66 sections in this chapter.
R.3701-22-01 Definitions
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19.03 PDF: As used in this chapter:(A) "Administrator" means the person responsible for the overall daily management of the hospital and decisions regarding the hospital license.(B) "Adult open heart surgery service" or "pediatric cardiovascular surgery service" means the combina…
R.3701-22-02 Applicability of rules
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19.03 PDF: Until September 30, 2024, each hospital will comply with the following:(A) With a maternity unit, newborn care nursery, or both, complies with Chapter 3701-7 of the Administrative Code;(B) With a pediatric intensive care unit complies with the applicable requirements o…
R.3701-22-03 Application for initial, renewal, or transfer licensure; notice to the director; sales, assignments, or transfers
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19.03 PDF: (A) Application for a license to operate a hospital, renewal of an existing license may be made either in writing on a form provided by the director and signed by the applicant or the applicant's primary agent, or using an electronic system prescribed by the director a…
R.3701-22-04 Prohibitions
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19.03 PDF: (A) Upon licensure or temporary licensure as a hospital by the director of health or September 30, 2024, whichever is sooner, no person and no political subdivision, agency, or instrumentality of this state may operate a hospital without holding a license or a temporar…
R.3701-22-05 Inspections; compliance actions
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19.03 PDF: (A) The director of health monitors compliance with Chapter 3722. of the Revised Code and Chapter 3701-22 of the Administrative Code. The director may at any time inspect a licensed hospital in order to address an incident that may impact public health, respond to a co…
R.3701-22-06 Administration
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19.03 PDF: Each hospital, other than a critical access hospital or a rural emergency hospital, is to provide effective administration responsible for the following areas:(A) Compliance with federal, state, and local laws, in accordance with 42 CFR 482.11, including cooperation wi…
R.3701-22-07 Basic hospital functions
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19.03 PDF: Each hospital, other than a critical access hospital or a rural emergency hospital, is to provide for the following:(A) A quality assessment and performance improvement program, in accordance with 42 CFR 482.21. In addition, the hospital will participate in quality ass…
R.3701-22-08 Optional hospital functions
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19.03 PDF: Each hospital, other than a critical access hospital or rural emergency hospital may provide for any or all the following:(A) Surgical services, in accordance with 42 CFR 482.51;(B) Anesthesia services, in accordance with 42 CFR 482.52;(C) Nuclear medicine services, in…
R.3701-22-09 Critical access hospitals
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19.03 PDF: Each critical access hospital is to comply with 42 CFR 485 subpart F. In addition, each critical access hospital will:(A) Participate in quality assessment and performance improvement projects identified by the director in consultation with the representatives of the r…
R.3701-22-10 Rural emergency hospitals
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19.03 PDF: Each rural emergency hospital is to comply with 42 CFR 485 subpart E. In addition, each rural emergency hospital will:(A) Submit: (1) A complete application for a license to operate a rural emergency hospital or renewal of an existing license may be made either in writ…
R.3701-22-11 Quality assurance and patient health and safety
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19.03 PDF: The director will work with representatives of the regulated industry to determine reporting requirements that help to assure quality and patient health and safety within the hospital. Reporting requirements for quality and patient health and safety are subject to any …
R.3701-22-12 Annual report
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19.03 PDF: (A) Until September 30, 2024, each hospital is obligated to continue reporting information annually to the director in accordance with chapter 3701-59 of the Administrative Code.(B) The Ohio department of health will work with the regulated industry to determine what, …
R.3701-22-13 Data collection
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19.03 PDF: After consultation with representatives of the regulated industry, the director may require hospitals to submit data in areas including performance, quality, or other agreed upon areas.(A) Any information reported under this section that reveals the identity or that co…
R.3701-22-14 Hospital Zones
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19.03 PDF: The director may establish regional hospital zones to respond to public health events, outbreaks of disease, or similar incidents, as well as ongoing public health considerations resulting from those events. Such zones may include health care providers, including but n…
R.3701-22-19 Variances; waivers
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19.03 PDF: (A) The director may grant a variance or waiver from any requirement established by Chapter 3701- 22 of the Administrative Code, unless the requirement is mandated by statute.(B) Written requests by a hospital seeking a variance or waiver should include the following i…
R.3701-22-20 Maternity unit and newborn care nursery general facilities and equipment requirements
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19.03 PDF: (A) This rule is not to be construed to require any maternity unit licensed on or before March 20, 1997, to alter, upgrade, or otherwise improve the structure or fixtures of the maternity unit in order to comply with the requirements of this rule, unless one of the fol…
R.3701-22-21 Level I service standards
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19.03 PDF: (A) Obstetric license. A level I obstetric service will provide antepartum, intrapartum and postpartum care for obstetrical patients, including:(1) Low-risk patients, such as patients with:(a) Term deliveries;(b) Singleton deliveries; and(c) Deliveries with vertex pres…
R.3701-22-22 Level II service standards
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19.03 PDF: (A) Obstetric license. A level II obstetrical service will provide antepartum, intrapartum and postpartum care for obstetrical patients, including:(1) All low-risk patients;(2) All uncomplicated patients with higher-risk conditions;(3) Selected high-risk patients as id…
R.3701-22-23 Level III service standards
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19.03 PDF: (A) Obstetric license. A level III obstetrical service will provide antepartum, intrapartum and postpartum care for obstetrical patients, including:(1) All low-risk patients;(2) All uncomplicated patients with higher-risk conditions;(3) All high-risk patients;(4) Patie…
R.3701-22-24 Level IV service standards
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19.03 PDF: (A) Obstetric license. A level IV obstetric service will provide antepartum, intrapartum and postpartum care for obstetrical patients, including:(1) All low-risk patients;(2) All uncomplicated patients with higher-risk conditions;(3) All high-risk patients;(4) Patients…
R.3701-22-25 Freestanding children's hospitals with level III or level IV neonatal care services
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19.03 PDF: (A) A freestanding children's hospital with a level III neonatal care service will provide care for newborns, including:(1) Low-risk newborns;(2) Convalescing and moderately ill newborns;(3) Extremely low birth weight infants;(4) Newborns who require advanced respirato…
R.3701-22-26 Freestanding children's hospitals with level III or level IV neonatal care services that provide special delivery services
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19.03 PDF: (A) A freestanding children's hospital licensed under this chapter may provide special delivery services to pregnant women as part of a comprehensive multidisciplinary program of fetal and neonatal care when it is determined that the fetus, once delivered, will require…
R.3701-22-27 Freestanding children's hospitals with a level IV neonatal care services and a level III obstetrical service
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19.03 PDF: (A) A freestanding children's hospital with a level IV neonatal care service may also provide a level III obstetrical service. In addition to the standards set forth in paragraphs (C) to (H) of rule 3701-22-25 of the Administrative Code, a freestanding children's hospi…
R.3701-22-28 Newborn nutrition
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19.03 PDF: (A) Each maternity unit or newborn care nursery will develop and follow written service plans for the following:(1) Administration of donor human milk and donor human milk products, if used, including protocols, equipment, and supplies for the administration of donor m…
R.3701-22-29 Record keeping
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19.03 PDF: (A) Medical record. Each maternity unit or newborn care nursery will maintain a medical record for each patient that documents, in a timely manner and in accordance with acceptable standards of practice, the patient's needs and assessments, and services rendered. Each …
R.3701-22-30 Health care service notification requirements
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19.03 PDF: (A) At least thirty days prior to initiating a new HCS or reactivating a discontinued or temporarily suspended HCS the hospital will notify the director in writing, in a manner prescribed by the director, of its intentions to initiate the service. This notice will cont…
R.3701-22-31 Solid organ transplant service standards
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19.03 PDF: (A) Each solid organ transplant service will provide services in a manner that meets or exceeds the conditions of participation set forth in Title 42 CFR Part 482, 482.72 to 482.104.(B) Each solid organ transplant service will be located in a transplant hospital that i…
R.3701-22-32 Patient selection criteria
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19.03 PDF: (A) An extra-renal, solid organ transplant service will use written patient selection criteria in determining a patients suitability for placement on the waiting list or a patient's suitability for transplantation.(B) Patient selection criteria will comply with the org…
R.3701-22-33 Utilization levels - solid organ transplant services
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19.03 PDF: (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 …
R.3701-22-34 Bone marrow transplantation service standards
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19.03 PDF: (A) The provisions of rules 3701-22-34 to 3701-22-37 of the Administrative Code are applicable to each blood and bone marrow transplant service regardless of the date service was initiated.(B) Each blood and bone marrow transplantation service will be located in a hosp…
R.3701-22-35 Personnel/staffing - bone marrow transplantation service
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19.03 PDF: (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 hem…
R.3701-22-36 Facilities/safety standards - bone marrow transplantation service
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19.03 PDF: (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 de…
R.3701-22-37 Patient selection/utilization - blood and bone marrow transplantation service
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19.03 PDF: (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 prot…
R.3701-22-38 General adult cardiac catheterization service standards
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19.03 PDF: (A) The provisions of rules 3701-22-38 to 3701-22-42.1 of the Administrative Code are applicable to each provider of cardiac catheterization services performing procedures on adult patients greater than or equal to eighteen years of age. An adult cardiac catheterizatio…
R.3701-22-38.1 Level I cardiac catheterization service standards
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19.03 PDF: (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 …
R.3701-22-38.2 Level II cardiac catheterization service standards
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19.03 PDF: (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 proced…
R.3701-22-38.3 Level III adult cardiac catheterization service standards
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19.03 PDF: (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 procedure…
R.3701-22-38.4 Adult electrophysiology procedure rooms
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19.03 PDF: (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…
R.3701-22-39 General personnel/staffing - adult cardiac catheterization service
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19.03 PDF: (A) Each adult cardiac catheterization service will designate a medical director.(B) The medical director of service will:(1) Have at least five years catheterization experience and recognized skills in the cardiac catheterization laboratory;(2) Have performed at least…
R.3701-22-40 General facilities, equipment, and supplies - adult cardiac catheterization service
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19.03 PDF: (A) Each adult cardiac catheterization service, or "service" will provide adequate, properly designed space to perform cardiac catheterization procedures safely and effectively. The amount of space may vary with the types of procedures performed and the nature of the f…
R.3701-22-41 Safety standards - adult cardiac catheterization service
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19.03 PDF: (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 …
R.3701-22-42 Adult cardiac catheterization service performance measures
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19.03 PDF: (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 i…
R.3701-22-42.1 Inspection and review of adult cardiac catheterization services
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19.03 PDF: (A) In addition to the inspection and audit requirements set forth in rule 3701-22-05 of the Administrative Code, the director will conduct an inspection of each adult cardiac catheterization service approximately once every three years.(B) The number of procedures per…
R.3701-22-43 Open-heart surgery service standards
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19.03 PDF: (A) The provisions of rules 3701-22-43 to 3701-22-47 of the Administrative Code are applicable to open-heart surgery services performing procedures on adult patients greater than or equal to eighteen years of age. An adult open-heart surgery service may serve a patient…
R.3701-22-44 Personnel/staffing - open-heart surgery service
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19.03 PDF: (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 o…
R.3701-22-45 Facilities, equipment, and supplies - open-heart surgery service
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19.03 PDF: (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 …
R.3701-22-46 Quality assessment and performance improvement - open-heart surgery service
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19.03 PDF: (A) In addition to the general quality assessment and performance improvement requirements set forth in rule 3701-22-07 of the Administrative Code, each open-heart surgery service will:(1) As part of the service's overall quality assessment and performance improvement …
R.3701-22-47 Adult open- heart surgery service performance measures
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19.03 PDF: (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 co…
R.3701-22-48 Pediatric intensive care service standards
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19.03 PDF: (A) The provisions of rules 3701-22-48 to 3701-22-52 of the Administrative Code are applicable to each pediatric intensive care service (PICU) regardless of the date service was initiated.(B) Each PICU service will develop and follow written comprehensive and effective…
R.3701-22-49 Personnel and staffing standards - pediatric intensive care service
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19.03 PDF: (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; an…