Current through Register Vol. 46, No. 19, March 20, 2024
(1)
Purpose
and scope.
a. These standards are
measures of some of those criteria found in Iowa Code sections
135.64(1)
"a" to "q,
" and 135.64(3). Criteria which are measured by a standard are cited
in parentheses following each standard.
b. Certificate of need applications which are
to be evaluated against these cardiac catheterization and cardiovascular
surgery standards include:
(1) Proposals to
commence or expand capacity to perform cardiac catheterization.
(2) Proposals to add new or replace
cardiovascular surgery services.
(3) Any other applications which relate to
cardiac catheterization or cardiovascular surgery.
(2)
Definitions.
a. Adult cardiac catheterization laboratory-a
diagnostic facility exclusively for intracardiac or coronary artery
catheterization on adults.
b.
Pediatric cardiac catheterization laboratory-the same as adult cardiac
catheterization laboratory, except exclusively for children and
infants.
c. Cardiac
catheterization-
(1) Intracardiac-a diagnostic
study of the heart, and pulmonary arteries, or both, in which a small catheter
passes through a vein or artery in the neck, leg or arm and advances into the
great vessels, the heart or the pulmonary arteries. Through this procedure one
can measure pressure within the heart and in adjacent veins and arteries,
collect blood samples for blood gas analysis and inject radiopaque material,
visualize cardiac and vessel anatomy. The procedure permits detection of
congenital and acquired heart abnormalities, the study of ventricular function,
the estimation of the orifice size, the placement of pacemakers, etc. Cardiac
catheterization is incomplete without cineangiography, intracardiac pressure
measurements, blood gas analysis and the ability to diagnose intracardiac
shunts.
(2) Coronary artery
catheterization-a diagnostic study of the coronary arteries, in which a small
catheter passes through an artery in the leg, neck or arm into a coronary
artery orifice. Intravascular pressure measurements are taken, and angiography
of the coronary arteries is performed. Catheterization and
cineangiocardiography of the left ventricle are an integral part of this
procedure.
d.
Angiography.
The photographic recording of X-ray or radiologic images of
blood vessels, in any part of the body-the heart, the head, the great vessels,
the kidney, etc. In the procedure blood vessels are injected with a radiopaque
chemical. Immediately following injection, X-rays are employed to image the
path of the injected chemical. These X-ray images are then photographically
recorded.
Angiocardiography.
The recording of moving X-ray images (fluoroscopic images) of
the heart and great vessels. After injection of radiopaque chemicals, moving
X-rays of the chemical's flow are projected on a screen called a fluoroscope.
Moving pictures (cineangiocardiography) or still pictures in sequence
(serialography) may be recorded of the X-ray image.
e. Adult cardiovascular
surgery-cardiovascular surgery exclusively for adults.
f. Pediatric cardiovascular
surgery-cardiovascular surgery exclusively for infants and children.
g. Cardiovascular surgery-the services
associated with and surgery performed for congenital or acquired diseases of
the heart, great vessels, or pericardium, including the placement of travenous
and epicardial pacemakers.
(1) Open heart
surgery-cardiovascular surgery in which an incision of sufficient size is made
to allow direct vision of the area. Open heart surgery requires temporary use
of a heart-lung (cardiopulmonary bypass) machine, as blood flow through the
heart is greatly reduced or stopped altogether.
(2) Coronary artery surgery-surgery to
correct inadequate blood flow to the heart through using revascularization
techniques to bypass significantly obstructed coronary artery
lesions.
h. Closed heart
surgery-cardiovascular surgery in which a small incision and repairs are made
without direct vision of the area.
(3)
Availability of
services.
a. Minimum
utilization-cardiovascular surgery (Iowa Code sections
135.64(1)
"c, " "g, " "h").
(1) Adult cardiovascular surgical programs
should project an annual minimum rate of over 200, or no approval shall be
granted. Higher case loads over 200 per annum, are encouraged.
(2) Pediatric cardiovascular surgical units
should project a minimum of 100 pediatric heart operations after the first
year, at least 75 of which must be open heart procedures.
(3) Combined adult/pediatric cardiovascular
surgery units should project the minimum projected annual rates for both adult
and pediatric surgery, or no approval shall be granted.
(4) Applicants should project utilization of
cardiovascular surgery, catheterization and cardiac care units based upon
service area population demographics, current regional or national utilization
rates of the service, disease incidence and prevalence rates, current cardiac
care treatment modes, and in consideration those adult cardiovascular surgery
units currently operating in Iowa, and bordering states within two hours
surface travel time, if the applicant proposes an adult unit; and in
consideration of pediatric cardiovascular surgery units currently operating in
Iowa and bordering states within three hours surface travel time, if the
applicant's proposed unit is pediatric. If a combined unit is proposed both the
two- and three-hour considerations for existing adult and pediatric units
apply. The assumptions, data and methodology used to arrive at projections
shall be provided in each application.
b. Expansions-cardiovascular surgery
(sections
135.64(1)
"c, " "d, " "e, " "g, "
"h").
(1) There should be no
additional adult cardiovascular surgery units initiated unless each existing
unit within two hours surface travel time is operating at a minimum of 350 open
heart surgery cases per year.
(2)
There should be no additional pediatric cardiovascular surgery units initiated,
unless each existing unit within three hours surface travel time is operating
at 130 surgeries per year. (If one team serves more than one institution the
numbers for those institutions should be combined.)
(3) No additional cardiovascular surgery
units should be approved which will reduce the volume of existing services
below 350 procedures annually for adults and 130 annually, 75 of which are open
heart, for pediatric units. The applicant will demonstrate that an attempt was
made to determine with the cooperation of existing providers whether such a
reduction would occur. Existing providers of consequence are within two hours
surface travel time for adult services and within three for pediatric
services.
(4) Adult cardiovascular
surgical service units should be granted only to institutions which can
demonstrate an unserved population base of 500,000 persons. An unserved area is
one which lies outside of an existing unit's service area.
(5) Pediatric cardiovascular surgical
services should be granted unto institutions which can demonstrate an unserved
population base of 2.5 million with 30,000 live births per year.
c. Minimum utilization-cardiac
catheterization (sections
135.64(1)
"c, " "d," "g," "h").
(1) Adult cardiac catheterization
laboratories should be projected to operate at a minimum of 300
catheterizations per annum.
(2)
Pediatric catheterization laboratory units should project a minimum of 150
catheterizations annually.
(3)
Combined units should meet each of the adult and pediatric standards.
(4) Applicant should project utilization of
cardiac catheterization units based upon service area population demographics,
current regional or national utilization rates of the service, disease
incidence and prevalence rates, current cardiac care treatment modes, and in
consideration those adult cardiovascular surgery units currently operating in
Iowa, and bordering states within two hours surface travel time if the proposed
unit is for adults; and in consideration of pediatric cardiovascular surgery
units currently operating in Iowa, and bordering states within three hours
surface travel time if the proposed unit is for children. If a combined unit is
proposed both time considerations shall apply. The assumptions, data and
methodology used to arrive at projections shall be provided in the
application.
d.
Expansions-cardiac catheterizations (sections
135.64(1)
"c, " "d," "e," "g," "h").
(1) There should be no additional adult
cardiac catheterization unit opened unless the number of studies per year in
each existing unit within two hours surface travel time is greater than 500. No
additional pediatric unit should be opened unless the number of studies per
year in each existing unit within three hours surface travel time is greater
than 250.
(2) There should be no
additional cardiac catheterization units initiated which would reduce the
volume of existing units below 500 adult catheterizations, 200 of which are
intracardiac or coronary artery catheterizations, or 150 pediatric
catheterizations, or both for combined units. The applicant must attempt and
demonstrate that an attempt was made to determine with the cooperation of
existing providers whether such a reduction would occur. Existing providers of
consequence are those within two hours surface travel time for adults or three
hours for pediatrics.
e.
There should be no new cardiac catheterization unit open in any facility not
performing open heart surgery (sections
135.64(1)
"e, " "g," "h," "k").
(4)
Costs.
a.
Financial
feasibility. (Sections
135.64(1)
''f,"
"h"
"p") Cardiovascular surgery and catheterization equipment, and
associated remodeling or construction should be depreciated over a period
consistent with American Hospital Association schedules as limited by existing
reimbursement payors.
b.
Cost-effectiveness. Proposed new or replacement cardiac
catheterization laboratories cost per catheterization and cardiovascular
surgery services estimated costs per surgery should when compared to their
peers demonstrate cost-effectiveness.
(5)
Accessibility. (Sections
135.64(1)
"c, " "d")
a. Cardiovascular surgery units and cardiac
catheterization labs should be available 24 hours a day, seven days a week for
emergency coverage.
b. Facilities
with cardiovascular surgery/cardiac catheterization should have available
24-hour, seven days a week ambulance and emergency room service.
c. Travel distance should be within two hours
surface travel time or less for 80 percent of the projected service area for
pediatric services.
d. Cardiac
catheterization and cardiovascular surgery service should be provided
regardless of ability to pay, in consideration of those programs available in
the state which serve the medically indigent.
(6)
Quality. (Sections
135.64(1)
"i"
"k")
a. Each surgery unit and cardiac
catheterization lab shall demonstrate a reasonable set of criteria that are
used in selecting appropriate candidates for surgery and
catheterization.
b. Staffing
minimums.
(1) The open heart surgery team
should minimally consist of:
1. At least two
certified or board eligible cardiovascular surgeons for the first 75 to 130
pediatric open heart surgeries. If pediatric surgery is performed, one surgeon
must have special training and experience in surgery for congenital cardiac
defects.
2. A board certified or
board eligible adult or pediatric cardiologist(s). The latter only if pediatric
surgery is performed, the former only if adult surgery is performed.
3. Board certified or board eligible
anesthesiologist with special training in the management of cardiovascular
cases' respiratory care.
4.
Radiologist trained in the cardiovascular field.
5. Pathologist familiar with cardiac
problems.
6. Specially trained in
heart disease surgical nursing staff.
7. Cardiopulmonary bypass pump
technicians.
8. Other ancillary
staff as needed.
(2)
Each applicant shall document that the proposed surgery unit can be so staffed
when completed and operational.
c. Equipment and facilities. The applicant
seeking to provide cardiovascular surgery should demonstrate that the following
support services will be available:
(1)
General X-ray diagnostic facilities and facilities for emergency X-rays on a
24-hour basis.
(2) A cardiac
catheterization laboratory or angiography lab available on a 24-hour
basis.
(3) A cardiographies
laboratory, with facilities for recording the following tests: EKG, vector
cardiogram, phonocardiogram, echocardiogram, and exercise stress
testing.
(4) A supporting blood
bank and hematology laboratory.
(5)
A microbiology laboratory.
d. Cardiac catheterization labs serving
infants and children should have biplane angiographic equipment, either
cineangiocardiographic or cut film. Pediatric cardiac catheterization labs
should be supervised by board certified or board eligible pediatric
cardiologists; adult cardiac catheterization labs should be supervised by a
board certified or board eligible adult cardiologist.
(7)
Continuity. (Sections
135.64(1)
"g," "h," "i," "k")
a. The applicant should demonstrate that an
attempt was made to solicit letters and to establish referral agreements from
area hospitals and physicians to indicate a willingness to participate in a
cooperative endeavor to refer to the proposed service.
b. The applicant should provide documentation
that emergency medical transport services will be available.
c. Institutions providing cardiovascular
surgery services should include mechanisms for comprehensive medical followup
including adequate medical records exchange.
(8)
Acceptability. (Section
135.64(1)
"c") Facilities with
cardiovascular surgery and cardiac catheterization indicate a willingness to
observe and respect the rights of patients as stated in the Patients Bill of
Rights adopted by the American Hospital Association February 6, 1973, and
reprinted in 1975.