As used in this chapter:
(A) "Accreditation award letter" means the written survey findings concerning the provider of a health care service, prepared by an entity that the director has determined as having standards and a process for assessing compliance for a particular HCS which equals or exceeds the applicable requirements of Chapter 3701-84 of the Administrative Code, that documents compliance with the entity's standards.
(B) "Administrator" means the person responsible for the overall daily management of the health care service.
(C) "Anesthesiologist" means a physician who has completed a residency training program in anesthesiology accredited by the American council of graduate medical education or the American osteopathic association.
(D) "Bone marrow transplantation service" means the replacement or supplementation of a patient's bone marrow with autologous or allogeneic hematopoietic stem cells when the patient's own bone marrow has been ablated or partially ablated by disease or therapy for the purpose of achieving long-term management of certain hematologic, immunologic, oncologic or genetic conditions, or enzymatic deficiency disease. A bone marrow transplantation service includes a service in stem cell harvesting and reinfusion.
(E) "Autologous/syngeneic bone marrow transplantation" means autologous, peripheral blood stem cell or syngeneic transplants.
(F) "Low-risk allogeneic bone marrow transplantation" means fully matched allogeneic sibling donor transplants without any of the high risk features listed under paragraph (G) of this rule.
(G) "High-risk allogeneic bone marrow transplantation" means unrelated or haploidentical transplants, or matched sibling donor transplants with any of the following features:
(1) A primary diagnosis of myelodysplasia;
(2) Bone marrow transplant in relapse;
(3) Chronic myelogenous leukemia in anything other than in chronic phase;
(4) Primary refractory patients; or
(5) Patients with eastern cooperative oncology group performance status at time of transplant of greater than or equal to two.
(H) "Chiropractor" means a person licensed under Chapter 4734. of the Revised Code to practice chiropractic care.
(I) "Department" or "director" means the director of health or any official or employee of the department designated by the director of health.
(J) "Health care service" or "HCS" means any of the following:
(1) A heart, lung, liver, kidney, pancreas, small bowel, or islet cell transplantation service or all combinations of solid organ transplant services, collectively referred to as a solid organ transplant service;
(2) A bone marrow transplant service;
(3) A cardiac catheterization service;
(4) An open heart surgery service;
(5) A pediatric intensive care service;
(6) A linear accelerator, cobalt radiation, or gamma knife service;
(7) A pediatric cardiac catheterization service;
(8) A pediatric cardiovascular surgery service.
(L) "Licensed practical nurse" or "LPN" means a person licensed under Chapter 4723. of the Revised Code to practice nursing as a licensed practical nurse.
(M) "Medical director" means the physician who is responsible for managing and directing the provision of medical services at the health care service.
(N) "Nurse" means either a licensed practical nurse or a registered nurse.
(P) "Patient" means any individual who receives health care services.
(Q) "Patient representative" means either a person acting on behalf of a patient with the consent of the patient or the patient's legal guardian.
(R) "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.
(S) "Pharmacist" means a person registered under Chapter 4729. of the Revised Code to practice pharmacy.
(U) "Physician" means a person who is licensed under Chapter 4731. of the Revised Code to practice medicine and surgery, or osteopathic medicine and surgery.
(V) "Psychologist" means a person licensed to practice psychology pursuant to Chapter 4732. of the Revised Code.
(W) "Registered dietitian" means a person registered pursuant to Chapter 4759. of the Revised Code to practice dietetics.
(Y) "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.
(Z) "Social worker" means a person licensed to practice social work pursuant to Chapter 4757. of the Revised Code.
(AA) "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.
(BB) "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.
(CC) "Linear accelerator service" means the structural unit of a health care facility which provides radiation therapy or stereotactic radiosurgery using a linear accelerator.
(DD) "Cobalt service" means the structural unit of a health care facility which provides radiation therapy using a cobalt teletherapy machine.
(EE) "Gamma knife service" means the structural unit of a health care facility which provides stereotactic radiosurgery or stereotactic radiotherapy using a gamma knife.
(FF) "Stereotactic radiosurgery service" means the structural unit of a health care organization which provides stereotactic radiosurgery.
(GG) "Linear accelerator" means a medical linear accelerator which provides a collimated beam of electrons or electronically produced x-rays used for radiation therapy treatment.
(HH) "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.
(II) "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.
(JJ) "Stereotactic radiosurgery" means the closed-skull destruction of a precisely defined intracranial target by beam(s) of ionizing radiation in which the total dose is administered during a single treatment session.
(KK) "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.
(LL) "Dose" means energy imparted per unit mass of absorber at a specific site under certain conditions.
(MM) "Radiation therapy service" means the structural unit of a health care organization which provides radiation therapy.
(NN) "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.
(OO) "Radiation oncologist" means a physician who:
(1) Has satisfactorily completed a radiation oncology residency in an accreditation council for graduate medical education or American osteopathic association approved program; or
(2) Is certified in radiology by the American board of radiology or the American osteopathic board of radiology and who has had a practice limited to radiation oncology for the ten year period prior to May 1, 1996; or
(3) Is certified in radiation oncology or therapeutic radiology by the American board of radiology, the American osteopathic board of radiology, or the royal college of physicians and surgeons of Canada.
(PP) "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.
(QQ) "Simulation" means the mock-up of a patient treatment with radiographic documentation of the treatment portals.
(RR) "Cardiac catheterization" means all anatomic or physiological studies, including electrophysiology procedures, of interventions, both diagnostic and therapeutic, in which the heart or coronary arteries are entered via a systemic vein or artery using a catheter that is manipulated under fluoroscopic visualization. This definition does not include studies of cardiac function performed using flow directed catheters that are positioned without the use of fluoroscopy.
(SS) "Cardiac catheterization service" means the staff, equipment, physical space, and support services required to perform cardiac catheterization and percutaneous coronary interventions.
(TT) "Percutaneous coronary interventions" (PCI") means the broader group of percutaneous techniques capable of relieving coronary narrowing. Such PCI techniques include rotational atherectomy, directional atherectomy, extraction atherectomy, laser angioplasty, implantation of intracoronary stents and other devices for treating coronary atherosclerosis, including percutaneous transluminal coronary angioplasty.
(UU) "Percutaneous transluminal coronary angioplasty" ("PTCA") means the inflation of a balloon-tipped catheter at the site of a coronary artery stenosis to attempt to enlarge the diameter of the lumen.
(VV) "Adult open heart surgery service" or "pediatric cardiovascular surgery service" means the combination of staff, equipment, physical space and support services which are used to perform open-heart surgery and other non-invasive cardiovascular surgeries.
(WW) "Pediatric patient" means any patient less than twenty-two years of age, unless otherwise specified in this chapter.
(XX) "Provider of a health care service" means a person or governmental entity who assumes legal liability for purposes of compliance with this chapter.
(YY) For purposes of this chapter, "follow-up inspection" means an inspection, which may include on-site and off-site activities, conducted by the department to determine whether the HCS has corrected a violation or violations cited on a previous inspection and to verify whether the HCS is in compliance with the applicable criteria, standards, and requirements established by section 3702.16 of the Revised Code and Chapter 3701-84 of the Administrative Code.
Five Year Review (FYR) Dates: 02/27/2017 and 03/01/2022
Promulgated Under: 119.03
Statutory Authority: 3702.11, 3702.13
Rule Amplifies: 3702.11, 3702.12, 3702.13 , 3702.14, 3702.141, 3702.15, 3702.16, 3702.18, 3702.19, 3702.20
Prior Effective Dates: 3/1/1997, 3/24/03, 6/1/07, 5/15/08, 6/21/12