Attachment F - Question and Answer.pdf

This proposal includes data that shall not be disclosed outside the Government and shall not be duplicated, used, or disclosed--in whole or in part--for any purpose other than to evaluate this proposal. If, however, a contract is awarded to this offeror as a result of--or in connection with--the submission of this data, the Government shall have the right to duplicate, use, or disclose the data to the extent provided in the resulting contract. This restriction does not limit the Government’s right to use information contained in this data if it is obtained from another source without restriction. This proposal contains trade secret and confidential business, or financial information exempt from disclosure under the Freedom of Information Act.

Attachment F – Question and Answer W81K0023R0011 Chemistry and Immunoassay Testing

Question #1: Please allow a two-week extension to the response as we respectfully request our questions clarified and allows ample time to respond and prepare a thorough and thoughtful response to your request for solicitation to adequately account for your responses.

Government Response #1:

The proposal due date and time is extended as identified in the Solicitation 1449 Block 8.

Question #2: Referencing Page 1/29 Statement of Work: 1.1 The contractor shall provide

Chemistry/Immunoassay testing under CPRR agreement to include equipment, reagents, tools, materials, training, and water purification system.

a. Question/Point of Clarification: We understand that the CORE location includes ‘house” water supply and does not require a separate water system. Please clarify if EACH of the 4 locations does require the vendor to supply a water purification system and specify each location.

b. If the water source is house supplied, who is your water supplier?

Government Response #2:

a. Vendor supplied water required for the ED Lab and Moreno Clinic. House water supplied in the

Main Lab and Reference Lab.

b. House water is supplied via J&J Worldwide Services facilities contract. If supplied water is not of required resistivity for vendor analytics, water purification to be provided by vendor.

Question#3: We understand that you are just 5 years into your current agreement which included a new automation line. Are you requiring all vendors, including the incumbent to provide a NEW automation line?

Government Response #3:

Vendor awarded will be required to meet contract requirements.

Question #4: Are you willing to share the LIS file so that we can determine your actual capacity needs, based on this data?

Government Response #4:

The workload provided is from instrument cumulative reports to more accurately capture all testing performed. This is not a MHS Genesis report which is not equipped to capture workload originating from outside the hospital.

Question #5: Question/Point of Clarification: Referencing Page1/29 Statement of Work 1.2

The system shall provide triple redundancy (to ensure continuous operations).

a. Please clarify what Triple redundancy means to you? Does this mean assay or instruments or both?

b. Please share why you feel triple redundancy is necessary? Is triple redundancy due to the maintenance requirements, menu mix, number of assays being run, etc?

c. Please describe in detail what is driving the need for triple redundancy?

This proposal includes data that shall not be disclosed outside the Government and shall not be duplicated, used, or disclosed--in whole or in part--for any purpose other than to evaluate this proposal. If, however, a contract is awarded to this offeror as a result of--or in connection with--the submission of this data, the Government shall have the right to duplicate, use, or disclose the data to the extent provided in the resulting contract. This restriction does not limit the Government’s right to use information contained in this data if it is obtained from another source without restriction. This proposal contains trade secret and confidential business, or financial information exempt from disclosure under the

d. Please share how long it takes your laboratory to perform daily, weekly, monthly maintenance?

e. What are your desired improvements for maintenance?

Government Response #5:

a. Both, instruments and Stat assays.

b. Primary driver is risk mitigation for the hospital to ensure uptime on critical testing capabilities.

c. Given the BAMC’s critical role as a level-1 trauma center, strategic mission in the Military

Health System, and role to the community of South Texas, the leadership has identified having only duplicate capability in the main lab as an unacceptable risk. Duplicate systems routinely require running on a single platform due to scheduled downtimes for maintenance or unscheduled downtime due for unforeseen issues. The risk of the single operational system also failing in these periods has been deemed unacceptable.

d. Maintenance timing varies by complexity of location of testing, and specific analyzers.

e. Maximizing instrument uptime as specified in the Statement of Work.

Question #6: Referencing Page 3/29 SOW 2.1.2: Question/Point of Clarification:

a. Please clarify your request for automated pre-analytical system to handle screw caps?

b. Do you currently have the ability to unscrew caps?

c. Is this a requirement or a nice to have feature?

Government Response #6:

a. BAMC DPALS receives secondary tube specimens that utilize the Greiner white screw caps part number 459000 from multiple sites across DoD.

b. Yes, we currently have this ability.

c. This is a requirement specified in the Statement of Work.

Question #7: Referencing Page 4/29 SOW 3.5: The contractor shall sequester the required calibrator, quality control material and reagents to ensure no more than (2) lot changes per calendar year.

a. Question/Point of Clarification: Please provide insight to your requirement for no more than 2 lot changes per calendar year? Requiring lot sequestering is source limiting to certain vendors. We request this be removed from the solicitation.

Government Response #7:

a. This is a requirement to reduce amount of non-value added labor necessary to manage the extensive menu in this award.

Question #8: Referencing Page 4/29 SOW 3.6.3: The contractor shall provide Inventory

Program or System for continuous monitoring and management of all reagents, consumable and necessary supplies, and their utilization.

This proposal includes data that shall not be disclosed outside the Government and shall not be duplicated, used, or disclosed--in whole or in part--for any purpose other than to evaluate this proposal. If, however, a contract is awarded to this offeror as a result of--or in connection with--the submission of this data, the Government shall have the right to duplicate, use, or disclose the data to the extent provided in the resulting contract. This restriction does not limit the Government’s right to use information contained in this data if it is obtained from another source without restriction. This proposal contains trade secret and confidential business, or financial information exempt from disclosure under the

a. Question/Point of Clarification: Please clarify if analyzer onboard inventory capability is what you are looking for or if you are requesting a separate off-analyzer solution that would scan

RFID/barcode to monitor status of reagents, consumable, supplies etc?

Government Response #8:

a. Onboard inventory capability is acceptable.

Question #9: Referencing Page 4/29 SOW 3.1: All assays shall be FDA approved. You list a requirement and an evaluation factor that ALL assays must be available, and FDA approved.

This requirement is source limiting as only your incumbent vendor offers all assay listed. We request that this requirement be modified to allow for the alternative options to be available for consideration for some of the non-stat or certain low-volume esoteric testing.

a. Question/Point of Clarification: There are a handful of assays ex. ACTH, Anti Mullerian, Fructosamine, that are source limiting. How will you evaluate the vendors on this criteria? On page 75/ 77 on Solicitation document W81K00-23-R-0011 you state that “failure to provide all of the test required in the solicitation” will result in an unacceptable rating for the vendor for

FACTOR 1 -Technical Capability. This is a source limiting criteria favoring only one vendor.

We request that this requirement be modified to allow for the recommendation alternative options for certain low-volume esoteric testing, as this testing is not stat testing and does not require immediate results.

b. Question/Point of Clarification: We realize the importance of these tests to your patients; however, can the offeror propose alternative options for these tests?

Government Response #9:

Menu outlined is required on-site testing for our medical community. Alternatives such as open channel third party tests will be evaluated based on complexity to implement and peer-reviewed performance where available, and vendor support offered.

Question #10: Referencing Page 4/29 SOW 3.3 – the assays listed in Table 2 SHALL be approved by the FDA for plasma as well as serum samples.

a. Question/Point of Clarification: This provides a source limiting situation as only your incumbent vendor can provide all assays listed in Attachment D for serum samples.

b. Request: Please provide your send out list if possible.

Government Response #10:

a. To clarify, intent is all analytes be approved for plasma and serum OR plasma only. Serum only assays pose workflow challenges.

b. This is not applicable.

Question #11: Referencing Page 4/29 SOW 3.4: Contractor shall provide minimum specimen volume requirements. You list over 90 different assays that you perform.

a. Question/Point of Clarification: The list is available to share but is a large list to provide. To do so and still stay within the 30-page limit for this Technical Volume II would be restrictive. We request that this information be allowed to share via an Appendix or that this requirement be removed.

Government Response #11:

Solicitation Addendum to 52.212-1 has been updated via Amendment 0001. Appendix for Assay

This proposal includes data that shall not be disclosed outside the Government and shall not be duplicated, used, or disclosed--in whole or in part--for any purpose other than to evaluate this proposal. If, however, a contract is awarded to this offeror as a result of--or in connection with--the submission of this data, the Government shall have the right to duplicate, use, or disclose the data to the extent provided in the resulting contract. This restriction does not limit the Government’s right to use information contained in this data if it is obtained from another source without restriction. This proposal contains trade secret and confidential business, or financial information exempt from disclosure under the

Listing only will not be included in the page count limit.

Question #12: Referencing Instructions to Offerors, pages 72-73 of 77 Instructions, Conditions, and

Notices to Offerors in the W81K00-23-R-0011 document:

a. We request that the 30-page limitation for the Volume II – Technical be removed or modified to allow for inclusion of more pages / appendices, etc. given the number of questions asked, coupled with the site visit, adequate information is required. To provide the question and our response together for evaluation purposes, 30 pages is not sufficient to support our request:

b. The II Technical 30-page limitation does not allow for full and open competition as it benefits the incumbent vendor and hinders new vendors by restricting the amount of information they may provide.

c. Guidance during the walk through was to answer all of the questions in the solicitation; in order to answer the questions thoroughly, we request the need to open the page restriction to 60-70 pages of the

Technical compliance.

Government Response #12:

Solicitation Addendum to 52.212-1 has been updated via Amendment 0001 with an updated page limit.

Question #13: Question/Point of Clarification: Please confirm the option for the following to determine flexibility or limitations for full and open competition, can we recommend the option to move the Sysmex XN to a different location, keeping in the same area, but alter the position of the Sysmex XN?

Government Response #13:

Yes, position of Sysmex can be changed for optimal use of space.

Question #14: Question/Point of Clarification: Statement of Work 3.2 page 4/29 Assay must have a minimum calibration stability of greater than 10 days for Chemistry and Immuno-chemistries. Calibration stability to be evaluated per assay.

a. This is source limiting, please remove from the solicitation.

Government Response #14:

The minimum calibration specified in the Statement of Work will not be revised. This is not source limiting but necessary to support the BAMC mission.

Question #15: Can you expand on the need for an aliquoter? Is it for send- outs? Is it due to instrument limitations? If the latter, can you make the aliquoter optional if a vendor’s instruments don’t need it.

Government Response #15:

The aliquoter is not a requirement of the Statement of Work. Updated Attachment A - Statement of

Work provided via Amendment 0001.

Question #16: How many tubes do you process per day and how many days do you need to store them for? Can you change the requirements stating the number of tubes per day times the number of days you need to store them so every vendor can right size the stockyard instead of the general 20,000 tubes.

Government Response #16:

Laboratory processes ~3,000 tubes daily and tubes are stored for six days.

Question #17: For the reference lab analyzers: If that volume can be consolidated to the core lab

This proposal includes data that shall not be disclosed outside the Government and shall not be duplicated, used, or disclosed--in whole or in part--for any purpose other than to evaluate this proposal. If, however, a contract is awarded to this offeror as a result of--or in connection with--the submission of this data, the Government shall have the right to duplicate, use, or disclose the data to the extent provided in the resulting contract. This restriction does not limit the Government’s right to use information contained in this data if it is obtained from another source without restriction. This proposal contains trade secret and confidential business, or financial information exempt from disclosure under the equipment, is a separate analyzer still needed? This would improve workflow, reduce tech time and reduce overall costs.

Government Response #17:

Consolidating reference workload within the core lab will be considered. A separate analyzer is not required for the reference workload.

Question #18: Annual volume of G6PD?

Government Response #18:

Annual volume ~150,000/year.

Question #19: For Inventory Manager: Do the hospital labs all pull from the same supplies? Should we consolidate that inventory or does everyone have their own separate supplies? We understand the clinic is separate and would do theirs separately.

Government Response #19:

Hospital labs independently manage their inventories and are not currently consolidated.

Consolidation would be considered for co-located spaces Reference/Core.

Question #20: Will LIS date be provided? We understand that information is inaccurate, but we’d still like to evaluate it. However if we can just get a rough estimate on percentage of test volume arrival time, we can model that out. Ex. Tubes start coming in a 0600, with a bolus at 0800 that bolus is 15% of their daily volume etc. This would help in designing the best solution for your specific needs.

Government Response #20:

LIS file is not available from MHS Genesis team.

Question #21: For Single Operator interface: Do you want to be able to see every instrument at each site on one computer? Do you want the labs to also have access to all instruments or just their own?

Government Response #21:

Single operator interface is not required.

Question #22: Is the need to make labeled daughter tubes, cap and sort or aliquot to cups due to your current instrument needs?

Government Response #22:

See Response to Question #15.

Question #23: Can you removed the phrase “instruments in triplicate” so each vendor can design the best solution based on their portfolio and not based on Roche’s instrument’s limitations?

Government Response #23:

See Response to Question #5.

Question #24: Can you remove the chemistry throughput requirements so each vendor can present the best solution based on their portfolio and not based on Roche’s portfolio?

Government Response #24:

The Statement of Work will not be revised. This is not based on one vendor’s portfolio but necessary

This proposal includes data that shall not be disclosed outside the Government and shall not be duplicated, used, or disclosed--in whole or in part--for any purpose other than to evaluate this proposal. If, however, a contract is awarded to this offeror as a result of--or in connection with--the submission of this data, the Government shall have the right to duplicate, use, or disclose the data to the extent provided in the resulting contract. This restriction does not limit the Government’s right to use information contained in this data if it is obtained from another source without restriction. This proposal contains trade secret and confidential business, or financial information exempt from disclosure under the to support the BAMC mission.

Question #25: Is the 1449 document a total of all 5 years or is this a total per year?

Government Response #25:

See updated Attachment D for quantities specified. The solicitation will result in an IDIQ contract where up to the maximum quantities listed can be requested via delivery order during the ordering period.