S02 36C24424R0004 0003 Amendment QA 4 11 24.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. NUMBER 3. 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 ACKNOWLEDGMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY is not extended.

12. ACCOUNTING AND APPROPRIATION DATA

(REV. 11/2016)

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.)

(Number, street, county, State and ZIP Code)

(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)

VISN 4 Ref Lab

36C244

Department of Veterans Affairs Network Contracting Office 4 Services 6 1010 Delafield Road Pittsburgh PA 15215 Amanda.Saunders@va.gov

36C244

Department of Veterans Affairs Network Contracting Office 4 Services 6 1010 Delafield Road Pittsburgh PA 15215

To all Offerors/Bidders

36C24424R0004

01-10-2024

X

** HOUR & DATE for Receipt of Offers is EXTENDED to: April 25, 2024 at 12:00 PM EDT.

x 1

The purpose of this amendment is for the following items:

1. Provide answers to questions asked during the Q&A period. (Continuation pgs. 2-10 Page for Questions & Answers)

2. Section 2.2 and 4 of the PWS were revised. Provision 52.212-2 was revised. Refer to the updated 1449 RFP attachment.

Refer to the updated 1449 RFP document attachment to include updated PWS.

Contracting Officer

Questions Received for VISN 4 Reference Laboratory Services (Amendment)

Question 1:

Laboratory testing is complex, and each laboratory company has its own set of ordering codes.

In the latest posting, utilizations are included for all 9 sites. However, only Altoona, Pitts, But and W-B include the current test code/order code (col A). Our request would be that that information is provided on the remaining 5 to ensure vendors can best match (and price) to the correct test option.

We also noted that the format was different with Wilmington and was not sure you were aware of that. Since Wilmington is separate the request is actually for 13 pricing files to be completed, not 9 as stated. Since pricing is being requested for all testing (regardless of utilization), it requires that vendors match and price over 11,000-line items. Due to the size of this RFP and the work involved to price and match this many line items, we respectfully request an extension of 3-4 weeks to perform our necessary due diligence and respond with a package that is the most accurate and applicable.

Please consider adding the current provider test code to all files as well as a 3–4-week extension.

o Answer 1: Reviewed all nine (9) Attachments A's on SAM.GOV and all test names and CPT codes are provided.

There are five (5) Attachment A’s for Wilmington, because all the data could not fit on one spreadsheet due to its size, Extension is provided see block#11 of the Amendment.

(April 25, 2024, at 12:00 PM EDT.)

Question 2:

Separate utilizations have been provided for all 9 sites. However, only the utilizations for Altoona, Pittsburgh, Butler, and Wilkes Barre included the current test code (column A). Please provide the current vendor’s test code for the remaining 5 sites to ensure we can best match and price to the correct test option. We also noted that the format was different with Wilmington and was not sure you were aware of that.

o Answer 2: Same answer as question 1 above.

Question 3:

What should we do for test(s) that we are unable to find an appropriate match given the test information provided?

o Answer 3: The CPT Codes are provided for each test on the list and we reviewed the test names and they are accurate. If a vendor is not able to provide the test based on the information provided, then list as unable to perform that test in your proposal.

Question 4:

Refer to the updated 1449 attachment which includes revised PWS, Section 4.1 (p. 147); we would expect that multiple account numbers could be needed for each VA location, given the complexity of tracking at the test level and the sheer volume of tests ordered on a monthly basis, would the VA be open to receiving notification when overall contract amount invoiced is within 10% of the IDIQ contract maximum value and not at the specific test type level?

o Answer 4: Refer to updated PWS this section was revised.

Question 5:

In consideration of the above questions and the size/complexity of this RFP, we respectfully ask for a 3-4 week extension to the RFP due date. This will allow us enough time to perform our necessary due diligence and respond with a package that is the most accurate and applicable.

Answer 5: Same as above; extension was provided see block#11 of the Amendment.

(April 25, 2024, at 12:00 PM EDT.)

Question 6:

The RFP states that "“Offerors shall propose a fixed monthly price (per CLINs 0001-4009AM) IAW the PWS and per Attachment A, for each month for every VA facility that may order services from the contractor.” The RFP also notes that “Proposals that delineate separate costs not described herein will not be entertained. An all-inclusive monthly fixed price will enable the VA facilities to order as many tests as needed up to the monthly ceiling quantity for each test as identified in Attachment A.” The RFP makes it clear, however, that this is a commercial-item procurement. RFP at 1; RFP at 134 C.17 (incorporating FAR 52.212-5 CONTRACT TERMS AND

CONDITIONS REQUIRED TO IMPLEMENT STATUTES OR EXECUTIVE ORDERS—COMMERCIAL

PRODUCTS AND COMMERCIAL SERVICES (DEC 2023)). As explained in our response to the Sources Sought for this procurement, a monthly firm-fixed price structure is inconsistent with customary commercial practice in the medical laboratory testing industry. Please revise the RFP to include a per test pricing structure, which would be consistent with customary commercial practice. A price-per-test methodology, which was recently used by the VA in VISN 8 and in VISN 15, is more consistent with laboratories’ customary commercial practice, and consistent with how the VA has procured similar laboratory services in other commercial procurements.

o Answer 6: We are not using a price per test method; a waiver was obtained.

Question 7:

Section 4.1 of the PWS states that “Contractor shall be required to notify CO when a specific test type for a specific VA facility in a given month has reached its ceiling amount.” Attachment A to the solicitation states that the “monthly test ceiling quantities represent the maximum number of tests the contractor could be required to perform in any given month (so the contractor should take these maximum quantities into account when determining its monthly pricing).” In the event that the VA orders exceed the monthly test ceiling quantities, will the contractor be required to fill the order? If so, what price would apply to the tests that exceed the test ceiling quantities?

o Answer 7: Contractors are not obligated to fill an order once the monthly ceiling is reached. However, if a Contractor chooses to fill an order anyway, even after the monthly ceiling is reached, then the price is at no additional cost to the government unless the government changes the ceiling or places a separate order for it.

Question 8:

Under Factor 1, Technical Proposal, the RFP states that the “offeror’s technical capability will be evaluated based on whether the offer demonstrates that they can meet or exceed all VA requirements (all elements) as outlined in the PWS including, but not limited to the following:

a) The offeror’s technical capability will be evaluated based on whether the offer demonstrates that they can meet or exceed all VA requirements (all elements) as outlined in the PWS including, but not limited to the following:

e) Provide a plan to establish and implement an HL7 Interface that demonstrates that it can be

h) Ability to provide a courier service to pick up samples in accordance with pickup schedule within the PWS (STAT pickups as well) (Go/No Go)”

If the Offeror intends to use a subcontractor to perform tests, does the Offeror need to provide information with its proposal to address how subcontractors also meet or exceed all VA requirements as outlined in the PWS, including the abilities and information requested in (a)-

(h) above?

o Answer 8: Yes, to the extent that a subcontractor is being used to perform tests only.

Assuming the prime contractor continues to meet all of the requirements; to include turnaround times and CLIA accreditations.

Question 9:

There are some comments in the RFP posted on March 12 at pages 162 and 163 in tracked changes that indicate there may be additional changes needed to the instructions to offerors, and perhaps other areas of the RFP. If additional changes are made to address these comments in the RFP, will the VA give offerors additional time beyond April 5th to revise their proposals to address the amended RFP, even if they have already submitted a proposal?

o Answer 9: Refer to updated 1449 RFP attachment.

Question 10:

It is taking longer than expected to complete Attachment A given the volume of tests, and the per-test discounts requested. There may also be additional changes made to address the tracked-changes comments in the RFP, and to address the questions submitted on March 22, 2024. Could the VA extend the due date for receipt of proposals by another two weeks (i.e., until April 19, 2024), or for some other reasonable period of time, to allow offerors to continue to prepare and revise their proposals?

Answer 10: Same as above; extension was provided see block#11 of the Amendment.(April 25, 2024, at 12:00 PM EDT.)

Question 11:

Attachment A. In several attachments labeled A, using Altoona as an example. The same test is duplicated on several lines and the utilization is varying. How do you want us to handle this information? (see copied example, from Attachment A Altoona, below) o Answer 11: Surgical samples may contain several sites where the sample was taken.

While technically, these are all the same test code/CPT code, they do need a way to be differentiated while under the same report. During a patient procedure, multiple samples may be taken for pathology testing. Although multiple samples are submitted, they are all from the same patient and part of the same procedure. Thus the samples all have the same test code/CPT code, but are listed as 1st site, 2nd site, etc.…

Question 12:

Attachment A. Using Attachment A, Butler, as an example, there are test codes in column A (see highlighted yellow codes below) but no test information or utilization. How do you want the vendor to handle this information?

o Answer 12: These test codes do not need to be included for these sites that did not list a test name or quantity.

Question 13:

For the following tests, we need more information to match the testing. Please provide more detailed information such as current lab performing test with test code, panel components where indicated, food allergen details, etc. that will help with clarification of the tests. CPT codes will help as well.

o Answer 13: Test Codes:

Test Name Test Code

CHD: LDLR 120295

IntelliGEN 451953 Trypsin 252773 Streptozyme 006031 Warfarin 005199 Chlamydia 138338 CK Total 001362 GI Profile 183480 HLA Class I 168050 IgE Food 608005 igp aptim 507805 LD isoenz 001842 mexiletine 716076 NuSwab 180039 Protein C 080465 Sodium 24hr 003178 Urine Cyto 009068

Question 14:

The RFP states “The monthly test ceiling quantities represent the maximum number of tests the contractor could be required to perform in any given month (so the contractor should take these maximum quantities into account when determining its monthly pricing). The actual number of tests required per month, however, will fluctuate and will typically fall below the monthly test ceiling quantities. The ‘historical’ column in Attachment A reflects the average actual usage for each month.” Please confirm that the historical column in Attachment A reflect the average actual utilization. Some of the quantities appear lower than the actual utilization under the incumbent contract for VISN 4.

o Answer 14: All Nine (9) Stations Attachment A's reflect historical data averaging over the last 24 months.

Question 15:

In order to understand the expectations of this pricing structure, can the VISN provide reasoning on the proposed pricing structure and what is trying to be obtained with this proposed model?

o Answer 15: Standard commercial ordering and invoicing under CPT or CPRR has historically caused problems with VA’s electronic contract writing system, financial management system, and invoicing/payment system. Additionally, contracts for reference laboratory testing services are continually subject to Payment Information and Integrity Act (PIIA) improper payment findings. Specifically, the contractor’s invoices often do not reflect the accurate contract price and/or the invoiced test type is not listed in the contract, which results in an improper payment error. These negative PIIA findings are primarily caused by the high volume of orders placed each day by each VA medical facility and the difficulty of cross walking the ordered test type with the contract line items (LINs). Reconciling invoices with hundreds or thousands of LINs every month is not a reasonable ancillary duty for a certifying official to be asked to perform.

NCO 4 will be using a fixed-quantity contract vehicle. Under this approach, the contractor will perform services for all required test types and volume of tests per test type (up to a ceiling quantity per test type) for a fixed monthly price. All performance and price risks under the contract that are shouldered by the contractor will be mitigated by the ceiling quantities per test type that will be established in the solicitation and contract. To reduce the risk that the government may pay too much for unrendered services, the contractor may provide discounts (or rebates) if the VISN 4 orders fall short of the ceiling quantities for each test type. The Attachment A’s do not reflect a tiered pricing scheme, but do reflect a tiered discount methodology. A fixed-price contract will remedy the invoicing and audit issues associated with the large number of prior invoicing mistakes (and likelihood of rejected invoices) that VA experiences under the current standard commercial pricing practices. The VA wishes to try a new method of contracting for these services to address both current problems and potential problems before they arise. The agency believes this contract type can help to achieve faster payments to the contractor, the expenditure of fewer Government resources, and improved audit findings.

Question 16:

Amendment RFP. Page 145, Section 2.2 , Contractor Personnel: 9. Other Quality Assurance Monitors as defined by STVH. Could you please define the acronym STVH?

o Answer 16: Line #9 under Section 2.2 of the PWS was removed refer to updated 1449 RFP attachment which include the updated PWS.

Question 17:

We are an SDVOSB company interested in bidding for this RFQ. Our partner lab can satisfy 98% of the test but there are some tests for which we will have to look for another lab. Will the VA be fine with us using multiple labs to provide the full scope of tests?

Also, is there any requirement for the lab to be situated in the proximity of the delivery location at the VISN sites i.e., a local lab requirement.

o Answer 17: The prime contractor can use as many subcontractors as needed. There is no limitation; however these labs must be aware of limitations of subcontracting. No geographical requirement; however geography could impact turnaround times.

Turnaround times start from the time the lab test leaves the VA.

Question 18:

Are we able to modify the Attachment A files (i.e. add columns) for additional information, such as bidders test code, test name, etc.?

o Answer 18: No modifications to the requirement.

Question 19:

I have noticed that the provided details are somewhat limited, and I seek further clarification to better understand the scope and requirements of this role. My laboratory is based in Missouri, and I would like to inquire if there are any geographical restrictions for applicants, or if our location qualifies us to participate in this opportunity.

Additionally, could you please provide information on the timeline for this opportunity?

Understanding your schedule for filling this position would greatly assist us in planning our application and any necessary preparations.

o Answer 19: No, geographical restrictions. The timeline for this opportunity can be found in block #20 of the RFP.

End of Document