The New York State Department of Health Physician Office Laboratory Evaluation Program (POLEP), under contract with the Center for Medicare and Medicaid Services (CMS), is responsible for managing activities related to administration of the federal program implementing the Clinical Laboratory Improvement Amendment of 1988 (CLIA) for physician office laboratories (POL) throughout New York.
CLIA federal regulations apply unless the State has enacted laws relating to laboratory requirements that are equal to, or more stringent than, CLIA requirements.
In New York State, there are two programs that issue CLIA certificates based on the exception in the Public Health Law (§579.1) that dictates to which Program the facility will submit an application. To meet the POL exception, the facility must be entirely owned and operated by medical professionals allowed in §579.1 and perform laboratory tests, personally or through their own employees, solely as an adjunct to the treatment of their own patients. POLEP follows Federal regulations only (§493), hence we accept the CMS-116 application. All laboratories that do not fit the model of a POL must submit applications through the Clinical Laboratory Evaluation Program (CLEP) and adhere to the more stringent NYS regulations.
CLIA defines a clinical laboratory as any facility which performs laboratory testing on materials derived from the human body for the purpose of providing information for the diagnosis, treatment or prevention of disease or the assessment of a health condition. Testing includes procedures to determine, measure or describe the presence or absence of various substances, components, or organisms in the human body. An objective of the CLIA program is to ensure the accuracy, reliability, and timeliness of test results regardless of where the test was performed. Standards applied to laboratory personnel and procedures are based on test complexity and potential harm to the patient. These tests may be designated as waived, moderate, or high complexity testing, as categorized by the FDA.
For purposes of licensure requirements by the New York State Education Department, laboratories that hold a CLIA certificate under POLEP are not considered clinical laboratories.
Waived tests include test systems cleared by the FDA for home use and those tests approved for waiver under the CLIA criteria. Although CLIA requires that waived tests must be simple and have a low risk for erroneous results, this does not mean that waived tests are completely error-proof.
Certificate of Provider-Performed Microscopy Procedures (PPMP) permits a laboratory to perform a limited list of moderate complexity tests, as well as any waived tests. No survey is required but compliance with CLIA regulations is required. The primary instrument for performing the PPM procedures is a microscope, limited to bright field or phase-contrast microscopy. A list of CLIA-approved, PPM tests is provided.
CLIA categorization is determined after the FDA has cleared or approved a marketing submission. The FDA determines the test’s complexity by reviewing the package insert test instructions and using a criteria “scorecard” to categorize a test as moderate or high complexity. Each test is graded for level of complexity by assigning scores of 1, 2, or 3 for each of the seven criteria on the scorecard.
Clarification is provided for the allowable testing in the physician office laboratory, where the technical component/professional component (TC/PC) split affects pathology specimens.