N.J. Admin. Code § 8:43A-29.13

Current through Register Vol. 56, No. 11, June 3, 2024

Section 8:43A-29.13 - Data collection and reporting for performance improvement

(a) In addition to the requirements of N.J.A.C. 8:43A-18, licensees shall maintain the following information necessary for outcomes data collection:

1. The number of treatments provided at the facility;

2. The number of mortalities; and

3. Patients discharged for in-patient admission directly from outpatient lithotripsy treatment.

(b) The data identified in (a) above shall be filed with the Department on a quarterly basis, within 30 days of the close of each calendar quarter.

(c) Licensees shall report to the Department, by telephone at (800) 792-9770, incidents in which a medical device is connected with the death, serious injury, or serious illness of any individual, as required by the Safe Medical Devices Act of 1990, 21 U.S.C. § 360.

N.J. Admin. Code § 8:43A-29.13

Amended by 54 N.J.R. 60(a), effective 1/3/2022