Current through all regulations passed and filed through September 16, 2024
(A) The provisions of rules
3701-84-30 to
3701-84-34.2 of the
Administrative Code are applicable to each provider of cardiac catheterization
services performing procedures on adult patients greater than or equal to
eighteen years of age. An adult cardiac
catheterization service may serve a patient
less than eighteen
years of age if the patient's attending physician and the adult service's
medical director determine that the adult service best serves the needs of the
patient.
(B) Each provider of
cardiac catheterization services shall:
(1)
Designate in writing to the director the service level classification, as
defined in this chapter, it provides or intends to provide;
(2) Designate in writing to the director the
scope of services, including the number of procedure and control rooms,
provided within the service level classification;
(3) Meet the requirements of this chapter for
the service level classification designated; and
(4) Not hold itself out to any person or
government entity by means of signage, advertising, or other promotional
efforts as having a service level classification for which it is not
designated.
(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 preprocedure hemoglobin=<16 g/dL.
