Response to Vendor Questions 6_1_23.docx

Question #1: Based on the complexity of the questions submitted by all interested parties, we respectfully request an extension moving the due date to Friday June 16th or Monday June 19th. Accounting for the holiday weekend as well.

A. RFP shall solicitation end date is extended until Friday June 9, 2023.

Question #2: Referencing Evaluation Factor 3-Integration with VA Systems: page 2/24. Integration with VA System states that this factor will be used to assess the ability of the offerors system to integrate with the following Sysmex, Stago and Diasorin Liaison.

a. Question/Point of Clarification: Please identify if connection exist at any of current locations?

L.A. has automation

b. Question/Point of Clarification: What 3rd party connection is requested at each site? Please provide a chart to guide 3rd party requirements by site.

c. Question/Point of Clarification: If we are to provide a cost for the actual integrations, where does associated cost go within the price schedule? For example, add a line on Attachment A, Tab 4- Proposed Instruments?

Please see Attachment A, Tab 4. Proposed Instruments, section “Contractor Misc.”

Question #3: To support the requirement to provide solution designs for Sepulveda and LA Ambulatory Care Center we request a CAD for each location.

A. Amendment will be published soon with the space dimensions of these sites. A detailed design is not possible at this time.

Question #4: Controls Bio-Rad for all locations. QC contract is separate.

a. Question/Point of Clarification: Please identify which Control vendor you use? GSS

b. Question/Point of Clarification: Are you open to using other Control vendors? No

c. Question/Point of Clarification: Are you using QC software, and are we to include the software license for this? Yes we are using a QC software and No need to include the software license.

d. Question/Point of Clarification: Please also share volumes for controls today N/A.

Quality control material in not part of the contract.

Question #5: SOW Instrumentation Requirements 2.3.1.3: The ability of performing analysis on 100% of the required tests listed in section Attachment A Tab 1 & 2.

a. Question/Point of Clarification: This requirement as written is source limiting. Might you consider sending out certain testing that may be due to low testing volumes, non-essential testing.

QuanitFERON TB will be removed from requirements list.

Siorlimus and Free Testosterone will be removed from requirements list.

Open channel assay FDA approved to meet requirement is also acceptable.

b. Question/Point of Clarification: When we have an assay that is not available to perform in house and the recommendation is to send out, how may we indicate this on the Attachment A, tab 1. VISN CPRR, Colum J Extended Price?

All currently listed reagents on the updated attachment A, tab 1, are required tests.

Question #6: SOW Specimen Management System/Automated Track: 2.3.2.9. Single lot of reagents for each test/analyte per monthly shipment with a minimum reagent expiration date of 90-days unless otherwise specified and approved by laboratory point of contract prior to shipping.

a. Question/Point of Clarification: This requirement as written is source limiting. We request that this be reworded to remote source limitations, to read as “preferable 90 days”.

Acceptable change. Change will be reflected on attachment B, SOW, 2.3.2.9.

Question #7: Specimen Management System/Automation 2.3.3-The system shall be capable of or possess the following and 2.3.4 Capper/Decapper/Aliquoter- The system shall be capable of the following:

a. Question/Point of Clarification: Please provide a list by site of the required or optional inclusion for automation components such as number of centrifuges, decapper, resealer, storage, aliquoter, and bulk input.

This is minimum requirement depending on site volume and capability.

b. Question/Point of Clarification: Are these a must have, nice to have or optional in the future? Might you provide a chart, by site, required vs optional.

See chart above

Question #8: 4.1 Installation/Implementation:

a. Question/Point of Clarification: We request that timeframes defined in section 4.1.1 through section 4.1.2.8 add the verbiage that timelines will be based on mutually agreed upon timelines, post-award to the installation within 6 months.

VA agrees and will make change to 4. Inspection and Acceptance / Deliveries & Performance 4.1.1 through 4.1.2.8.

Question #9: Attachment A Chemistry Immunoassay Schedule 5.8.23 +r1:

a. Question/Point of Clarification: Attachment A, Tab 2. Please clarify if we price our CPRR based on the patient counts only found in Column B (Est. Test Volume) or use the total test counts including controls and repeats found in Column E?

CPRR would not include these items, CPT would. Column B is what is used.

Question #10: 2.3.6.5 states ‘Track reagent inventory by bar code or radio-frequency identification (RFID).’ Please clarify if this request is asking for this capability on the analyzer or is this referring to a stand-alone RFID technology platform for this requirement?

Instrument availability to recognize onboard reagents. Inventory management software as a stand alone function is value added.

Question #11: Factor 4 Specimen Propulsion Method. This factor will be used to assess the method the offeror’s proposed chemistry/immunochemistry analyzer system uses to propel test specimens through the chemistry/immunochemistry analyzer system and to the VISN 22 systems identified in Factor 4. For this factor, offerors shall submit a narrative that describes the method and technologies offeror’s proposed automation system uses to propel test specimens to the chemistry/immunochemistry analyzer system and to the VISN 22 systems identified in Factor 4.:

Question/Point of Clarification: Please clarify – are you looking for a description of how the analyzers propel test specimens or how the automation systems propel test specimens How automation propels specimens along the automation line.

Question/Point of Clarification: Office of Statewide Health Planning and Development (OSHPD). Please share if there are any requirements/guidelines for OSHPD being involved in any aspect of the solicitation?

No, none.

Question/Point of Clarification: 3rd Party Integration: Are you accounting for a budget for the portion from Stago, Sysmex, and Diasorin Liaison to the automation line as part of the integration? Each vendor could have associated costs for their own work to connect that would be above the position that interested parties submit. Also, is there any aspects of DI VA instance that needs to be considered or is the VISN addressing that under your contract with them?

DI is a separate contract. Require credit if additional costs are incurred for DI connectivity to automation/instrumentation. Third party connections would be customer responsibility.

Questions from Attachment B -SOW

1. 2.3.1.3 is worded such that all vendors except for a particular will be marked deficient because of the 100% verbiage. Can this be re-worded so that it does not state 100%? Specifically, Sirolimus is only sold by said vendor. Can this assay be made “preferred but not required” so that it does not bring a deficiency to all other vendors? Additionally, since this is such a low volume assay across all VISN22 sites, and presumably being sent out for testing, is the plan to bring this assay in-house or will VISN22 continue to send out for testing?

QuanitFERON TB will be removed from requirements list.

Siorlimus and Free Testosterone will be removed from requirements list.

Open channel assay FDA approved to meet requirement is also acceptable.

1. Please confirm that Instrumentation, including all automation accessories will be purchased up front and owned by VISN 22 according to 1.7.1.

Purchasing equipment and accessories, will be owned by VA.

1. Are the Reagents and Service/Maintenance to be surcharged based on the volumes provided in Attachment A?

The volumes in attachment A are the estimated volumes. Reagents and consumables are CPRR.

1. 2.2.1.1, CPRR states “It will also include the material to perform as well as all other costs associated with quality control, calibration and correlation study testing” implying that QC material needs to be included as part of the CPRR price. Please clarify if the awarded vendor is to supply all QC material, including third party vendors. We were under the impression that VISN22 had already directly secured a separate QC supplier contract.

QC material will not be the responsibility of the vendor. Item will be corrected on SOW.

2.3.3.1 implies that automation capabilities need to incorporate new technologies however, this may be limited by the current square footage available in smaller labs, please clarify if newer technologies would replace existing technologies or be added on within the current available space of each lab or allow for minimal construction.

Yes will replace with newer technology in current footprint.

1. Has the Santa Maria facility closed? They are not on the list of stations.

Santa Mara volumes have been absorbed by the other Los Angeles locations and not part of the solicitation.

Questions from Attachment Chem/IA Tradeoffs

1. Factor 1 – Test Accuracy, Please provide an explanation for the criteria used in selecting this particular list of assays to perform the analysis. Based on our internal calculations, we believe this limited list of assays heavily skews the data in favor of a single vendor. We can show that depending on the selection of assays can further favor one vendor over another. We can share the analysis with you if requested. We, therefore, respectfully ask that VISN 22 remove the Factor 1-Test Accuracy requirement since language is already in the RFP Statement of Work, Section 2.1.

We have also seen the industry, including other VISN’s alternately use the following language:

· The instrumentation shall perform all analyses for the required test with safety and precision as defined by the 1988 Clinical Laboratory Improvement Act (CLIA), the Clinical and Laboratory Standards Institute (CLSI), the College of American Pathologists (CAP) and the Food and Drug Administration (FDA). All analyzers shall be FDA approved.

· System and tests must meet The Joint Commission (YJC), College of America Pathologists (CAP), Clinical Laboratory Improvement Act of 9188 (CLIA 88) and Clinical Laboratory Standards Institute (CLSI; formerly NCCLS) Standards and demonstrate satisfactory performance on CAP peer group comparisons.

Factor 1 has been replaced in its entirety. College of American Pathologist data will not be used. Please take a look at the new Factor 1.

1. Factor 3 (4)- Can you expand on what information you are trying to gather since every vendor uses a propulsion system to move the tubes on the line. How are you going to score one vendors process versus the other?

We will analyze function, efficiency and noise of proposed system.

QuanitFERON TB shall be removed from this list.

Remaining tests on Attachment A tab 2 are required.

Siorlimus and Free Testosterone will be removed from requirements list.

Open channel assay FDA approved to meet requirement is also acceptable.

Sites Req Automation line: Loma Linda, Long Beach, San Diego, & West Los Angeles (main).

Sites NOT requesting automation line: LA ACC or Sep

Connectivity of additional instrumentation is value added trade off.

2.3.3.3 Attachment B

2.3.5 Refrigerated Stock Yard

Specimen archival through mapping of specimens to racks for room temperature samples or to a refrigerated stockyard for easy retrieval once moved off-line. Is a connected storage and retrieval system a requirement or value add?

Required. Long Beach stock yard is dependent on space.

Not required at this step. Can be submitted after selection.

Attachment B, Section 4.1.2.4, has been updated to remove erroneous reference.

Please use the existing attachment A, tabs 4, 5 and 6, to provide the information.

Extension required. 6/9/23