Current through all regulations passed and filed through September 16, 2024
(A) Level I cardiac catheterization service
or "level I service" means an adult cardiac catheterization service located in
a hospital without an on-site open heart surgery service that provides only
diagnostic cardiac catheterization procedures on an organized regular
basis.
(B)
Each
level I
service
shall perform only diagnostic cardiac catheterization procedures to diagnose
anatomical and/or physiological problems in the heart. Diagnostic cardiac
catheterization procedures include:
(1)
Intracoronary administration of drugs;
(2) Left heart catheterization;
(3) Right heart catheterization;
(4) Coronary angiography;
(5) Basic diagnostic electrophysiology
studies not involving transseptal puncture;
(6) Intra-aortic balloon pump or, if required
for patient stabilization for transfer, placement of percutaneous left
ventricular assist device; and
(7)
Device implantation, including, but not limited to defibrillators.
(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 designationand
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.
