N.J. Admin. Code § 10:61-2.1 - Clinical Laboratory Improvement Amendments (CLIA) requirements

  1. § 10:61-2.2 - Specific services
  2. § 10:61-2.3 - Limitations on laboratory services
  3. § 10:61-2.4 - Laboratory rebates

Current through Register Vol. 54, No. 7, April 4, 2022

(a) All independent clinical laboratories and other entities providing clinical laboratory services to Medicaid/NJ FamilyCare 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:
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 deemed CLIA exempt due to accreditation by a private, nonprofit accreditation organization or exempted under an approved state laboratory program. (See code of Federal Regulations 42 CFR 493 )

Notes

N.J. Admin. Code § 10:61-2.1
Amended by R.2006 d.37, effective 1/17/2006.
See: 37 New Jersey Register 3182(a), 38 New Jersey Register 807(a).
In introductory paragraph (a), added "NJ FamilyCare" following "Medicaid/".

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