Q--AVAHCS CAP Services

The Amarillo VA Health Care System (AVAHCS), located in Amarillo, TX, is seeking Service Disabled Veteran Owned Small Business (SDVOSB) or Veteran Owned Small Business (VOSB) sources capable of meeting the requirement listed below. The acquisition will be accomplished using commercial item procedures in accordance with FAR Part 12. NOTE: TO QUALIFY SDVOSB AND VOSB VENDORS MUST BE CERTIFIED IN THE VA VENDOR INFORMATION PAGES (VIP) DATABASE. The North American Industry Classification System (NAICS) is 621511. Any SDVOSB or VOSB firms who wish to identify their interests and capability to provide this product must provide product specifications, performance and delivery information by notifying the Contract Specialist no later than NOON Central Time, September 6, 2016. Notification shall be e-mailed to Mark Branum, at [email protected]. DISCLAIMER This Source Sought Notice is issued solely for information and planning purposes only and does not constitute a solicitation. All information received in response to this Notice that is marked as proprietary will be handled accordingly. In accordance with the Federal Acquisition Regulation, responses to this notice are not offers and cannot be accepted by the Government to form a binding contract. Responders are solely responsible for all expenses associated with responding to this Notice. Scope: A. Background The Amarillo Veterans Affairs Health Care System (AVAHCS) Department of Pathology & Laboratory Service (P&LMS) and all Community Based Outpatient Clinics (CBOC) that perform testing on patients (human specimens) must subscribe to an external proficiency testing program as an enhancement to the internal quality control program that meets Clinical Laboratory Improvement Act (CLIA) 1988 and amendments to: a. Ensure reliability of patient testing in the laboratory. b. Meet accreditation requirements. c. Must subscribe to external proficiency test (PT) programs for all analytes for which PT is available, including waived testing, provider performed microscopy, and unregulated analytes. AVAHCS P&LMS performs clinical diagnostic tests on patients (human specimens) and in the event should any or all departments within the P&LMS should fail to meet the PT requirements as described in 42 CFR 493, Subpart H, or who have demonstrated deficiencies which pose a direct threat to patients may be instructed to terminate those particular diagnostic testing. CAP has determined the analyte specific evaluation criteria and target values used to grade PT results for regulated analytes. 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 submitted by the manufacturer, and using a criteria "scorecard" to categorize a test as moderate or high complexity. B. Scope The overall purpose of this requirement is to obtain a contractor to provide a CLIA'88 approved proficiency testing program so that AVAHCS P&LMS and ancillary testing sites that perform patient testing are in compliance with the VHA Handbook 1106.01 proficiency testing requirements. AVAHCS P&LMS and ancillary testing sites perform patient testing in the following CLIA specialties/subspecialties: Arterial Blood Gases, General Immunology, Hematology, Routine Chemistry (serum and urine), and Urine Toxicology; as well as serum Alcohol, Ammonia, CRP, and Creatinine (eGFR) testing. PT shall be performed in each department of the P&LMS and all ancillary testing sites that perform patient testing in accordance with calendar of events or shipping table provided by the vendor. Each department/site must perform PT testing on every analyzer (including backup analyzers) for the primary test method for each test/assay performed on-site. The PT program must be CLIA approved for all aforementioned CLIA specialties/subspecialties. All pertinent proficiency testing information shall be internally managed via Microsoft database.