(A) Each
approved cardiac catheterization service shall maintain a minimum annual
caseload volume in accordance with Department guidelines, based on guidelines
and standards issued by American College of Cardiology, American Heart
Association and Society for Cardiac Angiography and Interventions.
(1) Any cardiac catheterization service
providing fewer than the specified number of procedures per year shall, within
30 days of the end of the Department's fiscal year reporting period, submit to
the Department a copy of the previous year's Quality Assessment and Performance
Improvement (QAPI) quarterly reports required under
105
CMR 130.965(E).
(2) In addition to the requirements of 105
CMR 130.935(A)(1), any cardiac catheterization service providing fewer than the
specified number of procedures per year shall, within 30 days of the end of the
Department's fiscal year reporting period, request a review of the
catheterization service by an appropriately qualified professional peer review
organization or individual(s) approved by the Department. Any physician
conducting the peer review shall certify that he or she does not have any
conflict of interest regarding the hospital and physicians to be reviewed.
The results of the review shall be submitted to the
Department within ten days of receipt.
(3) Based on a review of the QAPI reports
and, if applicable, the results of the assessment of the quality of the cardiac
catheterization service by an appropriately qualified peer review organization
or individual(s) approved by the Department, the Department shall determine
whether a facility will continue to be approved to provide the service and, if
applicable, subject to any conditions determined to be appropriate.
(4) New services shall reach the minimum
specified number of procedures within 24 months of approval of the
service.
(B) If a
hospital is required to submit its quarterly reports of the QAPI under 105 CMR
130.935, the hospital shall subsequently continue to submit the quarterly
reports of the QAPI to the Department for review each quarter until the
hospital receives a notice from the Department to discontinue submission of the
reports.
