W81K00-20-R-0002 Questions and Answers.pdf

Chemistry Immunoassay & Testing Reagent Kits & Equipment

W81K00-20-R-0002

RESPONSES TO QUESTIONS FROM VENDORS

1. Can we bid on just a stand-alone platform for just A1c's? I noticed the solicitation mentioned at minimum of 2 Analyzers.

RESPONSE: No, must be all inclusive and attach to fully automated line for all immunoassay/biomarkers.

2. Also looks like base year volumes listed are for one month and the option years are annual volumes. Can you confirm the annual volume for the entire term?

RESPONSE: The period of performance for the base period is one (1) month. Option periods are 11 or

12 months. “Annual volume” does not apply to the base period since it is only for one month.

3. Must provide QC material, are they using BioRad today?

RESPONSE: See response to 19. Yes current contractor providers Biorad but, controls are needed and not identified as specific to a given vendor name. Must be provided through the contract.

4. Ref. 5.1.2 - For SFMC (CC/IA) and SFCC (CC) must provide a single desktop analyzer to meet space restrictions. What are they using today?

RESPONSE: These are not desktop units, however both sites need integrated CC/IA analyzers. Error on the Purchase Description needs to be updated.

5. Ref 5.8.1 - No patient identifying information (PII) will be stored on the analyzer at any time, what information do they currently use on each tube of blood? Are they only utilizing a barcoded number?

RESPONSE: “store” refers to onboard the electronic analyzer software. Blood tubes in refrigerated storage do not count as lab PII as these are in a keycard area. The analyzer itself will not store any PII on the middleware, interface, analyzer, etc. All blood tube are labeled in compliance with TJC, National

Patient Safety Goals, and CAP requirements. Barcodes are used however, the systems should be able to interface with the LIS system so that tracking of the patient sample is done via accession area and accession number not patient specific HIPAA identifiers.

6. Ref Page 92 - The shop drawing of the space for the new hospital, is it possible to get a CAD or a

PDF of a CAD showing more details of the space set aside for the laboratory? Are there definite walls included in that shop drawing, or are those just space limitations without walls?

Is it possible to get some additional space for a better fit?

RESPONSE: A copy of the CAD drawings is provided with the solicitation. No other drawings are available. The areas of concern, such as an outline of the space and location of utilities are reflected on the drawings provided with the solicitation. There are no walls and only one utility pole, which is identified on the drawings as a square. The contractor should expect to work within the confines of the outlined space as other space in the lab is utilized for other instruments, desks, and equipment.

7. Ref Page 92 - Can you give us the measurement between the 2 drains shown in the shop drawing, as well as the horizontal and vertical distance from the drains to the columns?

RESPONSE: All available information is provided in the drawings included with the solicitation.

Specific measurements are not available and cannot be provided.

8. Ref Page 92 - Can you please provide the exterior dimensions of the columns and the distance between the columns? Will there be anything mounted to the columns that would require some clearance space?

RESPONSE: All available information is provided in the drawings included with the solicitation. Specific measurements are not available and cannot be provided.

9. Ref Page 92 - Where is the pneumatic tube located on this drawing?

RESPONSE: Information regarding the location of the pneumatic tube is not available and is not relevant to this requirement.

10. Ref Page 92 - Are the utility poles fixed, or can they be modified to fit the requirements of specific vendors?

RESPONSE: Utility poles are fixed.

11. Ref 1.3.1 - Operating hours listed for all 3 sites, but then you also request 24/7 service support.

Can we bid on classic service for the clinics which covers M-F operating hours, and Premium service for the core lab at the new hospital, which is 24/7?

RESPONSE: No, 24.7 support needs to be available for all sites. As if there is a situation with the clinics or clinic hours of operation change due to transition of the hospital space instrumentation can be supported at all sites.

12. Ref Section 1.1 Scope of Work, It requests integrated CC/IA analyzers for both clinics, yet in section 5.1.2 it requests CC/IA for Soldier Clinic and Chemistry CC only for Mendoza clinic.

Workload shows both IA and CC at both clinics? Are you requesting unintegrated desktop analyzers at both clinics or integrated analyzers at both clinics?

RESPONSE: This is an error both locations need integrated CC/IA. Purchase Description must be adjusted to reflect this.

13. Based on the information provided in the pricing spreadsheet (patient volumes), as well as within the Solicitation (the desire for no charge trouble shooting reagent use or install reagents), it appears that this solicitation is looking for a CPRR solution. Can you please confirm that a CPRR agreement is what is being requested? For avoidance of doubt, the generally accepted Cost-Per-

Test (CPT) definition is reagents needed to perform the total of all tests specified for the fiscal year.

Pricing will be established based on the total estimated annual volume of slides/tests/wells/cards to be shipped.

RESPONSE: No, the Government is looking for a CPT, where test is defined as whole box. The vendor should price the items by box of reagents not individual tests. Other Chemistry contracts have a CPR but, due to management of reagents and the increase in pricing our facility wants to have a CPT agreement. It has been determined this will work best for supply management for WBAMC. The costs for maintenance and everything else should be wrapped into the box costs. Vendors will be required to provide a spreadsheet with the part number, name of product, number of tests in the box, number of boxes (based on the workload numbers provided), and firm fixed cost per box prior to award of the contract, as annotated in Appendix 1 of the Purchase Description.

14. Is the expectation that the contractor will provide training using a contractor owned instrumentation in a mobile environment for initial training and the annual training there after?

RESPONSE: The vendor will provide training on the installed equipment. A mobile unit is not required for initial or annual training.

15. Can an integrated system be proposed for William Beaumont?

RESPONSE: It is unclear what is meant by an “integrated system”; thus the Government is unable to address this question.

16. Respectfully requesting the requirement for a desktop analyzer be removed as it is unduly restrictive.

RESPONSE: These are not desktop units, however both sites need integrated CC/IA analyzers. Error on the PD needs to be updated.

17. Respectfully requesting the requirement for 100% uptime be removed or updated to 98% as it is unduly restrictive without redundant instrumentation at each site.

RESPONSE: The requirement for uptime is revised to be 98%.

18. In order for [Contractor] to provide a workflow analysis as required in the solicitation, we would need ample time to come on-site to provide such. Can you provide the contact information for whom we should work with prior to the submission date to be able to conduct that analysis, or, in the alternative given the current pandemic, could we request an extension of time for this RFP so as to allow for on-site analysis once the restrictions ease up across the country.

RESPONSE: Due to the timeline for the hospital an extension cannot be made as installation, validation, verification require installation in June 2020 (90 days prior to start of contract). However, workflow analysis can be completed during this time as long as the vendor can agree to have that finished prior to

1SEP20 start date of the contract for first day of patient testing.

19. Would the facilities like the awardee to supply the Bio-Rad controls or provide a credit for the controls?

RESPONSE: The vendor is required to provide the controls. Biorad will suffice if the vendor uses a third party control and does not have their own available. However, these will be orders for controls placed directly with the contractor and not the third party and should be at no additional cost to WBAMC unless outlined in the quote.

20. Are physical copies of the MSDS required?

RESPONSE: Physical copies of the MSDS should be available, however, vendors may provide MSDS in electronic format (.pdf).

21. Will vendors be given the opportunity to do an onsite workflow and lean study (Valumetrix evaluation) to determine if turnaround times can be met?

RESPONSE: Onsite workflow/study can be completed during the end of the validation/verification timeframe with coordination of the COR and Technical Experts. However, the cost for any workflow/lean study must be included in the quoted price, otherwise it will be performed at no cost to the Government.

The vendor will not be allowed to request a post-award price adjustment for the study.

22. We respectfully request the requirement to currently have ATO be removed and request that requirement be modified to state: Vendor will submit all documentation in a timely manner with

Commands Sponsorship to obtain ATO.

RESPONSE: WBAMC is a DHA facility which requires the ATO. Due to the installation timeframe and the RMF timeframe, ATO only equipment must be provided to WBAMC to meet the need for direct installation onto the network. This is a need that cannot be removed and is required for the Chemistry section at WBAMC.