Amendment 2 Questions and Answers.docx
DOCX document 16 KB Posted
- Attached to
- Genotyping Analysis Services
- Solicitation number
- HT942626QE044
- Issued by
- Not on record
About this file
This is an Amendment 2 Questions and Answers document clarifying requirements for the genotyping analysis services solicitation HT942626QE044 issued by the US Army Research Institute of Environmental Medicine (USARIEM). The document addresses two primary inquiries from potential contractors regarding mandatory qualification requirements.
The first question clarifies the laboratory quality system standard referenced in PWS Part 5, which originally specified "Good Clinical Laboratory Practice (GCLP)" standards. The government confirms that CLIA certification and CAP accreditation, supported by documented and periodically reviewed Standard Operating Procedures (SOPs), satisfy the quality system requirement, resolving confusion between GLP (nonclinical laboratory standards under 21 CFR Part 58) and CLIA/CAP standards (applicable to human specimen testing in the United States). The second question addresses whether special qualifications, including previous federal genomics services experience with analysis of at least 10,000 samples and the required laboratory quality system standards, must reside with the prime contractor or may be satisfied through a proposed subcontractor. The government clarifies that since FAR 52.219-14 has been removed from the solicitation and is not applicable to this award, the qualifications may be satisfied by a subcontractor performing the array analysis on behalf of the prime contractor.
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Other files
| File | Type | Posted |
|---|---|---|
| Performance Work Statement - Updated.pdf | ||
| Amendment 1 Questions and Answers.docx | DOCX document | |
| Solicitation Amendment - HT942626QE0440002.pdf | ||
| Solicitation Amendment HT942626QE0440001 SF 30 1.pdf | ||
| Attachment 1 - Performance Work Statement .docx | DOCX document | |
| Solicitation - HT942626QE044.pdf | ||
| Attachment 2 - QASP Genomics Analyses.docx | DOCX document |
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Text version
1. Quality system standard. PWS Part 5, Special Qualifications, requires that the contractor’s laboratory systems “adhere to Good Clinical Laboratory Practice (GLP) Standards.” The term spelled out is Good Clinical Laboratory Practice (GCLP), while the abbreviation given is GLP. These are distinct frameworks: GLP is codified at 21 CFR Part 58 and governs nonclinical laboratory studies, and to our knowledge is not held by any laboratory performing array-based genotyping on human specimens. Human specimen testing in the United States is governed by CLIA certification and CAP accreditation. Request: Please confirm whether CLIA certification and CAP accreditation, supported by a documented and periodically reviewed SOP system, satisfy the Part 5 quality system requirement.
a. Please see updated PWS regarding above items.
2. Special Qualifications and subcontractors. PWS Part 5 states that the contractor must have previous history of providing genomics services to the Federal government involving analysis of at least 10,000 samples, and Amendment 0001 confirms this is a requirement. This solicitation is unrestricted, and FAR 52.219-14 by its own terms at paragraph (c) does not apply to unrestricted acquisitions. Request: Please confirm whether the Special Qualifications, including the 10,000-sample federal history and the laboratory quality system, may be satisfied by a proposed subcontractor performing the array analysis, or whether they must reside with the prime contractor.
a. FAR 52.219-14 has been removed from this solicitation and is not applicable to this award.
File details come from the government source that posted it. Updated .