(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) Each level II service shall
operate on an organized, regular, twenty-four hour a day, seven days a week
basis to perform primary PCI.
(C)(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) Atrial fibrillation
ablation;
(15)(14) Lead extractions;
and
(16)(15) Multivessel PCI
in the setting of severe left ventricular dysfunction.
(D)(C)
Each provider of a 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 shall not be construed as constituting precedent
for the granting of an accelerated designation for any other service
provider.
(E)(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.
(F)(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
shall
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.
(G)(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
shall
will have, at a minimum, equipment consistent with the
2014 expert consensus document, table 3: facility requirements.
(H)(G)
Each level II service shall comply with the safety standards set forth in rule
3701-84-33 of the Administrative
Code.
(I)(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
, 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
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.
(J)(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.
(K)(J) Major complications
and emergency transfers should be reviewed at least once every
ninety
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.
(L)(K) Each
provider of a level II service
shall
will
obtain enrollment and maintain participation in the
national cardiovascular data registry/CathPCI registry (NCDR)
a data registry to monitor operator and institutional
volumes and outcomes.
(M)(L)
Reporting:
Beginning
January 1, 2017, each provider of level II services shall submit an annual
report to the department based upon the data submitted to the NCDR during the
preceding year. At a minimum, the report shall;
(1)
Maintain
patient confidentiality
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.
(2) Be filed with the department
within one hundred twenty days after the close of the calendar year (April
thirtieth); and
(3) Include the following
information:
(a) All emergent transfers that
became necessary during or immediately after cardiac catheterization to the
receiving service for interventional medical management;
(b) The number of procedures
performed in the following categories:
(i) Diagnostic;
(ii) Elective PCI;
and
(iii) Primary PCI.
(c) PCI in-hospital risk adjusted
rate of bleeding (all patients);
(d) PCI in-hospital risk adjusted
mortality rate (patients with ST segment elevation myocardial
infarction);
(e) PCI in-hospital risk adjusted
mortality (ST segment elevation myocardial infarction patients
excluded):
(f) As appropriate, the proportion
of PCI procedures with post procedure myocardial infarction:
(i) Among hospitals routinely
collecting post-PCI biomarkers; or
(ii) Among hospitals who do not
routinely collect post-PCI biomarkers;
(g) Composite proportion of PCI
patients with death, emergency coronary artery bypass graft, stroke, or repeat
target vessel revascularization; and
(h) Median time to immediate PCI for
ST segment elevation myocardial infarction patients (in
minutes).
(N) Each level II service shall
provide notice to the department within thirty days of receipt of their
service's NCDR report, for any quarter in which the service falls at or below
the twenty-fifth percentile for the specific quality metrics designated in this
paragraph. The report shall include a statement for each metric not met, an
explanation as to why the service did not meet the metric, and how the service
intends to meet the metric in the future. The report shall include the
following metrics:
(1) PCI in-hospital risk adjusted
rate of bleeding (all patients);
(2) PCI in-hospital risk adjusted
mortality rate (patients with ST segment elevation myocardial
infarction);
(3) PCI in-hospital risk adjusted
mortality (ST segment elevation myocardial infarction patients
excluded);
(4) As appropriate, the proportion
of PCI procedures with post procedure myocardial infarction:
(a) Among hospitals routinely
collecting post-PCI biomarkers; or
(b) Among hospitals who do not
routinely collect post-PCI biomarkers;
(5) Composite proportion of PCI
patients with death, emergency coronary artery bypass graft, stroke, or repeat
target vessel revascularization; and
(6) Median time to immediate PCI for
ST segment elevation myocardial infarction patients (in
minutes).
(O)(M)
Prior to the performance of any procedure,
eachEach level II service shall
obtain an
a
signed informed consent form from each patient prior to performance of any
procedure. The informed consent shall
that
include
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.
(P)(N) Nothing in this
rule shall prohibit the provision of emergency care, including emergent PCI,
when clinically indicated. The service shall
notify
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
. The
and ensure the notification
shall:
(1)
Maintain
Maintains patient confidentiality;
(2)
Indicate
Indicates
when the incident occurred;
(3)
Describe
Describes the nature of the emergency and what actions
were taken; and
(4)
Include
Includes the outcome.
Notes
Ohio Admin. Code
3701-84-30.2
Effective:
5/15/2023
Five Year Review (FYR) Dates:
2/27/2023 and
05/05/2028
Promulgated
Under: 119.03
Statutory
Authority: 3702.11,
3702.13
Rule
Amplifies: 3702.14,
3702.141,
3702.15,
3702.16,
3702.18
Prior
Effective Dates: 03/20/1997, 06/17/1999, 01/20/2000, 03/24/2003, 05/15/2008,
11/10/2008, 06/21/2012, 04/30/2016,
08/01/2017
