National Laboratory Certification Program

AMENDMENT 1 -  Provides responses to Questions received under RFP 277-22-0576.  Additionally, this amendment includes revisions to accomodate for the inclusion of HHSAR 353.232-71 Electronic Submission of Payment Requests. 

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Pursuant to Executive Order 12564 and Public Law 100-71 (Section 503), the Department of Health and Human Services (HHS) has been given the responsibility to establish the requirements for collecting and testing specimens and reporting results for the Federal Workplace Drug Testing Program.  A key element of this effort has been the development of the scientific and technical requirements for the National Laboratory Certification Program (NLCP) as specified in Mandatory Guidelines for Federal Workplace Drug Testing Program: Final Rule, Federal Register, 82 FR 7920 – 2017 (Mandatory Guidelines), and as revised.  The certification of laboratories is essential to ensure the forensic and scientific supportability of test results reported to the Federal agencies.  The Department of Health and Human Services is proposing to establish scientific and technical guidelines for the testing of oral fluid, and hair specimens; scientific and technical guidelines for using on-site tests to test urine and oral fluid at the collection site; added standards for collectors, on-site testers, and medical review officers (MROs). 

The purpose of this contract is to provide the Division of Workplace Programs (DWP) with a Contractor that will satisfy all the requirements for the National Laboratory Certification Program (NLCP) as specified in the Mandatory Guidelines, and any subsequent revisions.  In addition, the Contractor must have the capacity to expand the NLCP to satisfy (1) the scientific and technical Guidelines for the testing of oral fluid, and hair specimens; (2) the scientific and technical Guidelines for onsite screening tests for urine and oral fluids at the collection site; and (3) the requirements for the certification of laboratories, and ongoing quality assurance and performance of NLCP-related activities at collection sites, laboratories, and by Medical Review Officers (MROs).
The Contractor shall operate the National Laboratory Certification Program (NLCP) as described in the Mandatory Guidelines for Urine, the Mandatory Guidelines for Oral Fluid, and the Mandatory Guidelines for Hair.  The Contractor shall independently furnish the necessary services, qualified personnel, material, equipment, and facilities not otherwise provided by the Government to perform the tasks described below.  A copy of the Public Law 100-71 (Section 503), Executive Order 12564, the NLCP Laboratory Application Form, the NLCP Laboratory Information Checklist, the NLCP Inspection Checklist, the NLCP Records Audit Checklist, and the NLCP Manual for Laboratories and Inspectors are available for review if necessary at SAMHSA, 5600 Fishers Lane Rockville, Maryland 20857 5600 Fishers Lane, in Room 16-N02.   The first three (3) references above can also be found on our website at http://www.samhsa.gov/workplace.
All costs associated with Tasks 1 through 9, and Task 14 through 22, are reimbursed by the Government.  All costs associated with Tasks 10 through 13 are recovered as fees charged to the laboratories participating in the NLCP, unless specifically noted as an exception or by direction of the Contracting Officer Representative or Alternate Contracting Officer Representative (COR / Alt COR).   All recovered fees in excess of actual cost are to be distributed back to the laboratories.
The Contractor awarded the contract shall propose a fee schedule that will be reviewed and approved by the Government at time of contract award.  The proposed fee schedule must describe all the different fees that laboratories will pay to participate in the NLCP.
The Contractor shall arrange the least expensive travel and accommodations in accordance with Government travel regulations and HHS Policy on Use of Appropriated Funds for Conferences and Meeting Space and receive conference approvals before obligating any government funds.  Upon approval of a conference request by the COR, SAMHSA’s Division of Contract Management (DCM) will provide authorization to the Contractor on the approved funding level for the conference being supported. After receiving this authorization, the Contractor can then begin making all travel arrangements for non-Federal employees attending the meeting.