Vendor Questions - RFQ 36C26223R0132.xlsx
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- Solicitation number
- 36C26223R0132
About this file
This document is a collection of vendor questions and answers related to Request for Quote (RFQ) 36C26223R0132 for a Chemistry/Immunoassay system for the Department of Veterans Affairs (VA) Veterans Integrated Service Network (VISN) 22.
The key details are:
- The RFQ is for an Indefinite Delivery, Indefinite Quantity (IDIQ) contract to provide a Chemistry/Immunoassay system for VISN 22 locations.
- The RFQ has been extended to May 17, 2024 at 1:00 PM Pacific Time for proposal submissions.
- The contract requires the ability to perform 100% of the tests listed in Attachment A, with the option to send out certain low-volume tests.
- Vendors must demonstrate integration with existing VISN 22 systems, including Sysmex hematology and Stago coagulation analyzers.
- The evaluation factors prioritize assay precision, total cost, integration, and other technical requirements. No site visits will be conducted, but floor plans have been provided.
- The government will not provide additional details on the evaluation criteria beyond what is included in the solicitation documents.
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Sheet1
| RFP Questions | |
| CHEMISTRY IMMUNOASSAY SYSTEM CPT - VISN 22 WEST | |
| RFP # | 36C26223R0132 |
| # | VENDOR QUESTIONS | ANSWERS | x |
| 1 | Would it be possible to receive an extension of the timeline for the final RFP response? | Deadline for proposals have been extended to 5/17/2024, 1:00PM Pacific Time. | |
| 2 | Factor 1 - If the end goal is to assess analyte precision as it relates to overall assay quality, is there other information we can provide to satisfy this requirement given potential changes in 510K requirements over time. Can you also please clarify how the data fits into the overall assessment and how the data will be used so that we can ensure that we provide the most relevant data for the intended purpose? | Proposals will be evaluated based on current FDA 510k clearance or as documented in the assay package insert for Total Precision. As stated in 52.212-2, the Government will compare each offeror’s self-reported coefficient of variation (CV) for the “total precision” of each assay required by this procurement against the CV for the total precision self-reported by the other offerors for the same assay. These comparisons will then be aggregated to create a rank ordering of offerors for this evaluation factor. As also stated in 52.212-2, Factors 1 and 2 are of equal importance and greater than other factors. The relevant data the VA requires is the data requested in Attachment E. | |
| 3 | Could you please clarify what needs to be included in the CPT? Attachment B- section 2.2.1 indicates including QC where applicable however, also states that QC material should not be included. | CPT does not include quality control material. Printers are to be included CPT. This will be updated in 2.2.1 for clarity. | |
| 4 | Attachment B – section 2.3.4 – Could you provide the purpose of the Aliquoter? Is the VISN intending for the Aliquoter to serve towards send out processing or automation line optimization? | To aliquot specimens into a secondary tube for additional testing which includes testing not on the automation line and send-out testing. | |
| 5 | Attachment B Section 2.3.4.6 – States refrigerated storage is a requirement yet at Long Beach, as space allows. Could you clarify if this is a requirement, specifically at VA Long Beach? Additionally, could you also clarify if 2 centrifuges are required at Long Beach. | Refrigerated storage is the required solution for VA Long Beach. |
VA Long Beach does require two centrifuges with one of those centrifuges required to be on the automation line. Please see changes to SOW section 2.3.4.6.
| 6 | ChemIA Tradeoffs RFP 36C26223R0132-0005, Chemistry/IA Instructions and Evaluation Criteria, 2. Factor 4 Integration with VA Systems. The instructions state, "Offerors shall provide a narrative that describes how the offeror’s proposed chemistry/immunochemistry analyzer system integrates with the following VISN 22 systems to allow for specimen transportation to and processing by those VISN 22 systems". We interpret this requirement and per the instructions provided in 1. Conformity to the Statement of Work means describing/explaining how the vendor's solution meets the requirements. Please confirm this is correct. | Interpretation is correct, vendor shall demonstrate in the proposal how their proposed solution integratges with the VISN22 third party analyzers to include specifications connectivity to the existing VISN22 equipment. | |
| 7 | Since you already signed a 1 year deal with Siemens, does that mean that those tests will not move to a new platform until that contract expires? | All tests will be moved to the new platform after go-live and validations are complete. | |
| 8 | We request an extension for a minimum of three weeks to June 7th to cover time for the extension with the questions due date and to compile the required information in Exhibit E Assay Data file. Please allow the industry time to pull and compile this information as it is a major factor for evaluation. | The solicitation has been extended to May 17, 2024 at 1:00 PM Pacific Standard Time | |
| 9 | Referencing Evaluation Factor 4 of the Tradeoffs document-Integration with VA Systems: 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 hematology and Stago coagulation. | ||
| a. Question/Point of Clarification: What 3rd party connection is requested at each | site? Please provide a chart to guide 3rd party requirements by site. | Sysmex 9100 w/ XN-IC (not Caresphere) and Stago StarMax are the VISN22 analyzers that a third party conection is desired. Please see trade-offs in Factor Four for addiitonal information. |
All four sites have one Sysmex 9100 and two Stago Star Max.
| b. Question/Point of Clarification: Please identify if connection exist at any of current locations? | No. | |||
| 10 | page 17, point 4.1.1 states that all sites have complete installation and go live within one year of award. Each installation for each individual site shall take no longer than six months. | |||
| a. | Question/Point of Clarification: This is a contradictory statement. Please indicate if the desired installation and go live shall be one year or six months. | Go live within one year of award is the intent. We understand this may be phased implementation where some sites begin before others. Individual site projects shall be completed upon a mutually agreeable timeline to be determined during project kick-off. This will be updated in the SOW section 4.1.1 for clarity. | ||
| 11 | page 6, point 2.3.1.3 requires capability of performing 100% of the required tests listed in Attachment A. | |||
| a: Question/Point of Clarification: Might you consider sending out certain testing that may be due to low testing volumes, non-essential testing. | Pricing shall be provided for all assays listed in attachment A. This is an indefinite delivery, idefinite quantity (IDIQ). Any determinations on sending out of a test based volume will be determined by the government. | |||
| 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. Colum J Extended Price? | Proposals should include the ability to perform all tests in Attachment A in-house. | ||
| c. Is it acceptable for the offeror to incorporate an allowance to cover the cost of this send out testing. | Attachment A has been updated with CRP removed and Hepatitis A Total Antibody or Hepatitis A IgG as one or the other. BNP and NT-proBNP cells have been combined in Attachment A. | |||
| 12 | We understand from prior engagements that you use Bio-Rad controls for all locations. There are three places within the SOW and attachments that contradicts if controls are to be included or not. For example, if the option is there to provide, or option to provide, we would need clarity. | |||
| a. Question/Point of Clarification: Please clarify if controls are to be included in the Cost per Test calculation. | CPT test structure does not include QC control material. | |||
| b. Question/Point of Clarification: Please confirm if GSS is providing these controls and what the control volumes are. | Controls are provided through GSS, QC volumes are provided in attachment A. | |||
| c. Question/Point of Clarification: Are you open to using other Control vendors? | No. | |||
| d. Question/Point of Clarification: Are you using QC software, and are we to include the software license for this? | This question is not applicable to the requirement. | |||
| e. Question/Point of Clarification: Please also share volumes for controls today. | Volume for quality controls test performed are in Attachment A and the second tab for each facility. Our quality control material are not applicable to this procurement. | |||
| 13 | Point 2.3.1.4 states a total equipment footprint that when installed in the laboratory shall not impact the functionality/operations of that laboratory. | |||
| a. | Question/Point of Clarification: We request the opportunity for site visits to revisit the laboratory locations to verify site status (that things have not changed over the past year – last time vendors were allowed to visit was over a year ago). As well the need to assess current workflow is essential to allow us to properly respond to the SOW requirements evaluation factors. It also underscores our ability to demonstrate conformance to the SOW that is part of step 1 and 2 of the proposal evaluations, and the evaluation factors 1 through 5, which supports how the government will evaluate tradeoff to make an award. Note – point 2.3.4.6 now defines refrigerator storage needs at each site. Previous version said Long Beach storage was ‘as space allows’ and now requests 7 days of storage as space allows. This underscores our request for site visits to verify needs. | No further site visits will be conducted as proposal deadlines have already been extended 1 week, vendors have been provided floorplans, and vendors provided opportunities to conduct site visits earlier in the procurement. | ||
| b. | Should these visits be granted, we request a minimum of an additional 4 weeks in order to conduct these visits. | This extension is not granted. The RFP has been extended to 5/17/2024, 1:00PM Pacific Time. | ||
| 14 | SOW Specimen Management System/Automated Track: 2.3.2.10. 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. | Notation: This requirement as written still remains source limiting as it enables a favorable tradeoff towards a singular vendor. | Verbiage listed for 2.3.2.10 was already updated to be "90 days, preferably" in the SOW. |
Approval from laboratory point of contact for shipping of reagents that do not meet the preferrable 90 day requirement is acceptable as an alternative to all reagents meeting the preferrable 90 day requirement.
| b. | Notation: the statement ‘specified and approved by laboratory point of contract prior to shipping’ is not administratively and logistically feasible. This will create an undue burden on the vendor. How will the government pay for this? | There is no plan to add an accounting line item for this cost. | ||
| c. | Question/Point of Clarification: Please provide the adjectival definition/rating scale that will be used to evaluate offers in the tradeoff process. At present these are not defined in the amended documents. | The agency has released the evaluation criteria in the solicitation and no additional information will be provided. | ||
| d. | Question/Point of Clarification: will you be using the VA source selection guide / adjectival rating which includes outstanding, good, acceptable, marginal and unacceptable? And what is the associated description? | The agency has released the evaluation criteria in the solicitation and no additional information will be provided. | ||
| 15 | Last time in the Debrief of Offeror Letter you used the terms Outstanding and Excellent. Please provide the definitions that will be used in the evaluation process and how these rankings are prioritized. | The agency has released the evaluation criteria in the solicitation and no additional information will be provided. | ||
| 16 | Some VA’s prefer network printers. | |||
| a. | Question/Point of Clarification: Please state if network printers are allowable. | Printers must be provided and should have network capability. | ||
| b. | Question/Point of Clarification: If printers are required, please provide a list of acceptable printers by VISN 22. | A list will be provided of compatible printers. Please see attachment "LIST OF COMPATIBLE LABEL PRINTER Cerner- List of Validated Peripheral List 6.1.21" | ||
| 17 | 6.2.8 references Attachment H. There is no Attachment H. Please revise this section or provide Attachment H. Should there be questions pertaining to this Attachment H, please allow more time for exchanges. | Reference should have been to the 6500 in Attachment D. Section 6.2.8 has been updated in the SOW. | ||
| 18 | In FAR part 52.212-1 instructions to offerors (as prescribed in FAR 12.301(b)(1)(10) past performance, Please explain if past performance will be evaluated and if so, how. There is no reference to past performance, albeit it is a part of FAR 52.212-1. | Past performance is not an evaluation factor. | ||
| 19 | In terms of the VA’s instance of Data Innovations middleware, has the VISN gone to version 9.0. If not, when? | Some sites have already upgraded to v9.0, Loma Linda, Phoenix, Prescott. The remaining will likely wait to be on v9.0 until migration to the VAEC AWS VISN22 Data Innovations Instrument Manager cloud instance. | ||
| 20 | Are there any aspects of Data Innovations middleware that need to be considered or is the VISN addressing that under your contract with Data Innovations? | VISN22 contracts directly with Data Innovations for Instrument Manager middleware, unless otherwise stipulated in the SOW, no further considerations must be met. | ||
| 21 | 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? | There are no state health planning requirements to this procurement. | ||
| 22 | In reference to point 2.1.1. and 2.1.3, how will interfering substances be evaluated, absent of the inclusion of that profile in Attachment E? The FDA has stated that interfering substances contribute to the quality of assay results. | The government has performed an extenstive market research on vendor solutions, including interferring substances. This was heavily considered in the crafting of the requirements listed throughour our solicitation. Interfering substances will not be seperately evaluated as part of the procurement. |
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