(a) Discussion
1. During the past four decades, an evolution
in cardiac catheterization has taken place. The role of the cardiac
catheterization laboratory has progressed from study of cardiac function and
anatomy for purposes of diagnosis to evaluation of candidates for surgery and
finally, to providing catheter-based, nonsurgical interventional treatment.
This progress has stimulated an increase in demand for cardiac catheterization
services.
2. From about 1982 to the
present, there has been an unprecedented proliferation of cardiac
catheterization services, which have now been expanded to a wider group of
patients and diseases. The increase in patients and laboratories has been
stimulated by the development of nonsurgical catheterization laboratory-based
therapeutic procedures for palliation of both stable and unstable ischemic
heart disease as well as selected valvular and congenital heart diseases,
arrhythmias, and other problems. Many noncardiac diagnostic and therapeutic
vascular procedures are now being performed in cardiac catheterization
laboratory settings, but this area is still evolving. As newer cardiac
diagnostic and treatment modalities are developed, it is highly likely that the
role of cardiac catheterization will continue to evolve. Certain cardiac
catheterization procedures are now offered in physicians' offices outside of
the usual hospital environment.
3.
Fixed-based cardiac catheterization services are the only acceptable method for
providing cardiac catheterization services to the people in Alabama.
4. For purposes of this section, a cardiac
catheterization "procedure equivalent" is defined as a unit of measure which
reflects the relative average length of time one patient spends in one session
in a cardiac catheterization laboratory. One procedure equivalent equals 1.5
hours utilization time.
(b) Planning Policies
1. Planning Policy. Diagnostic
catheterizations shall be weighed as 1.0 equivalents, while
therapeutic/interventional catheterizations (Percutaneous Transluminal Coronary
Angioplasty (PTCA), directional coronary atherectomy, rotational coronary
atherectomy, intracoronary stent deployment, and intracoronary fibrinolysis,
cardiac valvuloplasty, and similarly complex therapeutic procedures) and
pediatric catheterizations shall be weighed as 2.0 equivalents.
Electrophysiology shall be weighed as 3.0 equivalents for diagnostic and 4.0
equivalents for therapeutic procedures. For multi-purpose rooms, each special
procedure performed in such rooms which is not a cardiac catheterization
procedure shall be weighed as one equivalent.
2. Planning Policy - New Institutional
Service. New "fixed-based" cardiac catheterization services shall be approved
only if the following conditions are met:
(i)
Each facility in the county has performed at least 1,000 equivalent procedures
per unit for the most recent year;
(ii) An applicant for diagnostic/therapeutic
cardiac catheterization must project that the proposed service shall perform a
minimum of 875 equivalent procedures (60% of capacity) annually within three
years of initiation of services;
(iii) An applicant for diagnostic
catheterization only must project that the proposed service shall perform a
minimum of 750 procedures per room per year within three years of initiation of
services; and
(iv) At least two
physicians, licensed in Alabama, with training and experience in cardiac
catheterization shall provide coverage at the proposed facility.
3. Planning Policy - Expansion of
Existing Service. Expansion of an existing cardiac catheterization service
shall only be approved if:
(i) If an applicant
has performed 1,000 equivalent procedures per unit (80% of capacity) for each
of the past two years, the facility may apply for expansion of catheterization
services regardless of the utilization of other facilities in the
county;
(ii) Adult and pediatric
procedures may be separated for those institutions with a dedicated pediatric
catheterization lab in operation.
4. Planning Policy. Pediatric cardiac
catheterization laboratories shall only be located in institutions with
comprehensive pediatric services, pediatric cardiac surgery services, and a
tertiary pediatric intensive care unit.
5. Planning Policy. All cardiac
catheterization services without open-heart surgical capability ("OSS") shall
have written transfer agreements with an existing open-heart program located
within 45 minutes by air or ground ambulance service door to door from the
referring facility. Acute care hospitals providing diagnostic cardiac
catheterization services may provide emergency interventional/therapeutic
cardiac catheterization procedures. Notwithstanding anything in the State
Health Plan to the contrary, an acute care hospital without on-site open-heart
surgery capability may provide elective percutaneous coronary intervention
(PCI) if the following criteria are met:
(i)
The hospital shall maintain twenty-four (24) hour, seven (7) day a week
continuous coverage by at least one interventional cardiologist and
catheterization laboratory team for primary PCI treatment of ST elevation
myocardial infarction;
(ii) The
hospital shall participate in a recognized national registry for cardiac
catheterizations and PCI procedures, such as the National Cardiovascular Data
Registry (NCDR);
(iii) The hospital
shall obtain informed patient consent for all elective PCI procedures,
including an informed consent process in which it is clearly stated that the
hospital does not offer OSS, and which clearly states that the patient may
request at any time to be transferred to a hospital with OSS to undergo the PCI
procedure;
(iv) The hospital shall
conduct quarterly quality review of the elective PCI services under supervision
of its serving interventional cardiologists;
(v) The hospital shall demonstrate that
applicable requirements in Planning Policy 2 (b) of this subsection (Ala.
Admin. Code 410-2-3-.03(1)(b)(2) ) will be met; and
(vi) Hospitals shall use their best efforts
to perform a minimum of 200 PCI cases per year. Any hospital performing less
than 150 cases per year after the second full year of PCI operations must agree
to an independent quality review of its program by an outside interventional
cardiologist who is a member of the American College of Cardiology and to
report a summary of such quality review confidentially to the Executive
Director of SHPDA.
The CON Review Board shall consider the most recent
recommendations/ guidelines for cardiac catheterizations adopted by the
American College of Cardiology Foundation, the American Heart Association Task
Force on Practice Guidelines, and the Society for Cardiovascular Angiography
and Interventions as an informational resource in considering any CON
application for elective PCI services.
6. Planning Policy, Applicants for new or
expanded cardiac catheterization services must demonstrate that sufficient
numbers of qualified medical, nursing, and technical personnel will be
available to ensure that quality health care will be maintained without
detrimentally affecting staffing patterns at existing programs within the same
service area.