all physicians who
perform pediatric cardiac catheterization procedures will be: (1) A fully-accredited
member of the HCS's staff; and (2) Will participate in
laboratory quality assurance programs, including peer review. (E) In addition to the requirements of
paragraphs (A) and (C) of this rule, each pediatric cardiac catheterization
service will have available a sufficient number of qualified staff, who are
able to supervise and conduct the cardiac catheterization service and are
skilled in pediatric cardiopulmonary resuscitation, including the following, as
applicable: (1) Support staff
comprised of individuals skilled in the following: (a) Radiographic techniques; (b) Digital imaging; (c) Systematic quality control testing; (d) Patient observation; (e) Critical care; (f) Monitoring and recording electrocardiographic and
hemodynamic data; and (g) For catheterization laboratories where physiological
studies are performed: (i) Managing blood
samples; (ii) Performing blood gas
measurements and calculations; and (iii) Assisting with
indicator dilution studies. (2) Nursing personnel in
sufficient number and type based on the caseload and types of procedures
performed, which may include nurse practitioners, registered nurses, licensed
practical nurses, and nursing assistants. (a) Nursing personnel involved in the provision of
pediatric cardiac catheterization services will have experience in pediatric
critical care and knowledge of operating room techniques; (b) Nurse practitioners, registered nurses, and licensed
practical nurses involved in the provision of pediatric cardiac catheterization
services will have: (i) Knowledge of
cardiovascular medications; (ii) The ability to begin
administration of intravenous solutions and administer drugs; (iii) Experience with
sterile techniques; and (iv) Skills in monitoring
vital signs, neurologic status and pain level. (c) Nurse practitioners may assume some of the duties of a
physician as permitted by law, however, ultimate responsibility for procedures
will always remain with the physician on record. (F) Respiratory therapists and pediatric
critical care staff will be immediately available to care for pediatric
patients. (G) Biomedical, electronic, and radiation
safety experts will be involved in maintaining the cardiac catheterization
laboratory. (H) Cardiovascular anesthesiologists and
perfusion teams will be immediately available to care for
patients. (I) Staffing requirements of this rule
may be met by individuals with equivalent or greater qualifications if the
replacement's scope of practice encompasses the duties of the required
staff.
Last updated September 2, 2025 at 9:36 AM
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Rule 3701-22-56 | Facilities, equipment, and supplies - pediatric cardiac catheterization service.
Effective:
August 31, 2025
(A) Each pediatric cardiac
catheterization service will provide adequate, properly designed space to
perform cardiac catheterization procedures safely and effectively. The amount
of space may vary with the types of procedures performed and the nature of the
facility such as interventional versus diagnostic and teaching versus
non-teaching. (B) Each pediatric cardiac
catheterization service will ensure the following: (1) Procedure
rooms: (a) Have a minimum floor area of four hundred square
feet; (b) Have the following minimum clearances: (i) If anesthesia is
utilized, six feet at the head of the operating table. This dimension will
result in an anesthesia work zone with a clear floor area of six feet by eight
feet; and (ii) Sufficient footage
on each side of the procedure table to ensure that movement around and in the
sterile field does not compromise or contaminate the sterile
field. (c) Utilizing image-guided surgery or procedures requiring
more space for personnel or equipment are sized to accommodate the personnel
and equipment planned to be in the room during procedures and have a minimum
floor area of six hundred square feet with a minimum clear dimension of twenty
feet; (d) Classified as hybrid procedure rooms, will meet the
minimum clear floor area and clearances of paragraphs (B)(1)(a) and (B)(1)(b)
of this rule and include at least the additional minimum clear floor area,
clearances, and storage requirements for the imaging equipment contained in the
room; (e) Containing fixed encroachments into the minimum clear
floor area are permitted to include those fixed encroachments when determining
the minimum clear floor area for a procedure room as long as: (i) There are no
encroachments into the sterile field; (ii) The encroachments do
not extend more than twelve inches into the minimum clear floor area outside
the sterile field; and (iii) The encroachment
width along each wall does not exceed ten per cent of the length of that
wall. (2) Control rooms, if
utilized, will: (a) Accommodate the imaging system control
equipment; (b) Be sized and configured in compliance with manufacturer
recommendations for installation, service, and maintenance; (c) Have view panels that provide for a view of the patient
and the cardiac catheterization team; (d) Be permitted to serve more than one hybrid procedure
room, provided that manufacturer recommendations for installation, service, and
maintenance are accommodated for all rooms served; and (e) Be physically separated from a hybrid procedure room
with walls and a door. A door is not required where a control room serves only
one procedure room and is built, maintained, and controlled the same as the
procedure room. (3) Clean utility rooms
can sufficiently and efficiently supply the procedure rooms. (C) A general radiology room cannot be
used as a cardiac catheterization procedure room. (D) Each pediatric cardiac catheterization service will
ensure that each laboratory where a cardiac catheterization procedure is
conducted is appropriately equipped to provide high quality pediatric imaging,
physiological monitoring, and provision of emergency care. The service will be
equipped with: (1) Imaging equipment
appropriate to the procedures performed; (2) Immediate replay
capabilities; (3) A blood gas
analyzer; (4) A pulse
oximeter; (5) An infant warming
device; (6) Pacing
catheters; (7) An external
pacemaker; (8) A
defibrillator; (9) An emergency
cart; (10) A comprehensive
inventory of pediatric catheters and devices; and (11) Ultrasound. (E) Each pediatric cardiac catheterization service will
provide and maintain radiation generating equipment in accordance with
applicable state and federal requirements as specified in Chapter 3748. of the
Revised Code and the rules adopted thereunder.
Last updated September 2, 2025 at 9:36 AM
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Rule 3701-22-57 | Safety standards - pediatric cardiac catheterization service.
Effective:
August 31, 2025
(A) To assure a safe environment for patients, visitors,
and personnel, each pediatric cardiac catheterization service will establish
and maintain safety guidelines, practices and policies in accordance with
applicable United States nuclear regulatory commission regulations, applicable
provisions of Chapter 3748. of the Revised Code, and the rules adopted pursuant
to that chapter. (B) Each pediatric cardiac catheterization service will
establish, maintain, and follow electrical safety policies which
include: (1) A safe primary electrical wiring system; (2) Electrical isolation of all equipment attached to a
patient; (3) Use of an equipotential hardwired grounding system for
all equipment; and (4) Periodic inspection of the electrical system and
measurement of interequipment current leakage. (C) Each pediatric cardiac catheterization service will
periodically survey all of the equipment utilized by the service, perform
preventive maintenance on a schedule that conforms to manufacturers'
recommendations, and document all preventive maintenance
activities.
Last updated September 2, 2025 at 9:36 AM
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Rule 3701-22-58 | Pediatric cardiac catheterization service - performance measures.
Effective:
August 31, 2025
(A) A
pediatric cardiac catheterization service should maintain a volume of cardiac
catheterization procedures sufficient to ensure the safety and quality of
procedures performed at the service and individual cardiologist
proficiency. (B) No minimum cardiologist volume is recommended, however,
the combination of high risk adjusted mortality and low volume will trigger a
thorough internal review of an individual physician by the pediatric cardiac
catheterization service.
Last updated September 2, 2025 at 9:36 AM
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Rule 3701-22-59 | Quality assessment and performance improvement - pediatric cardiac catheterization services.
Effective:
August 31, 2025
(A) Each pediatric cardiac
catheterization service will have a regular formal morbidity and mortality
conference: (1) Chaired by the
medical director of the pediatric cardiac catheterization service or the
medical director's designee; (2) Held at a minimum of
once every sixty days or more frequently depending on the need;
and (3) Review all of the
following: (a) Deaths; (b) Rescue extracorporeal membrane
oxygenation; (c) Emergency surgery; and (d) Major complications, such as: (i) Readmission to
intensive care unit; (ii) Emergent readmission
to the hospital; or (iii) Major non-surgical
intervention. (B) Each pediatric cardiac
catheterization service will establish and maintain a method for reviewing the
quality of all cardiac catheterization procedures. This review will assess the
following: (1) Appropriateness of
cardiac catheterization studies and interventions; (2) Technical quality of
cardiac catheterization studies; (3) Procedure
result; (4) Rate of therapeutic
success; and (5) Rate of procedural
complications. (C) Each pediatric cardiac
catheterization service will establish and maintain a database to support the
review process detailed in paragraph (B) of this rule. The results of analyses
and review are to be documented and used to guide periodic internal reviews of
individual physicians with respect to maintaining their credentials to perform
specific cardiac catheterization procedures.
Last updated September 2, 2025 at 10:07 AM
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Rule 3701-22-60 | Pediatric cardiovascular surgery service standards.
Effective:
August 31, 2025
(A) The provisions of rules 3701-22-60 to
3701-22-64 of the Administrative Code are applicable to each pediatric
cardiovascular surgery service performing procedures on patients less than
eighteen years of age. Patients eighteen and older may be served at a pediatric
cardiovascular surgery service, if the patient's attending physician and
the service's medical director determine that the service best serves the
needs of the patient. (B) At all times, each pediatric
cardiovascular surgery service will have available in the same building as the
pediatric cardiovascular surgery service and accessible by gurney, adequate
facilities for the pediatric cardiovascular surgery service,
including: (1) Cardiac operating
rooms; (2) Pediatric intensive
care facilities appropriate for the recovery of post operative pediatric
cardiovascular surgical patients; and (3) A cardiac
catheterization service. (C) Each pediatric cardiovascular surgery
service will have the capability, equipment, and personnel to perform emergency
pediatric open-heart procedures on a twenty-four hours a day, seven days a week
basis. A pediatric cardiovascular surgical team will be available and on-site
in less than sixty minutes on a twenty-four hours a day, seven days a week
basis. (D) Each pediatric cardiovascular surgery
service will utilize a coordinated and integrated multidisciplinary approach to
patient care, including meetings to determine the appropriate course of
treatment for complex patients. Physicians and staff should function as a team
and should include adequate numbers of the following: (1) Qualified pediatric
cardiologists; (2) Pediatric
cardiovascular surgeons; (3) Pediatric
cardiovascular anesthesiologists; (4) Pediatric intensive
care physicians; (5) Neonatologists with
special expertise in the care of cardiac patients; and (6) Additional pediatric
specialists required for the overall care of patients. (E) Each pediatric cardiovascular surgery
service will have access to the following pediatric services and
subspecialties: (1) Cardiology, including
echocardiogram, doppler echocardiogram and cardiac
catheterization; (2) Hematology; (3) A general
surgeon; (4) Gastroenterology; (5) Nephrology; (6) Pulmonary
medicine; (7) Infectious
disease; (8) Radiology; (9) Interventional
radiology; (10) Neurology; (11) Emergency
care; (12) Pathology; (13) Pulmonary function
testing; (14) Preadmission
testing; and (15) Follow-up outpatient
nursing referral. (F) Each pediatric cardiovascular surgery
service will have access to the following services either on-site or by
arrangement with another facility: (1) Extracorporeal
membrane oxygenation (ECMO); and (2) Ventricular assist
device (VAD). (G) Each pediatric cardiovascular surgery
service will obtain and maintain enrollment in a data registry to monitor
operator and institutional volumes and outcomes. (H) A pediatric cardiovascular surgery
service will only be provided in a fully permanent setting within the permanent
frame of the building of a hospital that is classified as a general hospital, a
children's hospital or as a special hospital - cardiac that primarily
furnishes limited services to patients with cardiac conditions. The hospital
will be fully equipped to perform the service. (I) Each pediatric cardiovascular surgery
service will have established criteria that cardiovascular surgeons,
cardiologists, and physicians will utilize for patient selection and
appropriateness. (J) Each pediatric cardiovascular surgery
service will have a written policy requiring the documentation of any internal
review of surgeons with a combination of high risk adjusted mortality and low
individual surgeon volume.
Last updated September 2, 2025 at 10:08 AM
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Rule 3701-22-61 | Personnel/staffing - pediatric cardiovascular surgery service.
Effective:
August 31, 2025
(A) The medical director of a pediatric
cardiovascular surgery service will be board-certified in thoracic surgery or,
in lieu of the board certification requirements specified in this chapter, will
be: (1) A physician who is
board-certified by a foreign board and is eligible to take the examination of
an American board of medical specialties recognized board or an American
osteopathic association board may serve as medical director of an HCS;
or (2) In accordance with
rule 3701-22-19 of the Administrative Code, an HCS may request a waiver from
the department of health for physicians who are board-certified by a foreign
board who are not eligible to take the examination of an American board of
medical specialties recognized board or an American osteopathic association
board; (3) Responsible for
oversight and care in the service; (4) Credentialed to
provide pediatric cardiovascular surgery services at the hospital where they
are the medical director; and (5) Active in performing
pediatric cardiovascular surgery procedures at the hospital where they are the
medical director. (B) Each pediatric cardiovascular surgery
service will have on staff at least two thoracic surgeons who are credentialed
to perform and actively perform pediatric cardiovascular surgery procedures at
the hospital. (C) In addition to the requirements of
paragraphs (A) and (B) of this rule, each pediatric cardiovascular surgery
service will have competent and qualified staff available,
including: (1) Surgical assistants
to assist the surgeon. A surgical assistant may consist of a resident, another
physician, or a specially trained surgical assistant; (2) Anesthesiologists
with expertise in the anesthetic and support requirements of pediatric
cardiovascular surgery; (3) Nursing staff which
will include an appropriate number of scrub nurses or technicians and
circulating nurses or technicians. A minimum of one scrub nurse and one
circulating nurse, or technician alternative as noted, is necessary. Nursing
staff will be trained in pediatric cardiovascular surgical operating room
procedures and nurses will be pediatric advanced life support (PALS)
certified; (4) Pediatric intensive
care unit staff who are trained in pediatric advanced life support (PALS) at an
appropriate nurse to patient ratio commensurate with the acuity of each
individual patient and the amount of time following surgery that such care will
be necessary. Pediatric intensive care nurses and physicians will have
specialized training to develop the theoretical knowledge and clinical skills
required for the care of pediatric cardiovascular surgical patients;
and (5) A minimum of two
perfusionists. Perfusionists will be graduates of an accredited cardiovascular
perfusion or perfusion technology training program or have equivalent training
and experience. The perfusionists will have training, knowledge, and experience
with small body perfusion, extracorporeal membrane oxygenation (ECMO), and
ventricular assist devices (VAD) if those services are provided
onsite. (D) In addition to the requirements of
paragraph (C) of this rule, each pediatric cardiovascular surgery service will
have appropriate staff available, including pharmacists, dietitians,
respiratory therapists, physical therapists and social workers. (E) Staffing requirements of this rule
may be met by individuals with equivalent or greater qualifications if the
replacement's scope of practice encompasses the duties of the required
staff.
Last updated September 2, 2025 at 10:08 AM
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Rule 3701-22-62 | Facilities, equipment, and supplies - pediatric cardiovascular surgery service.
Effective:
August 31, 2025
(A) Operating rooms used for pediatric
cardiovascular surgery: (1) Standard operating
rooms will: (a) Have a minimum floor area of four hundred fifty square
feet; (b) Have the following minimum clearances: (i) If anesthesia is
utilized, six feet at the head of the operating table. This dimension will
result in an anesthesia work zone with a clear floor area of six feet by eight
feet; and (ii) Sufficient footage
on each side of the procedure table to ensure that movement around and in the
sterile field does not compromise or contaminate the sterile
field. (2) Operating rooms
utilizing image-guided surgery or procedures requiring more space for personnel
or equipment will be sized to accommodate the personnel and equipment planned
to be in the room during procedures and have a minimum floor area of six
hundred square feet with a minimum clear dimension of twenty feet. (3) Hybrid operating
rooms will meet the minimum floor area and clearances of paragraphs (A)(1)(a)
and (A)(1)(b) of this rule and include at least the additional minimum clear
floor area, clearances, and storage requirements for the imaging equipment
contained in the room. (4) Fixed encroachments
into the minimum clear floor area are permitted to be included when determining
the minimum clear floor area for an operating room as long as: (a) There are no encroachments into the sterile
field; (b) The encroachments do not extend more than twelve inches
into the minimum clear floor area outside the sterile field; and (c) The encroachment width along each wall does not exceed
ten percent of the length of that wall. (5) Control rooms, if
utilized, will: (a) Accommodate the imaging system control
equipment; (b) Be sized and configured in compliance with manufacturer
recommendations for installation, service, and maintenance; (c) Have view panels that provide for a view of the patient
and the cardiovascular surgery team; (d) Be permitted to serve more than one hybrid operating
room, provided that manufacturer recommendations for installation, service, and
maintenance are accommodated for all rooms served; (e) Be physically separated from a hybrid operating room
with walls and a door; and (f) A door is not required where a control room serves only
one operating room and is built, maintained, and controlled the same as the
procedure room. (B) Each operating room used for
pediatric cardiovascular surgery will have appropriate numbers of oxygen,
vacuum and electrical outlets sufficient in number to supply all necessary
equipment and proper operating room lighting, including fiber optic
headlights. (C) Each pediatric cardiovascular surgery
service will have equipment appropriate for the safe performance and care of
pediatric cardiovascular surgery patients. (D) Each pediatric cardiovascular surgery
service will ensure that a fully equipped and staffed pediatric intensive care
unit is available in the building and accessible by gurney from where the
pediatric cardiovascular surgery is performed. The number of available
pediatric intensive care unit beds will be approximately one-half the number of
pediatric open-heart operations performed per week. The physical space of this
unit will meet joint commission, American osteopathic association, or any other
national accrediting body approved for deeming authority by the centers for
medicare and medicaid services recommended standards, which are in effect on
the effective date of this rule, for intensive care unit beds. (E) The equipment described in this
paragraph may be replaced by newer technology that has equivalent or superior
capability as determined by the pediatric cardiac catheterization service. In
assessing these new technologies, consideration should be given to
recommendations of recognized professional societies and accrediting bodies
(e.g. the American college of cardiology; the American academy of pediatrics).
All pediatric cardiovascular surgery services will have the following
equipment: (1) Immediate replay
capabilities; (2) A blood gas
analyzer; (3) A pulse
oximeter; (4) An infant warming
device; (5) Pacing
equipment; (6) An external
pacemaker; (7) A
defibrillator; (8) An emergency cart;
and (9) A comprehensive
inventory of cannulas and conduits.
Last updated September 2, 2025 at 10:08 AM
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Rule 3701-22-63 | Pediatric cardiovascular surgery service - performance measures.
Effective:
August 31, 2025
(A) Each pediatric cardiovascular surgery service should
maintain a volume of cardiovascular procedures sufficient to ensure the safety
and quality of procedures performed at the service and individual surgeon
proficiency. (B) No minimum per surgeon volume is recommended, however,
the combination of high risk adjusted mortality and low volume will trigger a
thorough internal review of an individual physician by the pediatric
cardiovascular surgery service.
Last updated September 2, 2025 at 10:08 AM
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Rule 3701-22-64 | Quality assessment and performance improvement - pediatric cardiovascular surgery service.
Effective:
August 31, 2025
In addition to the general quality assessment and
performance improvement requirements set forth in rule 3701-22-07 of the
Administrative Code, each pediatric cardiovascular surgery service will: (A) As part of the service's overall
quality assessment and performance improvement process: (1) Utilize the quality
performance measures outcomes data obtained from the service's
participation in the service's chosen data registry; and (2) Include a periodic
review and evaluation of the multidisciplinary meetings required by paragraph
(C) of rule 3701-22-59 of the Administrative Code. (B) Have a regular formal morbidity and
mortality conference chaired by the medical director of the pediatric
cardiovascular surgery service or the medical director's designee. The
morbidity and mortality conferences will: (1) Be held at a minimum,
once a month or more frequently depending on the need; and (2) Review all deaths and
complications such as reoperation for bleeding, deep sternal wound infection,
stroke, perioperative myocardial infarction, and any patterns that might
indicate a problem will be investigated and remedied if necessary.
Last updated September 2, 2025 at 10:08 AM
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Rule 3701-22-65 | Order to suspend operations of a health care service.
Effective:
August 31, 2025
In addition with the actions taken by the director against a hospital
with a health care service under paragraphs (B)(1) and (B)(2) of rule
3701-22-05 of the Administrative Code, the director may issue an order to
suspend operations to a health care service, for the following: (A) The director determines, based on
clinical criteria including, but not limited to, major complications, the
frequency of emergency transfers, and death, that the service poses an imminent
threat of serious physical or life-threatening danger to the recipients of
health care services; (B) Failure of the service to meet
designated quality outcome benchmarks, as evidenced by annual reports of the
service's chosen data registry reports, or the service's annual
reportable interventions; or (C) Failure of the service to comply with the
provisions of this chapter.
Last updated September 2, 2025 at 10:08 AM
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