This website publishes administrative rules on their effective dates, as designated by the adopting state agencies, colleges, and
universities.
| Rule |
Rule 3701-83-01 | General definitions.
As used in this chapter: (A) "Accreditation
award letter" means an official letter stating the accreditation status and
effective dates issued to a health care facility by an entity that the director
has determined as having standards and a process for assessing compliance which
equal or exceed the requirements of section 3702.30 of the Revised Code and the
applicable requirements of Chapter 3701-83 of the Revised Code. (B) "Administrator" means the person responsible for the overall
daily management of the health care facility. (C) "Advanced directives" means a written document executed in
accordance with section 2133.02 or section 1337.12 of the Revised
Code. (D) "Current procedural terminology" or "CPT" means the
comprehensive listing of medical terms and codes published by the American
medical association for the uniform designation of diagnostic and therapeutic
procedures in surgery, medicine and the specialties. (E) "Dentist" means a person licensed under Chapter 4715. of the
Revised Code to practice dentistry. (F) "Department" means the Ohio department of
health. (G) "Dialysis station" or "station" means the equipment used to
provide chronic maintenance dialysis for a single patient at a given time,
including equipment used for self-dialysis and isolation stations. (H) "Director" means the director of health or any official or
employee of the department designated by the director of health. (I) "Health care facility" or "HCF" means any of the
following: (1) An ambulatory
surgical facility as defined in rule 3701-83-15 of the Administrative
Code; (2) A freestanding dialysis center as defined in rule 3701-83-23
of the Administrative Code; (3) A freestanding inpatient rehabilitation facility as defined
in rule 3701-83-25 of the Administrative Code; (4) A freestanding birthing center as defined in rule 3701-83-33
of the Administrative Code; (5) A freestanding radiation therapy center as defined in rule
3701-83-43 of the Administrative Code; and (6) A freestanding or mobile diagnostic imaging center as defined
in rule 3701-83-51 of the Administrative Code. (J) "Hospital" means an institution required to be registered
under section 3701.07 of the Revised Code. (K) "Licensed practical nurse" or "LPN" means a person licensed
under Chapter 4723. of the Revised Code to practice nursing as a licensed
practical nurse. (L) "Medical director" means the physician who is responsible for
managing and directing the provision of medical services at the health care
facility unless otherwise indicated in Chapter 3701-83 of the Administrative
Code. (M) "Nurse" means either a licensed practical nurse or a
registered nurse. (N) "Owner" means any person who holds a legal, equitable, or
possessory interest of any kind in a health care facility, including, without
limitation, a trust, vendor, vendee, lessor, or lessee. Owner does not include
a person who holds indicia of ownership primarily to protect the person's
security interest in the health care facility. (O) "Patient" means any individual who receives services in a
health care facility. (P) "Patient representative" means either a person acting on
behalf of a patient with the consent of the patient or the patient's legal
guardian. (Q) "Personnel" means all individuals working in the health care
facility. (R) "Physician" means a person who is licensed under Chapter
4731. of the Revised Code to practice medicine and surgery, or osteopathic
medicine and surgery. (S) "Podiatrist" means a person licensed to practice podiatry
under Chapter 4731. of the Revised Code. (T) "Registered nurse" or "RN" means a person who is licensed
under section 4723. of the Revised Code to practice nursing as a registered
nurse. (U) "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" does not include a
volunteer who provides direct care only to a member of his or her
family. (V) "Surgery" means any medical procedure performed upon the body
of a living human being, regardless of the length of time the procedure takes,
involving the invasion, alteration, cutting, disruption, destruction,
resection, or removal of human tissue or bone by use of sharp-edged
instruments, lasers, electrical cautery, cryoprobes, or any other medically
accepted means for the purposes of preserving health, diagnosing or curing
disease, repairing injury, correcting deformity or defects, prolonging life,
relieving suffering, or for aesthetic, reconstructive, or cosmetic purposes.
"Surgery" does not include the suturing of minor lacerations.
Last updated August 1, 2023 at 2:23 PM
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Rule 3701-83-02 | Applicability of rules.
(A) Except as provided in section 3702.301 of the Revised
Code and paragraph (B) of rule 3701-83-03 of the Administrative Code, all
health care facilities shall comply with rules 3701-83-02 to 3701-83-14 of the
Administrative Code. In addition, all: (1) Ambulatory surgical facilities shall comply with rules
3701-83-15 to 3701-83-22 of the Administrative Code; (2) Freestanding dialysis centers shall comply with rules
3701-83-23 to 3701-83-24 of the Administrative Code; (3) Freestanding inpatient rehabilitation facilities shall
comply with rules 3701-83-25 to 3701-83-32 of the Administrative
Code; (4) Freestanding birthing centers shall comply with rules
3701-83-33 to 3701-83-42 of the Administrative Code; (5) Freestanding radiation therapy centers shall comply
with rules 3701-83-43 to 3701-83-50 of the Administrative Code;
and (6) Freestanding or mobile diagnostic imaging centers shall
comply with rules 3701-83-51 to 3701-83-55 of the Administrative
Code. (B) Freestanding birthing centers exempted from licensure
under section 3702.301 of the Revised Code and paragraph (B) of rule 3701-83-03
of the Administrative Code shall comply with rules 3701-83-56 to 3701-83-59 of
the Administrative Code.
Last updated August 1, 2023 at 2:23 PM
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Rule 3701-83-03 | General provisions and prohibitions.
(A) Except as provided in section
3702.301 of the Revised Code and paragraph (B) of this rule, no person or
agency of state or local government shall operate an HCF without a current
valid license issued by the director under section 3702.30 of the Revised Code
or operate an HCF when the license has been suspended or revoked. (B) Except as provided in division (C) of
section 3702.301 of the Revised Code and paragraph (C) of rule 3701-83-59 of
the Administrative Code, a freestanding birthing center is not required to
obtain a license under section 3702.30 of the Revised Code if all of the
following are the case: (1) A religious
denomination, sect, or group owns and operates the center and has provided
written notice to the director of the following: (a) An attestation by the
administrator or director that the center will be owned and operated by members
of a religious denomination, sect, or group and that requiring that the center
be licensed significantly abridges or infringes on the religious practices and
beliefs of that religious denomination, sect, or group; (b) An attestation by the
administrator or director that the center will be admitting, retaining, and
providing care exclusively to women members of a religious denomination, sect,
or group that owns and operates the center; (c) The name of owner(s)
and identification of what religious denomination, sect, or group they are
members of; (d) The name of proposed
administrator or director of patient services and identification of what
religious denomination, sect, or group they are members of; (e) The name of board
members and identification of what religious denomination, sect, or group they
are members of; (f) The name of the
Ohio-licensed physician(s) who will provide obstetrical and/or pediatric
consultation and oversight of the center; (g) The number and type of
staff (e.g., traditional midwives, certified professional midwives, apprentice
midwives, state-licensed health care professionals) who will provide services
in the center; (h) The number of
admissions and deliveries at the center to date if services have commenced at
the center prior to providing this notice; (i) What arrangements are
in place with a hospital for transfer of a mother or newborn in the event of
medical complications; and (j) How and by whom each
expectant mother will be assessed prior to admission. (2) The center provides care only during low-risk pregnancy,
delivery, and the immediate postpartum period exclusively to women who are
members of that religious denomination, sect, or group; (3) The center monitors and evaluates the care provided to its
patients in accordance with at least the minimum patient safety monitoring and
evaluation requirements of rule 3701-83-57 of the Administrative Code;
and (4) The center meets the quality assessment and improvement
standards established in rule 3701-83-58 of the Administrative
Code. (C) No person or agency of state or local government
shall: (1) Interfere with an
inspection or investigation of an HCF by the director; or (2) Materially
misrepresent any information provided to the director pursuant to section
3702.30 of the Revised Code and Chapter 3701-83 of the Administrative
Code. (D) Each HCF shall comply with all applicable state and federal
laws and regulations. (E) Nothing in this chapter shall be construed to alter or affect
the law with respect to the corporate practice of medicine and surgery,
osteopathic medicine and surgery, or dentistry. (F) The HCF shall have an identifiable governing body responsible
for the following: (1) The development and
implementation of policies and procedures and a mission statement for the
orderly management of the HCF; (2) The evaluation of the
HCF's quality assessment and performance improvement program on an annual
basis; and (3) The development and
maintenance of a disaster preparedness plan, including evacuation
procedures. (G) Each HCF shall either maintain documentation of appropriate
liability insurance coverage of the staff and consulting specialists or inform
patients that the staff member or consulting specialist does not carry
malpractice insurance. (H) No HCF shall permit any person to smoke inside the HCF. The
HCF shall post a notice in a conspicuous place within the HCF stating that
smoking is prohibited inside the HCF. (I) Nothing in this chapter shall be construed as authorizing
individuals to provide services outside their licensed scope of
practice. (J) The owner, administrator, and medical director shall be
competent to perform the respective responsibilities. (K) An HCF may arrange for services to be
provided through a contract with an outside resource. The HCF shall retain
professional management responsibility for contracted services and shall ensure
that those services are furnished in a safe an effective manner.
Last updated August 1, 2023 at 2:23 PM
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Rule 3701-83-04 | License application and renewal procedures.
(A) A person or agency of state or local
government seeking a license to operate an HCF shall submit to the director an
application, on a form and in a manner prescribed by the director and shall
include the following: (1) A statement of
ownership containing the following information: (a) The name, address, and telephone number of the
HCF. (i) If the owner is an
individual, the owner's name, address, telephone number, business address,
and business telephone number. (ii) If the owner is an
association, corporation, limited liability company, or partnership, the legal
business entity name, address, and telephone number of the entity and the name
of every person who has an ownership interest of five per cent or more in the
entity. The corporate name; if any, and the names, titles, addresses and
telephone numbers of its officers and statutory agent. (iii) If the applicant is
an agency of state or local government, the name, address and telephone number
of the individual authorized to enter into agreements on behalf of the agency
of state or local government. (b) The name of the administrator; (c) The name and physician license number or dentist license
number of the medical director of the HCF; (d) The name and address of any of the following facilities which
either the owner, administrator or medical director has been affiliated through
ownership or employment in the five years prior to the date of the
application: (i) A nursing home,
residential care facility, or home for the aging as defined in section 3721.01
of the Revised Code; (ii) A residential facility for the mentally ill licensed by the
department of mental health under section 5119.22 of the Revised
Code; (iii) A facility licensed to provide methadone treatment under
section 3793.11 of the Revised Code; (iv) A residential facility licensed under section 5123.19 of the
Revised Code or otherwise regulated by the department of developmental
disabilities; (v) A terminal care facility for the homeless that has entered
into an agreement with a hospice care program under section 3712.07 of the
Revised Code; (vi) A health insuring corporation as defined by section 1751.01
of the Revised Code; (vii) A hospital; or (viii) An entity certified by the United States centers for medicare
and medicaid services for purposes of reimbursement under Part B of the
medicare program, Part B of Title XVIII of the "Social Security Act,"
49 Stat. 620 (1935), 42 U.S.C.A. 301, as amended (1981); or certified for the
purposes of reimbursement by medicaid, a state plan approved under Title XIX of
the Social Security Act," 49 Stat. 620 (1935), 42 U.S.C.A. 301, as amended
(1981). (e) Information about any criminal conviction, civil judgment or
administrative adjudication of the owner, administrator or medical director for
an offense related to the provision of care or bearing a direct or substantial
relationship to the job responsibilities he or she is to carry
out. (2) If applicable, a copy
of the fire inspection report required under paragraph (C) of rule 3701-83-06
of the Administrative Code and if applicable, the certificate of use and
occupancy required under rule 3701-83-10 of the Administrative
Code; (3) The type of HCF license for which the
applicant is applying; in addition: (a) An ASF shall specify the number of operating rooms, or
procedure rooms, or both; (b) A freestanding dialysis center shall specify the number of
dialysis stations, including the number of hemodialysis stations and peritoneal
stations; (c) A freestanding inpatient rehabilitation facility shall
specify the number of patient care beds; (d) A freestanding birthing center shall specify the number of
birth rooms; (e) A freestanding or mobile diagnostic imaging center shall
specify whether the radiopharmaceuticals being proposed for use are for use as
delineated in rule 3701:1-58-32, 3701:1-58-34, 3701:1-58-37 or 3701:1-58-53 of
the Administrative Code and the number and type of radiation-generating or
detecting equipment; (f) A freestanding radiation therapy center shall specify the
number and type of radiation-generating or detecting equipment being proposed
for use and whether radiopharmaceuticals or sealed sources being proposed for
use are for use as delineated in rule 3701:1-58-43 or 3701:1-58-55 of the
Administrative Code (4) A complete copy of the HCF's
current accreditation award letter, if applicable. (B) A person or agency of state or local
government seeking renewal of an HCF license shall submit to the director an
application for renewal each year during the month specified on the HCF's
license. A person or agency of state or local government seeking renewal of an
HCF license, or an amended license under paragraph (F) of this rule, shall
submit to the director an application on a form and in a manner prescribed by
the director, and shall include the following: (1) The name, address,
and telephone number of the facility; (2) The type of facility
for which the applicant is seeking license renewal; (3) Any changes or
updates to the information required by paragraph (A) of this rule, including a
copy of the most recent accreditation award letter, if applicable, unless the
department has been previously notified; (4) Copies of all
inspections, agreements, or approvals required by Chapter 3701-83 of the
Administrative Code, that have been conducted since submittal of the HCF's
previous application; (5) Any other information
the director may require regarding the owner's ability to operate the
facility. (C) An application for an HCF license,
license renewal or amended license shall include the following: (1) Attestation that to
the best of the applicant's knowledge, the information in the application
and any accompanying material is true and accurate; (2) Attestation by the
medical director and the administrator that to the best of their knowledge, the
information in the application submitted pursuant to paragraph (A)(1)(c) of
this rule is true and accurate; (3) Attestation that the
applicant, if not the owner, is the authorized representative of the owner,
and (4) A nonrefundable
application fee of three hundred dollars for an HCF license or license renewal
or a nonrefundable fee of one hundred and fifty dollars for an amended HCF
license payable to the "Treasurer, State of Ohio." (D) The director at any time may request
additional information the director determines to be necessary to assess
compliance with the applicable criteria, standards, and requirements
established by section 3702.30 of the Revised Code and Chapter 3701-83 of the
Administrative Code. The applicant shall submit any additional information
requested by the director within thirty days of the date of the director's
request. (1) For an initial
application for licensure, if the director does not receive the requested
information within sixty days of the director's request for additional
information, the director may consider the application abandoned;
and (2) Further consideration
for an initial license will require a new application accompanied by another
nonrefundable license fee as set forth in paragraph (C)(4) of this
rule. (E) The HCF shall notify the director in
writing no later than thirty days of: (1) Any changes in the
information contained in the statement of ownership made pursuant to paragraph
(A) of this rule; and (2) Any change in the
HCF's accreditation status. (F) The HCF shall apply for an amended
license if: (1) In the case of an
ASF, there is any increase or a permanent decrease in the number of operating
or procedure rooms; (2) In the case of a
freestanding dialysis center, there is any increase or a permanent decrease in
the number of dialysis stations; (3) In the case of a
freestanding inpatient rehabilitation facility, there is any increase or a
permanent decrease in the number of patient care beds; (4) In the case of a
freestanding birthing center, there is any increase or a permanent decrease in
the number of birthing rooms; (5) In the case of a
freestanding or mobile diagnostic imaging center, there is any increase in the
number or change in the type of radiation-generating or detecting equipment or
any change in the radiopharmaceuticals being used pursuant to rule
3701:1-58-32, 3701:1-58-34, 3701:1-58-37, or 3701:1-58-53 of the Administrative
Code; and (6) In the case of a
freestanding radiation therapy center, there is any increase in the number or
change in the type of radiation-generating or detecting equipment being used or
any change in the radiopharmaceuticals or sealed sources being used pursuant to
rule 3701:1-58-43 or 3701:1-58-55 of the Administrative Code (G) The HCF shall not use any additional
room, station, bed or equipment until an amended HCF license has been issued,
or the HCF has received other verifiable approval by the
department.
Last updated July 15, 2022 at 9:47 AM
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Rule 3701-83-05 | Issuance, renewal, and denial of licenses.
(A) The director shall issue or renew a
license to an HCF that submits an application for license in accordance with
rule 3701-83-04 of the Administrative Code and that demonstrates to the
director it meets the requirements of section 3702.30 of the Revised Code and
the requirements of Chapter 3701-83 of the Administrative Code. Nothing herein
shall exempt any HCF from the data reporting requirements of Chapter 3701-83 of
the Administrative Code, the fee requirements of paragraph (C) of rule
3701-83-04 of the Administrative Code, and any other applicable state or
federal law or regulation. (1) The director may renew an HCF license
without conducting an onsite inspection if: (a) The HCF is accredited by a national accrediting body approved
by the centers for medicare and medicaid services, as documented by a current
award letter from the accrediting body; (b) The HCF is deemed to meet or exceed the applicable medicare
program requirements for health care facilities as set forth in this chapter,
as documented by a current award letter from the accrediting body or an
approval letter from the centers for medicare and medicaid services;
or (c) The HCF, on the facility's most recent centers for
medicare and medicaid services survey, has been determined to be in compliance
with the medicare program participation requirements by virtue of a department
conducted medicare certification or recertification survey. (2) Notwithstanding paragraph (A) of this
rule, the director may conduct an on-site inspection prior to issuing a renewal
license. (3) The director shall only issue one
license of the same type at a given location for the following types of health
care facilities: (a) Ambulatory surgical facility; (b) Freestanding inpatient rehabilitation facility; (c) Freestanding birthing center; or (d) Freestanding dialysis center. (B) Any license issued to an
HCF: (1) Shall contain the
name and address of the facility for which it was issued, the effective date of
the license, and the month the HCF must apply for renewal of the license. In
addition: (a) The license for an ambulatory surgical facility shall specify
the maximum number of operating rooms, or procedure rooms, or
both; (b) The license for a freestanding dialysis center shall specify
the maximum number of dialysis stations; (c) The license for a freestanding inpatient rehabilitation
facility shall specify the maximum number of patient care beds; (d) The license for a freestanding birthing center shall specify
the number of birth rooms; (e) The license for a freestanding or mobile diagnostic imaging
center shall specify the number and type of equipment. (f) The license for a freestanding or mobile radiation therapy
center shall specify the number and type of equipment. (2) Is valid unless
revoked or suspended pursuant to Chapter 119. of the Revised Code, or voided at
the request of the owner, or the HCF fails to timely apply for a renewal in
accordance with paragraph (B) of rule 3701-83-04 of the Administrative Code;
and (3) Is valid only for the
facility specified on the license at the listed address. (C) The director shall, in accordance
with Chapter 119. of the Revised Code, deny an application for a license or an
application for amendment or renewal of a license if: (1) The HCF fails to make
application for a license in accordance with rule 3701-83-04 of the
Administrative Code; (2) Fails to demonstrate
to the director that the HCF meets or continues to meet the requirements of
section 3702.30 of the Revised Code and Chapter 3701-83 of the Administrative
Code; or (3) The director
determines that the owner, administrator, or medical director is not competent
to operate an HCF based on review of information pertaining to paragraphs
(A)(1)(c) and (A)(1)(d) of rule 3701-83-04 of the Administrative
Code. (D) The HCF shall notify the director in writing within thirty
days of termination of an accreditation. (E) In addition to any other provision of Chapter 3701-83 of the
Administrative Code, if the director granted a license based on the HCF
demonstrating compliance through submittal of an accreditation award letter and
one of the events listed in this paragraph occurs, the director may inspect or
request additional information from the HCF to determine whether the HCF meets
the requirements of section 3702.30 of the Revised Code and the applicable
requirements of Chapter 3701-83 of the Administrative Code. (1) The HCF's
accreditation is terminated; or (2) The HCF's
accreditation expires and is not renewed.
Last updated August 1, 2023 at 2:24 PM
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Rule 3701-83-05.1 | Compliance actions, revocation, and operating without a license.
(A) If the director determines that an
HCF is operating without a license in violation of division (E)(1) of section
3702.30 of the Revised Code, the director shall do one or more of the
following: (1) Notify the HCF that
it is operating without a license and issue a written order that the HCF apply
for a license. The order shall specify the time frame for filing a complete
application in accordance with rule 3701-83-04 of the Administrative Code that
shall not exceed thirty days after the date of the order; (2) Issue a written order
that the HCF cease its operations. The department shall deliver the written
order issued under section 3702.32 of the Revised Code to the HCF. The order
shall be effective no later than fifteen days after the facility receives the
order, and shall stay in effect until such time as specified by the director or
until a license is issued; (3) Issue a written order
that prohibits the HCF from performing certain types of services. The
department shall deliver the written order issued under section 3702.32 of the
Revised Code to the HCF. The order shall be effective on the date specified in
the order and shall stay in effect until such time as specified by the director
or until a license is issued; (4) Impose a civil
penalty as provided under paragraph (A) of rule 3701-83-05.2 of the
Administrative Code. The civil penalty shall not be less than one thousand
dollars and not more than two hundred fifty thousand dollars; (5) Impose an additional
civil penalty as provided under paragraph (D) of rule 3701-83-05.2 of the
Administrative Code. The civil penalty shall not be less than one thousand
dollars and not more than ten thousand dollars for each day that the HCF
continues to operate without a license in violation of an order issued under
paragraph (A) of this rule. (B) The director may file a petition in
the court of common pleas of the county in which a HCF is located for an
injunction enjoining the facility from operating if the HCF is subject to an
order issued: (1) Under paragraph
(A)(1) of this rule but the HCF continues to operate in violation of such order
after the time frame specified for filing an application; or (2) Under paragraph
(A)(2) of this rule but the HCF continues to operate or provide services in
violation of such order. (C) If the director determines that the
HCF is not complying with any provision of section 3702.30 of the Revised Code,
other than a violation under division (E)(1) or (E)(2) of that section, any
provision of Chapter 3701-83 of the Administrative Code, or any other rule
adopted by the director under section 3702.30 of the Revised Code, the director
may do any or all of the following: (1) Provide an
opportunity to correct the violation within a specified period of
time; (2) Revoke, suspend, or
refuse to renew the license; (3) Prior to or during
the pendency of an administrative hearing under Chapter 119. of the Revised
Code, issue an order that prohibits the HCF from performing certain types of
services. The order shall be effective on the date specified in the
order; (4) Impose a civil
penalty as provided under paragraph (A) of rule 3701-83-05.2 of the
Administrative Code. The civil penalty shall not be less than one thousand
dollars and not more than two hundred fifty thousand dollars; (5) Impose an additional
civil penalty as provided under paragraph (E) of rule 3701-83-05.2 of the
Administrative Code. The civil penalty shall not be less than five hundred
dollars and not more than ten thousand dollars for each day that the HCF fails
to correct the violation. (D) In determining which of the actions
to take under paragraph (C) of this rule, the director may consider, but is not
limited to, any or all of the following factors: (1) The danger of serious
physical or life threatening harm to one or more patients of the
HCF; (2) The nature, duration,
gravity, and extent of the violation; (3) Whether the violation
directly relates to patient care; (4) The number, if any,
of patients directly affected by the violation; (5) The extent of any
actual or potential harm to patients; (6) The actions taken by
the HCF to correct the violation; and (7) The compliance
history of the HCF. (E) The director may file a petition in
the court of common pleas of the county in which the facility is located for an
injunction enjoining: (1) A HCF that is
operating without a license from performing certain types of services if the
HCF is subject to an order issued under paragraph (A)(3) of this rule but
continues to perform the types of services prohibited by the order;
or (2) A licensed HCF from
performing certain types of services if the HCF is subject to an order issued
under paragraph (C)(3) of this rule but continues to perform the types of
services prohibited by the order. (F) If, after reporting under division
(E)(2) of section 3702.30 of the Revised Code that a physician failed to obtain
informed consent under any provision of the Revised Code, the department finds
that the physician has continued to engage in a pattern of violating the same
informed consent provision at the HCF and that the HCF has failed to take
reasonable steps to ensure that the physician does not continue the same
violation at the HCF, the department may, after providing the HCF an
opportunity for a hearing pursuant to Chapter 119. of the Revised Code, impose
a civil penalty on the HCF. The penalty shall be not less than one thousand
dollars and not more than fifty thousand dollars. For the purpose of this
paragraph, "pattern" means a violation of the same provision of the
Revised Code that reasonably could have been prevented by a facility's
corrective action and was determined by the department to have occurred at
least twice after the department made its report as provided in division (E)(2)
of section 3702.30 of the Revised Code.
Last updated August 1, 2023 at 2:24 PM
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Rule 3701-83-05.2 | Civil penalties.
(A) Except as provided under paragraph
(B) of this rule, civil penalties imposed under paragraph (A)(4) or paragraph
(C)(4) of rule 3701-83-05.1 of the Administrative Code for a violation of
section 3702.30 of the Revised Code, Chapter 3701-83 of the Administrative
Code, or any other rule adopted by the director under section 3702.30 of the
Revised Code shall be imposed as follows: (1) If no harm has
occurred to any patient, one thousand to fifty thousand dollars; (2) If harm has occurred
to one or more patients, fifty-one thousand to one hundred thousand
dollars; (3) If there has been
permanent injury to one or more patients, one hundred one thousand to one
hundred fifty thousand dollars; and (4) If death has occurred
to one or more patients, one hundred fifty-one thousand to two hundred fifty
thousand dollars. (B) Except as otherwise required by law,
if there has been a history of uncorrected violations of section 3702.30 of the
Revised Code, Chapter 3701-83 of the Administrative Code, or any other rule
adopted under section 3702.30 of the Revised Code that caused no actual harm to
a patient, but had the potential to cause more than minimal harm, a fine of up
to two hundred fifty thousand dollars may be imposed. (C) In determining the level of civil
monetary penalties imposed under this paragraph, the total amount of fines for
violations discovered during one inspection shall not exceed two hundred fifty
thousand dollars. (D) Additional civil penalties imposed
under paragraph (A)(5) of rule 3701-83-05.1 of the Administrative Code shall be
imposed on a per day basis of one thousand to ten thousand dollars for each day
that the HCF continues to operate without a license in violation of a written
order issued under paragraph (A) of rule 3701-83-05.1 of the Administrative
Code. (E) Additional civil penalties imposed
under paragraph (C)(5) of rule 3701-83-05.1 of the Administrative Code shall be
imposed on a per day basis of five hundred to ten thousand dollars for each day
the HCF fails to correct the violation. (F) Civil penalties imposed under
paragraph (F) of rule 3701-83-05.1 of the Administrative Code shall be imposed
as follows: (1) If a physician failed
to obtain informed consent from less than ten patients, but no patients were
harmed, one thousand to twenty-five thousand dollars; (2) If a physician failed
to obtain informed consent from ten or more patients, but no patients were
harmed, twenty-six thousand to fifty thousand dollars; and (3) If harm occurs to one
or more patients as a result of a physician's failure to obtain informed
consent, thirty thousand to fifty thousand dollars per patient. (G) In determining the amount of civil
penalties imposed under paragraphs (A) and (F) of this rule, the director may
consider, but is not limited to, any or all of the following
factors: (1) The compliance
history of the HCF; (2) The number of
patients directly affected; (3) The impact of the
noncompliance on the patient or patients; (4) Whether the violation
is repetitive in nature or is similar to previous violations; (5) The length or
duration of the violation; and (6) The time period
between the current violation and any similar previous violation. (H) The HCF may appeal the imposition of
civil penalties imposed under this rule in accordance with Chapter 119. of the
Revised Code. (I) If the department issues more than
one order, any administrative hearing resulting from such orders may be
consolidated into one hearing. Consolidation of the hearings does not affect
any effective dates prescribed in the orders.
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Rule 3701-83-06 | Inspections.
Effective:
October 6, 2011
(A) The director may make announced or unannounced inspections as the director considers necessary to determine compliance with section 3702.30 of the Revised Code and the applicable requirements of Chapter 3701-83 of the Administrative Code. The director may notify ASFs, freestanding dialysis centers, freestanding inpatient rehabilitation facilities, and freestanding birth centers prior to conducting announced inspections for initial and renewal licensing. Such prior notification shall be no earlier than thirty days and no later than two weeks prior to start date of the survey. (B) Immediately upon request, each HCF shall provide the director access to its premises, facility and patient records, including medical records, and staff to enable the director to determine compliance with section 3702.30 of the Revised Code and the applicable requirements of Chapter 3701-83 of the Administrative Code. (C) Prior to the issuance of an initial license the HCF shall obtain documentation from the state fire marshal or fire prevention officer of a municipal, township, or other legally constituted fire department approved by the fire marshal that the HCF is in compliance with the state fire code. In the case of an HCF regulated by the state fire code, following the initial license the HCF shall obtain documentation, every twelve months and at any other time requested by the director, that the HCF continues to be in compliance with the state fire code. (D) Information obtained by the director pertaining to specific patients is confidential. Information may be released in summary, statistical, or other form which does not disclose the identity of an individual patient. (E) The director may conduct an inspection to investigate alleged violations of section 3702.30 of the Revised Code and Chapter 3701-83 of the Administrative Code. The director shall inform the complainant and the HCF of the results of the inspection. (F) For purposes of this paragraph "follow-up inspection" means an inspection conducted by the department to determine whether an HCF has corrected a violation or violations cited on a previous inspection and to verify whether an HCF is in compliance with the applicable criteria, standards, and requirements established by section 3702.30 of the Revised Code and Chapter 3701-83 of the Administrative Code. "Validation inspection" means an inspection of an HCF that submitted an acceptable accreditation award letter or an approval letter. The HCF fee for inspections conducted by the director pursuant to section 3702.30 of the Revised Code and paragraphs (A) and (E) of this rule shall be as follows: (1) Inspection fee of one thousand seven hundred fifty dollars; (2) Complaint inspection fee of eight hundred seventy-five dollars; (3) Follow-up inspection fee of eight hundred seventy-five dollars; (4) Validation inspection fee of one thousand seven hundred fifty dollars: and (5) Desk audit or compliance review inspection fee of two hundred fifty dollars. (G) Notwithstanding the requirements of paragraph (F) of this rule, the fee for an inspection of a free-standing radiation therapy center or a free-standing diagnostic or mobile imaging center shall be determined as follows. To the extent practicable, inspections done to determine compliance with Chapter 3748. of the Revised Code shall be done concurrently with inspections to determine compliance with Chapter 3701-83 of the Administrative Code. (1) Inspection fee of nine hundred fifty dollars; (2) Follow-up inspection fee of four hundred seventy-five dollars; (3) Complaint fee of four hundred seventy-five dollars; and (4) Desk audit or compliance review inspection fee of two hundred fifty dollars. (H) The director shall provide to each HCF inspected pursuant to section 3702.30 of the Revised Code and paragraph (A) or (E) of this rule a written statement of the fee established in paragraph (F) or (G) of this rule. The statement shall itemize the total costs incurred. (I) Each HCF shall forward the total amount of the fee to the director payable to the "Treasurer, State of Ohio" within fifteen days after receiving a statement of the fee issued under paragraph (F) or (G) of this rule. (J) The director shall deposit HCF fees into the quality monitoring and inspection fund created in the state treasury pursuant to division (A) of section 3702.31 of the Revised Code.
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Rule 3701-83-07 | Patient care policies.
(A) The HCF shall develop and follow
comprehensive and effective patient care policies that include and
ensure: (1) Each patient is
treated with consideration, respect, and full recognition of dignity and
individuality, including privacy in treatment and personal care
needs; (2) Each patient is
allowed to refuse or withdraw consent for treatment; (3) Each patient has
access to their medical record, unless access is specifically restricted by the
attending physician for medical reasons; (4) Each patient's
medical and financial records are kept in confidence; and (5) Each patient
receives, if requested, a detailed explanation of facility charges including an
itemized bill for services received. (B) The HCF shall inform each patient of
the following: (1) The HCF's policy
on advance directives and do-not-resuscitate (DNR) orders; and (2) The name of the
attending physician or individual supervising the patient's care and the
manner in which that individual may be contacted. (C) The HCF shall implement a patient
satisfaction survey program.
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Rule 3701-83-08 | General personnel and staffing requirements.
(A) Each HCF shall utilize personnel that
have appropriate training and qualifications for the services that they
provide. Any staff member who functions in a professional capacity shall meet
the standards applicable to that profession, including but not limited to
possessing a current Ohio license, registration, or certification, if required
by law, and working within their scope of practice. Copies of current Ohio
licenses, registrations and certifications shall be kept in the employee's
personnel files or the provider of the HCF shall have an established system of
records necessary for the director to ascertain that all individuals employed
at the HCF who function in a professional capacity meet the standards
applicable to that profession, including, but not limited to, possessing a
current Ohio license, registration, or other certification if required by
law. (B) Each HCF shall develop and follow a
tuberculosis control plan that is based on the provider's assessment of
the facility. The control and assessment shall be consistent with the centers
for disease control and prevention (CDC) "Guidelines for Preventing the
Transmission of Mycobacterium tuberculosis in Health Care Settings, 2005,"
MMWR 2005, Volume 54, No. RR-17. The HCF shall retain documentation evidencing
compliance with this paragraph and shall furnish such documentation to the
director upon request. (C) Each HCF shall not knowingly permit a
staff member to provide services if the staff member: (1) Has a communicable
disease capable of being transmitted during the performance of their duties;
or (2) Is under the
influence of drugs or alcohol. (D) Each HCF shall provide each staff
member with a written job description delineating staff member's
responsibilities. (E) Each HCF shall provide an ongoing
training program for its staff. The program shall provide both orientation and
continuing training to all staff members. The orientation shall be appropriate
to the tasks that each staff member will be expected to perform. Continuing
training shall be designed to assure appropriate skill levels are maintained
and that staff are informed of changes in techniques, philosophies, goals, and
similar matters. The continuing training may include attending and
participating in professional meetings and seminars. (F) All staff shall have appropriate
orientation and training regarding the facility's equipment, safety
guidelines, practices, and policies. (G) Each HCF shall evaluate the
performance of each staff member at least every twelve months. (H) Each HCF shall retain staffing
schedules, time-worked schedules, on-call schedules, and payroll records for at
least two years.
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Rule 3701-83-09 | General service standards.
(A) Each HCF shall assure all staff
members provide services in accordance with: (1) Applicable current
and accepted standards of practice and the clinical capabilities of the HCF;
and (2) Applicable state and
federal laws and regulations. (B) Each HCF shall have the ancillary and
support services necessary for the provision of the HCF's
services. (C) Each HCF, as part of the quality
assessment and performance improvement program required by rule 3701-83-12 of
the Administrative Code, shall document and review any complications and
adverse events which arise during the provision of the facility's
service. (D) Each HCF shall establish and follow
written infection control policies and procedures for the surveillance, control
and prevention and reporting of communicable disease organisms by both the
contact and airborne routes which shall be consistent with current infection
control guidelines issued by the United States centers for disease control. The
policies and procedures shall address: (1) The utilization of
protective clothing and equipment; (2) The storage,
maintenance and distribution of sterile supplies and equipment; (3) The disposal of
biological waste; including blood, body tissue; and fluid in accordance with
Ohio law; (4) Standard
precautions/body substance isolation or equivalent; and (5) Tuberculosis and
other airborne diseases. (E) Each HCF shall maintain and operate
equipment in a safe manner and in accordance with the manufacturer's
instructions. (F) Each HCF shall provide the patient or
the patient's representative with: (1) Instruction and
education regarding the services to be performed; (2) Written information
about how to obtain appointments and needed services both during and after the
HCF's normal hours of operation; and (3) Verbal and written
instructions for post-treatment care and procedures for obtaining emergency
care. (G) Each HCF shall comply with rule
3701-3-03 of the Administrative Code pertaining to reportable disease
notification. (H) Each HCF shall require that each
physician practicing in the HCF complies with any provision of the Revised Code
related to obtaining informed consent from a patient and the policies and
procedures of the HCF. (I) If an HCF finds that a physician
practicing at the HCF does not comply with any provision of the Revised Code
related to the obtaining of informed consent from a patient, the HCF shall take
reasonable steps to ensure that the physician does not continue the practice at
the facility.
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Rule 3701-83-10 | General building and site requirements.
(A) Each HCF shall: (1) Have a certificate of
use and occupancy, from a local, certified building department or by the
department of commerce as meeting applicable requirements of Chapters 3781.,
3783., and 3791. of the Revised Code and any rules adopted under them or obtain
documentation from the appropriate building authority that the HCF is not
regulated by the state building code; and (2) Comply with the
applicable provisions of Chapter 3737. of the Revised Code and the rules
adopted under it. (B) Each HCF shall be maintained in a
safe and sanitary manner. (C) Each HCF shall develop a disaster
preparedness plan including evacuation in the event of a fire or other
emergency. Each HCF shall review evacuation procedures at least annually and
conduct practice drills with staff at least once every six months. (D) Each HCF shall label, store and
dispose of all poisons, hazardous wastes, and flammable materials in a safe
manner and in accordance with state and federal laws and
regulations.
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Rule 3701-83-11 | General medical records requirements.
(A) Each HCF shall 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, assessments,
and services rendered. Each medical record shall be legible and readily
accessible to staff for use in the ordinary course of treatment. (B) Each HCF shall not disclose
individual medical records except as provided by state and federal laws and
regulations. (C) Each HCF shall systematically review
the records for conformance with acceptable standards of practice and the
requirements of Chapter 3701-83 of the Administrative Code. (D) Each HCF shall maintain an adequate
medical record keeping system and take appropriate measures to protect medical
records against theft, loss, destruction, and unauthorized use. (E) Each HCF shall have policies and procedures to ensure
the confidentiality of patient medical records. (F) Each HCF shall maintain medical records as necessary to
verify the information and reports required by statute or regulation for at
least six years from the date of discharge.
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Rule 3701-83-12 | General quality assessment and performance improvement.
(A) Each HCF shall establish a quality
assessment and performance improvement program designed to systematically
monitor and evaluate the quality of patient care, pursue opportunities to
improve patient care, and resolve identified problems. (B) Each HCF shall develop a written plan
that describes the quality assessment and performance improvement
program's objectives, organization, scope, and mechanism for overseeing
the effectiveness of monitoring, evaluation, improvement and problem-solving
activities. (C) The quality assessment and
performance improvement program shall do all of the following: (1) Monitor and evaluate
all aspects of care including effectiveness, appropriateness, accessibility,
continuity, efficiency, patient outcome, and patient satisfaction; (2) Establish
expectations, develop plans, and implement procedures to assess and improve
quality of care and resolve identified problems; (3) Establish
expectations, develop plans, and implement procedures to assess and improve the
health care facility's governance, management, clinical, and support
processes; (4) Establish information
systems and appropriate data management processes to facilitate the collection,
management, and analysis of data needed for quality assessment and performance
improvement and to comply with the applicable data collection requirements of
Chapter 3701-83 of the Administrative Code; (5) Document and report
the status of the quality assessment and performance improvement program to the
governing body every twelve months; (6) Document and review
all unexpected complications and adverse events, whether serious injury or
death, that arise during an operation or procedure; and (7) Hold regular
meetings, chaired by the medical director of the HCF or designee, as necessary,
but at least within sixty days after a serious injury or death, to review all
deaths and serious injuries, and report findings. Any pattern that might
indicate a problem shall be investigated and remedied, if
necessary. (D) Each HCF shall implement a program
for proactive assessment of high-risk activities related to patient safety and
to undertake appropriate improvements. (E) Each HCF shall report to the
director, in a manner and interval prescribed by the director, the data
specified in the applicable rules of Chapter 3701-83 of the Administrative
Code.
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Rule 3701-83-13 | Complaints.
(A) Each HCF shall develop and follow
policies and procedures to receive, investigate, and report findings on
complaints regarding the quality or appropriateness of services provided by the
HCF. The documentation of complaints shall, at a minimum, include the
following: (1) The date complaint
was received; (2) The identity, if
provided, of the complainant; (3) A description of
complaint; (4) The identity of
persons or facility involved; (5) The findings of the
investigation; and (6) The resolution of the
complaint. (B) Each HCF shall post the toll free
complaint hotline of the department's complaint unit in a conspicuous
place in the HCF.
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Rule 3701-83-14 | Variances; waivers.
(A) The director may grant a variance or
waiver from any building or safety requirement established by Chapter 3701-83
of the Administrative Code, unless the requirement is mandated by
statute. (B) An HCF seeking a variance or waiver
must submit a written request to the director. Such written request must
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 HCF 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 HCF and why granting the waiver will not jeopardize the
health and safety of any patient. (C) Upon written request of the HCF the director may
grant: (1) A variance if the
director determines that the requirement has been met in an alternative manner;
or (2) A waiver if the
director determines that the strict application of the license requirement
would cause an undue hardship to the HCF 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 HCF must
meet for the variance or waiver to be operative. Such time period may be
different than the time period sought by the HCF in the written variance or
waiver request. (E) The director may establish conditions that the HCF 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 HCF 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 shall
not be construed as constituting precedence for the granting of any other
variance or waiver. All variance and waiver requests shall be considered on a
case-by-case basis.
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Rule 3701-83-15 | Definitions - ambulatory surgical facilities.
For the purposes of rules 3701-83-15 to 3701-83-22
of the Administrative Code, the following definitions shall apply: (A) "Ambulatory surgical
facility" or "ASF" means a facility in which surgical services
are provided to patients who do not require hospitalization for inpatient care,
the duration of services for any patient does not extend beyond twenty-four
hours after the patient's admission, and to which any of the following
apply: (1) The surgical services
are provided in a building that is separate from another building in which
inpatient care is provided, regardless of whether the separate building is part
of the same organization as the building in which inpatient care is
provided; (2) The surgical services
are provided within a building in which inpatient care is provided and the
entity that operates the portion of the building where the surgical services
are provided is not the entity that operates the remainder of the building;
or (3) The facility is held
out to any person or government entity as an ambulatory surgical facility or
similar facility by means of signage, advertising, or other promotional
efforts. "Ambulatory surgical facility" does
not include a hospital emergency department or an office of a physician,
podiatrist, or dentist. (B) "Anesthesia" means total
or partial loss of sensation, tactile sensibility, or protective reflexes, with
or without the loss of consciousness, produced by a pharmacological or
non-pharmacological agent or method, or combination thereof. (C) "Anesthesia qualified dentist" means a dentist who
holds a permit of authorization to utilize general anesthesia issued pursuant
to rule 4715-5-05 of the Administrative Code. (D) "Anesthesiologist" means a physician who has
completed a residency training program in anesthesiology accredited by the
accreditation council of graduate medical education or the American osteopathic
association. (E) "Certified registered nurse anesthetist" or
"CRNA" means a registered nurse who is authorized to practice as a
certified registered nurse anesthetist under section 4723.43 of the Revised
Code and is credentialed and privileged by the HCF to administer anesthetics to
patients within their scope of practice.
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Rule 3701-83-16 | Governing body - ambulatory surgical facilities.
(A) As required under paragraph (E) of
rule 3701-83-03 of the Administrative Code, each ASF shall have a governing
body. (B) The governing body
shall: (1) At least every
twenty-four months review, update, and approve the surgical procedures that may
be performed at the facility and maintain an up-to-date listing of these
procedures; (2) Grant or deny
clinical (medical-surgical and anesthesia) privileges, in writing and reviewed
or re-approved at least every twenty-four months, to physicians and other
appropriately licensed or certified health care professionals based on
documented professional peer advice and on recommendations from appropriate
professional staff. These actions shall be and based on documented evidence of
the following: (a) Current licensure and certification, if
applicable; (b) Relevant education, training, and experience;
and (c) Competence in performance of the procedures for which
privileges are requested, as indicated in part by relevant findings of quality
assessment and improvement activities and other reasonable indicators of
current competency. (3) In the case of an ASF
owned and operated by a single individual, provide for an external peer review
by an unrelated person not otherwise affiliated or associated with the
individual. The external peer review shall consist of a quarterly audit of a
random sample of surgical cases. (4) Designate a qualified
professional trained in infection control to direct the infection control
program required by paragraph (D) of rule 3701-83-09 of the Administrative
Code. For the purpose of this rule, a qualified professional trained in
infection control means a nurse or physician as defined in rule 3701-83-01 of
Administrative Code, who has documentation of completion of training in
infection control, including, but not limited to, continuing education units,
in-service training, or academic or vocational course completion.
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Rule 3701-83-17 | Admission; transfer; discharge - ambulatory surgical facilities.
(A) Each ASF shall only admit patients
who do not require planned inpatient care and who shall be kept in the ASF for
less than twenty-four hours. The twenty-four hour period begins at the start of
the operation or procedure, or the induction of anesthesia, whichever is first.
The twenty-four hour period may include an overnight stay if such stay meets
all of the conditions set forth in this rule and does not extend the length of
time a patient remains in the ASF. (B) Prior to operation or procedure, each
patient shall have a comprehensive medical history and physical exam performed
or updated, along with associated pre-procedure studies, unless the medical
staff has determined that patients undergoing specific outpatient procedures do
not require a full medical history and physical examination. In these
instances, a medical assessment will be completed and documented by a
physician. The different components of the history and physical may be
performed by different health care professionals, consistent with the type of
information required and the professionals' scope of practice, as defined
by applicable law. This history and physical exam shall document the
pre-operative diagnosis and the procedure to be performed and shall become part
of the patient's medical record prior to surgery. (C) Documentation, as contained in
paragraphs (A)(3), (C)(1), and (C)(7) to (C)(9) of rule 3701-83-21 of the
Administrative Code shall be in a patient's medical record prior to
surgery. (D) Immediately before surgery, the
attending physician, podiatrist, or dentist shall examine the patient to
evaluate the risks of the procedure to be performed. Each patient shall also be
examined by an anesthesiologist, physician, podiatrist, anesthesia qualified
dentist, or CRNA, as appropriate, to evaluate the risks of anesthetics and for
proper anesthesia recovery before discharge from post anesthesia
care. (E) The attending or other designated
physician, podiatrist, or anesthesia qualified dentist shall discharge a
patient meeting discharge criteria from the ASF within twenty-four hours of the
start of the operation or procedure, or induction of anesthesia, whichever is
first, or transfer the patient to a setting appropriate for the patient's
needs. (F) Patients transported to a hospital
shall be accompanied by their medical records that are of sufficient content to
ensure continuity of care. (G) Prior to discharge, the ASF shall
provide each patient with both verbal and written instructions for
post-treatment care and procedures for obtaining emergency care. (H) The physician, podiatrist, dentist,
or a nurse shall ensure that the patient or patient's representative
acknowledge, in writing, receipt of the physician's, podiatrist's, or
dentist's written discharge instructions. (I) Each ASF shall discharge a patient
only if accompanied by a responsible person, unless the attending or
discharging physician, podiatrist, or anesthesia qualified dentist determines
that the patient does not need to be accompanied and documents the
circumstances of discharge in the patient's medical record.
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Rule 3701-83-18 | Personnel and staffing requirements - ambulatory surgical facilities.
(A) Each ASF shall maintain qualified
nursing and physician staff, and qualified dental staff, as appropriate for the
services provided. Each ASF shall, based on the services provided and the
number of patients served, maintain a sufficient number of staff and other
personnel and an appropriate schedule of staff time to meet the needs of its
patients in a timely manner. (B) Each ASF shall have a medical
director and an administrator as defined in rule 3701-83-01 of the
Administrative Code. If the ASF limits its services: (1) To dental/oral and
maxillofacial surgery, a dentist may serve as the medical director;
or (2) To podiatric surgery,
a podiatrist may serve as the medical director. (C) Each ASF shall have a director of
nursing who is an RN with experience in surgical and recovery room nursing
care. The director of nursing shall be responsible for the management of
nursing services. (D) Each ASF shall only grant privileges
to physicians, podiatrists, dentists, and CRNAs: (1) Whose professional
license or certification is maintained in good standing; and (2) Who meet other
guidelines as determined by the governing body. (E) At all times when patients are
receiving treatment or recovering from treatment until they are discharged from
post anesthesia care, the ASF shall have present and on duty in the ASF at
least one member of the physician staff, podiatry staff, or dental staff, as
applicable. (F) At all times when patients are
receiving treatment or recovering from treatment until they are discharged, the
ASF shall: (1) Have at least two
nurses present and on duty in the ASF, at least one of whom shall be an RN and
at least one of whom is currently certified in advanced cardiac life support
who shall be present and on duty in the recovery room when patients are
present; (2) In addition to the
requirement of paragraph (F)(1) of this rule, have at least one RN shall be
readily available on an on-call basis; and (3) Have sufficient and
qualified additional staff present to attend to the needs of the patients shall
be present. (G) Each ASF shall maintain the
following: (1) An established system
of records sufficient for the director to ascertain that all individuals
employed at the ASF in a professional capacity meet the standards applicable to
that profession, including, but not limited to, possessing a current Ohio
license, registration, or other certification required by law; and (2) Staffing schedules,
time-worked schedules, on-call schedules, and payroll records for at least two
years. (H) Each ASF shall provide an ongoing
training program for its personnel. The program shall provide both orientation
and continuing training to all staff members. (1) The orientation shall
be appropriate to the tasks that each staff member will be expected to perform;
and (2) The continuing
training shall be designed to assure appropriate skill levels are maintained
and that staff are informed of changes in techniques, philosophies, goals, and
similar matters. The continuing training may include attending and
participating in professional meetings and seminars. (I) Each ASF shall require that each
physician who practices at the facility complies with any provision of the
Revised Code related to the obtaining of informed consent from a
patient.
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Rule 3701-83-19 | Service standards- ambulatory surgical facilities.
(A) Each ASF shall provide medical
services, dental services, nursing services, pharmaceutical services, and
anesthesia services. Each service shall be provided in a safe, effective manner
that is consistent with the needs of the patient. (B) Each ASF shall: (1) Provide adequate
space, equipment, and staff for storage and the administration of drugs in
compliance with state and federal laws and regulations. (2) Establish and
implement a program for the control and accountability of drug products
throughout the facility and maintain a list of medications that are always
available. (C) Each ASF shall: (1) Ensure that all
anesthetics are administered by individuals acting within their licensed scopes
of practice. (2) Maintain an
anesthesia record for each patient who receives anesthetics in the facility.
This record shall become a part of the patient's medical record and shall
include patient identification data, dosage and duration of anesthesia, and a
record of administration of other drugs or therapeutics. (3) Ensure that,
following the administration of general anesthetics, patients are constantly
attended by the responsible anesthesiologist, CRNA, anesthesia qualified
dentist, physician or podiatrist acting within their scope of practice, or an
RN until conscious and in the ambulatory condition normal for him or
her. (D) Each ASF shall respond to medical
emergencies including emergency cardiac care that may arise in the provision of
services to patients. (E) Each ASF shall have a written
transfer agreement with a hospital for transfer of patients in the event of
medical complications, emergency situations, and for other needs as they
arise. (1) A copy of the written
transfer agreement shall be filed with the ASF's application for license
renewal in accordance with paragraph (B) of rule 3701-83-04 of the
Administrative Code. (2) A formal agreement is
not required in those instances where the licensed ASF is a provider-based
entity of a hospital and the ASF policies and procedures to accommodate medical
complications, emergency situations, and for other needs as they arise are in
place and approved by the governing body of the parent hospital. (F) Prior to the surgery, the physician,
podiatrist, or dentist, shall obtain a statement documenting informed consent,
signed by the patient or patient representative, for the performance of the
specific surgical procedure or procedures. This statement shall be made part of
the patient's medical record. The ASF shall ensure that informed consents
for surgical procedures have been signed. (G) Each ASF may provide or contract for
other services including, but not limited to, laboratory and radiology
services. (H) When a blood supply may be needed for
a surgical procedure, the ASF shall: (1) Have a policy and
procedure to obtain blood, blood components, or blood products on a timely
basis. (2) Ensure that blood,
blood components or blood products are administered by physicians, anesthesia
qualified dentists, or RNs.
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Rule 3701-83-20 | Building and site requirements; equipment - ambulatory surgical facilities.
(A) Each ASF shall have one or more
operating rooms or procedure rooms, each of which is designed and equipped so
that the types of surgery conducted can be performed in a manner that protects
the health and well-being of all individuals in the area. The recovery area
shall be adequately equipped for the proper care of post anesthesia recovery of
surgical patients. (B) Each ASF shall have the following
equipment accessible to the operating suite and recovery area: (1) Adequate
resuscitation equipment: (a) ASFs providing surgical procedures under topical and local
infiltration blocks with or without oral or intramuscular preoperative sedation
shall have: airways, bag mask respirator, oxygen source, suction equipment, and
age-appropriate resuscitative drugs; (b) ASFs providing surgical procedures performed in conjunction
with oral, parenteral, or intravenous sedation or under analgesic or
dissociative drugs or providing surgical procedures that require general or
regional block anesthesia and support of vital bodily functions shall have:
airways, endotracheal tubes, laryngoscope, oxygen delivery capability under
positive pressure, suction equipment and suitable resuscitative
drugs. (2) Appropriate
monitoring equipment: (a) Each ASF shall have size-specific blood pressure apparatus
and stethoscopes, electrocardiogram, oscilloscopes and when pediatric patients
are treated, size-specific emergency equipment and medications; (b) ASFs performing surgical procedures in conjunction with oral,
parenteral, or intravenous sedation or under an analgesic or dissociative
drugs, or performing surgical procedures that require general or regional block
anesthesia and support of vital bodily functions shall have a defibrillator,
pulse oximeter with alarm, and temperature monitor. (c) ASFs using inhalation anesthesia shall have an anesthesia
machine. (3) Each ASF shall have
suitable surgical instruments customarily available for the planned surgical
procedure in the operating suite. (4) Each ASF shall have
in the recovery room, an emergency call system that is connected
electronically, electrically, by radio transmission or in a like manner and
that effectively alerts staff. (C) Each ASF shall establish and follow a
preventive maintenance program which includes periodic calibration, cleaning
and adjustment of all equipment in accordance with manufacturer's
instructions. Each ASF using inhalation anesthesia shall develop and follow
policies and procedures for monitoring the anesthesia machine which are
consistent with the standards recommended by the American society of
anesthesiologists. (D) Each ASF shall have appropriate
ventilation and humidity levels in order to minimize the risk of infection and
to provide for the safety of the patient. (E) Each ASF shall have emergency power
available in operative, procedure, and recovery areas. (F) Each ASF shall have separate closed
off and distinct areas used as waiting rooms, recovery rooms, treatment rooms,
toilet facilities, and storage rooms. The ASF and another entity may not mix
functions and operations in a common space during concurrent or overlapping
hours of operation. Operating, procedure, and recovery rooms must be used
exclusively for surgical procedures. (G) New construction, alterations or
renovations that provide space for operating rooms or procedure rooms may not
be used or occupied until authorization for such occupancy has been received by
the ASF from the department. (H) Each ASF shall develop and follow
policies and procedures for the storage and use of all medical gases in
accordance with the requirements of the national fire protection association
(NFPA) 99. (I) If the ASF uses medications or drugs
that may induce malignant hyperthermia, it shall have policies and procedures
in place, as well as equipment and medication available, to treat
it. (J) Each ASF shall have appropriate
intravenous fluids and administration equipment. (K) Each ASF shall have sufficient and
appropriate stretchers and wheelchairs for the services performed.
Last updated July 15, 2022 at 9:48 AM
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Rule 3701-83-21 | Medical records - ambulatory surgical facilities.
Each medical record required by paragraph (A) of
rule 3701-83-11 of the Administrative Code shall contain at least the following
information as applicable for the surgery to be performed: (A) Admission data: (1) Name, address, date of birth,
gender, and race or ethnicity; (2) Date and time of admission;
and (3) Pre-operative diagnosis, which
shall be recorded prior to or at the time of admission. (B) History and physical examination
data: (1) Personal medical history,
including but not limited to allergies, current medications and past adverse
drug reactions; (2) Family medical history;
and (3) Physical
examination. (C) Treatment data: (1) Physician's,
podiatrist's or dentist's orders; (2) Physician's,
podiatrist's or dentist's notes; (3) Physician assistant's notes,
if applicable; (4) Nurse's notes; (5) Medications; (6) Temperature, pulse, and
respiration; (7) Any special examination or
report, including but not limited to, x-ray, laboratory, or pathology
reports; (8) Signed informed consent
form; (9) Evidence of advanced directives
and do-not-resuscitate orders, if applicable; (10) Operative record; (11) Anesthesia record, if
applicable; and (12) Consultation record, if
applicable. (D) Discharge data: (1) Final diagnosis; (2) Procedures and surgeries
performed; (3) Condition upon
discharge; (4) Post-treatment care and
instructions; and (5) Attending physician's,
podiatrist's or dentist's signature. (E) Other information required by
law.
Last updated August 1, 2023 at 2:26 PM
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Rule 3701-83-22 | Quality assessment and performance improvement system - ambulatory surgial facilities.
As part of the quality assessment and performance
improvement program required under paragraph (A) of rule 3701-83-12 of the
Administrative Code, each ASF shall collect and maintain the following data on
an annual basis and shall report such data to the director upon request: (A) The total number of patient
visits; (B) The total number of patient transfers
to a hospital and the reason why; (C) The total number of deaths in the
ASF; and (D) The total number of deaths resulting
either from the surgery or from surgical complications that occur in the
ASF.
Last updated July 15, 2022 at 9:48 AM
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Rule 3701-83-23 | Definitions - freestanding dialysis centers.
For purposes of rules 3701-83-23 to 3701-83-24 of
the Administrative Code the following definitions shall apply: (A) "Chronic maintenance
dialysis" means the regular provision of dialysis for an end stage renal
disease patient with any level of patient involvement. (B) "Dialysis" means a process
by which dissolved substances are removed from a patient's body by
diffusion from one fluid compartment to another across a semipermeable
membrane. (C) "End stage renal disease
patient" or "patient" means an individual who is at a stage of
renal impairment that appears irreversible and permanent and who requires a
regular course of dialysis or renal transplantation to ameliorate uremic
symptoms and maintain life. (D) "Freestanding dialysis
center" or "dialysis center" means a facility that provides
chronic maintenance dialysis to end stage renal disease patients on an
outpatient basis, including the provision of dialysis services in the
patient's place of residence. A freestanding dialysis center does not
include the following: (1) A hospital or other
entity that provides dialysis services, other than non-emergent chronic
maintenance dialysis, within the same hospital or facility or in another
building located on the same property as the hospital or facility, that are
reviewed and accredited or certified as part of the hospital's
accreditation or certification as required by section 3727.02 of the Revised
Code; and (2) Home dialysis as
defined in paragraph (E) of this rule. (E) "Home dialysis" means
either peritoneal dialysis or hemodialysis performed by an appropriately
trained patient, with or without minimal assistance, at the patient's
place of residence.
Last updated August 1, 2023 at 2:26 PM
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Rule 3701-83-23.1 | Services standards- freestanding dialysis centers.
(A) Each dialysis center
shall: (1) Develop and follow
policies and procedures for the provision of care consistent with national
standards of care or guidelines; (2) Develop and follow
protocols for the prevention of disease and infection transmission utilizing
standards of care or guidelines for dialysis patients that comply with the
regulations for end stage renal disease services contained in 42 C.F.R. 494.30
(October 1, 2009); (3) Provide services in
accordance with the clinical capabilities of the facility; (4) Develop and follow
policies and procedures for the administration of medication; (5) Develop and follow
policies and procedures for the provision of water and dialysate that comply
with the regulations for end stage renal disease services contained in 42
C.F.R. 494.40 (October 1, 2009 ) and are consistent with the association for
advancement of medical instrumentation (AAMI) standards, including criteria for
the biological and chemical composition of the water; (6) Develop and follow
policies and procedures for the re-use of hemodialyzers that comply with the
regulations for end stage renal disease services contained in 42 C.F.R. 494.50
(October 1, 2009) and are consistent with the association for advancement of
medical instrumentation (AAMI) standards; (7) Develop and follow
policies and procedures for direct care staff to notify appropriate health care
professionals of problems related to the provision of dialysis
care; (8) Develop and follow
emergency plans to include patient self disconnect; (9) Provide each patient
with both verbal and written instructions for post treatment care and
procedures for obtaining emergency care; and (10) Develop and follow
policies and procedures for documenting and responding to adverse events. The
policies and procedures shall include the course of action to be taken by staff
to respond to adverse events, including patient care and evaluation of
equipment, water, or dialysate solution. Each dialysis center shall report to
the director all adverse events involving the following: (a) An event requiring emergency treatment, or
hospitalization; (b) An involuntary discharge of a patient; (c) Contamination of the water or dialysate; (d) Development of infection or communicable disease;
and (e) An event having a direct or immediate impact on the health,
safety, or security of a patient or staff member. (B) Each dialysis center shall utilize a
coordinated and integrated interdisciplinary team working in conjunction with
the patient, to develop and implement a written, individualized, comprehensive
patient care plan. The care plan shall: (1) Be based upon an
evaluation of the nature of the patient's illness, the treatment modality
prescribed, and an assessment of the patient's needs; (2) Address the
patient's physical, medical, dietary, psychosocial, functional, and
rehabilitation needs (3) Be reviewed at least
semi-annually if the patient is stable and monthly if the patient is not
stable. (C) Each dialysis center shall provide
the necessary ancillary and support services to meet the dialysis needs of
patients and in accordance with the patients' care plans. (D) No dialysis center may set up
dialysis stations for patient use which exceed the authorized maximum number of
licensed dialysis stations. (E) No dialysis center shall provide
dialysis services for hepatitis B positive patients unless the facility has an
in-house isolation room, a designated station or area. (F) Each dialysis center shall provide
the patient or the patient's representative in writing the
following: (1) Information regarding
the policies, procedures, and mission statement of the dialysis center and the
services provided at the facility; (2) Information
concerning the services to be performed; (3) Information about the
complaint policies and procedures required by rule 3701-83-13 of the
Administrative Code; and (4) Information regarding
the center's policy on advanced directives and do-not-resuscitate orders,
if applicable. (G) Each dialysis center shall maintain
operational records for: (1) The dialysate
solution delivery system; (2) The reuse of
hemodialyzers and bloodlines; (3) The reprocessing
system; (4) The water treatment
system; and (5) The water treatment
quality. (H) Each dialysis center shall maintain
records of water test results and necessary treatment for two
years. (I) Each dialysis center shall maintain
an appropriately stocked emergency tray or cart consistent with the types of
services being provided. (J) Each dialysis center shall ensure
that all drugs and supplies have not exceeded the expiration date. (K) Each dialysis center shall develop
and follow procedures to respond to medical emergencies that may arise in the
provision of services to patients, including emergency cardiac
care.
Last updated August 1, 2023 at 2:26 PM
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Rule 3701-83-23.2 | Personnel and staffing requirements - freestanding dialysis centers.
(A) Each dialysis center shall maintain the
following: (1) An established system of records sufficient
for the director to ascertain that all individuals employed by the dialysis
center who function in a professional capacity meet the standards applicable to
that profession, including but not limited to, possessing a current Ohio
license, registration, or certification, if required by law; (2) Staffing schedules, time-worked schedules,
on-call schedules, and payroll records for at least two years; and (3) Documentation that the facility has offered
the hepatitis B vaccination to staff members. (B) Each dialysis center shall provide an ongoing training
program for its personnel. The program shall provide orientation, initial
training, and continuing training to all staff members. (1) The orientation and initial training shall be
conducted within thirty days of hire and shall be appropriate to the tasks that
each staff member will be expected to perform; (2) The initial training shall include
instruction in the infection control, equipment, and dialysate policies and
procedures required by rules 3701-83-23.1 and 3701-83-23.4 of the
Administrative Code; and (3) Continuing training shall be designed to
assure appropriate skill levels are maintained and that staff are informed of
changes in techniques, mission, goals, policies and procedures including those
related to infection control and blood-borne pathogens, and similar matters.
The continuing training may include attending and participating in professional
meetings and seminars.
Last updated August 1, 2023 at 2:27 PM
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Rule 3701-83-23.3 | Medical records - freestanding dialysis centers.
Each patient medical record required by paragraph
(A) of rule 3701-83-11 of the Administrative Code shall contain at least the
following information: (A) Patient information
including: (1) Name, address, date
of birth, gender, and race or ethnicity; (2) History and physical
examination data including allergies, current medications, past adverse drug
reactions, and family medical history; (3) Diagnosis;
and (4) Dialysis
prescriptions. (B) Treatment data
including; (1) A written
individualized comprehensive patient care plan; (2) Progress notes;
and (3) Treatment notes
including dates and times the patient was on or off dialysis, pre-dialysis
safety checks, vital signs monitoring during dialysis, and notations of adverse
reactions. (C) Medication
administration. (D) Any special examination or report,
including x-ray, laboratory, or pathology report. (E) Signed consent for treatment
form. (F) Documentation indicating that the
patient or patient's representative received in writing the
following: (1) Information on
complaint policies and grievance procedures; (2) Information regarding
the center's policy on advanced directives and do-not-resuscitate orders,
if applicable; and (3) Information about the
services to be performed. (G) Documentation indicating that the
patient or patient's representative received information
about: (1) Emergency self
disconnect; and (2) Measures to be taken
in the event of an at home post-treatment medical emergency. (H) Discharge data including, condition
upon discharge, and post-discharge care and instructions. (I) When a dialysis patient is
transferred to another dialysis center or to a facility for inpatient care, the
transferring dialysis center shall send all requested medical records and
information to the receiving dialysis center or facility within one day of the
transfer.
Last updated August 1, 2023 at 2:27 PM
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Rule 3701-83-23.4 | Infection control and prevention - freestanding dialysis centers.
(A) In addition to the requirements
established in rules 3701-83-09 and 3701-83-23.1 of the Administrative Code,
each dialysis center shall develop and follow written policies and procedures
for preventing and controlling infections. The policies and procedures shall
include, but are not limited to, the following: (1) The aseptic and
isolation techniques to be used; (2) Use of the isolation
room or dedicated station or area, where applicable; (3) Handling and disposal
of biohazardous and potentially infectious waste; (4) Cleaning and
maintenance of equipment; (5) Cleaning and
disinfection of surfaces; and (6) Use of standard
precautions and personal protective equipment. (B) Each dialysis center shall establish
and follow a preventive maintenance program that includes periodic calibration,
cleaning and adjustment of all equipment in accordance with manufacturer's
instructions. (C) In addition to the water requirements
established in rule 3701-83-23.1 of the Administrative Code, each dialysis
center shall: (1) Culture and conduct
water specimen analysis used for dialysis purposes at least every thirty days
for bacteria; (2) Analyze water used
for dialysis purposes at least every one hundred and eighty days for
chemicals; (3) Treat water as
necessary to maintain a continuous water supply that is biologically and
chemically compatible with acceptable dialysis techniques. (D) Each dialysis center shall conduct
routine surveillance of patients and staff for hepatitis B using the most
sensitive test methods available. (1) Each patient must be
screened for hepatitis B surface antigen (HBsAG) and hepatitis B surface
antibody before admission to the dialysis facility in order to determine their
serologic status for surveillance purposes; (2) New employees must be
screened for hepatitis B surface antigen (HBsAG) and hepatitis B surface
antibody before or at the time of hire in order to determine their serologic
status for surveillance purposes; and (3) Each dialysis center
shall offer the hepatitis B vaccine to all susceptible patients and all staff
and document such action in the patient's medical record or the staff
member's personnel record. (E) Each dialysis facility shall
investigate and report to the director incidents of infections associated with
the provision of dialysis services. Efforts shall be made to determine the
origin of any such infection and remedial action shall be taken to protect all
non-infected patients and prevent recurrence. (F) Each dialysis facility shall comply
with the reporting requirements established by rule 3701-3-03 and paragraph
(A)(10) of rule 3701-83-23.1 of the Administrative Code.
Last updated August 1, 2023 at 2:27 PM
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Rule 3701-83-24 | Quality assessment and performance improvement - freestanding dialysis centers.
(A) Each freestanding dialysis center
governing body shall conduct an ongoing, comprehensive, integrated
self-assessment of the quality and appropriateness of care provided by the
facility, including: (1) Adequacy of
dialysis; (2) Vascular
access; (3) Medical injuries and
medical error identification; (4) Infection
control; (5) Nutritional
status; (6) Mineral metabolism
and renal bone disease; (7) Anemia
management; (8) Hemodialysizer reuse
program where applicable; and (9) Patient satisfaction
and grievance resolution. (B) The dialysis center shall designate
an individual or individuals to be responsible for the quality assessment and
performance improvement program who shall be responsible for the following
activities related to the quality of care and services provided by the dialysis
center: (1) Developing and
implementing mechanisms for monitoring; (2) Identifying and
resolving issues; (3) Providing suggestions
to the governing body for improvement; and (4) Reporting program
activities and findings to the governing body. (C) The dialysis center shall use the
findings of the quality assessment and performance improvement program to set
priorities for performance improvement, correct identified problems, and to
revise policies and procedures as necessary. (D) Identified performance problems that
threaten the health or safety of patients shall be immediately
corrected. (E) As part of the quality assessment and performance
improvement system required under rule 3701-83-12 of the Administrative Code,
each freestanding dialysis center shall provide to the director, upon request,
copies of data reports provided to the "renal network" designated by
the centers for medicare and medicaid services to include the state of Ohio or
any portion of the state of Ohio pursuant to 42 C.F.R. section 405.2112. All
patient specific information submitted to the director under this paragraph
that identifies a patient shall be maintained in a confidential
manner.
Last updated August 1, 2023 at 2:27 PM
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Rule 3701-83-25 | Definitions - freestanding inpatient rehabilitation facilities.
For purposes of rules 3701-83-25 to 3701-83-32 of
the Administrative Code the following definitions apply: (A) "Freestanding inpatient
rehabilitation facility" or "inpatient rehabilitation facility"
means a facility operated for the exclusive purpose of providing specialized
rehabilitation services, on an inpatient basis, to persons with functional
limitations or chronic disabling conditions who are in a medically stable
condition and have the potential to achieve significant improvement in
independent functioning. Freestanding inpatient rehabilitation facility does
not include the following: (1) A facility established and
operated for the primary purpose of providing rehabilitation treatment services
for alcohol or drug abuse; (2) A general hospital as defined in
rule 3701-59-01 of the Administrative Code or other entity that provides
rehabilitation services that are reviewed and accredited or certified as part
of a general hospital's accreditation or certification as required by
section 3727.02 of the Revised Code; or (3) A nursing home licensed under
Chapter 3721. of the Revised Code, a skilled nursing facility that meets the
requirements for participation in medicare, or a nursing facility that meets
the requirements for participation in medicaid. (B) "Interdisciplinary
team" means a group of individuals representing appropriate licensed
disciplines providing an integrated approach to serving the rehabilitation
needs specific to a particular patient in an inpatient rehabilitation
facility. (C) "Occupational
therapist" means a person licensed to practice occupational therapy
pursuant to section 4755.07 of the Revised Code. (D) "Physical therapist"
means a person licensed to practice physical therapy pursuant to section
4755.44 of the Revised Code. (E) "Psychologist" means a
person licensed to practice psychology pursuant to Chapter 4732. of the Revised
Code. (F) "Social worker" means a
person licensed to practice social work pursuant to Chapter 4757. of the
Revised Code. (G) "Speech-language
pathologist" means a person licensed to practice speech pathology pursuant
to Chapter 4753. of the Revised Code.
Last updated August 1, 2023 at 2:27 PM
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Rule 3701-83-26 | Service standard and minimum services - inpatient rehabilitation facilities.
(A) Each inpatient rehabilitation
facility shall provide services that meet the needs of its patients in
accordance with the patient's individual plan of care. The facility shall
provide the patient or the patient's representative with: (1) Information regarding
the policies, procedures, and philosophy of the inpatient rehabilitation
facility and the services provided at the facility; and (2) Information
concerning the services to be performed. (B) Each inpatient rehabilitation
facility shall: (1) Develop and follow
current care protocols utilizing accepted standards of care; (2) Provide services in
accordance with applicable state and federal laws and regulations;
and (3) Provide services in
accordance with the clinical capabilities of the facility. (C) Each inpatient rehabilitation
facility shall utilize a coordinated and integrated, interdisciplinary approach
to assess patient needs and to provide treatment and evaluation of physical,
psychosocial and cognitive deficits. Each patient shall be provided the
services of an interdisciplinary team that: (1) Is directed by a
physician who is board certified in physical medicine and rehabilitation or a
specialty appropriate to the services provided or has comparable qualifications
and experience, as determined by the medical director; and (2) Participates in the
provision and management of rehabilitation and medical services. (D) Each inpatient rehabilitation
facility shall provide the services identified by the interdisciplinary team
for each individual patient, as set forth in the following
documents: (1) The preliminary
assessment required by paragraph (C) of rule 3701-83-27 of the Administrative
Code; (2) The comprehensive
inpatient rehabilitation evaluation and the treatment plan required by
paragraphs (A) and (B) of rule 3701-83-28 of the Administrative Code;
and (3) The discharge plan
required by paragraph (E) of rule 3701-83-28 of the Administrative
Code. (E) Each inpatient rehabilitation
facility shall respond to medical emergencies that may arise in the provision
of services to patients, including emergency cardiac care.
Last updated August 1, 2023 at 2:27 PM
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Rule 3701-83-27 | Admission procedures and preliminary assessment - inpatient rehabilitation facilities.
(A) Each inpatient rehabilitation
facility shall develop written criteria for admission of patients to the
facility that includes a description of the programs and services available at
the facility. (B) Each inpatient rehabilitation
facility shall not admit a patient to the facility unless the following
conditions are met: (1) The patient is able
to tolerate a minimum of three hours of rehabilitation therapy, five days per
week; (2) The patient is
medically stable; and (3) The patient's
prognosis indicates a progressively improved medical condition with the
potential for increased independence. (C) Each inpatient rehabilitation
facility shall ensure that a written preliminary assessment of each patient is
completed by an interdisciplinary team within forty-eight hours of admission
that includes, at a minimum, the following: (1) An evaluation of the
appropriateness of the patient's placement in relation to the services
available at the particular facility; and (2) Identification of the
immediate needs of the patient.
Last updated August 1, 2023 at 2:29 PM
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Rule 3701-83-28 | Comprehensive inpatient rehabilitation evaluation, treatment plan, and discharge plan - inpatient rehabilitation facilities.
(A) Each inpatient rehabilitation
facility shall perform a written comprehensive inpatient rehabilitation
evaluation for each patient admitted to the facility. The comprehensive
inpatient rehabilitation evaluation shall be developed by the interdisciplinary
team and include the following: (1) Purpose and source of the
patient's referral; (2) Summary of the patient's
clinical condition; (3) Functional strengths and
limitations of the patient; and (4) A determination of the
patient's need for the following services: (a) Medical; (b) Nursing; (c) Rehabilitation
nursing; (d) Dietary; (e) Occupational
therapy; (f) Physical therapy; (g) Prosthetics and
orthotics; (h) Psychological assessment and
therapy; (i) Therapeutic
recreation; (j) Rehabilitation medicine;
and (k) Speech-language
pathology. (B) Each inpatient rehabilitation
facility shall develop a written treatment plan for each patient admitted to
the facility. The treatment plan shall be developed by the interdisciplinary
team and shall include findings and services identified in the comprehensive
inpatient evaluation completed in accordance with paragraph (A) of this rule,
and information regarding the following: (1) Level of function prior to the
disabling condition; (2) Current functional
limitations; (3) Specific service
needs; (4) A summary of the treatments to be
provided; (5) Supports and adaptations to be
provided; (6) Specific treatment goals and
expected outcomes; (7) Disciplines to be utilized and
their respective responsibilities for implementing the treatment plan;
and (8) Anticipated time frames for
achieving treatment goals and expected outcomes. (C) The treatment plan shall be
periodically reviewed by the interdisciplinary team as indicated, but not less
than once every seven days. The periodic review of the treatment plan shall be
documented in the patient's records and include documentation of, at a
minimum, the following: (1) Progress toward achieving defined
goals; and (2) Any changes in the treatment
plan. (D) Each inpatient rehabilitation
facility shall designate an individual from the patient's
interdisciplinary team to be the case manager for each patient who shall be
responsible for coordination of the patient's treatment plan. (E) Each inpatient rehabilitation
facility shall develop a written discharge plan for each patient admitted to
the facility which is based on the treatment goals and expected outcomes
defined in the treatment plan. The discharge plan shall: (1) Identify the expected care
setting for the patient after discharge; (2) Be revised periodically based on
the patient's progress in achieving the defined goals and any changes in
treatment; and (3) Document any referrals provided
to the patient. (F) Each inpatient rehabilitation
facility shall complete and initiate implementation of a comprehensive
inpatient evaluation, treatment plan, and discharge plan within seventy-two
hours of admission.
Last updated August 1, 2023 at 2:29 PM
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Rule 3701-83-29 | Personnel and staffing requirements - inpatient rehabilitation facilities.
(A) Each inpatient rehabilitation
facility shall provide or arrange for the services of personnel in sufficient
number and with appropriate qualifications to meet the rehabilitation and
medical needs of the patients being served in the facility. Personnel shall be
scheduled in sufficient number: (1) To meet the needs of
all patients in a timely manner; and (2) Provide services to
each patient as required in rule 3701-83-26 of the Administrative
Code. (B) At a minimum, each inpatient
rehabilitation facility shall maintain the following staff: (1) A medical director to
be responsible for overseeing and managing medical and rehabilitation services.
The medical director shall be a physician who has appropriate experience and
training to provide rehabilitation physician services, as demonstrated by at
least one of the following: (a) Certification as a physiatrist by the American board of
physical medicine and rehabilitation or the American osteopathic board of
rehabilitation medicine; (b) Formal residency in physical medicine and
rehabilitation; (c) Fellowship in rehabilitation for at least one year;
or (d) At least two years experience in providing inpatient
rehabilitation services. (2) A director of nursing
to be responsible for managing nursing services. The director of nursing shall
be an RN with appropriate experience and training in rehabilitation nursing as
demonstrated by the following; (a) Certification as a rehabilitation nurse by the American
rehabilitation nursing certification board; or (b) At least three years experience in rehabilitation
nursing. (3) A sufficient number
of nurses, physical therapists, occupational therapists, speech-language
pathologists, social workers and psychologists to meet the needs of patients
and provide necessary services. (C) Any licensed professional may be used
to meet the needs of patients and provide necessary services consistent with
the licensed professional's scope of practice as defined by applicable
law. (D) Each inpatient rehabilitation
facility shall maintain the following: (1) An established system
of records sufficient for the director to ascertain that all individuals
employed by the facility who function in a professional capacity meet the
standards applicable to that profession, including but not limited to,
possessing a current Ohio license, registration, or certification, if required
by law. (2) Staffing schedules,
time-worked schedules, on-call schedules, and payroll records for at least two
years. (E) Each inpatient rehabilitation
facility shall provide an ongoing training program for its personnel. The
program shall provide both orientation and continuing training to all staff
members. (1) The orientation shall
be appropriate to the tasks that each staff member will be expected to perform;
and (2) Continuing training
shall be designed to assure appropriate skill levels are maintained and that
staff are informed of changes in techniques, philosophies, goals, and similar
matters. The continuing training may include attending and participating in
professional meetings and seminars.
Last updated August 1, 2023 at 2:29 PM
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Rule 3701-83-30 | Building and site requirements - inpatient rehabilitation facilities.
(A) Each inpatient rehabilitation
facility shall have patient bedrooms that, at a minimum, meet the following
requirements: (1) Sufficient open floor
space to allow each patient or personnel to easily maneuver a wheelchair and to
allow for the transfer of each patient from the wheelchair to the
bed; (2) Maximum bedroom
capacity shall be no more than four patients; (3) A call system that is
connected electrically, electronically, by radio frequency transmission, or in
a like manner that: (a) Provides for independent operation by each patient from the
patient's bed; and (b) Effectively alerts the staff member or members on duty of
emergencies or patient needs; (4) A bed of adjustable
height with appropriate supports, which facilitates patient transfer from a
wheelchair to the bed, for each patient; and (5) Appropriate
furnishings and adequate storage space designed to meet the special needs of
rehabilitation patients for each patient. (B) Each inpatient rehabilitation
facility shall provide the following structural features: (1) Flooring shall be
designed to minimize slipping; (2) Patient bathrooms
shall: (a) Have sufficient space to allow private use of hand washing,
toilet, and bathing or shower facilities by a patient in a wheelchair, with an
assisting attendant; (b) Be equipped with grab bars and appropriate supports so that
physically disabled patients may use toilet, hand washing, and bathing or
shower facilities; and (c) Have a call system that is connected electrically,
electronically, by radio frequency transmission, or in a like manner that
effectively alerts the staff member or members on duty of emergencies or
patient needs. (3) Hand rails on both
sides of corridors, ramps, and stairs in areas used by patients; (4) Doors to be used by
patients shall be wide enough to accommodate wheelchairs; (5) Adequate space
designated for group recreation and dining designed to accommodate patients in
wheelchairs; and (6) Adequate and
appropriate space for the rehabilitation treatment services provided in the
facility that facilitate the treatment goals of the patients
served.
Last updated August 1, 2023 at 2:29 PM
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Rule 3701-83-31 | Equipment and supplies - inpatient rehabilitation facilities.
(A) Each inpatient rehabilitation
facility shall have equipment and supplies of the type and quantity sufficient
to meet the needs of individual patients and to provide services in accordance
with rule 3701-83-26 of the Administrative Code. (B) Each inpatient rehabilitation
facility shall maintain all equipment and supplies, including equipment and
supplies not used for rehabilitation purposes, in a safe and sanitary
manner. (C) Each inpatient rehabilitation
facility shall develop, maintain, and implement a preventive maintenance plan
for all equipment, designed to assure that the equipment is maintained in a
safe manner. The preventive maintenance plan shall include periodic cleaning,
adjustment and inspection in accordance with manufacturer's
instructions.
Last updated August 1, 2023 at 2:29 PM
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Rule 3701-83-32 | Quality assessment and performance improvement - inpatient rehabilitation facilities.
As part of the quality assessment and performance
improvement program required under rule 3701-83-12 of the Administrative Code,
each inpatient rehabilitation facility shall collect and maintain the following
data on an annual basis and shall report such data to the director upon
request: (A) The total number of patients admitted
to the facility; (B) The total number of patients
discharged from the facility; (C) The total number of patients
transferred to an acute care setting such as, but not limited to, a
hospital; (D) The total number of patients
transferred to a long-term care setting such as, but not limited to, a nursing
home; (E) The total number of patients who
achieved discharge goals; and (F) The total number of patients
readmitted to the facility for rehabilitation needs based on the same
episode.
Last updated August 1, 2023 at 2:30 PM
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Rule 3701-83-33 | Definitions - freestanding birthing centers.
As used in rules 3701-83-33 to 3701-83-42 of the
Administrative Code: (A) "Certified nurse-midwife"
or "CNM" means an individual with a certificate to practice
nurse-midwifery issued under Chapter 4723. of the Revised Code. (B) "Director of patient
services" means the individual responsible for managing and directing the
provision of patient services at the freestanding birthing center. (C) "Family" means the
individual or individuals designated by the expectant mother to participate in
the birthing center's program. (D) "Freestanding birthing
center" or "center" means a facility, or part of a facility,
which provides care during pregnancy, delivery, and the immediate postpartum
period to the low-risk expectant mother. "Freestanding birthing
center" does not include a hospital registered under section 3701.07 of
the Revised Code, or an entity that is reviewed as part of a hospital
accreditation or certification program. (E) "Low-risk expectant mother"
means an expectant mother that does not exhibit evidence of: (1) Diabetes mellitus or
gestational diabetes that is not controlled by diet; (2) Heart disease in
which there is any limitation of physical activity and ordinary physical
activity does not cause undue fatigue, palpitation, dyspnea, or anginal
pain; (3) Renal
disease; (4) Endocrine disorder,
except treated hypothyroidism; (5) Hematologic
disorder; (6) Severe anemia
(hemoglobin less than ten grams/deciliter); (7) Chronic or
gestational hypertension or pre-eclampsia; (8) Rh factor
sensitization or other isoimmunization; (9) Respiratory disease
with significant chance of fetal hypoxia or maternal respiratory
distress; (10) Active
herpes; (11) Prior uterine
incisions other than low transverse uterine incisions; (12) Prematurity (less
than thirty-seven weeks gestation); (13) Human
immunodeficiency virus positive; (14) Known congenital
anomalies except for anomalies that do not require services beyond the extent
of services the center is authorized by law to provide; (15) Previous
abruption; (16) Known or suspected
drug or alcohol abuse; (17) Suspected or
documented intrauterine growth retardation or fetal macrosomia; (18) Placental
abnormalities; (19) Multiple
births; (20) Non-vertex
presentation; or (21) Deep venous
thrombophlebitis.
Last updated August 1, 2023 at 2:30 PM
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Rule 3701-83-34 | General provisions - freestanding birthing centers.
(A) Freestanding birthing centers are
licensed to provide care during pregnancy, birth, and the immediate postpartum
period to the low-risk expectant mother and her newborn. Each center shall
admit and retain only low-risk expectant mothers anticipating a normal
full-term, spontaneous vaginal birth. (B) Freestanding birthing centers shall
consult with the attending physician or the CNM in consultation with the
physician prior to providing services to low-risk expectant mothers exhibiting
evidence of the following: (1) Previous low
transverse cesarean birth; (2) Previous postpartum
hemorrhage requiring treatment by transfusion; (3) Epilepsy or seizures
controlled by medication; (4) Postmaturity (greater
than forty-two weeks gestation); (5) Grand
multiparity; (6) No prenatal care,
sporadic prenatal care, or prenatal care beginning after the first
trimester; (7) Known or suspected
drug or alcohol use; (8) Cephalopelvic
disproportion; or (9) Other medical
conditions, except those listed in paragraph (E) of rule 3701-83-33 of the
Administrative Code. (C) Unless medical intervention or
non-routine technology can be safely performed or administered by an attending
physician at the freestanding birthing center, each freestanding birthing
center shall transfer a patient requiring medical intervention or non-routine
technology to a hospital or other appropriate health care setting that can meet
the patient's needs. Medical intervention or non-routine technology
includes: (1) Anesthetics other
than local anesthetics or pudendal; (2) Pharmacological
augmentation of labor; or (3) Forceps or vacuum
extraction. (D) If an attending physician at a
freestanding birthing center performs or administers any medical intervention
or non-routine technology under paragraph (C) of this rule, the attending
physician must remain with the patient throughout active labor and the
immediate postpartum period. (E) Each freestanding birthing center shall provide a home-like
environment with adequate space for furnishings, equipment and supplies to
provide comfortable accommodations for the number of patients and families
served and the personnel providing services. (F) In addition to the requirements established under paragraph
(F) of rule 3701-83-09 of the Administrative Code, each freestanding birthing
center shall establish and enforce written policies and procedures for the
following: (1) Infection control for
patients and families; and (2) Handwashing for
patients and families.
Last updated August 1, 2023 at 2:30 PM
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Rule 3701-83-35 | Governing body - freestanding birthing centers.
(A) The governing body of each
freestanding birthing center shall include at least one member who is a
consumer and is not a health care provider. (B) The governing body
shall: (1) Meet regularly to
execute responsibilities for the operation of the center and shall maintain
minutes of each meeting; (2) Maintain records of
the names and addresses of all owners, controlling parties, directors, and
officers and shall establish a policy on conflict of interest
disclosure; (3) Formulate the
mission, goals and long range plans for the center; (4) Adopt bylaws and
establish an organizational structure which clearly delineates lines of
authority, responsibility, and accountability; (5) Adopt policies and
procedures for the orderly development, management, and operation of the center
to ensure its compliance with applicable rules and regulations; (6) Appoint the
administrator and the director of patient services; (7) Approve the
qualifications for the center staff and ensure that all staff have the
qualifications required by Chapter 3701-83 of the Administrative
Code; (8) Establish the quality
assessment and performance improvement program required under rule 3701-83-12
of the Administrative Code; (9) Establish policies
and procedures for the handling of all legal matters relating to the operation
of the center; (10) Approve all
contracts and agreements with individuals or service agencies, such as
hospitals, laboratories, emergency transport, consulting specialists, teaching
institutions, and organizations conducting research; and (11) Encourage
collaboration and networking with community agencies and special interest
groups.
Last updated August 1, 2023 at 2:30 PM
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Rule 3701-83-36 | Service standards - freestanding birthing centers.
(A) Each freestanding birthing center
shall provide services that meet the needs of the center's patients and
are in accordance with the patient's plan of care. The center shall
provide the patient or the patient's representative: (1) Information
regarding the policies, procedures, and philosophy of the center and the
services provided at the center; (2) Information
concerning the services to be performed, including the process of pregnancy,
process of labor, birth and postpartum care of the mother and the
newborn; (3) Information about
immunizations, vaccines, and state of Ohio newborn screening
requirements; (4) Written information
about how to obtain appointments and needed services both during and after
normal hours of operation; and (5) Verbal and written
instructions for post-treatment care and procedures for obtaining emergency
care. (B) Each center shall develop and follow
current care protocols utilizing nationally recognized and accepted standards
of care while maintaining the holistic environment. Each center shall maintain
a current listing of the procedures and protocols and shall provide services in
accordance with the clinical capabilities of the center. (C) Each center shall provide intrapartum
care that requires minimal intervention and technology including: (1) Observation of
maternal vital signs; (2) Fetal
auscultation; (3) Nourishment; (4) Activities; (5) Comfort
measures; (6) Assessment and
evaluation of labor; and (7) Interaction with and
support of the family. (D) Each center shall provide postpartum
and newborn care that promotes bonding and includes, at a minimum: (1) Postpartum care for
the mother, including: (a) Observation and evaluation of maternal
condition; (b) Education and initiation of newborn feeding; (c) Self-care assessment and education; (d) Ensuring that the center's discharge criteria for the
mother are met; and (e) Evaluation of the need for, the provision of, and the
administration of immunizations or vaccines and Rh immune globin as
necessary. (2) Care for the newborn,
including: (a) Observation and evaluation of the newborn's
condition; (b) Ensuring that the center's discharge criteria for the
newborn are met; and (c) Evaluation of the need for, the provision of, and the
administration of immunizations, vaccines, and screening as necessary or
required. (E) Each center shall respond to medical
emergencies that may arise in the provision of services to patients, including
emergency cardiac care.
Last updated August 1, 2023 at 2:30 PM
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Rule 3701-83-37 | Admission; discharge; transfer - freestanding birthing centers.
(A) Each freestanding birthing center
shall establish policies and procedures for the assessment of expectant mothers
to determine: (1) If the expectant
mother meets the low-risk requirements for admission to the center;
and (2) If a normal, full
term, spontaneous vaginal birth is anticipated. (B) Each center shall establish and
follow admission policies and procedures. The center shall upon admission of a
patient: (1) Review the
patient's health records; (2) Observe and document
vital signs; (3) Observe and document
labor progress; and (4) Determine whether
diagnostic or screening procedures are required. (C) Each center shall have a written
transfer agreement with a hospital for the transfer of a mother or a newborn in
the event of medical complications, emergency situations, or as the need
arises. (D) Each center shall maintain all
necessary and appropriate medical equipment and a sufficient staff to provide
for the timely transfer and transport to a hospital. (E) Each center shall evaluate each expectant mother to determine
whether an intrapartum transfer is necessary. The evaluation shall include an
assessment of the following: (1) Abnormal progress of
labor; (2) Development of
maternal complications; (3) Need for cesarean
birth; and (4) Development of fetal
complications. (F) Each center shall evaluate each mother and newborn to
determine whether a postpartum transfer is necessary including evaluation of
the following: (1) Medical complications
of the mother; and (2) Medical complications
of the newborn. (G) Each center shall establish and follow discharge criteria
utilizing nationally recognized standards. Prior to discharge each center shall
identify a primary care provider for both mother and baby. For postpartum stays
less than forty-eight hours, each center shall provide or arrange for the
examination of the mother and newborn within seventy-two hours after discharge
by a licensed health care provider acting within their scope of
practice.
Last updated July 15, 2022 at 9:48 AM
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Rule 3701-83-38 | Personnel and staffing requirements- freestanding birthing centers.
(A) Each freestanding birthing center
shall have an administrator. (B) Each center shall have a director of
patient services who shall be a physician or a CNM who has contracted with a
collaborating physician. (C) Each center shall establish a
personnel file for each staff member that shall be retained for two years after
the staff member is no longer associated with the center.,, is maintained in a
manner to ensure confidentiality, as provided by law, and contains, at a
minimum, the following: (1) Documentation of the
qualifications of the staff to provide services; (2) An established
system of records sufficient for the director to ascertain that all individuals
employed by the center who function in a professional capacity meet the
standards applicable to that profession, including but not limited to,
possessing a current Ohio license, registration, or certification, if required
by law; (3) Documentation of any
malpractice insurance carrier, if applicable; (4) Reports of
malpractice claims, if applicable; (5) The regular
performance evaluations required under paragraph (G) of rule 3701-83-08 of the
Administrative Code; (6) Documentation of
current certification from the American heart association in cardiac life
support or current certification from the American academy of pediatrics in
neonatal resuscitation, if applicable; and (7) Documentation of
compliance with paragraph (D) of rule 3701-83-08 of the Administrative
Code. (D) Each center shall provide staff
access to reference materials and provide continuing education, orientation,
and ongoing training that shall be appropriate to the tasks that each staff
member will be expected to perform. Training shall be designed to ensure
appropriate skill levels are maintained and that staff are informed of changes
in techniques, philosophies, goals, and similar matters. Ongoing training may
include attending and participating in professional meetings and seminars and
may also include: (1) Universal precautions
and infection control procedures; (2) Fire, safety and
disaster procedures; (3) Licensure
requirements; (4) The philosophy of the
center; and (5) Procedures for the
stabilization of newborns from birth to transport. (E) Each center shall provide information
concerning the philosophy of the center to applicants for
employment. (F) Each center shall provide for the
availability of and access to consulting specialists. (G) Each center shall maintain a
sufficient number of staff and schedule staff for availability within the
center in number and type to: (1) Meet the demand for
services routinely provided by the center; (2) Meet the needs of
each patient; (3) Ensure patient
safety; and (4) Ensure that no mother
in active labor is left unattended. (H) Each center shall establish and post
a schedule for staff and consulting specialists that includes coverage for
periods of high demand or emergency. (I) A staff member who is current in
certification from the American heart association in cardiac life support and a
second staff member who is current in certification from the American academy
of pediatrics in neonatal resuscitation shall be present at each
birth. (J) A physician or CNM shall attend each
birth. (K) A physician shall be available for
stabilization and care of ill newborns and mothers.
Last updated August 1, 2023 at 2:30 PM
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Rule 3701-83-39 | Building and site requirements - freestanding birthing centers.
(A) Each freestanding birthing center
shall provide sufficient space for the number of patients and patient families
and staff members to assure privacy for patients and families
including: (1) A waiting room; (2) An examination room; (3) A staff area, conference area, or
classroom; and (4) A family room with a designated
play area for children. (B) Each center shall have a minimum
of two birth rooms. The birth room shall: (1) Be of adequate size and
appropriate configuration to provide for the equipment, staff members, supplies
and emergency procedures required for the physical and emotional care of the
mother, family, and the newborn during birth, labor, and the postpartum
period; (2) Have a minimum floor area of one
hundred and sixty square feet. The length or width of the room shall have a
minimum dimension of eleven feet. The vestibule, toilet and bathing areas and
closets will not be considered in determining the square footage; (3) Have doorways and hallways of
adequate width and configuration to accommodate the maneuvering of ambulance
stretchers and beds; (4) Be located to provide rapid
unimpeded access to an exit of the building which can accommodate emergency
transportation vehicles and the type and size of emergency equipment utilized
for emergency transport; and (5) Have hot and cold running
water. (C) Each center shall
provide: (1) Toilet and bathing facilities
that include a toilet, sink, bath or shower facilities with appropriately
placed grab bars for patients. The toilet and bathing facilities shall be
shared by not more than two birth rooms; (2) Toilet and hand washing
facilities for families and personnel; (3) Space for coats, boots, and
umbrellas in inclement weather; (4) A system of communication between
the birth room and other areas of the center that effectively can alert the
staff on duty of emergencies or patient needs; (5) Access to an outside telephone
line; (6) Handrails in halls, stairwells,
and bathrooms; (7) Childproof electrical outlets in
public areas; (8) Access to a drinking fountain or
potable drinking water with a disposable cup dispenser; (9) A system to provide emergency
lighting; and (10) A separate area for storing
clean and sterile supplies. (D) Each center shall establish and
maintain safety guidelines, practices, and policies which are reviewed at least
once every twelve months to ensure a safe environment for patients, families,
visitors and staff members. The center shall conduct and maintain records of
the following: (1) Evaluation of the heat,
ventilation, emergency lighting, waste disposal, water supply, laundry, and
kitchen equipment; and (2) Evaluation of the physical
environment for hazards that may cause injury from falls, electrical shock,
poisoning, and burns. Risk factors of hazards include, but are not limited to,
unsafe toys, unprotected stairs, and unlocked storage cabinets. The review of
the physical environment shall include the exterior of the facility including
walkways, parking lots, and outside recreation areas. (E) Each center may provide laundry
services on-site or off-site. Centers that provide laundry services on-site
shall provide an area for laundry equipment with counter and storage space. The
center shall provide for the separate collection, storage, and disposal of
soiled materials. Soiled laundry shall be held in the soiled holding area until
deposited in the washer. (F) Sterile supplies may be
prepackaged disposables or processed off-site. If the center sterilizes
instruments and supplies on-site, an area for accommodation of sterilizing
equipment in a a type and number sufficient and appropriate to the patient
volume of the center shall be provided. (G) Each center shall provide an area
for families to store and serve light refreshments. The area shall include a
sink, counter space, oven or microwave, refrigerator, cooking utensils,
disposable tableware or dishwasher, storage space, and a seating
area. (H) Each center shall provide in each
birth room, an area for equipment and supplies for newborn care and a separate
area for the equipment and supplies for maternal care.
Last updated August 1, 2023 at 2:30 PM
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Rule 3701-83-40 | Equipment standards - freestanding birthing centers.
(A) Each freestanding birthing center
shall have a readily accessible and securely stored emergency cart or tray for
the newborn, equipped in accordance with national standards of care or
guidelines, to carry out the written emergency procedures established by the
center. (B) Each center shall have a readily
accessible and securely stored emergency cart or tray for the resuscitation of
the mother, equipped in accordance with national standards of care or
guidelines, to carry out the written emergency procedures of the
center. (C) Each center shall designate an area
for the maternal and newborn emergency equipment and supplies that shall be
immediately accessible to any room in which a birth may occur, but out of the
direct line of traffic within the facility. (D) Each center shall develop and
implement an equipment preventive maintenance and repair program in accordance
with manufacturer's specifications. The center shall maintain records of
equipment performance, maintenance and malfunctions for the lifetime of the
equipment's use at the center and a minimum of three years following the
decommissioning or discontinuation of use of any piece of
equipment.
Last updated August 1, 2023 at 2:31 PM
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Rule 3701-83-41 | Supplies and medications - freestanding birthing centers.
(A) Each freestanding birthing center
shall maintain an inventory of supplies and medications in the type and
quantity necessary to meet the needs of and care for the number of patients
served by the center. (B) Each center shall establish and
follow protocols in accordance with standards established by the American
college of obstetrics and gynecology for the use of medications during labor or
at the time of birth. (C) Each center shall: (1) Monitor the shelf life of all
medications and supplies and dispose of expired items according to industry
standards or practices; (2) Secure, store or dispose of all
disposable supplies such as needles and prescription pads appropriately in
accordance with state and federal laws; (3) Maintain controlled drugs in a
double-locked secured cabinet and provide refrigeration for biologicals;
and (4) Establish and follow written
policies and procedures for accountability of all medications and
supplies.
Last updated August 1, 2023 at 2:31 PM
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Rule 3701-83-42 | Quality assessment and performance improvement - freestanding birthing centers.
(A) As part of the quality assessment and
performance improvement program required under rule 3701-83-12 of the
Administrative Code, each freestanding birthing center shall evaluate the
provision of services to the mothers and newborns who receive care from the
center. The evaluation shall, at a minimum, include: (1) Development and
evaluation of risk criteria for determining eligibility for admission to and
the continuation of care for a mother and newborn in the birth center program
of care; (2) Documentation and
review of complications and adverse events which arise during the provision of
the center's services including complications of pregnancy, labor and the
postpartum period; (3) Review and evaluation
of the management of care; (4) Evaluation of the
appropriateness of diagnostic and screening procedures including laboratory
studies, sonography, and non-stress tests; (5) Evaluation of the
appropriateness of medications prescribed, dispensed or administered in the
center; (6) Review of all
transfers of mothers and newborn to a hospital, health care provider, or other
health care setting to determine the appropriateness and quality of each
transfer; (7) Development of
discharge criteria for mother and the newborn patients served by the
center; (8) Regular review of
medical records including a review of legibility and completeness; (9) Annual review of all
protocols, policies and procedures relating to maternal and newborn care
provided by the center; (10) Review of the
maternal and newborn assessment procedures as they impact on quality of care
and cost to the patient; (11) Review of the
provision of emergency services including services listed in paragraph (C) of
rule 3701-83-34 of the Administrative Code; and (12) Evaluation of the
center's compliance with local, state, and federal requirements and
national standards of care related to the provision of care to mothers and
newborns. (B) As part of the quality assessment and
performance improvement program required under paragraph (A) of rule 3701-83-12
of the Administrative Code, each freestanding birth center shall report to the
director: (1) The total number of women who
delivered; (2) The total number of live births by
weight, in grams; (3) The total number of fetal
deaths; (4) The total number of neonatal
deaths; (5) The total number of maternal
deaths; (6) The total number of emergency
cesarean-sections performed including: (a) The total number of primary cesarean-sections,
and (b) The total number of repeat cesarean-section; (7) The total number of attempted vaginal
births after a previous cesarean-section and the total number of successful
vaginal births after a cesarean-section; (8) The total number of newborns whose
estimated gestational age is less than thirty-seven weeks, and the total number
of newborns whose estimated gestational age is greater than forty-two
weeks; (9) The total number of maternal
transfers to an obstetric and newborn care service including; (a) The total number of transfers prior to delivery,
and (b) The total number of transfers after delivery; (10) The total number of patients seeking
admission and the total number of patients admitted.
Last updated August 1, 2023 at 2:31 PM
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Rule 3701-83-43 | Definitions - freestanding radiation therapy centers.
As used in rules 3701-83-43 to 3701-83-50 of the
Administrative Code: (A) "Authorized user" means a
physician who meets the definition of "authorized user" in rule
3701:1-58-01 of the Administrative Code and is listed as the authorized user on
the radioactive materials license issued by the director to the freestanding
radiation therapy center. (B) "Brachytherapy" means a
method of radiation therapy in which sources are used to deliver a radiation
dose at a distance of up to a few centimeters by surface, intracavitary,
intraluminal, or interstitial application. (C) "Dose" or "radiation
dose" is a generic term that means absorbed dose, dose equivalent,
committed effective dose equivalent, or total effective dose equivalent as
defined in rule 3701:1-38-01 of the Administrative Code. (D) "Freestanding radiation therapy
center" means a facility, part of a facility, or any arrangement in which
radiation therapy services are transported to various sites, at which radiation
therapy is provided to patients. "Freestanding radiation therapy
center" does not include the provision of radiation therapy by a hospital
registered under section 3701.07 of the Revised Code, or the provision of
radiation therapy by an entity that is reviewed as part of a hospital
accreditation or certification program. (E) "Interstitial application"
means the use of sealed radioactive sources within special applicators placed
in tissue in a predetermined pattern. (F) "Intracavitary application"
means the use of radioactive sources in closed containers placed in body
cavities. (G) "Intraluminal" means within
the lumen of a tube or tubular organ, such as a blood vessel. (H) "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. (I) "Nuclear medicine
physician" means a physician listed as an authorized user on a radioactive
materials license issued by the director for that modality as required in
Chapter 3701:1-58 of the Administrative Code. (J) "Radiation oncologist"
means a physician who meets the requirements of paragraph (C) of rule
3701:1-67-02 of the Administrative Code. (K) "Radiologist" means a
physician board certified in radiology by the American board of radiology, the
American osteopathic board of radiology, or by the royal college of physicians
and surgeons of Canada, or who has completed a formal accreditation council for
graduate medical education (ACGME) or American osteopathic association approved
residency in radiology. (L) "Radiation therapy" means
the use of ionizing radiation or radiopharmaceuticals for therapy, including
external beam radiation therapy (teletherapy), intraoperative radiation
therapy, brachytherapy, and radioactive materials for therapeutic
administration as authorized on a radioactive materials license issued by the
director pursuant to rules 3701:1-58-43 and 3701:1-58-55 of the Administrative
Code in the treatment of human illness. (M) "Simulation" means the
mock-up of a patient treatment with radiographic documentation of the treatment
portals. (N) "Teletherapy physicist"
means a physicist who meets the definition in rule 3701:1-58-01 of the
Administrative Code and the training criteria specified in rule 3701:1-58-71 of
the Administrative Code.
Last updated July 15, 2022 at 9:48 AM
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Rule 3701-83-44 | General service standards - freestanding radiation therapy centers.
(A) Each freestanding radiation therapy
center shall evaluate the patient and assess tumors. (1) The evaluation shall
be conducted by the radiation oncologist and shall include a medical history, a
physical examination, a review of the patient's diagnostic studies and
reports, and, when appropriate, consultation by the radiation oncologist with
the referring physician. (2) The assessment of
tumors shall include a definition of tumor location, and the extent and stage
of the tumor. (B) Each freestanding radiation therapy
center shall provide services necessary to meet the needs of the patient
including: (1) Consultation; (2) Treatment planning,
including the selection of dose, selection of treatment modality, and selection
of treatment technique; (3) Determination of
optimal treatment program and calculation of dose; (4) Simulation of
treatment; and (5) Clinical treatment
management and patient education. (C) Each freestanding radiation therapy
center shall establish policies and implement procedures for the follow-up of
patients who are treated with curative intent and patients who are treated with
palliative intent by the radiation oncologist. (1) The radiation
oncologist shall establish a post-treatment follow-up plan for each
patient. (2) The follow-up of
patients treated with curative intent shall: . (a) Be for a five year period whenever feasible or practical; and
(b) Include documentation of the outcome of therapy including the
results of treatment such as tumor control or survival, and significant
sequelae. (3) If the center is
unable to conduct the follow-up as planned, the center shall document the
reason in the patient's medical record. (D) Radiation therapy shall be provided
only upon written order of a radiation oncologist. Each freestanding radiation
therapy center shall communicate with referring physicians regarding the
radiation therapy. (E) Each freestanding radiation therapy
center shall 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 July 15, 2022 at 9:49 AM
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Rule 3701-83-45 | Personnel requirements and qualifications - freestanding radiation therapy centers.
(A) Each freestanding radiation therapy
center shall have an administrator. (B) Each freestanding radiation therapy
center shall have a medical director who is a radiation oncologist, nuclear
medicine physician, radiologist, or other authorized user, as defined in
paragraph (I), (J), or (K) of rule 3701-83-43 of the Administrative Code or
rule 3701:1-58-40, 3701:1-58-51 or 3701:1-58-54 of the Administrative Code. The
medical director shall: (1) Approve specific
duties that may be performed by each member of the physics staff as specified
by the medical physicist under paragraph (E) of this rule; and (2) Ensure appropriate
coverage of the radiation therapy center by radiation oncologists or other
authorized users and staff. (C) The medical director, radiation
oncologists, radiologists, nuclear medicine physicians, and authorized users
shall be qualified by training, experience, and certification to perform the
scope of radiation therapy services provided by the facility. A radiation
oncologist, nuclear medicine physician, radiologist, or other authorized user
shall be available for direct care and quality review on a daily basis. If the
radiation oncologist, nuclear medicine physician, radiologist, or other
authorized user is not on-site, the radiation oncologist, nuclear medicine
physician, radiologist, or other authorized user shall be accessible by phone,
beeper, or other designated mechanism. (D) Each freestanding radiation therapy
center shall have a medical physicist or teletherapy physicist: (1) For radioactive
materials, meets the requirements of rules 3701:1-58-19 and 3701:1-58-21 of the
Administrative Code; and (2) For radiation therapy
equipment, meets the requirements of paragraph (C)(1), (C)(2), (C)(3), or
(C)(4) of rule 3701:1-66-03 of the Administrative Code; or who is certified by
the Ohio department of health as a certified radiation expert in accordance
with paragraph (C) of rule 3701:1-66-03 of the Administrative
Code. (E) The medical physicist or teletherapy
physicist shall be available for consultation with the radiation oncologist,
nuclear medicine physician, radiologist, or other authorized user to provide
advice or direction to staff when patient treatments are being planned or
patients are being treated. Radiation therapy centers shall have regular
on-site physics support during hours of clinical activity. The on-site support
shall, at a minimum, be provided on a weekly basis. When a medical physicist or
teletherapy physicist is not available on-site, other physics duties shall be
established and documented in writing by the medical physicist or teletherapy
physicist. The medical physicist shall specify the specific physics duties to
be performed by each member of the physics staff in accordance with their
qualification and competence. (F) Each freestanding radiation therapy
center shall have available a sufficient number of qualified staff for the
radiation therapy services provided including individuals licensed as radiation
therapy technologists or nuclear medicine technologists under Chapter 4773. of
the Revised Code, who are able to supervise and conduct the radiation therapy
services as appropriate for the services being offered. The nuclear medicine
physician, radiologist, radiation oncologist, or other authorized user and
support staff shall be available on a twenty-four hour basis to initiate urgent
treatment within a medically appropriate response time. (G) Each freestanding radiation therapy
center shall establish personnel files for all individuals who provide
radiation therapy services and shall: (1) Maintain files for
each individual which specify the types of procedures or services the
individual is permitted to perform; and (2) Update all files at
least every twelve months.
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Rule 3701-83-46 | Treatment standards - freestanding radiation therapy centers.
(A) Each freestanding radiation therapy
center shall ensure that the radiation oncologist establishes the doses desired
throughout the tumor and set dose limits to critical structures. Treatment
deliveries shall meet the specifications of the radiation
oncologist. (B) Each freestanding radiation therapy
center shall ensure all treatment applications are described in detail and
signed by the radiation oncologist. The radiation oncologist shall be notified
of any changes that may be necessary in the planned schedule of
treatment. (C) Each freestanding radiation therapy
center shall: (1) Provide or arrange
for appropriate radiation treatment localization, simulation and
verification; (2) Provide or arrange
for isodose treatment planning with complex analyses generated in appropriate
cases; (3) Provide accurate
calculation of doses and dose distribution; (4) Provide a system for
independently checking initial dose calculations through the use of another
individual or an alternative method approved and documented by the medical
physicist. The check shall be conducted before the third fraction, or before
twenty per cent of the total dose when the treatment schedule provides less
than ten fractions. The verification check must be documented in the
patient's medical radiation treatment record. (5) Conduct ongoing
reviews of accumulating doses; (6) Conduct a chart and
port film review weekly; (7) Accurately chart
treatment doses; and (8) Maintain records of
all data used in planning the specific treatment for a patient in the
patient's medical record. (D) Each freestanding radiation therapy
center shall provide devices to aid in positioning and immobilizing the
patient. Normal tissue shields, compensating filters, wedges and other aids
shall be provided as medically appropriate. (E) Initial port films shall be reviewed
by the radiation oncologist prior to the second treatment and the port films
shall be reviewed at least every ten treatments. (F) Each freestanding radiation therapy
center shall establish and maintain written procedures at the facility for
handling medical emergencies, including cardiac care.
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Rule 3701-83-47 | Radiation safety standards - freestanding radiation therapy centers.
(A) Each freestanding radiation therapy
center shall maintain and follow written policies and procedures for the
handling of emergencies which may threaten the health and safety of patients,
staff, or the general public. (B) Each freestanding radiation therapy
center shall comply with the applicable provisions of Chapter 3748. of the
Revised Code and the rules adopted pursuant to that chapter. (C) Each freestanding radiation therapy
center shall identify, document, and report to the department: (1) Medical events
involving radiation treatment with radiation therapy equipment in accordance
with rule 3701:1-67-12 of the Administrative Code; or (2) Medical events
involving radioactive material therapeutic administration in accordance with
rule 3701:1-58-101 of the Administrative Code.
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Rule 3701-83-48 | Equipment standards - freestanding radiation therapy centers.
(A) Each freestanding radiation therapy
center shall have the necessary equipment to provide services with accuracy,
precision, and efficiency. Each freestanding radiation therapy center
shall: (1) Provide, either
on-site or by referral, for diagnostic services including computerized
tomography (CT), magnetic resonance imaging (MRI), fluoroscopy, nuclear
medicine, and clinical and surgical pathology; and (2) Document arrangements
for referrals to one or more other radiation therapy sites so that the patients
will have access to a broad spectrum of radiation therapy equipment and a
variety of treatment modalities including at least brachytherapy and a unit of
radiation therapy equipment providing photons of at least ten megavolts (MV)
and electron energies to at least twelve megaelectron volts (MeV). (B) Each freestanding radiation therapy
center shall develop and implement a program to monitor the calibration and
measurement of radiation beam characteristics to assure accurate and reliable
delivery of ionizing radiations. Calibration and operation of radiation therapy
equipment shall be in accordance with the radiation requirements specified in
rules 3701:1-67-05, 3701:1-67-06 and 3701:1-67-10 of the Administrative
Code. (C) Each freestanding radiation therapy
center shall develop and implement a preventive maintenance and repair program
for equipment in accordance with manufacturer's specifications. The center
shall maintain records of equipment performance, maintenance and malfunctions
for the lifetime of the equipment's use at the center. (D) Each freestanding radiation therapy
center that operates a linear accelerator, cobalt radiation therapy unit, or
gamma knife shall comply with the applicable provisions of section 3702.11 of
the Revised Code and the rules adopted pursuant to that section. (E) Each freestanding radiation therapy
center shall maintain emergency equipment and medications appropriate for the
services provided.
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Rule 3701-83-49 | Medical record - freestanding radiation therapy centers.
In addition to the requirements of rule 3701-83-11
of the Administrative Code, each freestanding radiation therapy center shall
maintain documentation of the following in each patient's medical
record: (A) Confirmation of the presence of
malignancy by histopathology, or a statement of benign condition, or other
alternative evidence for diagnosis of all cases accepted for
radiation; (B) Documentation of the services and
radiographic images, including localization films, appropriate to the therapy
provided; (C) Report of the initial evaluation
including a definition of the tumor location and the extent of each cancer as a
basis for staging; (D) The treatment plan including the
selection of dose, selection of treatment modality, and selection of treatment
technique; (E) The dosimetry
calculations; (F) The patient's progress and
tolerance throughout treatment; and (G) The completion of treatment including
the follow-up plan required by rule 3701-83-44 of the Administrative
Code.
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Rule 3701-83-50 | Quality assessment and performance improvement program - freestanding radiation therapy centers.
As part of the quality assessment and performance
improvement program requirements under paragraph (C) of rule 3701-83-12 of the
Administrative Code, each freestanding radiation therapy center shall evaluate
the provision of radiation therapy services. The review shall include: (A) A
review of case management and treatment results; and (B) A
review of complications and adverse events which occurred during the provision
of the center's services.
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Rule 3701-83-51 | Definitions - freestanding diagnostic imaging centers.
As used in rules 3701-83-51 to 3701-83-55 of the
Administrative Code: (A) "Authorized user" means a
physician who meets the definition of authorized user in rule 3701:1-58-01 of
the Administrative Code for the specified modality. (B) "Certified nurse-midwife"
or "CNM" means an individual licensed as an advanced practice
registered nurse under Chapter 4723. of the Revised Code and designated as a
certified nurse-midwife under section 4723.42 of the Revised Code working in
collaboration with one or more physicians and in accordance with a standard
care arrangement. (C) "Certified nurse
practitioner" or "CNP" means an individual licensed as an
advanced practice registered nurse under Chapter 4723. of the Revised Code and
designated as a certified nurse practitioner under section 4723.42 of the
Revised Code working in collaboration with one or more physicians and in
accordance with a standard care arrangement. (D) "Chiropractic radiologist" means a
chiropractor with: (1) Diplomat status by
the American chiropractic board of radiology; and (2) CT and MRI
credentialing by the American chiropractic board of radiology. (E) "Certified nurse
specialist" or "CNS" means an individual licensed as an advanced
practice registered nurse under Chapter 4723. of the Revised Code and
designated as a certified nurse specialist under section 4723.42 of the Revised
Code working in collaboration with one or more physicians and in accordance
with a standard care arrangement. (F) "Computed tomography" or "CT" means
the production of a tomogram by the acquisition and computer processing of
X-ray transmission data. (G) "Diagnostic imaging" means the production of
images used for medical diagnosis using: (1) MRI; (2) PET; (3) CT; (4) Nuclear medicine as
authorized on a radioactive materials license issued by the director pursuant
to rule 3701:1-58-32, 3701:1-58-34, 3701:1-58-37 or 3701:1-58-53 of the
Administrative Code; and (5) Fluoroscopy. "Diagnostic imaging" does not mean
the production of images for medical diagnosis using diagnostic x-ray,
mammography, or ultrasound. (H) "Diagnostic x-ray" means the irradiation of
any part of the human body for the purpose of diagnosis or
visualization. (I) "Freestanding diagnostic imaging center"
means a facility, or part of a facility, at which diagnostic imaging services
are provided, but does not include a hospital registered under section 3701.07
of the Revised Code, or an entity that is reviewed as part of a hospital
accreditation or certification program. (J) "Fluoroscopy" means the use of a fluorescent
screen suitably mounted, either separately or in conjunction with a roentgen
tube for visualizing and imaging internal structures which uses the injection
or ingestion of contrast media for medical diagnosis. (K) "Local anesthesia" has the
same meaning as defined in section 4730.201 of the Revised Code. (L) "Magnetic resonance imaging" or
"MRI" means the use of an integrated set of machines utilizing radio
frequency and magnetic fields to produce images of organs and tissue or
spectroscopic quantitative data. (M) "Mammography" means radiography of the
breast. (N) "Mobile diagnostic imaging center" means any
arrangement in which diagnostic imaging services are transported to various
sites. A mobile diagnostic imaging center does not include movement within a
hospital or movement to a site where the equipment will be located permanently
and does not include the provision of diagnostic imaging by an entity that is
reviewed as part of a hospital accreditation program. (O) "Nuclear medicine" means the use of internal
radiopharmaceuticals for the diagnosis and treatment of patients. (P) "Physician assistant" or
"PA" means an individual authorized under section 4730.08 of the
Revised Code to practice as a physician assistant under the supervision,
control, and direction of a physician with whom the physician assistant has
entered into a supervision agreement under section 4730.19 of the Revised Code,
and in accordance with the policies of the health care facility in which the
physician assistant is practicing. (Q) "Positron emission tomography" or
"PET" means a nuclear medicine imaging technique employing a
radiotracer radiopharmaceutical with a positron emitting radionuclide to
provide functional information such as on blood flow or
metabolism. (R) "Radiologist" means a physician board
certified in radiology by the American board of radiology, the American
osteopathic board of radiology, or by the royal college of physicians and
surgeons of Canada, or who has completed a formal accreditation council for
graduate medical education (ACGME) or American osteopathic association approved
residency in radiology. (S) "Nuclear medicine physician" means a
physician listed as an authorized user on a radioactive materials license
issued by the director for that modality as required in Chapter 3701:1-58 of
the Administrative Code. (T) "Ultrasound" means a diagnostic imaging
technique which employs high frequency low energy sound waves for imaging and
doppler examinations.
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Rule 3701-83-52 | Personnel and staffing requirements - freestanding diagnostic imaging centers.
(A) Each freestanding or mobile
diagnostic imaging center shall have a radiologist, nuclear medicine physician,
authorized user, physician acting within their scope of practice, or
chiropractic radiologist, as appropriate to the diagnostic imaging services
being offered, that has overall responsibility for the diagnostic imaging
services being provided by the freestanding or mobile diagnostic imaging
center. (B) Each freestanding or mobile
diagnostic imaging center shall have; (1) A physician on site
when anesthesia, other than local anesthesia, is being administered; and
(2) One of the following
on site when local anesthesia or diagnostic imaging contrast are being
administered: (a) A physician; (b) A certified nurse practitioner; (c) A certified nurse-midwife; (d) A certified nurse specialist; or (e) A physician assistant. (3) If the administration
of local anesthesia or diagnostic imaging contrast agents are being supervised
by a certified nurse practitioner, clinical nurse specialist, certified
nurse-midwife, or physician assistant, the approval for the supervision of the
administration of the local anesthesia or diagnostic imaging contrast shall be
documented in the standard care arrangement or supervision
agreement. (C) CT freestanding and mobile diagnostic
imaging centers shall have available sufficient and qualified personnel as
appropriate for the services being offered as follows: (1) CT services shall be
provided only upon the written order of a physician, chiropractor, dentist or
podiatrist; (2) CT image
interpretation shall be conducted by: (a) A radiologist; or (b) A physician or chiropractic radiologist acting within their
scope of practice who does not meet the requirements of paragraph (N) of rule
3701-83-51 of the Administrative Code who has at least two years
cross-sectional imaging and interpretation experience; (3) A medical physicist
who meets the requirements of paragraph (D)(1), (D)(2), or (D)(3) of rule
3701:1-66-03 of the Administrative Code, or who is certified by the Ohio
department of health as a certified radiation expert in accordance with rule
3701:1-66-03 of the Administrative Code; and (4) An individual
licensed as a radiographer under Chapter 4773. of the Revised
Code. (D) MRI freestanding and mobile
diagnostic imaging centers shall have available sufficient and qualified
personnel as appropriate for the services being offered as
follows: (1) MRI services shall be
provided only upon the written order of a physician, chiropractor, dentist or
podiatrist; (2) MRI image
interpretation shall be conducted by: (a) A radiologist; or (b) A physician or chiropractic radiologist acting within their
scope of practice who does not meet the requirements of paragraph (S) of rule
3701-83-51 of the Administrative Code who has at least six months experience or
training in cross-sectional body imaging and image evaluation and
interpretation. (3) A service engineer,
or medical physicist certified by: (a) The American board of radiology in diagnostic medical
or diagnostic radiologic physics; or (b) The American board of medical physics in diagnostic
medical physics or MRI physics; or (c) The Canadian college of physicists in medicine in MRI
physics. (4) A technologist for
preparing and positioning the patient and for obtaining the MRI data in a
manner suitable for interpretation. As used in this paragraph,
"technologist" means an individual: (a) Registered with the American registry of radiologic
technologists in the categories of "radiography," "nuclear
medicine technology," "radiation therapy technology" or
"magnetic resonance imaging;" (b) Certified by the American registry of magnetic resonance
imaging technologists; or (c) Registered as a nuclear medicine technologist with the
nuclear medicine technology certification board. (E) PET and nuclear medicine freestanding
and mobile diagnostic imaging centers shall have available sufficient and
qualified personnel as appropriate for the services being offered as
follows: (1) PET and nuclear
medicine services shall be provided only upon the written order of an
authorized user pursuant to rule 3701:1-58 of the Administrative
Code; (2) PET and nuclear
medicine image interpretation shall be conducted by one of the
following: (a) A nuclear medicine physician; (b) A radiologist; (c) A physician acting within their scope of practice who meets
the requirements of rule 3701:1-58-36 of the Administrative Code; (d) A physician acting within their scope of practice who does
not meet the requirements of paragraph (R) or (S) of rule 3701-83-51 of the
Administrative Code that is supervised by a physician who is qualified pursuant
to paragraph (E)(2)(a), (E)(2)(b), or (E)(2)(c) of this rule while the
physician is completing a training program that will result in certification as
a physician listed in paragraph (E)(2)(a), (E)(2)(b), or (E)(2)(c) of this
rule. (3) An individual
licensed as a nuclear medicine technologist under Chapter 4773. of the Revised
Code; and (4) A radiation safety
officer who meets the requirements of rule 3701:1-58-18 of the Administrative
Code and is listed on the Ohio radioactive materials license. (F) Fluoroscopy freestanding and mobile
diagnostic imaging centers shall have available sufficient and qualified
personnel as appropriate for the services being offered as
follows: (1) Fluoroscopy services
shall only be provided upon the written order of a physician, dentist, or
chiropractor; (2) Fluoroscopy image
interpretation shall be conducted by one of the following: (a) A radiologist; (b) A physician or chiropractic radiologist acting within their
scope of practice who does not meet the requirements of paragraph (S) of rule
3701-83-51 of the Administrative Code who has at least six months experience or
training in the performance and interpretation of fluoroscopy; (3) A medical physicist
who meets the requirements of paragraph (D)(1), (D)(2), or (D)(3) of rule
3701:1-66-03 of the Administrative Code, or who is certified by the Ohio
department of health as a certified radiation expert in accordance with rule
3701:1-66-03 of the Administrative Code; and (4) An individual
licensed as a radiographer under Chapter 4773. of the Revised
Code. (G) Each freestanding or mobile
diagnostic imaging center shall establish personnel files for all individuals
who provide diagnostic imaging services and shall: (1) Maintain files for
each individual which specify the types of procedures the individual is
permitted to perform; and (2) Update all files at
least every twelve months. (H) For CT and fluoroscopy services, the
medical physicist shall be available for consultation with the radiologist or
authorized user responsible for diagnostic imaging services to provide advice
and direction. The freestanding or mobile diagnostic imaging center shall
document the availability of the medical physicist in a written record that
also includes: (1) Documentation that
the medical physicist performed an annual on-site survey of the imaging
equipment in accordance with the manufacturer's specifications to evaluate
compliance with: (a) Applicable rules adopted pursuant to Chapter 3748. of the
Revised Code; (b) The equipment management program required by rule 3701-83-53
of the Administrative Code; and (c) The quality assessment and improvement program required by
rules 3701-83-12 and 3701-83-55 of the Administrative Code. (2) The medical
physicist's written procedures to specify the physics duties to be
performed by each member of the physics staff in accordance with their
qualifications and competence, and with the approval of the radiologist or
authorized user responsible for diagnostic imaging services, as applicable to
the services provided. (I) For MRI services, the service
engineer or the medical physicist shall be available for consultation with the
physcian or radiologist. The availability of the service engineer or the
medical physicist shall be documented in a written record that also
includes: (1) The service
engineer's or medical physicist's annual on-site survey to evaluate
the equipment management program, as required by rule 3701-83-53 of the
Administrative Code; and (2) The service
engineer's or medical physicist's written procedures to specify the
service and preventive maintenance duties to be performed by each member of the
staff in accordance with their qualifications and competence that are approved
by the individual specified in paragraph (A) of this rule. (J) For PET and nuclear medicine
services, radiation safety officer qualified under the requirements of
paragraph (E)(4) of this rule shall implement and conduct the activities
specified in rules 3701:1-58-38, 3701:1:58-40, 3701:1-58-50 and 3701:1-58-58 of
the Administrative Code.
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Rule 3701-83-53 | Service standards and equipment - freestanding diagnostic imaging centers.
(A) Each freestanding or mobile
diagnostic imaging center shall have equipment necessary to provide services
with accuracy, precision, and efficiency, as evidenced by all of the
following: (1) All diagnostic
imaging equipment is certified for clinical use by the United States food and
drug administration; (2) The specifications
and performance of all diagnostic imaging equipment meets all applicable state
and federal requirements; and (3) The center's
development and maintenance of an equipment management program that, at a
minimum: (a) Maintains a current inventory of all diagnostic imaging
equipment utilized by the freestanding or mobile diagnostic imaging
center; (b) Maintains and identifies the clinical applications,
maintenance requirements, and equipment malfunction history of all diagnostic
imaging equipment utilized by the freestanding or mobile diagnostic imaging
center; (c) Assesses the clinical and physical risks of all fixed and
mobile equipment utilized in the provision of diagnostic imaging
services; (d) Includes the implementation of established procedures for the
regular maintenance and testing of equipment in accordance with
manufacturer's guidelines; and (e) Provides appropriate equipment orientation and training
programs to personnel who use or maintain the freestanding or mobile diagnostic
imaging center's equipment. (B) Each freestanding or mobile
diagnostic imaging center shall identify, document, and report to the
department incidents in which equipment utilized by the diagnostic imaging
center contributed or may have contributed to patient injury, illness, or
death. (C) Each freestanding or mobile
diagnostic imaging center shall establish and maintain safety guidelines, and
practices and policies in accordance with applicable United States nuclear
regulatory commission regulations, the 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. (D) Safety factors established and
maintained by each freestanding or mobile diagnostic imaging center shall also
include: (1) Precautions against
electrical and mechanical hazards; (2) Precautions against
the potential interactions of the magnetic field with ferromagnetic
objects. (E) Each freestanding or mobile
diagnostic imaging center shall establish and maintain procedures for handling
medical emergencies, including emergency cardiac care. Each site at which
diagnostic imaging services are provided shall have the equipment, supplies,
and personnel necessary to handle clinical emergencies that might occur,
including adverse reactions to contrast agents. (F) Each freestanding or mobile
diagnostic imaging center shall have a staff member current in basic life
support on duty at the center when patients are there.
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Rule 3701-83-54 | Medical records requirements - freestanding diagnostic imaging centers.
(A) In addition to the general medical
record requirements of rule 3701-83-11 of the Administrative Code, each
freestanding or mobile diagnostic imaging center shall maintain a diagnostic
imaging radiology report for each patient, which includes the
following: (1) Patient name or
identifier; (2) Name of referring
physician, podiatrist, dentist, or chiropractor; (3) Name of physician or
chiropractic radiologist conducting image interpretation; (4) Name and type of
diagnostic image performed and any contrast media used; (5) Date of
image; (6) Findings; (7) Factors limiting
interpretability of exam; (8) Pertinent clinical
issues; and (9) Conclusion or
diagnosis. (B) Each freestanding or mobile
diagnostic imaging center shall maintain the reports and medical records
required by this rule and rule 3701-83-11 of the Administrative Code for a
period of six years from the date of service. (C) A mobile diagnostic imaging center
may, by contract with a facility being served, require the facility to maintain
such reports and medical records, provided that such reports and medical
records are made available to the department for purposes of section 3702.30 of
the Revised Code and Chapter 3701-83 of the Administrative Code.
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Rule 3701-83-55 | Quality assessment and performance improvement- freestanding diagnostic imaging centers.
(A) As part of the quality assessment and
performance improvement program required under paragraph (C) of rule 3701-83-12
of the Administrative Code, each freestanding or mobile diagnostic imaging
center shall: (1) Establish and
maintain a clinical image quality control program to monitor and document
images repeated due to poor image quality; (2) Monitor and evaluate
the accuracy of image interpretations by: (a) Establishing a clinical image review program; (b) Establishing policies and procedures and the semiannual audit
of a random, representative sample of total clinical images performed at the
center; (c) Having a radiologist, physician, or chiropractor perform a
semiannual audit of the image interpretation under paragraphs (C)(2), (D)(2),
(E)(2), and (F)(2) of rule 3701-83-52 of the Administrative Code: (i) Diagnostic imaging
centers under the operation of more than one physician or chiropractic
radiologist may conduct their own internal semiannual audit of a random sample
of clinical images. (ii) Diagnostic imaging
centers operated by a single physician or chiropractic radiologist shall
provide for the external semiannual audit of a random sample of clinical
images. External audits shall not be conducted by an individual who is
associated with, or has a financial interest in the center. (3) Monitor and evaluate
any problems associated with sedation, the administration of contrast agents,
and problems identified as part of the semiannual audit of a random sample of
clinical images. (B) As part of the quality assessment and
performance improvement program required under paragraph (A) of rule 3701-83-12
of the Administrative Code, each freestanding or mobile diagnostic imaging
center shall report to the director: (1) The number, type, and
age of diagnostic imaging equipment, including magnetic strength when
applicable, and whether diagnostic imaging equipment is fixed or
mobile; (2) If diagnostic imaging
equipment is mobile, a list of the locations where the service is delivered,
including contracted sites for which the service is currently not
operational; (3) The number of
procedures performed by CPT code; (4) The number of repeat
procedures taken which were conducted in order to obtain a sufficient image
relating to the patient's image order; (5) The number and type
of complications associated with sedation and the administration of contrast
agents; (6) The number of
patients who required hospitalization, as a result of a complication, within
twenty-four hours of a procedure; (7) The number of
diagnostic procedures performed and the number that revealed negative findings;
and (8) The number of
clinical images audited by the center or an external individual, and the number
of cases in which there was variance between audited findings and original
findings.
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Rule 3701-83-56 | Definitions - exempt freestanding birthing centers.
Effective:
April 24, 2011
As used in rules 3701-83-56 to 3701-83-59 of the Administrative Code: (A) "Apprentice midwife" means an individual who is currently serving an apprenticeship under a practicing midwife. (B) "Certified professional midwife" means an independent practitioner who has met the standards for certification set by the North American registry of midwives. (C) "Certified nurse-midwife" or "CNM" has the same meaning as in paragraph (A) of rule 3701-83-33 of the Administrative Code. (D) "Director of patient services" means the individual who is responsible for managing and directing the provision of patient services at the exempt center. The director of patient services may serve as the administrator of the exempt center. (E) "Doula" means an assistant who provides various forms of non-medical, non-midwifery and non-clinical physical or emotional support during the pre-natal, childbirth, and postpartum periods. (F) "Exempt freestanding birthing center," "exempt freestanding birth center," "exempt birth center," or "exempt center" means a health care facility that is not required to obtain a license under section 3702.30 of the Revised Code and paragraph (B) of rule 3701-83-03 of the Administrative Code. (G) "Lay midwife" or "traditional midwife" means an individual who has entered the profession as an apprentice to a practicing midwife rather than a formal school or certification program. (H) "Low-risk pregnancy" means an expectant mother that does not exhibit evidence of: (1) Diabetes mellitus or gestational diabetes that is not controlled by diet; (2) Heart disease in which there is any limitation of physical activity and ordinary physical activity does not cause undue fatigue, palpitation, dyspnea or anginal pain; (3) Renal disease; (4) Endrocrine disorder, except treated by hypothyroidism; (5) Hematologic disorder; (6) Severe anemia (hemoglobin less than ten grams per deciliter); (7) Chronic or gestational hypertension or pre-eclampsia; (8) RH factor sensitization or other isoimmunization; (9) Respiratory disease with significant chance of fetal hypoxia or maternal respiratory distress; (10) Active herpes; (11) Prior uterine incisions other than low transverse uterine incisions; (12) Prematurity as defined as less than thirty-seven weeks gestation; (13) Human immunodeficiency virus positive; (14) Known congenital anomalies except for anomalies that do not require services beyond the extent of services the center is authorized by law to provide; (15) Previous abruption; (16) Known or suspected drug or alcohol use; (17) Suspected or documented intrauterine growth retardation or fetal macrosomia; (18) Placental abnormalities; (19) Expectation of multiple births; (20) Non-vertex presentation; and (21) Deep venous thrombophlebitis. (I) "Low-risk delivery" means the delivery by a woman not exhibiting evidence of: (1) Previous low transverse cesarean birth; (2) Previous postpartum hemorrhage requiring treatment by transfusion; (3) Epilepsy or seizures controlled by medication; (4) Previous postmaturity delivery as defined as greater than forty-two weeks gestation; (5) A lack of prenatal care; (6) Cephalopelvic disproportion; or (7) Other serious or acute medical conditions. (J) "Medical director" means the physician the exempt center has appointed to provide medical consultation and direction regarding the operations of the center. (K) "Midwife" means a certified professional midwife, a lay midwife, or a traditional midwife. (L) "Patient" means an expectant mother, mother, or newborn.
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Rule 3701-83-57 | Patient safety monitoring and evaluation - exempt freestanding birthing centers.
(A) Each exempt freestanding birthing
center shall admit, retain, discharge and transfer patients in accordance with
the requirements of this rule to assure the safety of its
patients. (1) Exempt centers may
admit, retain, and provide care exclusively to women members of the religious
denomination, sect, or group that owns and operates the center who anticipate a
low-risk pregnancy, low-risk delivery and normal full-term spontaneous vaginal
birth, and to their newborns. (2) Prior to admission,
each expectant mother shall be assessed by a physician, CNM, or midwife as
defined in paragraph (K) of rule 3701-83-56 of the Administrative Code to
determine whether she is a low-risk pregnancy and whether a low-risk and
full-term, spontaneous vaginal delivery is anticipated. (a) Exempt centers shall consult with a physician before
admitting or retaining an expectant mother exhibiting signs of having other
than a low-risk pregnancy or low-risk and full-term spontaneous vaginal
delivery, or an expectant mother who has had no prenatal care. (b) If the consulting physician determines that the expectant
mother may not have a low risk pregnancy or low risk and full-term spontaneous
vaginal delivery, the exempt center shall not admit or retain the expectant
mother. (c) If the expectant mother presents at the exempt center in
actual labor or showing impending labor, and has had no prenatal care, the
expectant mother must be transferred to a hospital or other health care
facility or evaluated by a physician prior to admission to the exempt
center. (3) Each exempt center
shall have in place an arrangement with a hospital, other appropriate health
care setting, or provider for the transfer of a mother or newborn in the event
of medical complications, emergency situations or as need arises. (4) Except as set forth
in paragraph (A)(5) of this rule, each exempt center shall transfer the patient
to a hospital, other approved health care setting or provider that can meet the
needs of the patient if medical intervention or non-routine technology is
necessary. Medical intervention or non-routine technology
includes: (a) Anesthetics other than local anesthetics or pudendal
block; (b) Pharmacological augmentation of labor; or (c) Forceps or vacuum extraction. (5) An exempt center is
not required to transfer a patient requiring medical intervention or
non-routine technology if the medical intervention or non-routine technology
can be safely and effectively performed by the physician who attends the birth
and the attending physician remains with the patient throughout active labor
and the immediate postpartum period. (B) Each exempt freestanding birthing
center shall periodically evaluate each patient's health and safety in
accordance with the following standards: (1) The exempt center
shall, upon admission of a patient: (a) Review the patient's health history and prenatal care
records; (b) Observe and document vital signs; (c) Observe and document labor progress; (d) Consult with a physician when possible or evident risk for
delivery is detected; and (e) Determine whether further diagnostic or screening procedures
at an appropriate health care facility are advisable. (2) Each exempt center
shall evaluate the expectant mother to determine whether an intrapartum
transfer to a hospital or other appropriate health care setting is necessary.
The evaluation shall include an assessment for the following: (a) Abnormal progress of labor; (b) Development of maternal complications; (c) Probable need for cesarean birth; and (d) Development of fetal complications. (3) Each exempt center
shall, in consultation with a physician, evaluate the mother and newborn to
determine whether a postpartum transfer to a hospital or other appropriate
health care setting is necessary including evaluation for the
following: (a) Medical complications of the mother; and (b) Medical complications of the newborn. (C) Each exempt center shall monitor the
provision of services to ensure they are provided in a safe, considerate and
timely manner that meets the needs of the exempt center's patients. Each
exempt center shall: (1) Arrange for and
consult with a physician or certified nurse midwife to perform the following
activities: (a) Periodically review the exempt center's patient care
policies and procedures and recommend revisions as may be
indicated; (b) Oversee the quality of patient care through periodic review
of patient care records; (c) Periodically review the exempt center's quality and
patient safety data; and (d) Provide consultation to the exempt center regarding
admissions, retentions, transfers, and discharges of patients. (2) Practice infection
control including observation of all accepted standard precautions and hand
washing for staff, patients, and families. (3) Provide for the
separate storage, security, and disposal of hazardous waste. (4) Ensure that no mother
in active labor is left unattended and that a midwife, physician, or CNM
attends each birth. A doula of the mother's choosing may attend the mother
in active labor, but shall be limited to only non-medical, non-midwifery and
non-clinical assistance and support. (5) Timely respond to
medical emergencies that may arise in the provision of services to
patients. (6) Provide intrapartum
care that requires minimal intervention and technology including: (a) Fetal auscultation; (b) Nourishment; (c) Activities as may be appropriate; (d) Comfort measures; (e) Assessment and evaluation of labor; and (f) Interaction with family and support of the
family. (7) Provide postpartum
and newborn care that promotes bonding and meets patients'
needs. (8) Provide the patient
or the patient's representative: (a) Information about recommended immunizations, vaccines, and
metabolic screenings for newborns; and (b) Instructions for post-treatment care and procedures for
obtaining emergency care. (c) If so designated by the mother, the patient's
doula may be the representative for the purpose of receiving the information
and instructions indicated in the this paragraph. (9) Maintain sufficient
equipment, supplies and medicinals to care for its patients. Each exempt center
shall: (a) Have a readily accessible and securely stored emergency cart
or tray equipped to respond to emergency situations involving either the mother
or newborn and consistent with the capabilities of the facility
staff; (b) Monitor the shelf life of all medicinals and supplies
maintained by the exempt center for use in the care of services to
patients; (c) Maintain equipment in good working order; and (d) Operate equipment in a safe manner. (D) Each exempt freestanding birthing
center shall establish and maintain a safe and sanitary environment to ensure
patient safety. Each exempt center shall: (1) Provide, maintain,
and periodically evaluate the functional condition of the heating, ventilation,
emergency lighting, waste disposal and water supply systems, laundry and
kitchen equipment, and handrails in hallways and stairwells; (2) Maintain and
evaluate the physical environment for hazards that may cause injury from falls,
electrical shock, poisoning and burns. Risk factors of hazards include, but are
not limited to, unsafe toys in family areas, unprotected stairs and unlocked
storage cabinets. The review of the physical environment shall include the
exterior of the facility including walkways, parking areas and outside
recreation areas; (3) Provide and maintain
a home-like environment of adequate size and appropriate configuration with
sufficient space for furnishings, equipment, and supplies to provide
comfortable and safe accommodations for the number of patients and families
served and the personnel providing services; (4) Provide birth rooms
that: (a) Are of adequate size and appropriate configuration to provide
for the equipment, staff members, supplies, and emergency procedures required
for the physical and emotional care of the mother, family, and the newborn
during labor, birth and the postpartum period; (b) Have doorways and hallways of adequate width and
configuration to accommodate maneuvering of ambulance stretchers and beds in
emergencies; (c) Are located to provide rapid unimpeded access to an exit of
the building that will accommodate emergency transportation vehicles and
equipment; and (d) Have toilet and bathing facilities including toilet, sink,
bath or shower facilities with hot and cold running water, and appropriately
placed grab bars for patients. (5) Establish and, when
necessary, follow procedures for handling of patients in the event of fire or
natural disaster or any other emergency situation requiring the evacuation of
patients.
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Rule 3701-83-58 | Quality assessment and performance improvement - exempt freestanding birthing centers.
(A) Each exempt center shall monitor and
evaluate the provision of direct care services to its patients and shall
implement procedures to improve the quality of care and resolve identified
problems. The quality assessment shall, at minimum, include: (1) The review of all
transfers of patients to a hospital or other health care setting;
and (2) The review of
complications and adverse events during the provision of the exempt
center's services. (B) As part of the quality assessment and
performance improvement activities and to assist the director in determining if
the exempt center is in compliance with rules 3701-83-57 and 3701-83-58 of the
Administrative Code, each exempt freestanding birth center shall report to the
director of health, as may be required, but not less frequently than January
twentieth of each year, the following information and data in the format and
manner prescribed by the director and appendix A to this rule: (1) The identification of
the administrator or director of patient services of the birth
center; (2) The identification of
the physician(s) providing obstetrical or pediatric consultation and oversight
to the exempt birth center staff, and number of patient care-related contacts
initiated by staff; (3) Staffing of the
exempt birth center, including the number of traditional midwives, apprentice
midwives, certified professional midwives, and any state-licensed health care
professionals; (4) How and by whom
potential patients are being assessed for risk prior to admission; (5) The total number of
patients seeking admission and total number admitted; (6) The total number of
post delivery admissions, the reason for admission, and the length of
stay; (7) The number of
deliveries at the exempt birth center; (8) The number of
deliveries by a physician, a certified nurse midwife, a certified professional
midwife, an apprentice midwife, or a lay midwife; (9) Identification of who
attended each delivery within the exempt birth center; (10) The total number of
live births by weight in grams; (11) The total number of
newborns where estimated gestational age was less than thirty-seven weeks and
the total number of newborns where estimated gestational age was greater than
forty-two weeks; (12) The total number of
fetal, neonatal, and maternal deaths; (13) The total number of
maternal transfers to a hospital obstetric service or other health care
setting; whether before or following delivery; the reason for transfer; the
date of the transfer; and the name of the receiving entity; and (14) The total number of
neonate transfers to a hospital newborn service or other health care setting;
the reason for the transfer; the date of the transfer; and the name of the
receiving entity; (C) The data submitted under this rule
shall be reviewed by the exempt center's consulting physician prior to
submission.
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Rule 3701-83-59 | Compliance - Exempt freestanding birthing center.
(A) If the director of health determines that an exempt freestanding birthing center is no longer in compliance with divisions (4) and (5) of section 3702.301 of the Revised Code or rules 3701-83-57 and 3701-83-58 of the Administrative Code, the director may order the facility to come into compliance. (B) In the order, the director may do any or all of the following: (1) Identify which requirement the exempt center is not in compliance with and what actions the center needs to take to come into compliance; (2) Require that the exempt center come into compliance within a period specified in the order; (3) Require that the exempt center provide the director with a written notice within a time period specified in the order that contains all of the following: (a) An attestation that the center has come into compliance; (b) The signature of the exempt freestanding birthing center's administrator or medical director and an attestation that the administrator or medical director, whomever signs the notice, is the center's authorized representative; (c) An attestation that the information contained in the notice and any accompanying documentation are true and accurate; (d) Any other information or documentation that the director may require to verify that the center has come into compliance; and (e) If the noncompliance pertains to patient care, an attestation that the information or documentation provided has been reviewed by the medical director or the consulting physician. (C) If the exempt freestanding birthing center fails to comply with the director's order within the time period specified in the order, the director may issue a second order that requires the center to cease operations until the center obtains a license as a freestanding birthing center under section 3702.30 of the Revised Code. (D) In determining whether to issue orders under paragraph (C) of this rule, the director may consider any of the following factors: (1) The danger of serious physical or life-threatening harm existing or having existed to the patient or patients of the center; (2) The nature, duration, gravity, and extent of the identified condition, situation or practice existing or continuing; (3) Whether the violation directly relates or related to patient care; (4) The center's history of quality of care data; (5) The extent and appropriateness of the actions taken by the center to correct the deficient practice or contributing condition; and (6) Whether the administrator, medical director, or other staff of the center materially misrepresented any information provided to the director.
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Rule 3701-83-60 | Health Care Facility Quality Standards for Gender Reassignment Surgery and Genital Gender Reassignment Surgery for Minors.
(A) As used in this rule: (1) "Biological
sex," "birth sex," and "sex" mean the biological
indication of male and female, including sex chromosomes, naturally occurring
sex hormones, gonads, and nonambiguous internal and external genitalia present
at birth, without regard to an individual's psychological, chosen, or
subjective experience of gender. (2) "Gender
reassignment surgery" means any surgery performed for the purpose of
assisting an individual with gender transition that seeks to surgically alter
or remove healthy physical or anatomical characteristics or features that are
typical for the individual's biological sex, in order to instill or create
physiological or anatomical characteristics that resemble a sex different from
the individual's birth sex, including genital or non-genital gender
reassignment surgery. (3) "Gender
transition" means the process in which an individual goes from identifying
with and living as a gender that corresponds to his or her biological sex to
identifying with and living as a gender different from his or her biological
sex, including social, legal, or physical changes. (4) "Genital gender
reassignment surgery" means surgery performed for the purpose of assisting
an individual with gender transition and includes both of the
following: (a) Surgeries that sterilize, such as castration,
vasectomy, hysterectomy, oophorectomy, orchiectomy, and penectomy;
or (b) Surgeries that artificially construct tissue with the
appearance of genitalia that differs from the individual's biological sex,
such as metoidiplasty, phalloplasty, and vaginoplasty. (5) "Health Care
Facility" means: (a) An ambulatory surgical facility; (b) A freestanding dialysis center; (c) A freestanding inpatient rehabilitation
facility; (d) A freestanding birthing center; (e) A freestanding radiation therapy center; (f) A freestanding or mobile diagnostic imaging
center. (B) It is impermissible for gender
reassignment surgery or genital gender reassignment surgery or any direct or
indirect referral for such procedures to be provided at a health care facility
to any minor individual. (1) "Direct or
indirect referral" includes, but is not limited to, in any way
facilitating such care at another facility or providing any resources or
information on where or how to receive such care. (C) This rule does not prohibit treating,
including by performing surgery on or prescribing drugs or hormones for, a
minor individual who meets any of the following: (1) Was born with a
medically verifiable disorder of sex development, including an individual with
external biological sex characteristics that are irresolvably ambiguous, such
an as individual born with forty-six XX chromosomes with virilization,
forty-six XY chromosomes with undervirilization, or having both ovarian and
testicular tissue; (2) Received a diagnosis
of a disorder of sexual development, in which a physician has determined
through genetic or biochemical testing that the individual does not have normal
sex chromosome structure, sex steroid hormone production, or sex steroid
hormone action for a biological male or biological female; or (3) Needs treatment for
any infection, injury, disease, or disorder that has been caused or exacerbated
by the performance of gender transition services, whether or not the services
were performed in accordance with state or federal law.
Last updated May 3, 2024 at 7:38 AM
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