Section 405.432 - Laboratory Services: Eligibility to Provide ServicesA CHC may claim payment for the laboratory services listed in Subchapter 6 of the Community Health Center Manual only when all of the following conditions are met.
(A) The laboratory services are performed in the CHC.(B) The laboratory tests are performed on properly and regularly calibrated equipment, and daily controls are carried out.(C) The CHC has been certified by the Centers for Medicare & Medicaid Services (CMS) for performing in-house clinical laboratory services, based on the criteria set forth in the Clinical Laboratory Improvement Amendments (CLIA) of 1988, as it may be amended. In addition, the CHC's laboratory must maintain its own quality-control program and successfully participate in one or more proficiency testing programs that cover all Medicare-certified specialties and subspecialties of the laboratory. The CHC must make the results of the proficiency testing programs available to the MassHealth agency and the Attorney General's Medicaid Fraud Division upon request or during an on-site visit.(D) If the CHC is located in-state, the CHC has been approved by the Massachusetts Department of Public Health to perform in-house clinical laboratory services. If the CHC is located out-of-state, in addition to meeting the requirements of 130 CMR 405.404(B), 405.432(A) through (C), and 450.109: Out of State Services, the CHC must also meet its own state's requirements for performing in-house clinical laboratory services.Amended by Mass Register Issue S1277, eff. 1/2/2015.Amended by Mass Register Issue 1387, eff. 3/22/2019.