This website publishes administrative rules on their effective dates, as designated by the adopting state agencies, colleges, and
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| Rule |
Rule 3701-84-01 | General definitions.
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) "Blood and 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. (E) "Autologous/syngeneic bone
marrow transplantation" means autologous, peripheral blood stem cell or
syngeneic transplants. (F) "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. (G) "Chiropractor" means a person licensed under
Chapter 4734. of the Revised Code to practice chiropractic care. (H) "Department" or "director" means
the director of health or any official or employee of the department designated
by the director of health. (I) "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 blood and bone
marrow transplant service, including stem cell harvesting and
reinfusion; (3) An adult cardiac
catheterization service; (4) An adult 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. (J) "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) 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. (K) "Licensed practical nurse" or "LPN"
means a person licensed under Chapter 4723. of the Revised Code to practice
nursing as a licensed practical nurse. (L) "Medical director" means the physician who is
responsible for managing and directing the provision of medical services for a
health care service. (M) "Nurse" means either a licensed practical
nurse or a registered nurse. (N) "Occupational therapist" means a person
licensed to practice occupational therapy pursuant to section 4755.07 of the
Revised Code. (O) "Patient" means any individual who receives
health care services. (P) "Patient representative" means either a
person acting on behalf of a patient with the consent of the patient or the
patient's legal guardian. (Q) "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. (R) "Pharmacist" means a person registered under
Chapter 4729. of the Revised Code to practice pharmacy. (S) "Physical therapist" means a person licensed
to practice physical therapy pursuant to section 4755.44 of the Revised
Code. (T) "Physician" means a person who is licensed
under Chapter 4731. of the Revised Code to practice medicine and surgery, or
osteopathic medicine and surgery. (U) "Psychologist" means a person licensed to
practice psychology pursuant to Chapter 4732. of the Revised Code. (V) "Registered dietitian" means a person
registered pursuant to Chapter 4759. of the Revised Code to practice
dietetics. (W) "Registered nurse" or "RN" means a
person who is licensed under section 4723.09 of the Revised Code to practice as
a licensed registered nurse. (X) "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. (Y) "Social worker" means a person licensed to
practice social work pursuant to Chapter 4757. of the Revised
Code. (Z) "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. (AA) "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. (BB) "Linear accelerator service" means the
structural unit of a health care facility which provides radiation therapy or
stereotactic radiosurgery using a linear accelerator. (CC) "Cobalt service" means the structural unit of
a health care facility which provides radiation therapy using a cobalt
teletherapy machine. (DD) "Stereotactic radiosurgery service" means the
structural unit of a health care organization which provides stereotactic
radiosurgery. (EE) "Linear accelerator" means a medical linear
accelerator which provides a collimated beam of electrons or electronically
produced x-rays used for radiation therapy treatment. (FF) "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. (GG) "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. (HH) "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. (II) "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. (JJ) "Dose" means energy imparted per unit mass of
absorber at a specific site under certain conditions. (KK) "Radiation therapy service" means the
structural unit of a health care organization which provides radiation
therapy. (LL) "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. (MM) "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. (NN) "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. (OO) "Simulation" means the mock-up of a patient
treatment and may include equipment, staff, radiographic documentation of the
treatment portals or other methods of reproduction of techniques and
treatments. (PP) "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. (QQ) "Cardiac catheterization service" means the
staff, equipment, physical space, and support services required to perform
cardiac catheterization and percutaneous coronary interventions. (RR) "Percutaneous coronary interventions"
(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. (SS) "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. (TT) "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. (UU) "Pediatric patient" means any patient less
than eighteen years of age, unless otherwise specified in this chapter. This
definition does not prohibit children's hospitals from providing care to
patients up to their twenty-second birthday and older as may be clinically
appropriate during the patient's transition from a pediatric to an adult
provider, or if the patient's congenital or chronic disease of childhood
is best managed by pediatric providers. (VV) "Provider of a health care service" means a
person or governmental entity who assumes legal liability for purposes of
compliance with this chapter. (WW) 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. (XX) "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. (YY) "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
ICD devices and other electrophysiology procedures within the scope of
procedures authorized at each level of a cardiac catheterization
service. (ZZ) "Psychosocial
health" means the combined influence of psychological factors and the
surrounding social environment on an individual's physical, emotional,
and/or mental wellness.
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Rule 3701-84-02 | Applicability of rules.
(A) All health care services shall comply
with rules 3701-84-02 to 3701-84-14 of the Administrative Code. In addition,
all: (1) Solid organ
transplant services shall comply with rules 3701-84-16 to 3701-84-21 of the
Administrative Code; (2) Blood and bone marrow
transplant services, including stem cell harvesting and reinfusion, shall
comply with rules 3701-84-24 to 3701-84-27 of the Administrative
Code; (3) Adult cardiac
catheterization services shall comply with rules 3701-84-30 to 3701-84-34.2 of
the Administrative Code; (4) Open heart surgery
services shall comply with rules 3701-84-36 to 3701-84-40 of the Administrative
Code; (5) Pediatric intensive care services
shall comply with rules 3701-84-61 to 3701-84-65 of the Administrative
Code; (6) Linear accelerator, cobalt, and gamma
knife services shall comply with rule 3701-84-67 of the Administrative
Code; (7) Pediatric cardiac catheterization
services shall comply with rules 3701-84-75 to 3701-84-79 of the Administrative
Code; and (8) Pediatric cardiovascular surgery
services shall comply with rules 3701-84-81 to 3701-84-85 of the Administrative
Code. (B) The director will review the
provisions of Chapter 3701-84 of the Administrative Code periodically, consult
with constituent groups and interested parties, and propose changes, as needed,
to address technological advances and concerns with current rules.
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Rule 3701-84-03 | General provisions and prohibitions.
(A) No person or agency of state or local
government shall operate a HCS that does not comply with the provisions of this
chapter of the Administrative Code. (B) No person or agency of state or local
government shall: (1) Interfere with an
inspection or investigation of a HCS by the director or the director's
designee. As used in this paragraph, "interfere" means to obstruct
directly or indirectly any individual conducting an authorized inspection or
investigation from carrying out their prescribed duties. Interference includes,
but is not limited to, harassment, intimidation, and refusal to permit the
director or the director's authorized representative upon presentation of
official department identification, for the purpose of inspecting or
investigating the operation of a HCS, to enter and inspect at any time the
building or premises of a HCS, or to enter and inspect records that are kept
concerning the operations of the HCS for information pertinent to the
legitimate interests of the department. (2) Materially
misrepresent any information provided to the director pursuant to section
3702.16 of the Revised Code and Chapter 3701-84 of the Administrative
Code. (C) Each HCS shall ensure that the
building or structure where it is located is in compliance with all applicable
federal, state and local laws and regulations including, but not limited to,
building codes. (D) Nothing in this chapter shall be construed as
authorizing individuals to provide services outside their licensed scope of
practice.
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Rule 3701-84-04 | Service notification.
(A) At least thirty days prior to initiating a new HCS or
reactivating a discontinued or temporarily suspended HCS the HCS shall notify
the director in writing, in a manner prescribed by the director, of its
intentions to initiate the service. This notice shall contain: (1) The name, address,
and telephone number of the facility where the HCS is located; (2) The type of HCS which
the provider is seeking to initiate including the scope of services to be
provided; and (3) The projected date of
initiation. (B) Prior to initiating a new HCS or
reactivating a discontinued or temporarily suspended HCS, the HCS shall file
with the director: (1) An attestation of
compliance, with the applicable provisions of this chapter for the HCS to be
initiated or reinstated. The attestation will be signed by the medical director
of the HCS and the service manager of the HCS; (2) Attestation that to
the best of the knowledge of the individual signing the attestation, the
information in the attestation and any accompanying material is true and
accurate; and (3) Any other information the director
may require regarding the ability to operate the HCS. (C) The HCS shall submit a revised
attestation within thirty days of the following: (1) Change of medical
director; or (2) Change of service
manager who previously signed an attestation. (D) The director may request additional information relative to
the continuing operation or initiation of a HCS. (E) At any time, the director may request
additional information that the director reasonably determines to be necessary
to assess 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. The HCS shall submit any additional information requested
by the director within thirty days of the director's request. The director
may require any additional information requested to be submitted in less than
thirty days of the date of mailing of the request if patient health or safety
is of concern. (F) If the director determines that the
HCS has failed to demonstrate compliance with the provisions of this chapter,
the director may take action under rule 3701-84-05 of the Administrative
Code. (G) At least thirty days prior to a
change in the scope of the HCS, the HCS shall notify the director in writing of
its intentions to change the scope of service and the specific changes to be
implemented. (H) Within thirty days of recognizing
that the HCS is not in compliance with applicable criteria, standards or
requirements established by section 3702.16 of the Revised Code or this chapter
of the Administrative Code, the HCS shall notify the director in writing
of: (1) The criteria,
standard or requirement not met; (2) The reason for
failure to meet the criteria, standard or requirement; (3) The corrective action
that will be taken; and (4) The time table for
meeting the criteria, standard or requirement. (I) At least thirty days prior to
discontinuing a HCS, the HCS shall notify the director in writing of its
intentions to discontinue the service. If the discontinuation is out of the
control of the HCS and the thirty day requirement in this paragraph cannot be
met, the written notice shall be given prior to discontinuing the service and
include the projected date of discontinuance.
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Rule 3701-84-05 | Compliance actions.
(A) If a HCS fails to comply with section
3702.14 of the Revised Code or Chapter 3701-84 of the Administrative Code, the
director will provide the HCS a reasonable and appropriate amount of time to
correct the violation and, in accordance with Chapter 119. of the Revised Code,
may: (1) Impose a civil penalty based on the
severity of the violation as follows: (a) For violations that present an imminent threat of serious
physical or life-threatening danger, or an immediate serious threat to the
psychosocial health as defined in paragraph (ZZ) or rule 3701-84-01 of the
Administrative Code, safety or security of patients, a civil penalty of not
less than one hundred thousand dollars and not more than two hundred fifty
thousand dollars; (b) For violations that directly threaten physical or
psychosocial health, safety, or security of patients, a civil penalty of not
less than ten thousand dollars and not more than one hundred thousand
dollars; (c) For violations that indirectly threaten or potentially
threaten the physical or psychosocial health, safety, or security of patients,
a civil penalty of not less than one thousand dollars and not more than ten
thousand dollars; and (2) Issue an order that the HCS cease
operation: (a) For a second or subsequent violation of section 3701.14 of
the Revised Code or Chapter 3701-84 of the Administrative Code; or (b) For an initial violation that the director has determined to
cause or pose an imminent threat of serious physical harm or life-threatening
danger. (B) In determining which of the actions
to take under paragraph (A) of this rule, the director may consider the
following factors: (1) The danger of serious
physical or life-threatening harm to one or more patients utilizing the health
care service; (2) The nature, duration,
gravity, and extent of the violation; (3) The number, if any,
of patients directly affected by the violation; (4) Whether the violation
directly relates to patient care and the extent of the actual or potential harm
to patients; (5) The number of staff
involved in the violation; (6) The actions taken by
the provider of the HCS to correct the violation; and (7) The HCS's
history of compliance.
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Rule 3701-84-06 | Inspections and audits.
(A) The director may make announced or
unannounced inspections to determine and monitor compliance with section
3702.14 of the Revised Code and the applicable requirements of Chapter 3701-84
of the Administrative Code. (B) If patient survival or complications
of the HCS are outside the industry norm or outside the range of expected
values, the director may conduct a review of the HCS or require the HCS to
contract for an independent review of the HCS, to be performed by at least two
experts that the director has approved for the situation, to determine the
probable cause of the adverse outcomes and make recommendations for
improvement. (1) In determining
whether to approve an expert, the director will consider the individual's
knowledge and expertise in the service area and affiliation with the provider
of the HCS; (2) The contract shall
require a written report to be submitted to the director by the reviewers
within one hundred and twenty days of the director's notice to the HCS of
the requirement for a review; (3) Based on the findings
of the review, the director may require the HCS to implement recommendations of
the experts; and (4) The HCS shall assume
all costs of the review. The costs incurred under this paragraph are not
subject to or included in the maximum annual fees specified in paragraph (G) of
this rule. (C) Each HCS shall ensure the director
access to its premises, records, including business and medical records, and
staff to demonstrate compliance with the requirements established under section
3702.14 of the Revised Code and the applicable requirements of Chapter 3701-84
of the Administrative Code. (D) Information obtained by the director pertaining to specific
patients is confidential. Information may be released in summary, statistical,
or other form which does not disclose the identity of an individual patient and
is devoid of personal health information (PHI). Information may be shared with
other state or federal agencies if such information is necessary in carrying
out their official duties. An agency or person that receives such patient
record information shall protect and preserve patient
confidentiality. (E) The director may conduct an inspection to investigate alleged
violations of section 3702.14 of the Revised Code and Chapter 3701-84 of the
Administrative Code. The director will inform the complainant and the HCS of
the results of the investigation. (F) The HCS fee for the inspections conducted by the director
pursuant to section 3702.15 of the Revised Code and paragraphs (A) and (E) of
this rule will be, subject to paragraph (G) of this rule, as
follows: (1) Inspection fee one
thousand seven hundred fifty dollars; (2) Complaint inspection
six hundred fifty dollars; (3) Follow-up inspection
six hundred fifty dollars; and (4) Desk audit or
compliance review inspection fee of two hundred fifty dollars. (G) In charging a HCS a fee under paragraph (F) of this rule the
total fees charged to a HCS, for services described in section 3702.11 of the
Revised Code, will not exceed five thousand dollars annually. (H) The director will provide to each HCS a statement of the fee
charged under paragraph (F) of this rule which itemizes and totals the costs
incurred by the department. (I) The HCS shall forward the total amount of the fee to the
director payable to the "Treasurer, State of Ohio" within fifteen
days after receiving a statement of the fee issued under paragraph (H) of this
rule. (J) The director will deposit HCS fees into the quality
monitoring and inspection fund created in the state treasury pursuant to
division (A) of section 3702.31 of the Revised Code.
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Rule 3701-84-07 | Patient care policies.
(A) Each HCS shall develop and follow
comprehensive and effective patient care policies that include the following
requirements: (1) Each patient shall be
treated with consideration, respect, and full recognition of dignity and
individuality, including privacy in treatment and personal care
needs; (2) Each patient shall
give informed consent and be allowed to refuse or withdraw consent for
treatment or give conditional consent for treatment. Written documentation of
patient consent shall be maintained in the patient's medical
record; (3) Each patient shall
have access to his or her medical record, unless access is specifically
restricted by the attending physician for medical reasons; (4) Each patient's
medical and financial records shall be kept confidential; and (5) Upon request, each
patient shall receive a detailed explanation of charges including an itemized
bill for services received. (B) Each HCS shall ensure that each
patient is informed of the following: (1) The diagnosis and
treatment alternatives and the risks involved with each; (2) The HCS's policy
on advanced directives, including do-not-resuscitate orders (DNR);
and (3) The name of the
attending physician or individual supervising the patient's care and the
manner in which that individual may be contacted.
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Rule 3701-84-08 | General personnel and staffing requirements.
(A) Each HCS shall, based on the services
provided and the number of patients served, maintain a sufficient number of
qualified staff members and other personnel and schedule staff in number and
type necessary to meet the needs of its patients in a timely manner. Each HCS
shall be responsible for the care provided by the staff and personnel of that
HCS. (B) Each provider of a HCS shall only
utilize personnel to provide services who have appropriate training and
qualifications for the services that they provide. (1) Any staff member who
functions in a professional capacity is obligated to meet the standards
applicable to that profession, including but not limited to, possessing a
current Ohio license, registration, or certification, if required by law, and
working within their scope of practice; and (2) Each HCS shall have
an established system of records necessary for the director to ascertain that
all individuals employed at the HCS who function in a professional capacity
meet the standards applicable to that profession. (C) Each HCS shall have a medical
director for the HCS. In lieu of the board certification requirements specified
in this chapter; (1) A physician who is
board certified by a foreign board and is eligible to take the examination of
an American board of medical specialties recognized board or an American
osteopathic association board may serve as medical director of an HCS;
or (2) In accordance with
rule 3701-84-14 of the Administrative Code, a HCS may request a waiver or
variance from the department of health for physicians who are board certified
by a foreign board who are not eligible to take the examination of an American
board of medical specialties recognized board or an American osteopathic
association board. (D) Each HCS shall develop and follow a tuberculosis
control plan based on the provider's assessment of the HCS that is
consistent with the United States centers for disease control and prevention
(CDC) "Tuberculosis Screening, Testing, and Treatment of U.S. Health Care
Personnel: Recommendations from the National Tuberculosis Controllers
Association and CDC," MMWR 2019, Rep 2019; 68:439-443. The HCS will retain
documentation evidencing compliance with this paragraph and furnish such
documentation to the director upon request. (E) Each HCS shall not knowingly permit a staff member to
provide services if the staff member: (1) Has a disease capable
of being transmitted during the performance of his or her duties; (2) Is under the
influence of drugs or alcohol; or (3) After training and
orientation by the HCS, has not demonstrated sufficient knowledge or expertise
for the responsibilities of the position. (F) Each HCS shall provide: (1) A written job
description to each staff member delineating responsibilities; (2) An ongoing training
program for all staff that includes both an initial orientation and continuing
training: (a) Orientation that is appropriate to the tasks that each
staff member will be expected to perform; and (b) Continuing training designed to assure appropriate
skill levels are maintained and that staff are informed of changes in
techniques, philosophies, goals, and similar matters. The continuing training
may include attending and participating in professional meetings and seminars
and include information specific to the type of HCS; (3) An orientation and
training for the HCS's equipment, safety guidelines, practices, and
policies; and (4) Documentation of
orientation and training documented in each staff member's personnel
record. (G) Each HCS shall develop and implement an ongoing process
for ensuring the competence of staff members that includes: (1) A periodic assessment
and re-determination of necessary skill levels identified for the staff
member's position; and (2) At least every
thirty-six months, a performance evaluation stating whether each staff member
has achieved the skill levels identified for the staff member's
position. (H) Each HCS shall retain staffing schedules, time-worked
schedules, on-call schedules, and payroll records for at least two
years.
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Rule 3701-84-09 | General service standards.
(A) Each HCS shall ensure that all staff
members provide services in accordance with: (1) The patient's
plan of care; (2) The policies and
procedures developed by the HCS; (3) Applicable current
and accepted standards of practice and the clinical capabilities of the
HCS; (4) Applicable state and
federal laws and regulations; and (5) The applicable
quality of care and safety standards set forth in this chapter. (B) Each HCS shall document all medical
services performed in the care of the patient in the patient's medical
record. (C) Each HCS shall provide for the
ancillary and support services necessary for the provision of the HCS's
services. (D) Each HCS shall establish and follow written infection control
policies and procedures for the surveillance, control and prevention of
communicable disease organisms by both the contact and airborne routes that are
consistent with current infection control guidelines issued by the United
States centers for disease control and prevention (CDC) and facilitate the
activities associated with the prevention and spread of communicable infectious
diseases. Each HCS shall retain documentation evidencing compliance with this
paragraph and furnish such documentation upon request. The policies and
procedures shall, at a minimum, address: (1) The utilization of
protective clothing and equipment; (2) The storage,
maintenance and distribution of sterile supplies and equipment; (3) The disposal of
biological waste; including blood, body tissue, and fluid in accordance with
Ohio law; (4) Standard
precautions/body substance isolation or equivalent; and (5) Tuberculosis and
other airborne diseases. (E) Each HCS shall maintain and operate equipment in a safe
manner, in accordance with the manufacturer's instructions, and not
jeopardize patient health or safety through operation of the
equipment. (F) Each HCS shall provide the patient or the patient's
representative: (1) Instruction and
education regarding the services to be performed; (2) Written information
about how to obtain appointments and needed services, both during and after the
HCS's normal hours of operation; and (3) Prior to discharge,
verbal and written instructions for post-treatment care and procedures for
obtaining emergency care.
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Rule 3701-84-10 | General building and site requirements.
(A) Each HCS shall ensure that the
building or structure where the HCS is located: (1) Has a certificate of
use from a local, certified building department or by the department of
commerce as meeting applicable requirements of Chapters 3781., 3783., and 3791.
of the Revised Code and any rules adopted under them; (2) Complies with the
Ohio fire code; and (3) Complies with the applicable
provisions of Chapter 3737. of the Revised Code and the rules adopted under
it. (B) Each HCS shall adopt and follow a
disaster preparedness plan, including evacuation in the event of a fire or
other emergency that includes an annual review of evacuation procedures and
practice drills with staff at least once every six months. (C) Each HCS shall label, store and
dispose all poisons, hazardous wastes, and flammable materials in accordance
with state and federal laws and regulations and in a safe manner that does not
jeopardize patient health or safety. (D) The minimum space or square footage
requirements specified in this chapter are of clear floor space and exclusive
of fixed or wall mounted cabinets, desks, and closets that are floor
based.
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Rule 3701-84-11 | General medical records requirements.
(A) Each HCS shall maintain a legible
medical record for each patient that is readily accessible to staff for use
throughout the course of the patient's treatment that documents, in a
timely manner and in accordance with acceptable standards of practice, the
patient's needs, assessments, and services rendered. (B) Each HCS shall not disclose
individual medical records except as authorized by the patient or allowed by
state and federal laws and regulations, and the provisions of this
chapter. (C) Each HCS shall systematically review
records for conformance with acceptable standards of practice and the
requirements of Chapter 3701-84 of the Administrative Code. (D) Each HCS shall maintain an adequate
medical record keeping system and take appropriate measures to protect medical
records against theft, loss, destruction, and unauthorized use. (E) Each HCS shall have policies and
procedures to ensure the confidentiality of patient medical
records. (F) Each HCS shall maintain medical records as necessary to
verify the information and reports required by statute or regulation for six
years from the date of the patient's discharge.
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Rule 3701-84-12 | General quality assessment and performance improvement.
(A) Each HCS shall establish a quality
assessment and performance improvement program designed to: (1) Systematically
monitor and evaluate the quality of patient care provided; (2) Pursue opportunities
to improve patient care; (3) Ensure compliance
with the applicable quality standards set forth in this chapter;
and (4) Resolve identified
problems. (B) Each HCS shall develop a written plan
for each HCS that describes the quality assessment and performance improvement
program's objectives, organization, scope, and mechanism for overseeing
the effectiveness of monitoring, evaluation, improvement, and problem-solving
activities. (C) The quality assessment and
performance improvement program shall do all of the following: (1) Monitor and evaluate
all aspects of care including effectiveness, appropriateness, accessibility,
continuity, efficiency, patient outcome, and patient satisfaction; (2) Establish
expectations, develop plans, and implement procedures to assess and improve the
quality of care and resolve identified problems; (3) Establish
expectations, develop plans, and implement procedures to assess and improve the
health care service's governance, management, clinical, and support
processes; (4) Establish information
systems and appropriate data management processes to facilitate the collection,
management, and analysis of data needed for quality improvement; (5) Internally document
and report findings, conclusions, actions taken, and the results of any actions
taken to the health care service's management and medical
director; (6) Document and review
all unexpected complications and adverse events, being serious injury or death
resulting from medical management, which arise during the provision of the
service or during the hospital stay; and (7) Hold regular
meetings, chaired by the medical director of the HCS, or designee, as
necessary, but at least within sixty days after a death or complication, to
review all deaths and complications and to report findings. Any pattern that
might indicate a problem shall be investigated and remedied, if
necessary.
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Rule 3701-84-13 | Complaints.
(A) Each HCS shall develop and follow
policies and procedures to effectively receive, investigate, and report
findings of complaints regarding the quality or appropriateness of services
provided by the HCS. The documentation of complaints shall, include the
following: (1) The date the
complaint was received; (2) The identity, if
provided, of the complainant; (3) A description of the
complaint; (4) The identity, if
provided, of persons and/or the provider of the HCS involved; (5) The findings of the
investigation; and (6) The resolution of the
complaint. (B) Each HCS is obligated to post the
toll free complaint hotline of the Ohio department of health's complaint
unit in a conspicuous place in the HCS.
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Rule 3701-84-14 | Variances; waivers.
(A) In accordance with paragraph (B) of
this rule, the director may grant a variance or waiver from any requirement
established by Chapter 3701-84 of the Administrative Code. (B) Upon written request of the HCS, the
director will grant or deny a variance or waiver by written response within
forty-five days of receipt of the request and all information determined
necessary by the director to make a decision. In granting a variance or waiver,
the director will stipulate a time period for which the variance or waiver is
to be effective and establish conditions that the HCS must meet for the
variance or waiver to be operative. The director may grant: (1) A variance if the
director determines that the requirement has been met in an alternative manner;
or (2) A waiver if the
director determines that the strict application of the requirement would cause
an undue hardship to the HCS and that granting the waiver would not jeopardize
the health and safety of any patient. (C) The granting of a variance or waiver
is a discretionary act by the director based upon documentation: (1) In the case of a
variance request, as to how the HCS is meeting the intent of the requirement in
an alternative manner; and (2) In the case of a
waiver request, as to how the requirement is an undue hardship to the HCS and
why the waiver will not jeopardize the health and safety of any
patient. (D) The granting of a variance or waiver
by the director shall not be construed as constituting precedent for the
granting of any other variance or waiver. All variance and waiver requests will
be considered on a case-by-case basis. (E) A HCS whose request for a waiver or
variance under this rule is denied may request a reconsideration of the
decision by the director. (1) A request for
reconsideration must be received in writing by the director within thirty days
of receipt of the director's denial of a waiver or variance request and
include information that: (a) Presents significant, relevant information that was not
previously submitted to the director by the HCS, because it was not available
to the HCS at the time the waiver or variance request was filed;
or (b) Demonstrates that there have been significant changes in
factors or circumstances relied upon by the director in reaching the initial
decision. (2) A decision on an appropriately filed
request for reconsideration will be issued within forty-five days of the
director's receipt of the request for reconsideration and all information
determined necessary by the director to make a decision. (3) The reconsideration process is an
informal procedure not subject to Chapter 119. of the Revised Code. The
director's decision on reconsideration is final. (F) Each new HCS shall provide the
service in compliance with all provisions of Chapter 3701-84 of the
Administrative Code, unless a waiver or variance is granted for all provisions
not met.
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Rule 3701-84-16 | Solid organ transplant service standards.
(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.
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Rule 3701-84-20 | Patient selection criteria.
(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.
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Rule 3701-84-21 | Utilization levels - solid organ transplant services.
(A) Each solid organ transplant service
designated as an adult or combined adult/ pediatric transplant service
performing surgeries in a single hospital or university multi-hospital
transplant service, should achieve volume goals consistent with Title 42 CFR
482.80 and 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.
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Rule 3701-84-24 | Bone marrow transplantation service standards.
(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. (2) Meets the following
administrative requirements: (a) Appropriate patient management plans and protocols consistent
with nationally accepted standards, including: (i) Patient selection
criteria; (ii) Plans for long-term
management; (iii) Protocols to
address the prevention of opportunistic infections among blood and bone marrow
transplant recipients; and (iv) Protocols for
liaising with the patient's family and primary care
physician. (b) Quality assurance standards for the procurement of
hematopoietic stem cells including the procurement of bone marrow via a bone
marrow harvest, as well as procurement of hematopoietic progenitor cells (stem
cells) by the use of leukapheresis or umbilical cord blood collection;
and (c) A procedure for conducting systematic evaluation of clinical
outcomes resulting from hematopoietic stem-cell transplantation. (3) Has a documented
agreement to cooperate with other blood and bone marrow transplantation
services in Ohio relative to patient selection that is non-discriminatory as to
race, gender, and ability to pay. (C) Prior to initiating transplantation
services, the blood and bone marrow transplantation service will specify to the
director: (1) The type of patient
population to be served: (a) Pediatric patients aged seventeen years or
younger; (b) Adult patients aged eighteen or older. A blood and bone marrow transplantation
service may serve patients greater than or equal to eighteen years of age as a
pediatric or an adult patient, whichever best serves the needs of the patient,
as determined by the transplant physician and transplant service's medical
director; (2) The type of
transplantation service: (a) Autologous; (b) Allogeneic; or (c) Both.
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Rule 3701-84-25 | Personnel/staffing - bone marrow transplantation service.
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. (B) At a minimum, one other primary
transplantation physician actively participating in the service. (C) A nursing team that, in order to
ensure adequate continuity of care, is committed to the transplant service on a
full-time basis and has the training and skills commensurate with the required
tasks performed. (D) The care of blood and bone marrow
transplant patients will be coordinated by a multidisciplinary team whose
members have training and skills commensurate with the required tasks
performed.
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Rule 3701-84-26 | Facilities/safety standards - bone marrow transplantation service.
(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. (B) Each blood and bone marrow transplant
service will have the following readily available: (1) Tissue-typing
laboratory; (2) Apheresis capability
with adequate blood cell component therapy and routine access to a blood
irradiator; and (3) Facilities to
cryopreserve hematopoietic stem cells for transplantation and which
additionally may be used to manipulate hematopoietic stem cells
ex-vivo.
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Rule 3701-84-27 | Patient selection/utilization - blood and bone marrow transplantation service.
(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 (2) After sufficient
review time, an affirmative vote of a majority of the members of the team that
the transplant is appropriate. (C) Each blood and bone marrow
transplantation service should achieve the following volume goals per year to
ensure efficiency and a minimum floor of competency: (1) Adult blood and bone
marrow transplantation service performing transplants at a single clinical
site: (a) Autologous only transplantation services should perform
an average of at least five autologous transplants per year; or (b) Combined autologous and allogeneic services should
perform an average of at least ten allogeneic transplants per
year. (2) Adult blood and bone
marrow transplantation service performing transplants at multiple clinical
sites: (a) Autologous only transplantation services should perform
an average of at least five autologous transplants per year at each site;
or (b) Combined autologous and allogeneic transplantation
services should perform an average of at least five autologous and five
allogeneic transplants per year at each site. (3) Pediatric blood and
bone marrow transplantation service performing transplants at a single clinical
site: or (a) Autologous only transplantation services should perform
an average of at least five autologous transplants per year; or (b) Combined autologous and allogeneic services should
perform an average of at least five allogeneic and five autologous transplants
per year. (4) Pediatric blood and
bone marrow transplantation service performing transplants at multiple clinical
sites: (a) Autologous only transplantation services should perform
an average of at least five autologous transplants per year at each site;
or (b) Combined autologous and allogeneic transplantation
services should perform an average of at least five autologous transplants per
year at each site. (5) Combined adult and
pediatric blood and bone marrow transplantation services performing transplants
at a single clinical site: (a) Autologous only transplantation services should perform
an average of at least five pediatric autologous transplants and five adult
autologous transplants per year; or (b) Combined autologous and allogeneic services should
perform an average of at least five pediatric allogeneic transplants and five
adult allogeneic transplants per year. (6) Combined adult and
pediatric blood and bone marrow transplantation services performing transplants
at multiple clinical sites: (a) Autologous only transplantation services should perform
an average of at least five autologous transplants per year at each site;
or (b) Combined autologous and allogeneic transplantation
services should perform an average of at least five pediatric and five adult
autologous transplants per year and and at least five pediatric allogeneic and
five adult allogeneic transplants per year at each site. (D) Volume goals may be considered by the
director in conjunction with other indicators of quality, not as the sole
indicator of service performance.
View Appendix
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Rule 3701-84-30 | General adult cardiac catheterization service standards.
(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. (C) Each provider of cardiac
catheterization services shall have an established written protocol for the
emergency transfer and care of patients who require emergency medical/surgical
management during or immediately after cardiac catheterization. (D) Each provider of cardiac
catheterization services shall have immediate access to services for hematology
and coagulation disorders; electrocardiography; and diagnostic radiology.
Access to clinical pathology, nuclear medicine and nuclear cardiology,
doppler-echocardiography, pulmonary function testing, and microbiology will be
available within a reasonable amount of time to meet the needs of the
service. (E) Each provider of cardiac
catheterization services shall establish and maintain a quality assessment
review process, including methodology, for reviewing the quality of cardiac
catheterization procedures performed by each physician credentialed to perform
such procedures. The review methodology will, at a minimum, assess the
following: (1) Appropriateness of
cardiac catheterization studies and interventions; (2) Technical quality of
cardiac catheterization studies; (3) Procedure
result; (4) Rate of therapeutic
success; and (5) Rate of procedural
complications. (F) Each provider of cardiac
catheterization services shall have explicit criteria based upon current
recommendations of recognized professional societies and accrediting bodies,
specifying the number of times a year an appropriately privileged physician
shall perform each catheterization procedure in order to retain privileges to
perform that procedure. (G) Each provider of cardiac
catheterization services shall conduct an ongoing review of all cases with
mortality or significant morbidity within sixty days of the
procedure. (H) Each provider of cardiac
catheterization services shall establish and maintain a database to support the
review process detailed in paragraph (E) of this rule. The results of analysis
and review will be documented and used to guide periodic random and selected
peer reviews of individual physicians with respect to maintaining their
credentials to perform specific cardiac catheterization
procedures. (I) Adult cardiac catheterization service
will only be provided in a fully permanent setting within the permanent frame
of the building of a registered hospital that is classified as a general
hospital or a special hospital-cardiac that primarily furnishes limited
services to patients with cardiac conditions. The hospital will: (1) Operate inpatient
medical and surgical services in the same building and accessible by gurney
from the cardiac catheterization laboratory; (2) Operate an
intensive/critical care unit with registered special care beds, that is:
(a) Reviewed and accredited or certified as such as part of
the hospital's accreditation or certification program in the same
building; (b) Accessible by gurney from the cardiac catheterization
laboratory; and (c) The unit will provide appropriate equipment and staff
to care for coronary patients and have twenty-four hour monitoring
capability. (3) Provide a setting in
the same building as the adult cardiac catheterization laboratory in which
ambulatory cardiac catheterization patients can be observed for at least two to
six hours after the procedure depending on the access site and the nursing
assessment of the patient; and (4) Provide adequate
physician coverage to manage post-procedure complications. (J) For the purpose of rules 3701-84-30
to 3701-84-34.2 of the Administrative Code the following references are defined
and all documents are available at www.acc.org: (1) "2012 expert
consensus document" means 2012 American college of cardiology
foundation/society for cardiovascular angiography and interventions expert
consensus document on cardiac catheterization laboratory standards update (June
12, 2012); (2) "2014 expert
consensus document" means the 2014 society for cardiovascular angiography
and interventions/American college of cardiology/American heart association
expert consensus document update on percutaneous coronary intervention without
on-site surgical backup (June 17, 2014); (3) "Table 2: support services"
means 2012 American college of cardiology foundation/society for cardiovascular
angiography and interventions expert consensus document on cardiac
catheterization laboratory standards update, table 2: optimal (recommended)
on-site support services for invasive cardiac procedures (June 12,
2012). (4) "Table 3: facility
requirements" means 2014 Society for cardiovascular angiography and
interventions/American college of cardiology/American heart association expert
consensus document update on percutaneous coronary intervention without on-site
surgical backup, table 3: facility requirements for percutaneous coronary
intervention programs without on-site surgery (June 17, 2014); (5) "Table 4: personnel
recommendations" means 2014 society for cardiovascular angiography and
interventions/American college of cardiology/American heart association expert
consensus document update on percutaneous coronary intervention without on-site
surgical backup, table 4: personnel recommendations (June 17,
2014); (6) "Table 5: general exclusion
criteria" means the 2012 American college of cardiology foundation/society
for cardiovascular angiography and interventions expert consensus document on
cardiac catheterization laboratory standards update, table 5: general exclusion
criteria for invasive cardiac procedures in a setting without cardiothoracic
surgery (June 12, 2012); (7) "Table 5: recommendations for
off-site surgical backup and case selection" means the 2014 Society for
cardiovascular angiography and interventions/American college of
cardiology/American heart association expert consensus document update on
percutaneous coronary intervention without on-site surgical backup, table 5:
recommendations for off-site surgical backup and case selection (June 17,
2014); and (8) "Table 6: patient and lesion
characteristics" means the 2014 Society for cardiovascular angiography and
interventions/American college of cardiology/American heart association expert
consensus document update on percutaneous coronary intervention without on-site
surgical backup, table 6: patient and lesion characteristics that could be
unsuitable for nonemergency procedures at facilities without an on-site cardiac
surgery (June 17, 2014); (K) For the purpose of rules 3701-84-30
to 3701-84-34.2 of the Administrative Code, major bleeding is defined
as: (1) Bleeding event within
seventy two hours; (2) Hemorrhagic
stroke; (3) Tamponade; (4) Post-PCI transfusion
for patients with a pre-procedure hemoglobin >8 g/dL; or (5) Absolute hemoglobin
decrease from pre-PCI to post-PCI of >= 3 g/dl and pre- procedure
hemoglobin=<16 g/dL.
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Rule 3701-84-30.1 | Level I cardiac catheterization service standards.
(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. (C) Each level I service will implement
patient exclusion criteria consistent with the 2012 table 5: general exclusion
criteria. (D) Each level I service will comply with
the personnel and staffing requirements set forth in rule 3701-84-31 of the
Administrative Code. (E) Each level I service will comply with
the facilities, equipment, and supplies requirements set forth in rule
3701-84-32 of the Administrative Code. (F) Each level I service will comply with
the safety standards set forth in rule 3701-84-33 of the Administrative
Code. (G) Each level I service shall maintain a
formal written transfer protocol for emergency medical/surgical management with
a registered hospital that provides open heart surgery services, which can be
reached expeditiously from the level I service by available emergency vehicle
within a reasonable amount of time and that provides the greatest assurance for
patient safety. The open heart surgery service that is party to a transfer
protocol is referred to as the receiving service. Each protocol shall include,
but not be limited to: (1) Provisions addressing
indications, contraindications, and other criteria for the emergency transfer
of patients in a timely manner; (2) Assurance of the
initiation of appropriate medical/surgical management in a timely
manner; (3) Assurance that
surgical back-up is available for urgent cases at all hours; (4) Specification of
mechanisms for continued substantive communication between the services party
to the agreement and between their medical directors and
physicians; (5) Provisions for
collaborative training programs among staff of the services party to the
agreement, including the cardiologists from the level I service and the
cardiologist/cardiothoracic surgeon from the receiving service; (6) Provisions for the
recommendation by the medical director of the receiving service, regarding the
cardiac catheterization service's credentialing criteria; and (7) Provisions for annual
drilling activities to review and test the components of the written transfer
protocol. An actual emergent patient transfer consistent with the written
transfer protocol within the calendar year meets the requirement for an annual
drill. (H) Major complications and emergency
transfers should be reviewed at least once every sixty days by the quality
assessment review process required in paragraph (E) of rule 3701-84-30 of the
Administrative Code and rule 3701-84-12 of the Administrative
Code. (I) Reporting: (1) Beginning January 1,
2023, and ending on December 31, 2024, each level I services will submit the
following information to the department by March first of each year
that; (a) Maintains patient confidentiality; (b) Includes the numbers for the following: (i) Diagnostic cardiac
catheterization and electrophysiology studies as provided in paragraphs (B)(1)
to (B)(7) conducted in a cardiac catheterization procedure room; (ii) Diagnostic
electrophysiology studies conducted in an electrophysiology procedure room;
(iii) Post-procedure
in-hospital mortality number; (iv) Vascular access
injury requiring surgery or other intervention; (v) Major bleeding as
defined in paragraph (K) of rule 3701-84-30 of the Administrative
Code; (vi) Emergent transfers
to the receiving service for interventional medical management, that became
necessary as a result of the cardiac catheterization or electrophysiology study
during or immediately after the cardiac catheterization or electrophysiology
study: and (vii) Emergency PCI
procedures performed when clinically indicated and reported to the department
in accordance with paragraph (L) of this rule. (2) Beginning January 1, 2025, each
level I service will submit the following information to the department by
March first of each year as part of the hospital's annual report
that: (a) Maintains patient confidentiality; (b) Includes the numbers for the following; (i) Diagnostic
catheterization and electrophysiology studies as provided in paragraphs (B)(1)
to (B)(7) conducted in a cardiac catheterization procedure room; (ii) Diagnostic
electrophysiology studies conducted in an electrophysiology procedure room;
(iii) Post-procedure
in-hospital mortality number; (iv) Vascular access
injury requiring surgery or other intervention; (v) Major bleeding as
defined in paragraph (K) of rule 3701-84-30 of the Administrative
Code; (vi) Emergent transfers
to the receiving service for interventional medical management, that became
necessary as a result of the cardiac catheterization or electrophysiology study
during or immediately after the cardiac catheterization or electrophysiology
study: and (vii) Emergency PCI procedures performed when clinically
indicated and reported to the department in accordance with paragraph (L) of
this rule. (J) Prior to performance of a diagnostic
procedure, each level I service shall obtain a signed informed consent form
that includes an acknowledgment by the patient that the diagnostic procedure is
being performed in a cardiac catheterization service without an on-site open
heart surgery service and an acknowledgment that, if necessary as the result of
an adverse event, the patient may be transferred to a receiving service for
medical/surgical management. (K) Nothing in this rule shall prohibit
the provision of emergency care, including emergent PCI, when clinically
indicated. The service shall provide notice to the department within
forty-eight hours of any incident requiring action outside the scope of
services authorized to be performed at the level I designation and ensure the
notification: (1) Maintains patient
confidentiality; (2) Indicates when the
incident occurred; (3) Describes the nature
of the emergency and what actions were taken; and (4) Includes the
outcome.
Last updated May 15, 2023 at 12:45 AM
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Rule 3701-84-30.2 | Level II cardiac catheterization service standards.
(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. (C) Each level II 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 II 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 provider. (D) Level II services shall: (1) Implement patient
screening criteria consistent with the 2014 expert consensus
document: (a) Table 5: recommendations for off-site surgical backup and
case selection; and (b) Table 6: patient and lesion characteristics. (2) Ensure that the
medical director for the level II service monitors and ensures strict adherence
to the patient selection criteria and treatment protocols. (E) In addition to the general personnel and staffing
requirements set forth in rule 3701-84-31 of the Administrative Code, each
level II service will: (1) Provide nursing and
laboratory staff consistent with the 2014 expert consensus document, table 4:
personnel recommendations; and (2) Maintain personnel
capable of endotracheal intubation and ventilator management within their scope
of practice, both on-site and during transfer of the patient if
necessary. (F) In addition to the general facilities, equipment, and
supplies requirements set forth in rule 3701-84-32 of the Administrative Code,
each level II service will have, at a minimum, equipment consistent with the
2014 expert consensus document, table 3: facility requirements. (G) Each level II service shall comply with the safety
standards set forth in rule 3701-84-33 of the Administrative Code. (H) Each level II service shall maintain a formal written
transfer protocol for emergency medical/surgical management with a registered
hospital that provides open heart surgery services, which can be reached
expeditiously from the level II service by available emergency vehicle within a
reasonable amount of time and that provides the greatest assurance for patient
safety. The open heart surgery service that is party to a transfer protocol is
referred to as the receiving service. Each protocol shall include: (1) Provisions addressing
indications, contraindications, and other criteria for the emergency transfer
of patients in a timely manner; (2) Assurance of the
initiation of appropriate medical/surgical management in a timely
manner; (3) Assurance that
surgical back-up is available for urgent cases during all hours of
operation; (4) Specification of
mechanisms for continued substantive communication between the services party
to the agreement and between their medical directors and physicians;
(5) Provisions for a
collaborative training program among the staff of the services party to the
agreement, including the cardiologists from the level II service and the
cardiologist/cardiothoracic surgeon from the receiving service; (6) Provisions for the
recommendation by the medical director of the receiving service, regarding the
cardiac catheterization service's credentialing criteria; and (7) Provisions for annual
drilling activities to review and test the components of the written transfer
protocol. An actual emergent patient transfer consistent with the written
transfer protocol within the calendar year meets the requirement for an annual
drill. (I) Each level II service shall maintain a formal written
agreement with a ground and/or air ambulance service that can commit to on-site
availability within thirty minutes of notification and is capable of advanced
cardiac life support and intra-aortic balloon pump transfer of a patient to the
hospital party to the written transfer protocol required by paragraph (I) of
this rule. Ground and/or air ambulance service agreements should be consistent
with the recommendations set forth in the 2014 expert consensus document, table
3: facility requirements. (J) Major complications and emergency transfers should be
reviewed at least once every sixty days by the quality assessment review
process required in paragraph (E) of rule 3701-84-30 of the Administrative Code
and rule 3701-84-12 of the Administrative Code. (K) Each level II service will obtain enrollment and
maintain participation in a data registry to monitor operator and institutional
volumes and outcomes. (L) Reporting: (1) Beginning January 1,
2023 and ending December 31, 2024, each level II service shall submit an annual
report to the department by March first of each year that; (a) Maintains patient confidentiality; (b) Includes the numbers for the following: (i) Cardiac
catheterization procedures and electrophysiology studies or procedures
conducted in a cardiac catheterization procedure room; (ii) Electrophysiology
studies or procedures conducted in an electrophysiology procedure room;
(iii) Elective
PCI; (iv) Primary
PCI; (v) Post-procedure
in-hospital mortality number; (vi) Vascular access
injury requiring surgery or other intervention; (vii) Major bleeding as
defined in paragraph (K) of rule 3701-84-30 of the Administrative Code.
(viii) Emergent transfers
to the receiving service for interventional medical management, that became
necessary as a result of the cardiac catheterization procedure or
electrophysiology study or procedure during or immediately after a cardiac
catheterization procedure or an electrophysiology study or procedure:
and (ix) Emergency PCI
procedures performed when clinically indicated and reported to the department
in accordance with paragraph (N) of this rule. (2) Beginning January 1,
2025, each level III service shall submit the following information to the
department by March first of each year as part of the hospital's annual
report that: (a) Maintains patient confidentiality; (b) Includes the numbers for the following: (i) Cardiac
catheterization procedures and electrophysiology studies or procedures
conducted in a cardiac catheterization procedure room; (ii) Electrophysiology
studies or procedures conducted in an electrophysiology procedure room;
(iii) Elective
PCI; (iv) Primary
PCI; (v) Post-procedure
in-hospital mortality number; (vi) Vascular access
injury requiring surgery or other intervention; (vii) Major bleeding as
defined in paragraph (K) of rule 3701-84-30 of the Administrative Code.
(viii) Emergent transfers
to the receiving service for interventional medical management, that became
necessary as a result of the cardiac catheterization procedure or
electrophysiology study or procedure during or immediately after a cardiac
catheterization procedure or electrophysiology study or procedure:
and (ix) Emergency PCI
procedures performed when clinically indicated and reported to the department
in accordance with paragraph (N) of this rule. (M) Prior to the performance of any procedure, each level
II service shall obtain a signed informed consent form from each patient prior
to performance of any procedure that includes an acknowledgment by the patient
that the procedure is being performed in a cardiac catheterization service
without an on-site open heart surgery service and an acknowledgment that, if
necessary as the result of an adverse event, the patient may be transferred to
a receiving service for medical/surgical management. (N) Nothing in this rule shall prohibit the provision of
emergency care, including emergent PCI, when clinically indicated. The service
shall provide notice to the department within forty-eight hours of any incident
requiring action outside the scope of services authorized to be performed at
the level II designation and ensure the notification: (1) Maintains patient
confidentiality; (2) Indicates when the
incident occurred; (3) Describes the nature
of the emergency and what actions were taken; and (4) Includes the
outcome.
Last updated May 15, 2023 at 12:45 AM
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Rule 3701-84-30.3 | Level III adult cardiac catheterization service standards.
(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. (E) Each level III service will comply
with the personnel and staffing requirements set forth in rule 3701-84-31 of
the Administrative Code. (F) In addition to the general
facilities, equipment, and supplies requirements set forth in rule 3701-84-32
of the Administrative Code, each level III service, will have: (1) One or more surgical
suites that are equipped to accommodate thoracic and cardiac surgical
procedures requiring cardiopulmonary bypass, with appropriate staff available
in less than sixty minutes; and (2) At a minimum,
equipment consistent with the 2014 expert consensus document, table: 3 facility
requirements. (G) Each level III service will comply
with the safety standards set forth in rule 3701-84-33 of the Administrative
Code. (H) Major complications and emergency
transfers should be reviewed at least once every sixty days by the quality
assessment review process required in paragraph (E) of rule 3701-84-30 of the
Administrative Code and rule 3701-84-12 of the Administrative
Code. (I) Each level III service will obtain
enrollment and maintain participation in a data registry to monitor operator
and institutional volumes, outcomes, and procedural appropriateness.
(J) Reporting: (1) Beginning January 1,
2023, and ending on December 31, 2024, each level III services will submit an
annual report to the department by March first of each year that: (a) Maintains patient confidentiality; (b) Includes the numbers for the following: (i) Cardiac
catheterization procedures and electrophysiology studies or procedures
conducted in a cardiac catheterization procedure room; (ii) Electrophysiology
studies or procedures conducted in an electrophysiology procedure room;
(iii) Elective PCI;
(iv) Primary
PCI; (v) Post-procedure
in-hospital mortality number; (vi) Vascular access
injury requiring surgery or other intervention; and (vii) Major bleeding as
defined in paragraph (K) of rule 3701-84-30 of the Administrative Code.
(2) Beginning January 1,
2025, each level III service will submit the following information to the
department by March first of each year as part of the hospital's annual
report that: (a) Maintains patient confidentiality; (b) Includes the number of procedures performed in the
following categories: (i) Cardiac
catheterization procedures and electrophysiology studies or procedures
conducted in a cardiac catheterization procedure room; (ii) Electrophysiology
studies or procedures conducted in an electrophysiology procedure room;
(iii) Elective PCI;
(iv) Primary
PCI; (v) Post-procedure
in-hospital mortality number; (vi) Vascular access
injury requiring surgery or other intervention; and (vii) Major bleeding as
defined in paragraph (K) of rule 3701-84-30 of the Administrative
Code. (K) Each level III service shall obtain a
signed informed consent from each patient prior to the performance of any
procedure.
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Rule 3701-84-30.4 | Adult electrophysiology procedure rooms.
(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. (C) The following equipment will be
available to each procedure room where adult electrophysiology studies are
conducted: (1) Electrogram recording
systems; (2) Programmed stimulators; (3) Defibrillator; (4) Electrocardiogram and hemodynamic
monitoring equipment; (5) Non-invasive blood pressure monitor;
(6) Supplies specific to the procedure
being performed; (7) Emergency equipment and supplies;
(8) If the procedure requires
fluoroscopy, radiation shielded barriers that meet state and federal
requirements are required; and (9) When determined
necessary, three-dimensional (3D) mapping systems may be provided by a service
onsite or through agreement or contract with another hospital. (D) Electrophysiology study numbers are
to be included in each adult cardiac catheterization service's annual
report of the number and type of procedures performed.
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Rule 3701-84-31 | General personnel/staffing - adult cardiac catheterization service.
(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. (C) In addition to the requirements of paragraph (B) of this
rule, the medical director of a level II or level III service
will: (1) Be board certified in
interventional cardiology; and (2) Have at least five
years experience in interventional cardiology; or (3) Have performed, as
the primary operator, at least five hundred percutaneous coronary
interventions. (D) Each adult cardiac catheterization service will have at least
two licensed physicians credentialed to provide cardiac catheterization
services on staff who are knowledgeable of the laboratory's protocols and
equipment by providing cardiac catheterization services at the hospital. Only
physicians appropriately credentialed to provide cardiac catheterization
services may be the primary operator of a cardiac catheterization
procedure. (E) Each adult cardiac catheterization service will consider the
American college of cardiology/American heart association/American college of
physicians task force 2013 update of clinical competence statement on coronary
artery interventional procedures in assessing clinical competency. At a
minimum, all physicians who perform cardiac catheterization procedures
will: (1) Have training that
includes at least one year dedicated to cardiac catheterization
procedures; (2) Be a fully-accredited member of the
service's staff; and (3) Participate in the cardiac
catheterization laboratory's quality assurance programs, including peer
review. (F) In addition to requirements contained in paragraph (E) of
this rule, physicians performing percutaneous coronary interventions (PCI) who
have not performed PCI prior to March 20, 1997 will have completed a fellowship
training program in interventional cardiology. (G) In addition to the requirements of paragraphs (A), (B), and
(D) of this rule and the general personnel requirements of paragraph (B) of
rule 3701-84-08 of the Administrative Code, the adult cardiac catheterization
service will have available a sufficient number of qualified staff who are able
to supervise and conduct the service including the following: (1) Support staff, all
of whom are skilled in cardiac life support, comprised of individuals skilled
in the following: (a) Digital imaging; (b) Systematic quality control testing; (c) Patient observation; (d) Critical care; (e) Monitoring and recording electrocardiographic and hemodynamic
data; (f) Radiographic and angiographic imaging techniques and safety
principles; and (g) For catheterization laboratories where physiological studies
are performed: (i) Managing blood
samples: (ii) Performing blood gas
measurements and calculations; and (iii) Assisting with
indicator dilution studies. (2) Nursing personnel: (a) May include nurse practitioners, registered nurses,
licensed practical nurses, and nursing assistants; (b) Nursing personnel involved in the provision of cardiac
catheterization services will: (i) Have knowledge of operating room techniques;
and (ii) Have experience in
critical care: or (iii) The adult cardiac
catheterization service must provide nursing personnel with an orientation and
training in critical care for the adult cardiac catheterization patient and
document the orientation and training in the nurse's personnel
record. (c) Nurse practitioners, registered nurses, and licensed
practical nurses involved in the provision of cardiac catheterization services
will: (i) Be advanced cardiac
life support certified; (ii) Have experience in
cardiovascular medications; and (iii) Have the ability to
begin administration of intravenous solutions. (d) Nurse practitioners may assume some of the duties of a
physician as permitted by law. However, ultimate responsibility for procedures
will always remain with the physician of record. (H) Respiratory therapists and critical care staff will be
immediately available at all times to care for patients. (I) Biomedical, electronic, and radiation safety experts will be
involved in maintaining the equipment utilized by the service. (J) Staffing requirements of this rule may be met by individuals
with equivalent or greater qualifications if the replacement's scope of
practice encompasses the duties of the required staff.
Last updated May 15, 2023 at 12:45 AM
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Rule 3701-84-32 | General facilities, equipment, and supplies - adult cardiac catheterization service.
(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. (2) Control rooms, if
utilized, will: (a) Accommodate the imaging system control
equipment; (b) Be sized and configured in compliance with manufacturer
recommendations for installation, service, and maintenance; (c) Have view panels that provide for a view of the patient
and the cardiac catheterization team; (d) Be permitted to serve more than one hybrid procedure
room, provided that manufacturer recommendations for installation, service, and
maintenance are accommodated for all rooms served; and (e) Be physically separated from a hybrid procedure room
with walls and a door. (f) A door is not required where a control room serves only
one procedure room and is built, maintained, and controlled the same as the
procedure room. (3) Clean utility rooms
that can sufficiently and efficiently supply the procedure rooms. (C) A general radiology room cannot be
used as a cardiac catheterization procedure room. (D) Equipment described in this paragraph may be replaced by
newer technology that has equivalent or superior capability as determined by
the provider of the service. In assessing these new technologies, consideration
should be given to recommendations of recognized professional societies and
accrediting bodies (e.g. the American college of cardiology). All services
will, at a minimum have the following equipment: (1) High quality x-ray
imaging with mutiaxial position capability; (2) A three-phase, twelve
pulse generator with an output of eighty to one hundred kilowatts or a constant
potential generator with an output of at least one hundred kilowatts at one
hundred kilovolts; (3) Multimode or cesium
iodide image intensifiers; (4) High-quality matched
optics; (5) Appropriate imaging
modality for review and storage of images; (6) Digital imaging
equipment; (7) Carbon-fiber table
tops; (8) A mechanism for continuous monitoring
of a patient's blood pressure and electrocardiogram; (9) An adequate supply and variety of
catheters, guide wires, and sheaths; (10) A crash cart with equipment for
ventilatory support; (11) A defibrillator; (12) A temporary pacemaker;
and (13) An intra-aortic
balloon pump or other percutaneous mechanical circulatory assistance device of
superior capability. (E) Each adult cardiac catheterization service will provide and
maintain radiation generating equipment in accordance with applicable state and
federal requirements as specified in Chapter 3748. of the Revised Code and the
rules adopted thereunder.
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Rule 3701-84-33 | Safety standards - adult cardiac catheterization service.
(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. (C) Each service will periodically survey
all of the equipment utilized by the service and perform preventive maintenance
on a schedule that, at a minimum, conforms to manufacturers'
recommendations. Results of surveillance and preventive maintenance activities
will be internally documented.
Last updated May 15, 2023 at 12:45 AM
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Rule 3701-84-34 | Adult cardiac catheterization service performance measures.
(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.
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Rule 3701-84-34.1 | Inspection and review of adult cardiac catheterization services.
(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.
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Rule 3701-84-34.2 | Order to cease operations of an adult cardiac catheterization service.
(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. (B) The director will provide a written
order to cease operations to the service via certified mail. (C) An order to cease operations may
appealed in accordance with Chapter 119. of the Revised Code. A notice of
appeal must be filed with the director not later than thirty days after the
notice's date of mailing. If requested by the service, the director will
provide a hearing in accordance with Chapter 119. of the Revised
Code.
Last updated May 15, 2023 at 12:45 AM
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Rule 3701-84-36 | Open heart surgery service standards.
(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. (C) Each open heart surgery service will
have the capability, equipment, and personnel to perform emergency open heart
procedures on a twenty four hour a day, seven days a week basis. A
cardiovascular surgical team will be available in less than sixty minutes on a
twenty-four hour a day basis. (D) Each open heart surgery service will
have access to the following services: (1) Cardiology; (2) Hematology; (3) Nephrology; (4) Pulmonary
medicine; (5) Infectious
disease; (6) Radiology; (7) Neurology; (8) Emergency
care; (9) Electrocardiography; (10) Stress
testing; (11) Nuclear
medicine; (12) Pathology; (13) Blood banking
services; (14) Echocardiography; (15) Pulmonary function
testing; (16) Cardiac rehabilitation; (17) Pre-admission testing;
and (18) Follow-up outpatient nursing referral
services. (E) An open heart surgery service will
only be provided in a fully permanent setting within the permanent frame of the
building of a hospital that is classified as a general hospital or as a special
hospital - cardiac that primarily furnishes limited services to patients with
cardiac conditions. The hospital will be fully equipped and have all resources
necessary to perform open heart surgery. (F) Each an adult open heart surgery
service will obtain and maintain enrollment in a data registry to monitor
operator and institutional volumes and outcomes. (G) Reporting: (1) Beginning January 1,
2023 and ending December 31, 2024, each adult open-heart service will submit an
annual report to the department by March first of each year that; (a) Maintains patient confidentiality; (b) Includes numbers for the following: (i) The number of
procedures performed by the adult open heart service; (ii) Post procedure
in-hospital mortality number; (iii) In hospital
prolonged intubation (ventilation) for a period of longer than seven
days; (iv) Deep sternal wound
infection (mediastinitis); (v) Post-operative renal
insufficiency; (vi) Surgical
re-exploration; and (vii) Stroke. (2) Beginning January 1,
2025, each level III service will submit the following information to the
department by March first of each year as part of the hospital's annual
report that: (a) Maintains patient confidentiality; (b) Includes numbers for the following: (i) The number of
procedures performed by the adult open heart service; (ii) Post procedure
in-hospital mortality number; (iii) In hospital
prolonged intubation (ventilation) for a period of longer than seven
days; (iv) Deep sternal wound
infection (mediastinitis); (v) Post-operative renal
insufficiency; (vi) Surgical
re-exploration; and (vii) Stroke. (H) Each adult open heart surgery service will have a
written policy requiring the documentation of any internal review of surgeons
with a combination of higher than expected risk adjusted mortality and low
individual surgeon volume. (I) Each adult open heart surgery service will utilize a
coordinated and integrated multidisciplinary approach to patient care,
including meetings between cardiologists and cardiovascular surgeons as
necessary, to address the needs of patients with complex cardiovascular
disease. (J) Each adult open heart surgery service will have
established criteria that cardiologists and surgeons will utilize for the
purposes of patient selection and appropriateness. (K) Each adult open heart surgery will have patient
selection and appropriateness criteria: (1) Consistent with the
2021 American college of cardiology/American heart association (ACC/AHA)
guideline update for coronary artery bypass graft surgery, available at
www.acc.org; and (2) For patients with
adult congenital heart disease, are consistent with the 2018 American college
of cardiology/American heart association guidelines for the management of
adults with congenital heart disease: executive summary, available at
www.acc.org.
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Rule 3701-84-37 | Personnel/staffing - open heart surgery service.
(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. (B) Each open heart surgery service will
have at least two thoracic surgeons on staff, credentialed to perform open
heart procedures at the hospital who actively perform open heart procedures at
the hospital. The medical director of the open heart surgery service may be
counted as one of the two required thoracic surgeons. (C) Each open heart surgery service will
have competent and qualified staff available, including but not limited
to: (1) Surgical assistants
to assist the surgeon. A surgical assistant may be a resident, another
physician, or a specially trained surgical assistant; (2) Cardiac
anesthesiologists with special training in the anesthetic and supportive
requirements of open heart surgery; (3) Nursing staff that
will include appropriate numbers of scrub nurses or technicians and a
circulating nurse based on the needs of the surgeons and the patient. A minimum
of two staff, including a circulating nurse and one scrub nurse or technician
will be present for each procedure. Nursing staff will be trained in cardiac
surgical operating room procedures; (4) A cardiac surgical
intensive care unit will be staffed at the appropriate nurse patient ratio
commensurate with the acuity of the patients and the amount of time following
surgery that such care is necessary. Cardiac surgical intensive care nurses
will be advanced cardiac life support (ACLS) certified and have specialized
training to develop the theoretical knowledge and clinical skills required for
the care of cardiac surgical patients; and (5) A minimum of two
perfusionists who are graduates of an accredited cardiovascular perfusion or
perfusion technology program or have equivalent training and
experience. (D) In addition to the requirements of
paragraph (C) of this rule, an open heart surgery service will have appropriate
staff available, including but not limited to: (1) Pharmacists; (2) Dietitians; (3) Respiratory
therapists; (4) Physical
therapists; (5) Cardiac
rehabilitation therapists; and (6) Social
workers. (E) Staffing requirements of this rule
may be met by individuals with equivalent or greater qualifications if the
replacement's scope of practice encompasses the duties of the required
staff.
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Rule 3701-84-38 | Facilities, equipment, and supplies - open heart surgery service.
(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. (2) Operating 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. (3) Hybrid operating
rooms will meet the minimum floor area and clearances of paragraphs (A)(1)(a)
and (A)(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. (4) Fixed encroachments into the minimum
floor area are permitted to be included when determining the minimum clear
floor area for an operating room as long as: (a) There are no encroachments into the sterile
field; (b) The encroachments do not extend more than twelve inches
into the minimum clear floor area outside the sterile field; and (c) The encroachment width along each wall does not exceed
ten percent of the length of that wall. (5) Control rooms if
utilized, will: (a) Accommodate the imaging system control
equipment; (b) Be sized and configured in compliance with manufacturer
recommendations for installation, service, and maintenance; (c) Have view panels that provide for a view of the patient
and the open heart surgery team; and (d) Be permitted to serve more than one hybrid operating
room, provided that manufacturer recommendations for installation, service, and
maintenance are accommodated for all rooms served. (e) Be physically separated from a hybrid operating room
with walls and a door. (f) A door is not required where a control room serves only
one operating room and is built, maintained, and controlled the same as the
operating room. (B) Each operating room used for open
heart surgery will have appropriate numbers of oxygen and vacuum outlets and
proper operating room lighting. Fiber optic headlights will be
provided. (C) Equipment and technology described in
this paragraph may be replaced by newer technology and equipment with
equivalent or superior capability. In assessing this new equipment and
technology, consideration should be given to the recommendations of recognized
professional societies and accrediting bodies. An open heart surgery service
will have at least the following: (1) Two fully operational
cardiopulmonary bypass machines equipped with; (a) A time and temperature module; (b) An air bubble and level detector system; (c) A blender (air and oxygen mixer); (d) An oxygen analyzer; (e) A saturation monitor; (f) Two pressure monitors; (g) A back up pump head; and (h) A heater/cooler (one back up). (2) Appropriate patient
monitoring equipment with overhead slave, electrocardiogram, three pressure
reading, and cardiac output; (3) An
electrocauter; (4) A heat
exchanger; (5) Drug infusion
equipment; (6) Transportable
monitoring equipment including electrocardiogram, defibrillator, oxygen
saturation monitor, and pressure transducer; (7) An intra-aortic
balloon pump or other percutaneous mechanical circulatory assistance device of
superior capability; (8) The availability of a
transesophageal echo; (9) A cardiac
pacemaker; (10) Routine blood gas
analysis and chemistry including blood sugar analysis in the operating
room; (11) Defibrillators; (12) A heating
blanket; (13) An ice
bath; (14) An automated
coagulation timer (ACT) machine; and (15) A cell
saver. (D) Each open heart surgery service will
ensure that a fully equipped and staffed cardiac surgical intensive care unit
that meets the needs of the cardiac surgery patient is available in the
building and accessible by gurney from where the open heart surgery is
performed. The cardiac surgical intensive care unit will ensure that a
sufficient number of intensive care unit beds are available to meet the needs
of open heart surgery patients each week, however, the beds are not required to
be dedicated only to cardiac surgery patients. (E) Each open heart surgery service will
ensure that a post-intensive care "step-down" unit with telemetry is
available in the building and accessible by gurney from where the open heart
surgery is performed. The number of "step-down" beds will be
sufficient to meet the needs of open heart surgery patients each week, however,
the beds are not required to be dedicated only to cardiac surgery
patients.
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Rule 3701-84-39 | Quality assessment and performance improvement - open heart surgery service.
(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. (2) Have a regular formal
morbidity and mortality conference chaired by the medical director of the open
heart surgery service or the medical director's designee. The morbidity
and mortality conferences will: (a) Be held at least once every sixty days or more
frequently depending on the need; and (b) Review all deaths and complications such as reoperation
for bleeding, deep sternal wound infection, stroke, and perioperative
myocardial infarction and any patterns that might indicate a problem will be
investigated and remedied if necessary. (B) Each open heart surgery service will
maintain a clinical pathway for coronary bypass graft surgery and valve
replacements.
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Rule 3701-84-40 | Adult open heart surgery service performance measures.
(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.
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Rule 3701-84-61 | Pediatric intensive care service standards.
(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. (F) The following services will be
available by phone or teleconference within sixty minutes on a twenty-four hour
a day, seven days a week basis: (1) A
nephrologist; (2) A
hematologist/oncologist; (3) An
endocrinologist; (4) An infectious disease
specialist; and (5) A pathologist with
demonstrated training and experience in pediatrics. (G) A psychiatrist or psychologist with
demonstrated training and experience in pediatrics will be available to the
PICU by phone or teleconference within twenty four hours on a twenty four hours
a day seven days a week basis. (H) Each PICU service will have access to the following
pediatric specialists for consultation and treatment as necessary, either on
staff or by arrangement or contract: (1) A
neonatologist; (2) An allergist or
immunologist; (3) A geneticist;
(4) A cardiovascular surgeon;
and (5) A radiologist with
demonstrated training and experience in pediatrics. (I) Each PICU service without an on-site pediatric cardiac
catheterization service and a pediatric cardiovascular surgery service will
maintain a written transfer agreement for emergency pediatric cardiovascular
surgery services with a provider of pediatric cardiac catheterization services
and pediatric cardiovascular surgery services that, once the patient can safely
be transported, can be reached expeditiously by available emergency vehicle in
less than sixty minutes on a twenty-four hour a day, seven days a week basis
and that provides the greatest assurance for patient safety. (J) Each PICU service without an on-site
pediatric radiologist or radiologist with training and experience in pediatrics
will maintain a written transfer agreement for emergency pediatric radiologic
services with a provider of pediatric radiologic services that, once the
patient can safely be transported, can be reached expeditiously by available
emergency vehicle in less than sixty minutes on a twenty-four hour a day, seven
days a week basis and that provides the greatest assurance for patient
safety. (K) Each PICU service will have available at least two
operating rooms with the capability, equipment and personnel to perform
emergency procedures in less than sixty minutes on a twenty-four hour a day,
seven days a week basis. (L) Each PICU service will have access to a blood bank with
all blood components available twenty-four hours a day, seven days a week.
Unless some unusual antibody is encountered, blood typing and cross matching
will allow for transfusion in less than sixty minutes. (M) Each PICU service will have radiology services
available to the PICU at all times to meet the needs of the patient and will
include: (1) Portable
radiology; (2) Fluoroscopy; (3) Computerized
tomography scanning; (4) Ultrasonography; (5) Angiography; (6) Nuclear scanning;
and (7) Magnetic resonance
imaging; (N) Radiation therapy services will be available on-site or
through contract with another hospital. (O) Each PICU service will have the following clinical
laboratory capabilities: (1) Microspecimen
capability and one hour turnaround time for: (a) Clotting studies and measurements of complete blood cell
count; (b) Differential count; (c) Platelet count; (d) Urinalysis; (e) Electrolytes; (f) Blood urea nitrogen; (g) Creatinine; (h) Glucose; (i) Calcium; (j) Prothrombin time; (k) Partial thromboplastin time; and (l) Cerebrospinal fluid cell counts; (2) Blood gas values
available within fifteen minutes; (3) Within three hours,
results of: (a) Drug screening and levels of serum ammonia; (b) Serum and urine osmolarity; (c) Phosphorus; and (d) Magnesium. (4) Preparation of gram
stains and bacteriological cultures available twenty-four hours a day, seven
days a week. (P) Each PICU service will have access to the
hospital's pharmacy service and personnel on-site capable of dispensing
all necessary medications for pediatric patients of all types and ages,
twenty-four hours a day, seven days a week. (Q) Diagnostic cardiac and neurological services will be
available twenty-four hours per day to the PICU service as needed and
technicians with special training in pediatrics should be available to perform
the following studies: (1) Electrocardiograms,
two-dimensional and echocardiograms and electroencephalograms; and (2) Doppler ultrasonograph devices and
evoked potential monitoring equipment. (R) Each PICU service will timely provide hemodialysis
equipment and competent and qualified staff experienced with pediatric patients
available twenty-four hours a day, seven days a week. Each provider of a PICU
service without an on-site hemodialysis service will maintain a written
transfer agreement for emergency hemodialysis services with a provider of
hemodialysis services that, once the patient can safely be transported, can be
reached expeditiously by available emergency vehicle in less than sixty minutes
on a twenty-four hour a day, seven days a week basis and that provides the
greatest assurance for patient safety. (S) Each PICU service will have an integrated communication
system with a local emergency medical transport system. (T) Each PICU service will have a secondary emergency
communication system available twenty-four hours a day, seven days a week into
the PICU. (U) Each PICU service will have an internal transportation
system and competent and qualified staff for effective transport. (V) Each PICU service will maintain a communication link to
a federal, state, or local poison control center. (W) A PICU will only be operated in a fully permanent
setting within the permanent frame of the building of a hospital that is
classified as a general hospital or a children's hospital. The hospital
will be fully equipped to meet the needs of the PICU.
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Rule 3701-84-62 | Personnel and staffing standards - pediatric intensive care service.
(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. (C) The PICU medical director will: (1) Participate in
development, review, and implementation of PICU policies; (2) Participate in budget
preparation; (3) Coordinate staff
education; (4) Maintain a data base and/or vital
statistics that describe unit experience and performance; (5) Supervise resuscitation techniques,
including educational component; (6) Supervise quality control, assessment
and improvement activities, including morbidity and mortality
reviews; (7) Coordinate research; (8) Have the authority to consult on any
PICU patient; and (9) Name qualified designees to fulfill
the medical director's duties during absences. (D) Other individuals may supervise the
activities required in paragraph (C) of this rule, but the PICU director will
participate in each. (E) In addition to the pediatric intensivist required in
paragraph (D) of rule 3701-84-61 of the Administrative Code, each PICU service
will have a licensed physician assigned to the PICU who: (1) Is available to
provide bedside care to the patients in the PICU; and (2) Is skilled in and has
the credentials to provide emergency care to critically ill
children. These responsibilities may be shared or
delegated to an advanced practice nurse with specialized training in pediatric
critical care and credentials and privileges to provide care in the
PICU. (F) Each PICU service will have a nurse manager dedicated to the
PICU who will be supervised by the director of pediatric nursing or equivalent.
The PICU nurse manager will have specific training and experience in pediatric
critical care. Pediatric critical care registered nurse (CCRN) certification is
recommended for the nurse manager, but not required. (G) The PICU nurse manager will participate in the
following: (1) Development, review,
and implementation of written policies and procedures for the
PICU; (2) Coordination of
multidisciplinary staff education; (3) Quality
assurance; (4) Nurse
research; (5) Budget preparation
with the medical director; and (6) Name qualified
designees to fulfill their duties during absences. These responsibilities may be shared or
delegated to advanced practice nurses, but the PICU nurse manager will maintain
overall responsibility for these requirements. (H) Nursing to patient ratios in the PICU service will be
sufficient to accommodate the acuity level and volume of patients, usually
ranging from two nurses to one patient to one nurse to three patients and
adjusted as needed. (I) Required nursing skills for PICU nurses will
include: (1) Recognition,
interpretation and recording of various physiologic variables; (2) Drug and fluid
administration; (3) Cardio-pulmonary
resuscitation (CPR) certification; (4) Pediatric advanced
life support certification (PALS); (5) Respiratory care techniques including
chest physiotherapy, endotracheal suctioning and management, and tracheostomy
care; (6) Preparation and maintenance of
patient monitors; and (7) Psychosocial skills to meet the needs
of both patient and family. (J) Each PICU service will provide to nursing staff and document
in each nurse's personnel file the following: (1) An orientation the
the PICU; (2) A clinical and
didactic orientation in pediatric critical care; and (3) On-going pediatric
critical care in-service education. (K) Each PICU service will have respiratory therapy staff
assigned to the unit in-house twenty-four hours a day, seven days a week
who: (1) Have clinical
experience managing pediatric patients with respiratory failure;
and (2) It is recommended
that all respiratory therapy staff have pediatric advanced life support (PALS)
training or an equivalent course. (L) Other PICU staff will include: (1) Biomedical
technicians (in-house or available within one hour on a twenty-four hours a
day, seven day a week basis); (2) A social
worker; (3) A pharmacist in-house
twenty-four hours per day; (4) A radiology
technician; (5) A registered
dietitian; (6) A physical
therapist; (7) An occupational
therapist; (8) A child life
specialist; and (9) A unit
clerk. (M) As part of a continuing education program, the PICU service
will: (1) Have staff
participate in regional pediatric critical care education programs;
and (2) Provide regularly
scheduled resuscitation practice sessions. (N) Staffing requirements of this rule may be met by individuals
with equivalent or greater qualifications if the replacement's scope of
practice encompasses the duties of the required staff.
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Rule 3701-84-63 | Physical design and facilities - pediatric intensive care service.
(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. (C) Each PICU will contain the following
distinct areas: (1) Patient isolation
rooms; (2) A clean linen
room; (3) A soiled linen
room; (4) Equipment
storage; (5) Counseling; (6) A medication station
with drug refrigerator and locked narcotic cabinet; (7) A nourishment
station; (8) Hand washing
facilities; (9) Staff and patient
toilets; and (10) Patient personal
effects storage. (D) All patient rooms will
have: (1) The capacity to
provide patient privacy, such as through the use of walls or
curtains; (2) Easy, rapid access to
the head of the bed; and (3) Adequate electrical
outlets, compressed air, oxygen, and vacuum outlets per bed sufficient in
number to supply all necessary equipment. (E) Each PICU will have a rapid and
reliable system that timely reports and receives laboratory
results.
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Rule 3701-84-64 | Equipment and supplies - pediatric intensive care service.
(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. (2) Respiratory equipment
appropriate to meet the needs of all patients, including: (a) Mechanical ventilators suitable for pediatric patients of all
sizes; (b) Pulse oximeters and transcutaneous oxygen
monitors; (c) Cardon dioxide (CO2) monitors; (d) Inhalation therapy equipment; (e) Chest physiotherapy and suctioning; (f) Spirometers; and (g) Continuous oxygen analyzers with alarms. (3) Small equipment
including: (a) Tracheal intubation equipment in adequate numbers and type to
intubate patients of all ages; (b) Endotracheal tubes of all pediatric sizes; (c) Oral/nasal airways; (d) Flexible bronchoscope; (e) Suction catheters; (f) Vascular access equipment; and (g) Surgical trays for the following:; (i) Vascular
cut-downs; (ii) Open chest
procedures; (iii) Cricothyroidectomy;
and (iv) Tracheostomy;
(h) Intraosseous (IO) needles. (4) Bedside monitors that
are capable of providing continuous, sufficient and appropriate monitoring that
have visible and audible alarms and are capable of producing a permanent hard
copy of the rhythm strip. (C) Each PICU service will have the
capability to continuously monitor a patient's: (1) Electrocardiogram and
heart rate; (2) Respiration; (3) Temperature; (4) Systemic arterial
pressure; (5) Oxygen; (6) Carbon
dioxide; (7) Central venous
pressure; (8) Intracranial pressure;
and (9) Four pressures
simultaneously.
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Rule 3701-84-65 | Quality assessment and performance improvement program - pediatric intensive care service.
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.
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Rule 3701-84-67 | Radiation therapy, stereotactic radiosurgery, and stereotactic radiotherapy service standards.
(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.
Last updated May 15, 2023 at 12:45 AM
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Rule 3701-84-75 | Pediatric cardiac catheterization service standards.
(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. (C) Each pediatric cardiac
catheterization service will have explicit criteria consistent with current
recommendations of recognized professional societies and accrediting bodies,
specifying the number of times a year an appropriately privileged physician
performs each catheterization procedure in order to retain privileges to
perform that procedure. (D) Each pediatric cardiac
catheterization service will have immediate access to services
for: (1) Hematology and
coagulation disorders; (2) Electrocardiography; (3) Diagnostic
radiology, (4) Clinical
pathology; (5) Doppler-electrocardiography; (6) Pulmonary function
testing; and (7) Microbiology. (E) Each pediatric cardiac
catheterization service will have established criteria for patient selection
and appropriateness that are specific to each procedure performed in the
service. (F) Each pediatric cardiac
catheterization service will have a written policy requiring the documentation
of any internal review of surgeons with a combination of high risk adjusted
mortality and low individual surgeon volume. (G) Each pediatric cardiac
catheterization service, will enroll and be actively submitting data to a
pediatric cardiac catheterization data registry. (H) A cardiac catheterization service for
pediatric patients will only be provided in a fully permanent setting within
the permanent frame of the building of a registered hospital that is classified
as a general hospital, a children's hospital or a special hospital -
cardiac, that primarily furnishes limited services to patients with cardiac
conditions. The hospital will: (1) Operate inpatient
pediatric medical and surgical services in the same building that are
accessible by gurney from the pediatric cardiac catheterization
laboratory; (2) Operate a pediatric
intensive/critical care unit with registered special care beds, that is
reviewed and accredited or certified as such as part of the hospital's
accreditation or certification program in the same building and accessible by
gurney from the pediatric cardiac catheterization laboratory. The unit will
provide appropriate equipment and staff to care for pediatric cardiac patients
and have twenty-four hour monitoring capability (3) Provide a setting in
the same building as the pediatric cardiac catheterization laboratory in which
ambulatory pediatric cardiac catheterization patients can be observed for at
least four hours after the procedure; and (4) Provide adequate
physician coverage to manage postprocedure complications. (I) A pediatric cardiac catheterization
service that performs same-day pediatric cardiac catheterization will have
written criteria for same-day catheterization and discharge. (1) These written
criteria should establish discharge requirements such as: (a) Absence of bleeding; (b) Presence and adequacy of pulses and
perfusion; (c) Access to medical evaluation and care after discharge;
and (d) Parental understanding and ability to observe
overnight. (2) The written criteria should account
for the following when determining whether the patient is eligible for
discharge on the day of the cardiac catheterization: (a) Cardiac physiology; (b) Differences in procedure type; (c) Patient age; (d) Expected patient and parental compliance with discharge
instructions; (e) Travel distance; and (f) Duration of procedure and time of
completion.
Last updated May 15, 2023 at 12:45 AM
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Rule 3701-84-76 | Personnel/staffing - pediatric cardiac catheterization service.
(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. (B) The medical director of the pediatric
cardiac catheterization service will be board-certified in pediatric cardiology
by the American board of pediatrics or the American osteopathic board of
pediatrics and have additional education or experience in pediatric cardiac
catheterization and intervention. (C) Each pediatric cardiac
catheterization service will have at least two licensed physicians credentialed
to provide pediatric cardiac catheterization services on staff who are
knowledgeable of the laboratory's protocols and equipment by providing
pediatric cardiac catheterization services at the hospital. Only physicians
appropriately credentialed to provide pediatric cardiac catheterization
services may be the primary operator of a pediatric cardiac catheterization
procedure. (D) At a minimum, all physicians who perform pediatric cardiac
catheterization procedures will be: (1) A fully-accredited
member of the HCS's staff; and (2) Will participate in
laboratory quality assurance programs, including peer review. (E) In addition to the requirements of paragraphs (A) and (C) of
this rule, each pediatric cardiac catheterization service will have available a
sufficient number of qualified staff, who are able to supervise and conduct the
cardiac catheterization service and are skilled in pediatric cardiopulmonary
resuscitation, including the following, as applicable: (1) Support staff
comprised of individuals skilled in the following: (a) Radiographic techniques; (b) Digital imaging; (c) Systematic quality control testing; (d) Patient observation; (e) Critical care; (f) Monitoring and recording electrocardiographic and hemodynamic
data; and (g) For catheterization laboratories where physiological studies
are performed: (i) Managing blood
samples; (ii) Performing blood gas
measurements and calculations; and (iii) Assisting with
indicator dilution studies. (2) Nursing personnel in sufficient
number and type based on the caseload and types of procedures performed, which
may include nurse practitioners, registered nurses, licensed practical nurses,
and nursing assistants. (a) Nursing personnel involved in the provision of pediatric
cardiac catheterization services will have experience in pediatric critical
care and knowledge of operating room techniques; (b) Nurse practitioners, registered nurses, and licensed
practical nurses involved in the provision of pediatric cardiac catheterization
services will have: (i) Knowledge of
cardiovascular medications; (ii) The ability to begin
administration of intravenous solutions and administer drugs; (iii) Experience with
sterile techniques; and (iv) Skills in
monitoring vital signs, neurologic status and pain level. (c) Nurse practitioners may assume some of the duties of a
physician as permitted by law, however, ultimate responsibility for procedures
will always remain with the physician of record. (F) Respiratory therapists and pediatric critical care staff will
be immediately available to care for pediatric patients. (G) Biomedical, electronic, and radiation safety experts will be
involved in maintaining the cardiac catheterization laboratory. (H) Cardiovascular anesthesiologists and perfusion teams will be
immediately available to care for patients. (I) Staffing requirements of this rule may be met by individuals
with equivalent or greater qualifications if the replacement's scope of
practice encompasses the duties of the required staff.
Last updated May 15, 2023 at 12:45 AM
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Rule 3701-84-77 | Facilities, equipment, and supplies - pediatric cardiac catheterization service.
(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. (2) Control rooms, if
utilized, will: (a) Accommodate the imaging system control
equipment; (b) Be sized and configured in compliance with manufacturer
recommendations for installation, service, and maintenance; (c) Have view panels that provide for a view of the patient
and the cardiac catheterization team; (d) Be permitted to serve more than one hybrid procedure
room, provided that manufacturer recommendations for installation, service, and
maintenance are accommodated for all rooms served. (e) Be physically separated from a hybrid procedure room
with walls and a door. A door is not required where a control room serves only
one procedure room and is built, maintained, and controlled the same as the
procedure room. (3) Clean utility rooms
can sufficiently and efficiently supply the procedure rooms. (C) A general radiology room cannot be
used as a cardiac catheterization procedure room. (D) Each pediatric cardiac
catheterization service will ensure that each laboratory where a cardiac
catheterization procedure is conducted is appropriately equipped to provide
high quality pediatric imaging, physiological monitoring, and provision of
emergency care. (E) The equipment described in this
paragraph may be replaced by newer technology that has equivalent or superior
capability as determined by the pediatric cardiac catheterization service. In
assessing these new technologies, consideration should be given to
recommendations of recognized professional societies and accrediting bodies
(e.g. the American college of cardiology; the American academy of pediatrics).
All pediatric cardiac catheterization services will have the following
equipment: (1) Imaging equipment
appropriate to the procedures performed; (2) Immediate replay
capabilities; (3) A blood gas
analyzer; (4) A pulse
oximeter; (5) An infant warming
device; (6) Pacing
catheters; (7) An external
pacemaker; (8) A
defibrillator; (9) An emergency cart;
(10) A comprehensive
inventory of pediatric catheters and devices; and (11) Ultrasound. (F) Each pediatric cardiac
catheterization service will provide and maintain radiation generating
equipment in accordance with applicable state and federal requirements as
specified in Chapter 3748. of the Revised Code and the rules adopted
thereunder.
Last updated May 15, 2023 at 12:45 AM
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Rule 3701-84-78 | Safety standards - pediatric cardiac catheterization service.
(A) To assure a safe environment for
patients, visitors, and personnel, each pediatric cardiac catheterization
service will establish and maintain safety guidelines, 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. (B) Each pediatric cardiac
catheterization service will establish, maintain, and follow electrical safety
policies which 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. (C) Each pediatric cardiac
catheterization service will periodically survey all of the equipment utilized
by the service, perform preventive maintenance on a schedule that conforms to
manufacturers' recommendations, and document all preventive maintenance
activities.
Last updated May 15, 2023 at 12:45 AM
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Rule 3701-84-79 | Pediatric cardiac catheterization service - performance measures.
(A) A pediatric 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 risk adjusted mortality and low
volume will trigger a thorough internal review of an individual physician by
the pediatric cardiac catheterization service.
Last updated May 15, 2023 at 12:45 AM
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Rule 3701-84-80 | Quality assessment and performance improvement - pediatric cardiac catheterization service.
(A) Each pediatric cardiac
catheterization service will have a regular formal morbidity and mortality
conference: (1) Chaired by the medical director of the pediatric
cardiac catheterization service or the medical director's
designee; (2) Be held at a minimum of once every ninety sixty days or
more frequently depending on the need; and (3) Review all of the
following: (a) Deaths; (b) Rescue extracorporeal membrane
oxygenation; (c) Emergency surgery; and (d) Major complications, such as: (i) Readmission to
intensive care unit; (ii) Emergent readmission
to the hospital; or (iii) Major non-surgical
intervention. (B) Each pediatric cardiac
catheterization service will establish and maintain a method for reviewing the
quality of all cardiac catheterization procedures. This review will assess the
following: (1) Appropriateness of
cardiac catheterization studies and interventions; (2) Technical quality of
cardiac catheterization studies; (3) Procedure
result; (4) Rate of therapeutic
success; and (5) Rate of procedural
complications. (C) Each pediatric cardiac
catheterization service will establish and maintain a database to support the
review process detailed in paragraph (B) of this rule. The results of analyses
and review are to be documented and used to guide periodic internal reviews of
individual physicians with respect to maintaining their credentials to perform
specific cardiac catheterization procedures.
Last updated May 15, 2023 at 12:45 AM
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Rule 3701-84-81 | Pediatric cardiovascular surgery service standards.
(A) The provisions of rules 3701-84-81 to
3701-84-85 of the Administrative Code are applicable to each pediatric
cardiovascular surgery service performing procedures on patients less than
eighteen years of age. Patients eighteen and older may be served at a pediatric
cardiovascular surgery service, if the patient's attending physician and
the service's medical director determine that the service best serves the
needs of the patient. (B) At all times, each pediatric
cardiovascular surgery service will have available in the same building as the
pediatric cardiovascular surgery service and accessible by gurney, adequate
facilities for the pediatric cardiovascular surgery service,
including: (1) Cardiac operating
rooms; (2) Pediatric intensive
care facilities appropriate for the recovery of post operative pediatric
cardiovascular surgical patients; and (3) A cardiac
catheterization service. (C) Each pediatric cardiovascular surgery
service will have the capability, equipment, and personnel to perform emergency
pediatric open heart procedures on a twenty-four hour a day, seven days a week
basis. A pediatric cardiovascular surgical team will be available and on-site
in less than sixty minutes on a twenty-four hour a day, seven days a week
basis. (D) Each pediatric cardiovascular surgery
service will utilize a coordinated and integrated multidisciplinary approach to
patient care, including meetings to determine the appropriate course of
treatment for complex patients. Physicians and staff should function as a team
and should include adequate numbers of the following: (1) Qualified pediatric
cardiologists: (2) Pediatric
cardiovascular surgeons: (3) Pediatric
cardiovascular anesthesiologists; (4) Pediatric intensive
care physicians; (5) Neonatologists with
special expertise in the care of cardiac patients; and (6) Additional pediatric
specialists required for the overall care of patients. (E) Each pediatric cardiovascular surgery
service will have access to the following pediatric services and
subspecialties: (1) Cardiology, including
echocardiogram, doppler echocardiogram and cardiac
catheterization; (2) Hematology; (3) A general
surgeon; (4) Gastroenterology; (5) Nephrology; (6) Pulmonary
medicine; (7) Infectious
disease; (8) Radiology; (9) Interventional
radiology; (10) Neurology; (11) Emergency
care; (12) Pathology; (13) Pulmonary function
testing; (14) Preadmission
testing; and (15) Follow-up outpatient
nursing referral. (F) Each pediatric cardiovascular surgery
service will have access to the following services either on site or by
arrangement with another facility: (1) Extracorporeal
membrane oxygenation (ECMO); and (2) Ventricular assist
device (VAD). (G) Each pediatric cardiovascular surgery
service will obtain and maintain enrollment in a data registry to monitor
operator and institutional volumes and outcomes. (H) A pediatric cardiovascular surgery
service will only be provided in a fully permanent setting within the permanent
frame of the building of a hospital that is classified as a general hospital, a
children's hospital or as a special hospital - cardiac, that primarily
furnishes limited services to patients with cardiac conditions. The hospital
will be fully equipped to perform the service. (I) Each pediatric cardiovascular surgery
service will have established criteria that cardiovascular surgeons,
cardiologists, and physicians will utilize for patient selection and
appropriateness. (J) Each pediatric cardiovascular surgery
service will have a written policy requiring the documentation of any internal
review of surgeons with a combination of high risk adjusted mortality and low
individual surgeon volume.
Last updated May 15, 2023 at 12:45 AM
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Rule 3701-84-82 | Personnel/staffing - pediatric cardiovascular surgery service.
(A) The medical director of a pediatric
cardiovascular surgery service will be board certified in thoracic surgery. The
medical director will be: (1) Responsible for
oversight and care in the service; (2) Credentialed to
provide pediatric cardiovascular surgery services at the hospital where they
are the medical director; and (3) Active in performing
pediatric cardiovascular surgery procedures at the hospital where they are the
medical director. (B) Each pediatric cardiovascular surgery
service will have on staff at least two thoracic surgeons who are credentialed
to perform and actively perform pediatric cardiovascular surgery procedures at
the hospital. (C) In addition to the requirements of
paragraphs (A) and (B) of this rule, each pediatric cardiovascular surgery
service will have competent and qualified staff available,
including: (1) Surgical assistants
to assist the surgeon. A surgical assistant may consist of a resident, another
physician, or a specially trained surgical assistant; (2) Anesthesiologists
with expertise in the anesthetic and support requirements of pediatric
cardiovascular surgery; (3) Nursing staff which
will include an appropriate numbers of scrub nurses or technicians and
circulating nurses or technicians. A minimum of one scrub nurse and one
circulating nurse or technician alternative as noted, is necessary. Nursing
staff will be trained in pediatric cardiovascular surgical operating room
procedures and nurses will be pediatric advanced life support (PALS)
certified; (4) Pediatric intensive
care unit staff who are trained in pediatric advanced life support (PALS) at an
appropriate nurse to patient ratio commensurate with the acuity of each
individual patient and the amount of time following surgery that such care will
be necessary. Pediatric intensive care nurses and physicians will have
specialized training to develop the theoretical knowledge and clinical skills
required for the care of pediatric cardiovascular surgical patients;
and (5) A minimum of two
perfusionists. Perfusionists will be graduates of an accredited cardiovascular
perfusion or perfusion technology training program or have equivalent training
and experience. The perfusionists will have training, knowledge, and experience
with small body perfusion, extracorporeal membrane oxygenation (ECMO), and
ventricular assist devices (VAD) if those services are provided onsite.
(D) In addition to the requirements of
paragraph (C) of this rule, each pediatric cardiovascular surgery service will
have appropriate staff available, including pharmacists, dietitians,
respiratory therapists, physical therapists and social workers. (E) Staffing requirements of this rule
may be met by individuals with equivalent or greater qualifications if the
replacement's scope of practice encompasses the duties of the required
staff.
Last updated May 15, 2023 at 12:45 AM
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Rule 3701-84-83 | Facilities, equipment, and supplies - pediatric cardiovascular surgery service.
(A) Operating rooms used for pediatric
cardiovascular 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. (2) Operating 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. (3) Hybrid operating
rooms will meet the minimum floor area and clearances of paragraphs (A)(1)(a)
and (A)(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. (4) Fixed encroachments
into the minimum clear floor area are permitted to be included when determining
the minimum clear floor area for an operating room as long as: (a) There are no encroachments into the sterile
field; (b) The encroachments do not extend more than twelve inches
into the minimum clear floor area outside the sterile field; and (c) The encroachment width along each wall does not exceed
ten percent of the length of that wall. (5) Control rooms, if
utilized, will: (a) Accommodate the imaging system control
equipment; (b) Be sized and configured in compliance with manufacturer
recommendations for installation, service, and maintenance; (c) Have view panels that provide for a view of the patient
and the cardiovascular surgery team; (d) Be permitted to serve more than one hybrid operating
room, provided that manufacturer recommendations for installation, service, and
maintenance are accommodated for all rooms served; and (e) Be physically separated from a hybrid operating room
with walls and a door. (f) A door is not required where a control room serves
only one operating room and is built, maintained, and controlled the same as
the procedure room. (B) Each operating room used for
pediatric cardiovascular surgery will have appropriate numbers of oxygen,
vacuum and electrical outlets sufficient in number to supply all necessary
equipment and proper operating room lighting, including fiber optic
headlights. (C) Each pediatric cardiovascular surgery
service will have equipment appropriate for the safe performance and care of
pediatric cardiovascular surgery patients. (D) Each pediatric cardiovascular surgery
service will ensure that a fully equipped and staffed pediatric intensive care
unit is available in the building and accessible by gurney from where the
pediatric cardiovascular surgery is performed. The number of available
pediatric intensive care unit beds will be approximately one-half the number of
pediatric open heart operations performed per week. The physical space of this
unit will meet joint commission, american osteopathic association, or any other
national accrediting body approved for deeming authority by the centers for
medicare and medicaid services recommended standards, which are in effect on
the effective date of this rule, for intensive care unit beds. (E) The equipment described in this
paragraph may be replaced by newer technology that has equivalent or superior
capability as determined by the pediatric cardiac catheterization service. In
assessing these new technologies, consideration should be given to
recommendations of recognized professional societies and accrediting bodies
(e.g. the American college of cardiology; the American academy of pediatrics).
All pediatric cardiovascular surgery services will have the following
equipment: (1) Immediate replay
capabilities; (2) A blood gas
analyzer; (3) A pulse
oximeter; (4) An infant warming
device; (5) Pacing
equipment; (6) An external
pacemaker; (7) A
defibrillator; (8) An emergency cart;
and (9) A comprehensive
inventory of cannulas and conduits.
Last updated May 15, 2023 at 12:45 AM
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Rule 3701-84-84 | Pediatric cardiovascular surgery service - performance measures.
(A) Each pediatric cardiovascular surgery
service should maintain a volume of cardiovascular procedures sufficient to
ensure the safety and quality of procedures performed at the service and
individual surgeon proficiency. (B) No minimum per surgeon volume is
recommended, however, the combination of high risk adjusted mortality and low
volume will trigger a thorough internal review of an individual physician by
the pediatric cardiovascular surgery service.
Last updated May 15, 2023 at 12:45 AM
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Rule 3701-84-85 | Quality assessment and performance improvement - pediatric cardiovascular surgery service.
In addition to the general quality assessment and
performance improvement requirements set forth in rule 3701-84-12 of the
Administrative Code, each pediatric cardiovascular surgery service will: (A) As part of the service's overall
quality assessment and performance improvement process: (1) Utilize the quality
performance measures outcomes data obtained from the service's
participation in the service's chosen data registry; and (2) Include a periodic
review and evaluation of the multidisciplinary meetings required by paragraph
(D) of rule 3701-84-81 of the Administrative Code. (B) Have a regular formal morbidity and
mortality conference chaired by the medical director of the pediatric
cardiovascular surgery service or the medical director's designee. The
morbidity and mortality conferences will: (1) Be held at a minimum,
once a month or more frequently depending on the need; and (2) Review all deaths and
complications such as reoperation for bleeding, deep sternal wound infection,
stroke, perioperative myocardial infarction, and any patterns that might
indicate a problem will be investigated and remedied if necessary.
Last updated May 15, 2023 at 12:45 AM
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