Microbiological Laboratory Testing Q and A 8-6-2026.pdf
PDF 91 KB Posted
- Attached to
- H299 - MICROBIOLOGICAL LABORATORY TESTING Federal contract opportunity
- Solicitation number
- 36C25026Q0687
About this file
This is a Questions and Answers document for a microbiological laboratory testing solicitation issued by the VA. The document clarifies requirements across multiple service areas and operational parameters.
The solicitation involves microbiological environmental monitoring services for a VA compounding pharmacy with 46 compounding staff members, 1 designated supervisor, 4 buffer rooms, 3 ante rooms, and 1 C-SCA, with 48 surface sampling locations. Key services include viable air sampling, surface sampling, gloved fingertip sampling, and personnel competency testing under USP <797> standards. The VA will collect air samples using a contractor-provided SAS 180, SAS 360, or equivalent air sampler available for rent, then ship samples to the contractor for incubation and analysis. No cleanroom certification testing is required. The contractor must maintain ISO/IEC 17025 accreditation from a nationally or internationally recognized accrediting body with applicable testing methods in the accredited scope; accreditation may be satisfied through a subcontracted laboratory performing the actual testing. A single Gloved Fingertip Sample Set consists of two individual sampling media devices, one per gloved hand. Monthly Surface Sampling Kits (CLIN 0004) are distinct from Enverify Surface Sampling Competency Kits (CLIN 0009); the former supports routine environmental monitoring while the latter evaluates personnel competency. Monthly Surface Sampling Kits must include shipping to the collection site, insulated shipping containers, packing materials, compliant microbial growth media plates for minimum 28 viable samples plus controls, sterile bags, return shipping labels, and laboratory analysis. Pricing must include both shipment of kits to the collection site and return shipment of samples to the laboratory.
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Other files for this federal contract opportunity
| File | Type | Posted |
|---|---|---|
| Microbiological Laboratory Testing Q and A 8-12-2026.pdf | ||
| SOW Environmental and Personnel Sampling.docx | DOCX document | |
| 36C25026Q0687.pdf | ||
| Service Contract Act WD 2015-4727.pdf |
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Text version
Microbiological Laboratory Testing Q&A
Q: After reading the solicitation, we had a question regarding air samples. Does the VA have air samplers or is this something you are asking contractors to provide? It has been our experience that air samples are collected during clean room inspections and hood certifications.
A: We are requesting the contractor have a SAS 180, SAS 360, or other equivalent air sampling device available for rent. Our intention is to collect viable air samples ourselves, providing us with more flexibility independent of a cleanroom certification company. Collected samples will be shipped to the contractor for incubation and analysis.
Q:Number of compounding staff members.
A: 46 Compounding Staff Members
Q: Number of designated persons / supervisors (non-compounders)
A: 1 designated person (non-compounder)
Q: Number of ISO-classified rooms and surface sampling locations
A: 4 buffer rooms, 3 ante rooms, 1 C-SCA; 48 surface sampling locations
Q: You’re requesting an Air Sampler in the SOW attached …are you renting one from me?
Do you need full 797 Certification 2x per year? If 797 certification is required, I’m going to need more information.
A: Renting air sampler to collect air samples and send to lab for incubation/testing. No certification testing requested in this statement of work.
Accreditation
Q: Page 9 of 47 of the solicitation states that the contractor must be ISO/IEC 17025 accredited by A2LA. Please clarify whether the Government requires accreditation specifically through A2LA, or whether ISO/IEC 17025 accreditation through another recognized accrediting body, such as AIHA LAP, will satisfy this requirement, provided the applicable testing methods are included within the laboratory’s accredited scope.
A: ISO/IEC 17025 accreditation through another recognized accrediting body is acceptable, provided the accrediting body is nationally or internationally recognized and the laboratory's accredited scope includes the applicable USP <797> environmental monitoring and personnel competency testing methods relevant to the services being provided (e.g., viable air sampling, surface sampling, microbial enumeration and identification, media fill, and other applicable microbiological testing).
Q: If a subcontracted laboratory holds the required ISO/IEC 17025 accreditation, would this satisfy the accreditation requirement for the solicitation?
A: A subcontracted laboratory may satisfy the ISO/IEC 17025 accreditation requirement, provided the subcontracted laboratory is the laboratory performing the testing, holds the required ISO/IEC 17025 accreditation, and has the applicable testing methods included within its accredited scope.
Gloved Fingertip Sampling (page 7 of 47, 5.4 Task 4 and CLIN 0001)
Q: Please clarify the quantity represented by one (1) Gloved Fingertip Sample Set under CLIN 0001. Specifically, how many individual gloved fingertip samples constitute a single sample set?
A: A single Gloved Fingertip Sample Set consists of two individual sampling media devices, with one sampling media device used to sample each gloved hand.
Monthly Surface Sampling Kits (page 4 of 47, 5.1 Task 1, a.5)
Q: Please clarify which CLIN includes the Monthly Surface sampling Kit, as this service appears to include costs beyond laboratory analysis.
A: CLIN 0004 is the Monthly Surface Sampling Kits.
Q: Is the Monthly Surface Sampling Kit synonymous with the Enverify Surface Sampling Competency Kit referenced on page 5 of 47 and CLIN 0009?
A: Monthly Surface Sampling Kits (CLIN 0004) and Enverify Surface Sampling Competency Kits (CLIN 0009) are not synonymous. Monthly Surface Sampling Kits are used to collect viable surface samples from the cleanroom environment as part of routine environmental monitoring. Enverify Surface Sampling Competency Kits are commercially available kits used to evaluate and document personnel competency in performing viable surface sampling using contact plates.
Q: Please identify all materials that must be included in the Monthly Surface Sampling Kit.
Specifically, should the kit include: (A) Insulated shipping container (B) Packing materials
(C) Ice packs or other temperature-control materials ?
A: Monthly Surface Sampling Kits must include:
- Shipping to the collection site;
- An insulated shipping container;
- Packing materials to ensure safe transport to the collection site and the safe return of collected samples to the laboratory for analysis;
- A sufficient quantity of compliant microbial growth media plates to collect a minimum of 28 viable surface samples, plus one (1) positive control and one (1) negative control. The growth media plates must remain in their original manufacturer's sterile packaging until use;
- A sufficient quantity of sterile bags for packaging collected sample plates;
- A return shipping label; and
- Laboratory analysis of the submitted samples.
Q: Please clarify shipping requirements associated with the Monthly Surface Sampling Kit.
Should pricing include:
a. Shipment of the kit to VANEOHS or the collection site; and yes
b. Return shipment of samples from VANEOHS to the laboratory for analysis?
A: Yes
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