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This website publishes administrative rules on their effective dates, as designated by the adopting state agencies, colleges, and universities.

Chapter 3701-22 | Hospital Licensure

 
 
 
Rule
Rule 3701-22-01 | Definitions.
 

As used in this chapter:

(A) "Administrator" means the person responsible for the overall daily management of the hospital and decisions regarding the hospital license.

(B) "Adult open heart surgery service" or "pediatric cardiovascular surgery service" means the combination of staff, equipment, physical space and support services which are used to perform open-heart surgeries.

(C) "Advanced practice registered nurse" means an individual who holds a valid license under Chapter 4723. of the Revised Code to practice nursing as a certified registered nurse anesthetist, clinical nurse specialist, certified nurse-midwife, or certified nurse practitioner.

(D) "Alcohol and drug hospital" means a hospital engaged primarily in providing specialized care to inpatients with alcoholism or chemical dependency rehabilitative service needs.

(E) "Alcohol or drug abuse rehabilitation bed" means a hospital bed that is staffed and equipped for care of inpatients whose primary diagnosis is alcoholism or other chemical dependency.

(F) "Anesthesiologist" means a physician who has completed a residency training program in anesthesiology accredited by the accreditation council for graduate medical education or the American osteopathic association.

(G) "Anesthesiologist assistant" means an individual who holds a valid certificate of registration under Chapter 4760. of the Revised Code to practice as a anesthesiologist assistant.

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

(I) "Average daily census" means total patient days for a given calendar year divided by the number of days in the year.

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

(K) "Burn care bed" means a hospital bed that is staffed and equipped for care of inpatients whose primary diagnosis is burn-related.

(L) "Burn care hospital" means a hospital engaged primarily in providing inpatient care to patients requiring specialized burn-related diagnostic or therapeutic services.

(M) "Cancer hospital" means a hospital that is classified as a cancer hospital under 42 C.F.R. 412.23(f) (1985) and is organized primarily for treatment and research on cancer.

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

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

(P) "Certified nurse-midwife" means a registered nurse who holds a valid license issued under Chapter 4723. of the Revised Code to practice as a certified nurse-midwife in accordance with section 4723.43 of the Revised Code and rules adopted by the board of nursing.

(Q) "Certified nurse practitioner" means a registered nurse who holds a valid license issued under Chapter 4723. of the Revised Code to practice as a certified nurse practitioner in accordance with section 4723.43 of the Revised Code and rules adopted by the board of nursing.

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

(S) "Children's hospital" means either of the following:

(1) A hospital that provides general pediatric medical and surgical care in which at least seventy-five per cent of annual inpatient discharges for the preceding two calendar years were individuals less than eighteen years of age;

(2) A distinct portion of a hospital that provides general pediatric medical and surgical care, has a total of at least one hundred fifty pediatric special care and pediatric acute care beds, and in which at least seventy-five per cent of annual inpatient discharges for the preceding two calendar years were individuals less than eighteen years of age.

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

(U) "Cobalt service" means the structural unit of a hospital which provides radiation therapy using a cobalt teletherapy machine.

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

(W) "Consultation" means an individual is capable of rendering advice, opinions, recommendations, suggestions, and counsel in evaluating a patient upon notice by the requesting licensed health care provider and in accordance with the medical needs of the patient. This may be done by telemedicine or e-medicine in accordance with accepted professional standards.

(X) "Critical access hospital" means a hospital that is certified by the federal government as meeting the conditions of participation in the medicare program under 42 C.F.R. part 485, subpart F (1993).

(Y) "Deceased patient" means a human body or part of a human body from the condition of which it reasonably may be concluded that death recently occurred.

(Z) "Department" means the Ohio department of health.

(AA) "Director" means the director of health or his duly authorized representative.

(BB) "Direct care services" means any in-person patient contact where health care or personal care is provided in the hospital.

(CC) "Discharge" means a patient who is formally released from a hospital, including deaths. Discharge does not include temporary transfers to other settings.

(DD) "Donor human milk" means milk from a lactating mother or lactating mothers, other than the milk of the mother of the newborn, that has been screened pursuant to the guidelines issued by the "Human milk bank association of North America."

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

(FF) "Feeding preparation area" means a designated clean area within the newborn care nursery that is specifically for the storage and preparation of human milk, donor human milk, or commercial infant formula.

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

(HH) "Emergency department" means a distinct portion of a hospital or a freestanding building that provides care to individuals with emergency medical conditions.

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

(JJ) "Final disposition" means the interment, cremation, removal from the state, donation, or other authorized disposition of a dead body or a fetal death.

(KK) "Freestanding emergency department" means a facility that provides emergency care and is structurally separate and distinct from a hospital.

(LL) "Full-time equivalent" means at least one thousand eight hundred twenty hours per calendar year.

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

(NN) "Gamma knife service" means the structural unit of a hospital which provides stereotactic radiosurgery or stereotactic radiotherapy using a gamma knife.

(OO) "Guidelines for perinatal care" means the eighth edition of the "Guidelines for Perinatal Care" issued by the American academy of pediatrics and the American congress of obstetricians and gynecologists.

(PP) "Gynecologic patient" means a woman with or suspected of having a disorder related to her reproductive organs.

(QQ) "Health care service" or "HCS" means any of the following:

(1) Pediatric intensive care;

(2) Solid organ and bone marrow transplantation;

(3) Stem cell harvesting and reinfusion;

(4) Cardiac catheterization;

(5) Open heart surgery;

(6) Operation of linear accelerators;

(7) Operation of cobalt radiation therapy units;

(8) Operation of gamma knives.

(RR) "Heart hospital" means a hospital primarily engaged in providing inpatient care to patients requiring specialized cardiac diagnostic or therapeutic services.

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

(TT) "Hospice beds" means the inpatient beds of a hospice care program as defined in division (A) of section 3712.01 of the Revised Code.

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

(1) A hospital operated by the federal government;

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

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

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

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

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

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

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

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

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

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

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

(13) A facility registered to provide a pediatric transition care program under section 3712.042 of the Revised Code that is used exclusively for pediatric transition care patients.

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

(VV) "Hospital bed" or "bed" means a bed in a hospital, with the attendant physical space, fixtures, and equipment for use in caring primarily for inpatients, including those beds used in caring for patients who stay for less than twenty-four hours, but the primary use of such beds is for care of inpatients.

(WW) "Human milk" means the milk produced by a mother to feed her newborn.

(XX) "Inpatient" means a patient who is admitted to the hospital.

(YY) "Inpatient surgical operating room" means a room in a hospital used to perform any operative or manual procedure undertaken for the diagnosis or treatment of a disease or other disorder.

(ZZ) "Ionizing radiation" means gamma rays and x-rays, alpha and beta particles, high-speed electrons, neutrons, protons, and other atomic or nuclear particles or rays.

(AAA) "Lactation consultant" means an individual who holds credentials as an "International board certified lactation consultant."

(BBB) "Level classification" means the level designation of the maternity unit and newborn care nursery that determines the services that may be provided.

(CCC) "Licensed dietitian" means an individual licensed under Chapter 4759. of the Revised Code to practice as a licensed dietitian.

(DDD) "Licensed practical nurse" means an individual licensed under Chapter 4723. of the Revised Code to practice nursing as a licensed practical nurse.

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

(FFF) "Linear accelerator service" means the structural unit of a hospital which provides radiation therapy or stereotactic radiosurgery using a linear accelerator.

(GGG) "Long term acute care hospital", or LTACH, means a hospital that is classified as a long-term care hospital under 42 C.F.R. 412.23(e) (1985), that is engaged primarily in providing medically necessary specialized acute hospital care for medically complex patients who are critically ill or have multi-system complications or failures, and that has an average length of stay of forty-five days or less.

(HHH) "Long term acute care hospital bed" means a bed in a long term acute care hospital.

(III) "Low-risk allogeneic bone marrow transplantation" means fully matched allogeneic sibling donor transplants without any of the high-risk features listed under paragraph (SS) of this rule.

(JJJ) "Maternity unit" means a distinct portion of a hospital in which inpatient care is provided to women during all or part of the maternity cycle.

(KKK) "Medical director" means the physician who is responsible for managing and directing the provision of medical services at the maternity unit or newborn care nursery or health care service.

(LLL) "Medical/surgical bed" means a hospital bed in a medical or surgical unit where general medical/surgical services are provided.

(MMM) "Neonate" or "neonatal" means a newborn up to thirty days old.

(NNN) "Neonatal care service" also known as a "newborn care nursery," means a distinct portion of a hospital in which inpatient care is provided to infants and may include a distinct portion of a hospital in which intensive care is provided to infants.

(OOO) "Neonatal resuscitation program" means the neonatal resuscitation program developed by the American heart association and American academy of pediatrics, or an equivalent program approved by the director.

(PPP) "Number of admissions" means the number of patients accepted for inpatient service of twenty-four hours or more.

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

(RRR) "Nursing staff" means registered nurses, licensed practical nurses, and other staff that render care under the direction or delegation of a registered nurse.

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

(TTT) "Obstetric service" means a maternity unit.

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

(VVV) "On-call" means an individual is capable of being reached by telephone or other electronic device and able to return to the unit in accordance with facility policies.

(WWW) "On-duty" means in the unit alert and responsive to patient needs.

(XXX) "On-site" means in the building.

(YYY) "On-staff" means a member of the formal organization of physicians and other health professionals approved by the governing body with the delegated responsibility to provide for the quality of all medical care, and other health care as appropriate, provided to patients.

(ZZZ) "Owner" means the legal entity that holds the hospital license and seeks reimbursement for hospital services from patients and/or third party payors. A change of owner is evidenced by a change in the federal tax identification number (FEIN) of such entity.

(AAAA) "Outpatient" means a patient who receives medical treatment and is not admitted to the hospital as an inpatient.

(BBBB) "Outpatient surgical operating room" means a room in a hospital designed to perform an operative or manual procedure undertaken for the diagnosis or treatment of a disease or other disorder on non-inpatients.

(CCCC) "Patient" means any individual who receives care in a hospital.

(DDDD) "Patient days of care" means annual total number of inpatients in a hospital on a daily count at a specific uniform time of day.

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

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

(GGGG) "Pediatric intensive care beds" means beds located in a separate and distinct pediatric intensive care unit where pediatric patients suffering from critical illness receive care;

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

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

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

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

(LLLL) "Pharmacist" means an individual registered under Chapter 4729. of the Revised Code to practice pharmacy.

(MMMM) "Physical rehabilitation bed" means a hospital bed that is staffed and equipped for care of inpatients requiring intensive, multi-disciplinary physical restorative services.

(NNNN) "Physical rehabilitation hospital" means a hospital engaged primarily in providing specialized care to inpatients with intensive, multi-disciplinary physical restorative service needs.

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

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

(QQQQ) "Physician assistant" means a individual who holds a valid certificate to practice issued under Chapter 4730. of the Revised Code to provide services to patients as a physician assistant under the supervision, control, and direction of one or more physicians who are responsible for the physician assistant's performance.

(RRRR) "Political subdivision" means a county, township, municipal corporation, or other body corporate and politic responsible for governmental activities in a geographic area smaller than that of the state.

(SSSS) "Primary agent" means a person granted authority to act for a principal under a power of attorney, whether denominated an agent, attorney in fact, or otherwise.

(TTTT) "Proof of accreditation" means the written proof of compliance with the Conditions of Participation by a CMS-approved accreditation organization.

(UUUU) "Psychiatric care bed" means a hospital bed that is staffed and equipped for care of inpatients whose primary diagnosis in mental illness not licensed by the Ohio department of mental health and addiction services.

(VVVV) "Psychiatric hospital" means a hospital engaged primarily in providing specialized care to inpatients diagnosed with mental illness licensed by the Ohio department of mental health and addition services.

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

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

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

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

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

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

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

(AAAAA) "Radiation therapy service" means the structural unit of a hospital which provides radiation therapy.

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

(CCCCC) "Registered nurse" means an individual who is licensed under section 4723.09 of the Revised Code to practice as a licensed registered nurse.

(DDDDD) "Rural emergency hospital" means an entity that is certified by the federal government as meeting the conditions of participation in the medicare program under 42 C.F.R. part 485, subpart E (2023).

(EEEEE) "Serious harm" means an adverse outcome that results in or is likely to result in any of the following:

(1) Death;

(2) A significant decline in physical, mental, or psychosocial health that is not solely due to the normal progression of a disease or aging process;

(3) A loss of limb, or disfigurement;

(4) Avoidable pain that is excruciating, and more than transient; or

(5) Other serious harm that creates life-threatening complications/conditions.

(FFFFF) "Social worker" means an individual licensed to practice social work under Chapter 4757. of the Revised Code.

(GGGGG) "Special care bed" means a hospital bed in which special medical/surgical services, beyond general medical/surgical care and including intensive care or coronary care, are provided.

(HHHHH) "Special delivery services" means services provided by a freestanding children's hospital that does not offer typical obstetric services as a level I obstetric service, level II obstetric service, or level III obstetric service, but is licensed as a level III or level IV neonatal care service, and is designed and equipped to provide delivery services to pregnant women as part of a comprehensive multidisciplinary program of fetal and neonatal care when it is determined that the fetus, once delivered, will require immediate highly subspecialty neonatal intensive care or neonatal surgery typically provided by a level III or level IV neonatal care service.

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

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

(KKKKK) "State university" has the same meaning as in section 3345.12 of the Revised Code.

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

(MMMMM) "Stereotactic radiosurgery service" means the structural unit of a hospital which provides stereotactic radiosurgery.

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

(OOOOO) "Stillbirth" means that an infant of at least twenty weeks of gestation suffered a fetal death.

(PPPPP) "Temporary license" means a license issued by the director of health to a new hospital applying for licensure under Chapter 3722. of the Revised Code, authorizing the new hospital to see patients for accreditation or certification purposes as part of the completion of the final licensing process.

Last updated September 16, 2024 at 8:35 AM

Supplemental Information

Authorized By: 3722.06
Amplifies: 3722.01
Five Year Review Date: 9/4/2029
Rule 3701-22-02 | Applicability of rules.
 

Until September 30, 2024, each hospital will comply with the following:

(A) With a maternity unit, newborn care nursery, or both, complies with Chapter 3701-7 of the Administrative Code;

(B) With a pediatric intensive care unit complies with the applicable requirements of Chapter 3701-84 of the Administrative Code;

(C) With a solid organ and bone marrow transplantation service complies with the applicable requirements of Chapter 3701-84 of the Administrative Code;

(D) With a stem cell harvesting and reinfusion complies with the applicable requirements of Chapter 3701-84 of the Administrative Code;

(E) With a cardiac catheterization service complies with the applicable requirements of Chapter 3701-84 of the Administrative Code;

(F) With a open heart surgery service complies with the applicable requirements of Chapter 3701-84 of the Administrative Code;

(G) That operates linear accelerators complies with the applicable requirements of Chapter 3701-84 of the Administrative Code;

(H) With a cobalt radiation therapy unit complies with the applicable requirements of Chapter 3701-84 of the Administrative Code;

(I) That operates gamma knives complies with the applicable requirements of Chapter 3701-84 of the Administrative Code;

Last updated September 16, 2024 at 8:35 AM

Supplemental Information

Authorized By: 3722.06
Amplifies: 3722.02
Five Year Review Date: 9/4/2029
Rule 3701-22-03 | Application for initial, renewal, or transfer licensure; notice to the director; sales, assignments, or transfers.
 

(A) Application for a license to operate a hospital, renewal of an existing license may be made either in writing on a form provided by the director and signed by the applicant or the applicant's primary agent, or using an electronic system prescribed by the director and affirmed by the applicant or the applicant's agent. A completed application includes the following:

(1) A nonrefundable license application or renewal fee based on the number of beds within the hospital as follows:

(a) One to fifty beds, four thousand four hundred twenty-five dollars;

(b) Fifty-one to one hundred beds, eight thousand eight hundred fifty dollars;

(c) One hundred one to one hundred fifty beds, thirteen thousand two hundred fifty dollars;

(d) One hundred fifty-one to three hundred beds, seventeen thousand six hundred seventy-five dollars;

(e) Three hundred one to five hundred beds, twenty-six thousand five hundred dollars;

(f) Five hundred one to seven hundred fifty beds, thirty-five thousand three hundred fifty dollars,

(g) Seven hundred fifty-one to one thousand beds, forty four thousand one hundred seventy-five dollars;

(h) One thousand one to one thousand five hundred beds, fifty-three thousand dollars; or

(i) More than one thousand five hundred beds, sixty-one thousand eight hundred fifty dollars;

Any fee paid pursuant to this section may be paid either in full at the time of application, renewal, or transfer, or in increments of one-third of the total amount annually.

(2) A nonrefundable service fee in the form of a check or money order made payable to the "treasurer, state of Ohio" or as payment submitted through an electronic system prescribed by the director as follows:

(a) For each maternity unit, three thousand dollars;

(b) For each newborn care nursery, three thousand dollars; and

(c) For each health care service, three thousand dollars;

Any fee paid pursuant to this section may be paid either in full at the time of application, renewal, or transfer, or in increments of one-third of the total amount annually.

(3) The name to appear on the license;

(4) The address of the main hospital location and an attestation signed by the hospital administrator as defined in paragraph (A) of rule 3701-22-01 of the Administrative Code, that includes the address(es) of each "department of a provider," remote location of a hospital," "satellite facility," and "provider based location" as those terms are defined in 42 CFR 413.65.

(a) Locations listed pursuant to this section are operated under the license issued under Chapter 3722. to the hospital that is the "main provider" as that term is defined in 42 CFR 413.65. Only those locations are permitted to be operated under the main hospital's license; and

(b) Hospitals are to maintain a current list of all provider-based locations and notify the director within thirty days of the removal or addition of a provider based location. Failure to provide notice to the director may result in compliance actions set forth in rule 3701-22-05 of the Administrative Code.

(5) A copy of the proof of certification or accreditation, if applicable. For a newly-constructed hospital seeking licensure after October 1, 2024, a copy of the hospital's proof of temporary accreditation.

(6) A listing of the beds within the hospital, under the following categories:

(a) Adult medical/surgical;

(b) Adult special care (ICU/CCU);

(c) Alcohol or drug abuse rehabilitation;

(d) Burn care;

(e) Hospice;

(f) Long term acute care;

(g) Long term, reported in the following categories:

(i) Skilled nursing facility beds certified under Title XVIII of the Social Security Act, 49 Stat. 620 (1935), 42 U.S.C. 301, as amended (1981) and which are not licensed under Chapter 3721. of the Revised Code;

(ii) Nursing facility beds certified under Title XIX of the Social Security Act, 49 Stat. 620 (1935), 42 U.S.C. 301, as amended (1981) and which are not licensed under Chapter 3721. of the Revised Code;

(iii) Nursing facility beds certified under Title XVIII of the Social Security Act, 49 Stat. 620 (1935), 42 U.S.C. 301, as amended (1981) and Title XIX of the Social Security Act, 49 Stat. 620 (1935), 42 U.S.C. 301, as amended (1981) and which are not licensed under Chapter 3721. of the Revised Code; or

(iv) Special skilled nursing beds certified as skilled nursing facility beds under Title XVIII of the Social Security Act, 49 Stat. 620 (1935), 42 U.S.C. 301, as amended (1981) that were originally authorized by and are operated in accordance with section 3702.521 of the Revised Code or its predecessor;

(h) Neonatal, reported in the following categories:

(i) Level I;

(ii) Level II;

(iii) Level III;

(iv) Level IV;

(i) Obstetric, reported in the following categories:

(i) Level I;

(ii) Level II;

(iii) Level III, including special delivery beds;

(iv) Level IV, including special delivery beds;

(j) Pediatric intensive care (beds in a separate and distinct pediatric intensive care unit where pediatric patients suffering from critical illness receive care);

(k) Pediatric - general (services for patients less than twenty-two years of age are provided);

(l) Physical rehabilitation;

(m) Psychiatric care (beds not licensed by the Ohio department of mental health and addiction services); and

(n) Emergency service.

(B) If the applicant satisfies the requirements described in paragraph (A) of this rule, the director will, as applicable, issue to the applicant a license to operate a hospital, or renew an applicant's license unless the applicant to renew is barred from renewing in accordance with rule 3701-22-05 of the Administrative Code.

(C) The license is valid only for the hospital and any department(s) of a provider, remote location(s) of the hospital, satellite facility(ies), and provider based locations.

(D) If a hospital licensed under this chapter is to be assigned, sold, or transferred to a new owner, the prospective new owner will, at least thirty days prior to the effective date of the assignment, sale, or transfer, apply, on an application provided by the director, for a change of owner and provide the information required by paragraphs (A)(3) to (A)(6) of this rule.

(1) Once the license transfer is approved, the new owner will be responsible for compliance with any action taken or proposed by the director under sections 3722.07 or 3722.08 of the Revised Code, or rule 3701-22-05 of the Administrative Code. If a notice has been issued under section 119.07 of the Revised Code, the new owner becomes party to the notice.

(E) The license holder will post a copy of the license in a conspicuous place in the main hospital and all locations listed pursuant to paragraph (A)(4) of this rule.

(F) Each license issued under this rule is valid for a three-year period unless revoked or suspended. A license expires on the date that is three years from the date of issuance and may be renewed for additional three-year periods.

(G) The license renewal fee, including fees paid as one-third increments annually, specified in paragraph (A) of this rule will be paid not later than ninety days after the director of health mails an invoice for the fee to the license holder. A penalty of ten per cent of the amount of the renewal fee will be assessed for each month the fee is overdue.

(H) Application for a temporary license to operate a new hospital after October 1, 2024 may be made either in writing on a form provided by the director and signed by the applicant or the applicant's agent, or using an electronic system prescribed by the director and affirmed by the applicant or the applicant's agent. A completed application for a temporary licensure will include the following:

(1) The information required under paragraphs (A)(3) to (A)(6) of this rule;

(2) A copy of the applicant's occupancy permit; and

(3) A copy of the current state fire marshal inspection report documenting that the applicant is in compliance with the state fire code.

(I) If an applicant satisfies the requirements described in paragraph (H) of this rule, the director will issue to the applicant a temporary license to allow the applicant to operate as a hospital for up to six months for the purposes of completing a certification or accreditation process. Once the applicant receives proof of certification or accreditation, the applicant will apply for full licensure under paragraph (A) of this rule.

(1) The applicant may apply for one extension of a temporary license for up to an additional six months;

(2) If an applicant fails to apply to the department for full licensure by the date of expiration of a temporary license to operate as a hospital, the applicant will cease operating as a hospital.

(J) The licensee will notify the director, in writing:

(1) Within seven days of a change in administrator or name of the hospital.

(2) Seven days prior to the voluntary suspension of operation or closing of the hospital. In the event of involuntary closure, the licensee will provide written notice as soon as possible after learning of the closure.

(3) Ninety days prior to any change to the owner of the entity holding the license. For purposes of this section, such change is not a change of ownership.

(K) Except in the event of emergencies, the licensee will notify the director, in writing, at least fifteen days prior to any construction, modernization, major acquisition, or significant alteration that:

(1) Will result in an interruption of patient care services in any department(s) of a provider, remote location(s) of the hospital, or satellite facility(ies).

(2) Adds a department(s) of a provider, remote location(s) of the hospital, or satellite facility(ies).

(3) Adds hospital building(s), replaces hospital building(s), or expands hospital building(s) patient care areas;

(4) Changes the layout of a patient care area of the hospital that involves removing or replacing walls, adding new or extending existing plumbing or electric service, adding new or extending existing heating, ventilation, or air conditioning service; or adding vacuum or gases; or

(5) Converts non-patient care area(s) to patient care area(s) that involves removing or replacing walls, adding new or extending existing plumbing or electric service, adding new or extending existing heating, ventilation, or air conditioning service; or adding vacuum or gases.

Emergencies resulting in an interruption of hospital services are to be reported as soon as possible, no later than within twenty-four hours, to the director by phone or electronic mail. For purposes of this rule, emergency means an unexpected serious event restricting patient access to hospital services or represents the potential for harm to patients. This may include events involving emergency evacuations, fire suppression, disaster response, law enforcement, and other forms of hazard control and mitigation of an ongoing event.

(L) Failure to provide notice to the director required by paragraph (K) of this rule may result in compliance actions set forth in rule 3701-22-05 of the Administrative Code.

(M) The director may inspect a hospital prior to issuing or denying a license to operate a hospital, or when renewing a license. An applicant may avoid this inspection if the applicant submits with the application a copy of the hospital's most recent final on-site survey report from the federal centers for medicare and medicaid services or an accrediting organization approved under 42 U.S.C. 1395bb(a) demonstrating that the hospital is certified or accredited.

Last updated September 16, 2024 at 8:35 AM

Supplemental Information

Authorized By: 3722.06
Amplifies: 3722.02, 3722.03, 3722.04
Five Year Review Date: 9/4/2029
Rule 3701-22-04 | Prohibitions.
 

(A) Upon licensure or temporary licensure as a hospital by the director of health or September 30, 2024, whichever is sooner, no person and no political subdivision, agency, or instrumentality of this state may operate a hospital without holding a license or a temporary license issued by the director of health under section 3722.03 of the Revised Code.

(B) If the director of health determines that a hospital is operating without a license or temporary license in violation of Chapter 3722. of the Revised Code or this chapter, the director may do any of the following:

(1) Notify the hospital that it is operating without a license or a temporary license and provide it with an opportunity to apply for licensure, but only within the thirty-day period beginning on the date the hospital received the director's notice;

(2) Direct the hospital to cease operations;

(3) Impose a civil penalty of not more than two hundred fifty thousand dollars;

(4) In addition to the imposition of a civil money penalty, impose a penalty of not less than one thousand dollars and not more than ten thousand dollars for each day the hospital operates without a license or temporary license.

(C) If the hospital described in paragraph (B) of this rule continues to operate without a license or a temporary license, the director may petition the court of common pleas of the county in which the hospital is located for an order enjoining the hospital from operating.

(D) No person and no political subdivision, agency, or instrumentality of this state may:

(1) Interfere with an inspection or investigation of a hospital, maternity unit, or health care service. As used in this paragraph, "interfere" means to obstruct directly or indirectly any individual conducting an authorized inspection or investigation from carrying out his or her duties, including:

(a) Harassment;

(b) Intimidation;

(c) Refusal to permit the director upon presentation of official department identification, to inspect or investigate the operation of a hospital, maternity unit, or health care service; or

(d) Refusal to permit the director upon presentation of official department identification to enter and inspect records that are kept concerning the operations of the hospital, maternity unit, or health care service, for information necessary to determine compliance with the applicable rules of this chapter.

(2) Materially misrepresent any information provided to the director pursuant to Chapter 3722. of the Revised Code and this chapter.

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

Last updated September 16, 2024 at 8:35 AM

Supplemental Information

Authorized By: 3722.06
Amplifies: 3722.02
Five Year Review Date: 9/4/2029
Rule 3701-22-05 | Inspections; compliance actions.
 

(A) The director of health monitors compliance with Chapter 3722. of the Revised Code and Chapter 3701-22 of the Administrative Code. The director may at any time inspect a licensed hospital in order to address an incident that may impact public health, respond to a complaint submitted to the director, or otherwise ensure the safety of patients cared for by the hospital. Inspections may be scheduled and announced or random and unannounced.

(B) If the director determines the existence of a violation of any provision of Chapter 3722. of the Revised Code or Chapter 3701-59 of the Administrative Code, the director may do any of the following:

(1) Request the licensee to submit an acceptable plan of correction to the director stating the actions being taken or to be taken to correct a violation, the time frame for completion and the means by which continuing compliance will be monitored; and

(2) In accordance with Chapter 119. of the Revised Code:

(a) Impose a civil penalty based on the severity of the violation as follows:

(i) For violations that present an imminent threat of serious physical or life threatening danger, or an immediate serious threat to the health, safety or security of one or more patients, a civil penalty of not less than one hundred thousand dollars and not more than two hundred thousand dollars, not including per day civil penalties for ongoing violations;

(ii) For violations that directly threaten the health, safety, or security of one or more patients, a civil penalty of not less than ten thousand dollars and not more than one hundred thousand dollars, not including per day civil penalties for ongoing violations; or

(iii) For violations that indirectly threaten or potentially threaten the health, safety, or security of one or more patients, a civil penalty of not less than one thousand dollars and not more than ten thousand dollars, not including per day civil penalties for ongoing violations;

In addition to the civil monetary penalties set forth in this rule, the director may impose a civil penalty of one thousand dollars per day for each day the director determines a violation is ongoing.

(b) Suspend a health care service or revoke the hospital's license, in accordance with paragraph (D)(3) of this rule, if the director believes that there is clear and convincing evidence that the continued operation of the hospital, maternity unit, newborn care nursery, or health care service unit present a danger of immediate and serious harm to patients or residents. The director will provide the hospital with written notice of the proposed action to the hospital that specifies the:

(i) Nature of the conditions giving rise to the director's judgment;

(ii) Measures that the director determines the hospital needs to take to respond to the conditions;

(iii) Date, which will be not later than thirty days after the notice is delivered, on which the director intends to suspend the health care service or revoke the hospital's license if the conditions are not corrected and the director determines that the license holder has not come into substantial compliance;

(C) In determining whether a violation warrants a civil money penalty, the director may consider all of the following:

(1) The danger of serious physical or life-threatening harm to one or more patients or residents, including a determination whether the harm presents an:

(a) Imminent threat of serious physical or life threatening danger, or an immediate serious threat to the emotional health, safety, or security one or more patients;

(b) Direct threat to the physical or emotional health, safety, or security of one or more patients; or

(c) Indirect threat or potential threat to the physical or emotional health, safety, or security of one or more patients;

(2) The number of patients directly affected by the violation;

(3) The number of hospital staff involved in the violation;

(4) Any actions taken by the hospital to correct or mitigate the violation, including the timeliness and sufficiency of the hospital's response to the violation and the outcome of that response; and

(5) The hospital's history of compliance.

(D) If the director determines the need for a civil money penalty under this rule, the director may enter into settlement negotiations with the affected hospital. Settlements may include any or all of the following:

(1) A lesser civil money penalty than initially proposed;

(2) Allowing the hospital to invest an amount equal to the proposed civil penalty on remedial measures designed to reduce the likelihood of similar violations occurring in the future. Unless authorized by the director, such remedial measures are to be conducted or undertaken by a third party; or

(3) Alternative remedies warranted by the deficient practice and negotiations.

(E) If the director suspends a health care service or revokes the license of a hospital under paragraph (B)(2)(b) of this rule, the director will issue a written order of suspension or a revocation, as applicable, and cause it to be delivered by certified mail or in person in accordance with section 119.07 of the Revised Code. The order is not subject to suspension by the court while an appeal filed under section 119.12 of the Revised Code is pending. If the license holder subject to the suspension or revocation requests an adjudication, the date set for the adjudication will be within seven days after the license holder makes the request, unless another date is agreed to by both the license holder and the director. The suspension of the health care service or revocation of a hospital's license will remain in effect, unless reversed by the director, until a final adjudication order issued by the director pursuant to this chapter and Chapter 119. of the Revised Code becomes effective. The director will issue a final adjudication order not later than fourteen days after completion of the adjudication. If the director does not issue a final order within the fourteen-day period, the suspension or revocation is void, but any final adjudication order issued subsequent to the fourteen-day period is not affected.

(F) During the period specified in paragraph (B)(2)(b)(iii) of this rule, the hospital may, without staying the proceedings, notify the director that the conditions giving rise to the director's determination have been corrected and that the hospital is in substantial compliance with Chapter 3722. of the Revised Code and this chapter, the director shall conduct an inspection. Based on this inspection, if the director determines that the conditions have not been corrected and the license holder has not come into substantial compliance, the director may suspend the health care service or revoke the license.

(G) If the licensed hospital fails to notify the director, within the period of time specified in paragraph (B)(2)(b)(iii) of this rule, that the conditions giving rise to the director's determination have been corrected and that the hospital is in substantial compliance with this chapter and shall not be affected, the director may suspend the health care service or revoke the license.

(H) If the director issues a final adjudication order suspending a health care service or suspending or revoking a license issued under this chapter and the license holder continues to operate a hospital, the director may ask the attorney general to apply to the court of common pleas of the county in which the hospital is located for an order enjoining the license holder from operating the hospital.

Last updated September 16, 2024 at 8:35 AM

Supplemental Information

Authorized By: 3722.06
Amplifies: 3722.05
Five Year Review Date: 9/4/2029
Rule 3701-22-06 | Administration.
 

Each hospital, other than a critical access hospital or a rural emergency hospital, is to provide effective administration responsible for the following areas:

(A) Compliance with federal, state, and local laws, in accordance with 42 CFR 482.11, including cooperation with any public health investigation;

(B) Governing body, in accordance with 42 CFR 482.12;

(C) Patient's rights, in accordance with 42 CFR 482.13;

(D) Emergency preparedness, in accordance with 42 CFR 482.15.

Last updated September 16, 2024 at 8:35 AM

Supplemental Information

Authorized By: 3722.06
Amplifies: 3722.02
Five Year Review Date: 9/4/2029
Rule 3701-22-07 | Basic hospital functions.
 

Each hospital, other than a critical access hospital or a rural emergency hospital, is to provide for the following:

(A) A quality assessment and performance improvement program, in accordance with 42 CFR 482.21. In addition, the hospital will participate in quality assessment and performance improvement projects identified by the director in consultation with the representatives of the regulated industry. Such projects may include those:

(1) Required by the United States centers for medicare and medicaid services or the hospital's accrediting organization; or

(2) For a hospital with a maternity unit and newborn care nursery, implementation of one or more maternal safety bundle(s) developed by the alliance for innovation in maternal health.

(B) Medical staff, in accordance with 42 CFR 482.22;

(C) Nursing services, in accordance with 42 CFR 482.23;

(D) Medical records services, in accordance with 42 CFR 482.24;

(E) Pharmaceutical services, in accordance with 42 CFR 482.25;

(F) Radiologic services, in accordance with 42 CFR 482.26;

(G) Laboratory services, in accordance with 42 CFR 482.27;

(H) Food and dietetic services, in accordance with 42 CFR 482.28;

(I) Utilization review, in accordance with 42 CFR 482.30;

(J) Physical environment, in accordance with 42 CFR 482.41;

(K) Infection prevention and control and antibiotic stewardship programs, in accordance with 42 CFR 482.42. In addition, the hospital will:

(1) Maintain a tuberculosis control plan that meets the standards set forth in rule 3701-15-03 of the Administrative Code;

(2) Implement a written surveillance plan outlining the activities for monitoring/tracking infections based on nationally-recognized surveillance criteria such as the CDC's national healthcare safety network (NHSN) criteria to define infections or other nationally recognized system for hospitals and:

(a) Includes a surveillance system that includes a data collection tool; and

(b) Uses surveillance data to implement timely corrective actions when:

(i) A greater than expected number healthcare-associated infections are detected;

(ii) Transmission of targeted multi-drug resistant organisms (e.g., cre, candida auris) are detected;

(3) Establish and implement an effective water management program to identify hazardous conditions, and take steps to manage the risk of occurrence and transmission of waterborne pathogens, including but not limited to legionella, in building water systems in accordance with guidance from the United States centers for disease control and prevention (available at https://www.cdc.gov/control-legionella/php/toolkit/wmp-toolkit.html) and recommendations of the United States centers for disease control and prevention healthcare infection control practices advisory committee, "Environmental Infection Control Guidelines" (2019) or its successors.

(a) Within the first twelve months, two sets of validation testing in the building water system of each building that provides inpatient medical or surgical services, taken no fewer than four months apart and more than eight months apart, is to occur. Each set of water samples will be representative of all hot potable water loops and water sources based upon the risk assessment and conditions identified in the water management program, including but not limited to cooling towers, therapy spas, decorative fountains or water features where exposure to aerosols may occur in order to evaluate the performance of the water management program in controlling legionella risk or other waterborne pathogens. A hospital that has demonstrated detections of less than one cfu/ml of legionella through at least two prior validation test sets collected over a one year period may conduct annual validation testing in lieu of twice-yearly testing. Validation testing includes all of the following:

(i) At least one cold water sample obtained from the incoming water mains from the public water system or the water source;

(ii) At minimum, representative samples obtained from distal and proximal locations on each hot water loop on the hot water distribution system; and

(iii) Measurement of total or free chlorine residual, as appropriate, at the time of sample collection, and the observed sustained maximum temperatures for cold and hot water samples.

(b) Collection of water samples under this paragraph will conform to the United States centers for disease control and prevention's guidelines for water testing for legionella available at https://www.cdc.gov/control-legionella/php/toolkit/routine-testing-module.html and https://www.cdc.gov/investigate-legionella/media/pdfs/cdc-sampling-procedure.pdf. Samples collected may be less than one liter in volume. Collected samples are to be analyzed at a laboratory that has been accredited by a national or international accrediting body according to national or international recognized standards, that has legionella culture testing included in the laboratory's scope of accreditation.

(4) As it relates to waterborne pathogens, coordinate with the Ohio department of health and the local health district having jurisdiction when there is a legionellosis presumptive healthcare-associated case, there are two or more legionellosis possible healthcare-associated cases in a twelve-month period, or when a legionellosis outbreak occurs. When an investigation is required, investigation activities are coordinated with the disease surveillance and recommendations in the Ohio department of health's "Infectious Disease Control Manual," available online at https://odh.ohio.gov/know-our-programs/infectious-disease-control-manual, the CDC guidance on defining healthcare-associated cases available at https://www.cdc.gov/investigate-legionella/php/healthcare-resources/healthcare-facilities.html, and CDC guidance on conducting investigations available at https://www.cdc.gov/investigate-legionella/php/healthcare-resources/testing-collecting-specimens.html, and includes any or all of the following:

(a) Implementing water use restrictions and/or installation of absolute 0.2 micron biological United States food and drug administration-approved point of use filters on potable hot water fixtures throughout the facility as appropriate or where separate water loops are present and can be isolated within the facility, in locations where the legionellosis case or cases resided, or received treatment or services while in the facility, or otherwise may have been exposed to aerosols from the hot water system or other water features. A hospital with a continuous secondary disinfection system that has demonstrated detections of less than one cfu/ml of legionella through validation testing and control measures specified in the water management plan, may, after consultation of the Ohio department of health and the local health district having jurisdiction, avoid installation of point of use water filters;

(b) Conducting or updating an environmental facility assessment using the United States centers for disease control and prevention's "Legionella Environmental Assessment Form," available online at https://www.cdc.gov/legionella/downloads/legionella-environmental-assessment-p.pdf, or equivalent assessment, for the facility to identify risk conditions that may promote the growth of Legionella or other waterborne pathogens;

(c) Providing a copy of the water management program and at least one year of prior validation testing results to the Ohio department of health and the health district having jurisdiction;

(d) Identification and collection of a set of water samples that is representative of all potable water loops and water sources associated with the investigation, including but not limited to cooling towers, therapy spas, decorative fountains or water features where exposure to aerosols may occur. Water sample testing includes:

(i) At least one cold water sample will be obtained from the incoming water mains from the public water system or the water source;

(ii) Representative samples obtained from a minimum of distal and proximal locations on each floor of each hot water loop on the hot water distribution system, including hot water storage tanks or storage units when present, both a swab or first draw sample, and a bulk water sample from the fixture or location;

(iii) A sample or samples from locations in the hot water system or water features where the legionellosis case or cases resided, or received treatment or services while in the facility, or otherwise may have been exposed to aerosols from the hot water system or other water features;

(iv) Measurement of total and free chlorine residual, as appropriate, at the time of sample collection, and the observed sustained maximum temperatures for cold and hot water samples.

(v) Preservation and provision of all cultured water and swab samples with observed Legionella cultures that were collected during an investigation of a case or outbreak to the Ohio department of health's public health laboratory for potential comparison against clinically cultured samples.

(e) Collection of water samples under this paragraph will conform to the United States centers for disease control and prevention's "Sampling Procedure and Potential Sampling Sites for Investigation" available at https://www.cdc.gov/legionella/downloads/cdc-sampling-procedure.pdf, to include collection of one liter samples, and "CDC Laboratory Guidance for Processing Environmental Samples" (2005), respectively, with collected samples to be analyzed at a laboratory that has been accredited by a national or international accrediting body according to national or international recognized standards, that has legionella culture testing included in the laboratory's scope of accreditation, and that has demonstrated proficiency in the detection of legionella culture in accordance with the United States centers for disease control and prevention environmental legionella isolation techniques evaluation program.

(f) Implementation of identified actions to correct the risk conditions identified as part of the environmental facility assessment, and environmental water testing results, which may include but not be limited to:

(i) Adjustments to hot water temperatures in storage tanks or circulation systems;

(ii) Correction of areas of poor water flow or stagnation;

(iii) Conducting short-term remediation; or

(iv) Installing permanent disinfection systems;

(g) Provision of appropriate communications to patients, employees, and visitors regarding the investigative and corrective actions to help reduce risk of further exposures;

(h) After remediation actions are completed, or permanent disinfection is installed, collection of the same sample locations and types as set forth in paragraph (K)(4)(d) of this rule as follows:

(i) The first sample set, no earlier than forty-eight hours after remediation actions have ceased; and

(ii) For the second and subsequent sample sets, no earlier than ten days having elapsed since the last sample collection date;

All sample results collected under this paragraph are to be reported to both the Ohio department of health and the local health district having jurisdiction.

(i) Obtaining the concurrence of the Ohio department of health and the local health district having jurisdiction, before lifting of water restrictions or removal of point of use water filters from fixtures when all water or swab samples have legionella detections of less than one colony forming unit per milliliter for potable water

(j) Flushing of all hot water distribution systems and fixtures after water restrictions are lifted and/or point of use water filters are removed; and

(k) An investigation conducted under this paragraph includes revising the hospital's water management program based on the full investigations results and the recommendations of the Ohio department of health and the local health district.

(L) Discharge planning, in accordance with 42 CFR 482.43; and

(M) Organ, tissue, and eye procurement, in accordance with 42 CFR 482.45.

Last updated September 16, 2024 at 8:36 AM

Supplemental Information

Authorized By: 3722.06
Amplifies: 3722.02
Five Year Review Date: 9/4/2029
Rule 3701-22-08 | Optional hospital functions.
 

Each hospital, other than a critical access hospital or rural emergency hospital may provide for any or all the following:

(A) Surgical services, in accordance with 42 CFR 482.51;

(B) Anesthesia services, in accordance with 42 CFR 482.52;

(C) Nuclear medicine services, in accordance with 42 CFR 482.53;

(D) Outpatient services, in accordance with 42 CFR 482.54;

(E) Emergency services, in accordance with 42 CFR 482.55;

(F) Rehabilitation services, in accordance with 42 CFR 482.56;

(G) Respiratory services, in accordance with 42 CFR 482.57; or

(H) Special requirements for hospital providers of long-term care services ("swing-beds"), in accordance with 42 CFR 482.58.

Last updated September 16, 2024 at 8:36 AM

Supplemental Information

Authorized By: 3722.06
Amplifies: 3722.02
Five Year Review Date: 9/4/2029
Rule 3701-22-09 | Critical access hospitals.
 

Each critical access hospital is to comply with 42 CFR 485 subpart F. In addition, each critical access hospital will:

(A) Participate in quality assessment and performance improvement projects identified by the director in consultation with the representatives of the regulated industry. Such projects may include those required by the United States centers for medicare and medicaid services or the hospital's accrediting organization.

(B) Meet the infection control and waterborne pathogen provisions sets forth in paragraphs (K)(1) to (K)(5) of rule 3701-22-07 of the Administrative Code.

(C) Cooperate with any public health investigation.

Last updated September 16, 2024 at 8:36 AM

Supplemental Information

Authorized By: 3722.06
Amplifies: 3722.02, 3722.03
Five Year Review Date: 9/4/2029
Rule 3701-22-10 | Rural emergency hospitals.
 

Each rural emergency hospital is to comply with 42 CFR 485 subpart E. In addition, each rural emergency hospital will:

(A) Submit:

(1) A complete application for a license to operate a rural emergency hospital or renewal of an existing license may be made either in writing on a form provided by the director and signed by the applicant or the applicant's agent, or using an electronic system prescribed by the director and affirmed by the applicant or the applicant's agent. A complete application includes:

(a) The name to appear on the license;

(b) The address of the main hospital location and an attestation signed by the hospital administrator as defined in paragraph (B) of rule 3701-22-01 of the Administrative Code, that includes the following:

(i) The address(es) of each "provider based location" as those terms are defined in 42 CFR 413.65;

(ii) Locations listed pursuant to this section are operated under the license issued under Chapter 3722. of the Revised Code to the hospital that is the "main provider" as that term is defined in 42 CFR 413.65. Only those locations are permitted to be operated under the main hospital's license; and

(iii) Rural emergency hospitals are to maintain a current list of all provider-based locations and notify the director within thirty days of the removal or addition of a provider based location. Failure to provide notice to the director may result in compliance actions set forth in rule 3701-22-05 of the Administrative Code.

(2) A nonrefundable license application or renewal fee in the form of a check or money order for three thousand dollars made payable to the "treasurer, state of Ohio" or as payment submitted through an electronic system prescribed by the director. The fee paid pursuant to this section may be paid either in full at the time of application, renewal, or transfer, or in increments of one-third of the total amount annually; and

(3) Documents as prescribed on the application for a license to operate a rural emergency hospital, including, but not limited to, an attestation signed by the administrator, that the facility will follow the process for conversion to a rural emergency hospital as prescribed by CMS and comply with the conditions of participation set forth in 42 CFR 485 subpart E during the conversion process.

(B) Participate in quality assessment and performance improvement projects identified by the director in consultation with the representatives of the regulated industry. Such projects may include those required by the United States centers for medicare and medicaid services or the hospital's accrediting organization.

(C) Meet the infection control and waterborne pathogen provisions sets forth in paragraphs (K)(1) to (K)(5) of rule 3701-22-07 of the Administrative Code.

(D) Cooperate with any public health investigation.

(E) If the applicant satisfies the requirements set forth in paragraph (A) of this rule, the director will, as appropriate, issue to the applicant a license to operate a rural emergency hospital or renew an applicant's license unless the applicant is barred from renewal for failure to comply with the applicable requirements to operate as a rural emergency hospital.

Last updated September 16, 2024 at 8:36 AM

Supplemental Information

Authorized By: 3722.06
Amplifies: 3722.02, 3722.03
Five Year Review Date: 9/4/2029
Rule 3701-22-11 | Quality assurance and patient health and safety.
 

The director will work with representatives of the regulated industry to determine reporting requirements that help to assure quality and patient health and safety within the hospital. Reporting requirements for quality and patient health and safety are subject to any state or federal privacy laws or regulations.

Last updated September 16, 2024 at 8:36 AM

Supplemental Information

Authorized By: 3722.06
Amplifies: 3722.11 and 3722.12
Five Year Review Date: 9/4/2029
Rule 3701-22-12 | Annual report.
 

(A) Until September 30, 2024, each hospital is obligated to continue reporting information annually to the director in accordance with chapter 3701-59 of the Administrative Code.

(B) The Ohio department of health will work with the regulated industry to determine what, if any, new annual reporting requirements for hospitals to report to the department after September 30, 2024.

Last updated September 16, 2024 at 8:37 AM

Supplemental Information

Authorized By: 3722.06
Amplifies: 3722.11 and 3722.12
Five Year Review Date: 9/4/2029
Rule 3701-22-13 | Data collection.
 

After consultation with representatives of the regulated industry, the director may require hospitals to submit data in areas including performance, quality, or other agreed upon areas.

(A) Any information reported under this section that reveals the identity or that could be used to lead to the identity of any individual is considered protected health information in accordance with section 3701.17 of the Revised Code. Information that does not identify nor lead to the identity of an individual may be released in summary, statistical or aggregate form.

(B) A third-party organization may report as described in this division on behalf of the hospital.

Last updated September 16, 2024 at 8:37 AM

Supplemental Information

Authorized By: 3722.06
Amplifies: 3722.11 and 3722.12
Five Year Review Date: 9/4/2029
Rule 3701-22-14 | Hospital Zones.
 

The director may establish regional hospital zones to respond to public health events, outbreaks of disease, or similar incidents, as well as ongoing public health considerations resulting from those events. Such zones may include health care providers, including but not limited to, hospitals, nursing homes, residential care facilities, home health agencies, and hospice care programs.

Last updated September 16, 2024 at 8:37 AM

Supplemental Information

Authorized By: 3722.06
Amplifies: 3722.06
Five Year Review Date: 9/4/2029
Rule 3701-22-19 | Variances; waivers.
 

(A) The director may grant a variance or waiver from any requirement established by Chapter 3701- 22 of the Administrative Code, unless the requirement is mandated by statute.

(B) Written requests by a hospital seeking a variance or waiver should include the following information:

(1) The specific nature of the request and the rationale for the request;

(2) The specific building or safety requirement in question, with a reference to the relevant administrative code provision;

(3) The time period for which the variance or waiver is requested;

(4) If the request is for a variance, a statement of how the hospital will meet the intent of the requirement in an alternative manner; and

(5) If the request is for a waiver, a statement regarding why application of the requirement will cause undue hardship to the hospital and why granting the waiver will not jeopardize the health and safety of any patient.

(C) Upon written request of the hospital the director may:

(1) Request additional information from the hospital seeking a variance or waiver;

(2) Grant a variance if the director determines that the requirement has been met in an alternative manner; or

(3) Grant a waiver if the director determines that the strict application of the license requirement would cause an undue hardship to the hospital and that granting the waiver would not jeopardize the health and safety of any patient.

(D) The director may stipulate a time period for which a variance or a waiver is to be effective and may establish conditions that the hospital must meet for the variance or waiver to be operative. Such time period may be different than the time period sought by the hospital in the written variance or waiver request.

(E) The director may establish conditions that the hospital must meet for the variance or waiver to be operative. The director may, in the director's discretion, rescind the waiver or variance at any time upon determining that the hospital is not meeting such conditions.

(F) The refusal of the director to grant a variance or waiver, in whole or in part, shall be final and shall not be construed as creating any rights to a hearing under Chapter 119. of the Revised Code.

(G) The granting of a variance or waiver by the director does not constitute a precedent for the granting of any other variance or waiver. All variance and waiver requests will be considered on a case-by-case basis.

Last updated September 16, 2024 at 8:37 AM

Supplemental Information

Authorized By: 3722.06
Amplifies: 3722.06
Five Year Review Date: 9/4/2029