reglab/statecodes huggingface dataset:
Ohio Administrative Code › Title 3701 - Department of Health - Administration and Director › Chapter 3701-84 - Quality Standards for Providers of Health Care Service (HCS) › Section 3701-84-16 - Solid organ transplant service standards

Current through all regulations passed and filed through July 1, 2024
(A)
								Each solid organ
			 transplant service will provide services in a manner that meets or exceeds the
			 conditions of participation set forth in Title 42 CFR Part 482,
			 482.72 to
			 482.104.
(B)
								Each solid organ
			 transplant service must be located in a transplant hospital that is a member of
			 and abides by the rules and requirements of the organ procurement and
			 transplantation network (OPTN) established and operated in accordance with
			 section 372 of the Public Health Service (PHS) Act,
			 42 U.S.C.
			 274, (November 21, 2013).
(C)
								Each solid organ
			 transplant service will:
(1)
									Demonstrate an institutional commitment to graduate
			 medical education and research programs;
(2)
									Execute letters
			 of agreement or contracts with an independent organ procurement organization
			 which can provide sufficient numbers of organs to support the applicable volume
			 level specified by rule
			 3701-84-21 of the Administrative
			 Code;
(3)
									Ensure that kidney transplant services are a member of
			 the appropriate end-stage renal disease coordinating council designated for the
			 medicare program under 42
			 C.F.R. 405.2110 (August 26,
			 1986);
(4)
									Develop a procedure to evaluate access for the
			 uninsured or financially indigent patientl; and
(5)
									Have written
			 patient management policies and protocols for organ transplantation,
			 including:
(a)
										Detailed plans for the acute and long-term management of
			 each transplant patient by a multidisciplinary care team, including the waiting
			 period, in hospital phase, and immediate post-discharge period;
(b)
										Transplant
			 experienced social services available to the patient and the patient's family
			 at all times;
(c)
										Appropriate and thorough education of the
			 patient;
(d)
										Liaison with the patient's primary care physician to
			 provide timely notification of changes in the patient's condition;
			 and
(e)
										If the solid organ transplant service performs living
			 donor transplants, detailed plans for the donor, that include the evaluation,
			 donation, and discharge phases of living organ donation.
Replaces: 3701-84-16
Ohio Administrative Code › Title 3701 - Department of Health - Administration and Director › Chapter 3701-84 - Quality Standards for Providers of Health Care Service (HCS) › Section 3701-84-20 - Patient selection criteria

Current through all regulations passed and filed through July 1, 2024
(A)
								An extra-renal,
			 solid organ transplant service must use written patient selection criteria in
			 determining a patient's suitability for placement on the waiting list or a
			 patient's suitability for transplantation.
(B)
								Patient selection
			 criteria must comply with the organ procurement and transplantation network
			 (OPTN) organ allocation priorities and be based on objective medical
			 criteria.
(C)
								Patient selection criteria must include a psychosocial
			 evaluation.
(D)
								Patient selection criteria must ensure a fair
			 non-discriminatory distribution of organs and be in compliance with centers for
			 medicare and medicaid services (CMS) and OPTN oversight.
(E)
								Documentation of
			 the patient selection criteria utilized must be included in the patient's
			 medical record.
Replaces: 3701-84-20
Ohio Administrative Code › Title 3701 - Department of Health - Administration and Director › Chapter 3701-84 - Quality Standards for Providers of Health Care Service (HCS) › Section 3701-84-21 - Utilization levels - solid organ transplant services

Current through all regulations passed and filed through July 1, 2024
(A)
								Each solid organ
			 transplant service designated as an adult or combined adult/pediatric
			 transplant service performing surgeries in a single hospital or university
			 multihospital transplant service, should achieve volume goals consistent with
			 Title 42 CFR
			 482.80 and
			 482.82 to ensure efficiency and a
			 minimum floor of competency:
(B)
								Volume goals may
			 be considered by the director in conjunction with other indicators of quality,
			 not as the sole indicator of service performance.
(C)
								The following
			 solid organ transplant services are not subject to volume goals:
(1)
									Heart-lung;
(2)
									Intestinal;
(3)
									Pancreas;
			 and
(4)
									Pediatric.
Replaces: 3701-84-21
Ohio Administrative Code › Title 3701 - Department of Health - Administration and Director › Chapter 3701-84 - Quality Standards for Providers of Health Care Service (HCS) › Section 3701-84-24 - Blood and bone marrow transplantation service standards

Current through all regulations passed and filed through July 1, 2024
(A) The provisions of rules
			 3701-84-24 to
			 3701-84-27 of the Administrative
			 Code are applicable to each 
								blood and bone marrow transplant
			 
								service regardless of the date service was
			 initiated.
(B) Each
			 
								blood
			 and bone marrow transplantation service 
								will be
			 located in a  hospital classified as a general
			 hospital, a children's hospital or as a specialty hospital that primarily
			 furnishes oncology services that meets all of the following criteria:
(1) Participates with other hospitals
			 nationally in cancer treatment research, such as national cancer institute
			 sponsored research. The hospital's research activities
			 
									should
			 include all of the following:
(a) Use of
			 uniform patient treatment protocols;
(b) On-site audits at least every five years
			 by a cancer research organization or another hospital involved in national
			 cancer treatment research; and
(c)
			 Reporting of patient eligibility and treatment data to the research
			 organization in which the hospital participates.
Ohio Administrative Code › Title 3701 - Department of Health - Administration and Director › Chapter 3701-84 - Quality Standards for Providers of Health Care Service (HCS) › Section 3701-84-25 - Personnel/staffing - blood and bone marrow transplantation service

Current through all regulations passed and filed through July 1, 2024
Each 
								blood and bone marrow transplant service
				
								will
				meet the following staffing criteria:
(A) A medical director responsible for the
			 oversight of the care provided on the unit who actively performs
			 blood and bone marrow transplant services as part
			 of that transplant service and who is:
(1)
			 Board-certified in hematology, oncology, immunology, or pediatric
			 hematology/oncology or have documented experience in the field of hematopoietic
			 progenitor cell (HPC) transplantation extending over ten years;
(2) An active physician on staff at the
			 hospital providing the blood or bone marrow transplant
			 who is involved in direct patient care; and
(3) Has a minimum of one year clinical
			 blood and bone marrow transplantation training at
			 a  transplant center in the United
			 States formally recognized as a blood and bone
			 marrow transplant center by at least one of the following:
(a) A national cooperative chemotherapy
			 group;
(b) The national bone marrow
			 donor program; or
(c) A national
			 institute of health-supported blood and bone
			 marrow transplant research program.
Ohio Administrative Code › Title 3701 - Department of Health - Administration and Director › Chapter 3701-84 - Quality Standards for Providers of Health Care Service (HCS) › Section 3701-84-26 - Facilities/safety standards - blood and bone marrow transplantation service

Current through all regulations passed and filed through July 1, 2024
(A) The hospital at which the
			 blood and bone marrow transplant service is
			 located 
								will provide all of the following on site:
(1) A designated blood and bone marrow transplant unit with a
			 sufficient number of beds to meet the needs of the  transplant service;
(2) Active departments or sections in
			 hematology/oncology, immunology and infectious diseases;
(3) Laboratories;
(4) Adequate intensive care
			 facilities;
(5) Protective reverse
			 isolation rooms with appropriate air handling characteristics (i.e.,
			 hepa-filtered positive pressure patient rooms);
(6) Radiologic services including, but not
			 limited to, tomography, computed tomography (CT) scans and/or magnetic
			 resonance imaging (MRI) scans;
(7)
			 Radionuclide scans and ultrasonography;
(8) Immunopathology and
			 hepatopathology;
(9)
			 Histopathology;
(10) Microbiology
			 laboratory;
(11) Blood banking
			 services capable of routinely providing irradiated blood products appropriate
			 for cytomegalovirus (CMV) seronegative patients;
(12) Clinical pharmacology services with a
			 pharmacist familiar with antineoplastic agents;
(13) Modern radiotherapy capabilities
			 including the ability to provide total body irradiation either on-site or
			 through agreement or contract with another hospital;
(14) Operating room facilities; and
(15) Echocardiography or multigated
			 blood-pool imaging (MUGA) scan capability.
Ohio Administrative Code › Title 3701 - Department of Health - Administration and Director › Chapter 3701-84 - Quality Standards for Providers of Health Care Service (HCS) › Section 3701-84-27 - Patient selection/utilization - blood and bone marrow transplantation service

Current through all regulations passed and filed through July 1, 2024
(A)
								All candidates
			 for blood and bone marrow transplantation are subject to prospective patient
			 selection criteria as specified in appendix A to this rule.
(B)
								If a
			 transplantation service desires to perform a transplant on a patient who does
			 not meet the selection protocols set forth in appendix A to this rule, the
			 service is obligated to undertake a thorough review of the case, conducted by a
			 blood and bone marrow transplant team comprised of members of the service's
			 ethics, legal, and medical staff, to determine that the transplant is
			 appropriate and include:
(1)
									Preparation of a detailed clinical summary of the
			 patient that includes:
(a)
										A brief medical history;
(b)
										Complete
			 laboratory data related to the diagnosis;
(c)
										A thorough
			 psychosocial evaluation that includes:
(i)
											The
			 identification of the patient's support system, including potential
			 caregivers;
(ii)
											Identification of psychosocial
			 barriers;
(iii)
											Identification of potential barriers and challenges of
			 the transplant; and
(iv)
											The patient's attitude toward the transplant, the
			 patient's understanding of the transplant, and the patient's understanding of
			 the treatment, including whether the intention is to be palliative or
			 curative.
(d)
										A justification of the transplant despite failure to
			 meet the selection criteria; and
Ohio Administrative Code › Title 3701 - Department of Health - Administration and Director › Chapter 3701-84 - Quality Standards for Providers of Health Care Service (HCS) › Section 3701-84-30 - General adult cardiac catheterization service standards

Current through all regulations passed and filed through July 1, 2024
(A) The provisions of rules
			 3701-84-30 to
			 3701-84-34.2 of the Administrative Code
			 are applicable to each provider of cardiac catheterization services performing
			 procedures on adult patients greater than or equal to
			 
								eighteen years of age. An adult cardiac
			 catheterization service may serve a patient 
								less than eighteen
			 years of age  if the patient's attending physician and the adult service's
			 medical director determine that the adult service best serves the needs of the
			 patient.
(B) Each provider of
			 cardiac catheterization services shall:
(1)
			 Designate in writing to the director the service level classification, as
			 defined in this chapter, it provides or intends to provide;
(2) Designate in writing to the director the
			 scope of services, including the number of procedure and control rooms,
			 provided within the service level classification;
(3) Meet the requirements of this chapter for
			 the service level classification designated; and
(4) Not hold itself out to any person or
			 government entity by means of signage, advertising, or other promotional
			 efforts as having a service level classification for which it is not
			 designated.
Ohio Administrative Code › Title 3701 - Department of Health - Administration and Director › Chapter 3701-84 - Quality Standards for Providers of Health Care Service (HCS) › Section 3701-84-30.1 - Level I cardiac catheterization service standards

Current through all regulations passed and filed through July 1, 2024
(A) Level I cardiac catheterization service
			 or "level I service" means an adult cardiac catheterization service located in
			 a hospital without an on-site open heart surgery service that provides only
			 diagnostic cardiac catheterization procedures on an organized regular
			 basis.
(B)
								Each
								
								level I 
								service
			 shall perform only diagnostic cardiac catheterization procedures to diagnose
			 anatomical and/or physiological problems in the heart. Diagnostic cardiac
			 catheterization procedures include:
(1)
			 Intracoronary administration of drugs;
(2) Left heart catheterization;
(3) Right heart catheterization;
(4) Coronary angiography;
(5) Basic diagnostic electrophysiology
			 studies not involving transseptal puncture;
(6) Intra-aortic balloon pump or, if required
			 for patient stabilization for transfer, placement of percutaneous left
			 ventricular assist device; and
(7)
			 Device implantation, including, but not limited to defibrillators.
Ohio Administrative Code › Title 3701 - Department of Health - Administration and Director › Chapter 3701-84 - Quality Standards for Providers of Health Care Service (HCS) › Section 3701-84-30.2 - Level II cardiac catheterization service standards

Current through all regulations passed and filed through July 1, 2024
(A) Level II cardiac catheterization service
			 or "level II service" means an adult cardiac catheterization service located in
			 a hospital without an on-site open heart surgery service that provides only
			 diagnostic and authorized therapeutic cardiac catheterization procedures on an
			 organized and regular basis.
(B) Level II services
			 are prohibited from providing the following procedures:
(1) Transcatheter aortic valve replacement
			 (TAVR);
(2) Revascularization of
			 chronic total occlusion (CTO);
(3)
			 Rotational coronary artherectomy;
(4) Alcohol septal ablation;
(5) Cardiac biopsy;
(6) Mitral valve clip;
(7) Transcatheter mitral valve (TMV) repair
			 or replacement;
(8) Laser lead
			 extraction;
(9) Atrial septal
			 defect (ASD), patent foramen ovale (PFO), and ventricular septal defect (VSD)
			 closure;
(10) Balloon aortic
			 valvuloplasty;
(11) PCI of last
			 remaining coronary artery;
(12)
			 Left atrial appendage closure;
(13)
			 Ventricular tachycardia ablation;
(14) Lead extractions;
			 and
(15) Multivessel PCI
			 in the setting of severe left ventricular dysfunction.
Ohio Administrative Code › Title 3701 - Department of Health - Administration and Director › Chapter 3701-84 - Quality Standards for Providers of Health Care Service (HCS) › Section 3701-84-30.3 - Level III adult cardiac catheterization service standards

Current through all regulations passed and filed through July 1, 2024
(A)
								Level III cardiac
			 catheterization service or "level III service" means an adult cardiac
			 catheterization service located in a hospital with an on-site open heart
			 surgery service that provides all levels of diagnostic and therapeutic cardiac
			 catheterization procedures.
(B)
								Each level III
			 service shall operate on an organized, regular, twenty-four hour a day, seven
			 days a week basis to perform primary PCI.
(C)
								Each level III
			 service shall have provided at least one year of service performing diagnostic
			 cardiac catheterizations prior to providing notice to the director of their
			 intent to provide level III services. Accelerated designation may be granted to
			 a service on a case-by-case basis by the director and not be construed as
			 constituting precedent for the granting of an accelerated designation for any
			 other service.
(D)
								Each level III service shall have the following:
(1)
									An on-site adult
			 open heart surgery service available within the same hospital as the cardiac
			 catheterization laboratory and is immediately accessible from the cardiac
			 catheterization laboratory by gurney;
(2)
									An experienced
			 cardiovascular surgical team that is readily available in less than sixty
			 minutes on a twenty-four hour a day basis in the event that emergency open
			 heart surgery is required; and
(3)
									Support services
			 consistent with the 2012 expert consensus document, table 2: support
			 services.
Ohio Administrative Code › Title 3701 - Department of Health - Administration and Director › Chapter 3701-84 - Quality Standards for Providers of Health Care Service (HCS) › Section 3701-84-30.4 - Adult electrophysiology procedure rooms

Current through all regulations passed and filed through July 1, 2024
(A)
								Adult
			 electrophysiology studies may be conducted in any level adult cardiac
			 catheterization laboratory or an electrophysiology procedure
			 room.
(B)
								Procedure rooms where adult electrophysiology studies
			 are conducted will:
(1)
									Have a minimum floor area of three hundred fifty square
			 feet.
(2)
									Have the following minimum clearances:
(a)
										Sufficient
			 footage on each side of the procedure table to ensure that movement around and
			 in the sterile field does not compromise or contaminate the sterile field;
			 and
(b)
										Clearance at the head of the bed should be allocated
			 for anesthesia equipment on either side and sterile access to jugular vein
			 entry sites, if employed, while allowing for free range of movement of a
			 fluoroscopy C-arm.
(3)
									Hybrid procedure
			 rooms where adult electrophysiology studies are conducted will meet the minimum
			 clear floor area and clearances of paragraphs (B)(1) and (B)(2) of this rule
			 and include at least the additional minimum clear floor area, clearances, and
			 storage requirements for the imaging equipment contained in the
			 room.
(4)
									Provide the following:
(a)
										Positive
			 airflow;
(b)
										High flow oxygen and vacuum for
			 suctioning;
(c)
										Medical gas availability;
(d)
										Substerile scrub
			 area; and
(e)
										A patient post-procedural care area.
(5)
									Provide adequate utilities based upon the types of
			 procedures and workload, including:
(a)
										Water taps;
(b)
										Overhead and task
			 lighting will be adequate to perform electrophysiology procedures and for
			 clinical evaluation and treatment of the patient and include:
(i)
											Overhead lighting
			 will be able to be dimmed during fluoroscopy;
(ii)
											Lighting to
			 flood the main procedure area; and
(iii)
											A dedicated
			 workspace light for the nursing/anesthesia area.
(c)
										Electrical
			 outlets;
(d)
										Emergency power;
(e)
										Telephones;
(f)
										Heating and
			 cooling; and
(g)
										Ventilation.
Ohio Administrative Code › Title 3701 - Department of Health - Administration and Director › Chapter 3701-84 - Quality Standards for Providers of Health Care Service (HCS) › Section 3701-84-31 - General personnel/staffing - adult cardiac catheterization service

Current through all regulations passed and filed through July 1, 2024
(A)
								
								Each adult cardiac catheterization
			 service
								will designate a medical director.
(B) In addition to the requirements of rule
			 3701-84-08 of the Administrative
			 Code and any requirements of this rule, the medical director of service
			 
								will:
(1) Have at least five years catheterization
			 experience and recognized skills in the cardiac catheterization
			 laboratory;
(2) Have performed at
			 least five hundred catheterizations;
(3) Be an active participant in the operation
			 of the cardiac catheterization laboratory by actively performing  cardiac catheterization procedures
			  in the cardiac catheterization
			 service where 
									they are the medical director; and
(4) Be responsible for oversight of quality
			 of care provided in the cardiac catheterization laboratory and be an active
			 participant in the cardiac catheterization laboratory's quality assessment
			 review process required by paragraph (E) of rule
			 3701-84-30 of the Administrative
			 Code.
Ohio Administrative Code › Title 3701 - Department of Health - Administration and Director › Chapter 3701-84 - Quality Standards for Providers of Health Care Service (HCS) › Section 3701-84-32 - General facilities, equipment, and supplies - adult cardiac catheterization service

Current through all regulations passed and filed through July 1, 2024
(A) Each  adult cardiac catheterization service, or "service" shall
			 provide adequate, properly designed space to perform cardiac catheterization
			 procedures safely and effectively. The amount of space may vary with the types
			 of procedures performed and the nature of the facility (e.g., interventional
			 versus diagnostic, teaching versus non-teaching).
(B) Each service shall utilize the following:
(1) Procedure rooms will:
(a)
										Have a minimum
			 floor area of four hundred square feet;
(b)
										Have the
			 following minimum clearances:
(i)
											If anesthesia is utilized, six feet at the head of the
			 operating table. This dimension will result in an anesthesia work zone with a
			 clear floor area of six feet by eight feet; and
(ii)
											Sufficient
			 footage on each side of the procedure table to ensure that movement around and
			 in the sterile field does not compromise or contaminate the sterile
			 field.
(c)
										Procedure rooms utilizing image-guided surgery or
			 procedures requiring more space for personnel or equipment will be sized to
			 accommodate the personnel and equipment planned to be in the room during
			 procedures and have a minimum floor area of six hundred square feet with a
			 minimum clear dimension of twenty feet.
(d)
										Hybrid procedure
			 rooms will meet the minimum floor area and clearances of paragraphs (B)(1)(a)
			 and (B)(1)(b) of this rule and include at least the additional minimum floor
			 area, clearances, and storage requirements for the imaging equipment contained
			 in the room.
(e)
										Fixed encroachments into the minimum clear floor area
			 are permitted to be included when determining the minimum clear floor area for
			 a procedure room as long as:
(i)
											There are no encroachments into the sterile
			 field;
(ii)
											The encroachments do not extend more than twelve inches
			 into the minimum clear floor area outside the sterile field;
			 and
(iii)
											The encroachment width along each wall does not exceed
			 ten percent of the length of that wall.
Ohio Administrative Code › Title 3701 - Department of Health - Administration and Director › Chapter 3701-84 - Quality Standards for Providers of Health Care Service (HCS) › Section 3701-84-33 - Safety standards - adult cardiac catheterization service

Current through all regulations passed and filed through July 1, 2024
(A)
								
								Each adult cardiac catheterization
			 service, or "service," 
								will establish and maintain safety guidelines,
			 and practices and policies in accordance with applicable United States nuclear
			 regulatory commission regulations, applicable provisions of Chapter 3748. of
			 the Revised Code, and the rules adopted pursuant to that chapter to assure a
			 safe environment for patients, visitors, and personnel.
(B)
								
								Each service
			 
								will
			 establish, maintain and follow electrical safety policies that, at a minimum,
			 include:
(1) A safe primary electrical wiring
			 system;
(2) Electrical isolation of
			 all equipment attached to a patient;
(3) Use of an equipotential hardwired
			 grounding system for all equipment; and
(4) Periodic inspection of the electrical
			 system and measurement of interequipment current leakage.
Ohio Administrative Code › Title 3701 - Department of Health - Administration and Director › Chapter 3701-84 - Quality Standards for Providers of Health Care Service (HCS) › Section 3701-84-34 - Adult cardiac catheterization service performance measures

Current through all regulations passed and filed through July 1, 2024
(A)
								Each adult
			 cardiac catheterization service should maintain a volume of cardiac
			 catheterization procedures sufficient to ensure the safety and quality of
			 procedures performed at the service and individual cardiologist
			 proficiency.
(B)
								No minimum cardiologist volume is recommended, however,
			 the combination of high mortality and low volume will trigger a thorough
			 internal review of an individual physician by the adult cardiac catheterization
			 service.
(C)
								Volume may be considered by the director in conjunction
			 with other indicators of quality and not as the sole indicator of service
			 performance. An adult cardiac catheterization service with significant rates of
			 in hospital complications, emergent transfers, or mortality may be subject to
			 an independent third party review, including individual case review, by a third
			 party approved by the director. The service will be responsible for:
(1)
									Providing a copy
			 of the review to the director; and
(2)
									Payment of any
			 fees associated with the independent third party review to the provider of the
			 review.
Replaces: 3701-84-34
Ohio Administrative Code › Title 3701 - Department of Health - Administration and Director › Chapter 3701-84 - Quality Standards for Providers of Health Care Service (HCS) › Section 3701-84-34.1 - Inspection and review of adult cardiac catheterization services

Current through all regulations passed and filed through July 1, 2024
(A) In addition to the inspection and audit
			 requirements set forth in rule
			 3701-84-06 of the Administrative
			 Code, the director 
								will conduct an inspection of each adult cardiac
			 catheterization service approximately once every three years.
(B) The number of procedures performed by the
			 service 
								may be considered by the director in conjunction with
			 other indicators of quality and not as the sole indicator of the service's
			 performance.
(C) Failure to
			 
								maintain a volume of cardiac catheterization
			 procedures 
								sufficient to ensure the safety and
			 quality of procedures performed at the service and individual cardiologist
			 proficiency may result in any or all of the following:
(1) An extended review of the service by the
			 director;
(2) Mandatory peer review
			 of PCI procedures performed by the service;
(3) Annual inspections until such time as the
			 service performs the established number of procedures for a period of two
			 consecutive years or the director determines that annual inspection is no
			 longer required; or
(4) At the
			 discretion of the director, the establishment of a probationary period. If a
			 probationary period is imposed, at a minimum, the service
			 
									will be
			 notified of the following:
(a) The time
			 period for which the probationary period is effective;
(b) The actions that may be taken by the
			 director for a service's failure to successfully complete the probationary
			 period.
Ohio Administrative Code › Title 3701 - Department of Health - Administration and Director › Chapter 3701-84 - Quality Standards for Providers of Health Care Service (HCS) › Section 3701-84-34.2 - Order to cease operations of an adult cardiac catheterization service

Current through all regulations passed and filed through July 1, 2024
(A) In accordance with the compliance actions
			 set forth in rule
			 3701-84-05 of the Administrative
			 Code, the director may issue an order to cease operations to an adult cardiac
			 catheterization service, or service, for the following:
(1) The director determines, based on
			 clinical criteria including, but not limited to, major complications, the
			 frequency of emergency transfers, and death, that the service poses an imminent
			 threat of serious physical or life-threatening danger to the recipients of
			 cardiac catheterization services;
(2) Failure of the service to meet designated
			 quality outcome benchmarks, as evidenced by annual reports of the service's
			 
									chosen data registry reports, or the service's
			 annual reportable interventions; or
(3) Failure of the service to comply with the
			 provisions of this chapter.
Ohio Administrative Code › Title 3701 - Department of Health - Administration and Director › Chapter 3701-84 - Quality Standards for Providers of Health Care Service (HCS) › Section 3701-84-36 - Open heart surgery service standards

Current through all regulations passed and filed through July 1, 2024
(A) The provisions of rules
			 3701-84-36 to
			 3701-84-40 of the Administrative
			 Code are applicable to 
			 open heart surgery services performing procedures on adult patients greater
			 than or equal to 
								eighteen years of age. An adult open heart
			 surgery service may serve a patient 
								less than  eighteen years of age  if the patient's attending physician and the
			 adult service's medical director determine that the adult service best serves
			 the needs of the patient.
(B) Each
			  an open heart surgery service
			 
								will
			 have available at all times and accessible by gurney in the same building,
			 adequate facilities for the open heart surgery service, including but not
			 limited to the following:
(1) Cardiac
			 operating rooms;
(2) A cardiac
			 surgery intensive care unit;
(3) A
			 post-intensive care "step-down" unit; and
(4) Cardiac catheterization
			 services.
Ohio Administrative Code › Title 3701 - Department of Health - Administration and Director › Chapter 3701-84 - Quality Standards for Providers of Health Care Service (HCS) › Section 3701-84-37 - Personnel/staffing - open heart surgery service

Current through all regulations passed and filed through July 1, 2024
(A) The medical director of the adult open
			 heart surgery service 
								will be board-certified in thoracic surgery. The
			 medical director 
								will:
(1)
									Be a physician certified or eligible for certification
			 by the American board of thoracic surgery, the American board of surgery, or
			 meet the requirements set forth in paragraph (C) of rule
			 3701-84-08 of the Administrative
			 Code;
(2) Be responsible for
			 oversight of care in the service;
(3) Be credentialed to
			 provide adult open heart surgery services at the hospital where the adult open
			 heart surgery service is located; and
(4) Actively perform
			 open heart procedures at the open heart surgery service where they are the
			 medical director.
Ohio Administrative Code › Title 3701 - Department of Health - Administration and Director › Chapter 3701-84 - Quality Standards for Providers of Health Care Service (HCS) › Section 3701-84-38 - Facilities, equipment, and supplies - open heart surgery service

Current through all regulations passed and filed through July 1, 2024
(A) Operating rooms used for open heart
			 surgery :
(1)
									Standard
			 operating rooms will:
(a)
										Have a minimum floor area of four hundred fifty square
			 feet;
(b)
										Have the following minimum clearances:
(i)
											If anesthesia is
			 utilized, six feet at the head of the operating table. This dimension will
			 result in an anesthesia work zone with a clear floor area of six feet by eight
			 feet; and
(ii)
											Sufficient footage on each side of the procedure table
			 to ensure that movement around and in the sterile field does not compromise or
			 contaminate the sterile field.
Ohio Administrative Code › Title 3701 - Department of Health - Administration and Director › Chapter 3701-84 - Quality Standards for Providers of Health Care Service (HCS) › Section 3701-84-39 - Quality assessment and performance improvement - open heart surgery service

Current through all regulations passed and filed through July 1, 2024
(A) In addition to the general quality
			 assessment and performance improvement requirements set forth in rule
			 3701-84-12 of the Administrative
			 Code, each  open heart
			 surgery service 
								will:
(1) As
			 part of the service's overall quality assessment and performance improvement
			 process:
(a) Utilize the quality performance
			 measures outcomes data obtained from the service's participation in
			 
										a
										
										data registry to monitor operator and institutional
			 volumes and outcomes; and
(b)
			 Include a periodic review and evaluation of the multidisciplinary meetings
			 required by paragraph (J) of rule
			 3701-84-36 of the Administrative
			 Code.
Ohio Administrative Code › Title 3701 - Department of Health - Administration and Director › Chapter 3701-84 - Quality Standards for Providers of Health Care Service (HCS) › Section 3701-84-40 - Adult open heart surgery service performance measures

Current through all regulations passed and filed through July 1, 2024
(A) Each adult
			 open heart surgery service should 
								maintain a volume  of  open heart procedures per year
			 sufficient to ensure 
								the safety and quality of procedures performed at the
			 service and individual surgeon proficiency.
(B) Volume may be considered by the director
			 in conjunction with other indicators of quality and not as the sole indicator
			 of service performance.
(C)
								
								No minimum
			 volume  is recommended, however,
								 the
			 combination of high  mortality
			 and low individual surgeon volume 
								will trigger a thorough internal review of an
			 individual surgeon by the provider of the open heart surgery service.
(D)
			 Failure to 
								maintain the safety and quality
			 of the procedures performed at the service
								 may result in any or all of the following:
(1) An extended review of the service by the
			 director;
(2) Mandatory peer review
			 of  procedures performed by the
			 service;
(3) Annual inspections
			 until such time as  the director determines that annual inspection is no longer
			 required; or
(4) At the discretion
			 of the director, the establishment of a probationary period. If a probationary
			 period is imposed, at a minimum, the service 
									will be
			 notified of the following:
(a) The time period
			 for which the probationary period is effective;
(b) The actions that may be taken by the
			 director for a service's failure to successfully complete the probationary
			 period.
Ohio Administrative Code › Title 3701 - Department of Health - Administration and Director › Chapter 3701-84 - Quality Standards for Providers of Health Care Service (HCS) › Section 3701-84-61 - Pediatric intensive care service standards

Current through all regulations passed and filed through July 1, 2024
(A) The provisions of rules
			 3701-84-61 to
			 3701-84-65 of the Administrative
			 Code are applicable to each 
			 pediatric intensive care service (PICU)  regardless of the date service was
			 initiated.
(B) Each
			  PICU service
			 
								will
			 develop and follow written comprehensive and effective patient care policies
			 and procedures that designate the severity of illnesses that may be treated and
			 the types of care that may be provided in the PICU. The PICU
			 
								will
			 operate within the scope of this service plan.
(C) A temporary expansion of PICU services
			 due to seasonal illness or outbreak necessitating an increase in the number of
			 PICU beds does not require notification to the director under the change in the
			 scope of the HCS requirement set forth in paragraph (G) of rule
			 3701-84-04 of the Administrative
			 Code. Any expansion of PICU services for these purposes
			 will
			 meet all established requirements for a PICU.
(D) Each  PICU service 
								will
								
								ensure that  a pediatric intensivist
			 
								is on-site
			 in-house
								 twenty-four
			 
								hours
								
								per day, seven days a week
								.
(E) The following physicians
			 
								will be
			 available on-site to the PICU
			 
								within sixty minutes on a twenty-four hour a day,
			 seven days a week basis:
(1) An
			 anesthesiologist with demonstrated training and experience in
			 pediatrics;
(2) A pediatric surgeon
			 or a general surgeon with demonstrated training and experience in
			 pediatrics;
(3) Pediatric
			 subspecialists to include:
(a) A cardiologist;
(b)
			 A gastroenterologist;
(c) A pulmonologist
			 or other physician proficient in pediatric flexible
			 bronchoscopy;
(d) A
			 neurologist.
(4) Surgeon
			 subspecialists with demonstrated training and experience in pediatrics, to
			 include:
(a) A neurosurgeon;
(b) An otolaryngologist;
(c) A plastic surgeon;
(d) An oral surgeon; and
(e) An orthopedist.
Ohio Administrative Code › Title 3701 - Department of Health - Administration and Director › Chapter 3701-84 - Quality Standards for Providers of Health Care Service (HCS) › Section 3701-84-62 - Personnel and staffing standards - pediatric intensive care service

Current through all regulations passed and filed through July 1, 2024
(A) Each  PICU service 
								will have a medical director whose appointment,
			 acceptance and responsibilities 
								will be in writing and on file in the
			 PICU.
(B) The PICU medical director
			 
								will
			 be:
(1) An active service provider in the
			 PICU where he or she is the medical director; and
(2) Be board-certified in one of the
			 following:
(a) Pediatric critical
			 care;
(b) Anesthesiology with
			 practice limited to infants and children and with special qualifications in
			 critical care medicine; or
(c)
			 Pediatric surgery with added qualifications in surgical critical care
			 medicine.
Ohio Administrative Code › Title 3701 - Department of Health - Administration and Director › Chapter 3701-84 - Quality Standards for Providers of Health Care Service (HCS) › Section 3701-84-63 - Physical design and facilities - pediatric intensive care service

Current through all regulations passed and filed through July 1, 2024
(A) Each PICU 
								will have
			 controlled access with no through traffic.
(B) The location of the PICU:
(1) Is recommended to be in close proximity
			 to the physician on-call office.
(2)
									
									Will be in close proximity to a family waiting
			 area; and
(3)
									
									Will be
			 available by gurney to the emergency department, the surgical area, and the
			 recovery area.
Ohio Administrative Code › Title 3701 - Department of Health - Administration and Director › Chapter 3701-84 - Quality Standards for Providers of Health Care Service (HCS) › Section 3701-84-64 - Equipment and supplies - pediatric intensive care service

Current through all regulations passed and filed through July 1, 2024
(A) Appropriate drugs for resuscitation and
			 pediatric advanced life support 
								will be present and immediately available for use
			 in the treatment of any patient in the PICU.
(B) The following life-saving, therapeutic
			 and monitoring equipment 
								will be present or immediately available in the
			 PICU:
(1) Portable equipment including:
(a) An emergency ("code" or "crash")
			 cart;
(b) A procedure
			 lamp;
(c) Pediatric sized blood
			 pressure cuffs for systemic arterial pressure determination;
(d) A doppler ultrasound;
(e) An electrocardiograph;
(f) A defibrillator or cardioverter with
			 pediatric paddles;
(g) Thermometers
			 with a range sufficient to identify extremes of hypothermia and
			 hyperthermia;
(h) Automated blood
			 pressure apparatus;
(i)
			 Transthoracic pacer with pediatric pads;
(j) Devices for accurately measuring body
			 weight;
(k) Cribs and beds with
			 head pressure apparatus;
(l) Infant
			 warmers;
(m) Heating and cooling
			 blankets;
(n) Bilirubin
			 lights;
(o) Temporary
			 pacemakers;
(p) A blood warming
			 apparatus;
(q) A transport
			 monitor;
(r) Infusion pumps with
			 microinfusion capability;
(s)
			 Oxygen tanks for transport and backup;
(t) Suction machines for transport and
			 backup;
(u) Volumetric infusion
			 pumps;
(v) Air-oxygen
			 blenders;
(w) An air
			 compressor;
(x) Gas
			 humidifiers;
(y) Bag-valve mask
			 resuscitators;
(z) An otoscope and
			 ophthalmoscope;
(aa) Isolation
			 carts; and
(bb) A portable
			 electro-encephalogram available in the hospital for recordings.
Ohio Administrative Code › Title 3701 - Department of Health - Administration and Director › Chapter 3701-84 - Quality Standards for Providers of Health Care Service (HCS) › Section 3701-84-65 - Quality assessment and performance improvement program - pediatric intensive care service

Current through all regulations passed and filed through July 1, 2024
Each PICU 
								will have a multidisciplinary collaborative
				quality assessment and performance improvement program. The written quality
				assessment and performance improvement program plan required under rule
				3701-84-12 of the Administrative
				Code 
								will, at a minimum, include a review of:
(A) All morbidity and mortality
			 instances;
(B)
			 Utilization;
(C) Medical
			 records;
(D) Discharge criteria and
			 discharge planning; and
(E) Patient
			 safety.
Ohio Administrative Code › Title 3701 - Department of Health - Administration and Director › Chapter 3701-84 - Quality Standards for Providers of Health Care Service (HCS) › Section 3701-84-67 - Radiation therapy, stereotactic radiosurgery, and stereotactic radiotherapy service standards

Current through all regulations passed and filed through July 1, 2024
(A)
								Each radiation
			 therapy, stereotactic radiotherapy, or stereotactic radiosurgery service will
			 operate in accordance with Chapter 3748. of the Revised Code and all rules
			 adopted thereunder.
(B)
								Each radiation therapy service, stereotactic
			 radiotherapy, and stereotactic radiosurgery service will comply with the
			 requirements pertaining to the Ohio cancer incidence surveillance system
			 established under sections
			 3701.261 and
			 3701.262 of the Revised Code and
			 Chapter 3701-4 of the Administrative Code.
Replaces: 3701-84-67
Ohio Administrative Code › Title 3701 - Department of Health - Administration and Director › Chapter 3701-84 - Quality Standards for Providers of Health Care Service (HCS) › Section 3701-84-75 - Pediatric cardiac catheterization service standards

Current through all regulations passed and filed through July 1, 2024
(A) The provisions of rules
			 3701-84-75 to
			 3701-84-79 of the Administrative
			 Code are applicable on the effective date of this rule to each
			 
								pediatric cardiac catheterization
			 
								service performing procedures on patients less than
			 
								eighteen years of age, regardless of the date the
			 service was initiated. A pediatric cardiac
			 catheterization service may serve a patient greater than eighteen years of age
			 if the patient's attending physician and the pediatric service's medical
			 director determine that the pediatric service best serves the needs of the
			 patient.
(B) All pediatric
			 cardiac catheterization services 
								will:
(1) Have
			 on-site a pediatric cardiovascular surgery service immediately accessible from
			 the pediatric cardiac catheterization laboratory by gurney; and
(2) Have an experienced pediatric
			 cardiovascular surgical team available in less than sixty minutes on a
			 twenty-four hour a day, seven days a week basis in the event that emergency
			 open heart surgery is required.
Ohio Administrative Code › Title 3701 - Department of Health - Administration and Director › Chapter 3701-84 - Quality Standards for Providers of Health Care Service (HCS) › Section 3701-84-76 - Personnel/staffing - pediatric cardiac catheterization service

Current through all regulations passed and filed through July 1, 2024
(A) Each  pediatric cardiac catheterization service
			 
								will
			 designate a medical director for the pediatric cardiac catheterization service.
			 The medical director 
								will:
(1)
			 Possess the experience and leadership qualities that are necessary to manage
			 the laboratory appropriately and to ensure safe and effective delivery of
			 catheterization services to pediatric patients; and
(2) The medical director
			 
									will
			 actively perform pediatric cardiac catheterization procedures at the hospital
			 where he or she is the medical director.
Ohio Administrative Code › Title 3701 - Department of Health - Administration and Director › Chapter 3701-84 - Quality Standards for Providers of Health Care Service (HCS) › Section 3701-84-77 - Facilities, equipment, and supplies - pediatric cardiac catheterization service

Current through all regulations passed and filed through July 1, 2024
(A)
								Each pediatric
			 cardiac catheterization service will provide adequate, properly designed space
			 to perform cardiac catheterization procedures safely and effectively. The
			 amount of space may vary with the types of procedures performed and the nature
			 of the facility such as interventional versus diagnostic and teaching versus
			 non-teaching.
(B)
								Each pediatric cardiac catheterization service will
			 ensure the following:
(1)
									Procedure rooms:
(a)
										Have a minimum
			 floor area of four hundred square feet;
(b)
										Have the
			 following minimum clearances:
(i)
											If anesthesia is utilized, six feet at the head of the
			 operating table. This dimension will result in an anesthesia work zone with a
			 clear floor area of six feet by eight feet.
(ii)
											Sufficient
			 footage on each side of the procedure table to ensure that movement around and
			 in the sterile field does not compromise or contaminate the sterile
			 field.
(c)
										Utilizing image-guided surgery or procedures requiring
			 more space for personnel or equipment are sized to accommodate the personnel
			 and equipment planned to be in the room during procedures and have a minimum
			 floor area of six hundred square feet with a minimum clear dimension of twenty
			 feet.
(d)
										Classified as hybrid procedure rooms, will meet the
			 minimum clear floor area and clearances of paragraphs (B)(1)(a) and (B)(1)(b)
			 of this rule and include at least the additional minimum clear floor area,
			 clearances, and storage requirements for the imaging equipment contained in the
			 room.
(e)
										Containing fixed encroachments into the minimum clear
			 floor area are permitted to be include those fixed encroachments when
			 determining the minimum clear floor area for a procedure room as long as:
(i)
											There are no
			 encroachments into the sterile field;
(ii)
											The
			 encroachments do not extend more than twelve inches into the minimum clear
			 floor area outside the sterile field; and
(iii)
											The
			 encroachment width along each wall does not exceed ten per cent of the length
			 of that wall.