PWS Attachment 9 - Deliverables FINAL 20260423.pdf
PDF 189 KB Posted
- Attached to
- Clinical Reference Laboratory Testing Services
- Solicitation number
- HT001526RE001FINAL
- Issued by
-
Defense Health Agency
About this file
PWS Attachment 9 – Deliverables Schedule Summary
This document is a Performance Work Statement (PWS) attachment establishing the deliverables schedule for RFP HT001526RE001, a Department of Defense reference laboratory testing contract. The deliverables encompass quality assurance and control documentation, operational reports, staffing plans, and cybersecurity assessments.
The contractor must provide quarterly reports on processor staffing at DoD sites processing more than 2,000 specimens monthly with expenses exceeding $30,000, ensuring specimens are processed the same day or within one business day. Quality-related deliverables include submission of existing Quality Management Plans and proposed Quality Control Programs within 15 days of award; Quality Assurance policies, QC results, performance calculations, Levy-Jennings graphs, analyzer maintenance documentation, verification results for nonregulated analytes, and non-FDA approved method validation plans within 7 days of request. External proficiency survey participation listings and CAP inspection reports must be submitted within 14 days of award and upon request. Operational deliverables include monthly staffing reports (10th calendar day), quarterly Critical Results and Turnaround Time reports, and a listing of tests not performed upon request. The contractor must designate a full-time representative with contact information within 10 working days and submit a Mission Essential Contractor Services Plan within 30 days of award. Additionally, the contractor must complete a NIST SP 800-171 cybersecurity assessment and enter results electronically in SPRS within 180 days of award. All documents must be submitted in searchable PDF or spreadsheet format to the Contracting Officer, Contracting Officer's Representative, and/or Alternate COR as specified for each deliverable.
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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 .