Current through all regulations passed and filed through September 16, 2024
(A) Level II cardiac catheterization service
or "level II service" means an adult cardiac catheterization service located in
a hospital without an on-site open heart surgery service that provides only
diagnostic and authorized therapeutic cardiac catheterization procedures on an
organized and regular basis.
(B) Level II services
are prohibited from providing the following procedures:
(1) Transcatheter aortic valve replacement
(TAVR);
(2) Revascularization of
chronic total occlusion (CTO);
(3)
Rotational coronary artherectomy;
(4) Alcohol septal ablation;
(5) Cardiac biopsy;
(6) Mitral valve clip;
(7) Transcatheter mitral valve (TMV) repair
or replacement;
(8) Laser lead
extraction;
(9) Atrial septal
defect (ASD), patent foramen ovale (PFO), and ventricular septal defect (VSD)
closure;
(10) Balloon aortic
valvuloplasty;
(11) PCI of last
remaining coronary artery;
(12)
Left atrial appendage closure;
(13)
Ventricular tachycardia ablation;
(14) Lead extractions;
and
(15) Multivessel PCI
in the setting of severe left ventricular dysfunction.
(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
procedurethat
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.
