Accrediation and the Proficiency Testing of Army Laboratory Services

The TRICARE Management Activity (TMA), Contract Operations Division -Falls Church (COD-FC), 7700 Arlington Blvd., Falls Church, Virginia, 22042, intends to enter into a sole source agreement with the College of American Pathologists to acquire the following services: Description of Services: 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 AFIP Pamphlet 40-24, 01 September 2007, Department of Defense Clinical Laboratory Improvement Program (DOD CLIP). The CLIP is DoD's equivalent program to Federal law regulating civilian laboratories, the Clinical Laboratory Improvement Amendments of 1988 (42 CFR 493), which is overseen by the Centers for Medicare and Medicaid Services (CMS). This procurement shall provide accreditation services, to include on-site inspections to be performed by a CMS-approved accreditation organization authorized to evaluate, validate, and enforce compliance. The accreditation cycle shall include DoD laboratories of all CLIA-designated complexity categories (i.e., Waived, Provider Performed Microscopy, Moderate Complexity, and High Complexity). The accreditation services should also include an internal self-inspection, monitored by the accrediting entity, utilizing contractor provided inspection checklists. The inspection agency must also evaluate complaints from patients, commanders or other users. Reports of complaint inspections are governed by 10 U.S.C 1102 as quality assurance documents. This procurement shall provide an annual proficiency testing program that must include samples of organisms and/or specimens that are representative of analytes or specimens tested. Laboratories are then evaluated on their performance and must successfully score at least 80 percent of acceptable responses for performance for the testing event. Unsatisfactory analyte performance in 2 of 3 or 3 of 4 consecutive testing events will be considered unsuccessful analyted performance. The proficiency testing program will furnish products/surveys containing proficiency testing challenges for analytes and tests regulated by CMS as stated in 42 CFR Part 493, Subpart I - Proficiency Testing Programs for Non-waived Testing. The PT program must include all regulated analytes and tests for all specialties and subspecialties in the clinical laboratory and anatomic pathology services as required within Subpart I. The PT program shall also include challenges for non-regulated analytes and tests sufficient to maximize coverage of the non-regulated analytes and tests performed in DoD laboratories. The frequency of inclusion of non-regulated analyte and test PT challenges in a PT program should, as a minimum, satisfy the frequency requirements listed in 42 CFR 493.1253 through 493.1255 and the CLIP requirement of two challenges per year. The proficiency testing program furnished products/surveys shall be acceptable to the accrediting agency. The proficiency testing program shall also provide any other proficiency-related materials as may be helpful in fostering laboratory compliance with CLIA. Such materials may include, but are not limited to, surveys/materials for Instrument Calibration and/or Linearity Verification, Personnel Competency Testing modules, and Quality Management or Educational surveys. The Government intends to solicit and negotiate with only one source under authority of FAR 6.302-1. This notice of intent is not a request for competitive proposals. All information shall be furnished at a no cost or obligation to the Government. A determination not to compete this proposed contract, based upon responses received, will be made entirely at the discretion of the Government. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement. Please submit information to Mr. Stephen Ching at Stephen.ching@tma.osd.mil no later than 13 December 2012 at 12:00PM Eastern Standard Time. The North American Industry Classification System Code is 541380.