DRAFT RFP HT001526RE001 - QandA - Government Response.xlsx
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Defense Health Agency
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This is a Questions and Answers (Q&A) document containing government responses to industry feedback on Draft RFP HT001526RE001 for Clinical Reference Laboratory Testing Services, issued by the Defense Health Agency on February 20, 2026. The document does not address specific procurement timelines, response dates, or award dates, as it serves solely to clarify requirements and evaluation criteria for the draft solicitation phase.
The Q&A addresses 21 substantive questions spanning formatting requirements, evaluation methodology, technical specifications, and operational parameters. Key clarifications include: (1) revised font size requirements standardized to 11-point minimum throughout all volumes; (2) confirmation that the evaluation will utilize a best-value tradeoff approach based on Technical (Acceptable/Unacceptable), Past and Present Performance (rated with confidence levels), and Price factors, with Past Performance serving as the primary differentiator; (3) small business participation minimum requirement of 3% total small business participation, replacing previous goal-based language; (4) confirmation that New York State Department of Health licenses are required where applicable for laboratories processing New York specimens; (5) the authoritative pricing source is Exhibit A with estimated yearly quantities of 1,799,616 total units across all tests (with the 500,000,000 unit figure in CLIN 0002 representing only a system placeholder for contract ceiling purposes); (6) clarification on staffing methodology flexibility with historical workload data provided; (7) allowance for CLIA-certified specialty laboratories and reference laboratories as subcontractors, including those performing advanced molecular diagnostics and esoteric testing; (8) acceptance of industry-standard HL7 interfaces for electronic data integration with MHS Genesis; and (9) confirmation that the 3-hour STAT courier pickup requirement applies globally to all DoW and DHA sites including OCONUS locations. The Government maintained non-concurrence on several vendor recommendations, including requests for standardized monthly pricing structures, restricted competition through small business set-asides, and extended specimen storage as a separately priced line item.
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Q&A
DRAFT - RFP HT001526RE001
Issued 20 Feb 2026
| Question # | PWS Reference, Attachment or Exhibit | Concern/Question/Comment | Vendor Recommendation/Rationale | Government Response |
| 1 | Attachment 2, Sec/Para. A.3.d General Formatting | RFP states, "A minimum of 11-point font size . . .", and also "Tables and illustrations may use a reduced font size of not lett than 8-point . . .". Later in same paragraph you state, "12-point font. Tables and exhibits may use a minimum 10-point font." | Please rewite to read "All narrative text must not be less than 12-point Times New Roman or Arial font size and type. Text within tables and illustrations must use Times New Roman or Arial font type, with a minimum font size of 9-points." | Concur: Attachment 2, - Addendum to Far 52.212-1, paragraph A.3.d. has been revised as "General Formatting. A minimun of 11-point Times New Roman or Arial font size applies throughout all volumes. Margins: Standard 1" around the page (top, bottom. left and right sides), Width - 8.5 nches, Height - 11 inches with margins of at lest one (1) inch on all sides. Tables and illustrations may use a reduced font size not less than 8-point and may be landscape. |
| 2 | Attachment 2, Sec. C. Basis of Award, 1st Paragraph; |
Sub-bullet 2 & Attachment 3, Sec. B. Basis for Award
Attachment 3, Sec. M Solicitation states, "best-value tradeoff process . . .", with its ". . . Non-price factor (Past Performance)" being the only evaluation factor in which best-value trade-off analysis can be performed on.
Factor 2 (Past Performance) is the only non-price factor that allows for any differentiation in a Best-Value evaluation.
As the RFP is currently written there is a a structural issue in Section M affecting the Government’s ability to conduct a true ”best value tradeoff” as intended. Although Factor 1 (Technical) is identified as the most important evaluation factor, it is currently evaluated only on an Acceptable/Unacceptable basis. When the highest weighted factor is binary—and Past Performance is assessed using a normalized confidence rating—the evaluation effectively becomes Lowest Priced Technically Acceptable (LPTA). Under this structure, meaningful differentiation in technical quality, innovation, or approach risk cannot influence the award decision, and price becomes the de facto primary discriminator.
To preserve the intended best value tradeoff, Section M should be revised to allow:
• Adjectival ratings with integrated risk assessment for Factor 1 (Technical)
• Adjectival confidence ratings for Factor 2 (Past and Present Performance)
• A clear statement that Factors 1 and 2 together carry significantly more weight than price
• A tradeoff methodology allowing the Government to select higher technical merit even at a higher price when justified by value or reduced risk Non-Concur: The Government has determined the requirements for Factor 1 (Technical) are well-defined and can be objectively evaluated on an Acceptable/Unacceptable basis. The Government does not anticipate receiving additional value or innovation for this factor that would warrant paying a price premium.
Therefore, this procurement is structured to emphasize past performance as the primary differentiator for the best-value tradeoff decision. The tradeoff analysis, as intended and described in Attachment 3, will occur between Factor 2 (Past and Present Performance) and Factor 4 (Price). This allows the Government to assess its confidence in an offeror's ability to successfully perform the work and to determine whether a higher confidence rating in past performance justifies a higher price.
The evaluation criteria as stated in the solicitation are consistent with FAR Part 15 and provide the flexibility for the Government to conduct the intended best-value tradeoff.
| 3 | N/A | To support budget stability and simplified administration, would the DoD consider inclusion of a standardized monthly pricing structure as an allowable pricing methodology within the RFP? | N/A | Non-concur: The Government is satisfied with the pricing structure as written. |
| 4 | Attachment 3, Sec. H. Volum V - Factor 4: Small Business Subcontracting Participation Proposal | Subsection 1 states the small business goals rather than the minimum requirements. | The clinical laboratory testing industry is subject to significant government regulation at the federal, state, and local levels. The technical equipment and supplies it requires are subject to stringent regulatory requirements. These regulatory compliance standards limits the labooratory's ability to procure such services and supplies from many small businesses. As such, we propose rewriting the Sec. H and Subsection 1 as follows - |
The offeror’s Small Business Participation Commitment Document will be evaluated on an “Acceptable” or “Unacceptable” basis. The Small Business Participation Commitment Document must demonstrate a comprehensive, realistic, and sound commitment to meeting the Government's socioeconomic objectives for this acquisition. To be rated Acceptable, the Small Business Participation Commitment Document must meet the minimum requirement outlined below. A proposal that fails to meet the minimum requirement will be rated Unacceptable and will be ineligible for award.
1. Standard for Quantitative Participation (Acceptable/Unacceptable)
To be rated Acceptable, the offeror’s proposal must meet or exceed the minimum requirement listed below.
The minimum requirement for Total Small Business participation is 3%.
The Government’s small business goals for this acquisition are:
a. Total Small Business: 30%
b. Small Disadvantaged Business (SDB): 5%.
c. Woman-Owned Small Business (WOSB): 5%
d. HUBZone Small Business: 3%
e. Service-Disabled Veteran-Owned Small Business (SDVOSB): 3%
| A document that fails to meet the minimum requirement above will be rated Unacceptable. | Concur: Attachment 3 Section G Volume IV Factor 3: Small Business Subcontractng Participation Plan has been revised to replace "small business goals/objectives" with "minimum requirements" | |||
| 5 | Attachment 3, Sec. E Subsection 3 Subfactor 1A Technical Approach | Clarification for New York Department of Health licenses requirement | New York State Department of Health licenses are required when laboratories accept or perform testing on specimens originating from New York State. |
Please rewrite Laboratory Testing Evaluation Criteria to read -
To be Acceptable: The proposal provides documentation certifying that all proposed prime and subcontractor laboratories are licensed to perform testing on human specimens in accordance with the Clinical Laboratory Improvement Amendments (CLIA) of 1988 and possess, where applicable, New York State Department of Health licenses. Unacceptable: The proposal fails to provide the required certifications.
| Concur: Attachment 2, Paragraph F, subparagraph 6b, Attachment 3, Paragraph E subparagraph 3, Subfactor 1A Technical Approach, and PWS paragraph 5.2.1. have all been revised. | |
| 6 | Attachment 1 - DRAFT - Performance Work Statement #6.3.1 |
#6.3.1.1
| #6.3.1.1.2 | 6.3.1 (6.3.1 - 6.3.1.1.2) Is the requirement for Contractor Information Assurance staff to be located at a DoD facility? Or for Contractor Information Assurance staff generally? | Clear distinction will promote consistent proposal assumptions. | Clarification: PWS paragraph 6.3.1. and subparagraphs 6.3.1.1. and 6.3.1.1.2 are applicable to all contractors (regardless of location) that access the DHA Network, DoW Network, or MHS Genesis. |
| 7 | Exhibit A - DRAFT Price List Schedule of Required Tests | We recommend including the following for each test: |
Current provider test code, Current performing vendor name,
| CPT code | In order for all Offerors to provide an accurate and equitable test comparison, and accurately price the provided test list. To Reduce the odds of incorrect test mapping. | Concur: See updated Exhibit A - Price List - Schedule of Required Tests, Column A - Current Lab Test Name, Column E - CPT Code, and Column G - Prime Vendor or Subcontract Performed. The Government does not concur with adding "current provider test code" or the "current performing vendor name". | |||
| 8 | Exhibit A - DRAFT Price List Schedule of Required Tests | We recommend adding a column(s) to provide space for Offerors to include their specific Test Code, Service Code, and Test Description within the pricing attachment. | To improve the accuracy of proposals and prevent potential discrepancies. | Concur: See updated Exhibit A Price List - Schedule of Required Tests that includes additional columns: C - Test Methodology, D - FDA or LDT, F -Turnaround Time, and G- Prime vendor or subcontractor performed. Additonal pertinent information may be enterred in Column L - Comments for the correlating test. | |
| 9 | PWS Sections 1.13 (Contractor Travel) and 1.14 (Other Direct Costs) | Reserved Sections: PWS Sections are marked as "RESERVED". | These sections are essential for pricing non-routine requirements, such as medico-legal testimony, which the PWS notes is not included in the fixed price. | Non-concur: The Government believes these paragraphs were incorrectly identified in the question. The Government does not anticipate the need for travel (PWS paragraph 1.8) or Other Direct Costs (PWS paragraph 1.9), but reserves the right to add them if determined in the best interest of the Government. Offerors should provide for any non-routine requirements in their proposal submissions as they feel appropriate. | |
| 10 | Exhibit A - DRAFT Price List Schedule of Required Tests and SF1449 | There is a significant lack of clarity regarding projected volumes. Exhibit A (Price List) identifies a total estimated yearly quantity of 1,799,616 units, whereas the Solicitation Supplies or Services section for CLIN 0002 lists 500,000,000 units. | This discrepancy must be resolved to allow for accurate pricing | Clarification: The Government confirms the discrepancy and provides the following clarification, which shall be considered the definitive guidance for proposal preparation: | |
| 1. | Authoritative Source for Pricing: The Exhibit A, Price List, is the sole and authoritative source for all quantities to be used in preparing your price proposal. Offerors MUST use the estimated quantities for each individual test as specified in Exhibit A. The total estimated yearly quantity of 1,799,616 units is the correct aggregate figure for proposal evaluation purposes. | ||||
| 2. | Purpose of CLIN 0002 Quantity: The quantity of 500,000,000 units shown for CLIN 0002 is a notional value required due to a system limitation within the Government's contract writing software. Its purpose is solely to establish the total contract price ceiling in the master IDIQ contract, where the quantity will represent the total dollar value and the unit of issue will be a "JOB" with a unit price of $1.00. This figure MUST be disregarded for all proposal pricing and calculation purposes. | ||||
| 3. | Basis for Evaluation: All proposals will be evaluated based on the detailed pricing and estimated quantities provided in Exhibit A, Price List. A failure to adhere to the quantities in Exhibit A may result in the proposal being considered non-compliant and therefore ineligible for award. |
| 11 | PWS 5.3.5.2 "Unscheduled/STAT" Courier Requirements | The requirement is for pickup "within 3 hours after notification." For remote or OCONUS sites (e.g., Landstuhl,Germany), a 3-hour physical pickup window by a courier may be logistically impossible or prohibitively expensive if the contractor does not have a local hub. | Recommendation: Clarify if this 3-hour window applies to all locations globally or only | ||
| CONUS locations near major metropolitan hubs or consider expanding this requirement. | Concur: PWS paragraph 5.3.5.2. is applicable to all DoW and DHA sites to include OCONUS and CONUS locations. Paragraph language has been revised for clarification. | ||||
| 12 | FAR 52.212-1 Addendum | The instructions provide a clear structure for the five required volumes and the "Demonstrate, Don't Restate" principle. However, there is a conflict in formatting requirements: Font Size Inconsistency: Paragraph (d) states that a "minimum of 11-point font" applies throughout yet later specifies that "All pages shall be in Times New Roman or Arial, 12-point font". This inconsistency could lead to inadvertent non-compliance. | Requesting Clarity | Concur: See Response #1 | |
| 13 | Sub-factor 1A | New York State Licensing: Sub-factor 1Amandates that all proposed prime and subcontractor laboratories possess New York State Department of Health licenses. Because many regional labs do not maintain this license if they do not process New York specimens, this requirement may inadvertently limit competition. | appear[s] overly restrictive or lack sufficient detail to ensure a level playing | ||
| field | Non-concur: See Response #5, New York State Department of Health licenses are required as applicable. | ||||
| 14 | PWS 1.6 | Processor Scheduling: PWS 1.6 allows the contractor to determine a "staffing formula" for on-site specimen processors. This is ambiguous and may lead to inconsistent service levels across the 16 MTFs. Providing minimum hours of on-site coverage would ensure uniform service. Is the government asking for a specific number of Full-Time Equivalents (FTEs) based on volume, or just a methodology? Without a baseline workload estimate, offerors may drastically over- or under-bid the labor required. | Recommendation: Provide historical data on the average number of processors currently |
utilized at these 16 sites or provide a "workload per FTE" standard to ensure fair
| competition. | Concur: The Government has amended the PWS. A column has been added to the chart at PWS paragraph 1.5.3. providing the average monthly test volume handled by the incumbent. This historical data is provided for informational purposes only and to assist offerors in preparing their proposals. It does not represent a guarantee of future test volumes. Each offeror is solely responsible for developing a comprehensive staffing methodology and approach to meet the performance requirement of ensuring all specimens are processed and sent out in accordance with the PWS, regardless of fluctuations in workload. The Government will not dictate or endorse any specific staffing solution. | ||
| 15 | PWS 5.3.7.2. | Web-Portal Intent: There is ambiguity regarding the web-based system mentioned in PWS 5.3.7.2. It is unclear if this is intended strictly for emergency/contingency use or for daily redundant access alongside the LIS interface. The understanding is that the orders are placed in MHS GENESIS which is integrated with the vendor LIS and direct access | |
| to the LIS is on an emergency/contingency basis. | Clairification: The web-based system identified in PWS paragraph 5.3.7.2 needs to be available at all times in the event of a contigency that prevents the transmission of data through MHS Genesis/LIS Interface. | ||
| 16 | PWS 5.3.14 | Specimen Retention: PWS 5.3.14 requires retention for 7 days (up to 30 upon request). Standard commercial retention for serum/blood is often 7-10 days due to storage volume | |
| constraints. 30 days is significant. | Recommendation: Ensure the pricing schedule (Exhibit A) allows the contractor to account for the storage costs of the "30-day on request" requirement, or make "Extended Storage" a separately priced CLIN. | Non-concur: Offerors should consider the timeframe identified in PWS paragraph 5.3.14 and address in their proposal as they deem appropriate. No adjustments of this nature will be made to the Pricing Schedule (Exhibit A) | |
| 17 | Sub Contracting Proposal | Given that large national laboratory contractors possess significantly greater market share and infrastructure compared with regional laboratories, could the Government |
clarify how it intends to ensure adequate competition and price reasonableness if the requirement is competed on an unrestricted basis? Additionally, given the presence of numerous CLIA-certified high-complexity laboratories that qualify as small businesses and are capable of performing the required testing services, would the Government consider structuring the procurement as a total or partial small-business set-aside in accordance with FAR 19.502-2 (Rule of Two) to promote broader competition and participation by qualified small laboratories? Non-concur: Market research conducted in advance of this requirement determined that it was unlikely the Government would receive proposals from two or more small businesses that were capable of performing at the scope, scale and geographic coverage required. As such, the Government made the determination to solicit this requirement as a full and open competition.
The Government will ensure price reasonableness through adequate price competition among offerors and may use other price analysis techniques as described in FAR 15.404-1. The evaluation criteria are designed to ensure a fair and equitable competition for all offerors.
| 18 | PWS - Laboratory Testing Scope | Please clarify whether the Government intends to allow subcontracted CLIA-certified specialty laboratories to perform advanced molecular diagnostics such as next-generation sequencing (NGS), hereditary cancer testing, and pharmacogenomic testing. | Recommend allowing qualified CLIA-certified specialty laboratories to support advanced molecular and genetic diagnostic services as subcontractors to the prime contractor. | Concur: Subcontracted CLIA-certified laboratories are acceptable provided those subcontracted labs meet all required regulatory, accreditation, and security requirements. |
| 19 | PWS - Electronic Data Interface | Will the Government permit integration using industry-standard HL7 interfaces or secure API connections between contractor Laboratory Information Systems and the MHS Genesis electronic health record? | Recommend permitting industry-standard HL7 or API-based integrations to support interoperability and reduce implementation complexity. | Concur: HL7 is the standard messaging interface. |
| 20 | PWS - Specialized Testing | For esoteric or low-volume specialty testing, may the prime contractor utilize qualified reference laboratories as subcontractors? | Recommend allowing subcontracted reference laboratories for esoteric or specialized testing to ensure clinical accuracy and operational efficiency. | Concur: Refer to Response #18. |
| 21 | Evaluation Criteria | Will the Government consider specialized laboratory subcontractors as part of the prime contractor's past performance evaluation? | Recommend allowing subcontractor past performance for specialized molecular diagnostic services to be considered in the technical evaluation. | Concur: Offerors submitting proposals must consider the entirity of this requirement. Prime vendors may elect to choose subcontractors with specialized laboratory experience as a part of their solution and may submit relative past performance in their Performance Risk (Present and Past Performance) volume (Factor 2) for consideration/evaluation. Specialized laboratory experience will not be considered under the Technical (Factor 1) evaluation. |
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