Skip to main content
Back To Top Top Back To Top
This website publishes administrative rules on their effective dates, as designated by the adopting state agencies, colleges, and universities.

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

 
 
 
Rule
Rule 3701-84-01 | General definitions.
 

As used in this chapter:

(A) "Accreditation award letter" 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) "Blood and marrow transplantation service" also known as "hematopoietic stem cell transplantation" or "(HSCT)" means the replacement or supplementation of a patient's bone marrow with autologous or allogeneic hematopoietic stem cells when the patient's own bone marrow has been ablated or partially ablated by disease or therapy for the purpose of achieving long-term management of certain hematologic, immunologic, oncologic or genetic conditions, or enzymatic deficiency disease. A bone marrow transplantation service includes a service in stem cell harvesting and reinfusion.

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

(F) "High-risk allogeneic bone marrow transplantation" is determined according to the combination of: hematopoietic cell transplant comorbidity index (HCT-CI), performance status of recipient, and disease-risk index (DRI) as defined by established criteria.

(G) "Chiropractor" means a person licensed under Chapter 4734. of the Revised Code to practice chiropractic care.

(H) "Department" or "director" means the director of health or any official or employee of the department designated by the director of health.

(I) "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 blood and bone marrow transplant service, including stem cell harvesting and reinfusion;

(3) An adult cardiac catheterization service;

(4) An adult open heart surgery service;

(5) A pediatric intensive care service;

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

(7) A pediatric cardiac catheterization service;

(8) A pediatric cardiovascular surgery service.

(J) "Hospital" means an institution or facility that provides inpatient medical or surgical services for a continuous period longer than twenty-four hours. "Hospital" includes a children's hospital. Hospital does not include:

(1) A hospital operated by the federal government;

(2) An ambulatory surgical facility or other health care facility licensed as described in section 3702.30 of the Revised Code;

(3) A nursing home or residential care facility licensed under Chapter 3721. of the Revised Code;

(4) A hospital or inpatient unit licensed under section 5119.33 of the Revised Code;

(5) A residential facility as defined in section 5119.34 of the Revised Code;

(6) A residential facility as defined in section 5123.19 of the Revised Code;

(7) A community addiction services provider as defined in section 5119.01 of the Revised Code;

(8) A facility providing services under a contract with the department of developmental disabilities under section 5123.18 of the Revised Code;

(9) A facility operated by a hospice care program licensed under section 3712.04 of the Revised Code and that is used exclusively for the care of hospice patients;

(10) A facility operated by a pediatric respite care program licensed under section 3712.041 of the Revised Code and that is used exclusively for the care of pediatric respite care patients;

(11) The site where a health care practice is operated, regardless of whether the practice is organized as an individual or group practice;

(12) A clinic providing ambulatory patient services where patients are not regularly admitted as inpatients;

(13) An institution for the sick that is operated exclusively for patients who use spiritual means for healing and for whom the acceptance of medical care is inconsistent with their religious beliefs, accredited by a national accrediting organization, exempt from federal income taxation under section 501 of the Internal Revenue Code of 1986, 26 U.S.C. 1, and providing twenty-four-hour nursing care pursuant to the exemption from the licensing requirements of Chapter 4723. of the Revised Code described in division (E) of section 4723.32 of the Revised Code.

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

(L) "Medical director" means the physician who is responsible for managing and directing the provision of medical services for a health care service.

(M) "Nurse" means either a licensed practical nurse or a registered nurse.

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

(O) "Patient" means any individual who receives health care services.

(P) "Patient representative" means either a person acting on behalf of a patient with the consent of the patient or the patient's legal guardian.

(Q) "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.

(R) "Pharmacist" means a person registered under Chapter 4729. of the Revised Code to practice pharmacy.

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

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

(U) "Psychologist" means a person licensed to practice psychology pursuant to Chapter 4732. of the Revised Code.

(V) "Registered dietitian" means a person registered pursuant to Chapter 4759. of the Revised Code to practice dietetics.

(W) "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.

(X) "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.

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

(Z) "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.

(AA) "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.

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

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

(DD) "Stereotactic radiosurgery service" means the structural unit of a health care organization which provides stereotactic radiosurgery.

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

(FF) "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.

(GG) "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.

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

(II) "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.

(JJ) "Dose" means energy imparted per unit mass of absorber at a specific site under certain conditions.

(KK) "Radiation therapy service" means the structural unit of a health care organization which provides radiation therapy.

(LL) "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.

(MM) "Radiation oncologist" means a physician who:

(1) Has satisfactorily completed a radiation oncology residency in an accreditation council for graduate medical education or American osteopathic association approved program; 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.

(NN) "Radiation therapy" means the use of ionizing radiation, including external beam radiation therapy (teletherapy), or intraoperative radiation therapy and radioactive materials for therapeutic administration as authorized on a radioactive materials license issued by the director pursuant to Chapter 3701:1-58 of the Administrative Code in the treatment of human illness.

(OO) "Simulation" means the mock-up of a patient treatment and may include equipment, staff, radiographic documentation of the treatment portals or other methods of reproduction of techniques and treatments.

(PP) "Cardiac catheterization" means a procedure used to diagnose and treat various cardiac and circulatory diseases that involves inserting a thin, pliable catheter into a major blood vessel and manipulating the tip of the catheter through veins or arteries to the heart.

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

(RR) "Percutaneous coronary interventions" (PCI") commonly known as coronary angioplasty or simply angioplasty, is a non-surgical procedure used to treat the stenotic (narrowed) coronary arteries of the heart found in coronary heart disease.

(SS) "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.

(TT) "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.

(UU) "Pediatric patient" means any patient less than eighteen years of age, unless otherwise specified in this chapter. This definition does not prohibit children's hospitals from providing care to patients up to their twenty-second birthday and older as may be clinically appropriate during the patient's transition from a pediatric to an adult provider, or if the patient's congenital or chronic disease of childhood is best managed by pediatric providers.

(VV) "Provider of a health care service" means a person or governmental entity who assumes legal liability for purposes of compliance with this chapter.

(WW) For purposes of this chapter, "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.

(XX) "Pediatric intensivist" means a physician who is board eligible or board certified in pediatric critical care medicine after training in an ACGME-accredited program and participates in training to meet ongoing education and certification requirements for pediatric critical care medicine.

(YY) "Electrophysiology study" means a test performed to assess the heart's electrical system or activity and is used to diagnose abnormal heartbeats or arrhythmias. For the purpose of this chapter, the term also includes the implantation of permanent pacemakers and ICD devices and other electrophysiology procedures within the scope of procedures authorized at each level of a cardiac catheterization service.

(ZZ) "Psychosocial health" means the combined influence of psychological factors and the surrounding social environment on an individual's physical, emotional, and/or mental wellness.

Last updated May 15, 2023 at 12:45 AM

Supplemental Information

Authorized By: 3702.11, 3702.13
Amplifies: 3702.11, 3702.12, 3702.13, 3702.14, 3702.141, 3702.15, 3702.16, 3702.18, 3702.19, 3702.20
Five Year Review Date: 5/5/2028
Prior Effective Dates: 3/1/1997, 6/1/2007
Rule 3701-84-02 | Applicability of rules.
 

(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) Blood and 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 3701-84-34.2 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) Pediatric intensive care services shall comply with rules 3701-84-61 to 3701-84-65 of the Administrative Code;

(6) Linear accelerator, cobalt, and gamma knife services shall comply with rule 3701-84-67 of the Administrative Code;

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

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

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

Last updated May 15, 2023 at 12:45 AM

Supplemental Information

Authorized By: 3702.11
Amplifies: 3702.12, 3702.13, 3702.14, 3702.141, 3702.15, 3702.16, 3702.18, 3702.19, 3702.20
Five Year Review Date: 5/5/2028
Rule 3701-84-03 | General provisions and prohibitions.
 

(A) 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 or the director's designee. As used in this paragraph, "interfere" means to obstruct directly or indirectly any individual conducting an authorized inspection or investigation from carrying out their prescribed duties. Interference includes, but is not limited to, harassment, intimidation, and refusal to permit the director or the director's 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 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) Nothing in this chapter shall be construed as authorizing individuals to provide services outside their licensed scope of practice.

Last updated May 15, 2023 at 12:45 AM

Supplemental Information

Authorized By: 3702.11; 3702.13
Amplifies: 3702.12, 3702.13, 3702.14, 3702.141, 3702.15, 3702.16, 3702.18, 3702.19, 3702.20
Five Year Review Date: 5/5/2028
Prior Effective Dates: 3/24/2003, 6/1/2007
Rule 3701-84-04 | Service notification.
 

(A) At least thirty days prior to initiating a new HCS or reactivating a discontinued or temporarily suspended HCS the HCS shall notify the director in writing, in a manner prescribed by the director, 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 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 will be signed by the medical director of the HCS and the service manager of the HCS;

(2) Attestation that to the best of the knowledge of the individual signing the attestation, the information in the attestation and any accompanying material is true and accurate; and

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

(C) The HCS shall submit a revised attestation within thirty days of the following:

(1) Change of medical director; or

(2) Change of service manager who previously signed an attestation.

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

(E) At any time, the director may request additional information that the director 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 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 of the date of mailing of the request if patient health or safety is of concern.

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

(G) At least thirty days prior to a change in the scope of the HCS, 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 HCS shall notify the director in writing of:

(1) The criteria, standard or requirement not met;

(2) The reason for failure to meet the criteria, standard or requirement;

(3) The corrective action that will be taken; and

(4) The time table for meeting the criteria, standard or requirement.

(I) At least thirty days prior to discontinuing a HCS, 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 HCS and the thirty day requirement in this paragraph cannot be met, the written notice shall be given prior to discontinuing the service and include the projected date of discontinuance.

Last updated May 15, 2023 at 12:45 AM

Supplemental Information

Authorized By: 3702.11; 3702.13
Amplifies: 3702.12, 3702.13, 3702.14, 3702.141, 3702.15, 3702.16, 3702.18, 3702.19, 3702.20
Five Year Review Date: 5/5/2028
Prior Effective Dates: 3/1/1997, 8/1/2017
Rule 3701-84-05 | Compliance actions.
 

(A) If a HCS fails to comply with section 3702.14 of the Revised Code or Chapter 3701-84 of the Administrative Code, the director will provide the HCS a reasonable and appropriate amount of time to correct the violation and, in accordance with Chapter 119. of the Revised Code, may:

(1) 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 psychosocial health as defined in paragraph (ZZ) or rule 3701-84-01 of the Administrative Code, safety or security of patients, a civil penalty of not less than one hundred thousand dollars and not more than two hundred fifty thousand dollars;

(b) For violations that directly threaten physical or psychosocial 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 or potentially threaten the physical or psychosocial 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) Issue an order that the HCS cease operation:

(a) For a second or subsequent violation of section 3701.14 of the Revised Code or Chapter 3701-84 of the Administrative Code; or

(b) For an initial violation that the director has determined to cause or pose an imminent threat of serious physical harm or life-threatening danger.

(B) In determining which of the actions to take under paragraph (A) of this rule, the director may consider 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 HCS's history of compliance.

Last updated May 15, 2023 at 12:45 AM

Supplemental Information

Authorized By: 3702.11, 3702.13
Amplifies: 3702.12, 3702.13, 3702.14, 3702.141, 3702.15, 3702.16, 3702.18, 3702.19, 3702.20
Five Year Review Date: 5/5/2028
Prior Effective Dates: 3/1/1997, 3/24/2003
Rule 3701-84-06 | Inspections and audits.
 

(A) The director may make announced or unannounced inspections 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 industry norm or outside the range of expected values, the director may conduct a review of the HCS or require 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 adverse outcomes and make recommendations for improvement.

(1) In determining whether to approve an expert, the director will consider the individual's knowledge and expertise in the service area and affiliation with the provider of the HCS;

(2) 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 the requirement for a review;

(3) Based on the findings of the review, the director may require the HCS to implement recommendations of the experts; and

(4) 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 (G) of this rule.

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

(D) Information obtained by the director pertaining to specific patients is confidential. Information may be released in summary, statistical, or other form which does not disclose the identity of an individual patient and is devoid of personal health information (PHI). 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.

(E) 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 will inform the complainant and the HCS of the results of the investigation.

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

(1) Inspection fee one thousand seven hundred fifty dollars;

(2) Complaint inspection six hundred fifty dollars;

(3) Follow-up inspection six hundred fifty dollars; and

(4) Desk audit or compliance review inspection fee of two hundred fifty dollars.

(G) In charging a HCS a fee under paragraph (F) of this rule the total fees charged to a HCS, for services described in section 3702.11 of the Revised Code, will not exceed five thousand dollars annually.

(H) The director will provide to each HCS a statement of the fee charged under paragraph (F) of this rule which itemizes and totals the costs incurred by the department.

(I) The HCS shall forward the total amount of the fee to the director payable to the "Treasurer, State of Ohio" within fifteen days after receiving a statement of the fee issued under paragraph (H) of this rule.

(J) The director will 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.

Last updated May 15, 2023 at 12:45 AM

Supplemental Information

Authorized By: 3702.11, 3702.13, 3702.31
Amplifies: 3702.12, 3702.13, 3702.14, 3702.141, 3702.15, 3702.16, 3702.18, 3702.19, 3702.20
Five Year Review Date: 5/5/2028
Prior Effective Dates: 5/23/1998, 3/24/2003
Rule 3701-84-07 | Patient care policies.
 

(A) Each 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) Each 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, including do-not-resuscitate orders (DNR); 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.

Last updated May 15, 2023 at 12:45 AM

Supplemental Information

Authorized By: 3702.11, 3702.13
Amplifies: 3702.12, 3702.13, 3702.14, 3702.141, 3702.15, 3702.16, 3702.18, 3702.19, 3702.20
Five Year Review Date: 5/5/2028
Prior Effective Dates: 8/1/2017
Rule 3701-84-08 | General personnel and staffing requirements.
 

(A) Each 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 schedule staff in number and type necessary to meet the needs of its patients in a timely manner. Each HCS shall be responsible for the care provided by the staff and personnel of that HCS.

(B) Each provider of a HCS shall only utilize personnel to provide services who have appropriate training and qualifications for the services that they provide.

(1) Any staff member who functions in a professional capacity is obligated to 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

(2) Each HCS shall have an established system of records necessary for the director to ascertain that all individuals employed at the HCS who function in a professional capacity meet the standards applicable to that profession.

(C) Each HCS shall have a medical director for the HCS. In lieu of the board certification requirements specified in this chapter;

(1) A physician who is board certified by a foreign board and is eligible to take the examination of an American board of medical specialties recognized board or an American osteopathic association board may serve as medical director of an HCS; or

(2) In accordance with rule 3701-84-14 of the Administrative Code, a HCS may request a waiver or variance from the department of health for physicians who are board certified by a foreign board who are not eligible to take the examination of an American board of medical specialties recognized board or an American osteopathic association board.

(D) Each HCS shall develop and follow a tuberculosis control plan based on the provider's assessment of the HCS that is consistent with the United States centers for disease control and prevention (CDC) "Tuberculosis Screening, Testing, and Treatment of U.S. Health Care Personnel: Recommendations from the National Tuberculosis Controllers Association and CDC," MMWR 2019, Rep 2019; 68:439-443. The HCS will retain documentation evidencing compliance with this paragraph and furnish such documentation to the director upon request.

(E) Each 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 HCS, has not demonstrated sufficient knowledge or expertise for the responsibilities of the position.

(F) Each HCS shall provide:

(1) A written job description to each staff member delineating responsibilities;

(2) An ongoing training program for all staff that includes both an initial orientation and continuing training:

(a) Orientation that is appropriate to the tasks that each staff member will be expected to perform; and

(b) Continuing training 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 include information specific to the type of HCS;

(3) An orientation and training for the HCS's equipment, safety guidelines, practices, and policies; and

(4) Documentation of orientation and training documented in each staff member's personnel record.

(G) Each HCS shall develop and implement an ongoing process for ensuring the competence of staff members that includes:

(1) A periodic assessment and re-determination of necessary skill levels identified for the staff member's position; and

(2) At least every thirty-six months, a performance evaluation stating whether each staff member has achieved the skill levels identified for the staff member's position.

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

Last updated May 15, 2023 at 12:45 AM

Supplemental Information

Authorized By: 3702.11, 3702.13
Amplifies: 3702.12, 3702.13, 3702.14, 3702.141, 3702.15, 3702.16, 3702.18, 3702.19, 3702.20
Five Year Review Date: 5/5/2028
Prior Effective Dates: 6/1/2007, 8/1/2017
Rule 3701-84-09 | General service standards.
 

(A) Each HCS shall ensure that 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.

(B) Each HCS shall document all medical services performed in the care of the patient in the patient's medical record.

(C) Each HCS shall provide for the ancillary and support services necessary for the provision of the HCS's services.

(D) Each 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 that are consistent with current infection control guidelines issued by the United States centers for disease control and prevention (CDC) and facilitate the activities associated with the prevention and spread of communicable infectious diseases. Each HCS shall retain documentation evidencing compliance with this paragraph and furnish such documentation upon request. The policies and procedures shall, at a minimum, address:

(1) The utilization of protective clothing and equipment;

(2) The storage, maintenance and distribution of sterile supplies and equipment;

(3) The disposal of biological waste; including blood, body tissue, and fluid in accordance with Ohio law;

(4) Standard precautions/body substance isolation or equivalent; and

(5) Tuberculosis and other airborne diseases.

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

(F) Each 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) Prior to discharge, verbal and written instructions for post-treatment care and procedures for obtaining emergency care.

Last updated May 15, 2023 at 12:45 AM

Supplemental Information

Authorized By: 3702.11; 3702.13
Amplifies: 3702.11, 3702.12, 3702.13, 3702.14, 3702.141, 3702.15, 3702.16, 3702.18, 3702.19, 3702.20
Five Year Review Date: 5/5/2028
Prior Effective Dates: 6/21/2012, 8/1/2017
Rule 3701-84-10 | General building and site requirements.
 

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

(1) Has a certificate of use from a local, certified building department or by the department of commerce as meeting applicable requirements of Chapters 3781., 3783., and 3791. of the Revised Code and any rules adopted under them;

(2) Complies with the Ohio fire code; and

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

(B) Each HCS shall adopt and follow a disaster preparedness plan, including evacuation in the event of a fire or other emergency that includes an annual review of evacuation procedures and practice drills with staff at least once every six months.

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

(D) The 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.

Last updated May 15, 2023 at 12:45 AM

Supplemental Information

Authorized By: 3702.11, 3702.13
Amplifies: 3702.11, 3702.12, 3702.13, 3702.14, 3702.141, 3702.15, 3702.16, 3702.18, 3702.19, 3702.20
Five Year Review Date: 5/5/2028
Prior Effective Dates: 6/21/2012
Rule 3701-84-11 | General medical records requirements.
 

(A) Each HCS shall maintain a legible medical record for each patient that is readily accessible to staff for use throughout the course of the patient's treatment that documents, in a timely manner and in accordance with acceptable standards of practice, the patient's needs, assessments, and services rendered.

(B) Each HCS shall not disclose individual medical records except as authorized by the patient or allowed by state and federal laws and regulations, and the provisions of this chapter.

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

(D) Each HCS shall maintain an adequate medical record keeping system and take appropriate measures to protect medical records against theft, loss, destruction, and unauthorized use.

(E) Each HCS shall have policies and procedures to ensure the confidentiality of patient medical records.

(F) Each HCS shall maintain medical records as necessary to verify the information and reports required by statute or regulation for six years from the date of the patient's discharge.

Last updated May 15, 2023 at 12:45 AM

Supplemental Information

Authorized By: 3702.11, 3702.13
Amplifies: 3702.11, 3702.12, 3702.13, 3702.14, 3702.141, 3702.15, 3702.16, 3702.18, 3702.19, 3702.20
Five Year Review Date: 5/5/2028
Prior Effective Dates: 3/1/1997, 6/21/2012
Rule 3701-84-12 | General quality assessment and performance improvement.
 

(A) Each HCS shall establish a quality assessment and performance improvement program designed to:

(1) Systematically monitor and evaluate the quality of patient care provided;

(2) Pursue opportunities to improve patient care;

(3) Ensure compliance with the applicable quality standards set forth in this chapter; and

(4) Resolve identified problems.

(B) Each HCS shall develop a written plan for each HCS that describes the quality assessment and performance improvement program's objectives, organization, scope, and mechanism for overseeing the effectiveness of monitoring, evaluation, improvement, and problem-solving activities.

(C) The quality assessment and performance improvement program shall do all of the following:

(1) Monitor and evaluate all aspects of care including effectiveness, appropriateness, accessibility, continuity, efficiency, patient outcome, and patient satisfaction;

(2) Establish expectations, develop plans, and implement procedures to assess and improve 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.

Last updated May 15, 2023 at 12:45 AM

Supplemental Information

Authorized By: 3702.11, 3702.13
Amplifies: 3702.11, 3702.12, 3702.13, 3702.14, 3702.141, 3702.15, 3702.16, 3702.18, 3702.19, 3702.20
Five Year Review Date: 5/5/2028
Prior Effective Dates: 3/24/2003, 6/1/2007, 6/21/2012
Rule 3701-84-13 | Complaints.
 

(A) Each HCS shall develop and follow policies and procedures to effectively receive, investigate, and report findings of complaints regarding the quality or appropriateness of services provided by the HCS. The documentation of complaints shall, include the following:

(1) The date the complaint was received;

(2) The identity, if provided, of the complainant;

(3) A description of the complaint;

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

(5) The findings of the investigation; and

(6) The resolution of the complaint.

(B) Each HCS is obligated to post the toll free complaint hotline of the Ohio department of health's complaint unit in a conspicuous place in the HCS.

Last updated May 15, 2023 at 12:45 AM

Supplemental Information

Authorized By: 3702.11, 3702.13
Amplifies: 3702.11, 3702.12, 3702.13, 3702.14, 3702.141, 3702.15, 3702.16, 3702.18, 3702.19, 3702.20
Five Year Review Date: 5/5/2028
Prior Effective Dates: 8/1/2017
Rule 3701-84-14 | Variances; waivers.
 

(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 HCS, the director will grant or deny a variance or waiver by written response within forty-five days of receipt of the request and all information determined necessary by the director to make a decision. In granting a variance or waiver, the director will stipulate a time period for which the variance or waiver is to be effective and establish conditions that the HCS must meet for the variance or waiver to be operative. The director may grant:

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

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

(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 will be considered on a case-by-case basis.

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

(1) A request for reconsideration must be received in writing by the director within thirty days of receipt of the director's denial of a waiver or variance request and include information that:

(a) Presents significant, relevant information that was not previously submitted to the director by the HCS, because it was not available to the HCS at the time the waiver or variance request was filed; or

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

(2) A decision on an appropriately filed request for reconsideration will 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.

(3) 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) Each new 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.

Last updated May 15, 2023 at 12:45 AM

Supplemental Information

Authorized By: 3702.11, 3702.13
Amplifies: 3702.11, 3702.12, 3702.13, 3702.14, 3702.141, 3702.15, 3702.16, 3702.18, 3702.19, 3702.20
Five Year Review Date: 5/5/2028
Prior Effective Dates: 3/1/1997, 6/21/2012, 8/1/2017
Rule 3701-84-16 | Solid organ transplant service standards.
 

(A) Each solid organ transplant service will provide services in a manner that meets or exceeds the conditions of participation set forth in Title 42 CFR Part 482, 482.72 to 482.104.

(B) Each solid organ transplant service must be located in a transplant hospital that is a member of and abides by the rules and requirements of the organ procurement and transplantation network (OPTN) established and operated in accordance with section 372 of the Public Health Service (PHS) Act, 42 U.S.C. 274, (November 21, 2013).

(C) Each solid organ transplant service will:

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

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

(3) Ensure that kidney transplant services are a member of the appropriate end-stage renal disease coordinating council designated for the medicare program under 42 C.F.R. 405.2110 (August 26, 1986);

(4) Develop a procedure to evaluate access for the uninsured or financially indigent patientl; and

(5) Have written patient management policies and protocols for organ transplantation, including:

(a) Detailed plans for the acute and long-term management of each transplant patient by a multidisciplinary care team, including the waiting period, in-hospital phase, and immediate post-discharge period;

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

(c) Appropriate and thorough education of the patient;

(d) Liaison with the patient's primary care physician to provide timely notification of changes in the patient's condition; and

(e) If the solid organ transplant service performs living donor transplants, detailed plans for the donor, that include the evaluation, donation, and discharge phases of living organ donation.

Last updated May 15, 2023 at 12:45 AM

Supplemental Information

Authorized By: 3702.11, 3702.13
Amplifies: 3702.11, 3702.12, 3702.13, 3702.14, 3702.141, 3702.15, 3702.16, 3702.18, 3702.19, 3702.20
Five Year Review Date: 5/5/2028
Prior Effective Dates: 3/1/1997
Rule 3701-84-20 | Patient selection criteria.
 

(A) An extra-renal, solid organ transplant service must use written patient selection criteria in determining a patient's suitability for placement on the waiting list or a patient's suitability for transplantation.

(B) Patient selection criteria must comply with the organ procurement and transplantation network (OPTN) organ allocation priorities and be based on objective medical criteria.

(C) Patient selection criteria must include a psychosocial evaluation.

(D) Patient selection criteria must ensure a fair non-discriminatory distribution of organs and be in compliance with centers for medicare and medicaid services (CMS) and OPTN oversight.

(E) Documentation of the patient selection criteria utilized must be included in the patient's medical record.

Last updated May 15, 2023 at 12:45 AM

Supplemental Information

Authorized By: 3702.11, 3702.13
Amplifies: 3702.11, 3702.12, 3702.13, 3702.14, 3702.141, 3702.15, 3702.16, 3702.18, 3702.19, 3702.20
Five Year Review Date: 5/5/2028
Prior Effective Dates: 5/20/2004, 6/21/2012
Rule 3701-84-21 | Utilization levels - solid organ transplant services.
 

(A) Each solid organ transplant service designated as an adult or combined adult/ pediatric transplant service performing surgeries in a single hospital or university multi-hospital transplant service, should achieve volume goals consistent with Title 42 CFR 482.80 and 482.82 to ensure efficiency and a minimum floor of competency:

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

(C) The following solid organ transplant services are not subject to volume goals:

(1) Heart-lung;

(2) Intestinal;

(3) Pancreas; and

(4) Pediatric.

Last updated May 15, 2023 at 12:45 AM

Supplemental Information

Authorized By: 3702.11, 3702.13
Amplifies: 3702.11, 3702.12, 3702.13, 3702.14, 3702.141, 3702.15, 3702.16, 3702.18, 3702.19, 3702.20
Five Year Review Date: 5/5/2028
Prior Effective Dates: 6/1/2007, 5/15/2008
Rule 3701-84-24 | Bone marrow transplantation service standards.
 

(A) The provisions of rules 3701-84-24 to 3701-84-27 of the Administrative Code are applicable to each blood and bone marrow transplant service regardless of the date service was initiated.

(B) Each blood and bone marrow transplantation service will be located in a hospital classified as a general hospital, a children's hospital or as a specialty hospital that primarily furnishes oncology services that meets all of the following criteria:

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

(a) Use of uniform patient treatment protocols;

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

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

(2) Meets the following administrative requirements:

(a) Appropriate patient management plans and protocols consistent with nationally accepted standards, including:

(i) Patient selection criteria;

(ii) Plans for long-term management;

(iii) Protocols to address the prevention of opportunistic infections among blood and bone marrow transplant recipients; and

(iv) Protocols for liaising with the patient's family and primary care physician.

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

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

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

(C) Prior to initiating transplantation services, the blood and bone marrow transplantation service will specify to the director:

(1) The type of patient population to be served:

(a) Pediatric patients aged seventeen years or younger;

(b) Adult patients aged eighteen or older.

A blood and bone marrow transplantation service may serve patients greater than or equal to eighteen years of age as a pediatric or an adult patient, whichever best serves the needs of the patient, as determined by the transplant physician and transplant service's medical director;

(2) The type of transplantation service:

(a) Autologous;

(b) Allogeneic; or

(c) Both.

Last updated May 15, 2023 at 12:45 AM

Supplemental Information

Authorized By: 3702.11, 3702.13
Amplifies: 3702.11, 3702.12, 3702.13, 3702.14, 3702.141, 3702.15, 3702.16, 3702.18, 3702.19, 3702.20
Five Year Review Date: 5/5/2028
Prior Effective Dates: 3/1/1997
Rule 3701-84-25 | Personnel/staffing - bone marrow transplantation service.
 

Each blood and bone marrow transplant service will meet the following staffing criteria:

(A) A medical director responsible for the oversight of the care provided on the unit who actively performs blood and bone marrow transplant services as part of that transplant service and who is:

(1) Board-certified in hematology, oncology, immunology, or pediatric hematology/oncology or have documented experience in the field of hematopoietic progenitor cell (HPC) transplantation extending over ten years;

(2) An active physician on staff at the hospital providing the blood or bone marrow transplant who is involved in direct patient care; and

(3) Has a minimum of one year clinical blood and bone marrow transplantation training at a transplant center in the United States formally recognized as a blood and bone marrow transplant center by at least one of the following:

(a) A national cooperative chemotherapy group;

(b) The national bone marrow donor program; or

(c) A national institute of health-supported blood and bone marrow transplant research program.

(B) At a minimum, one other primary transplantation physician actively participating in the service.

(C) A nursing team that, in order to ensure adequate continuity of care, is committed to the transplant service on a full-time basis and has the training and skills commensurate with the required tasks performed.

(D) The care of blood and bone marrow transplant patients will be coordinated by a multidisciplinary team whose members have training and skills commensurate with the required tasks performed.

Last updated May 15, 2023 at 12:45 AM

Supplemental Information

Authorized By: 3702.11, 3702.13
Amplifies: 3702.11, 3702.12, 3702.13, 3702.14, 3702.141, 3702.15, 3702.16, 3702.18, 3702.19, 3702.20
Five Year Review Date: 5/5/2028
Prior Effective Dates: 8/1/2017
Rule 3701-84-26 | Facilities/safety standards - bone marrow transplantation service.
 

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

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

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

(3) Laboratories;

(4) Adequate intensive care facilities;

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

(6) Radiologic services including, but not limited to, tomography, computed tomography (CT) scans and/or magnetic resonance imaging (MRI) scans;

(7) Radionuclide scans and ultrasonography;

(8) Immunopathology and hepatopathology;

(9) Histopathology;

(10) Microbiology laboratory;

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

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

(13) Modern radiotherapy capabilities including the ability to provide total body irradiation either on-site or through agreement or contract with another hospital;

(14) Operating room facilities; and

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

(B) Each blood and bone marrow transplant service will have the following readily available:

(1) Tissue-typing laboratory;

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

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

Last updated May 15, 2023 at 12:45 AM

Supplemental Information

Authorized By: 3702.11, 3702.13
Amplifies: 3702.11, 3702.12, 3702.13, 3702.14, 3702.141, 3702.15, 3702.16, 3702.18, 3702.19, 3702.20
Five Year Review Date: 5/5/2028
Prior Effective Dates: 6/21/2012
Rule 3701-84-27 | Patient selection/utilization - blood and bone marrow transplantation service.
 

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

(B) If a transplantation service desires to perform a transplant on a patient who does not meet the selection protocols set forth in appendix A to this rule, the service is obligated to undertake a thorough review of the case, conducted by a blood and bone marrow transplant team comprised of members of the service's ethics, legal, and medical staff, to determine that the transplant is appropriate and include:

(1) Preparation of a detailed clinical summary of the patient that includes:

(a) A brief medical history;

(b) Complete laboratory data related to the diagnosis;

(c) A thorough psychosocial evaluation that includes:

(i) The identification of the patient's support system, including potential caregivers;

(ii) Identification of psychosocial barriers;

(iii) Identification of potential barriers and challenges of the transplant; and

(iv) The patient's attitude toward the transplant, the patient's understanding of the transplant, and the patient's understanding of the treatment, including whether the intention is to be palliative or curative.

(d) A justification of the transplant despite failure to meet the selection criteria; and

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

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

(1) Adult blood and bone marrow transplantation service performing transplants at a single clinical site:

(a) Autologous only transplantation services should perform an average of at least five autologous transplants per year; or

(b) Combined autologous and allogeneic services should perform an average of at least ten allogeneic transplants per year.

(2) Adult blood and bone marrow transplantation service performing transplants at multiple clinical sites:

(a) Autologous only transplantation services should perform an average of at least five autologous transplants per year at each site; or

(b) Combined autologous and allogeneic transplantation services should perform an average of at least five autologous and five allogeneic transplants per year at each site.

(3) Pediatric blood and bone marrow transplantation service performing transplants at a single clinical site: or

(a) Autologous only transplantation services should perform an average of at least five autologous transplants per year; or

(b) Combined autologous and allogeneic services should perform an average of at least five allogeneic and five autologous transplants per year.

(4) Pediatric blood and bone marrow transplantation service performing transplants at multiple clinical sites:

(a) Autologous only transplantation services should perform an average of at least five autologous transplants per year at each site; or

(b) Combined autologous and allogeneic transplantation services should perform an average of at least five autologous transplants per year at each site.

(5) Combined adult and pediatric blood and bone marrow transplantation services performing transplants at a single clinical site:

(a) Autologous only transplantation services should perform an average of at least five pediatric autologous transplants and five adult autologous transplants per year; or

(b) Combined autologous and allogeneic services should perform an average of at least five pediatric allogeneic transplants and five adult allogeneic transplants per year.

(6) Combined adult and pediatric blood and bone marrow transplantation services performing transplants at multiple clinical sites:

(a) Autologous only transplantation services should perform an average of at least five autologous transplants per year at each site; or

(b) Combined autologous and allogeneic transplantation services should perform an average of at least five pediatric and five adult autologous transplants per year and and at least five pediatric allogeneic and five adult allogeneic transplants per year at each site.

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

View Appendix

Last updated May 15, 2023 at 12:45 AM

Supplemental Information

Authorized By: 3702.11, 3702.13
Amplifies: 3702.11, 3702.12, 3702.13, 3702.14, 3702.14, 3702.141, 3702.15, 3702.16, 3702.18, 3702.19, 3702.20
Five Year Review Date: 5/5/2028
Prior Effective Dates: 6/21/2012, 8/1/2017, 1/20/2020
Rule 3701-84-30 | General adult cardiac catheterization service standards.
 

(A) The provisions of rules 3701-84-30 to 3701-84-34.2 of the Administrative Code are applicable to each provider of cardiac catheterization services performing procedures on adult patients greater than or equal to eighteen years of age. An adult cardiac catheterization service may serve a patient less than eighteen years of age if the patient's attending physician and the adult service's medical director determine that the adult service best serves the needs of the patient.

(B) Each provider of cardiac catheterization services shall:

(1) Designate in writing to the director the service level classification, as defined in this chapter, it provides or intends to provide;

(2) Designate in writing to the director the scope of services, including the number of procedure and control rooms, provided within the service level classification;

(3) Meet the requirements of this chapter for the service level classification designated; and

(4) Not hold itself out to any person or government entity by means of signage, advertising, or other promotional efforts as having a service level classification for which it is not designated.

(C) Each provider of cardiac catheterization services shall have an established written protocol for the emergency transfer and care of patients who require emergency medical/surgical management during or immediately after cardiac catheterization.

(D) Each provider of cardiac catheterization services 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 will be available within a reasonable amount of time to meet the needs of the service.

(E) Each provider of cardiac catheterization services shall establish and maintain a quality assessment review process, including methodology, for reviewing the quality of cardiac catheterization procedures performed by each physician credentialed to perform such procedures. The review methodology will, at a minimum, assess the following:

(1) Appropriateness of cardiac catheterization studies and interventions;

(2) Technical quality of cardiac catheterization studies;

(3) Procedure result;

(4) Rate of therapeutic success; and

(5) Rate of procedural complications.

(F) Each provider of cardiac catheterization services shall have explicit criteria based upon current recommendations of recognized professional societies and accrediting bodies, specifying the number of times a year an appropriately privileged physician shall perform each catheterization procedure in order to retain privileges to perform that procedure.

(G) Each provider of cardiac catheterization services shall conduct an ongoing review of all cases with mortality or significant morbidity within sixty days of the procedure.

(H) Each provider of cardiac catheterization services shall establish and maintain a database to support the review process detailed in paragraph (E) of this rule. The results of analysis and review will be documented and used to guide periodic random and selected peer reviews of individual physicians with respect to maintaining their credentials to perform specific cardiac catheterization procedures.

(I) Adult cardiac catheterization service will only be provided in a fully permanent setting within the permanent frame of the building of a 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 will:

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

(2) Operate an intensive/critical care unit with registered special care beds, that is:

(a) Reviewed and accredited or certified as such as part of the hospital's accreditation or certification program in the same building;

(b) Accessible by gurney from the cardiac catheterization laboratory; and

(c) The unit will provide appropriate equipment and staff to care for coronary patients and have twenty-four hour monitoring capability.

(3) Provide a setting in the same building as the adult cardiac catheterization laboratory in which ambulatory cardiac catheterization patients can be observed for at least two to six hours after the procedure depending on the access site and the nursing assessment of the patient; and

(4) Provide adequate physician coverage to manage post-procedure complications.

(J) For the purpose of rules 3701-84-30 to 3701-84-34.2 of the Administrative Code the following references are defined and all documents are available at www.acc.org:

(1) "2012 expert consensus document" means 2012 American college of cardiology foundation/society for cardiovascular angiography and interventions expert consensus document on cardiac catheterization laboratory standards update (June 12, 2012);

(2) "2014 expert consensus document" means the 2014 society for cardiovascular angiography and interventions/American college of cardiology/American heart association expert consensus document update on percutaneous coronary intervention without on-site surgical backup (June 17, 2014);

(3) "Table 2: support services" means 2012 American college of cardiology foundation/society for cardiovascular angiography and interventions expert consensus document on cardiac catheterization laboratory standards update, table 2: optimal (recommended) on-site support services for invasive cardiac procedures (June 12, 2012).

(4) "Table 3: facility requirements" means 2014 Society for cardiovascular angiography and interventions/American college of cardiology/American heart association expert consensus document update on percutaneous coronary intervention without on-site surgical backup, table 3: facility requirements for percutaneous coronary intervention programs without on-site surgery (June 17, 2014);

(5) "Table 4: personnel recommendations" means 2014 society for cardiovascular angiography and interventions/American college of cardiology/American heart association expert consensus document update on percutaneous coronary intervention without on-site surgical backup, table 4: personnel recommendations (June 17, 2014);

(6) "Table 5: general exclusion criteria" means the 2012 American college of cardiology foundation/society for cardiovascular angiography and interventions expert consensus document on cardiac catheterization laboratory standards update, table 5: general exclusion criteria for invasive cardiac procedures in a setting without cardiothoracic surgery (June 12, 2012);

(7) "Table 5: recommendations for off-site surgical backup and case selection" means the 2014 Society for cardiovascular angiography and interventions/American college of cardiology/American heart association expert consensus document update on percutaneous coronary intervention without on-site surgical backup, table 5: recommendations for off-site surgical backup and case selection (June 17, 2014); and

(8) "Table 6: patient and lesion characteristics" means the 2014 Society for cardiovascular angiography and interventions/American college of cardiology/American heart association expert consensus document update on percutaneous coronary intervention without on-site surgical backup, table 6: patient and lesion characteristics that could be unsuitable for nonemergency procedures at facilities without an on-site cardiac surgery (June 17, 2014);

(K) For the purpose of rules 3701-84-30 to 3701-84-34.2 of the Administrative Code, major bleeding is defined as:

(1) Bleeding event within seventy two hours;

(2) Hemorrhagic stroke;

(3) Tamponade;

(4) Post-PCI transfusion for patients with a pre-procedure hemoglobin >8 g/dL; or

(5) Absolute hemoglobin decrease from pre-PCI to post-PCI of >= 3 g/dl and pre- procedure hemoglobin=<16 g/dL.

Last updated May 15, 2023 at 12:45 AM

Supplemental Information

Authorized By: 3702.11, 3702.13
Amplifies: 3702.14, 3702.141, 3702.15, 3702.16, 3702.18
Five Year Review Date: 5/5/2028
Prior Effective Dates: 6/21/2012, 4/30/2016
Rule 3701-84-30.1 | Level I cardiac catheterization service standards.
 

(A) Level I cardiac catheterization service or "level I service" means an adult cardiac catheterization service located in a hospital without an on-site open heart surgery service that provides only diagnostic cardiac catheterization procedures on an organized regular basis.

(B) Each level I service shall perform only diagnostic cardiac catheterization procedures to diagnose anatomical and/or physiological problems in the heart. Diagnostic cardiac catheterization procedures include:

(1) Intracoronary administration of drugs;

(2) Left heart catheterization;

(3) Right heart catheterization;

(4) Coronary angiography;

(5) Basic diagnostic electrophysiology studies not involving transseptal puncture;

(6) Intra-aortic balloon pump or, if required for patient stabilization for transfer, placement of percutaneous left ventricular assist device; and

(7) Device implantation, including, but not limited to defibrillators.

(C) Each level I service will implement patient exclusion criteria consistent with the 2012 table 5: general exclusion criteria.

(D) Each level I service will comply with the personnel and staffing requirements set forth in rule 3701-84-31 of the Administrative Code.

(E) Each level I service will comply with the facilities, equipment, and supplies requirements set forth in rule 3701-84-32 of the Administrative Code.

(F) Each level I service will comply with the safety standards set forth in rule 3701-84-33 of the Administrative Code.

(G) Each level I service shall maintain a formal written transfer protocol for emergency medical/surgical management with a registered hospital that provides open heart surgery services, which can be reached expeditiously from the level I service by available emergency vehicle within a reasonable amount of time and that provides the greatest assurance for patient safety. The open heart surgery service that is party to a transfer protocol is referred to as the receiving service. Each protocol shall include, but not be limited to:

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

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

(3) Assurance that surgical back-up is available for urgent cases at all hours;

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

(5) Provisions for collaborative training programs among staff of the services party to the agreement, including the cardiologists from the level I service and the cardiologist/cardiothoracic surgeon from the receiving service;

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

(7) Provisions for annual drilling activities to review and test the components of the written transfer protocol. An actual emergent patient transfer consistent with the written transfer protocol within the calendar year meets the requirement for an annual drill.

(H) Major complications and emergency transfers should be reviewed at least once every sixty days by the quality assessment review process required in paragraph (E) of rule 3701-84-30 of the Administrative Code and rule 3701-84-12 of the Administrative Code.

(I) Reporting:

(1) Beginning January 1, 2023, and ending on December 31, 2024, each level I services will submit the following information to the department by March first of each year that;

(a) Maintains patient confidentiality;

(b) Includes the numbers for the following:

(i) Diagnostic cardiac catheterization and electrophysiology studies as provided in paragraphs (B)(1) to (B)(7) conducted in a cardiac catheterization procedure room;

(ii) Diagnostic electrophysiology studies conducted in an electrophysiology procedure room;

(iii) Post-procedure in-hospital mortality number;

(iv) Vascular access injury requiring surgery or other intervention;

(v) Major bleeding as defined in paragraph (K) of rule 3701-84-30 of the Administrative Code;

(vi) Emergent transfers to the receiving service for interventional medical management, that became necessary as a result of the cardiac catheterization or electrophysiology study during or immediately after the cardiac catheterization or electrophysiology study: and

(vii) Emergency PCI procedures performed when clinically indicated and reported to the department in accordance with paragraph (L) of this rule.

(2) Beginning January 1, 2025, each level I service will submit the following information to the department by March first of each year as part of the hospital's annual report that:

(a) Maintains patient confidentiality;

(b) Includes the numbers for the following;

(i) Diagnostic catheterization and electrophysiology studies as provided in paragraphs (B)(1) to (B)(7) conducted in a cardiac catheterization procedure room;

(ii) Diagnostic electrophysiology studies conducted in an electrophysiology procedure room;

(iii) Post-procedure in-hospital mortality number;

(iv) Vascular access injury requiring surgery or other intervention;

(v) Major bleeding as defined in paragraph (K) of rule 3701-84-30 of the Administrative Code;

(vi) Emergent transfers to the receiving service for interventional medical management, that became necessary as a result of the cardiac catheterization or electrophysiology study during or immediately after the cardiac catheterization or electrophysiology study: and

(vii) Emergency PCI procedures performed when clinically indicated and reported to the department in accordance with paragraph (L) of this rule.

(J) Prior to performance of a diagnostic procedure, each level I service shall obtain a signed informed consent form that includes an acknowledgment by the patient that the diagnostic procedure is being performed in a cardiac catheterization service without an on-site open heart surgery service and an acknowledgment that, if necessary as the result of an adverse event, the patient may be transferred to a receiving service for medical/surgical management.

(K) Nothing in this rule shall prohibit the provision of emergency care, including emergent PCI, when clinically indicated. The service shall provide notice to the department within forty-eight hours of any incident requiring action outside the scope of services authorized to be performed at the level I designation and ensure the notification:

(1) Maintains patient confidentiality;

(2) Indicates when the incident occurred;

(3) Describes the nature of the emergency and what actions were taken; and

(4) Includes the outcome.

Last updated May 15, 2023 at 12:45 AM

Supplemental Information

Authorized By: 3702.11, 3702.13
Amplifies: 3702.14, 3702.141, 3702.15, 3702.16, 3702.18
Five Year Review Date: 5/5/2028
Prior Effective Dates: 6/17/1999, 5/15/2008
Rule 3701-84-30.2 | Level II cardiac catheterization service standards.
 

(A) Level II cardiac catheterization service or "level II service" means an adult cardiac catheterization service located in a hospital without an on-site open heart surgery service that provides only diagnostic and authorized therapeutic cardiac catheterization procedures on an organized and regular basis.

(B) Level II services are prohibited from providing the following procedures:

(1) Transcatheter aortic valve replacement (TAVR);

(2) Revascularization of chronic total occlusion (CTO);

(3) Rotational coronary artherectomy;

(4) Alcohol septal ablation;

(5) Cardiac biopsy;

(6) Mitral valve clip;

(7) Transcatheter mitral valve (TMV) repair or replacement;

(8) Laser lead extraction;

(9) Atrial septal defect (ASD), patent foramen ovale (PFO), and ventricular septal defect (VSD) closure;

(10) Balloon aortic valvuloplasty;

(11) PCI of last remaining coronary artery;

(12) Left atrial appendage closure;

(13) Ventricular tachycardia ablation;

(14) Lead extractions; and

(15) Multivessel PCI in the setting of severe left ventricular dysfunction.

(C) Each level II service shall have provided at least one year of service performing diagnostic cardiac catheterizations prior to providing notice to the director of their intent to provide level II services. Accelerated designation may be granted to a service on a case-by-case basis by the director and not be construed as constituting precedent for the granting of an accelerated designation for any other service provider.

(D) Level II services shall:

(1) Implement patient screening criteria consistent with the 2014 expert consensus document:

(a) Table 5: recommendations for off-site surgical backup and case selection; and

(b) Table 6: patient and lesion characteristics.

(2) Ensure that the medical director for the level II service monitors and ensures strict adherence to the patient selection criteria and treatment protocols.

(E) In addition to the general personnel and staffing requirements set forth in rule 3701-84-31 of the Administrative Code, each level II service will:

(1) Provide nursing and laboratory staff consistent with the 2014 expert consensus document, table 4: personnel recommendations; and

(2) Maintain personnel capable of endotracheal intubation and ventilator management within their scope of practice, both on-site and during transfer of the patient if necessary.

(F) In addition to the general facilities, equipment, and supplies requirements set forth in rule 3701-84-32 of the Administrative Code, each level II service will have, at a minimum, equipment consistent with the 2014 expert consensus document, table 3: facility requirements.

(G) Each level II service shall comply with the safety standards set forth in rule 3701-84-33 of the Administrative Code.

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

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

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

(3) Assurance that surgical back-up is available for urgent cases during all hours of operation;

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

(5) Provisions for a collaborative training program among the staff of the services party to the agreement, including the cardiologists from the level II service and the cardiologist/cardiothoracic surgeon from the receiving service;

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

(7) Provisions for annual drilling activities to review and test the components of the written transfer protocol. An actual emergent patient transfer consistent with the written transfer protocol within the calendar year meets the requirement for an annual drill.

(I) Each level II service shall maintain a formal written agreement with a ground and/or air ambulance service that can commit to on-site availability within thirty minutes of notification and is capable of advanced cardiac life support and intra-aortic balloon pump transfer of a patient to the hospital party to the written transfer protocol required by paragraph (I) of this rule. Ground and/or air ambulance service agreements should be consistent with the recommendations set forth in the 2014 expert consensus document, table 3: facility requirements.

(J) Major complications and emergency transfers should be reviewed at least once every sixty days by the quality assessment review process required in paragraph (E) of rule 3701-84-30 of the Administrative Code and rule 3701-84-12 of the Administrative Code.

(K) Each level II service will obtain enrollment and maintain participation in a data registry to monitor operator and institutional volumes and outcomes.

(L) Reporting:

(1) Beginning January 1, 2023 and ending December 31, 2024, each level II service shall submit an annual report to the department by March first of each year that;

(a) Maintains patient confidentiality;

(b) Includes the numbers for the following:

(i) Cardiac catheterization procedures and electrophysiology studies or procedures conducted in a cardiac catheterization procedure room;

(ii) Electrophysiology studies or procedures conducted in an electrophysiology procedure room;

(iii) Elective PCI;

(iv) Primary PCI;

(v) Post-procedure in-hospital mortality number;

(vi) Vascular access injury requiring surgery or other intervention;

(vii) Major bleeding as defined in paragraph (K) of rule 3701-84-30 of the Administrative Code.

(viii) Emergent transfers to the receiving service for interventional medical management, that became necessary as a result of the cardiac catheterization procedure or electrophysiology study or procedure during or immediately after a cardiac catheterization procedure or an electrophysiology study or procedure: and

(ix) Emergency PCI procedures performed when clinically indicated and reported to the department in accordance with paragraph (N) of this rule.

(2) Beginning January 1, 2025, each level III service shall submit the following information to the department by March first of each year as part of the hospital's annual report that:

(a) Maintains patient confidentiality;

(b) Includes the numbers for the following:

(i) Cardiac catheterization procedures and electrophysiology studies or procedures conducted in a cardiac catheterization procedure room;

(ii) Electrophysiology studies or procedures conducted in an electrophysiology procedure room;

(iii) Elective PCI;

(iv) Primary PCI;

(v) Post-procedure in-hospital mortality number;

(vi) Vascular access injury requiring surgery or other intervention;

(vii) Major bleeding as defined in paragraph (K) of rule 3701-84-30 of the Administrative Code.

(viii) Emergent transfers to the receiving service for interventional medical management, that became necessary as a result of the cardiac catheterization procedure or electrophysiology study or procedure during or immediately after a cardiac catheterization procedure or electrophysiology study or procedure: and

(ix) Emergency PCI procedures performed when clinically indicated and reported to the department in accordance with paragraph (N) of this rule.

(M) Prior to the performance of any procedure, each level II service shall obtain a signed informed consent form from each patient prior to performance of any procedure that includes an acknowledgment by the patient that the procedure is being performed in a cardiac catheterization service without an on-site open heart surgery service and an acknowledgment that, if necessary as the result of an adverse event, the patient may be transferred to a receiving service for medical/surgical management.

(N) Nothing in this rule shall prohibit the provision of emergency care, including emergent PCI, when clinically indicated. The service shall provide notice to the department within forty-eight hours of any incident requiring action outside the scope of services authorized to be performed at the level II designation and ensure the notification:

(1) Maintains patient confidentiality;

(2) Indicates when the incident occurred;

(3) Describes the nature of the emergency and what actions were taken; and

(4) Includes the outcome.

Last updated May 15, 2023 at 12:45 AM

Supplemental Information

Authorized By: 3702.11, 3702.13
Amplifies: 3702.14, 3702.141, 3702.15, 3702.16, 3702.18
Five Year Review Date: 5/5/2028
Prior Effective Dates: 3/20/1997, 6/21/2012
Rule 3701-84-30.3 | Level III adult cardiac catheterization service standards.
 

(A) Level III cardiac catheterization service or "level III service" means an adult cardiac catheterization service located in a hospital with an on-site open heart surgery service that provides all levels of diagnostic and therapeutic cardiac catheterization procedures.

(B) Each level III service shall operate on an organized, regular, twenty-four hour a day, seven days a week basis to perform primary PCI.

(C) Each level III service shall have provided at least one year of service performing diagnostic cardiac catheterizations prior to providing notice to the director of their intent to provide level III services. Accelerated designation may be granted to a service on a case-by-case basis by the director and not be construed as constituting precedent for the granting of an accelerated designation for any other service.

(D) Each level III service shall have the following:

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

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

(3) Support services consistent with the 2012 expert consensus document, table 2: support services.

(E) Each level III service will comply with the personnel and staffing requirements set forth in rule 3701-84-31 of the Administrative Code.

(F) In addition to the general facilities, equipment, and supplies requirements set forth in rule 3701-84-32 of the Administrative Code, each level III service, will have:

(1) One or more surgical suites that are equipped to accommodate thoracic and cardiac surgical procedures requiring cardiopulmonary bypass, with appropriate staff available in less than sixty minutes; and

(2) At a minimum, equipment consistent with the 2014 expert consensus document, table: 3 facility requirements.

(G) Each level III service will comply with the safety standards set forth in rule 3701-84-33 of the Administrative Code.

(H) Major complications and emergency transfers should be reviewed at least once every sixty days by the quality assessment review process required in paragraph (E) of rule 3701-84-30 of the Administrative Code and rule 3701-84-12 of the Administrative Code.

(I) Each level III service will obtain enrollment and maintain participation in a data registry to monitor operator and institutional volumes, outcomes, and procedural appropriateness.

(J) Reporting:

(1) Beginning January 1, 2023, and ending on December 31, 2024, each level III services will submit an annual report to the department by March first of each year that:

(a) Maintains patient confidentiality;

(b) Includes the numbers for the following:

(i) Cardiac catheterization procedures and electrophysiology studies or procedures conducted in a cardiac catheterization procedure room;

(ii) Electrophysiology studies or procedures conducted in an electrophysiology procedure room;

(iii) Elective PCI;

(iv) Primary PCI;

(v) Post-procedure in-hospital mortality number;

(vi) Vascular access injury requiring surgery or other intervention; and

(vii) Major bleeding as defined in paragraph (K) of rule 3701-84-30 of the Administrative Code.

(2) Beginning January 1, 2025, each level III service will submit the following information to the department by March first of each year as part of the hospital's annual report that:

(a) Maintains patient confidentiality;

(b) Includes the number of procedures performed in the following categories:

(i) Cardiac catheterization procedures and electrophysiology studies or procedures conducted in a cardiac catheterization procedure room;

(ii) Electrophysiology studies or procedures conducted in an electrophysiology procedure room;

(iii) Elective PCI;

(iv) Primary PCI;

(v) Post-procedure in-hospital mortality number;

(vi) Vascular access injury requiring surgery or other intervention; and

(vii) Major bleeding as defined in paragraph (K) of rule 3701-84-30 of the Administrative Code.

(K) Each level III service shall obtain a signed informed consent from each patient prior to the performance of any procedure.

Last updated May 15, 2023 at 12:45 AM

Supplemental Information

Authorized By: 3702.11, 3702.13
Amplifies: 3702.14, 3702.141, 3702.15, 3702.16, 3702.18
Five Year Review Date: 5/5/2028
Prior Effective Dates: 3/20/1997, 5/15/2008, 11/10/2008, 6/21/2012
Rule 3701-84-30.4 | Adult electrophysiology procedure rooms.
 

(A) Adult electrophysiology studies may be conducted in any level adult cardiac catheterization laboratory or an electrophysiology procedure room.

(B) Procedure rooms where adult electrophysiology studies are conducted will:

(1) Have a minimum floor area of three hundred fifty square feet.

(2) Have the following minimum clearances:

(a) Sufficient footage on each side of the procedure table to ensure that movement around and in the sterile field does not compromise or contaminate the sterile field; and

(b) Clearance at the head of the bed should be allocated for anesthesia equipment on either side and sterile access to jugular vein entry sites, if employed, while allowing for free range of movement of a fluoroscopy C-arm.

(3) Hybrid procedure rooms where adult electrophysiology studies are conducted will meet the minimum clear floor area and clearances of paragraphs (B)(1) and (B)(2) of this rule and include at least the additional minimum clear floor area, clearances, and storage requirements for the imaging equipment contained in the room.

(4) Provide the following:

(a) Positive airflow;

(b) High flow oxygen and vacuum for suctioning;

(c) Medical gas availability;

(d) Substerile scrub area; and

(e) A patient post-procedural care area.

(5) Provide adequate utilities based upon the types of procedures and workload, including:

(a) Water taps;

(b) Overhead and task lighting will be adequate to perform electrophysiology procedures and for clinical evaluation and treatment of the patient and include:

(i) Overhead lighting will be able to be dimmed during fluoroscopy;

(ii) Lighting to flood the main procedure area; and

(iii) A dedicated workspace light for the nursing/anesthesia area.

(c) Electrical outlets;

(d) Emergency power;

(e) Telephones;

(f) Heating and cooling; and

(g) Ventilation.

(C) The following equipment will be available to each procedure room where adult electrophysiology studies are conducted:

(1) Electrogram recording systems;

(2) Programmed stimulators;

(3) Defibrillator;

(4) Electrocardiogram and hemodynamic monitoring equipment;

(5) Non-invasive blood pressure monitor;

(6) Supplies specific to the procedure being performed;

(7) Emergency equipment and supplies;

(8) If the procedure requires fluoroscopy, radiation shielded barriers that meet state and federal requirements are required; and

(9) When determined necessary, three-dimensional (3D) mapping systems may be provided by a service onsite or through agreement or contract with another hospital.

(D) Electrophysiology study numbers are to be included in each adult cardiac catheterization service's annual report of the number and type of procedures performed.

Last updated May 15, 2023 at 12:45 AM

Supplemental Information

Authorized By: 3702.11, 3702.13
Amplifies: 3702.14, 3702.141, 3702.15, 3702.16, 3702.18
Five Year Review Date: 5/5/2028
Rule 3701-84-31 | General personnel/staffing - adult cardiac catheterization service.
 

(A) Each adult cardiac catheterization service will designate a medical director.

(B) In addition to the requirements of rule 3701-84-08 of the Administrative Code and any requirements of this rule, the medical director of service will:

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

(2) Have performed at least five hundred catheterizations;

(3) Be an active participant in the operation of the cardiac catheterization laboratory by actively performing cardiac catheterization procedures in the cardiac catheterization service where they are the medical director; and

(4) Be responsible for oversight of quality of care provided in the cardiac catheterization laboratory and be an active participant in the cardiac catheterization laboratory's quality assessment review process required by paragraph (E) of rule 3701-84-30 of the Administrative Code.

(C) In addition to the requirements of paragraph (B) of this rule, the medical director of a level II or level III service will:

(1) Be board certified in interventional cardiology; and

(2) Have at least five years experience in interventional cardiology; or

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

(D) Each adult cardiac catheterization service will have at least two licensed physicians credentialed to provide cardiac catheterization services on staff who are knowledgeable of the laboratory's protocols and equipment by providing cardiac catheterization services at the hospital. Only physicians appropriately credentialed to provide cardiac catheterization services may be the primary operator of a cardiac catheterization procedure.

(E) Each adult cardiac catheterization service will consider the American college of cardiology/American heart association/American college of physicians task force 2013 update of clinical competence statement on coronary artery interventional procedures in assessing clinical competency. At a minimum, all physicians who perform cardiac catheterization procedures will:

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

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

(3) Participate in the cardiac catheterization laboratory's quality assurance programs, including peer review.

(F) In addition to requirements contained in paragraph (E) of this rule, physicians performing percutaneous coronary interventions (PCI) who have not performed PCI prior to March 20, 1997 will have completed a fellowship training program in interventional cardiology.

(G) In addition to the requirements of paragraphs (A), (B), and (D) of this rule and the general personnel requirements of paragraph (B) of rule 3701-84-08 of the Administrative Code, the adult cardiac catheterization service will have available a sufficient number of qualified staff who are able to supervise and conduct the service including the following:

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

(a) Digital imaging;

(b) Systematic quality control testing;

(c) Patient observation;

(d) Critical care;

(e) Monitoring and recording electrocardiographic and hemodynamic data;

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

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

(i) Managing blood samples:

(ii) Performing blood gas measurements and calculations; and

(iii) Assisting with indicator dilution studies.

(2) Nursing personnel:

(a) May include nurse practitioners, registered nurses, licensed practical nurses, and nursing assistants;

(b) Nursing personnel involved in the provision of cardiac catheterization services will:

(i) Have knowledge of operating room techniques; and

(ii) Have experience in critical care: or

(iii) The adult cardiac catheterization service must provide nursing personnel with an orientation and training in critical care for the adult cardiac catheterization patient and document the orientation and training in the nurse's personnel record.

(c) Nurse practitioners, registered nurses, and licensed practical nurses involved in the provision of cardiac catheterization services will:

(i) Be advanced cardiac life support certified;

(ii) Have experience in cardiovascular medications; and

(iii) Have the ability to begin administration of intravenous solutions.

(d) Nurse practitioners may assume some of the duties of a physician as permitted by law. However, ultimate responsibility for procedures will always remain with the physician of record.

(H) Respiratory therapists and critical care staff will be immediately available at all times to care for patients.

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

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

Last updated May 15, 2023 at 12:45 AM

Supplemental Information

Authorized By: 3702.11, 3702.13
Amplifies: 3702.14, 3702.141, 3702.15, 3702.16, 3702.18
Five Year Review Date: 5/5/2028
Prior Effective Dates: 3/20/1997
Rule 3701-84-32 | General facilities, equipment, and supplies - adult cardiac catheterization service.
 

(A) Each adult cardiac catheterization service, or "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 service shall utilize the following:

(1) Procedure rooms will:

(a) Have a minimum floor area of four hundred square feet;

(b) Have the following minimum clearances:

(i) If anesthesia is utilized, six feet at the head of the operating table. This dimension will result in an anesthesia work zone with a clear floor area of six feet by eight feet; and

(ii) Sufficient footage on each side of the procedure table to ensure that movement around and in the sterile field does not compromise or contaminate the sterile field.

(c) Procedure rooms utilizing image-guided surgery or procedures requiring more space for personnel or equipment will be sized to accommodate the personnel and equipment planned to be in the room during procedures and have a minimum floor area of six hundred square feet with a minimum clear dimension of twenty feet.

(d) Hybrid procedure rooms will meet the minimum floor area and clearances of paragraphs (B)(1)(a) and (B)(1)(b) of this rule and include at least the additional minimum floor area, clearances, and storage requirements for the imaging equipment contained in the room.

(e) Fixed encroachments into the minimum clear floor area are permitted to be included when determining the minimum clear floor area for a procedure room as long as:

(i) There are no encroachments into the sterile field;

(ii) The encroachments do not extend more than twelve inches into the minimum clear floor area outside the sterile field; and

(iii) The encroachment width along each wall does not exceed ten percent of the length of that wall.

(2) Control rooms, if utilized, will:

(a) Accommodate the imaging system control equipment;

(b) Be sized and configured in compliance with manufacturer recommendations for installation, service, and maintenance;

(c) Have view panels that provide for a view of the patient and the cardiac catheterization team;

(d) Be permitted to serve more than one hybrid procedure room, provided that manufacturer recommendations for installation, service, and maintenance are accommodated for all rooms served; and

(e) Be physically separated from a hybrid procedure room with walls and a door.

(f) A door is not required where a control room serves only one procedure room and is built, maintained, and controlled the same as the procedure room.

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

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

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

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

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

(3) Multimode or cesium iodide image intensifiers;

(4) High-quality matched optics;

(5) Appropriate imaging modality for review and storage of images;

(6) Digital imaging equipment;

(7) Carbon-fiber table tops;

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

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

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

(11) A defibrillator;

(12) A temporary pacemaker; and

(13) An intra-aortic balloon pump or other percutaneous mechanical circulatory assistance device of superior capability.

(E) Each adult cardiac catheterization service will provide and maintain radiation generating equipment in accordance with applicable state and federal requirements as specified in Chapter 3748. of the Revised Code and the rules adopted thereunder.

Last updated May 15, 2023 at 12:45 AM

Supplemental Information

Authorized By: 3702.11, 3702.13
Amplifies: 3702.14, 3702.141, 3702.15, 3702.16, 3702.18
Five Year Review Date: 5/5/2028
Prior Effective Dates: 3/24/2003, 5/15/2008, 4/30/2016
Rule 3701-84-33 | Safety standards - adult cardiac catheterization service.
 

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

(B) Each service will establish, maintain and follow electrical safety policies that, at a minimum, include:

(1) A safe primary electrical wiring system;

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

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

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

(C) Each service will periodically survey all of the equipment utilized by the service and perform preventive maintenance on a schedule that, at a minimum, conforms to manufacturers' recommendations. Results of surveillance and preventive maintenance activities will be internally documented.

Last updated May 15, 2023 at 12:45 AM

Supplemental Information

Authorized By: 3702.11, 3702.13
Amplifies: 3702.14, 3702.141, 3702.15, 3702.16, 3702.18
Five Year Review Date: 5/5/2028
Rule 3701-84-34 | Adult cardiac catheterization service performance measures.
 

(A) Each adult cardiac catheterization service should maintain a volume of cardiac catheterization procedures sufficient to ensure the safety and quality of procedures performed at the service and individual cardiologist proficiency.

(B) No minimum cardiologist volume is recommended, however, the combination of high mortality and low volume will trigger a thorough internal review of an individual physician by the adult cardiac catheterization service.

(C) Volume may be considered by the director in conjunction with other indicators of quality and not as the sole indicator of service performance. An adult cardiac catheterization service with significant rates of in hospital complications, emergent transfers, or mortality may be subject to an independent third party review, including individual case review, by a third party approved by the director. The service will be responsible for:

(1) Providing a copy of the review to the director; and

(2) Payment of any fees associated with the independent third party review to the provider of the review.

Last updated May 15, 2023 at 12:45 AM

Supplemental Information

Authorized By: 3702.11, 3702.13
Amplifies: 3702.14, 3702.141, 3702.15, 3702.16, 3702.18
Five Year Review Date: 5/5/2028
Prior Effective Dates: 3/20/1997, 3/24/2003
Rule 3701-84-34.1 | Inspection and review of adult cardiac catheterization services.
 

(A) In addition to the inspection and audit requirements set forth in rule 3701-84-06 of the Administrative Code, the director will conduct an inspection of each adult cardiac catheterization service approximately once every three years.

(B) The number of procedures performed by the service may be considered by the director in conjunction with other indicators of quality and not as the sole indicator of the service's performance.

(C) Failure to maintain a volume of cardiac catheterization procedures sufficient to ensure the safety and quality of procedures performed at the service and individual cardiologist proficiency may result in any or all of the following:

(1) An extended review of the service by the director;

(2) Mandatory peer review of PCI procedures performed by the service;

(3) Annual inspections until such time as the service performs the established number of procedures for a period of two consecutive years or the director determines that annual inspection is no longer required; or

(4) At the discretion of the director, the establishment of a probationary period. If a probationary period is imposed, at a minimum, the service will be notified of the following:

(a) The time period for which the probationary period is effective;

(b) The actions that may be taken by the director for a service's failure to successfully complete the probationary period.

Last updated May 15, 2023 at 12:45 AM

Supplemental Information

Authorized By: 3702.11, 3702.13
Amplifies: 3702.14, 3702.141, 3702.15, 3702.16, 3702.18, 3702.19, 3702.20
Five Year Review Date: 5/5/2028
Prior Effective Dates: 4/30/2016
Rule 3701-84-34.2 | Order to cease operations of an adult cardiac catheterization service.
 

(A) In accordance with the compliance actions set forth in rule 3701-84-05 of the Administrative Code, the director may issue an order to cease operations to an adult cardiac catheterization service, or service, for the following:

(1) The director determines, based on clinical criteria including, but not limited to, major complications, the frequency of emergency transfers, and death, that the service poses an imminent threat of serious physical or life-threatening danger to the recipients of cardiac catheterization services;

(2) Failure of the service to meet designated quality outcome benchmarks, as evidenced by annual reports of the service's chosen data registry reports, or the service's annual reportable interventions; or

(3) Failure of the service to comply with the provisions of this chapter.

(B) The director will provide a written order to cease operations to the service via certified mail.

(C) An order to cease operations may appealed in accordance with Chapter 119. of the Revised Code. A notice of appeal must be filed with the director not later than thirty days after the notice's date of mailing. If requested by the service, the director will provide a hearing in accordance with Chapter 119. of the Revised Code.

Last updated May 15, 2023 at 12:45 AM

Supplemental Information

Authorized By: 3702.11, 3702.13
Amplifies: 3702.14, 3702.141, 3702.15, 3702.16, 3702.18, 3702.19, 3702.20
Five Year Review Date: 5/5/2028
Prior Effective Dates: 4/30/2016
Rule 3701-84-36 | Open heart surgery service standards.
 

(A) The provisions of rules 3701-84-36 to 3701-84-40 of the Administrative Code are applicable to open heart surgery services performing procedures on adult patients greater than or equal to eighteen years of age. An adult open heart surgery service may serve a patient less than eighteen years of age if the patient's attending physician and the adult service's medical director determine that the adult service best serves the needs of the patient.

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

(1) Cardiac operating rooms;

(2) A cardiac surgery intensive care unit;

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

(4) Cardiac catheterization services.

(C) Each open heart surgery service will have the capability, equipment, and personnel to perform emergency open heart procedures on a twenty four hour a day, seven days a week basis. A cardiovascular surgical team will be available in less than sixty minutes on a twenty-four hour a day basis.

(D) Each open heart surgery service will have access to the following services:

(1) Cardiology;

(2) Hematology;

(3) Nephrology;

(4) Pulmonary medicine;

(5) Infectious disease;

(6) Radiology;

(7) Neurology;

(8) Emergency care;

(9) Electrocardiography;

(10) Stress testing;

(11) Nuclear medicine;

(12) Pathology;

(13) Blood banking services;

(14) Echocardiography;

(15) Pulmonary function testing;

(16) Cardiac rehabilitation;

(17) Pre-admission testing; and

(18) Follow-up outpatient nursing referral services.

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

(F) Each an adult open heart surgery service will obtain and maintain enrollment in a data registry to monitor operator and institutional volumes and outcomes.

(G) Reporting:

(1) Beginning January 1, 2023 and ending December 31, 2024, each adult open-heart service will submit an annual report to the department by March first of each year that;

(a) Maintains patient confidentiality;

(b) Includes numbers for the following:

(i) The number of procedures performed by the adult open heart service;

(ii) Post procedure in-hospital mortality number;

(iii) In hospital prolonged intubation (ventilation) for a period of longer than seven days;

(iv) Deep sternal wound infection (mediastinitis);

(v) Post-operative renal insufficiency;

(vi) Surgical re-exploration; and

(vii) Stroke.

(2) Beginning January 1, 2025, each level III service will submit the following information to the department by March first of each year as part of the hospital's annual report that:

(a) Maintains patient confidentiality;

(b) Includes numbers for the following:

(i) The number of procedures performed by the adult open heart service;

(ii) Post procedure in-hospital mortality number;

(iii) In hospital prolonged intubation (ventilation) for a period of longer than seven days;

(iv) Deep sternal wound infection (mediastinitis);

(v) Post-operative renal insufficiency;

(vi) Surgical re-exploration; and

(vii) Stroke.

(H) Each adult open heart surgery service will have a written policy requiring the documentation of any internal review of surgeons with a combination of higher than expected risk adjusted mortality and low individual surgeon volume.

(I) Each adult open heart surgery service will utilize a coordinated and integrated multidisciplinary approach to patient care, including meetings between cardiologists and cardiovascular surgeons as necessary, to address the needs of patients with complex cardiovascular disease.

(J) Each adult open heart surgery service will have established criteria that cardiologists and surgeons will utilize for the purposes of patient selection and appropriateness.

(K) Each adult open heart surgery will have patient selection and appropriateness criteria:

(1) Consistent with the 2021 American college of cardiology/American heart association (ACC/AHA) guideline update for coronary artery bypass graft surgery, available at www.acc.org; and

(2) For patients with adult congenital heart disease, are consistent with the 2018 American college of cardiology/American heart association guidelines for the management of adults with congenital heart disease: executive summary, available at www.acc.org.

Last updated May 15, 2023 at 12:45 AM

Supplemental Information

Authorized By: 3702.11, 3702.13
Amplifies: 3702.11, 3702.12, 3702.13, 3702.14, 3702.141, 3702.15, 3702.16, 3702.18, 3702.19, 3702.20
Five Year Review Date: 5/5/2028
Prior Effective Dates: 3/24/2003, 5/15/2008, 6/21/2012
Rule 3701-84-37 | Personnel/staffing - open heart surgery service.
 

(A) The medical director of the adult open heart surgery service will be board-certified in thoracic surgery. The medical director will:

(1) Be a physician certified or eligible for certification by the American board of thoracic surgery, the American board of surgery, or meet the requirements set forth in paragraph (C) of rule 3701-84-08 of the Administrative Code;

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

(3) Be credentialed to provide adult open heart surgery services at the hospital where the adult open heart surgery service is located; and

(4) Actively perform open heart procedures at the open heart surgery service where they are the medical director.

(B) Each open heart surgery service will have at least two thoracic surgeons on staff, credentialed to perform open heart procedures at the hospital who actively perform open heart procedures at the hospital. The medical director of the open heart surgery service may be counted as one of the two required thoracic surgeons.

(C) Each open heart surgery service will have competent and qualified staff available, including but not limited to:

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

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

(3) Nursing staff that will include appropriate numbers of scrub nurses or technicians and a circulating nurse based on the needs of the surgeons and the patient. A minimum of two staff, including a circulating nurse and one scrub nurse or technician will be present for each procedure. Nursing staff will be trained in cardiac surgical operating room procedures;

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

(5) A minimum of two perfusionists who are graduates of an accredited cardiovascular perfusion or perfusion technology program or have equivalent training and experience.

(D) In addition to the requirements of paragraph (C) of this rule, an open heart surgery service will have appropriate staff available, including but not limited to:

(1) Pharmacists;

(2) Dietitians;

(3) Respiratory therapists;

(4) Physical therapists;

(5) Cardiac rehabilitation therapists; and

(6) Social workers.

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

Last updated May 15, 2023 at 12:45 AM

Supplemental Information

Authorized By: 3702.11, 3702.13
Amplifies: 3702.11, 3702.12, 3702.13, 3702.14, 3702.141, 3702.15, 3702.16, 3702.18, 3702.19, 3702.20
Five Year Review Date: 5/5/2028
Prior Effective Dates: 3/24/2003
Rule 3701-84-38 | Facilities, equipment, and supplies - open heart surgery service.
 

(A) Operating rooms used for open heart surgery:

(1) Standard operating rooms will:

(a) Have a minimum floor area of four hundred fifty square feet;

(b) Have the following minimum clearances:

(i) If anesthesia is utilized, six feet at the head of the operating table. This dimension will result in an anesthesia work zone with a clear floor area of six feet by eight feet; and

(ii) Sufficient footage on each side of the procedure table to ensure that movement around and in the sterile field does not compromise or contaminate the sterile field.

(2) Operating rooms utilizing image-guided surgery or procedures requiring more space for personnel or equipment will be sized to accommodate the personnel and equipment planned to be in the room during procedures and have a minimum floor area of six hundred square feet with a minimum clear dimension of twenty feet.

(3) Hybrid operating rooms will meet the minimum floor area and clearances of paragraphs (A)(1)(a) and (A)(1)(b) of this rule and include at least the additional minimum clear floor area, clearances, and storage requirements for the imaging equipment contained in the room.

(4) Fixed encroachments into the minimum floor area are permitted to be included when determining the minimum clear floor area for an operating room as long as:

(a) There are no encroachments into the sterile field;

(b) The encroachments do not extend more than twelve inches into the minimum clear floor area outside the sterile field; and

(c) The encroachment width along each wall does not exceed ten percent of the length of that wall.

(5) Control rooms if utilized, will:

(a) Accommodate the imaging system control equipment;

(b) Be sized and configured in compliance with manufacturer recommendations for installation, service, and maintenance;

(c) Have view panels that provide for a view of the patient and the open heart surgery team; and

(d) Be permitted to serve more than one hybrid operating room, provided that manufacturer recommendations for installation, service, and maintenance are accommodated for all rooms served.

(e) Be physically separated from a hybrid operating room with walls and a door.

(f) A door is not required where a control room serves only one operating room and is built, maintained, and controlled the same as the operating room.

(B) Each operating room used for open heart surgery will have appropriate numbers of oxygen and vacuum outlets and proper operating room lighting. Fiber optic headlights will be provided.

(C) Equipment and technology described in this paragraph may be replaced by newer technology and equipment with equivalent or superior capability. In assessing this new equipment and technology, consideration should be given to the recommendations of recognized professional societies and accrediting bodies. An open heart surgery service will have at least the following:

(1) Two fully operational cardiopulmonary bypass machines equipped with;

(a) A time and temperature module;

(b) An air bubble and level detector system;

(c) A blender (air and oxygen mixer);

(d) An oxygen analyzer;

(e) A saturation monitor;

(f) Two pressure monitors;

(g) A back up pump head; and

(h) A heater/cooler (one back up).

(2) Appropriate patient monitoring equipment with overhead slave, electrocardiogram, three pressure reading, and cardiac output;

(3) An electrocauter;

(4) A heat exchanger;

(5) Drug infusion equipment;

(6) Transportable monitoring equipment including electrocardiogram, defibrillator, oxygen saturation monitor, and pressure transducer;

(7) An intra-aortic balloon pump or other percutaneous mechanical circulatory assistance device of superior capability;

(8) The availability of a transesophageal echo;

(9) A cardiac pacemaker;

(10) Routine blood gas analysis and chemistry including blood sugar analysis in the operating room;

(11) Defibrillators;

(12) A heating blanket;

(13) An ice bath;

(14) An automated coagulation timer (ACT) machine; and

(15) A cell saver.

(D) Each open heart surgery service will ensure that a fully equipped and staffed cardiac surgical intensive care unit that meets the needs of the cardiac surgery patient is available in the building and accessible by gurney from where the open heart surgery is performed. The cardiac surgical intensive care unit will ensure that a sufficient number of intensive care unit beds are available to meet the needs of open heart surgery patients each week, however, the beds are not required to be dedicated only to cardiac surgery patients.

(E) Each open heart surgery service will ensure that a post-intensive care "step-down" unit with telemetry is available in the building and accessible by gurney from where the open heart surgery is performed. The number of "step-down" beds will be sufficient to meet the needs of open heart surgery patients each week, however, the beds are not required to be dedicated only to cardiac surgery patients.

Last updated May 15, 2023 at 12:45 AM

Supplemental Information

Authorized By: 3702.11, 3702.13
Amplifies: 3702.11, 3702.12, 3702.13, 3702.14, 3702.141, 3702.15, 3702.16, 3702.18, 3702.19, 3702.20
Five Year Review Date: 5/5/2028
Prior Effective Dates: 8/1/2017
Rule 3701-84-39 | Quality assessment and performance improvement - open heart surgery service.
 

(A) In addition to the general quality assessment and performance improvement requirements set forth in rule 3701-84-12 of the Administrative Code, each open heart surgery service will:

(1) As part of the service's overall quality assessment and performance improvement process:

(a) Utilize the quality performance measures outcomes data obtained from the service's participation in a data registry to monitor operator and institutional volumes and outcomes; and

(b) Include a periodic review and evaluation of the multidisciplinary meetings required by paragraph (J) of rule 3701-84-36 of the Administrative Code.

(2) Have a regular formal morbidity and mortality conference chaired by the medical director of the open heart surgery service or the medical director's designee. The morbidity and mortality conferences will:

(a) Be held at least once every sixty days or more frequently depending on the need; and

(b) Review all deaths and complications such as reoperation for bleeding, deep sternal wound infection, stroke, and perioperative myocardial infarction and any patterns that might indicate a problem will be investigated and remedied if necessary.

(B) Each open heart surgery service will maintain a clinical pathway for coronary bypass graft surgery and valve replacements.

Last updated May 15, 2023 at 12:45 AM

Supplemental Information

Authorized By: 3702.11, 3702.13
Amplifies: 3702.11, 3702.12, 3702.13, 3702.14, 3702.141, 3702.15, 3702.16, 3702.18, 3702.19, 3702.20
Five Year Review Date: 5/5/2028
Prior Effective Dates: 3/1/1997, 3/24/2003, 6/21/2012
Rule 3701-84-40 | Adult open heart surgery service performance measures.
 

(A) Each adult open heart surgery service should maintain a volume of open heart procedures per year sufficient to ensure the safety and quality of procedures performed at the service and individual surgeon proficiency.

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

(C) No minimum volume is recommended, however, the combination of high mortality and low individual surgeon volume will trigger a thorough internal review of an individual surgeon by the provider of the open heart surgery service.

(D) Failure to maintain the safety and quality of the procedures performed at the service may result in any or all of the following:

(1) An extended review of the service by the director;

(2) Mandatory peer review of procedures performed by the service;

(3) Annual inspections until such time as the director determines that annual inspection is no longer required; or

(4) At the discretion of the director, the establishment of a probationary period. If a probationary period is imposed, at a minimum, the service will be notified of the following:

(a) The time period for which the probationary period is effective;

(b) The actions that may be taken by the director for a service's failure to successfully complete the probationary period.

Last updated May 15, 2023 at 12:45 AM

Supplemental Information

Authorized By: 3702.11, 3702.13
Amplifies: 3702.11, 3702.12, 3702.13, 3702.14, 3702.141, 3702.15, 3702.16, 3702.18, 3702.19, 3702.20
Five Year Review Date: 5/5/2028
Prior Effective Dates: 3/24/2003, 5/15/2008, 6/21/2012
Rule 3701-84-61 | Pediatric intensive care service standards.
 

(A) The provisions of rules 3701-84-61 to 3701-84-65 of the Administrative Code are applicable to each pediatric intensive care service (PICU) regardless of the date service was initiated.

(B) Each PICU service will develop and follow written comprehensive and effective patient care policies and procedures that designate the severity of illnesses that may be treated and the types of care that may be provided in the PICU. The PICU will operate within the scope of this service plan.

(C) A temporary expansion of PICU services due to seasonal illness or outbreak necessitating an increase in the number of PICU beds does not require notification to the director under the change in the scope of the HCS requirement set forth in paragraph (G) of rule 3701-84-04 of the Administrative Code. Any expansion of PICU services for these purposes will meet all established requirements for a PICU.

(D) Each PICU service will ensure that a pediatric intensivist is on-site in-house twenty-four hours per day, seven days a week.

(E) The following physicians will be available on-site to the PICU within sixty minutes on a twenty-four hour a day, seven days a week basis:

(1) An anesthesiologist with demonstrated training and experience in pediatrics;

(2) A pediatric surgeon or a general surgeon with demonstrated training and experience in pediatrics;

(3) Pediatric subspecialists to include:

(a) A cardiologist;

(b) A gastroenterologist;

(c) A pulmonologist or other physician proficient in pediatric flexible bronchoscopy;

(d) A neurologist.

(4) Surgeon subspecialists with demonstrated training and experience in pediatrics, to include:

(a) A neurosurgeon;

(b) An otolaryngologist;

(c) A plastic surgeon;

(d) An oral surgeon; and

(e) An orthopedist.

(F) The following services will be available by phone or teleconference within sixty minutes on a twenty-four hour a day, seven days a week basis:

(1) A nephrologist;

(2) A hematologist/oncologist;

(3) An endocrinologist;

(4) An infectious disease specialist; and

(5) A pathologist with demonstrated training and experience in pediatrics.

(G) A psychiatrist or psychologist with demonstrated training and experience in pediatrics will be available to the PICU by phone or teleconference within twenty four hours on a twenty four hours a day seven days a week basis.

(H) Each PICU service will have access to the following pediatric specialists for consultation and treatment as necessary, either on staff or by arrangement or contract:

(1) A neonatologist;

(2) An allergist or immunologist;

(3) A geneticist;

(4) A cardiovascular surgeon; and

(5) A radiologist with demonstrated training and experience in pediatrics.

(I) Each PICU service without an on-site pediatric cardiac catheterization service and a pediatric cardiovascular surgery service will maintain a written transfer agreement for emergency pediatric cardiovascular surgery services with a provider of pediatric cardiac catheterization services and pediatric cardiovascular surgery services that, once the patient can safely be transported, can be reached expeditiously by available emergency vehicle in less than sixty minutes on a twenty-four hour a day, seven days a week basis and that provides the greatest assurance for patient safety.

(J) Each PICU service without an on-site pediatric radiologist or radiologist with training and experience in pediatrics will maintain a written transfer agreement for emergency pediatric radiologic services with a provider of pediatric radiologic services that, once the patient can safely be transported, can be reached expeditiously by available emergency vehicle in less than sixty minutes on a twenty-four hour a day, seven days a week basis and that provides the greatest assurance for patient safety.

(K) Each PICU service will have available at least two operating rooms with the capability, equipment and personnel to perform emergency procedures in less than sixty minutes on a twenty-four hour a day, seven days a week basis.

(L) Each PICU service will have access to a blood bank with all blood components available twenty-four hours a day, seven days a week. Unless some unusual antibody is encountered, blood typing and cross matching will allow for transfusion in less than sixty minutes.

(M) Each PICU service will have radiology services available to the PICU at all times to meet the needs of the patient and will include:

(1) Portable radiology;

(2) Fluoroscopy;

(3) Computerized tomography scanning;

(4) Ultrasonography;

(5) Angiography;

(6) Nuclear scanning; and

(7) Magnetic resonance imaging;

(N) Radiation therapy services will be available on-site or through contract with another hospital.

(O) Each PICU service will have the following clinical laboratory capabilities:

(1) Microspecimen capability and one hour turnaround time for:

(a) Clotting studies and measurements of complete blood cell count;

(b) Differential count;

(c) Platelet count;

(d) Urinalysis;

(e) Electrolytes;

(f) Blood urea nitrogen;

(g) Creatinine;

(h) Glucose;

(i) Calcium;

(j) Prothrombin time;

(k) Partial thromboplastin time; and

(l) Cerebrospinal fluid cell counts;

(2) Blood gas values available within fifteen minutes;

(3) Within three hours, results of:

(a) Drug screening and levels of serum ammonia;

(b) Serum and urine osmolarity;

(c) Phosphorus; and

(d) Magnesium.

(4) Preparation of gram stains and bacteriological cultures available twenty-four hours a day, seven days a week.

(P) Each PICU service will have access to the hospital's pharmacy service and personnel on-site capable of dispensing all necessary medications for pediatric patients of all types and ages, twenty-four hours a day, seven days a week.

(Q) Diagnostic cardiac and neurological services will be available twenty-four hours per day to the PICU service as needed and technicians with special training in pediatrics should be available to perform the following studies:

(1) Electrocardiograms, two-dimensional and echocardiograms and electroencephalograms; and

(2) Doppler ultrasonograph devices and evoked potential monitoring equipment.

(R) Each PICU service will timely provide hemodialysis equipment and competent and qualified staff experienced with pediatric patients available twenty-four hours a day, seven days a week. Each provider of a PICU service without an on-site hemodialysis service will maintain a written transfer agreement for emergency hemodialysis services with a provider of hemodialysis services that, once the patient can safely be transported, can be reached expeditiously by available emergency vehicle in less than sixty minutes on a twenty-four hour a day, seven days a week basis and that provides the greatest assurance for patient safety.

(S) Each PICU service will have an integrated communication system with a local emergency medical transport system.

(T) Each PICU service will have a secondary emergency communication system available twenty-four hours a day, seven days a week into the PICU.

(U) Each PICU service will have an internal transportation system and competent and qualified staff for effective transport.

(V) Each PICU service will maintain a communication link to a federal, state, or local poison control center.

(W) A PICU will only be operated in a fully permanent setting within the permanent frame of the building of a hospital that is classified as a general hospital or a children's hospital. The hospital will be fully equipped to meet the needs of the PICU.

Last updated May 15, 2023 at 12:45 AM

Supplemental Information

Authorized By: 3702.11, 3702.13
Amplifies: 3702.11, 3702.12, 3702.13, 3702.14, 3702.141, 3702.15, 3702.16, 3702.18, 3702.19, 3702.20
Five Year Review Date: 5/5/2028
Prior Effective Dates: 8/1/2017
Rule 3701-84-62 | Personnel and staffing standards - pediatric intensive care service.
 

(A) Each PICU service will have a medical director whose appointment, acceptance and responsibilities will be in writing and on file in the PICU.

(B) The PICU medical director will be:

(1) An active service provider in the PICU where he or she is the medical director; and

(2) Be board-certified in one of the following:

(a) Pediatric critical care;

(b) Anesthesiology with practice limited to infants and children and with special qualifications in critical care medicine; or

(c) Pediatric surgery with added qualifications in surgical critical care medicine.

(C) The PICU medical director will:

(1) Participate in development, review, and implementation of PICU policies;

(2) Participate in budget preparation;

(3) Coordinate staff education;

(4) Maintain a data base and/or vital statistics that describe unit experience and performance;

(5) Supervise resuscitation techniques, including educational component;

(6) Supervise quality control, assessment and improvement activities, including morbidity and mortality reviews;

(7) Coordinate research;

(8) Have the authority to consult on any PICU patient; and

(9) Name qualified designees to fulfill the medical director's duties during absences.

(D) Other individuals may supervise the activities required in paragraph (C) of this rule, but the PICU director will participate in each.

(E) In addition to the pediatric intensivist required in paragraph (D) of rule 3701-84-61 of the Administrative Code, each PICU service will have a licensed physician assigned to the PICU who:

(1) Is available to provide bedside care to the patients in the PICU; and

(2) Is skilled in and has the credentials to provide emergency care to critically ill children.

These responsibilities may be shared or delegated to an advanced practice nurse with specialized training in pediatric critical care and credentials and privileges to provide care in the PICU.

(F) Each PICU service will have a nurse manager dedicated to the PICU who will be supervised by the director of pediatric nursing or equivalent. The PICU nurse manager will have specific training and experience in pediatric critical care. Pediatric critical care registered nurse (CCRN) certification is recommended for the nurse manager, but not required.

(G) The PICU nurse manager will participate in the following:

(1) Development, review, and implementation of written policies and procedures for the PICU;

(2) Coordination of multidisciplinary staff education;

(3) Quality assurance;

(4) Nurse research;

(5) Budget preparation with the medical director; and

(6) Name qualified designees to fulfill their duties during absences.

These responsibilities may be shared or delegated to advanced practice nurses, but the PICU nurse manager will maintain overall responsibility for these requirements.

(H) Nursing to patient ratios in the PICU service will be sufficient to accommodate the acuity level and volume of patients, usually ranging from two nurses to one patient to one nurse to three patients and adjusted as needed.

(I) Required nursing skills for PICU nurses will include:

(1) Recognition, interpretation and recording of various physiologic variables;

(2) Drug and fluid administration;

(3) Cardio-pulmonary resuscitation (CPR) certification;

(4) Pediatric advanced life support certification (PALS);

(5) Respiratory care techniques including chest physiotherapy, endotracheal suctioning and management, and tracheostomy care;

(6) Preparation and maintenance of patient monitors; and

(7) Psychosocial skills to meet the needs of both patient and family.

(J) Each PICU service will provide to nursing staff and document in each nurse's personnel file the following:

(1) An orientation the the PICU;

(2) A clinical and didactic orientation in pediatric critical care; and

(3) On-going pediatric critical care in-service education.

(K) Each PICU service will have respiratory therapy staff assigned to the unit in-house twenty-four hours a day, seven days a week who:

(1) Have clinical experience managing pediatric patients with respiratory failure; and

(2) It is recommended that all respiratory therapy staff have pediatric advanced life support (PALS) training or an equivalent course.

(L) Other PICU staff will include:

(1) Biomedical technicians (in-house or available within one hour on a twenty-four hours a day, seven day a week basis);

(2) A social worker;

(3) A pharmacist in-house twenty-four hours per day;

(4) A radiology technician;

(5) A registered dietitian;

(6) A physical therapist;

(7) An occupational therapist;

(8) A child life specialist; and

(9) A unit clerk.

(M) As part of a continuing education program, the PICU service will:

(1) Have staff participate in regional pediatric critical care education programs; and

(2) Provide regularly scheduled resuscitation practice sessions.

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

Last updated May 15, 2023 at 12:45 AM

Supplemental Information

Authorized By: 3702.11, 3702.13
Amplifies: 3702.11, 3702.12, 3702.13, 3702.14, 3702.141, 3702.15, 3702.16, 3702.18, 3702.19, 3702.20
Five Year Review Date: 5/5/2028
Prior Effective Dates: 3/1/1997, 3/24/2003, 8/1/2017, 1/20/2020
Rule 3701-84-63 | Physical design and facilities - pediatric intensive care service.
 

(A) Each PICU will have controlled access with no through traffic.

(B) The location of the PICU:

(1) Is recommended to be in close proximity to the physician on-call office.

(2) Will be in close proximity to a family waiting area; and

(3) Will be available by gurney to the emergency department, the surgical area, and the recovery area.

(C) Each PICU will contain the following distinct areas:

(1) Patient isolation rooms;

(2) A clean linen room;

(3) A soiled linen room;

(4) Equipment storage;

(5) Counseling;

(6) A medication station with drug refrigerator and locked narcotic cabinet;

(7) A nourishment station;

(8) Hand washing facilities;

(9) Staff and patient toilets; and

(10) Patient personal effects storage.

(D) All patient rooms will have:

(1) The capacity to provide patient privacy, such as through the use of walls or curtains;

(2) Easy, rapid access to the head of the bed; and

(3) Adequate electrical outlets, compressed air, oxygen, and vacuum outlets per bed sufficient in number to supply all necessary equipment.

(E) Each PICU will have a rapid and reliable system that timely reports and receives laboratory results.

Last updated May 15, 2023 at 12:45 AM

Supplemental Information

Authorized By: 3702.11, 3702.13
Amplifies: 3702.11, 3702.12, 3702.13, 3702.14, 3702.141, 3702.15, 3702.16, 3702.18, 3702.19, 3702.20
Five Year Review Date: 5/5/2028
Prior Effective Dates: 3/24/2003
Rule 3701-84-64 | Equipment and supplies - pediatric intensive care service.
 

(A) Appropriate drugs for resuscitation and pediatric advanced life support will be present and immediately available for use in the treatment of any patient in the PICU.

(B) The following life-saving, therapeutic and monitoring equipment will be present or immediately available in the PICU:

(1) Portable equipment including:

(a) An emergency ("code" or "crash") cart;

(b) A procedure lamp;

(c) Pediatric sized blood pressure cuffs for systemic arterial pressure determination;

(d) A doppler ultrasound;

(e) An electrocardiograph;

(f) A defibrillator or cardioverter with pediatric paddles;

(g) Thermometers with a range sufficient to identify extremes of hypothermia and hyperthermia;

(h) Automated blood pressure apparatus;

(i) Transthoracic pacer with pediatric pads;

(j) Devices for accurately measuring body weight;

(k) Cribs and beds with head pressure apparatus;

(l) Infant warmers;

(m) Heating and cooling blankets;

(n) Bilirubin lights;

(o) Temporary pacemakers;

(p) A blood warming apparatus;

(q) A transport monitor;

(r) Infusion pumps with microinfusion capability;

(s) Oxygen tanks for transport and backup;

(t) Suction machines for transport and backup;

(u) Volumetric infusion pumps;

(v) Air-oxygen blenders;

(w) An air compressor;

(x) Gas humidifiers;

(y) Bag-valve mask resuscitators;

(z) An otoscope and ophthalmoscope;

(aa) Isolation carts; and

(bb) A portable electro-encephalogram available in the hospital for recordings.

(2) Respiratory equipment appropriate to meet the needs of all patients, including:

(a) Mechanical ventilators suitable for pediatric patients of all sizes;

(b) Pulse oximeters and transcutaneous oxygen monitors;

(c) Cardon dioxide (CO2) monitors;

(d) Inhalation therapy equipment;

(e) Chest physiotherapy and suctioning;

(f) Spirometers; and

(g) Continuous oxygen analyzers with alarms.

(3) Small equipment including:

(a) Tracheal intubation equipment in adequate numbers and type to intubate patients of all ages;

(b) Endotracheal tubes of all pediatric sizes;

(c) Oral/nasal airways;

(d) Flexible bronchoscope;

(e) Suction catheters;

(f) Vascular access equipment; and

(g) Surgical trays for the following:;

(i) Vascular cut-downs;

(ii) Open chest procedures;

(iii) Cricothyroidectomy; and

(iv) Tracheostomy;

(h) Intraosseous (IO) needles.

(4) Bedside monitors that are capable of providing continuous, sufficient and appropriate monitoring that have visible and audible alarms and are capable of producing a permanent hard copy of the rhythm strip.

(C) Each PICU service will have the capability to continuously monitor a patient's:

(1) Electrocardiogram and heart rate;

(2) Respiration;

(3) Temperature;

(4) Systemic arterial pressure;

(5) Oxygen;

(6) Carbon dioxide;

(7) Central venous pressure;

(8) Intracranial pressure; and

(9) Four pressures simultaneously.

Last updated May 15, 2023 at 12:45 AM

Supplemental Information

Authorized By: 3702.11, 3702.13
Amplifies: 3702.11, 3702.12, 3702.13, 3702.14, 3702.141, 3702.15, 3702.16, 3702.18, 3702.19, 3702.20
Five Year Review Date: 5/5/2028
Prior Effective Dates: 3/24/2003
Rule 3701-84-65 | Quality assessment and performance improvement program - pediatric intensive care service.
 

Each PICU will have a multidisciplinary collaborative quality assessment and performance improvement program. The written quality assessment and performance improvement program plan required under rule 3701-84-12 of the Administrative Code will, at a minimum, include a review of:

(A) All morbidity and mortality instances;

(B) Utilization;

(C) Medical records;

(D) Discharge criteria and discharge planning; and

(E) Patient safety.

Last updated May 15, 2023 at 12:45 AM

Supplemental Information

Authorized By: 3702.11, 3702.13
Amplifies: 3702.11, 3702.12, 3702.13, 3702.14, 3702.141, 3702.15, 3702.16, 3702.18, 3702.19, 3702.20
Five Year Review Date: 5/5/2028
Prior Effective Dates: 8/1/2017
Rule 3701-84-67 | Radiation therapy, stereotactic radiosurgery, and stereotactic radiotherapy service standards.
 

(A) Each radiation therapy, stereotactic radiotherapy, or stereotactic radiosurgery service will operate in accordance with Chapter 3748. of the Revised Code and all rules adopted thereunder.

(B) Each radiation therapy service, stereotactic radiotherapy, and stereotactic radiosurgery service will comply with the requirements pertaining to the Ohio cancer incidence surveillance system established under sections 3701.261 and 3701.262 of the Revised Code and Chapter 3701-4 of the Administrative Code.

Last updated May 15, 2023 at 12:45 AM

Supplemental Information

Authorized By: 3702.11, 3702.13
Amplifies: 3702.11, 3702.12, 3702.13, 3702.14, 3702.141, 3702.15, 3702.16, 3702.18, 3702.19, 3702.20
Five Year Review Date: 5/5/2028
Prior Effective Dates: 5/15/2008, 8/1/2017
Rule 3701-84-75 | Pediatric cardiac catheterization service standards.
 

(A) The provisions of rules 3701-84-75 to 3701-84-79 of the Administrative Code are applicable on the effective date of this rule to each pediatric cardiac catheterization service performing procedures on patients less than eighteen years of age, regardless of the date the service was initiated. A pediatric cardiac catheterization service may serve a patient greater than eighteen years of age if the patient's attending physician and the pediatric service's medical director determine that the pediatric service best serves the needs of the patient.

(B) All pediatric cardiac catheterization services will:

(1) Have on-site a pediatric cardiovascular surgery service immediately accessible from the pediatric cardiac catheterization laboratory by gurney; and

(2) Have an experienced pediatric cardiovascular surgical team available in less than sixty minutes on a twenty-four hour a day, seven days a week basis in the event that emergency open heart surgery is required.

(C) Each pediatric cardiac catheterization service will have explicit criteria consistent with current recommendations of recognized professional societies and accrediting bodies, specifying the number of times a year an appropriately privileged physician performs each catheterization procedure in order to retain privileges to perform that procedure.

(D) Each pediatric cardiac catheterization service will have immediate access to services for:

(1) Hematology and coagulation disorders;

(2) Electrocardiography;

(3) Diagnostic radiology,

(4) Clinical pathology;

(5) Doppler-electrocardiography;

(6) Pulmonary function testing; and

(7) Microbiology.

(E) Each pediatric cardiac catheterization service will have established criteria for patient selection and appropriateness that are specific to each procedure performed in the service.

(F) Each pediatric cardiac catheterization service will have a written policy requiring the documentation of any internal review of surgeons with a combination of high risk adjusted mortality and low individual surgeon volume.

(G) Each pediatric cardiac catheterization service, will enroll and be actively submitting data to a pediatric cardiac catheterization data registry.

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

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

(2) Operate a pediatric intensive/critical care unit with 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 pediatric cardiac catheterization laboratory. The unit will provide appropriate equipment and staff to care for pediatric cardiac patients and have twenty-four hour monitoring capability

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

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

(I) A pediatric cardiac catheterization service that performs same-day pediatric cardiac catheterization will have written criteria for same-day catheterization and discharge.

(1) These written criteria should establish discharge requirements such as:

(a) Absence of bleeding;

(b) Presence and adequacy of pulses and perfusion;

(c) Access to medical evaluation and care after discharge; and

(d) Parental understanding and ability to observe overnight.

(2) The written criteria should account for the following when determining whether the patient is eligible for discharge on the day of the cardiac catheterization:

(a) Cardiac physiology;

(b) Differences in procedure type;

(c) Patient age;

(d) Expected patient and parental compliance with discharge instructions;

(e) Travel distance; and

(f) Duration of procedure and time of completion.

Last updated May 15, 2023 at 12:45 AM

Supplemental Information

Authorized By: 3702.11, 3702.13
Amplifies: 3702.11, 3702.12, 3702.13, 3702.14, 3702.141, 3702.15, 3702.16, 3702.18, 3702.19, 3702.20
Five Year Review Date: 5/5/2028
Prior Effective Dates: 6/1/2007, 8/1/2017
Rule 3701-84-76 | Personnel/staffing - pediatric cardiac catheterization service.
 

(A) Each pediatric cardiac catheterization service will designate a medical director for the pediatric cardiac catheterization service. The medical director will:

(1) Possess the experience and leadership qualities that are necessary to manage the laboratory appropriately and to ensure safe and effective delivery of catheterization services to pediatric patients; and

(2) The medical director will actively perform pediatric cardiac catheterization procedures at the hospital where he or she is the medical director.

(B) The medical director of the pediatric cardiac catheterization service will be board-certified in pediatric cardiology by the American board of pediatrics or the American osteopathic board of pediatrics and have additional education or experience in pediatric cardiac catheterization and intervention.

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

(D) At a minimum, all physicians who perform pediatric cardiac catheterization procedures will be:

(1) A fully-accredited member of the HCS's staff; and

(2) Will participate in laboratory quality assurance programs, including peer review.

(E) In addition to the requirements of paragraphs (A) and (C) of this rule, each pediatric cardiac catheterization service will have available a sufficient number of qualified staff, who are able to supervise and conduct the cardiac catheterization service and are skilled in pediatric cardiopulmonary resuscitation, including the following, as applicable:

(1) Support staff comprised of individuals skilled in the following:

(a) Radiographic techniques;

(b) Digital imaging;

(c) Systematic quality control testing;

(d) Patient observation;

(e) Critical care;

(f) Monitoring and recording electrocardiographic and hemodynamic data; and

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

(i) Managing blood samples;

(ii) Performing blood gas measurements and calculations; and

(iii) Assisting with indicator dilution studies.

(2) Nursing personnel in sufficient number and type based on the caseload and types of procedures performed, which may include nurse practitioners, registered nurses, licensed practical nurses, and nursing assistants.

(a) Nursing personnel involved in the provision of pediatric cardiac catheterization services will have experience in pediatric critical care and knowledge of operating room techniques;

(b) Nurse practitioners, registered nurses, and licensed practical nurses involved in the provision of pediatric cardiac catheterization services will have:

(i) Knowledge of cardiovascular medications;

(ii) The ability to begin administration of intravenous solutions and administer drugs;

(iii) Experience with sterile techniques; and

(iv) Skills in monitoring vital signs, neurologic status and pain level.

(c) Nurse practitioners may assume some of the duties of a physician as permitted by law, however, ultimate responsibility for procedures will always remain with the physician of record.

(F) Respiratory therapists and pediatric critical care staff will be immediately available to care for pediatric patients.

(G) Biomedical, electronic, and radiation safety experts will be involved in maintaining the cardiac catheterization laboratory.

(H) Cardiovascular anesthesiologists and perfusion teams will be immediately available to care for patients.

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

Last updated May 15, 2023 at 12:45 AM

Supplemental Information

Authorized By: 3702.11, 3702.13
Amplifies: 3702.11, 3702.12, 3702.13, 3702.14, 3702.141, 3702.15, 3702.16, 3702.18, 3702.19, 3702.20
Five Year Review Date: 5/5/2028
Prior Effective Dates: 3/1/1997, 6/21/2012, 8/1/2017
Rule 3701-84-77 | Facilities, equipment, and supplies - pediatric cardiac catheterization service.
 

(A) Each pediatric cardiac catheterization service will provide adequate, properly designed space to perform cardiac catheterization procedures safely and effectively. The amount of space may vary with the types of procedures performed and the nature of the facility such as interventional versus diagnostic and teaching versus non-teaching.

(B) Each pediatric cardiac catheterization service will ensure the following:

(1) Procedure rooms:

(a) Have a minimum floor area of four hundred square feet;

(b) Have the following minimum clearances:

(i) If anesthesia is utilized, six feet at the head of the operating table. This dimension will result in an anesthesia work zone with a clear floor area of six feet by eight feet.

(ii) Sufficient footage on each side of the procedure table to ensure that movement around and in the sterile field does not compromise or contaminate the sterile field.

(c) Utilizing image-guided surgery or procedures requiring more space for personnel or equipment are sized to accommodate the personnel and equipment planned to be in the room during procedures and have a minimum floor area of six hundred square feet with a minimum clear dimension of twenty feet.

(d) Classified as hybrid procedure rooms, will meet the minimum clear floor area and clearances of paragraphs (B)(1)(a) and (B)(1)(b) of this rule and include at least the additional minimum clear floor area, clearances, and storage requirements for the imaging equipment contained in the room.

(e) Containing fixed encroachments into the minimum clear floor area are permitted to be include those fixed encroachments when determining the minimum clear floor area for a procedure room as long as:

(i) There are no encroachments into the sterile field;

(ii) The encroachments do not extend more than twelve inches into the minimum clear floor area outside the sterile field; and

(iii) The encroachment width along each wall does not exceed ten per cent of the length of that wall.

(2) Control rooms, if utilized, will:

(a) Accommodate the imaging system control equipment;

(b) Be sized and configured in compliance with manufacturer recommendations for installation, service, and maintenance;

(c) Have view panels that provide for a view of the patient and the cardiac catheterization team;

(d) Be permitted to serve more than one hybrid procedure room, provided that manufacturer recommendations for installation, service, and maintenance are accommodated for all rooms served.

(e) Be physically separated from a hybrid procedure room with walls and a door. A door is not required where a control room serves only one procedure room and is built, maintained, and controlled the same as the procedure room.

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

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

(D) Each pediatric cardiac catheterization service will ensure that each laboratory where a cardiac catheterization procedure is conducted is appropriately equipped to provide high quality pediatric imaging, physiological monitoring, and provision of emergency care.

(E) The equipment described in this paragraph may be replaced by newer technology that has equivalent or superior capability as determined by the pediatric cardiac catheterization service. In assessing these new technologies, consideration should be given to recommendations of recognized professional societies and accrediting bodies (e.g. the American college of cardiology; the American academy of pediatrics). All pediatric cardiac catheterization services will have the following equipment:

(1) Imaging equipment appropriate to the procedures performed;

(2) Immediate replay capabilities;

(3) A blood gas analyzer;

(4) A pulse oximeter;

(5) An infant warming device;

(6) Pacing catheters;

(7) An external pacemaker;

(8) A defibrillator;

(9) An emergency cart;

(10) A comprehensive inventory of pediatric catheters and devices; and

(11) Ultrasound.

(F) Each pediatric cardiac catheterization service will provide and maintain radiation generating equipment in accordance with applicable state and federal requirements as specified in Chapter 3748. of the Revised Code and the rules adopted thereunder.

Last updated May 15, 2023 at 12:45 AM

Supplemental Information

Authorized By: 3702.11, 3702.13
Amplifies: 3702.11, 3702.12, 3702.13, 3702.14, 3702.141, 3702.15, 3702.16, 3702.18, 3702.19, 3702.20
Five Year Review Date: 5/5/2028
Prior Effective Dates: 8/1/2017
Rule 3701-84-78 | Safety standards - pediatric cardiac catheterization service.
 

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

(B) Each pediatric cardiac catheterization service will establish, maintain, and follow electrical safety policies which include:

(1) A safe primary electrical wiring system;

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

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

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

(C) Each pediatric cardiac catheterization service will periodically survey all of the equipment utilized by the service, perform preventive maintenance on a schedule that conforms to manufacturers' recommendations, and document all preventive maintenance activities.

Last updated May 15, 2023 at 12:45 AM

Supplemental Information

Authorized By: 3702.11, 3702.13
Amplifies: 3702.11, 3702.12, 3702.13, 3702.14, 3702.141, 3702.15, 3702.16, 3702.18, 3702.19, 3702.20
Five Year Review Date: 5/5/2028
Prior Effective Dates: 8/1/2017
Rule 3701-84-79 | Pediatric cardiac catheterization service - performance measures.
 

(A) A pediatric cardiac catheterization service should maintain a volume of cardiac catheterization procedures sufficient to ensure the safety and quality of procedures performed at the service and individual cardiologist proficiency.

(B) No minimum cardiologist volume is recommended, however, the combination of high risk adjusted mortality and low volume will trigger a thorough internal review of an individual physician by the pediatric cardiac catheterization service.

Last updated May 15, 2023 at 12:45 AM

Supplemental Information

Authorized By: 3702.11, 3702.13
Amplifies: 3702.11, 3702.12, 3702.13, 3702.14, 3702.141, 3702.15, 3702.16, 3702.18, 3702.19, 3702.20
Five Year Review Date: 5/5/2028
Prior Effective Dates: 8/1/2017
Rule 3701-84-80 | Quality assessment and performance improvement - pediatric cardiac catheterization service.
 

(A) Each pediatric cardiac catheterization service will have a regular formal morbidity and mortality conference:

(1) Chaired by the medical director of the pediatric cardiac catheterization service or the medical director's designee;

(2) Be held at a minimum of once every ninety sixty days or more frequently depending on the need; and

(3) Review all of the following:

(a) Deaths;

(b) Rescue extracorporeal membrane oxygenation;

(c) Emergency surgery; and

(d) Major complications, such as:

(i) Readmission to intensive care unit;

(ii) Emergent readmission to the hospital; or

(iii) Major non-surgical intervention.

(B) Each pediatric cardiac catheterization service will establish and maintain a method for reviewing the quality of all cardiac catheterization procedures. This review will assess the following:

(1) Appropriateness of cardiac catheterization studies and interventions;

(2) Technical quality of cardiac catheterization studies;

(3) Procedure result;

(4) Rate of therapeutic success; and

(5) Rate of procedural complications.

(C) Each pediatric cardiac catheterization service will establish and maintain a database to support the review process detailed in paragraph (B) of this rule. The results of analyses and review are to be documented and used to guide periodic internal reviews of individual physicians with respect to maintaining their credentials to perform specific cardiac catheterization procedures.

Last updated May 15, 2023 at 12:45 AM

Supplemental Information

Authorized By: 3702.11, 3702.13
Amplifies: 3702.11, 3702.12, 3702.13, 3702.14, 3702.141, 3702.15, 3702.16, 3702.18, 3702.19, 3702.20
Five Year Review Date: 5/5/2028
Prior Effective Dates: 3/1/1997
Rule 3701-84-81 | Pediatric cardiovascular surgery service standards.
 

(A) The provisions of rules 3701-84-81 to 3701-84-85 of the Administrative Code are applicable to each pediatric cardiovascular surgery service performing procedures on patients less than eighteen years of age. Patients eighteen and older may be served at a pediatric cardiovascular surgery service, if the patient's attending physician and the service's medical director determine that the service best serves the needs of the patient.

(B) At all times, each pediatric cardiovascular surgery service will have available in the same building as the pediatric cardiovascular surgery service and accessible by gurney, adequate facilities for the pediatric cardiovascular surgery service, including:

(1) Cardiac operating rooms;

(2) Pediatric intensive care facilities appropriate for the recovery of post operative pediatric cardiovascular surgical patients; and

(3) A cardiac catheterization service.

(C) Each pediatric cardiovascular surgery service will have the capability, equipment, and personnel to perform emergency pediatric open heart procedures on a twenty-four hour a day, seven days a week basis. A pediatric cardiovascular surgical team will be available and on-site in less than sixty minutes on a twenty-four hour a day, seven days a week basis.

(D) Each pediatric cardiovascular surgery service will utilize a coordinated and integrated multidisciplinary approach to patient care, including meetings to determine the appropriate course of treatment for complex patients. Physicians and staff should function as a team and should include adequate numbers of the following:

(1) Qualified pediatric cardiologists:

(2) Pediatric cardiovascular surgeons:

(3) Pediatric cardiovascular anesthesiologists;

(4) Pediatric intensive care physicians;

(5) Neonatologists with special expertise in the care of cardiac patients; and

(6) Additional pediatric specialists required for the overall care of patients.

(E) Each pediatric cardiovascular surgery service will have access to the following pediatric services and subspecialties:

(1) Cardiology, including echocardiogram, doppler echocardiogram and cardiac catheterization;

(2) Hematology;

(3) A general surgeon;

(4) Gastroenterology;

(5) Nephrology;

(6) Pulmonary medicine;

(7) Infectious disease;

(8) Radiology;

(9) Interventional radiology;

(10) Neurology;

(11) Emergency care;

(12) Pathology;

(13) Pulmonary function testing;

(14) Preadmission testing; and

(15) Follow-up outpatient nursing referral.

(F) Each pediatric cardiovascular surgery service will have access to the following services either on site or by arrangement with another facility:

(1) Extracorporeal membrane oxygenation (ECMO); and

(2) Ventricular assist device (VAD).

(G) Each pediatric cardiovascular surgery service will obtain and maintain enrollment in a data registry to monitor operator and institutional volumes and outcomes.

(H) A pediatric cardiovascular surgery service will only be provided in a fully permanent setting within the permanent frame of the building of a hospital that is classified as a general hospital, a children's hospital or as a special hospital - cardiac, that primarily furnishes limited services to patients with cardiac conditions. The hospital will be fully equipped to perform the service.

(I) Each pediatric cardiovascular surgery service will have established criteria that cardiovascular surgeons, cardiologists, and physicians will utilize for patient selection and appropriateness.

(J) Each pediatric cardiovascular surgery service will have a written policy requiring the documentation of any internal review of surgeons with a combination of high risk adjusted mortality and low individual surgeon volume.

Last updated May 15, 2023 at 12:45 AM

Supplemental Information

Authorized By: 3702.11, 3702.13
Amplifies: 3702.11, 3702.12, 3702.13, 3702.14, 3702.141, 3702.15, 3702.16, 3702.18, 3702.19, 3702.20
Five Year Review Date: 5/5/2028
Prior Effective Dates: 6/21/2012
Rule 3701-84-82 | Personnel/staffing - pediatric cardiovascular surgery service.
 

(A) The medical director of a pediatric cardiovascular surgery service will be board certified in thoracic surgery. The medical director will be:

(1) Responsible for oversight and care in the service;

(2) Credentialed to provide pediatric cardiovascular surgery services at the hospital where they are the medical director; and

(3) Active in performing pediatric cardiovascular surgery procedures at the hospital where they are the medical director.

(B) Each pediatric cardiovascular surgery service will have on staff at least two thoracic surgeons who are credentialed to perform and actively perform pediatric cardiovascular surgery procedures at the hospital.

(C) In addition to the requirements of paragraphs (A) and (B) of this rule, each pediatric cardiovascular surgery service will have competent and qualified staff available, including:

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

(2) Anesthesiologists with expertise in the anesthetic and support requirements of pediatric cardiovascular surgery;

(3) Nursing staff which will include an appropriate numbers of scrub nurses or technicians and circulating nurses or technicians. A minimum of one scrub nurse and one circulating nurse or technician alternative as noted, is necessary. Nursing staff will be trained in pediatric cardiovascular surgical operating room procedures and nurses will be pediatric advanced life support (PALS) certified;

(4) Pediatric intensive care unit staff who are trained in pediatric advanced life support (PALS) at an appropriate nurse to patient ratio commensurate with the acuity of each individual patient and the amount of time following surgery that such care will be necessary. Pediatric intensive care nurses and physicians will have specialized training to develop the theoretical knowledge and clinical skills required for the care of pediatric cardiovascular surgical patients; and

(5) A minimum of two perfusionists. Perfusionists will be graduates of an accredited cardiovascular perfusion or perfusion technology training program or have equivalent training and experience. The perfusionists will have training, knowledge, and experience with small body perfusion, extracorporeal membrane oxygenation (ECMO), and ventricular assist devices (VAD) if those services are provided onsite.

(D) In addition to the requirements of paragraph (C) of this rule, each pediatric cardiovascular surgery service will have appropriate staff available, including pharmacists, dietitians, respiratory therapists, physical therapists and social workers.

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

Last updated May 15, 2023 at 12:45 AM

Supplemental Information

Authorized By: 3702.11, 3702.13
Amplifies: 3702.11, 3702.12, 3702.13, 3702.14, 3702.141, 3702.15, 3702.16, 3702.18, 3702.19, 3702.20
Five Year Review Date: 5/5/2028
Prior Effective Dates: 6/21/2012
Rule 3701-84-83 | Facilities, equipment, and supplies - pediatric cardiovascular surgery service.
 

(A) Operating rooms used for pediatric cardiovascular surgery:

(1) Standard operating rooms will:

(a) Have a minimum floor area of four hundred fifty square feet;

(b) Have the following minimum clearances:

(i) If anesthesia is utilized, six feet at the head of the operating table. This dimension will result in an anesthesia work zone with a clear floor area of six feet by eight feet; and

(ii) Sufficient footage on each side of the procedure table to ensure that movement around and in the sterile field does not compromise or contaminate the sterile field.

(2) Operating rooms utilizing image-guided surgery or procedures requiring more space for personnel or equipment will be sized to accommodate the personnel and equipment planned to be in the room during procedures and have a minimum floor area of six hundred square feet with a minimum clear dimension of twenty feet.

(3) Hybrid operating rooms will meet the minimum floor area and clearances of paragraphs (A)(1)(a) and (A)(1)(b) of this rule and include at least the additional minimum clear floor area, clearances, and storage requirements for the imaging equipment contained in the room.

(4) Fixed encroachments into the minimum clear floor area are permitted to be included when determining the minimum clear floor area for an operating room as long as:

(a) There are no encroachments into the sterile field;

(b) The encroachments do not extend more than twelve inches into the minimum clear floor area outside the sterile field; and

(c) The encroachment width along each wall does not exceed ten percent of the length of that wall.

(5) Control rooms, if utilized, will:

(a) Accommodate the imaging system control equipment;

(b) Be sized and configured in compliance with manufacturer recommendations for installation, service, and maintenance;

(c) Have view panels that provide for a view of the patient and the cardiovascular surgery team;

(d) Be permitted to serve more than one hybrid operating room, provided that manufacturer recommendations for installation, service, and maintenance are accommodated for all rooms served; and

(e) Be physically separated from a hybrid operating room with walls and a door.

(f) A door is not required where a control room serves only one operating room and is built, maintained, and controlled the same as the procedure room.

(B) Each operating room used for pediatric cardiovascular surgery will have appropriate numbers of oxygen, vacuum and electrical outlets sufficient in number to supply all necessary equipment and proper operating room lighting, including fiber optic headlights.

(C) Each pediatric cardiovascular surgery service will have equipment appropriate for the safe performance and care of pediatric cardiovascular surgery patients.

(D) Each pediatric cardiovascular surgery service will ensure that a fully equipped and staffed pediatric intensive care unit is available in the building and accessible by gurney from where the pediatric cardiovascular surgery is performed. The number of available pediatric intensive care unit beds will be approximately one-half the number of pediatric open heart operations performed per week. The physical space of this unit will meet joint commission, american osteopathic association, or any other national accrediting body approved for deeming authority by the centers for medicare and medicaid services recommended standards, which are in effect on the effective date of this rule, for intensive care unit beds.

(E) The equipment described in this paragraph may be replaced by newer technology that has equivalent or superior capability as determined by the pediatric cardiac catheterization service. In assessing these new technologies, consideration should be given to recommendations of recognized professional societies and accrediting bodies (e.g. the American college of cardiology; the American academy of pediatrics). All pediatric cardiovascular surgery services will have the following equipment:

(1) Immediate replay capabilities;

(2) A blood gas analyzer;

(3) A pulse oximeter;

(4) An infant warming device;

(5) Pacing equipment;

(6) An external pacemaker;

(7) A defibrillator;

(8) An emergency cart; and

(9) A comprehensive inventory of cannulas and conduits.

Last updated May 15, 2023 at 12:45 AM

Supplemental Information

Authorized By: 3702.11, 3702.13
Amplifies: 3702.11, 3702.12, 3702.13, 3702.14, 3702.141, 3702.15, 3702.16, 3702.18, 3702.19, 3702.20
Five Year Review Date: 5/5/2028
Prior Effective Dates: 8/1/2017
Rule 3701-84-84 | Pediatric cardiovascular surgery service - performance measures.
 

(A) Each pediatric cardiovascular surgery service should maintain a volume of cardiovascular procedures sufficient to ensure the safety and quality of procedures performed at the service and individual surgeon proficiency.

(B) No minimum per surgeon volume is recommended, however, the combination of high risk adjusted mortality and low volume will trigger a thorough internal review of an individual physician by the pediatric cardiovascular surgery service.

Last updated May 15, 2023 at 12:45 AM

Supplemental Information

Authorized By: 3702.11, 3702.13
Amplifies: 3702.11, 3702.12, 3702.13, 3702.14, 3702.141, 3702.15, 3702.16, 3702.18, 3702.19, 3702.20
Five Year Review Date: 5/5/2028
Prior Effective Dates: 3/1/1997
Rule 3701-84-85 | Quality assessment and performance improvement - pediatric cardiovascular surgery service.
 

In addition to the general quality assessment and performance improvement requirements set forth in rule 3701-84-12 of the Administrative Code, each pediatric cardiovascular surgery service will:

(A) As part of the service's overall quality assessment and performance improvement process:

(1) Utilize the quality performance measures outcomes data obtained from the service's participation in the service's chosen data registry; and

(2) Include a periodic review and evaluation of the multidisciplinary meetings required by paragraph (D) of rule 3701-84-81 of the Administrative Code.

(B) Have a regular formal morbidity and mortality conference chaired by the medical director of the pediatric cardiovascular surgery service or the medical director's designee. The morbidity and mortality conferences will:

(1) Be held at a minimum, once a month or more frequently depending on the need; and

(2) Review all deaths and complications such as reoperation for bleeding, deep sternal wound infection, stroke, perioperative myocardial infarction, and any patterns that might indicate a problem will be investigated and remedied if necessary.

Last updated May 15, 2023 at 12:45 AM

Supplemental Information

Authorized By: 3702.11, 3702.13
Amplifies: 3702.11, 3702.12, 3702.13, 3702.14, 3702.141, 3702.15, 3702.16, 3702.18, 3702.19, 3702.20
Five Year Review Date: 5/5/2028
Prior Effective Dates: 3/24/2003, 6/21/2012, 8/1/2017