Ohio Admin. Code 3701-22-01

Current through all regulations passed and filed through October 28, 2024

Section 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.

Ohio Admin. Code 3701-22-01

Effective: 9/14/2024
Five Year Review (FYR) Dates: 09/04/2029
Promulgated Under: 119.03
Statutory Authority: 3722.06
Rule Amplifies: 3722.01