B.08 W91YTZ24R0010 Q&A Final 05 10 24.pdf

W91YTZ-24-R-0010 Questions and Answers

Vendor 1 Questions

1- Regarding requirement: “Instrument required to fit in a space no larger than 7 feet by 7 feet wide without construction including necessary clearance to access.”

Question: Can the government provide CAD drawings of the space so that the vendors can provide the best instrument configuration? Most vendors have modular systems, but the cost will be variable, depending on the need for L turns, placement of sample modules, etc. In order to provide the best workflow and value to the government, the vendors require either a CAD drawing or an onsite visit to take measurements.

WINN RESPONSE: CAD drawings will not be provided. Site visits are not necessary.

Laboratory Management will determine placement /configuration of analyzers during installation. The space requirement is based Winn and Tuttle Lab spaces; Not on any particular analyzer/ vendor requirement.

EHCB Response: Acknowledged

2 - Regarding requirement:

“Must be free of Biotin Interference- cancer patients are frequently prescribed high level”

Question/Concern: This requirement is unduly restrictive and makes this solicitation non-competitive. Abbott is the only vendor with “free of Biotin interference” methods, and it is not best practice to pick only one interfering substance and ignore all others. Will the government consider changing the “interference substance” requirement to include a more comprehensive requirement such as: “minimum interference from commonly recognized interfering substances” so that the solicitation is competitive and comprehensive? Biotin is only one interfering substance among many.

WINN RESPONSE: Must have the ability to provide minimum interference for commonly recognized interfering substances on assay reported results. Including but not limited to medications and their metabolites, i.e biotin, hemolysis, icterus, lipemia and turbidity.

EHCB Response: Changed in the solicitation

Vendor 2 Questions

1. All analyzers must be same and supplies shall be FDA approved.

. Is it the requirement of the SOW that all proposed analyzers be the exact same model?

WINN RESPONSE: Models of chemistry analyzers installed at both locations, Winn and Tuttle, will be the same.

EHCB Response: Acknowledged

2. Instrument required to fit in a space no larger than 7 feet by 7 feet wide without construction including necessary clearance to access.

. Can you provide an updated CAD drawing of the lab with the location of the current analyzers.

a. Our analyzers have previously fit in the space and are not hindered by drains. The space requirement is specific to one vendor.

b. Will vendors have the opportunity to come onsite to determine footprint?

WINN RESPONSE: CAD drawings will not be provided. Site visits are not necessary.

Laboratory Management will determine placement /configuration of analyzers during installation. The space requirement is based Winn and Tuttle Lab spaces; Not on any particular analyzer/vendor requirement.

3. Sample/chemistry carryover prevention / Direct sampling from primary tube to reduce disposables usage, minimize carryover risk, and provide a more efficient operation.

. Respectfully request to expand on the need for carryover prevention, is it Winn Army’s desire to require disposable tips for all testing (chemistry and Immunoassay) to prevent the possibility of carryover?

WINN RESPONSE: Must utilize disposable tips for all testing.

EHCB Response: Acknowledged.

4. An on-board test capacity of, at a minimum 80 patient specimens. / Must have the ability to store quality control on board and run automatically.

. Can you elaborate on process and procedure to store and run quality control on board given your on-board test capacity requirements. There are a total of 56 assays in the SOW, if the assays and QC share a on-board position on a analyzer is it Winn Army’s intention to only store and run only a fraction of the assays onboard? We respectfully request that this requirement be removed.

WINN RESPONSE: Must have the ability to store and run QC reagents on board per laboratory’s test capacity requirement. This capacity is separate in regard to patient sample load.

5. Must have less than 30 minutes of total daily tech performed calibration and quality control per integrated immunochemistry instrument.

. To determine the total calibration experience per analyzer for your technicians we respectfully request that all vendors list out the calibration frequency for each assay and the number of calibrator points associated with each assay which would then require linearity studies every 6 months.

WINN RESPONSE: N/A to Winn Laboratory; will not be included as required for solicitation.

Vendor will determine practices to answer how they will meet this requirement.

6. Must have first pass linearity up to 1,500 for ALT, Amylase, CK and bHCG to help minimize timely dilutions.

. Can you explain the clinical need for this requirement on these four tests, what is the significance of the first pass linearity for these assays. What is the first pass linearity requirement for the other 52 tests in the SOW?

WINN RESPONSE: No change for first pass linearities. Vendor will determine practices to answer how they will meet this requirement. Vendor will establish adjustable measurement range.

7. Vendor must guarantee at least 99% uptime during contract period.

. This requirement references analyzer uptime in relation to the analyzer being non-functional can you elaborate on the requirement for the analyzer(s) being available for use based upon automated and manual maintenance? We respectfully request that all vendors use the maintenance requirement and times published in their operator manuals to respond to all maintenance questions. Additionally, we respectfully request that all vendors list out maintenance events except As-Needed, adding bi-weekly, bi-monthly, quarterly, semiannually and annually.

WINN RESPONSE: Vendor will determine practices to answer how they will meet this requirement. This is separate from routine maintenance.

8. Operate satisfactorily within a temperature range of 68°-80° F (Fahrenheit) and within a relative humidity range between 40-80%

. In the SOW there were requirements listed temperature and humidity ranges, what are the other environmental requirements? What is the maximum liters of water per hour consumption for each analyzer and what is the maximum heat output (BTU’s) per analyzer?

WINN RESPONSE: N/A for Laboratory.

9. Quality Control and Upkeep

. In an effort to minimize technician interaction with each analyzer is it the requirement of Winn Army for all assays to have ≥ once daily QC requirements?

WINN RESPONSE: Prefer QC for every assay to be ran once every 24-Hour period.

10. Pro- B-type Natriuretic Peptide (NT-proBNP)

. Is it the requirement for each proposed analyzer to have the ability to run NT PRO BNP testing and not BNP testing?

WINN RESPONSE: Analyzer must have the ability to run BNP and/ or NT PRO BNP

11. Must be free of Biotin Interference- cancer patients are frequently prescribed high levels of Biotin . We respectfully ask that this requirement be removed or modified to include all interfering substances. In addition, it is our understanding that Winn Army is not a cancer center.

WINN RESPONSE: Must have the ability to provide minimum interference for commonly recognized interfering substances on assay reported results. Including but not limited to medications and their metabolites, i.e biotin, hemolysis, icterus, lipemia and turbidity.

EHCB Response: Changed in solicitation

12. Additional Requests / Questions

. There are multiple references in the SOW referencing what is the maximum liters of water per hour that each proposed analyzer can consume? And are there any restriction or limitation in relation to water drainage?

WINN RESPONSE: No known restriction or limitation to water drainage

Is assessing common interferents with no additional reagents or consumables are used during that process preferred? And if so, what is the maximum amount of time that the analyzer can spend to process this information?

WINN RESPONSE: There are no time constraints for this metric.

The majority of the testing volume contained in the SOW are made up of CMP and BMP panels, what is the maximum amount of time required to run the two panels?

WINN RESPONSE: <1 Hour

a. Current volumes are reflecting Troponin I and, in the requirements, it states Troponin HS. Please confirm what you are currently running?

WINN RESPONSE: TROPONIN I High Sensitivity

b. Please confirm Tuttle Army Health Clinic is looking for instrumentation and if so, please provide volumes.

WINN RESPONSE: Review Solicitation. Instrumentation is for Winn Lab (2) and Tuttle Lab (1). Volumes will not be changed/ adjusted EHCB Response: Acknowledged

Vendor 3 Questions

Solicitation indicates “Tests performed by one (1) Chemistry Analyzer -Tuttle Army Health Clinic 230 Duncan Dr., Hunter Army Airfield Savanah, GA 31409, and two (2) Chemistry Analyzers - Winn Army Community Hospital Bldg. 302 1061 Harmon Ave, Fort Stewart, GA 31314.”

• Clarification #1 – is there to be only one Chemistry analyzer at Tuttle clinic, no redundancy? Please also confirm that there are no Immunoassay tests being run at Tuttle.

WINN RESPONSE: Immunoassay testing is not ran at Tuttle Laboratory with current test platforms.

• Clarification #2 – are there to be two (2) Chemistry-Immunoassay Integrated Workcells at Winn Army CH?

WINN RESPONSE: Winn Laboratory will have 2 Chemistry/ Immunoassay analyzers.

WINN RESPONSE: Government requires Current FDA Approval and Authority to Operate EHCB Response: Acknowledged ATO).

Solicitation indicates “Must have first pass linearity up to 1,500 for ALT, Amylase, CK and bHCG to help minimize timely dilutions.”

• Revision Request #3 – please revise to “up to 500 for ALT, 2000 for Amylase, 2000 for CK, and 1350 for bHCG…”

WINN RESPONSE: No change for first pass linearities Vendor will determine practices to answer how they will meet this requirement. Vendor will establish adjustable measurement range.

EHCB Response: Acknowledged

Solicitation indicates “The system installed at Winn Army Community Hospital laboratory shall be capable of performing the following FDA approved tests: NT-proBNP.”

WINN RESPONSE: Analyzer must have the ability to run BNP and/ or NT PRO BNP

EHCB Response: Corrected in the solicitation

Solicitation indicates “The system installed at Winn Army Community Hospital laboratory shall be capable of performing the following FDA approved tests: Fentanyl and Vitamin D”

• These are great… please provide expected Fentanyl and Vitamin D annual volumes as they are not listed on Clin Line Assays of Excel spreadsheet B.08+Chemistry+Test.

• Similarly… Vendor 3 (name removed) noticed there are no Drugs of Abuse Tests listed on Clin Line Assays of Excel spreadsheet B.08+Chemistry+Test (e.g., amphetamines, cocaine, opiates, etc.), please provide a full list of DATs and annual volumes.

WINN RESPONSE: Volumes will not be changed/ added. Analyzer must have the ability / be capable of performing subject tests.

EHCB Response: Acknowledged

Solicitation indicates “Must be free of Biotin Interference…”

• Revision Request #5 –Vendor 3 (name removed) has only 2 assays with Biotin interference (Free T3 and Total T3) currently run at Fort Stewart. Additionally, these are to be mitigated and resolved by Vendor 3 (name removed) over the next 12-months… please change requirement to “Must be free of Biotin Interference or have a stated mitigation plan with stated timeline for resolution.”

WINN RESPONSE: Must have the ability to provide minimum interference for commonly recognized interfering substances on assay reported results. Including but not limited to medications and their metabolites, hemolysis, icterus, lipemia and turbidity

EHCB Response: Verbiage amended in the solicitation.

Vendor 4 Questions

• Chemistry Test Spreadsheet - the volumes for several assays are different for CLIN 1001 vs. 2001-4001: ETOH, AST, D-Bili, BUN, CA, CO2, CHOL, CK, CKMB, and Creatinine all increase, Carb decreases. Is there a reason for these changes?

WINN RESPONSE: CLIN 1001 display quantities based on 6 months, CLIN 2001-4001 displays quantities based 12 months

• Chemistry Test Spreadsheet - provide a breakout of the annual volumes for Tuttle and Winn, which would allow the vendors to place the correct configuration of analyzers based on their volumes?

WINN RESPONSE: Volumes will not be changed/ added.

• W91YTZ24R0010 CPT RFQ 042924 FINAL, CLIN, pages 3-5/102 - the first paragraph for each CLIN notes that "one (1) Chemistry Nalyazer - Tuttle Army Health Clinic" and "two (2) Chemistry Analyers - Winn Army Community Hospital" are needed.

Based on the test menu provided in the Chemistry Test spreadsheet, we understand the analyzer need is for systems that can provide both chemistry and immunoassay testing within an integrated system. Please confirm our understanding is correct.

WINN RESPONSE: Correct.

EHCB Response: Acknowledged

Vendor 5 Questions

1. Section 2.1 on page 34 lists urinalysis analyzers, is this meant to say Chemistry?

WINN RESPONSE: Chemistry EHCB Response: Corrected in the solicitation

2. Section 2.2 on page 35 requests removal of the incumbent’s equipment. Please clarify if the incumbent will be responsible for removing their own equipment or if there will be an expectation for the awardee to remove the incumbent’s equipment. Traditionally, awardees are not expected to remove the incumbent’s equipment as it is not our property

WINN RESPONSE: Removal of the incumbent’s equipment will be the responsibility of the incumbent not awardee.

EHCB Response: Removed from the solicitation

3. Section 3 on page 35 requires service to be performed on Federal holidays and section

3.1.1 excludes Federal holidays from service. Can you please confirm if there is an expectation to service the instruments on Federal holidays?

WINN RESPONSE: Review Section 5: Specific Tasks Paragraphs 5.9, 5.10, 5.11, 5.12 EHCB Response: Acknowledged

4. Section 5.2, page 35 shares technical training for all shifts and during the first 14 working go live days. Can you please share the number of shifts and what the expectation is from industry during the first 14 working go live days?

WINN RESPONSE: Review normal duty hours. Laboratory Management will coordinate employee presence for technical training offered during first 14 working go live days.

EHCB Response: Acknowledged

5. Salient Characteristics “Instrument required to fit in a space no larger than 7 feet by 7 feet wide without construction including necessary clearance to access.”

• Can the government be more specific about the space limitations for each location (Tuttle Clinic and Winn Army)? Please share dimensions of the lab area to help understand the space.

• Is the 7’x7’ requirement for the total instrument solution, for one site, both sites?

The more details around space constraints the better.

WINN RESPONSE: CAD drawings will not be provided. Site visits are not necessary.

Laboratory Management will determine placement /configuration of analyzers during installation. The space requirement is based Winn and Tuttle Lab spaces; Not on any particular analyzer/vendor requirement.

EHCB Response: Acknowledged

6. Salient Characteristics, “Must have the ability to interface with 3rd party peer QC benchmarking programs”

• This capability to interface traditionally requires a middleware system. It’s our understanding that middleware is not currently a part of the government’s request.

Can the government please clarify whether the solicitation is requesting a middleware solution?

WINN RESPONSE: Have a bi-directional interface which is compatible with the current Cerner MHS Genesis hospital information systems- if middleware is required to meet this requirement, then solution must be included.

EHCB Response: Acknowledged

7. Water: Will the government be providing a water system to connect to the analyzers, or will the government be requiring industry to provide a water system?

WINN RESPONSE: If required for instrument operation, vender must provide water purification system.

EHCB Response: Acknowledged

8. Invoicing for the Instruments/other capital: Please specify the preferred billing method of the instruments: rental (separate CLIN) or included in reagents?

WINN RESPONSE: N/A to Laboratory: Refer to DoD Solicitation Guidelines- Contracting EHCB Response: Instructions for billing are included in Solicitation Clause 252.232-7006

9. Page 41, section 1.11. The vendor shall obtain a recommendation of Approval from a Government- appointed third party validator within twelve (12) months of contract award. Please clarify who is to obtain the third-party validator and what would they be validating?

WINN RESPONSE: N/A to Laboratory. Refer to DoD Solicitation Guidelines- Contracting EHCB Response: In accordance with DHA/Winn Army Community Hospital requires this in contracts where vendors will be connected to the network. This will be reconciled with the awardee and WINN.

10. Page 41, section 1.17. The proposed system shall be Internet Protocol version 6 (IPv6) capable or the vendor shall provide a detailed project, migration or planning documentation to show when the proposed system shall be IPv6 capable.

Minimum IPv6 capabilities include:

• Conformant with the IPv6 standards profile contained in the DoD IT Standards Registry (DISR);

• Maintaining interoperability in heterogeneous environments with IPv4;

• Commitment to upgrade as the IPv6 standard evolves;

• Availability of vendor IPv6 technical support.

This is a standard in DoD Solicitations; however, DHA has shared with industry that there has not been alignment on the time to implement IPv6; generally stating IPv4 is the current compliant standard until DHA implements this requirement themselves with some level of guidance. Can you please advise which standard the Army will accept or allow minimum to IPv4 until IPv6 guidance can be consistent with CyberLog who manages the RMF process?

WINN RESPONSE: N/A to Laboratory; Refer to DHA Cyber Guidance

11. Page 41, section 1.18. The contractor shall be able to demonstrate or provide documentation to prove that their product is IPv6 capable.

This is a standard in DoD Solicitations; however, DHA has shared with industry that there has not been alignment on the time to implement IPv6; generally stating IPv4 is the current compliant standard until DHA implements this requirement themselves with some level of guidance. Can you please advise which standard the Army will accept or allow minimum to IPv4 until IPv6 guidance can be consistent with CyberLog who manages the RMF process.

WINN RESPONSE: N/A to Laboratory; Refer to DHA