Amendments to NJCLIA

On January 9, 2017, Governor Christie signed into law certain amendments to the New Jersey Clinical Laboratory Improvement Act (CLIA) which went into effect immediately. As a result of extensive pressure from certain advocacy groups in search of a better understanding of these amendments, and their effect on the provision of clinical laboratory services in New Jersey, the New Jersey Department of Health Clinical Laboratory Improvement Service (CLIS) issued a guidance memorandum on April 10, 2017. The memorandum details the CLIA amendments and how CLIS intends to implement the changes, pending official revision to its implementing regulations. In short, the guidance memorandum details the following:

• CLIS licensure is not required for facilities that perform only point of care laboratory testing so long as certain criteria are met such as the where instruments or kits are used, place of testing, type of tests, management and quality controls
• Quality control program standards will not exceed the standards set forth in federal regulations, or alternative quality control testing procedures approved by Centers for Medicare & Medicaid Services
• CLIS must recognize all waived tests under the federal “Clinical Laboratory Improvement Amendments of 1988” (FCLIA), as well as require that standards for use of such waived tests not exceed the FCLIA standards, so long as CLIS by way of CLIA, or with additional amendments to CLIA, determine it necessary to protect the public health
• Collection station licensure is required for NJ schools that collect patient specimens and refer such specimens to reference laboratories
• Collection stations require CLIS licensure even if a certificate of waiver is obtained
• CLIS maintains authority to investigate all clinical laboratories and collection stations
• Anatomic pathology is within the scope of practice of a clinical laboratory, thereby requiring licensure by CLIS.