0001 Questions and Answers.docx

Questions and Answers

Question 1 Section 5 states that annual volumes are estimated and based upon historical utilization. Several assays listed in Attachment A appear to represent very low annual volumes and may not currently be performed on the laboratory's core chemistry/immunochemistry automation platform (e.g., ACTH, Alpha-2 Macroglobulin, EPO, Insulin-Like Growth Factor-1, and Thyroglobulin).

Would the Government consider removing these or allowing low-volume assays to be performed through a reference laboratory?

As these assays represent a small percentage of the overall workload, clarification would assist offerors in proposing the most efficient and cost-effective solution while maximizing competition and avoiding unnecessary limitations on otherwise capable systems.

Answer: No. The Government requires these assays to be performed in-house. In-house testing provides a faster turnaround time compared with sending specimens to a reference laboratory.

Question 2

The test menu appears to contain duplicate listings for certain assays:

· Free PSA (Pages 8 and 10)

· Free T3 / T3 Free (Pages 9 and 10)

· Free T4 / T4 Free (Pages 9 and 10) Can the Government clarify whether these are duplicate requirements and identify the correct annual volume to be used for proposal development and pricing?

Answer: Yes. These assays were inadvertently listed more than once. The duplicate entries will be removed. Offerors should use the following corrected annual volumes for proposal development and pricing:

· Free PSA: 1,900

· Free T3 / T3 Free: 1,357

· Free T4 / T4 Free: 16,925

Question 3 Section 7.1 states that if the proposed solution requires a water system outside the Government-maintained water system, the Contractor shall provide and maintain it.

Can the Government clarify whether the current Bay Pines laboratory infrastructure includes a validated laboratory-grade water system intended for use by the awarded chemistry/immunochemistry platform, or should offerors assume an independent water purification system will be required? What vendor is currently being used for this requirement?

Answer: Both current locations have Government-owned water systems available for use. Offerors are not required to assume that an independent water purification system will be needed at these locations.

There is currently no vendor providing a water system for this requirement.

Question 4 Page 12, first bullet of S02. 36C24826R0114 requires the system to have RFID technology for rapid onboard reagent placement and tracking; since manufacturers utilize various technologies, including 2D barcodes, RFID, and other equivalent methods, would the Government consider revising the requirement to state, “System shall have barcode or equivalent technology for rapid onboard reagent placement and tracking,” to allow systems that provide the same required functionality without restricting the requirement to RFID technology?

Answer: The Government will accept RFID or similar/equivalent technology, provided the proposed technology accomplishes the same intended functions and objectives.

Question 5

Section 7.1 states that the system shall have no requirement for sample pre-treatment.

Tacrolimus and other transplant immunosuppressant assays require sample pre-treatment because the analyte is extensively bound within the whole blood matrix, particularly to erythrocytes. This pre-treatment requirement is inherent to the analyte and is common across commercially available testing methods. Therefore, the requirement that all assays operate without pre-treatment is unnecessarily restrictive and should be removed to permit fair and open competition among qualified suppliers.

Answer: Yes. Section 7.1 will be revised to clarify that the no offline sample pre-treatment requirement applies specifically to A1C testing. Sample pre-treatment may be permitted for other assays when required by the assay methodology and the manufacturer’s instructions for use.

Question 6

Section 7.3 requires a minimum immunochemistry throughput of 250 tests per hour per instrument at CWBYVAMC.

Can the Government provide the operational basis for the 250 tests per hour threshold and clarify whether solutions that meet or exceed workload demands, STAT turnaround requirements, and redundancy requirements through alternative system configurations would be considered acceptable? Please adjust the requirement to 200 tests per hour to promote full and open competition.

Answer: More tests per hour are preferred throughput to give room for instrument downtime-maintenance and equipment issues. Also, immunology testing takes longer, and the department is currently struggling to keep up with the workload and turnaround time. Immunochemistry specimens have longer incubation times that occupies space in the analyzer.

Question 7 Section 7.3 requires cardiac STAT immunoassay incubation times not to exceed 10 minutes.

Because manufacturers employ different methodologies and incubation approaches while achieving similar patient result turnaround times, would the Government consider evaluating total assay turnaround time or time-to-first-result rather than incubation time alone?

Answer: The Government’s requirement is intended to ensure a quicker incubation time for cardiac STAT immunoassays.

The Government recognizes that manufacturers may employ different assay methodologies and incubation approaches while achieving comparable overall turnaround times. However, incubation time remains an important consideration because it is a fixed, methodology-dependent component of the testing process and can directly affect the timely availability of results.

The Government’s primary objective is to support rapid cardiac STAT testing. Therefore, proposed solutions should demonstrate a quicker incubation time consistent with the need for timely and efficient patient testing.

Question 8 Section 7.5 requires the decapper to accommodate rubber stoppers.

Can the Government confirm whether rubber-stopper tubes are currently utilized within the testing workflow and provide approximate annual utilization volumes associated with those tube types?

Answer: Yes. Rubber-stopper tubes are currently used within the laboratory workflow, including for blood and urine specimens associated with send-out testing.

The Government estimates a minimum utilization of approximately 100 rubber-stopper tubes per day, or approximately 36,500 tubes annually. Therefore, the requirement for the decapper to accommodate rubber stoppers will remain.

Question 9 Section 7.3 requires use of a "High/Ultra-sensitive reagent-based assay" to alleviate interferences.

Can the Government clarify which specific assay or clinical application this requirement is intended to address and what performance concerns the Government is seeking to mitigate?

Answer: The requirement is intended primarily to address Troponin testing. The proposed system shall provide a high-sensitivity Troponin assay or equivalent assay capability that meets the applicable performance requirements specified in the solicitation and provides appropriate analytical sensitivity, accuracy, and reliability.

Question 10 Can the Government clarify whether there's value in converting existing auto verification rules, middleware workflows, specimen routing rules, reflex algorithms, or decision-support logic currently in use are expected to be retained, rebuilt, or revalidated by the awarded contractor? Can this be incorporated into the evaluation criteria under the technical evaluation?

Answer: The Government’s evaluation factors and criteria have been established and issued as part of the solicitation and will not be revised to incorporate additional evaluation criteria. Proposals will be evaluated in accordance with the evaluation factors and requirements identified in the solicitation.

Question 11 Can the Government provide an estimate of:

· Current autoverification rates

· Number of active autoverification rules

· Number of analyzer interfaces

· Number of current instrument integrations supported within the existing workflow

· Number of workstations at [CWBYVAMC] and [Lee County] that will require access to the middleware.

This information will assist offerors in accurately estimating implementation and validation activities.

Answer: The Government estimates that approximately 25 workstations across the applicable locations will require access to the middleware.

The Government has provided the information determined necessary for offerors to address the requirements of the solicitation. Additional information regarding current autoverification rates, active autoverification rules, analyzer interfaces, and existing instrument integrations is not required for proposal development and will not be provided.

Question 12 Section 7.1 requires quality control frequency not to exceed once every 24 hours. Can the government adjust the requirement to add an exception for electrolytes every 8 hours?

Answer: The Government prefers less frequent QC interval times, including for electrolytes. This requirement reflects the Government’s operational need to minimize the frequency of QC activities while maintaining appropriate analytical performance and continuity of laboratory operations.

Can the Government also clarify:

· The current QC program in use BIORAD Unity Real Time

· Number of QC levels currently performed per assay 2-3 levels. Mostly, 2.

· Frequency of QC testing by assay category once daily except electrolytes

· Any assay-specific QC requirements beyond the stated 24-hour frequency None

Question 13

Can the Government identify the current external quality control provider and software platform utilized by the laboratory (e.g., Unity Real Time QC or equivalent) and indicate whether alternative quality management programs would be considered if they provide equivalent functionality?

Answer: The Government currently utilizes Bio-Rad Unity Real Time. Alternative quality management programs may be proposed, provided they offer equivalent functionality and support applicable peer-group comparisons with a minimum of 100 peers.

Question 14 Sections 8.2, 8.5, 8.8, and 14.2 establish multiple implementation, acceptance, and operational milestones, including:

· 90-day installation expectations

· 120-day responsibility transfer

· 180-day implementation completion

· 30-day performance acceptance

· Separate 90-day evaluation provisions Can the Government clarify:

· Formal acceptance criteria

· Beginning of operational responsibility

· Beginning of performance measurement

· Relationship between Sections 8 and 14

· How vendors ability to convert seamlessly and quickly would be considered under the evaluation criteria

Answer: The Government recognizes that implementation and transition may involve operational and logistical challenges. Offerors shall address the implementation, acceptance, transition, and performance requirements in accordance with the applicable timeframes and provisions identified in Sections 8 and 14 of the solicitation. Proposals will be evaluated in accordance with the evaluation factors and criteria established in the solicitation.

Question 15

Section 8.9 defines downtime at the analyzer level, while Section 9.10 requires redundant systems.

If one analyzer is unavailable but testing continues without interruption on a redundant analyzer, how will downtime be calculated for:

· Acceptance testing

· Service credits

· Performance monitoring

· Equipment replacement determinations Please clarify whether downtime is intended to be measured at the analyzer level, system level, or patient-testing capability level.

Answer: Downtime will be measured at the individual analyzer level, consistent with Section 8.9. The availability of a redundant analyzer and the continuation of patient testing on that redundant analyzer do not eliminate or suspend the downtime associated with an unavailable analyzer.

Accordingly, analyzer-level downtime will be used, as applicable, for acceptance testing, service credit calculations, performance monitoring, and equipment replacement determinations.

Section 9.10's redundancy requirement is intended to support continuity of testing operations and does not change the analyzer-level measurement of downtime established in Section 8.9.

Question 16 Section 9.10 requires redundant systems to eliminate the need for emergency backup equipment.

Can the Government clarify what constitutes an acceptable redundant solution and whether integrated backup capability within a proposed platform satisfies this requirement?

Answer: An acceptable redundant solution requires duplicate instruments with identical test menu capabilities. The intent is to ensure continuity of laboratory operations when one instrument is out of service due to scheduled maintenance, repair, or an unexpected equipment issue.

An integrated backup capability within a single instrument or platform does not satisfy this requirement unless it provides the same level of operational redundancy as a separate duplicate instrument. The laboratory must be able to continue performing the required test menu when one instrument is unavailable.

Question 17 Can the Government clarify whether implementation capability, validation methodology, transition planning, continuity of operations, service support structure, autoverification implementation, and maintenance support will be evaluated as part of Technical Capability, Past Performance, responsibility determination, or compliance review?

Answer: Implementation, validation methodology, transition planning, continuity of operations, and autoverification implementation will be addressed as part of the validation process.

Maintenance and service support will be considered under Subfactor C – Automation and Workflow, as applicable to the solicitation’s evaluation criteria.

Question 18 Section 8.6 requires method comparison studies against the current analyzer.

Can the Government confirm whether the incumbent contractor's existing systems will remain operational and available to support all required validation and method comparison studies throughout the entire implementation period?

Answer: Yes. The incumbent Contractor’s existing systems will remain operational and available during the implementation and transition period (if applicable) to support the required validation and method comparison studies.

Question 19 Section 9.7 requires a service repair person to be locally based within the geographical area.

Can the Government clarify how "locally based" will be defined and evaluated, including whether specific mileage, response-time, or residency requirements are intended?

Answer: For purposes of this requirement, “locally based” means that qualified service repair personnel must be located within approximately a 90-minute drive time of the applicable facility. This proximity is required to support an on-site response within two (2) hours of a service request.

There is no specific mileage or residency requirement; however, the Contractor must maintain sufficient local service coverage to consistently meet the required two-hour response time.

Question 20 To promote maximum competition and allow offerors adequate time to review responses, evaluate potential amendments, assess facility-specific clarifications, and incorporate changes into their proposals, would the Government consider extending the proposal due date to a minimum of three (3) weeks following release of final responses to vendor questions and any resulting solicitation amendments?

Answer: The Government does not anticipate extending the proposal due date at this time. Offerors should submit their proposals in accordance with the due date and time established in the solicitation.

Question 21 Will other operational considerations, including ISE maintenance frequency, labor burden, downtime, and workflow impact, along with QC time be evaluated as part of the overall value assessment?

Answer: These operational considerations, including ISE maintenance, labor burden, downtime, workflow impact, and QC time, will be considered under Subfactor C – Automation and Workflow as part of the overall value assessment.

Question 22 SARS-CoV-2-IgG and SARS-CoV-2S (Spike) are listed as required assays on page 10 of S02. 36C24826R0114; given their very low utilization, limited role in current diagnostic practice, and limited availability across commercially available testing platforms, would the Government consider removing these assays from the required test menu to promote competition and avoid excluding otherwise capable systems?

Answer: Yes. SARS-CoV-2-IgG and SARS-CoV-2S (Spike) are no longer routinely utilized and will be removed from the required test menu.

Question 23 Page 10, Section 6.1, second bullet of S02. 36C24826R0114 requires the provision of all reagents, calibrators, and Quality Control (QC) materials; since the Government typically procures third-party QC materials directly from manufacturers such as Bio-Rad or MAS for routine Chemistry and Immunoassay testing, can the Government clarify whether the Contractor is required to provide only vendor-manufactured QC materials specific to the proposed system or also provide third-party QC materials?

Answer: The Contractor is required to provide vendor-manufactured QC materials for the proposed system. The Government will procure third-party QC materials separately.

Question 24 Page 15, fourth bullet of S02. 36C24826R0114 states that routine immunoassay incubation times shall not exceed 30 minutes to maintain or improve current turnaround time (TAT); can the Government define what is considered a “routine immunoassay” for purposes of this requirement, particularly since certain immunoassays may have manufacturer-published incubation times exceeding 30 minutes?

Answer: For purposes of this requirement, “routine immunoassay” refers to immunoassay tests that are not commonly ordered as STAT and are not associated with an immediate or life-threatening clinical need. Examples of routine immunoassays include Vitamin B12, Vitamin D, Folate, PSA, and TSH.

Question 25

Page 29, Section 18, “Manufactured Products,” of S02. 36C24826R0114 states that the shelf life of all consumables shall be at least one year from the shipping date unless the FDA requires a different expiration date; since laboratory reagents and consumables commonly have manufacturer-established shelf lives of approximately three to six months, can the Government clarify which specific consumables are required to have a minimum one-year shelf life and whether manufacturer-established or FDA-approved expiration dates will be acceptable for reagents and consumables with shorter shelf lives?

Answer: Reagents are excluded from the one-year shelf-life requirement. Reagents shall be provided in accordance with the manufacturer-established and applicable FDA-approved expiration dates.

Question 26

Offeror that is not the equipment manufacturer. Statement of Work paragraph 7.3 states that secondary or backup analyzers must be manufactured by the same Contractor receiving the award, and that using third party analyzers to meet the test menu is not acceptable. Please confirm whether an offeror that is not itself the analyzer manufacturer may propose a single manufacturer's chemistry and immunochemistry platform through a subcontractor arrangement, provided all analyzers, reagents and test methodology come from that one manufacturer.

Answer: The Government requires the proposed chemistry and immunochemistry solution, including secondary or backup analyzers, to utilize a single manufacturer’s platform. The prime Offeror shall maintain responsibility for equipment, reagents, system performance, maintenance, and technical support throughout the contract.

Question 27

Subcontractor past performance. Section E.2, Volume II, requires references for chemistry automation systems of similar size and complexity. If the offeror performs through a subcontractor, may the offeror submit past performance references for that subcontractor, and will those references be evaluated under Factor 2?

Answer: Past performance information may include the Offeror’s own past performance and, where relevant to the proposed approach, past performance of predecessor companies, key personnel, or subcontractors that will perform major or critical aspects of the requirement.

The Government will evaluate past performance in accordance with the evaluation methodology established under Factor 2 and the applicable provisions of FAR 15.305.

Question 28

Letter of supply. Does the Government require a letter of supply, dealer authorization, or manufacturer commitment letter to be submitted with the proposal? If so, please identify the required form and content.

Answer: If the Offeror is not the manufacturer of the products being offered, a Letter of Supply or manufacturer authorization/commitment letter is required with the proposal. The documentation shall identify the Offeror as an authorized distributor or supplier and demonstrate the manufacturer’s commitment to provide the products, supplies, and support necessary for performance of the resulting contract.

In addition, the Offeror shall identify the extent of services that will be performed by the prime contractor and the services that will be performed by the manufacturer and/or subcontractor(s), including, as applicable, installation, maintenance, repairs, technical support, training, and other required services.

Question 29

Price schedule format. Item numbers 0001, 1001, 2001, 3001 and 4001 each show an estimated quantity of one with a unit of issue of each, while Attachment A lists every assay with an estimated annual volume. Please confirm that the parent item price is the sum of the individual assay unit prices multiplied by their estimated annual volumes, and confirm that Attachment A must be returned with the Unit Price and Amount columns completed for every assay in all five pricing periods.

Answer: Confirmed. For each applicable pricing period, the total price for the parent item shall equal the sum of the individual assay unit prices multiplied by their respective estimated annual volumes as identified in Attachment A. Offerors shall complete and return Attachment A with the Unit Price and Amount columns completed for each applicable assay for all five pricing periods. The totals provided in Attachment A shall correspond to the applicable parent item prices included in the Offeror’s price proposal.

Question 30 Attachment A submission format. Should Attachment A be returned in the original spreadsheet format, or converted to a portable document format file, and does it belong in Volume III with the price proposal?

Answer: For ease of viewing and evaluation, Attachment A shall be completed and returned in its original spreadsheet (Excel) format. Attachment A shall be submitted as part of Volume III – Price Proposal. Offerors shall not convert Attachment A to PDF.

Question 31 Current system and incumbent. Please identify the chemistry and immunochemistry platform and automation track currently installed at both locations, and the current contract number, so offerors can properly scope removal, transition and interface work.

Answer: The currently installed systems are as follows:

Lee County: One (1) Abbott Alinity c analyzer and one (1) Abbott Alinity ci-series analyzer.

Bay Pines: Two (2) Abbott Alinity ci-series analyzers, one (1) Abbott Alinity i analyzer, and one (1) AC3600 (Inpeco) automation track.

Question 32 Sysmex-9100 interface. Paragraph 7.5 requires a Food and Drug Administration cleared interface to the Sysmex-9100 system at the C.W. Bill Young Department of Veterans Affairs Medical Center. Please confirm whether that hematology system is Government owned and will remain in place, and identify the middleware currently managing that connection. It is in place and will be connected to the track.

Answer: The Sysmex-9100 system is currently in place and will remain in place. The system will be connected to the automation track. The current configuration utilizes Caresphere through Data Innovations for the interface connection.

Question 33 Volume I page limitation. Is there a page limit for the Technical Capability volume, and does manufacturer literature and specification documentation count against that limit?

Answer: Volume I – Technical Capability is limited to 50 pages. All information necessary to demonstrate compliance with the solicitation’s technical requirements, including any manufacturer literature and specification documentation the Offeror wishes the Government to consider, must be included within the 50-page limitation. Any information submitted beyond the 50-page limit will not be considered or evaluated.

Question 34 Business Associate Agreement. Please confirm whether the agreement in Attachment 2 must be signed and returned with the proposal or executed at award, and whether subcontractor personnel with access to protected health information must also be covered.

Answer: Attachment 2, Business Associate Agreement, is provided for informational and reference purposes only and is not required to be signed or submitted with the proposal.

Question 35 Trade Agreements Certificate. With respect to the certificate at 52.225-6, please confirm whether analyzers, automation track components and reagents originating in a non-designated country are excluded from award consideration.

Answer: Offerors are responsible for identifying the country of origin of offered products and completing the certification at FAR 52.225-6 in accordance with the solicitation. Products from non-designated countries are subject to the requirements of FAR 52.225-5, Trade Agreements, and other applicable solicitation provisions and clauses. The Government will evaluate offered products for compliance with these requirements and the terms and conditions of the solicitation.