N.J. Admin. Code § 10:58-2.9

Current through Register Vol. 57, No. 1, January 6, 2025

Section 10:58-2.9 - Clinical laboratory services; general

(a) Clinical laboratory services shall be furnished by clinical laboratories and by provider office laboratories (POLs) that meet the Centers for Medicare and Medicaid Services (CMS) regulations pertaining to clinical laboratory services (Section 1902(a)9 of the Social Security Act; 42 U.S.C. § 1396(a)9; 42 CFR 440.30 and 493) defined in the Clinical Laboratory Improvement Amendments (CLIA) of 1988 ( P.L. 100-518), and as indicated at N.J.A.C. 10:61-2.1, the Medicaid/NJ FamilyCare programs' Independent Clinical Laboratory Services Manual (N.J.A.C. 10:61) and N.J.A.C. 8:44 and 8:45.

(b) All independent clinical laboratories and other entities performing clinical laboratory testing for Medicaid/NJ FamilyCare-Plan A fee-for-service beneficiaries must meet the requirements of the Clinical Laboratory Improvement Amendments (CLIA) of 1988. These requirements include that the provider must have one of the following certificates; as required by 42 C.F.R. 493:

1. A certificate of waiver;

2. A certificate of compliance;

3. A registration certificate;

4. A certificate for provider-performed microscopy (PPM) procedures;

5. A certificate of accreditation, and a registration certificate or a certificate of compliance; or

6. Be CLIA exempt due to accreditation by a private nonprofit accreditation organization or exempted under an approved state laboratory program.

N.J. Admin. Code § 10:58-2.9

Amended by R.2001 d.204, effective 6/18/2001.
See: 33 N.J.R. 1160(a), 33 N.J.R. 2188(a).
In (a), substituted "NJ FamilyCare programs"' for "program's"; in (b), inserted "NJ FamilyCare-Plan A fee-for-service" following "Medicaid".

Amended by 53 N.J.R. 1843(c), effective 11/1/2021