DRAFT - PWS Attachment 9 - Deliverables FINAL 20260423.pdf
PDF 189 KB Posted
- Attached to
- Clinical Reference Laboratory Testing Services
- Solicitation number
- HT001526RE001DRAFT
- Issued by
-
Defense Health Agency
About this file
This is a Deliverables Schedule (PWS Attachment 9) for RFP HT001526RE001, outlining contractor obligations for a Defense Health Agency reference laboratory testing contract. The schedule specifies 23 distinct deliverables with defined frequencies, formats, and submission recipients.
Key deliverables include quarterly reports on specimen processor staffing at DoD sites exceeding 2,000 monthly specimens and $30,000 in monthly expenses; phase-in/phase-out services documentation within 21 days of Contracting Officer request; and comprehensive quality management and quality control program documentation due within 15 days of contract award. Quality assurance deliverables comprise the majority of requirements, including quality control results, Levy-Jennings graphs, analyzer maintenance documentation, and verification results for non-regulated and non-proficiency-tested analytes—all due within 7 days of request. Additional quality requirements include external proficiency survey participation listings due within 14 days of award, FDA approval documentation for test methods within 7 days of request, and CAP inspection reports within 14 days. Operational deliverables include monthly specimen acceptance reports due the 10th calendar day of each month, quarterly critical results and turnaround time reports, contact information for contractor representatives within 10 working days, and a Mission Essential Contractor Services Plan due within 30 days of award. One cybersecurity deliverable requires submission of a NIST SP 800-171 Basic Assessment using the DoD Assessment Scoring Template to SPRS within 180 days of contract award. All quality and most operational documents must be submitted in searchable PDF format to the Contracting Officer and/or Contracting Officer's Representative, with select deliverables also sent to the Alternate Contracting Officer's Representative.
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Text version
Solicitation Number
RFP HT001526RE001
PWS Attachment 9
PWS Attachment 9 Deliverables Schedule
Deliverable Frequency Medium/Format Submit To Applicable to:
The contractor will provide processors to DoD sites sending more than 2,000 specimens and expending more than $30,000 in monthly expenses for reference lab testing. The contractor will determine a staffing formula for those sites ensuring that specimens are sent out the same day or not less than the following day
Quarterly Report
Searchable PDF COR 1.5.3
The Contractor shall, upon the Contracting Officer’s written notice, (1) furnish phase-in, phase-out services for up to 180 days after this contract expires.
Within 21 days of COR written request.
Searchable PDF CO and COR 1.6.1 and 1.6.2
The Contractor shall provide a copy of its existing QMP and QC program
Within 15 days after contract award
Searchable PDF COR 1.10.1
The Contractor’s Proposed Quality Control Program
(QCP).
Within 15 days after contract award
Searchable PDF COR 1.10.1.2
Quality Assurance (QA) policies.
Within 7 days of request
Searchable PDF COR and ACOR 1.10.1.4.1
QC results for assays. Within 7 days of request
Searchable PDF COR and ACOR 1.10.1.4.2
On-going calculations of QC performance (coefficient of variation, mean and standard deviation).
Within 7 days of request
Searchable PDF COR and ACOR 1.10.1.4.3
PWS Attachment 9 Monthly Levy- Jennings graphs.
Within 7 days of request
Searchable PDF COR and ACOR 1.10.1.4.4
Documentation of appropriate analyzer maintenance.
Within 7 days of request
Searchable PDF COR and ACOR 1.10.1.4.5
Verification results for assays of non-regulated analytes.
Within 7 days of request
Searchable PDF COR and ACOR 1.10.1.4.6
Verification results for analytes for which proficiency testing does not currently exist.
Within 7 days of request
Searchable PDF COR and ACOR 1.10.1.4.7
The Contractor shall provide the DHA COR a listing of external proficiency surveys that the laboratory participates in accordance with
(IAW) CLIA
requirements. Survey results and statistical reviews for specific laboratory specialties shall be provided to DHA COR upon request.
Within 14 days of contract award, and upon request
Searchable PDF COR and ACOR 1.10.1.7
All test methods shall be United States (US) Food and Drug Administration (FDA) approved. Any non- FDA approved method being performed shall have a documented validation plan that as a minimum meets guidelines established by CLIA, CAP, Clinical Laboratory Standards Institute (CLSI), and any additional applicable portions of the Code of Federal Regulations (CFR) for the implementation of non-FDA approved
Within 7 days of request
Searchable PDF COR and ACOR 1.10.1.8
PWS Attachment 9 (commonly referred to as LDT) assays for use in human testing.
Documentation will be provided to DHA COR upon request.
Upon DHA COR request, the Contractor shall provide CAP interim checklist reports and CAP inspection reports to include deficiencies and corrective actions.
Within 14 days Searchable PDF COR and ACOR 1.10.1.9
Name, telephone number, pager, cell phone number, facsimile number and e-mail address of a full-time Contractor representative and alternate.
Within 10 working days
Searchable PDF or electronic message
COR and ACOR 5.3.16.14
Monthly SA Report 10th calendar day of the month
Spreadsheet COR and ACOR 5.3.16.3
Tests not Performed Upon request Spreadsheet COR and ACOR 5.3.16.5
Critical Results Report
Quarterly Spreadsheet COR and ACOR 5.3.11 (5.3.16.8)
Quarterly TAT Quarterly Spreadsheet COR and ACOR 5.3.16.9
Basic Assessment, using the NIST SP 800-171 DoD Assessment Scoring Template, and enter the results electronically in SPRS for each covered contractor IS that is relevant to an offer, contract, task order, or delivery order.
Within 180 days of contract award.
Enter the results electronically in SPRS
Private Sector Care IT Program Manager
6.4.2
PWS Attachment 9 Mission Essential Contractor Services Plan
Within 30 days of contract award
Searchable PDF CO and COR 5.3.17
| PWS Attachment 9 |
| Deliverables Schedule |
File details come from the government source that posted it. Updated .