Laboratory Accreditation Initiative (LAI) - Accreditation, Auditing & Assistance

Subject: Laboratory Accreditation Initiative (LAI) - Accreditation, Auditing & Assistance
Solicitation Number: 000HCPQ1-2021-53007
Notice Type: PRESOL
NAICS: 813920
Notice Published: 06-10-21
Response Due: 04-15-21

Agency: Department of Health and Human Services
Contact: Jasmine Powell This email address is being protected from spambots. You need JavaScript enabled to view it.
Office Address: ATLANTA, GA 30333
Place of Performance: Atlanta, GA 30341

Related Notices:
        03-31-21 PRESOL

Click for official SAM (FBO) notice, additional information, and accompanying attachments

The Centers for Disease Control and Prevention (CDC), Office of Acquisition Services (OAS), located at 2900 Woodcock Blvd, Atlanta, GA 30341, intends to issue a Request for Proposal (RFP) # 75D301-21-R-71846 on on or after April 15, 2021 for services in support of the Office of Laboratory Science (OLSS) Laboratory Accreditation Initiative (LAI). The intent of this requirement is to obtain lab accreditation and auditing services and certification specialist support to ensure CDC laboratories are operating to standard. The resultant contract is expected to be a Firm Fixed Price (FFP) contract awarded on or before September 30, 2021. The term of the contract is expected to be for a base of (1) year with four (4) 12- month option periods. The applicable NAICS code is 813920 Professional standards review boards, with a size standard of $16.5 Million. The Government expects to solicit full and open competition. The purpose of this requirement is to secure comprehensive project management, technical support, and staffing support for CDC Laboratories. Proposed laboratory accreditation and certification standards relevant to the CDC laboratory branches are the current editions of the following: ISO/IEC 17025, General requirements for the competence of testing and calibration laboratories (accreditation standard) ISO 15189, Medical laboratories Requirements for quality and competence (accreditation standard) ISO 15195, Laboratory medicine Requirements for the competence of calibration laboratories using reference measurement procedures (supplemental accreditation standard to ISO/IEC 17025 or ISO 15189). ISO 13485, Medical devices Quality management systems Requirements for regulatory purposes (certification standard) ISO 17034, General requirements for the competence of reference material producers (accreditation standard) ISO/IEC 17043, Conformity assessment General requirements for proficiency testing (accreditation standard) ISO 45001, Occupational health and safety management systems Requirements with guidance for use (certification standard) In general, the contractor will provide support in the following areas: 1. Project Management The contractor shall provide project management at a sufficient level of effort and expertise to document, monitor and report the status of the overall project and branch-level progress, deliverables and interdependencies of deliverables. Project management functions will also include the management of preparation documents, assiting CIOs in development of laboratory accreditation and certification implementation, assure accreditation and certifications are integrated horizontally and vertically with applicable agency policies and regulatory requirements. 2. Laboratory Accreditation and Certification Specialists (LACS) and Subject Matter Experts The contractor shall provide laboratory accreditation and certification specialists and subject matter experts. LACS must be experienced and qualified. LACS will be responsible for performing audit based gap analyses, prepare lab accreditation and certification documentation, provide functional training to branches, establish methods for integrating applicable policy and regulatory requirements. In addition, subject matter experts shall be provided for each of the seven (7) ISO accreditation and certification standards listed above. Subject matter experts will assure effectiveness of accreditation and certification LACS, ensure documentation accuracy, adequacy, and consistency; and may be required to perform secondary audits. The laboratory test method technology subject matter experts (SME) must be available to the extent necessary to audit testing procedures, validations and performance of a variety of test methods. 3. Harmonized Tools The contractor will develop and establish a comprehensive set of tools to guide and assist laboratories in the implementation of the requirements specified for accreditation or certification including requirements specified by the accrediting or conformity body applicable to the laboratory. Specifically, development and establishment of template policies, processes, procedures and guidance; development of intranet layout for Office of Laboratory Safety and Science (OLSS) approval; establish and maintain document control of all tools, IAW ISO 9001 compliance procedures. 4. Training The contractor will provide accreditation/certification standard requirements training for laboratory branches and their leadership. Training will be delivered for up to seven (7) ISO certification/accrediation standards and must also include integration of the Clinical Laboratory Improvement Amendments (CLIA) and Quality System Regulation (QSR) regulatory requirements. Trainings must include: detailed requirements for each laboratory accreditation standard, leadership requirements for each accreditation standard identified for implementation, internal auditing and corrective actions training, and incorporation of new laboratory processes and procedures to the accreditation or certification requirements implemented within each laboratory to include interoperability of laboratory systems. For any questions regarding this pre-award synopsis, please contact Jasmine Powell at This email address is being protected from spambots. You need JavaScript enabled to view it..