Proficiency Testing, Accreditation, and Compentency Assessments of DoD Laboratories

This procurement shall provide accreditation LAP, PT, and CoAP services at DoD MTF laboratories within the continental United States (CONUS) and outside the continental United States (OCONUS) to include on-site inspections to be performed at intervals of every two years by a Center for Medicare and Medicaid Services (CMS) approved accreditation organization authorized to evaluate, validate, and enforce compliance. There are three services required. The first is the professional accreditation of all DoD laboratories of any CLIA designated complexity level (Waived, Provider Performed Microscopy, Moderate, or High) performing testing on human specimens for the purpose of providing information for the diagnosis, prevention, or treatment of any disease or impairment of, or the assessment of the health of, human beings. The second service is the complete assessment of the testing performance of each laboratory through analysis of PT surveys, and the provision of additional survey related materials so as to assist sites in complying with the requirements of CLIA and CLIP, which is the DoD equivalent of the CMS CLIA requirement. The third service is a competency program that will allow for individual laboratories to show compliance with 42 CFR Part 493 and accrediting body's standards. The LAP, PT, and CoAP must be provided by the contractor as part of a comprehensive, integrated program to minimize administrative requirements. This ensures coordinated actions between the accreditation agency and that the PT provider and that competency program meet CFR and CMS requirements. The coordination of these functions is critical in the assessment of the laboratory's overall performance, demonstrating the quality of service provided and the expeditious identification of non-compliance or unsatisfactory performance requiring corrective actions. Laboratories performing testing on specimens derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of any disease, or the impairment of, or the assessment of the health of, human beings must meet the requirements set forth in Department of Defense (DoD) Clinical Laboratory Improvement Program (CLIP). The CLIP is the DoD's program in place to meet the regulatory requirements of the Federal regulations pertaining to civilian laboratories which are governed by the Clinical Laboratory Improvement Amendments of 1988 (42 Code of Federal Regulation (CFR) 493). Regulations pertaining to civilian laboratories are overseen by the Department of Health and Human Services, Centers for Medicare and Medicaid Services (CMS). Military laboratories must also meet these regulatory standards. - This procurement shall provide for a laboratory accrediting program (LAP), to include on-site inspections to be performed at intervals of every two years by a CMS-approved accreditation organization authorized to evaluate, validate, and enforce compliance checklists. - This procurement shall provide an annual proficiency testing (PT) program that must include samples of organisms or specimens that are representative of analytes or specimens tested. - This procurement shall provide DoD laboratories with a competency assessment program (CoAP). The CoAP will allow for DoD laboratories to monitor, assign, update and report training and competency assessments of individual laboratorians. The CoAP also must meet the training and assessment requirements of the accrediting agency. The Performance Work Statement requires that the LAP, PT, and CoAP be part of a comprehensive and fully integrated program to minimize administrative requirements and to ensure coordinated actions between the accreditation agency and the PT program provider.1 Comprehensive for accreditation means that a single entity must be able to and be approved to inspect and accredit all clinical and anatomic pathology disciplines. Comprehensive for PT means that a single entity must provide surveys containing PT challenges for all analytes and tests for all specialties and subspecialties in the clinical laboratory and anatomic pathology services. Comprehensive for CoAP means that it can meet the individual laboratory's needs as well as the accrediting agency's standards. Fully integrated, meaning that a single entity provides the three required services.