36C26223R0180 Vendor Responses for VA Prescott.pdf

5. PROJECT NUMBER (if applicable)

CODE 7. ADMINISTERED BY

2. AMENDMENT/MODIFICATION NUMBER

CODE

6. ISSUED BY

8. NAME AND ADDRESS OF CONTRACTOR

4. REQUISITION/PURCHASE REQ. NUMBER3. EFFECTIVE DATE

9A. AMENDMENT OF SOLICITATION NUMBER

9B. DATED

PAGE OF PAGES

10A. MODIFICATION OF CONTRACT/ORDER NUMBER

10B. DATED

BPA NO. 1. CONTRACT ID CODE

FACILITY CODE CODE

Offers must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended, by one of the following methods:

The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offers

E. IMPORTANT:

is extended,

(a) By completing Items 8 and 15, and returning __________ copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted; or (c) By separate letter or electronic communication which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR

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is required to sign this document and return ___________ copies to the issuing office. is not, A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT ORDER NO. IN ITEM 10A.

15C. DATE SIGNED

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES

SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b).

RESULT IN REJECTION OF YOUR OFFER. If by virtue of this amendment you desire to change an offer already submitted, such change may be made by letter or electronic communication, provided each letter or electronic communication makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

D. OTHER

Contractor

16C. DATE SIGNED

14. DESCRIPTION OF AMENDMENT/MODIFICATION

16B. UNITED STATES OF AMERICA

Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect.

15A. NAME AND TITLE OF SIGNER 16A. NAME AND TITLE OF CONTRACTING OFFICER

15B. CONTRACTOR/OFFEROR

STANDARD FORM 30 PREVIOUS EDITION NOT USABLE

Prescribed by GSA - FAR (48 CFR) 53.243

(Type or print) (Type or print)

(Organized by UCF section headings, including solicitation/contract subject matter where feasible.)

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(If other than Item 6)

(Specify type of modification and authority)

(such as changes in paying office, appropriation date, etc.)

(If required)

(SEE ITEM 11)

(SEE ITEM 13)

(X)

CHECK

ONE

13. THIS ITEM APPLIES ONLY TO MODIFICATIONS OF CONTRACTS/ORDERS,

IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

(Signature of person authorized to sign) (Signature of Contracting Officer)

1 5

8-30-2023

NA

36C262

Department of Veterans Affairs

Network Contracting Office 22

4811 Airport Plaza Drive

Suite 600

Long Beach CA 90815

Department of Veterans Affairs

Network Contracting Office 22

4811 Airport Plaza Drive

Suite 600

Long Beach CA 90815

To all Offerors/Bidders 36C26223R0180

X

X X

Sept 13, 2023 8:00am PDT

Please see the page two for the responses to vendor questions;

Important tidbit;

1. In the interest of time, the changes reflected/agreed upon, in the response shall be updated on their pertaining document, however it will not be posted on this site but may be subject to change.

VA Prescott Chemistry/IA RFP 36C26223R0180 Response to Vendor questions

Q1. Due to the complex nature of this RFP, we are respectfully requesting a two week extension post questions being answered.

A1. Moving the deadline date to 8:00am PST on Wednesday 9/13/23.

Q2. Please confirm if the volumes provided in Attachment A are patient volumes or usage volumes.

A2. Yes, confirmed.

Q3. In previous quotes, the site has requested Cost Per Test (“CPT”) pricing, but the solicitation is requesting Cost Per Reportable Result (“CPRR”) pricing. Please confirm if the request is for CPRR or CPT?

A3. This is a CPRR solicitation, as per all the relevant documents; SOW, Attachment A, and RFP.

Q4. For Attachment A, on Tab 3, can vendors provide a general list of consumables needed in order to run the full test menu?

A4. Yes.

Q5. Please clarify if this solicitation is for a cash purchase. In section 2.2.1.1 it appears the request is for a cash purchase of equipment including automation, hardware, and software.

A5. This is a CPRR requirement. Section 2.2.1.1. language will be considered removed/modified to avoid confusion.

Q6. Will the site allow for construction to fit instrumentation and automation in the lab space?

A6. There will be no construction. Construction dollars are/were not approved for this RFP.

However, moving equipment or benches (not permanently fixed), is not construction and is allowable.

Q7. Question is for analyzer’s that do not require water systems. So because some systems do not require this, is it safe to assume that the requirement for a ‘water’ would not be applicable. Can you please confirm or clarify your response?

A7. To clarify, if the system requires water, then a water system should be included in the proposal. If it does not, then it is not needed.

Q8. The base period and option years say “TBD” on page 2 of the SOW. How many years should we structure our bid? Can we propose a 7-year bid?

A8. This is a base and four option years solicitation. Please submit a 5 year bid/proposal.

Q9. Page 4 of the SOW defines the CPRR and it doesn’t say that control material should be included in the CPRR, just wanted to confirm that is not the expectation. Control material is otherwise known as “QC” material.

A9. QC will not be part of the CPRR, however, please list all available QC or any other reagents/tests available on the platform proposed, in tab “6. Optional Tests” of Attachment A.

Q10. Related to Attachment A, outlined on tab two, are the number of patient tests in column Q and the total volume in column T. But the request is for a CPRR which only charges only for patient volumes, and you will not pay for repeats or control runs. So should the “total volume” needed for this price workbook actually reflect column Q? This comes up on tab 3 (Reagent CPRR), because the numbers in column C reflects column T (from tab 2) instead of the patient volumes in column Q. The totals of column C on tab will be overly inflated.

A10. In regards to Colum Q and T of Attachment A, tab 2 “EST ANNUAL SITE VOL,” we believe the total number of test we will require for the base year is as shown; 966 tests. Whether or not we need that many test, that is our best guess, taking into account history, projections, and unknowns. The volumes in column T should be used.

Q11. Based on the complexity of the questions submitted by all interested parties, and the national holiday at the beginning of September, we respectfully request an extension moving the due date to Wednesday, September 20th.

A11. Moving the deadline date to 8:00am PST on Wednesday 9/13/23.

Q12 Attachment A – Consumables.

Question/Point of Clarification: Please confirm if controls are to be included as consumables. Please clarify if you procure controls on your own and are not to be included in the vendor cost per reportable. If they are to be included, please identify 3rd party, i.e. BioRad, vendor controls, or combination thereof.

A12. Controls, QC, are not included in the CPRR.

Q13. 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.

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

A13. We can agree, the verbiage shall change, in section 2.3.2.9, to reflect “... preferable 90 days...”

in this section.

Q14. Specimen Management System/Automated Track -2.3.3-The system shall be capable of/or possess the following and 2.3.4 Capper/Decapper and 2.3.5 Refrigerated Stock Yard (optional not required) and 2.3.9 Aliquoter (optional not required)- The system shall be capable of the following:

a. Question/Point of Clarification: Please provide a list of the required or optional (including quantities) inclusion for automation components such as number of centrifuges, decapper, resealer, storage, aliquoter.

A14a. See below

Centrifuge decapper capper aliquoter resealer storage

Required or optional

REQUIERED REQUIERED REQUIERED OPTIONAL REQUIERED OPTIONAL

Quantity 2 1 1 1 1 1

b. Question/Point of Clarification: Are these a must have, nice to have or optional in the future?

Might you provide a chart notating required vs optional?

A14b. Required will be a must to have. Optional/preferable or any other language to refer to it, is simply NOT REQUIRED. Please list the any optional instruments, QC, or tests that are available to the platform proposed on tab 6 of attachment A.

Q15. 4.1 Installation/Implementation: 4.1 Installation/Implementation timeframe on Attachment+B+ChemistryImmunoassay+SOW+PRE states that the site shall have complete installation and go live of their system preferably within six (6) months of award of this IDIQ but will be based on mutually agreed timelines. The ChemIA+Tradeoffs+RFP+36C26223R0180+PRE document page 1 states that the Delivery Timeframe: Delivery of equipment, installation, go live date and optimization of equipment should take no longer than a year after award.

a. Question/Point of Clarification: We request that timeframes defined in each be aligned to the same verbiage, preferably to change section 4.1.1 to read that timelines will be based on mutually agreed upon timelines, post-award to the installation within 12 months.

A15. Verbiage will be aligned to the SOW; “The site shall have complete installation and go live of their system preferably within six (6) months of award of this IDIQ, but will be based on mutually agreed timelines.”

Q16. 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?

A16. Please use total volume in Attachment A, Tab 2. “EST ANNUAL SITE VOL”, column T or Tab 1 VISN CPRR, column G (the tabs are the display the same volumes, for the base year. Subsequent years and 3% increase are reflected in Tab 1, VISN CPRR of attachment A.

Q17. 2.3.6.5 states ‘Track reagent inventory by bar code or radio-frequency identification (RFID).’

a. Question/Point of Clarification: 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?

A17. Capability of analyzer to track reagents.

Question #8: Factor 3 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 3. 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 3.:

a. 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?

A18. How the automation system propels specimens

Q19. Attachment A includes the NT Pro BNP assay.

a. Question/Point of Clarification: If an assay is available in an alternative method, for example, Creatine vs. Enzymatic Creatine or BNP as an alternative to NT-Pro BNP, can we offer clinical substitute?

A19. This is a brand name or equal solicitation, therefore clinical substitutes are acceptable. Please provide documentation to show clear, compelling, and convincing evidence that all “equal to items" meet all required salient characteristics/test requirement.

Q20. Attachment A line 64: Would you consider the number one worldwide Troponin assay for measuring high sensitive troponin? This assay was the first high-sensitivity assay cleared by the FDA. Since then leading cardiovascular hospitals in the US have implemented this high sensitive assay and benefited from a 9-minute turnaround time. The assay is the most independently investigated cardiac troponin available with over 600 peer-reviewed studies supporting its clinical use. Based upon this overview, you could confidently decide to offer this alternative cardiac troponin as a replacement for the RFP proposed hs Troponin I. Is that acceptable to you?

A20. It is acceptable.

Q21. Given the upcoming federal holiday and resources being out of the office, we request that the due date be extended by an additional week to 9/7/2023.

A21. Moving the deadline date to 8:00am PST on Wednesday 9/13/23.

Q22. How does the VA want to proceed with autoverification, continue with remaining on the current DI, or have vendors include it in their middleware solution?

A22. We will remain with DI. No need for vendor Autoverification.