RFQ 36C25526Q0653 Rapid ID – AST System

Note: Please clarify what is meant by “no offline sample processing” in section 2.4.2.1.:

The laboratory needs testing to be a simple “sample to answer” process. For example, add 1mL of blood to container or test cartridge and put on the instrument for analysis. Vendors need to make sure that the “hands on” steps of the testing process are clearly defined, so that even if all sample processing is automated, but the technologist has to move or transfer the sample from one piece of equipment to another that step is identified.

1. Equipment and Consumable Pricing The Price/Cost Schedule provides separate line items for the instrument and consumable kits, while Section 2.2.1 defines Cost per Patient Reportable Result (CPRR) as including five-year equipment use. Our pricing model used in other VA responses separately identifies a one-time purchase of the instrument, with consumable AST kits purchased separately as utilized. May we use this same structure for the St. Louis response by pricing the equipment as a one-time purchase under the Instrument CLIN and separately pricing the consumable kits under the applicable kit CLINs rather than incorporating the equipment cost into a CPRR price?

The laboratory didn’t intend to “own” the equipment, so that it was easier to update and change as needed as vendor updates become available. In addition, the CPRR allows the instrument cost including service to be included in the reagent cost. However, if the vendor cannot or prefers to not offer a CPRR model – they need to submit the bid for what they are able to do, but have costs clearly defined so that we have reagents and instrument and service for the life of the contract covered.

2. Instrument CLINs in Years 2–5 If the VA purchases the instrument during Ordering Period 1, should the Instrument CLINs in Ordering Periods 2–5 be entered as $0/N/A since an additional instrument would not be required? Alternatively, are these CLINs intended to represent continued equipment use under a CPRR/reagent-rental structure?

A CPRR allows the instrument cost including service to be included in the reagent cost.

However, if the vendor cannot or prefers to not offer a CPRR model – they need to submit the bid for what they are able to do, but have costs clearly defined so that we have reagents and instrument and service for the life of the contract covered.

3. Annual Service Following the Initial Warranty The Instrument CLIN indicates that the equipment includes a 12-month warranty, while the Instrument Service CLIN describes extended service following expiration of the initial 12-month warranty. May the offerors enter $0/N/A for Instrument Service during Ordering Period 1 and begin charging the annual service fee in Ordering Period 2?

A CPRR ensures all costs are covered. If the vendor cannot or prefers to not offer a CPRR model – they need to submit the bid for what they are able to do, but have costs clearly defined for each option year so that we have reagents, instrument and service costs for the life of the contract covered.

4. Training Fees Section 2.2.1 indicates that training is included within CPRR; however, the Price/Cost Schedule does not provide a separate training CLIN.

The offeror provides on-site training at the St. Louis VA at $2,500 per training week.

Offeror's standard Train-the-Trainer approach would train up to six designated individuals through two separate training sessions, with up to three individuals participating in each session. The two sessions are necessary to provide appropriate hands-on training while allowing the laboratory to maintain bench coverage and accommodate different work schedules/shifts.

The $2,500 weekly fee includes instructor airfare, hotel, rental car, and training across the required sessions/shifts scheduled during that week.

May training be separately identified and priced in our quotation, or should these costs be incorporated into one of the existing CLINs? If they should be incorporated, please advise which CLIN the VA would prefer us to use.

Training costs would be in the base year. If the vendor would prefer to create a separate CLIN that is fine with the laboratory, it also seems reasonable to just clearly define what is included in the total cost of each CLIN.

5. Training Approach Offerors can provide either a two-week Train-the-Trainer program for up to six designated individuals or direct All-Staff training, which may require up to four weeks depending upon the number of personnel and shifts requiring training. Does the St. Louis VA have a preferred approach, and can you provide an estimated number of staff members who will require direct training?

There would be 9 technologists on the day shift that should be trained as well as 2 evening shift technologists, for a total of 11 microbiology technologists needing training. The microbiology technologists can manage training the irregular tour core lab staff that cover evenings on the weekend and nights 24/7.

6. Routine Quality Control Testing Based on Offerors’ anticipated QC requirements, we estimate that approximately 208 individual tests annually will be required for routine quality control, in addition to tests utilized for patient testing. QC testing utilizes the same tests as patient testing and would therefore be priced at the same per-test rate.

Because these QC requirements increase total annual test utilization above the estimated patient-testing volume shown in the Price/Cost Schedule, please clarify how the VA would like this additional QC volume reflected in our quotation. Should the consumable quantity be increased to account for both patient testing and approximately 208 additional QC tests annually, or should the QC utilization be separately identified in our pricing response?

Update the total and make sure it’s clear that the volume of tests needed in the bid response is due to QC.

7. Start-Up QC, Validation Materials, and Validation Timeline Offeror performs the initial system start-up and qualification activities using Offeror-provided QC materials and can complete these start-up activities within two weeks of installation. Offeror will also provide technical support to the St. Louis VA throughout its validation process.

The scope and acceptance criteria for clinical laboratory validation are ultimately established by the VA laboratory and its Medical Director. Because the specific validation protocol, sample requirements, number of samples, and acceptance criteria have not yet been established, Offerors cannot determine in advance the quantity of tests that will be required for the VA's complete validation. Depending upon the validation criteria established by the VA, the validation process may extend for up to approximately three months.

Please clarify whether the requirement in Section 2.9.2 that the Contractor provide “all materials and reagents needed for such correlation at no cost to the Government” is intended to apply to the initial two-week instrument start-up, correlation, and qualification activities, or whether the VA expects the Contractor to provide, at no charge, all tests required for the VA's complete clinical validation regardless of the validation protocol, number of samples, or duration established by the VA.

If the latter is intended, please provide the anticipated validation protocol and estimated number of tests the VA expects the Contractor to supply so that Offeror can accurately account for this requirement in our quotation. Section 2.9.2 currently requires all correlation materials at no cost and states that the process is to be completed within two weeks, making clarification particularly important.

A validation plan has not yet been written because it depends on the vendor selected and the number of antibiotics available on their AST instrument. The general outline is that the laboratory will need to test:

• Recommended QC organisms three times per day for five days (15 tests/QC organism) vendor to multiply 15 by the number of QC organisms their instrument uses/recommends

• At least 15 isolates per antibiotic, with at least 30 total unique isolates for the system. add 30 tests onto the total kits

• Validation will be completed as quickly as physically possible for the instrument to process all the QC and test isolates, and hopefully MUCH sooner than three months.

• Supplies required for the vendor to supply would be those vendor/instrument specific reagents/kits. The vendor is NOT expected to supply QC or test patient isolates, unless they are unique to the process (i.e. special QC insert).

8. Frozen Insert CLIN The Price/Cost Schedule contains a separate Frozen Insert CLIN. The Gram- Negative AST kit does not require the purchase of a separate frozen reagent insert. May Offeror enter $0/N/A for this CLIN and provide an explanation that the applicable components are incorporated into the kit configuration?

Absolutely. Adjust as needed for an offer to make sense.

9. Estimated Consumable Volume The Price/Cost Schedule lists 15 consumable kits containing 20 units each, representing 300 individual tests per ordering period. Please confirm that the 300-test estimate represents anticipated annual patient-testing volume and does not include routine QC utilization.

Based on Offeror 's anticipated QC requirements, approximately 208 additional individual tests annually would be utilized for routine QC. Therefore, if the VA's 300-test estimate is for patient testing only, anticipated total annual utilization would be approximately 508 individual tests, or approximately 26 of the 20-test kits when ordered in full-kit quantities.

The 300 tests per year has included QC, since we’ve typically only performed weekly QC – which required 52 tests.

10. CPRR Requirement if Capital Purchase is Accepted If the VA permits Offeror to structure the proposal as a one-time capital equipment purchase, separately purchased AST consumables, and annual service beginning after expiration of the initial warranty, does the VA still require a separate calculated CPRR price, or will completion of the individual CLIN pricing schedule satisfy the pricing requirement?

A CPRR ensures all costs are covered. If the vendor cannot or prefers to not offer a CPRR model – they need to submit the bid for what they are able to do, but have costs clearly defined for each option year so that we have reagents, instrument and service costs for the life of the contract covered.

11. Rapid AST Without Integrated Identification As previously discussed, provides rapid phenotypic antimicrobial susceptibility testing directly from positive blood cultures but does not provide organism identification.

Section 2.4.2.9 identifies organism identification as a value-added feature. Please confirm that an FDA-cleared rapid AST system that otherwise meets the mandatory technical requirements may be considered technically acceptable without integrated organism identification.

Correct. The SOW was developed based on the instrument the laboratory was replacing (Accelerate Pheno), which also performed an organism ID. The laboratory is aware that none of the current vendors that are capable of providing a rapid AST solution have instrumentation that provide an organism identification. However, if the vendor has a way to help streamline organism identification, that asset/process should be listed in the response to the value added section.

12. Continuously Stocked Inventory / Ancillary Materials Section 2.1.5 requires the Contractor to provide a continuously stocked inventory of reagents, standards, controls, supplies, disposables, and other materials required to properly perform testing without interruption.

Offeror will maintain availability of the -specific reagents and consumables required for routine operation. During installation, training, and start-up, Offeror can also provide certain additional laboratory materials. However, general laboratory supplies and equipment such as control strains, pipette tips, transfer devices/syringes, calibrated pipettors and associated tips, vortex mixer, densitometer/nephelometer, and 0.9% saline are not products routinely sold or replenished by Offeror following implementation.

Please clarify whether the continuously stocked inventory requirement is intended to apply to Contractor-specific reagents, consumables, and supplies required for ongoing operation of the proposed system, or whether the VA expects the Contractor to continuously furnish these general laboratory supplies and equipment throughout the term of the BPA.

Contractor specific reagents.

13. Manual Modification of Susceptibility Breakpoints Section 2.4.2.7 states that the system should allow manual modification of susceptibility breakpoints to comply with new CLSI guidelines until the Contractor implements necessary software upgrades.

does not currently permit an end user to manually modify susceptibility breakpoints. Applicable FDA breakpoint changes are implemented by Offeror through its FDA-authorized breakpoint PCCP. Breakpoint changes subject to the PCCP must first undergo FDA review before the updated breakpoint can be implemented in the IVD software, a process Offeror anticipates will require approximately 90 days.

Please confirm whether end-user manual modification of susceptibility breakpoints is a mandatory requirement, or whether Offeror 's FDA-controlled breakpoint update process is acceptable.

The laboratory needs to ensure compliance with accreditation requirements:

MIC.11385 Current Antimicrobial Susceptibility Test Breakpoints Phase I The laboratory uses current breakpoints for interpretation of antimicrobial minimal inhibitory concentration (MIC) and disk diffusion test results. New breakpoints are implemented within three years of the date of publication by the FDA for laboratories subject to US regulations, or within three years of publication by CLSI, EUCAST or other standards development organizations (SDOs) for laboratories not subject to US regulations.

14. Built-In Quality Control Program Section 2.4.2.8 states that the system shall have a built-in quality control program to regularly monitor system performance.

Please clarify what functionality the VA intends by “built-in quality control program.” Is this intended to require software that schedules, tracks, and documents routine laboratory QC testing, automated internal instrument performance monitoring, or both?

If the instrument can track and monitor the performance of QC, that is fantastic – but what was intended by this requirement was that the instrument knows if it has produced a valid result (i.e. How confident is the system that the result it correct). Our previous instrument wouldn’t report a result if it determined there were too few cells for analysis.

15. Uninterruptible Power Supply Section 2.5.2 requires an uninterruptible power supply for each instrument “as necessary,” including replacement batteries.

A UPS is not part of Offeror's standard commercial configuration. Please clarify whether a Contractor-provided UPS is mandatory for , or whether the language “as necessary” permits the VA and Contractor to determine during site planning whether one is required based upon the instrument configuration and facility power infrastructure.

The VA typically has UPS for all instrumentation for preservation of instrumentation if there is power failure at the medical center. The laboratory attempts to put all equipment on emergency power, but there can still be a lag time between regular power going down and the generators turning on. If that few minute lag time doesn’t affect the performance of testing on the instrument, just state that it’s not needed.

16. Printer and Patient Demographic Reporting Section 2.5.4 requires a printer capable of printing a patient report containing, at minimum, the patient's name and accession or unique identifier.

A printer is not part of Offeror 's standard commercial configuration, and the current result report does not include patient demographic information in the manner described in Section 2.5.4. Please confirm whether this functionality is mandatory or whether an alternative workflow utilizing the laboratory's existing information/reporting system would be acceptable.

The laboratory is required to have tests uniquely identified. The vendor just needs to respond as to how reports are uniquely identified. For example, we have positive blood culture on Patient John Doe, and their Lab number is 12345. Can we scan our test barcode label for easy entry of 12345 into the instrument for specimen tracking?

17. Validation Data Analysis and FDA/CLSI Breakpoints Sections 2.6 and 2.9.2 require the Contractor to assist with validation/correlation studies and perform statistical analysis of the resulting data.

Offeror can assist with analysis of validation data within the appropriate FDA-cleared use of However, there may be organism/antimicrobial combinations for which current CLSI breakpoints and FDA-cleared breakpoints are not aligned.

is an FDA-cleared IVD system. Any FDA breakpoint change implemented as part of Offeror 's FDA-authorized Predetermined Change Control Plan (PCCP) must first be submitted to and reviewed by the FDA before Offeror can implement the updated breakpoint in the IVD software. Offeror anticipates this process to require approximately 90 days.

Does the St. Louis VA intend to utilize FDA-cleared breakpoints, current CLSI breakpoints, or a combination of both during validation and subsequent clinical reporting?

The laboratory typically follows the breakpoints that are FDA cleared on an automated instrument, which in many cases FDA breakpoints are now in alignment with CLSI breakpoints. However, we must maintain compliance with accreditation standards and ensure our breakpoints are accurate/current.

Where a newer CLSI breakpoint has not yet been incorporated into the FDA-cleared software, would it be acceptable for to continue reporting using the applicable FDA-cleared breakpoint until Offeror completes the PCCP process and implements the updated breakpoint in the IVD software?

The laboratory needs to ensure compliance with accreditation requirements:

MIC.11385 Current Antimicrobial Susceptibility Test Breakpoints Phase I The laboratory uses current breakpoints for interpretation of antimicrobial minimal inhibitory concentration (MIC) and disk diffusion test results. New breakpoints are implemented within three years of the date of publication by the FDA for laboratories subject to US regulations, or within three years of publication by CLSI, EUCAST or other standards development organizations (SDOs) for laboratories not subject to US regulations.

Additionally, where the VA elects to evaluate an application outside 's FDA-cleared labeling, would it be acceptable for Offeror to provide technical assistance and available system data while the VA laboratory retains responsibility for the analysis, validation, and clinical acceptance of that application?

Absolutely.

18. Technical Support and 24-Hour Equipment Response Section 2.9.4.1 requires telephone technical assistance 24 hours per day, seven days per week, with a maximum of two-hour callback. Section 2.9.4.3 separately states that equipment response time shall be no more than 24 hours.

Offeror can provide technical troubleshooting and initiate a service response within the required 24-hour period. If the issue cannot be resolved through technical support and an on-site repair is required, Offeror will have a qualified service engineer on-site within 48 hours of determining that an on-site repair is necessary.

Please confirm that this service model satisfies the VA's requirement or clarify whether Section 2.9.4.3 requires a service engineer to be physically on-site within 24 hours.

The 24-hour requirement is strictly referring to acknowledgement and initial receipt of the issue. If remote (i.e. troubleshooting via the phone) doesn’t correct the problem, it is completely understandable that if an issue requires a service technician to come onsite that it may be over 24 hours.

9. LIS Interface Requirements and Interface Costs Sections 2.9.6.1 through 2.9.6.3 address connection to the VA's universal interface and computerized hospital information system and assign certain interface hardware, software, licensing, and implementation responsibilities to the Contractor.

Can the VA provide the existing LIS/interface architecture or middleware currently utilized by the St. Louis laboratory, including whether a universal interface is already in place? This will allow Offeror to identify the hardware, software, licenses, ports/cards, cables, and interface services required for implementation.

In addition, because the Price/Cost Schedule does not contain a separate interface CLIN, may Offeror separately identify and price the one-time LIS/interface implementation cost in its quotation, or does the VA expect all interface-related costs to be incorporated into the Instrument CLIN or another existing CLIN? If these costs should be incorporated into an existing CLIN, please identify the appropriate CLIN.

The VA currently uses Data Innovations for the middleware, and VISTA or our LIS. However, we will be working over the next year to change from VISTA to Cerner for our LIS.

If there is a fee for the vendor to get the interface established that should be included in the CLIN for the instrument and the pricing can be adjusted between the base and option years depending on the needs of the vendor.

20. Annual Service Coverage and Non-Warranty Service Calls The pricing Offeror will provide under the annual Instrument Service CLIN is intended to cover the required annual preventive-maintenance service and warranty-covered service obligations applicable under the solicitation.

For an additional on-site service call required for an issue not covered under the applicable warranty or annual service coverage, Offeror 's standard charge would be $1,500 per on-site service event, plus the cost of any replacement parts required to complete the repair.

Because the Price/Cost Schedule does not contain a separate CLIN for non-warranty service events or replacement parts, please confirm whether Offeror may identify these charges separately in its quotation as $1,500 per non-warranty on-site service event plus replacement parts as required, or whether the VA expects these potential costs to be incorporated into the annual Instrument Service CLIN.

All service costs, including potential repair and/or parts costs have been traditionally included in our CPRR. The vendor can respond to the solicitation however it meets their needs, but it must be clear what is or is not covered if parts and repair are not covered under a service contract.

21. SF 1449 Blocks 23 and 24 – Reference to Attached Pricing Schedule The SF 1449 instructs the Offeror to complete Blocks 23 and 24. Because Offeror 's proposed pricing includes the instrument, consumables, annual service, training, interface costs, and other applicable pricing components that cannot be fully represented within the space available on the SF 1449, please clarify whether Offeror may enter “See Attached Pricing Schedule” in Blocks 23 and 24 and provide the detailed quantities, unit pricing, and extended pricing in an attachment to the quotation.

If this is acceptable, please confirm that the attached pricing schedule will be considered the Offeror's completion of the pricing information required by Blocks 23 and 24.

Respond to the solicitation as needed by the vendor. Make sure the pricing is clear for each of the listed CLINs.