Intent to Sole Source-OPQR St. Louis ISO Accreditation
ID: 75F40124Q00515Type: Special Notice
Overview

Buyer

HEALTH AND HUMAN SERVICES, DEPARTMENT OFFOOD AND DRUG ADMINISTRATIONFDA OFFICE OF ACQ GRANT SVCSBeltsville, MD, 20705, USA

Original Source

https://sam.gov/opp/a921115dec8d4f8f88b4ca644879e213/view
Timeline
    Description

    The Department of Health and Human Services, specifically the Food and Drug Administration (FDA), intends to negotiate a sole source contract with the American Association for Laboratory Accreditation (A2LA) for ISO accreditation services for the OPQR St. Louis laboratory. The objective of this procurement is to secure ongoing auditing services necessary for maintaining compliance with ISO 17025 standards, which are critical for the laboratory's operations and regulatory effectiveness. This contract, valued at $66,307.58, will cover biennial full accreditation audits and annual assessments to ensure the laboratory meets the required standards without risking lapsing accreditation. Interested parties may contact Natalie Brown at Natalie.Brown@fda.hhs.gov for further information regarding this opportunity.

    Point(s) of Contact
    Natalie Brown
    Natalie.Brown@fda.hhs.gov
    Files
    Title
    Posted
    JA.pdf
    The document presents a justification for an acquisition by the Department of Health and Human Services, specifically the Food and Drug Administration, to secure ongoing ISO accreditation services from the American Association for Laboratory Accreditation (A2LA). The OPQR St. Louis laboratory, which obtained ISO 17025 accreditation in 2023, requires a contract for regular evaluations to maintain compliance with ISO standards and A2LA requirements. The proposed contract, valued at $66,307.58, involves biennial full accreditation audits and annual assessments. A2LA's unique qualifications are emphasized, as the laboratory must adhere to specific policies to sustain its accreditation status. Market research was deemed unnecessary, considering the time constraints involved in switching vendors, which would risk lapsing accreditation. Maintaining the current relationship with A2LA is critical to avoid duplication of costs and activities associated with re-accreditation. The document outlines the contracting officer's and program office's certifications, indicating thorough review and agreement with the proposed actions to ensure compliance with federal regulations for streamlined contracting processes. Overall, this acquisition process is vital for the FDA's ongoing regulatory effectiveness related to drug products and public health emergencies.
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    Intent to Sole Source-OPQR St. Louis ISO Accreditation
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