PWS Attachment 9 - DRAFT Deliverables.docx
DOCX document 28 KB Posted
- Attached to
- Clinical Reference Laboratory Testing Services
- Solicitation number
- HT001526RE001
- Issued by
-
Defense Health Agency
About this file
This is a Performance Work Statement (PWS) Attachment detailing the deliverables schedule for Clinical Reference Laboratory Testing Services. The contractor must provide quarterly reports on processor staffing at DoD sites handling more than 2,000 specimens and $30,000 in monthly expenses, with specimens sent out same-day or by the next day. Within 15 days of contract award, the contractor shall submit its existing Quality Management Plan (QMP), Quality Control Program (QCP), and quality assurance policies in searchable PDF format to the Contracting Officer's Representative (COR). The contractor must provide quality control documentation including QC results, Levy-Jennings graphs, analyzer maintenance records, verification results, and proficiency testing participation within 7 days of request. All test methods must be FDA-approved, with non-FDA approved assays requiring documented validation plans meeting CLIA, CAP, and CLSI guidelines, submitted within 7 days of COR request.
Additional deliverables include CAP interim checklist and inspection reports within 14 days of request, contact information for a full-time contractor representative and alternate within 10 working days, and monthly Specimen Accountability (SA) reports due the 10th calendar day of each month. Quarterly deliverables include critical results reports and turnaround time (TAT) analyses submitted as spreadsheets. The contractor must complete a NIST SP 800-171 DoD Assessment and enter results electronically in SPRS within 180 days of contract award. Upon contract expiration, the contractor shall provide phase-in/phase-out services for up to 180 days. All deliverables must be submitted to the COR and Alternate Contracting Officer Representative (ACOR) as specified.
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Text version
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 |
| 1.6.1.1.3 |
| 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 |
| 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 (commonly referred to as LDT) assays for use in human testing. Documentation will be provided to DHA COR upon request. |
| Within 7 days of request |
| Searchable PDF |
| COR and ACOR |
| 1.10.1.8 |
| 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 |
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