(A) Each open heart surgery service should meet a volume goal of at least one hundred and fifty open heart procedures per year by the second full year of operation to ensure efficiency and a minimum competency.
(B) Volume goals shall be considered by the director in conjunction with other indicators of quality and not as the sole indicator of service performance.
(C) Failure to meet a volume goal for two consecutive years may trigger an extended review of the open heart surgery service by the director, including possible inspections.
(D) A volume goal of at least twenty five open heart procedures per surgeon per year is recommended and the combination of high risk adjusted mortality and low individual surgeon volume shall trigger a thorough internal review of an individual surgeon by the provider of the open heart surgery service.
(E) Failure to meet the volume goal established in paragraph (A) of this rule may result in any or all of the following:
(1) An extended review of the service by the director;
(2) Mandatory peer review of PCI procedures performed by the service;
(3) Annual inspections until such time as the service performs the established number of procedures for a period of two consecutive years or the director determines that annual inspection is no longer required; or
(4) At the discretion of the director, the establishment of a probationary period. If a probationary period is imposed, at a minimum, the service shall be notified of the following:
(a) The time period for which the probationary period is effective;
(b) The actions that may be taken by the director for a service's failure to successfully complete the probationary period.
Five Year Review (FYR) Dates: 03/01/2022
Promulgated Under: 119.03
Statutory Authority: 3702.11, 3702.13
Rule Amplifies: 3702.11, 3702.12, 3702.13 , 3702.14, 3702.141, 3702.15, 3702.16, 3702.18, 3702.19, 3702.20
Prior Effective Dates: 3/1/1997, 3/24/03, 5/15/08, 6/21/12