Chapter 3701-84 Quality Standards for Providers of Health Care Service (HCS)

As used in this chapter:

(A) “Accreditation inspection report” means the written survey findings concerning the provider of a health care service, prepared by an entity that the director has determined as having standards and a process for assessing compliance for a particular HCS which equals or exceeds the applicable requirements of Chapter 3701-84 of the Administrative Code, that documents compliance with the entity’s standards.

(B) “Administrator” means the person responsible for the overall daily management of the health care service.

(C) “Anesthesiologist” means a physician who has completed a residency training program in anesthesiology accredited by the American council of graduate medical education or the American osteopathic association.

(D) “Bone marrow transplantation service” means the replacement or supplementation of a patient’s bone marrow with autologous or allogeneic hematopoietic stem cells when the patient’s own bone marrow has been ablated or partially ablated by disease or therapy for the purpose of achieving long-term management of certain hematologic, immunologic, oncologic or genetic conditions, or enzymatic deficiency disease. A bone marrow transplantation service includes a service in stem cell harvesting and reinfusion.

(E) “Autologous/syngeneic bone marrow transplantation” means autologous, peripheral blood stem cell or syngeneic transplants.

(F) “Low-risk allogeneic bone marrow transplantation” means fully matched allogeneic sibling donor transplants without any of the high risk features listed under paragraph (G) of this rule.

(G) “High-risk allogeneic bone marrow transplantation” means unrelated or haploidentical transplants, or matched sibling donor transplants with any of the following features:

(1) A primary diagnosis of myelodysplasia;

(2) Bone marrow transplant in relapse;

(3) Chronic myelogenous leukemia in anything other than in chronic phase;

(4) Primary refractory patients;

(5) Patients with eastern cooperative oncology group performance status at time of transplant of greater than or equal to two; or

(6) Patients who are over forty years of age at the time of transplant

(H) “Chiropractor” means a person licensed under Chapter 4734. of the Revised Code to practice chiropractic care.

(I) “Department” or “director” means the director of health or any official or employee of the department designated by the director of health.

(J) “Freestanding birthing center” means a facility licensed under Chapter 3702. of the Revised Code and Chapter 3701-83 of the Administrative Code.

(K) “Health care service” or “HCS” means any of the following:

(1) A heart, lung, liver, kidney, pancreas, small bowel, or islet cell transplantation service or all combinations of solid organ transplant services, collectively referred to as a solid organ transplant service;

(2) A bone marrow transplant service;

(3) A cardiac catheterization service;

(4) An open heart surgery service;

(5) An obstetric and newborn care service;

(6) A pediatric intensive care service;

(7) A linear accelerator, cobalt radiation, or gamma knife service;

(8) A pediatric cardiac catheterization service;

(9) A pediatric cardiovascular surgery service.

(L) “Hospital” means an institution required to be registered under section 3701.07 of the Revised Code.

(M) “Level classification” means a perinatal unit designation that determines the level of services the unit may provide.

(N) “Licensed practical nurse” or “LPN” means a person licensed under Chapter 4723. of the Revised Code to practice nursing as a licensed practical nurse.

(O) “Live birth” means the complete expulsion or extraction from its mother of a product of human conception that after such expulsion or extraction breathes or shows any other evidence of life such as beating of the heart, pulsation of the umbilical cord, or definite movements of voluntary muscles, whether or not the umbilical cord has been cut or the placenta is attached.

(P) “Fetal death” means death prior to the complete expulsion or extraction from its mother of a product of conception of at least twenty weeks gestation, which after such expulsion or extraction, does not breathe or show any other evidence of life such as beating of the heart, pulsation of the umbilical cord, or definite movement of voluntary muscles.

(Q) “Neonatal death” means the death of a live-born infant occurring within the first twenty-seven days of life.

(R) “Infant death” means the death of a live born infant occurring within the first year of life.

(S) “Maternal deaths” are those for which the certifying physician has designated a maternal condition as the underlying cause of death. The maternal conditions are those assigned to deliveries and complications of pregnancy, childbirth, and the puerperium.

(T) “Repeat cesarean section” means a cesarean section in a patient who has previously had one or more cesarean sections.

(U) “Outborn infants” means infants less than twenty-eight days of age who are:

(1) Transferred from a freestanding birthing center or another hospital;

(2) Admitted to a hospital nursery from home; or

(3) Born outside a maternity unit licensed under Chapter 3711. of the Revised.

(V) “Medical director” means the physician who is responsible for managing and directing the provision of medical services at the health care service.

(W) “Nurse” means either a licensed practical nurse or a registered nurse.

(X) “Occupational therapist” means a person licensed to practice occupational therapy pursuant to section 4755.07 of the Revised Code.

(Y) “Patient” means any individual who receives health care services.

(Z) “Patient representative” means either a person acting on behalf of a patient with the consent of the patient or the patient’s legal guardian.

(AA) “Pediatric intensive care unit” or “PICU” or “pediatric intensive care service” means a separate and distinct unit in a hospital where pediatric patients, suffering from critical illness, receive care. “PICU” does not include a neonatal intensive care unit.

(BB) “Perinatal unit” means a distinct portion of a hospital, including a children’s hospital, registered under section 3701.07 of the Revised Code in which obstetrical, neonatal, or both types of care are provided.

(CC) “Pharmacist” means a person registered under Chapter 4729. of the Revised Code to practice pharmacy.

(DD) “Physical therapist” means a person licensed to practice physical therapy pursuant to section 4755.44 of the Revised Code.

(EE) “Physician” means a person who is licensed under Chapter 4731. of the Revised Code to practice medicine and surgery, or osteopathic medicine and surgery.

(FF) “Psychologist” means a person licensed to practice psychology pursuant to Chapter 4732. of the Revised Code.

(GG) “Registered dietitian” means a person registered pursuant to Chapter 4759. of the Revised Code to practice dietetics.

(HH) “Registered nurse” or “RN” means a person who is licensed under section 4723.09 of the Revised Code to practice as a licensed registered nurse.

(II) “Certified registered nurse anesthetist” or “CRNA” means an RN who meets the qualifications specified in section 4723.41 of the Revised Code and is credentialed and privileged by the provider of a health care service to administer anesthetics to patients within his or her scope of practice.

(JJ) “Social worker” means a person licensed to practice social work pursuant to Chapter 4757. of the Revised Code.

(KK) “Solid organ transplant service” means the transplantation of heart, lung, liver, kidney, pancreas, small bowel, islet cells, excluding autologous islet cell transplantation, and any and all combinations of such transplanted organs.

(LL) “Staff member” or “staff” means the administrator and individuals providing direct care to patients on a full-time, part-time, temporary, contract, or voluntary basis. Staff member or staff does not include volunteers who are family members of a patient.

(MM) “Linear accelerator service” means the structural unit of a health care facility which provides radiation therapy or stereotactic radiosurgery using a linear accelerator.

(NN) “Cobalt service” means the structural unit of a health care facility which provides radiation therapy using a cobalt teletherapy machine.

(OO) “Gamma knife service” means the structural unit of a health care facility which provides stereotactic radiosurgery or stereotactic radiotherapy using a gamma knife.

(PP) “Stereotactic radiosurgery service” means the structural unit of a health care organization which provides stereotactic radiosurgery.

(QQ) “Linear accelerator” means a medical linear accelerator which provides a collimated beam of electrons or electronically produced x-rays used for radiation therapy treatment.

(RR) “Cobalt teletherapy machine” means a machine that provides a collimated beam of gamma rays from a sealed cobalt-60 source for the purposes of radiation therapy treatment.

(SS) “Gamma knife” means a dedicated device for stereotactic radiosurgery which employs multiple cobalt-60 sealed radiation sources aimed at a single isocenter. The gamma knife may also be used to perform stereotactic radiotherapy.

(TT) “Stereotactic radiosurgery” means the closed-skull destruction of a precisely defined intracranial target by beam(s) of ionizing radiation in which the total dose is administered during a single treatment session.

(UU) “Stereotactic radiotherapy” means the closed-skull destruction of a precisely defined intracranial target by beam(s) of ionizing radiation in which the total dose of radiation is administered as fractions during multiple treatment sessions.

(VV) “Dose” means energy imparted per unit mass of absorber at a specific site under certain conditions.

(WW) “Radiation therapy service” means the structural unit of a health care organization which provides radiation therapy.

(XX) “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.

(YY) “Radiation oncologist” means a physician who:

(1) Has satisfactorily completed a radiation oncology residency within the last four years in an American council of graduate medical education or American osteopathic association approved program; or

(2) Is certified in radiology by the American board of radiology or the American osteopathic board of radiology and who has had a practice limited to radiation oncology for the ten year period prior to May 1, 1996; or

(3) Is certified in radiation oncology or therapeutic radiology by the American board of radiology, the American osteopathic board of radiology, or the royal college of physicians and surgeons of Canada.

(ZZ) “Radiation therapy” means the use of ionizing radiation, including external beam radiation therapy (teletherapy), or intraoperative radiation therapy and radioactive materials for therapeutic administration as authorized on a radioactive materials license issued by the director pursuant to 10 C.F.R. 35.400, and 10 C.F.R. 35.600 as delineated in rule 3701-39-02.1 of the Administrative Code in the treatment of human illness.

(AAA) “Simulation” means the mock-up of a patient treatment with radiographic documentation of the treatment portals.

(BBB) “Cardiac catheterization” means all anatomic or physiological studies of interventions, both diagnostic and therapeutic, in which the heart or coronary arteries are entered via a systemic vein or artery using a catheter that is manipulated under fluoroscopic visualization. This definition does not include studies of cardiac function performed using flow directed catheters that are positioned without the use of fluoroscopy.

(CCC) “Cardiac catheterization service” means the staff, equipment, physical space, and support services required to perform cardiac catheterization and percutaneous coronary interventions.

(DDD) “Percutaneous coronary interventions” (PCI”) means the broader group of percutaneous techniques capable of relieving coronary narrowing. Such PCI techniques include rotational atherectomy, directional atherectomy, extraction atherectomy, laser angioplasty, implantation of intracoronary stents and other devices for treating coronary atherosclerosis, including percutaneous transluminal coronary angioplasty.

(EEE) “Percutaneous transluminal coronary angioplasty” (“PTCA”) means the inflation of a balloon-tipped catheter at the site of a coronary artery stenosis to attempt to enlarge the diameter of the lumen.

(FFF) “Adult open heart surgery service” or “pediatric cardiovascular surgery service” means the combination of staff, equipment, physical space and support services which are used to perform open-heart surgery and other non-invasive cardiovascular surgeries.

(GGG) “Pediatric patient” means any patient less than twenty-two years of age, unless otherwise specified in this chapter.

(HHH) “Obstetric and newborn care service” means the staff, equipment, physical space, and support services required to care for pregnant women, fetuses, women who have recently delivered a child, and newborns.

(III) “Provider of a health care service” means a person or governmental entity who assumes legal liability for purposes of compliance with these rules.

(JJJ) “Lactation consultant” means an individual who holds credentials as an “International Board Certified Lactation Consultant.”

Effective: 05/15/2008

R.C. 119.032 review dates: 02/29/2008 and 03/01/2013

Promulgated Under: 119.03

Statutory Authority: 3702.11, 3702.13

Rule Amplifies: 3702.11, 3702.12, 3702.13, 3702.14, 3702.141, 3702.15, 3702.16, 3702.18, 3702.19, 3702.20

Prior Effective Dates: 3/1/1997, 3/24/03, 6/1/07

(A) All health care services shall comply with rules 3701-84-02 to 3701-84-14 of the Administrative Code. In addition, all:

(1) Solid organ transplant services shall comply with rules 3701-84-16 to 3701-84-21 of the Administrative Code;

(2) Bone marrow transplant services, including stem cell harvesting and reinfusion, shall comply with rules 3701-84-24 to 3701-84-27 of the Administrative Code;

(3) Adult cardiac catheterization services shall comply with rules 3701-84-30 to 3701-84-34 of the Administrative Code;

(4) Open heart surgery services shall comply with rules 3701-84-36 to 3701-84-40 of the Administrative Code;

(5) Obstetric and newborn care services shall comply with rules 3701-84-42 to 3701-84-59 of the Administrative Code; and

(6) Pediatric intensive care services shall comply with rules 3701-84-61 to 3701-84-65 of the Administrative Code.

(7) Linear accelerator, cobalt, and gamma knife services shall comply with rules 3701-84-67 to 3701-84-73 of the Administrative Code.

(8) Pediatric cardiac catheterization services shall comply with rules 3701-84-75 to 3701-84-79 of the Administrative Code;

(9) Pediatric cardiovascular surgery services shall comply with rules 3701-84-81 to 3701-84-85 of the Administrative Code;

(B) The director shall review the provisions of Chapter 3701-84 of the Administrative Code at least annually, consult with constituent groups and interested parties, and propose changes, as needed, to address technological advances and concerns with current rules.

Effective: 06/01/2007

R.C. 119.032 review dates: 03/01/2007 and 03/01/2012

Promulgated Under: 119.03

Statutory Authority: 3702.11

Rule Amplifies: 3702.12, 3702.13, 3702.14, 3702.141, 3702.15, 3702.16, 3702.18, 3702.19, 3702.20

Prior Effective Dates: 3/1/1997

(A) Upon the effective date of these rules, no person or agency of state or local government shall operate a HCS that does not comply with the provisions of this chapter of the Administrative Code.

(B) No person or agency of state or local government shall:

(1) Interfere with an inspection or investigation of a HCS by the director. As used in this paragraph, “interfere” means to obstruct directly or indirectly any individual conducting an authorized inspection or investigation from carrying out his or her prescribed duties. Interference includes, but is not limited to, harassment, intimidation, and refusal to permit the director or his authorized representative upon presentation of official department identification, for the purpose of inspecting or investigating the operation of a HCS, to enter and inspect at any time the building or premises of a HCS, or to enter and inspect records that are kept concerning the operations of the HCS for information pertinent to the legitimate interests of the department.

(2) Materially misrepresent any information provided to the director pursuant to section 3702.16 of the Revised Code and Chapter 3701-84 of the Administrative Code.

(C) Each provider of a HCS shall ensure that the building or structure where it is located is in compliance with all applicable federal, state and local laws and regulations including, but not limited to, building codes.

(D) No provider of a HCS shall permit any person to smoke inside the portion of the structure where the HCS is located. The provider of a HCS shall post a notice in a conspicuous place within the HCS stating that smoking is prohibited inside the HCS.

(E) Nothing in this chapter shall be construed as authorizing individuals to provide services outside their licensed scope of practice.

Effective: 06/01/2007

R.C. 119.032 review dates: 03/01/2007 and 03/01/2012

Promulgated Under: 119.03

Statutory Authority: 3702.11, 3702.13

Rule Amplifies: 3702.11, 3702.12, 3702.13, 3702.14, 3702.141, 3702.15, 3702.16, 3702.18, 3702.19, 3702.20

Prior Effective Dates: 3/1/1997, 3/24/03

(A) At least thirty days prior to initiating a new HCS or reactivating a discontinued or temporarily suspended HCS the provider of the HCS shall notify the director in writing of its intentions to initiate the service. This notice shall contain:

(1) The name, address, and telephone number of the facility where the HCS is located;

(2) The type of HCS which the provider is seeking to initiate including the scope of services to be provided; and

(3) The projected date of initiation.

(B) Prior to initiating a new HCS or reactivating a discontinued or temporarily suspended HCS, the provider of the HCS shall file with the director:

(1) An attestation of compliance, with the applicable provisions of this chapter for the HCS to be initiated or reinstated. The attestation shall be signed by the medical director of the HCS and the authorized representative of the provider of the HCS;

(2) Certification that to the best of the provider of the HCS’s knowledge, the information in the attestation and any accompanying material is true and accurate;

(3) Certification that the individual, if not the chief executive officer of the entity providing the HCS, is the authorized representative of the provider of the HCS; and

(4) Any other information the director may require regarding the ability to operate the HCS.

(C) The provider of the HCS shall submit a revised attestation within thirty days of any change in medical director or authorized representative signing an attestation previously filed with the department or any change in the provider of the HCS.

(D) The director may request additional information relative to the continuing operation or initiation of a HCS.

(E) The director may, at any time, request additional information he or she reasonably determines to be necessary to assess compliance with the applicable criteria, standards, and requirements established by section 3702.16 of the Revised Code and Chapter 3701-84 of the Administrative Code. The provider of the HCS shall submit any additional information requested by the director within thirty days of the director’s request. The director may require any additional information requested to be submitted in less than thirty days if patient health or safety is of concern.

(F) If the director determines that the provider of the HCS has failed to demonstrate compliance with the provisions of this chapter, the director may take action under rule 3701-84-05 of the Administrative Code.

(G) At least thirty days prior to a change in the scope of the HCS, the provider of the HCS shall notify the director in writing of its intentions to change the scope of service and the specific changes to be implemented.

(H) Within thirty days of recognizing that the HCS is not in compliance with applicable criteria, standards or requirements established by section 3702.16 of the Revised Code or this chapter of the Administrative Code, the provider of the HCS shall notify the director in writing of the criteria, standard or requirement not met, reason for failure to meet the criteria, standard or requirement and corrective action and time table for meeting the criteria, standard or requirement.

(I) At least thirty days prior to discontinuing a HCS, the provider of the HCS shall notify the director in writing of its intentions to discontinue the service. If the discontinuation is out of the control of the provider of the HCS and the thirty day requirement in this paragraph cannot be met, the written notice shall be given prior to discontinuing the service. The notice shall include the projected date of discontinuance.

Effective: 06/01/2007

R.C. 119.032 review dates: 03/01/2007 and 03/01/2012

Promulgated Under: 119.03

Statutory Authority: 3702.11, 3702.13

Rule Amplifies: 3702.11, 3702.12, 3702.13, 3702.14, 3702.141, 3702.15, 3702.16, 3702.18, 3702.19, 3702.20

Prior Effective Dates: 3/1/1997, 3/24/03

(A) If any provider of a HCS fails to comply with any requirements of section 3702.14 of the Revised Code and Chapter 3701-84 of the Administrative Code, the director shall provide the HCS a reasonable and appropriate amount of time to correct the violation and may:

(1) In accordance with Chapter 119. of the Revised Code, impose a civil penalty based on the severity of the violation as follows:

(a) For violations that present an imminent threat of serious physical or life-threatening danger, or an immediate serious threat to the emotional health, safety or security of patients, a civil penalty of not less than one hundred thousand dollars and not more than two hundred and fifty thousand dollars;

(b) For violations that directly threaten physical or emotional health, safety, or security of patients, a civil penalty of not less than ten thousand dollars and not more than one hundred thousand dollars;

(c) For violations that indirectly threaten of potentially threaten the physical or emotional health, safety, or security of patients, a civil penalty of not less than one thousand dollars and not more than ten thousand dollars; and

(2) In accordance with Chapter 119. of the Revised Code, for a second or subsequent violation of section 3701.14 of the Revised Code or Chapter 3701-84 of the Administrative Code, or for an initial violation the director determines has caused or poses an imminent threat of serious physical or life-threatening danger, issue an order that the HCS cease operation.

(B) In determining which of the actions to take under paragraph (A) of this rule, the director may consider all of the following factors:

(1) The danger of serious physical or life-threatening harm to one or more patients utilizing the health care service;

(2) The nature, duration, gravity, and extent of the violation;

(3) The number, if any, of patients directly affected by the violation;

(4) Whether the violation directly relates to patient care and the extent of the actual or potential harm to patients;

(5) The number of staff involved in the violation;

(6) The actions taken by the provider of the HCS to correct the violation; and

(7) The provider of the HCS’s history of compliance.

R.C. 119.032 review dates: 03/01/2007 and 03/01/2012

Promulgated Under: 119.03

Statutory Authority: 3702.11, 3702.13

Rule Amplifies: 3702.11, 3702.12, 3702.13, 3702.14, 3702.141, 3702.15, 3702.16, 3702.18, 3702.19, 3702.20

Prior Effective Dates: 3/1/1997, 3/24/03

(A) The director may make announced or unannounced inspections as the director considers necessary to determine and monitor compliance with section 3702.14 of the Revised Code and the applicable requirements of Chapter 3701-84 of the Administrative Code.

(B) If patient survival or complications of the HCS are outside the norm or outside the range of expected values, the director may conduct a review of the HCS or require the provider of the HCS to contract for an independent review of the HCS, to be performed by at least two experts that the director has approved for the situation, to determine the probable cause of the unfavorable outcomes and make recommendations for improvement. In determining whether to approve an expert, the director shall consider the individual’s knowledge and expertise in the service area and affiliation with the provider of the HCS. The contract shall require a written report to be submitted to the director by the reviewers within one hundred and twenty days of the director’s notice to the HCS of his or her requirement for the review. Based on the findings of the review, the director may require the HCS to implement recommendations of the experts. The provider of the HCS shall assume all costs of the review. The costs incurred under this paragraph are not subject to or included in the maximum annual fees specified in paragraph (H) of this rule.

(C) Each provider of HCS shall ensure the director access to its premises, records, including business and medical records, and staff to demonstrate to the director compliance with section 3702.14 of the Revised Code and the applicable requirements of Chapter 3701-84 of the Administrative Code.

(D) The director may inspect providers of a HCS to determine compliance with the provisions of this chapter of the Administrative Code.

(E) 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. Information may be shared with other state or federal agencies if such information is necessary in carrying out their official duties. An agency or person that receives such patient record information shall protect and preserve patient confidentiality.

(F) The director may conduct an inspection to investigate alleged violations of section 3702.14 of the Revised Code and Chapter 3701-84 of the Administrative Code. The director shall inform the complainant and the HCS of the results of the investigation.

(G) The HCS fee for the inspections conducted by the director pursuant to section 3702.15 of the Revised Code and paragraphs (A) and (F) of this rule shall be, subject to paragraph (H) of this rule, as follows:

(1) Inspection fee $1250.00

(2) Complaint inspection $ 650.00

(3) Follow-up inspection $ 650.00

For purposes of this paragraph “follow-up inspection” means an inspection, which may include on-site and off-site activities, conducted by the department to determine whether the HCS has corrected a violation or violations cited on a previous inspection and to verify whether the HCS is in compliance with the applicable criteria, standards, and requirements established by section 3702.16 of the Revised Code and Chapter 3701-84 of the Administrative Code.

(H) In charging a provider of a health care service a fee under paragraph (G) of this rule all of the following apply:

(1) For each service described in section 3702.11 of the Revised Code the fee shall not exceed one thousand two hundred fifty dollars annually.

(2) The total fees charged to a provider of a health care service, for services described in section 3702.11 of the Revised Code, shall not exceed five thousand dollars annually.

(I) The director shall provide to each provider of a health care service a statement of the fee charged under paragraph (G) of this rule which itemizes and totals the costs incurred by the department.

(J) The provider of a health care service shall, within fifteen days after receiving a statement of the fee under paragraph (I) of this rule, forward the total amount of the fee to the director payable to the “Treasurer, State of Ohio.”

(K) The director shall deposit HCS 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.

Effective: 06/01/2007

R.C. 119.032 review dates: 03/01/2007 and 03/01/2012

Promulgated Under: 119.03

Statutory Authority: 3702.11, 3702.13, 3702.31

Rule Amplifies: 3702.11, 3702.12, 3702.13, 3702.14, 3702.141, 3702.15, 3702.16, 3702.18, 3702.19, 3702.20

Prior Effective Dates: 3/1/1997, 3/24/03

(A) The provider of a HCS shall develop and follow comprehensive and effective patient care policies that include the following requirements:

(1) Each patient shall be treated with consideration, respect, and full recognition of dignity and individuality, including privacy in treatment and personal care needs;

(2) Each patient shall give informed consent and be allowed to refuse or withdraw consent for treatment or give conditional consent for treatment. Written documentation of patient consent shall be maintained in the patient’s medical record;

(3) Each patient shall have access to his or her medical record, unless access is specifically restricted by the attending physician for medical reasons;

(4) Each patient’s medical and financial records shall be kept confidential; and

(5) Upon request, each patient shall receive a detailed explanation of charges including an itemized bill for services received.

(B) The provider of a HCS shall ensure that each patient is informed of the following:

(1) The diagnosis and treatment alternatives and the risks involved with each;

(2) The HCS’s policy on advanced directives; and

(3) The name of the attending physician or individual supervising the patient’s care and the manner in which that individual may be contacted.

R.C. 119.032 review dates: 03/01/2007 and 03/01/2012

Promulgated Under: 119.03

Statutory Authority: 3702.11, 3702.13

Rule Amplifies: 3702.11, 3702.12, 3702.13, 3702.14, 3702.141, 3702.15, 3702.16, 3702.18, 3702.19, 3702.20

Prior Effective Dates: 3/1/1997, 3/24/03

(A) Each provider of a HCS shall, based on the services provided and the number of patients served, maintain a sufficient number of qualified staff members and other personnel and an appropriate schedule of staff time to meet the needs of its patients in a timely manner. The provider of the HCS shall be responsible for the care provided by the staff and personnel of the HCS.

(B) Each provider of a HCS shall utilize personnel to provide services 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 and shall undergo training specified in paragraph (H) of this rule. Copies of current Ohio licenses, registrations and certifications shall be kept in the employee’s personnel files or the provider of the HCS shall have an established system to verify and document the possession of current Ohio licenses, registrations, or other certifications, if required by law.

(C) Each provider of a HCS shall have a medical director for the HCS. In lieu of the board certification requirements specified in this chapter, a physician who is board certified by a foreign board and is eligible to take the examination of an American board of medical specialists recognized board or an American osteopathic association board may serve as medical director of an HCS.

(D) The owner, administrator and medical director shall be competent to perform the applicable job responsibilities and be suitable to own, operate or direct a HCS.

(E) The HCS shall develop and follow a tuberculosis control plan that is based on the provider’s assessment of the HCS. 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 HCS shall retain documentation evidencing compliance with this paragraph and shall furnish such documentation to the director upon request.

(F) The provider of a HCS shall not knowingly permit a staff member to provide services if the staff member:

(1) Has a disease capable of being transmitted during the performance of his or her duties;

(2) Is under the influence of drugs or alcohol; or.

(3) After training and orientation by the provider of the HCS, has not demonstrated sufficient knowledge or expertise for the responsibilities of the position.

(G) The provider of a HCS shall provide each staff member with a written job description delineating his or her responsibilities.

(H) Each provider of a HCS 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 and shall include information specific to the appropriate HCS.

(I) All staff shall have appropriate orientation and training regarding the HCS’s equipment, safety guidelines, practices, and policies.

(J) Each provider of a HCS shall develop and implement an ongoing process for ensuring the competence of staff members. This process shall include a periodic assessment and re-determination of necessary skill levels and a performance evaluation stating whether each staff member has achieved the skill levels. The performance evaluation of each staff member shall occur at least every thirty-six months.

(K) Each provider of a HCS shall retain staffing schedules, time-worked schedules, on-call schedules, and payroll records for at least two years.

Effective: 06/01/2007

R.C. 119.032 review dates: 03/01/2007 and 03/01/2012

Promulgated Under: 119.03

Statutory Authority: 3702.11, 3702.13

Rule Amplifies: 3702.11, 3702.14, 3702.141, 3702.15, 3702.16, 3702.18, 3702.19, 3702.20

Prior Effective Dates: 3/1/1997, 3/24/03, 12/1/06

(A) The provider of a HCS shall assure all staff members provide services in accordance with:

(1) The patient’s plan of care;

(2) The policies and procedures developed by the HCS;

(3) Applicable current and accepted standards of practice and the clinical capabilities of the HCS;

(4) Applicable state and federal laws and regulations; and

(5) The applicable quality of care and safety standards set forth in this chapter of the Administrative Code.

(B) The provider of a HCS shall document all medical services performed in the care of the patient in his or her medical record.

(C) The provider of a HCS shall provide for the ancillary and support services necessary for the provision of the HCS’s services.

(D) The provider of a HCS shall establish and follow written infection control policies and procedures for the surveillance, control and prevention 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 and prevention (CDC) and shall facilitate the activities associated with the prevention and spread of communicable infectious diseases. 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) Universal precautions/body substance isolation or equivalent; and

(5) Tuberculosis and other airborne diseases.

(E) The provider of a HCS shall maintain and operate equipment in a safe manner, in accordance with the manufacturer’s instructions, and shall not jeopardize patient health or safety through operation of the equipment.

(F) The provider of a HCS shall provide the patient or the patient’s representative:

(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 HCS’s normal hours of operation; and

(3) Verbal and written instructions for post-treatment care and procedures for obtaining emergency care.

R.C. 119.032 review dates: 03/01/2007 and 03/01/2012

Promulgated Under: 119.03

Statutory Authority: 3702.11, 3701.13

Rule Amplifies: 3702.11, 3702.12, 3702.13, 3702.14, 3702.141, 3702.15, 3702.16, 3702.18, 3702.19, 3702.20

Prior Effective Dates: 3/1/1997, 3/24/2003

(A) Each provider of a HCS shall ensure that the building or structure where the HCS is located:

(1) Has 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. and 3791. of the Revised Code and any rules adopted under them;

(2) Complies with the state fire code; and

(3) Complies with the applicable provisions of Chapter 3737. of the Revised Code and the rules adopted under it.

(B) The provider of a HCS shall adopt and follow a disaster preparedness plan including evacuation in the event of a fire. The HCS shall review evacuation procedures at least annually, and conduct practice drills with staff at least once every six months.

(C) Each provider of a HCS shall label, store and dispose all poisons, hazardous wastes and flammable materials in a safe manner that does not jeopardize patient health or safety, and in accordance with state and federal laws and regulations.

(D) Minimum space or square footage requirements specified in this chapter are of clear floor space and exclusive of fixed or wall mounted cabinets, desks, and closets that are floor based.

R.C. 119.032 review dates: 03/01/2007 and 03/01/2012

Promulgated Under: 119.03

Statutory Authority: 3702.11, 3702.13

Rule Amplifies: 3702.11, 3702.12, 3702.13, 3702.14, 3702.141, 3702.15, 3702.16, 3702.18, 3702.19, 3702.20

Prior Effective Dates: 3/1/1997, 3/24/03

(A) The provider of a HCS 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 and assessments, and services rendered. Each medical record shall be legible and readily accessible to staff for use in the ordinary course of treatment.

(B) The provider of a HCS shall not disclose individual medical records except as authorized by the patient or allowed by state and federal laws and regulations, including but not limited to the provisions of this chapter of the Administrative Code.

(C) The provider of a HCS shall systematically review records for conformance with acceptable standards of practice and the requirements of Chapter 3701-84 of the Administrative Code.

(D) The provider of a HCS shall maintain an adequate medical record keeping system and take appropriate measures to ensure the confidentiality of patient medical records.

(E) The provider of a HCS shall maintain medical records as necessary to verify the information and reports required by statute or regulation for five years from the date of discharge.

R.C. 119.032 review dates: 03/01/2007 and 03/01/2012

Promulgated Under: 119.03

Statutory Authority: 3702.11, 3702.13

Rule Amplifies: 3702.11, 3702.12, 3702.13, 3702.14, 3702.141, 3702.15, 3702.16, 3702.18, 3702.19, 3702.20

Prior Effective Dates: 3/1/1997, 3/24/03

(A) Each provider of a HCS shall establish a quality assessment and improvement program designed to systematically monitor and evaluate the quality of patient care provided in each HCS, pursue opportunities to improve patient care, ensure compliance with the applicable quality standards set forth in Chapter 3701-84 of the Administrative Code, and resolve identified problems.

(B) Each provider of a HCS shall develop a written plan for each HCS that describes the quality assessment and 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 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 the quality of care and resolve identified problems;

(3) Establish expectations, develop plans, and implement procedures to assess and improve the health care service’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 improvement;

(5) Internally document and report findings, conclusions, actions taken, and the results of any actions taken to the health care service’s management and medical director;

(6) Document and review all unexpected complications and adverse events, being serious injury or death resulting from medical management, which arise during the provision of the service or during the hospital stay; and

(7) Hold regular meetings, chaired by the medical director of the HCS, or designee, as necessary, but at least within sixty days after a death or complication, to review all deaths and complications and to report findings. Any pattern that might indicate a problem shall be investigated and remedied, if necessary.

Effective: 06/01/2007

R.C. 119.032 review dates: 03/01/2007 and 03/01/2012

Promulgated Under: 119.03

Statutory Authority: 3702.11, 3702.13

Rule Amplifies: 3702.11, 3702.12, 3702.13, 3702.14, 3702.141, 3702.15, 3702.16, 3702.18, 3702.19, 3702.20

Prior Effective Dates: 3/1/1997, 3/24/03

(A) Each provider of a HCS shall develop and follow policies and procedures to effectively receive, investigate, and report findings of complaints regarding the quality or appropriateness of services. 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 the complaint;

(4) The identity of persons and/or provider of the HCS involved;

(5) The findings of the investigation; and

(6) The resolution of the complaint.

(B) The provider of a HCS shall post the toll free complaint hotline of the department’s complaint unit in a conspicuous place in the HCS.

R.C. 119.032 review dates: 03/01/2007 and 03/01/2012

Promulgated Under: 119.03

Statutory Authority: 3702.11, 3702.13

Rule Amplifies: 3702.11, 3702.12, 3702.13, 3702.14, 3702.141, 3702.15, 3702.16, 3702.18, 3702.19, 3702.20

Prior Effective Dates: 3/1/1997, 3/24/03

(A) In accordance with paragraph (B) of this rule, the director may grant a variance or waiver from any requirement established by Chapter 3701-84 of the Administrative Code.

(B) Upon written request of the provider of the HCS, the director shall grant or deny a variance or waiver by written response within forty-five days of receipt of a request and all information determined necessary by the director to make a decision. The director may grant:

(1) A variance if the director determines that the requirement has been met in an alternative manner; and

(2) A waiver if the director determines that the strict application of the requirement would cause an undue hardship to the HCS and that granting the waiver would not jeopardize the health and safety of any patient.

In granting a variance or waiver, the director shall stipulate a time period for which the variance and waiver is to be effective and shall establish conditions that the HCS must meet for the variance or waiver to be operative.

(C) The granting of a variance or waiver is a discretionary act by the director based upon documentation:

(1) In the case of a variance request, as to how the HCS is meeting the intent of the requirement in an alternative manner; and

(2) In the case of a waiver request, as to how the requirement is an undue hardship to the HCS and why the waiver will not jeopardize the health and safety of any patient.

(D) The granting of a variance or waiver by the director shall not be construed as constituting precedent for the granting of any other variance or waiver. All variance and waiver requests shall be considered on a case-by-case basis.

(E) The provider of a HCS whose request for a waiver or variance under this rule is denied may request reconsideration of the decision by the director. A request for reconsideration must:

(1) Be received in writing by the director within thirty days of receipt of the director’s denial of a waiver or variance request; and

(2) Present significant, relevant information not previously submitted to the director by the provider of the HCS because it was not available to the provider of the HCS at the time the waiver or variance request was filed; or

(3) Demonstrate that there have been significant changes in factors or circumstances relied upon by the director in reaching the initial decision.

(4) A decision on an appropriately filed request for reconsideration shall be issued within forty-five days of the director’s receipt of the request for reconsideration, and all information determined necessary by the director to make a decision.

(5) The reconsideration process is an informal procedure not subject to Chapter 119. of the Revised Code. The director’s decision on reconsideration is final.

(F) The new provider of the HCS shall provide the service in compliance with all provisions of Chapter 3701-84 of the Administrative Code, unless a waiver or variance is granted for all provisions not met.

R.C. 119.032 review dates: 03/01/2007 and 03/01/2012

Promulgated Under: 119.03

Statutory Authority: 3702.11, 3702.13

Rule Amplifies: 3702.11, 3702.12, 3702.13, 3702.14, 3702.141, 3702.15, 3702.16, 3702.18, 3702.19, 3702.20

Prior Effective Dates: 3/1/1997, 3/24/03

Rescinded eff 6-1-07

(A) The provisions of rules 3701-84-16 to 3701-84-21 of the Administrative Code are applicable, upon the effective date of this rule, to each provider of solid organ transplant services regardless of the date service was initiated.

(B) A provider of a solid organ transplant service shall be a registered hospital classified as a general hospital or a children’s hospital that meets the following administrative requirements:

(1) Demonstrated institutional commitment to graduate medical education and research programs;

(2) Executed letters of agreement or contracts with an independent organ procurement organization which can provide sufficient numbers of organs to support the applicable volume level specified by rule 3701-84-21 of the Administrative Code;

(3) All kidney transplant services shall be a member of the appropriate end-stage renal disease coordinating council designated for the medicare program under 42 C.F.R. 405.2111;

(4) Cooperates with all extra-renal solid organ transplant services in Ohio relative to the following:

(a) Coordination of solid organ procurement, to be achieved to the extent practicable in cooperation with all established organ procurement organizations in Ohio;

(b) Participation in an effective method for assuring access to solid organ transplantation for the uninsured or financially indigent patient;

(c) Participation in a statewide registry to follow all transplant service patients from the time they receive approval by an inter-institutional patient selection committee until death; and

(d) Participation in a statewide service review process for solid organ transplant services.

(5) Membership in good standing in a statewide consortium of solid organ transplant services which provides the functions listed in paragraph (B)(4) of rule 3701-84-16 of the Administrative Code shall be sufficient to meet the requirements of that rule;

(6) The hospital shall have adequate and effective patient management plans and protocols for organ transplantation, including:

(a) Effective and detailed plans for the acute and long-term management of transplant patients including the waiting period, in-hospital phase, and immediate post-discharge period that adequately meets the needs of the patient;

(b) Transplant experienced social services available to the patient and the patient’s family at all times;

(c) Appropriate and thorough education of the patient; and

(d) Liaison with the patient’s primary care physician providing timely notification of changes in the patient’s condition.

Effective: 06/01/2007

R.C. 119.032 review dates: 03/01/2007 and 03/01/2012

Promulgated Under: 119.03

Statutory Authority: 3702.11, 3702.13

Rule Amplifies: 3702.11, 3702.12, 3702.13, 3702.14, 3702.141, 3702.15, 3702.16, 3702.18, 3702.19, 3702.20

Prior Effective Dates: 3/1/1997, 3/24/03

(A) Each provider of a solid organ transplant service shall have a medical director that is certified in the appropriate specialty and that actively performs solid organ transplant procedures at the hospital where he or she is the medical director.

(B) Each provider of a solid organ transplant service shall have on staff at least one dedicated transplant surgeon and at least one dedicated transplant physician, for each type of organ transplanted, that meet the personnel criteria for transplant surgeons and physicians, which are in effect on the effective date of this rule, as adopted by the national organ procurement and transplantation network, currently the united network for organ sharing. A transplant surgeon or transplant physician cannot be dedicated to more than one solid organ transplant service provider unless the providers have credentialed more than one transplant surgeon or transplant physician to provide transplant services for the appropriate type of organ. A qualified surgeon with an appropriate level of expertise for the procedure must be present in the operating room at all solid organ transplant surgeries.

(C) Each provider of a solid organ transplant service shall have a transplant surgeon and transplant physician for each type of organ transplanted available on a twenty-four hour basis to provide program coverage. A transplant surgeon shall be readily available to timely facilitate organ acceptance and implantation. A transplant surgeon or transplant physician shall be available on site within one hour to address urgent patient issues. When this coverage is not available, the program shall be temporarily suspended and the provider of the solid organ transplant service shall provide patients and the director with a written notice of the temporary suspension and expected date of reinstatement. Notice to patients shall be provided in their language of common use. A dated sample of the form letter provided to patients shall be provided to the director along with the director’s notice:

(1) For planned temporary suspensions, the notice required in this rule shall be provided at least five business days prior to the temporary suspension; and

(2) For unexpected temporary suspensions, the notice required in this rule shall be provided within five business days after the temporary suspension.

(D) The following staff, exclusive of the transplant surgeons and physicians, shall meet the criteria set forth below and shall be available at all times to the hospital where the service is located:

(1) For extra-renal transplant services, a designated anesthesiologist who;

(a) For heart transplantation, has training in open heart surgery anesthesia;

(b) For lung transplantation, has training in cardiopulmonary anesthesia;

(c) For liver transplantation, has had an on-site visit to an established liver transplant service and documented experience participating in liver transplant anesthesia or has formal training in liver transplantation anesthesia;

(2) A pathologist with training in detecting rejection in the transplanted organ;

(3) A nursing team trained in hemodynamic support and immunosuppression management. The training in immunosuppression management shall include training in isolation techniques and infection control methods;

(4) A nephrologist on site;

(5) An established division or section of infectious disease with physicians who are available for consultation and direct service;

(6) A full-time transplant patient coordinator with appropriate experience as a patient coordinator with a transplant service;

(7) A psychiatrist and a licensed independent social worker who are available for evaluation and ongoing support of both the patient and family;

(8) Available physicians specializing in radiology, respiratory disease, and physical medicine;

(9) Available on-site specialties of cardiovascular disease, endocrinology, gastroenterology, hematology, pediatrics (if applicable), pulmonary disease, general surgery, orthopedics, urology, neurosurgery and ophthalmology; and

(10) Expertise needed to manage organ rejection and the problems of immunosuppressed patients.

(E) Each provider of a solid organ transplant service shall provide sufficient staff to adequately monitor patients during the post-transplant period.

Effective: 05/15/2008

R.C. 119.032 review dates: 02/29/2008 and 03/01/2013

Promulgated Under: 119.03

Statutory Authority: 3702.11, 3702.13

Rule Amplifies: 3702.11, 3702.12, 3702.13, 3702.14, 3702.141, 3702.15, 3702.16, 3702.18, 3702.19, 3702.20

Prior Effective Dates: 3/1/1997, 3/24/03, 6/1/07

A provider of a solid organ transplant service shall have available at all times adequate facilities and resources for the transplant service. The following shall be available on-site at all times:

(A) Sufficient operating and recovery room resources;

(B) Intensive care facilities allowing reverse isolation;

(C) A dialysis unit:

(D) Sufficient bed capacity to accommodate at least the minimum volume level specified by rule 3701-84-21 of the Administrative Code for the applicable type of solid organ transplantation;

(E) Clinical laboratory services that include facilities for coagulation monitoring and blood bank resources capable of providing at least twenty units of blood, platelets, and fresh blood products on demand;

(F) Microbiology laboratory experienced in processing the pathogens of opportunistic infection;

(G) Physical therapy services;

(H) Electron microscopy; and

(I) The following on-site services shall be accessible by gurney and available at all times:

(1) Angiography;

(2) Cardiac catheterization;

(3) Diagnostic radioisotope scanning;

(4) Endoscopy;

(5) Nuclear medicine;

(6) Routine diagnostic radiology;

(7) Computed tomography;

(8) Bone marrow biopsy;

(9) Diagnostic ultrasound;

(10) Electroencephalography;

(11) Nerve conduction;

(12) Psychometrics;

(13) Pulmonary function; and

(14) Immunofluorescence.

(J) A provider of a solid organ transplant service shall have access to laboratory facilities for histocompatibility testing that are certified by the “American Society for Histocompatibility and Immunogenetics” at all times.

R.C. 119.032 review dates: 03/01/2007 and 03/01/2012

Promulgated Under: 119.03

Statutory Authority: 3702.11, 3702.13

Rule Amplifies: 3702.11, 3702.12, 3702.13, 3702.14, 3702.141, 3702.15, 3702.16, 3702.18, 3702.19, 3702.20

Prior Effective Dates: 3/1/1997, 3/24/03

The provider of a solid organ transplant service shall meet the following safety requirements:

(A) Heart or heart-lung transplantation services shall have an active open-heart surgery service that should be performing a minimum of two hundred fifty open heart surgery procedures annually, except that heart or heart-lung transplantation services that only serve pediatric patients less than twenty-two years of age shall have an active pediatric open-heart surgery service that should be performing a minimum of two hundred pediatric open heart surgery procedures annually;

(B) Heart-lung transplantation services shall have an active lung transplant service and an active heart transplant service; and

(C) Bowel transplantation services shall have an active liver transplant service.

Effective: 05/15/2008

R.C. 119.032 review dates: 02/29/2008 and 03/01/2013

Promulgated Under: 119.03

Statutory Authority: 3702.11, 3702.13

Rule Amplifies: 3702.11, 3702.12, 3702.13, 3702.14, 3702.141, 3702.15, 3702.16, 3702.18, 3702.19, 3702.20

Prior Effective Dates: 3/1/1997, 3/24/03, 6/1/07

(A) Each provider of an extra-renal, solid organ transplant service shall participate in a prospective, statewide review process for each patient prior to listing for transplant. The prospective review process shall include a separate review committee for each type of organ. Each review committee shall include at least one transplant physician or transplant surgeon from each program that actively participates in transplantation services for the appropriate organ. An affirmative vote of a majority of the members of the review committee is required in order to list a patient.

(B) Each provider of a solid organ transplant service shall adhere to identical patient selection criteria, including:

(1) For kidney patient selection, end stage renal disease defined as dialysis dependence or pre-dialysis deterioration of renal function as manifested by a creatinine clearance less than thirty milliliters/minute for diabetic patients and less than twenty milliliters/minute for all other patients;

(2) For liver, heart, combined heart/lung, pancreas, pancreas islet cell, lung, or small bowel patient selection, the prospective patient selection criteria listed in appendix A and screening criteria for patients presenting with histories of alcohol or substance dependency as listed in appendix B.

(3) For heart and lung patient selection, the screening criteria for patients presenting with histories of tobacco use as listed in appendix C to this rule.

(C) If a transplantation service desires to perform a transplant on a patient who does not meet the selection protocols set forth in appendix A, the facility will need to establish that a thorough review of the case was undertaken to determine that the transplant was appropriate. This review shall, at a minimum, include:

(1) Preparation of a detailed clinical summary of the patient including: a brief medical history, complete laboratory data, a thorough psychological evaluation including the patient’s support system, any psychological issues, attitude toward and understanding of the transplant, informed consent, and a justification of the transplant despite failure to meet the selection criteria;

(2) Circulation of the clinical summary to a committee comprised of, at a minimum, the director of health, one experienced transplant physician or transplant surgeon from each organ transplant program who actively participates in transplant services for the appropriate organ, an ethicist or bioethicist, and a lay representative who may be an attorney;

(3) Convening of the committee established in paragraph (C)(2) of this rule to discuss the clinical summary of the patient; and

(4) After sufficient review time, an affirmative vote of a majority of the members of the committee that the transplant is appropriate.

(D) Patients presenting for extra-renal transplantation that have histories of alcohol or substance dependency and do not meet the standard criteria conditions set forth in paragraph (B)(1)(a) or (B)(1)(b) of appendix B to this rule may be evaluated for listing by the chemical dependency committee, which shall be comprised of a representative from the department of health and a minimum of one chemical dependency counselor from each organ transplant program in Ohio that actively participates in transplant services. Every chemical dependency counselor that participates on the chemical dependency committee must be appropriately credentialed to diagnose chemical dependency conditions either independently or under the clinical supervision of an individual who is appropriately credentialed by the Ohio chemical dependency professionals board, the Ohio counselor, social worker, and marriage and family therapist board, or the American society of addiction medicine to diagnose chemical dependency and who reviews and co-signs the diagnosis. The chemical dependency committee shall make an advisory recommendation to the appropriate, organ specific patient selection committee under the prospective statewide review process.

APPENDIX A

Patient Selection Criteria

See Appendix at http://www.registerofohio.state.oh.us/pdfs/3701/0/84/3701-84-20_PH_FF_A_APP2_20080505_0920.pdf

APPENDIX B

Screening Criteria for Patients Presenting with Significant Histories of Alcohol or Substance Dependency

See Appendix at http://www.registerofohio.state.oh.us/pdfs/3701/0/84/3701-84-20_PH_FF_A_APP4_20080505_0920.pdf

APPENDIX C

Screening Criteria for Heart and Lung Patients Presenting Histories of Tobacco Use

See Appendix at http://www.registerofohio.state.oh.us/pdfs/3701/0/84/3701-84-20_PH_FF_A_APP5_20080505_0920.pdf

Effective: 05/15/2008

R.C. 119.032 review dates: 02/29/2008 and 03/01/2013

Promulgated Under: 119.03

Statutory Authority: 3702.11, 3702.13

Rule Amplifies: 3702.11, 3702.12, 3702.13, 3702.14, 3702.141, 3702.15, 3702.16, 3702.18, 3702.19, 3702.20

Prior Effective Dates: 3/1/1997, 3/24/03, 5/20/04, 6/1/07

(A) Each solid organ transplant service, including combined adult and pediatric transplants performed in a single hospital or university multi-hospital transplant service, should achieve the following volume goals per year after they have been in existence for two years or more to ensure efficiency and a minimum floor of competency:

(1) For kidney, fifteen transplants;

(2) For heart, ten transplants;

(3) For liver, ten transplants; and

(4) For lung, ten transplants.

(B) Volume goals will be considered by the director in conjunction with other indicators of quality, not as the sole indicator of service performance.

(C) Failure to meet a volume goal for two consecutive years will trigger an extended review of the solid organ transplant service including possible inspections by the director of health. The director may request a statewide consortium of solid organ transplant services to conduct the inspections for solid organ transplant services.

Replaces: 3701-84-21

Effective: 05/15/2008

R.C. 119.032 review dates: 03/01/2013

Promulgated Under: 119.03

Statutory Authority: 3702.11, 3702.13

Rule Amplifies: 3702.11, 3702.12, 3702.13, 3702.14, 3702.141, 3702.15, 3702.16, 3702.18, 3702.19, 3702.20

Prior Effective Dates: 3/1/1997, 3/24/03, 6/1/07

Rescinded eff 6-1-07

Rescinded eff 6-1-07

(A) The provisions of rules 3701-84-24 to 3701-84-27 of the Administrative Code are applicable, upon the effective date of this rule, to each provider of bone marrow transplant services regardless of the date service was initiated.

(B) A provider of a bone marrow transplantation service shall be a registered hospital classified as a general hospital, a children’s hospital or as a specialty hospital that primarily furnishes oncology services that meets all of the following criteria:

(1) Participates with other hospitals nationally in cancer treatment research, such as national cancer institute sponsored research. The hospital’s research activities shall include all of the following:

(a) Use of uniform patient treatment protocols;

(b) On-site audits at least every five years by a cancer research organization or another hospital involved in national cancer treatment research; and

(c) Reporting of patient eligibility and treatment data to the research organization in which the hospital participates.

(2) Meets the following administrative requirements:

(a) Appropriate patient management plans and protocols, including patient selection criteria, plans for long-term management, protocols to address the prevention of opportunistic infections among bone marrow transplant recipients, and appropriate liaison with the patient’s family and primary care physician. The patient management plans and protocols shall be consistent with nationally accepted standards;

(b) Quality assurance standards for the procurement of hematopoietic stem cells including the procurement of bone marrow via a bone marrow harvest, as well as procurement of hematopoietic progenitor cells (stem cells) by the use of leukapheresis or umbilical cord blood collection; and

(c) A procedure for conducting systematic evaluation of clinical outcomes resulting from hematopoietic stem-cell transplantation.

(3) Has a documented agreement to cooperate with all other bone marrow transplantation services in Ohio relative to patient selection that is non-discriminatory as to race, sex, and ability to pay.

(C) Prior to initiating transplantation services, the provider of the bone marrow transplantation service shall specify to the director, its intention to serve pediatric patients less than seventeen years of age, patients greater than or equal to seventeen years of age and less than twenty-two years of age, or adult patients twenty-two years of age or older. A bone marrow transplantation service may serve patients greater than or equal to seventeen years of age and less than twenty-two years of age as a pediatric or an adult patient, whichever best serves the needs of the patient, as determined by the transplant physician and transplant service’s medical director. It shall also specify its intention to provide an autologous transplantation service, an allogeneic transplantation service, or both services.

Effective: 06/01/2007

R.C. 119.032 review dates: 03/01/2007 and 03/01/2012

Promulgated Under: 119.03

Statutory Authority: 3701.11, 3701.13

Rule Amplifies: 3702.11, 3702.12, 3702.13, 3702.14, 3702.141, 3702.15, 3702.16, 3702.18, 3702.19, 3702.20

Prior Effective Dates: 3/1/1997, 3/24/03

(A) The provider of a bone marrow transplant service shall meet the following staffing criteria:

(1) Each service shall have a medical director responsible for oversight of care on the unit and actively performs bone marrow transplant services at the hospital where he or she is the medical director and at least one other primary tranplantation physician actively participating in the service;

(2) The medical director of the service shall be board certified in hematology, oncology, immunology, or pediatric hematology / oncology, on staff at the hospital, an active physician involved in direct patient care, and have a minimum of one year clinical bone marrow transplantation training at a major transplant center in the United States formally recognized as a bone marrow transplant center by a national cooperative chemotherapy group, the national bone marrow donor program, or a national institute of health-supported bone marrow transplant research program;

(3) A nursing team with training and skills commensurate with the required tasks shall be committed to the transplant service on a full-time basis to assure adequate continuity of care; and

(4) The care of bone marrow transplant patients shall be coordinated by a multidisciplinary team with training and skills commensurate with the required tasks.

R.C. 119.032 review dates: 03/01/2007 and 03/01/2012

Promulgated Under: 119.03

Statutory Authority: 3702.11, 3702.13

Rule Amplifies: 3702.11, 3702.12, 3702.13, 3702.14, 3702.141, 3702.15, 3702.16, 3702.18, 3702.19, 3702.20

Prior Effective Dates: 3/1/1997, 3/24/03

(A) The hospital at which the bone marrow transplant service is located shall provide all of the following on site:

(1) A designated bone marrow transplant unit with sufficient number of beds to meet the needs of the bone marrow transplant service;

(2) Active departments or sections in hematology/oncology, immunology and infectious diseases;

(3) Laboratories;

(4) Adequate intensive care facilities;

(5) Protective reverse isolation rooms with appropriate air handling characteristics (i.e., hepa-filtered positive pressure patient rooms);

(6) Radiologic services including tomography, computed tomography (CT) scans and/or magnetic resonance imaging (MRI) scans;

(7) Radionuclide scans and ultrasonography;

(8) Immunopathology and hepatopathology;

(9) Histopathology;

(10) Microbiology laboratory;

(11) Blood banking services capable of routinely providing irradiated blood products appropriate for cytomegalovirus (CMV) seronegative patients;

(12) Clinical pharmacology services with a pharmacist familiar with antineoplastic agents;

(13) Modern radiotherapy capabilities including the ability to provide total body irradiation;

(14) Operating room facilities; and

(15) Echocardiography or MultiGated blood-pool imaging (MUGA) scan capability.

(B) The provider of a bone marrow transplant service shall have the following readily available:

(1) Tissue-typing laboratory;

(2) Apheresis capability with adequate blood cell component therapy and routine access to a blood irradiator; and

(3) Facilities to cryopreserve hematopoietic stem cells for transplantation and which additionally may be used to manipulate hematopoietic stem cells ex-vivo.

Effective: 06/01/2007

R.C. 119.032 review dates: 03/01/2007 and 03/01/2012

Promulgated Under: 119.03

Statutory Authority: 3702.11, 3702.13

Rule Amplifies: 3702.11, 3702.12, 3702.13, 3702.14, 3702.141, 3702.15, 3702.16, 3702.18, 3702.19, 3702.20

Prior Effective Dates: 3/1/1997, 3/24/2003

(A) All candidates for bone marrow transplantation shall be subject to prospective patient selection criteria as specified in appendix A to this rule.

(B) If a transplantation service desires to perform a transplant on a patient who does not meet the selection protocols set forth in appendix A to this rule, the service shall undertake a thorough review of the case to determine that the transplant is appropriate. This review shall, at a minimum, include:

(1) Preparation of a detailed clinical summary of the patient including a brief medical history, complete laboratory data, a thorough psychological evaluation including the patient’s support system, any psychosocial issues, attitude toward and understanding of the transplant, informed consent, and a justification of the transplant despite failure to meet the selection criteria;

(2) Circulation of the clinical summary to a committee comprised of, at a minimum, five experienced transplant physicians from five different hospitals, an ethicist, and a lay representative who may be an attorney; and

(3) After sufficient review time, an affirmative vote of a majority of the members of the committee that the transplant is appropriate.

(4) Once a protocol has been reviewed and approved, pursuant to this paragraph, by a committee specified in paragraph (B)(2) of this rule, the bone marrow transplantation service may treat other patients with the same disease with that formal treatment/clinical research protocol that is reviewed and approved by the transplanting institution’s internal review board and renewed on an annual basis, provided that the bone marrow transplantation service determines that the protocol is appropriate for the patient based on the patient’s clinical summary specified in paragraph (B)(1) of this rule.

(C) Each bone marrow transplantation service should achieve the following volume goals per year to ensure efficiency and a minimum floor of competency:

(1) Except as specified in paragraph (C)(2) of this rule, services providing only autologous bone marrow transplantations should perform at least ten per year. From the date a service notifies the director of activation or reactivation of a service, the service should perform at least six transplants in the first twelve months and at least twenty transplants within the first twenty-four months;

(2) Services providing only autologous bone marrow transplantation exclusively to patients less than twenty-two years of age should perform at least ten transplants per twenty-four months. From the date this service notifies the director of activation or reactivation of a service, the service should perform at least four transplants in the first twelve months and at least ten transplants within the first twenty-four months;

(3) Except as specified in paragraph (C)(4) of this rule, services providing both autologous and allogeneic bone marrow transplantation should perform at least twelve per year with at least six being allogeneic bone marrow transplantations. From the date a service notifies the director of activation or reactivation of a combined autologous and allogeneic service, the service should perform at least eight transplants in the first twelve months and at least twenty-four transplants within the first twenty-four months, of which at least twelve should be allogeneic;

(4) Services providing both autologous and allogeneic bone marrow transplantation exclusively to patients less than twenty-two years of age should perform at least ten transplants per twenty-four months with at least five being allogeneic. From the date this service notifies the director of activation or reactivation of a service, the service should perform at least four transplants in the first twelve months with at least two being allogeneic and at least ten transplants within the first twenty-four months with at least five being allogeneic.

(D) Volume goals will be considered by the director in conjunction with other indicators of quality, not as the sole indicator of service performance.

(E) Failure to meet a volume goal for two consecutive years will trigger an extended review of the bone marrow transplantation service by the director, including possible inspections.

APPENDIX A

Patient Selection Criteria

I. Patients transplanted on protocols: Any patient that is registered on and treated on a protocol that has been reviewed and approved by the National Institute of Health is an appropriate bone marrow transplantation (BMT) candidate.

II. Criteria for eligibility for patients who do not meet the conditions of paragraph I, above:

A. General Considerations

1. Pulmonary function: forced expiratory volume in one second (FEVI) and diffusing capacity for carbon monoxide (DLCO) are greater than forty-five percent predicted. If the FEVI or DLCO is less than forty-five percent of predicted value, the patient should be evaluated by a pulmonologist.

2. Cardiology: multigated blood-pool imaging (MUGA) or echocardiogram showing the left ventricular ejection fraction of greater than or equal to fifty percent. If a left ventricular ejection fraction is less than fifty percent, the patient must be consulted to and approved by a cardiologist to proceed to transplant. For pediatric patients, if a left ventricular shortening fraction by echocardiogram is less than twenty-nine percent, the patient must have an evaluation and clearance by a pediatric cardiologist prior to transplant.

3. Renal: the patient must have a serum creatinine of less than two milligrams/milliliter or a glomerular filtration rate (GFR) of greater than or equal to sixty milliliters/minute/one point seven three meters squared. If the patient does not meet this criteria, a nephrology consult and clearance must be obtained prior to transplant, unless multiple myeloma is the known cause of the renal dysfunction.

4. Hepatic: patients with abnormal hepatic enzymes (bilirubin, aspartate aminotransferase (AST) or alanine aminotransferase (ALT) greater than two times normal) need to be calculated and cleared by a gastroenterologist in order to proceed with transplant.

5. Performance status: the patient must have an ECOG performance status of zero, one, or two or a Lasky performance of seventy percent or greater.

B. Criteria for Exclusion

1. The presence of an uncontrolled infection

2. A female patient who is pregnant or lactating

3. A patient with known human immunodeficiency virus (HIV) disease

4. Patients with known metastatic intra-cranial disease (with the exception of metastatic germ cell tumors with treated intra-cranial disease or patients with neuroblastoma or active leptomeningeal disease)

C. Disease Indications for Allogeneic Bone Marrow Transplantation

1. Background

a. Ablative bone marrow transplantation

b. Non-myeloablative BMT: defined as infusion of hematopoietic cells after a nonmyeloablative preparative regimen for the purpose of attempting to treat a patients underlying disease with donor marrow and possibly the immunologic by-product of donor marrow

c. Source of stem cells

i. Five out of six phenotypic antigen related or matched unrelated donor

ii. For cord blood, a three-antigen mismatch or less by high resolution typing

2. Indications

a. Acute myelogenous leukemia

b. Acute lymphocytic leukemia

c. Chronic myelogenous leukemia

d. Chronic lymphocytic leukemia

e. Myelodysplastic syndrome

f. Severe combined immune deficiency (SCID)

g. Wiscott-Aldrich syndrome

h. Paroxysmal nocturnal hemoglobinuria

i. Adrenoleukodystrophy, Hurlers syndrome, and other storage diseases

j. Hodgkin’s disease, excluding first complete remission

k. Non-Hodgkin’s lymphoma, excluding first complete remission

l. Multiple myeloma

m. Hemoglobinopathy

n. Myeloproliferative disorder

o. Juvenile myelomonocytic leukemia (JMML)

Hemophagocytic lymphohistiocytosis (HLH)

q. Bone marrow failure syndromes

r. Osteopetrosis

s. Aplastic anemia

t. Neuroblastoma

u. Renal cell carcinoma

3. Indications for Repeat Blood or Marrow Infusion

a. Graft rejection

b. Disease relapse

c. Engraftment failure

D. Indications for Donor Leukocyte Infusions for Relapsed or Persistent Hematologic Malignancy after Allogeneic BMT from Original Donor

1. General Considerations

a. Expected survival of greater than or equal to four weeks

b. Absence of active acute or chronic graft versus host disease (GVHD)

2. Indications: any patient treated with an allogeneic BMT suffering from disease relapse

E. Disease Indications for Autologous Hematopoietic Cell Transplantation

1. Indications

a. Hodgkin’s disease, excluding first complete remission

b. Non-Hodgkin’s lymphoma

c. Acute myelogenous leukemia

d. Acute lymphoblastic leukemia

e. Chronic myelogenous leukemia

f. Neuroblastoma

g. Breast cancer

i. Stage II to III with greater than or equal to ten positive nodes, done within six months of diagnosis

ii. Stage IV or recurrent disease

iii. Four to nine positive nodes transplanted within six months of diagnosis

iv. Inflammatory breast cancer

h. Germ cell tumors

i. Multiple myeloma

j. Ovarian cancer

k. Pediatric tumors (up to age twenty-one)

i. Brain tumors

ii. Wilms tumor

iii. Soft tissue sarcomas

iv. Ewing’s family of tumors

v. Desmoplastic small round cell tumors

vi. Neuroblastoma

2. Repeat transplants

a. Second transplants are acceptable if they are part of the “initial therapy.” Thus, a protocol that demands multiple sequential myeloablative therapies as a planned treatment course is appropriate if the patient is treated on such a protocol.

b. Treatment of relapse: if a patient achieved a complete remission after the last autologous transplant and that complete remission lasted a minimum of one year, then a second transplant is potentially reasonable. A second transplant at less than one year requires a case review as established under paragraph (B) of rule 3701-84-27 of the Administrative Code.

F. Indications for Hematopoietic Stem Cell Harvesting Without a Planned Transplant

1. Acute myelogenous leukemia: patients in complete remission

2. Acute lymphoblastic leukemia: patients in complete remission

3. Matched unrelated donor: patients undergoing a matched, unrelated donor allogeneic transplant with marrow used as “back up”

4. Pediatric tumors: (Wilms’ tumor, soft tissue sarcoma, neuroblastoma, brain tumors, Ewing’s family of tumors) and lymphomas in complete remission to receive future pelvic radiation therapy.

Effective: 07/09/2007

R.C. 119.032 review dates: 03/01/2007 and 03/01/2012

Promulgated Under: 119.03

Statutory Authority: 3702.11, 3702.13

Rule Amplifies: 3702.11, 3702.12, 3702.13, 3702.14, 3702.141, 3702.15, 3702.16, 3702.18, 3702.19, 3702.20

Prior Effective Dates: 3/1/1997, 3/24/03, 6/1/07

Rescinded eff 6-1-07

Rescinded eff 6-1-07

(A) The provisions of rules 3701-84-30 to 3701-84-34 of the Administrative Code are applicable upon the effective date of this rule to each provider of cardiac catheterization services performing procedures on adult patients greater than or equal to twenty-two years of age, regardless of the date service was initiated. An adult cardiac catheterization service may serve a patient greater than or equal to eighteen years of age and less than twenty-two years of age if the patient’s attending physician and the adult service’s medical director determine that the adult service best serves the needs of the patient.

(B) The provider of a cardiac catheterization service shall have explicit standards for the provision of cardiac catheterization to high-risk patients and for the provision of high-risk and therapeutic interventions. These standards shall be consistent with the recommendations set forth in appendix A to this rule.

(C) A provider of cardiac catheterization services may perform cardiac catheterization and electrophysiology procedures on high-risk patients and may perform high-risk and therapeutic percutaneous coronary interventions (PCI), including percutaneous transluminal coronary angioplasty (PTCA), only if:

(1) An on-site adult open heart surgery service is available within the same hospital as the cardiac catheterization laboratory and is immediately accessible from the cardiac catheterization laboratory by gurney; and

(2) An experienced cardiovascular surgical team is readily available in less than sixty minutes on a twenty-four hour basis in the event that emergency open heart surgery is required.

(D) Those cardiac catheterization services that do not meet the criteria specified in paragraph (C) of this rule may only perform low-risk diagnostic cardiac catheterization procedures, including diagnostic electrophysiology studies, and right heart radio frequency ablation procedures, not to include transceptal or left heart radio frequency ablation procedures, on low-risk patients, defined as those patients not meeting the conditions of a high-risk patient set forth in appendix A of this rule. Those cardiac catheterization services subject to the provisions of this paragraph may perform such procedures only if:

(1) Patients are screened by the attending physician as low-risk patients prior to the procedure;

(2) The medical director for the cardiac catheterization service monitors and ensures strict adherence to patient selection criteria and treatment protocols;

(3) A formal written transfer agreement is maintained for emergency medical/surgical management with a registered hospital, that provides open heart surgery services, that can be reached expeditiously from the catheterization service by available emergency vehicle within a reasonable amount of time and that provides the greatest assurance for patient safety. The open heart surgery service that is a party to a transfer agreement is referred to as the receiving service. Each agreement shall include:

(a) Protocols addressing indications, contraindications, and other criteria for the emergency transfer of patients in a timely manner;

(b) Assurance of the initiation of appropriate medical/surgical management in a timely manner;

(c) Specification of mechanisms for continued substantive communication between the services party to the agreement and between their medical directors and physicians;

(d) Provisions for a collaborative training program among staff of the services party to the agreement;

(e) Provisions for the recommendation by the medical director of the receiving service, regarding the cardiac catheterization service’s credentialing criteria; and

(f) Provisions for the recommendation by the medical director of the receiving service, regarding the cardiac catheterization service’s protocols addressing patient monitoring, the recognition of high-risk indications, and the care and management of high-risk patients.

(4) There is an established written protocol for the emergency transfer and care of patients who require emergency medical/surgical management during or immediately after cardiac catheterization;

(5) The provider of the cardiac catheterization service reports to the department all high-risk or therapeutic procedures performed, all high-risk patients served by the cardiac catheterization service and all emergent patient transfers, that became necessary during or immediately after cardiac catheterization, to the receiving service for interventional medical management. The report shall maintain patient confidentiality and include the circumstances requiring the high-risk intervention or transfer. The report shall be filed with the department within thirty days after the close of each calendar year quarter (April thirtieth, July thirtieth, October thirtieth and January thirtieth) and include all reportable interventions during the quarter being reported.

(E) The provider of a cardiac catheterization service shall have immediate access to services for hematology and coagulation disorders; electrocardiography; and diagnostic radiology. Access to clinical pathology, nuclear medicine and nuclear cardiology, doppler-echocardiography, pulmonary function testing, and microbiology must be available within a reasonable amount of time to meet the needs of the service.

(F) The provider of a cardiac catheterization service shall establish and maintain a method for reviewing the quality of all cardiac catheterization procedures performed by each physician credentialed to perform such procedures. The review methodology shall assess the following:

(1) Appropriateness of cardiac catheterization studies and interventions;

(2) Technical quality of cardiac catheterization studies;

(3) Procedure result;

(4) Rate of therapeutic success; and

(5) Rate of procedural complications.

(G) The provider of a cardiac catheterization service shall establish and maintain a database to support the review process detailed in paragraph (F) of this rule. The results of analysis and review shall be documented and used to guide periodic internal reviews of individual physicians with respect to maintaining their credentials to perform specific cardiac catheterization procedures.

(H) A cardiac catheterization service shall only be provided in a fully permanent setting within the permanent frame of the building of a registered hospital that is classified as a general hospital or a special hospital-cardiac that primarily furnishes limited services to patients with cardiac conditions. The hospital shall:

(1) Operate inpatient medical and surgical services in the same building and accessible by gurney from the cardiac catheterization laboratory;

(2) Operate an intensive/critical care unit with registered special care beds,, that is reviewed and accredited or certified as such as part of the hospital’s accreditation or certification program in the same building and accessible by gurney from the cardiac catheterization laboratory. The unit shall provide appropriate equipment and staff to care for coronary patients and have twenty-four hour monitoring capability;

(3) Provide a setting in the same building as the cardiac catheterization laboratory in which ambulatory cardiac catheterization patients can be observed for at least four to six hours after the procedure; and

(4) Provide adequate physician coverage to manage postprocedure complications.

(I) The director shall continue to monitor advances in cardiac medicine and review the provision of cardiac catheterization services in freestanding and mobile settings.

APPENDIX A

Selected Criteria for Identifying High Risk Conditions for Cardiac Catheterization

See Appendix at http://www.registerofohio.state.oh.us/pdfs/3701/0/84/3701-84-30_PH_FF_A_APP1_20080505_0920.pdf

Effective: 05/15/2008

R.C. 119.032 review dates: 02/29/2008 and 03/01/2013

Promulgated Under: 119.03

Statutory Authority: 3701.11, 3701.13

Rule Amplifies: 3702.11, 3702.12, 3702.13, 3702.14, 3702.141, 3702.15, 3702.16, 3702.18, 3702.19, 3702.20

Prior Effective Dates: 3/20/1997, 6/17/99, 1/20/00, 3/24/03,

(A) The provider of a cardiac catheterization service shall designate a medical director. In addition to the requirements of rule 3701-84-08 of the Administrative Code and any requirements of this rule, the medical director of the cardiac catheterization service shall:

(1) Have at least five years catheterization experience and recognized skills in the cardiac catheterization laboratory;

(2) Have performed at least five hundred catheterizations;

(3) Be an active participant in the operation of the cardiac catheterization laboratory by performing at least fifty cardiac catheterization procedures annually in the cardiac catheterization service where he or she is the medical director; and

(4) Be responsible for oversight of quality of care provided in the cardiac catheterization laboratory.

(B) The medical director of an adult cardiac catheterization service shall be board certified in cardiovascular disease by the American board of internal medicine or the American osteopathic board of internal medicine. If an adult cardiac catheterization service performs interventional procedures, the medical director shall:

(1) Be board certified in interventional cardiology;

(2) Have ten years experience in interventional cardiology; or

(3) Have performed, as the primary operator, at least five hundred percutaneous coronary interventions.

(C) The provider of a cardiac catheterization service shall have at least two licensed physicians credentialed to provide cardiac catheterization services on staff who are knowledgeable of the laboratory’s protocols and equipment by providing cardiac catheterization services at the hospital. Only physicians appropriately credentialed to provide cardiac catheterization services may be the primary operator of a cardiac catheterization procedure.

(D) At a minimum, all physicians who perform cardiac catheterization procedures shall:

(1) Have training that includes at least one year dedicated to cardiac catheterization procedures;

(2) Be a fully-accredited member of the service’s staff; and

(3) Participate in laboratory quality assurance programs, including peer review.

(E) In addition to requirements contained in paragraph (D) of this rule, physicians performing percutaneous coronary interventions (PCI) who have not performed PCI prior to March 20, 1997 shall have completed a fellowship training program in which he or she performed at least one hundred and twenty-five PCI and was the primary operator in at least seventy-five of these procedures.

(F) In addition to the requirements of paragraphs (A) and (C) of this rule, the provider of a cardiac catheterization service shall have available a sufficient number of qualified staff who are able to supervise and conduct the cardiac catheterization service including the following:

(1) Support staff, all of whom are skilled in cardiac life support, comprised of individuals skilled in the following:

(a) Radiographic techniques:

(b) Film processing, if film is used;

(c) Systematic quality control testing;

(d) Patient observation;

(e) Critical care;

(f) Monitoring and recording electrocardiographic and hemodynamic data;

(g) Radiographic and angiographic imaging techniques and safety principles;

(h) Darkroom techniques, if cinefilm is used; and

(i) For catheterization laboratories where physiological studies are performed:

(i) Managing blood samples:

(ii) Performing blood gas measurements and calculations; and

(iii) Assisting with indicator dilution studies.

(2) Nursing personnel which may include nurse practitioners, registered nurses, licensed practical nurses, and nursing assistants. Nursing personnel involved in the provision of cardiac catheterization services shall have experience in critical care and knowledge of operating room techniques. Nurse practitioners, registered nurses, and licensed practical nurses involved in the provision of cardiac catheterization services shall have experience in cardiovascular medications and shall have the ability to begin administration of intravenous solutions. Nurse practitioners may assume some of the duties of a physician as permitted by law. However, ultimate responsibility for procedures shall always remain with the physician of record.

(G) Cardiovascular anesthesiologists and perfusion teams shall be available in less than sixty minutes. Respiratory therapists and critical care staff shall be immediately available at all times to care for patients.

(H) Biomedical, electronic, and radiation safety experts shall be involved in maintaining the equipment utilized by the service.

(I) Staffing requirements of this rule may be met by individuals with equivalent or greater qualifications if the replacement’s scope of practice encompasses the duties of the required staff.

Effective: 05/15/2008

R.C. 119.032 review dates: 02/29/2008 and 03/01/2013

Promulgated Under: 119.03

Statutory Authority: 3702.11, 3702.13

Rule Amplifies: 3702.11, 3702.12, 3702.13, 3702.14, 3702.141, 3702.15, 3702.16, 3702.18, 3702.19, 3702.20

Prior Effective Dates: 3/20/1997, 3/24/03

(A) The provider of a cardiac catheterization service shall provide adequate, properly designed space to perform cardiac catheterization procedures safely and effectively. The amount of space may vary with the types of procedures performed and the nature of the facility (e.g., interventional versus diagnostic, teaching versus non-teaching).

(B) Each cardiac catheterization service shall utilize the following:

(1) Procedure rooms that meet or exceed minimum space requirements established by the equipment manufacturer and are at least four hundred square feet or, if constructed or renovated or cardiac catheterization services initiated after March 20, 1997, at least five hundred square feet. Each procedure room shall have a designated control room;

(2) Control rooms of at least ninety-six square feet for each procedure room served. Control rooms that are constructed or renovated or cardiac catheterization services initiated after March 20, 1997 shall have at least one hundred and fifty square feet for each procedure room served; and

(3) Clean utility rooms that can sufficiently and efficiently supply the procedure rooms.

(C) A general radiology room cannot be used as a cardiac catheterization procedure room.

(D) Any provider of a cardiac catheterization service in which percutaneous coronary interventions (PCI) will be performed shall ensure that the facility where the PCI will be performed contains one or more surgical suites that are equipped to accommodate thoracic and cardiac surgical procedures, including procedures requiring cardiopulmonary bypass, with appropriate staff available in less than sixty minutes.

(E) Equipment described in this paragraph and paragraph (F) of this rule may be replaced by newer technology that has equivalent or superior capability as determined by the provider of the HCS. In assessing these new technologies, consideration should be given to recommendations of recognized professional societies and accrediting bodies (e.g. the American college of cardiology). All cardiac catheterization services shall, at a minimum have the following equipment:

(1) High quality x-ray imaging with multi axial position capability;

(2) A three-phase, twelve pulse generator with an output of eighty to one hundred kilowatts or a constant potential generator with an output of at least one hundred kilowatts at one hundred kilovolts;

(3) Multimode or cesium iodide image intensifiers;

(4) High-quality matched optics;

(5) A synchronous thirty-five millimeter camera or other appropriate imaging modality for review and storage of images;

(6) Television fluoroscopy;

(7) Carbon-fiber table tops;

(8) Power injectors capable of delivering up to fifty milliliters per second;

(9) A mechanism for continuous monitoring of a patient’s blood pressure and electrocardiogram;

(10) An adequate supply and variety of catheters, guide wires, and sheaths;

(11) A crash cart with equipment for ventilatory support;

(12) A defibrillator; and,

(13) A temporary pacemaker.

(F) In addition to requirements identified in paragraph (E) of this rule, the provider of a cardiac catheterization service that will perform percutaneous coronary interventions (PCI) shall have, at a minimum, the following equipment:

(1) An ample inventory of balloon dilation catheters;

(2) An intra aortic balloon pump;

(3) A high resolution fluoroscopic system and optimal TV chain; and

(4) Either biplane fluoroscopy or an angulating x-ray tube image intensifier arm.

(G) The provider of a cardiac catheterization service shall provide and maintain radiation generating equipment in accordance with applicable state and federal requirements as specified in Chapter 3748. of the Revised Code and the rules adopted thereunder.

Effective: 05/15/2008

R.C. 119.032 review dates: 02/29/2008 and 03/01/2013

Promulgated Under: 119.03

Statutory Authority: 3702.11, 3702.13

Rule Amplifies: 3702.11, 3702.12, 3702.13, 3702.14, 3702.141, 3702.15, 3702.16, 3702.18, 3702.19, 3702.20

Prior Effective Dates: 3/20/1997, 3/24/03

(A) The provider of a cardiac catheterization service shall establish and maintain safety guidelines, and practices and policies in accordance with applicable United States nuclear regulatory commission regulations, applicable provisions of Chapter 3748. of the Revised Code, and the rules adopted pursuant to that chapter to assure a safe environment for patients, visitors, and personnel.

(B) The provider of a cardiac catheterization service shall establish, maintain and follow electrical safety policies that, at a minimum, include:

(1) A safe primary electrical wiring system;

(2) Electrical isolation of all equipment attached to a patient;

(3) Use of an equipotential hardwired grounding system for all equipment; and

(4) Periodic inspection of the electrical system and measurement of interequipment current leakage.

(C) The provider of a cardiac catheterization service shall periodically survey all of the equipment utilized by the service and perform preventive maintenance on a schedule that, at a minimum, conforms to manufacturers’ recommendations. Results of surveillance and preventive maintenance activities shall be internally documented.

Effective: 05/15/2008

R.C. 119.032 review dates: 02/29/2008 and 03/01/2013

Promulgated Under: 119.03

Statutory Authority: 3702.11, 3702.13

Rule Amplifies: 3702.11, 3702.12, 3702.13, 3702.14, 3702.141, 3702.15, 3702.16, 3702.18, 3702.19, 3702.20

Prior Effective Dates: 3/20/1997, 3/24/03

(A) The provider of a cardiac catheterization service shall have established criteria for patient selection and appropriateness that are specific to each procedure performed in the service.

(B) Criteria for elective cardiac catheterization procedures shall be distinguished clearly from criteria for emergency cardiac catheterization procedures and for procedures associated with the care of patients who have acute or evolving myocardial infarctions.

(C) All patient selection and appropriateness criteria required in paragraph (A) of this rule shall be consistent with the 2001 American college of cardiology / society for cardiac angiography and interventions clinical expert consensus document on cardiac catheterization laboratory standards and the 2005 American college of cardiology/American heart association/society for cardiovascular angiography and interventions guideline update for percutaneous coronary intervention regarding indications for outpatient (ambulatory) cardiac catheterization, indications for coronary angiography and indications for percutaneous coronary interventions. The 2001 clinical expert consensus document on cardiac catheterization laboratory standards is available at www.acc.org and www.scai.org. The 2005 guideline update for percutaneous coronary intervention is available at http://www.acc.org/qualityandscience/clinical/guidelines/percutaneous/update/index.pdf.

(D) The provider of a cardiac catheterization service should meet the following volume goals, per year, by the second full year of operation:

(1) For each catheterization service, three hundred procedures;

(2) For each catheterization service in which percutaneous coronary interventions are performed, at least two hundred of these procedures.

(E) Volume goals shall be considered by the director in conjunction with other indicators of quality and not as the sole indicator of service performance.

(F) Failure to meet a volume goal for two consecutive years will trigger an extended review of the cardiac catheterization service by the director, including possible inspections.

(G) The provider of a cardiac catheterization service shall have explicit criteria indicating the number of times each year an appropriately privileged physician shall perform each catheterization procedure in order to retain privileges to perform that procedure. These criteria shall be consistent with current recommendations of recognized professional societies and accrediting bodies.

Effective: 05/15/2008

R.C. 119.032 review dates: 02/29/2008 and 03/01/2013

Promulgated Under: 119.03

Statutory Authority: 3702.11, 3702.13

Rule Amplifies: 3702.11, 3702.12, 3702.13, 3702.14, 3702.141, 3702.15, 3702.16, 3702.18, 3702.19, 3702.20

Prior Effective Dates: 3/20/1997, 3/24/03

Rescinded eff 6-1-07

(A) The provisions of rules 3701-84-36 to 3701-84-40 of the Administrative Code are applicable upon the effective date of this rule to each provider of open heart surgery services performing procedures on adult patients greater than or equal to twenty-two years of age, regardless of the date service was initiated. An adult open heart surgery service may serve a patient greater than or equal to eighteen years of age and less than twenty-two years of age if the patient’s attending physician and the adult service’s medical director determine that the adult service best serves the needs of the patient.

(B) The provider of an open heart surgery service shall have available at all times in the same building as the open heart surgery service and accessible by gurney, adequate facilities for the open heart surgery service, including but not limited to the following:

(1) Cardiac operating rooms;

(2) A cardiac surgery intensive care unit;

(3) A post-intensive care “step-down” unit; and

(4) Cardiac catheterization services.

(C) The provider of an open heart surgery service shall have the capability, equipment, and personnel to perform twenty-four hour emergency open heart procedures. A cardiovascular surgical team shall be available in less than sixty minutes on a twenty-four hour basis.

(D) The provider of an open heart surgery service shall have access to the following services:

(1) Cardiology;

(2) Hematology;

(3) Nephrology;

(4) Pulmonary medicine;

(5) Infectious disease;

(6) Radiology;

(7) Neurology;

(8) Emergency care;

(9) Electrocardiography;

(10) Stress testing;

(11) Nuclear medicine;

(12) Pathology;

(13) Echocardiography;

(14) Pulmonary function testing;

(15) Cardiac rehabilitation;

(16) Pre-admission testing; and

(17) Follow-up outpatient nursing referral services.

(E) An open heart surgery service shall only be provided in a fully permanent setting within the permanent frame of the building of a registered hospital that is classified as a general hospital or as a special hospital – cardiac that primarily furnishes limited services to patients with cardiac conditions. The hospital shall be fully equipped to perform the service.

Effective: 05/15/2008

R.C. 119.032 review dates: 02/29/2008 and 03/01/2013

Promulgated Under: 119.03

Statutory Authority: 3702.11, 3702.13

Rule Amplifies: 3702.11, 3702.12, 3702.13, 3702.14, 3702.141, 3702.15, 3702.16, 3702.18, 3702.19, 3702.20

Prior Effective Dates: 3/1/1997, 3/24/03

(A) The medical director of the adult open heart surgery service shall be board certified in an appropriate specialty. The medical director shall:

(1) Be responsible for oversight of care in the service;

(2) Be credentialed to provide adult open heart surgery services at the hospital where he or she is the medical director; and

(3) Actively perform open heart procedures at the hospital where he or she is the medical director.

(B) The provider of an open heart surgery service shall have at least two thoracic surgeons on staff, credentialed to perform open heart procedures at the hospital and actively perform open heart procedures at the hospital.

(C) The provider of an open heart surgery service shall have competent and qualified staff available, including but not limited to:

(1) Surgical assistants to assist the surgeon. A surgical assistant may be a resident, another physician or a specially trained surgical assistant;

(2) Cardiac anesthesiologists with special training in the anesthetic and supportive requirements of open heart surgery;

(3) Nursing staff that shall include appropriate numbers of scrub nurses or technicians and circulating nurses or technicians. A minimum of one scrub nurse and one circulating nurse is necessary. Nursing staff shall be trained in cardiac surgical operating room procedures;

(4) A cardiac surgical intensive care unit shall be staffed at the appropriate nurse patient ratio commensurate with the acuity of the patients and the amount of time following surgery that such care is necessary. Cardiac surgical intensive care nurses shall have specialized training to develop the theoretical knowledge and clinical skills required for the care of cardiac surgical patients; and

(5) A minimum of two perfusionists. Perfusionists shall be graduates of an approved circulation technology training program or have equivalent training and experience.

(D) In addition to the requirements of paragraph (C) of this rule, an open heart surgery service shall have appropriate staff available, including but not limited to pharmacists, dieticians, respiratory therapists, physical therapists, cardiac rehabilitation therapists, and social workers.

(E) Staffing requirements of this rule may be met by individuals with equivalent or greater qualifications if the replacement’s scope of practice encompasses the duties of the required staff.

Effective: 05/15/2008

R.C. 119.032 review dates: 02/29/2008 and 03/01/2013

Promulgated Under: 119.03

Statutory Authority: 3702.11, 3702.13

Rule Amplifies: 3702.11, 3702.12, 3702.13, 3702.14, 3702.141, 3702.15, 3702.16, 3702.18, 3702.19, 3702.20

Prior Effective Dates: 3/1/1997, 3/24/03

(A) Operating rooms used for open heart surgery shall have at a minimum four hundred and fifty square feet provided sufficient additional support space is available adjacent to each room for perfusion supplies, set up, and other storage. Operating rooms for open heart surgery constructed or renovated or open heart surgery services initiated after March 1, 1997 shall have at a minimum of six hundred square feet.

(B) Each operating room used for open heart surgery shall have appropriate numbers of o