3701-84-75 Pediatric cardiac catheterization service standards.

(A) The provisions of rules 3701-84-75 to 3701-84-79 of the Administrative Code are applicable on the effective date of this rule to each provider of cardiac catheterization services performing procedures on patients less than twenty-two years of age, regardless of the date the service was initiated.

(B) All pediatric cardiac catheterization services shall:

(1) Have on-site a pediatric cardiovascular surgery service immediately accessible from the pediatric cardiac catheterization laboratory by gurney; and

(2) Have an experienced pediatric cardiovascular surgical team available in less than sixty minutes on a twenty-four hour a day, seven days a week basis in the event that emergency open heart surgery is required.

(C) Each provider of a pediatric cardiac catheterization services shall have explicit criteria specifying the number of times a year an appropriately privileged physician shall perform each catheterization procedure in order to retain privileges to perform that procedure. These criteria shall be consistent with current recommendations of recognized professional societies and accrediting bodies.

(D) Each provider of a pediatric cardiac catheterization service shall have immediate access to services for:

(1) Hematology and coagulation disorders;

(2) Electrocardiography;

(3) Diagnostic radiology,

(4) Clinical pathology;

(5) Doppler-electrocardiography;

(6) Pulmonary function testing; and

(7) Microbiology.

(E) Each provider of a pediatric cardiac catheterization service shall have established criteria for patient selection and appropriateness that are specific to each procedure performed in the service.

(F) Each provider of a pediatric cardiac catheterization service shall have a written policy requiring the documentation of any internal review of surgeons with a combination of high risk adjusted mortality and low individual surgeon volume.

(G) Each provider of a pediatric cardiac catheterization service, no later than January 1, 2018, shall enroll and be actively submitting data to the American college of cardiology national cardiovascular data registry (NCDR) "IMPACT" registry for catheterization.

(H) A cardiac catheterization service for pediatric patients shall only be provided in a fully permanent setting within the permanent frame of the building of a registered hospital that is classified as a general hospital, a children's hospital or a special hospital - cardiac, that primarily furnishes limited services to patients with cardiac conditions. The hospital shall:

(1) Operate inpatient pediatric medical and surgical services in the same building that are accessible by gurney from the pediatric cardiac catheterization laboratory;

(2) Operate a pediatric intensive/critical care unit with registered special care beds, that is reviewed and accredited or certified as such as part of the hospital's accreditation or certification program in the same building and accessible by gurney from the pediatric cardiac catheterization laboratory. The unit shall provide appropriate equipment and staff to care for pediatric cardiac patients and have twenty-four hour monitoring capability

(3) Provide a setting in the same building as the pediatric cardiac catheterization laboratory in which ambulatory pediatric cardiac catheterization patients can be observed for at least four hours after the procedure; and

(4) Provide adequate physician coverage to manage postprocedure complications.

Replaces: 3701-84-75

Effective: 8/1/2017
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, 6/1/07, 6/21/12