Alabama Administrative Code
Title 410 - STATE HEALTH PLANNING AND DEVELOPMENT AGENCY
Chapter 410-2-3 - SPECIALTY SERVICES
Section 410-2-3-.03 - Cardiac Services
Universal Citation: AL Admin Code R 410-2-3-.03
Current through Register Vol. 42, No. 11, August 30, 2024
(1) Fixed-Based Cardiac Catheterization Laboratories
(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 onsite 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.
(2) Open Heart Surgery
(a) Discussion
1. "Open heart surgery" is a descriptive term
for any surgical procedure that involves opening the chest to operate on the
heart.
2. In the last forty years,
open-heart surgery has emerged from operating rooms of medical centers to
become a mainstay of advanced medical treatment. In the year 2005, 699,000
open-heart surgeries were performed in the United States; and while the
procedure has become commonplace, it still requires uncommon skill and the most
advanced technology to insure successful outcomes.(www.americanheart.org).
3. Highly specialized open-heart operations
require very costly, highly specialized manpower and facility resources. Thus,
every effort should be made to limit duplication and unnecessary expenditures
for resources related to the performance of open-heart operations, while
maintaining high quality of care.
4. Based on recommendations by various
professional organizations and health planning agencies, a minimum of 200 heart
operations should be performed annually to maintain quality of patient care and
to minimize the unnecessary duplication of health resources. In order to
prevent duplication of existing resources which may not be fully utilized, the
opening of new open-heart surgery units should be contingent upon existing
units operating, and continuing to operate, at a level of at least 350
operations per year.
5. In units
that provide services to children, lower targets are indicated because of the
special needs involved. In case of units that provide services to both adults
and children, at least 200 open-heart operations should be performed including
75 for children.
6. In some areas,
open-heart surgical teams, including surgeons and specialized technologists,
are utilizing more than one institution. For these institutions, the guidelines
may be applied to the combined number of open heart operations performed by the
surgical team where an adjustment is justifiable and promotes more cost
effective use of available facilities and support personnel. In such cases, in
order to maintain quality care, a minimum of 75 open-heart operations in any
institution is advisable.
7. Data
collection and quality assessment and control activities should be part of all
open-heart surgery programs.
(b) Planning Policies
1. Planning Policy. Applicants for new and
expanded adult open-heart surgery facilities shall project a minimum of 200
adult open-heart operations annually, 150 of which shall be coronary artery
bypass grafts (CABG), within three years after initiation of service.
2. Planning Policy. Applicants for new and
expanded pediatric open-heart surgery facilities shall project a minimum of 100
pediatric open-heart operations annually within three years after initiation of
service.
3. Planning Policy. There
shall be no additional adult open heart units initiated unless each existing
unit in the county is operating and is expected to continue to operate at a
minimum of 350 adult operations per year; provided, that to insure availability
and accessibility, one adult open heart unit shall be deemed needed in each
county not having an open heart surgery unit in which the current population
estimate exceeds 150,000 without consideration of other facilities (as
published by the Center for Business and Economic Research, University of
Alabama).
4. Planning Policy. There
shall be no additional pediatric open-heart units initiated unless each
existing unit in the service area is operating and is expected to continue to
operate at a minimum of 130 pediatric open heart operations per year.
Author: Statewide Health Coordinating Council (SHCC)
Statutory Authority: Code of Ala. 1975, § 22-21-260(4).
Disclaimer: These regulations may not be the most recent version. Alabama may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the state site. Please check official sources.
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