S02 36C24424R0004 0004 QA and Extentsion.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)

1 11

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 x x

** HOUR & DATE for Receipt of Offers is EXTENDED to: April 30, 2024 at 10:00 AM EDT.

x 1

The purpose of this amendment is for the following items:

1. To extend the Questions & Answers period until 04/23/2024 at 12:00 PM EDT

2. To extend the solicitation to 04/30/2024 at 10:00 AM EDT. See Block #11 for details.

3. Provide clarification to Questions previosuly answered. See continuation pages below.

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.

Answer 1: The agency has reviewed all nine (9) Excel spreadsheets posted on SAM.GOV with the solicitation as Attachment A to confirm that the spreadsheets contain the name and CPT code for all tests listed.

• There are five (5) copies of Attachment A for the Wilmington VAMC because multiple Excel spreadsheets were needed to fit all data due to size constraints of the files.

Extension is provided see block#11 of the Amendment.

➢ 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 for each test are provided in the list. Please see the Excel spreadsheets posted on SAM.GOV with the solicitation as Attachment A. To the extent that a test name identified in the Excel spreadsheets does not match the offeror’s naming for its tests, we suggest relying on the CPT code to verify whether the offeror has the capability to perform the specific test listed.

➢ 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.

➢ 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. The agency prepared and obtained approval for a waiver in accordance with agency regulations and the FAR to deviate from customary commercial practice.

➢ 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 even after the monthly ceiling is reached for that test, then the price for conducting the test is at no additional cost to the government, unless the government changes the monthly ceiling amount for the specific month or places a separate order under the contract.

➢ 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:

b) Ability to perform all tests per our requirement (Go/No Go)

c) Ability to meet the turnaround times within the 24HR TAT attachment (Go/No Go)

d) CLIA Accredited (Go/No Go)

e) Provide a plan to establish and implement an HL7 Interface that demonstrates that it can be up and running within 60 calendar days after award (Go/No Go)

f) Ability to offer customer service 24/7 (Go/No Go)

g) Ability to provide all supplies for collection and transport of samples (Go/No Go)

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: No. Subcontractors only need to meet the turnaround times in paragraph c and CLIA accreditation in paragraph d, assuming the subcontractor is responsible only for conducting certain tests. If the prime contractor continues to meet all other requirements, then the subcontractor would not need to comply with paragraphs a, b, and e through h. If the prime contractor will rely on the subcontractor to deliver test results to the VA, provide customer services, collect and transport samples, etc., then the subcontractor would need to meet all requirements in paragraphs a through h.

➢ 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.

➢ 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: The nine (9) Excel spreadsheets posted on SAM.GOV with the solicitation as

Attachment A include historical averages of monthly quantities for each test type 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: Use of customary commercial practice for a cost-per-test or cost-per-reportable-result pricing methodology 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 numbers (CLINs). Reconciling invoices with hundreds or thousands of CLINs every month is not a reasonable ancillary duty for a certifying official to be asked to perform.

NCO 4 will use a fixed-quantity contract vehicle instead of an indefinite-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 will be asked to provide discounts (or rebates) if the VISN 4 orders fall short of the ceiling quantities for each test type each month. This will not be a tiered pricing scheme, but rather a tiered discount methodology. A fixed-price definite-quantity contract will remedy the invoicing and audit issues associated with the large number of 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 may use as many subcontractors as needed. There is no limitation on the number of subcontractors that a prime contractor may use;

however, the prime contractor must be aware of the limitations on subcontracting, if applicable.

There is no requirement in the solicitation that an offeror or contractor must have a facility within a certain geographical area; however, the location of the prime contractor’s and/or subcontractor’s/s’ facility(ies) may impact turnaround times. The solicitation establishes the required turnaround times for the tests; turnaround time is measured from when the sample is picked up by the contractor and leaves the VA facility.

➢ 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: Please do not modify the nine (9) Excel spreadsheets posted on SAM.GOV with the solicitation as Attachment A. Should an offeror decide to make adjustments to the Excel spreadsheets, please denote such changes in your proposal.

➢ 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: There is no requirement in the solicitation that an offeror or contractor must have a facility within a certain geographical area; however, the location of the prime contractor’s and/or subcontractor’s/s’ facility(ies) may impact turnaround times.

The solicitation establishes the required turnaround times for the tests; turnaround time is measured from when the sample is picked up by the contractor and leaves the

VA facility.

The due date for submission of proposals is reflected in both the SF30 for Amendment

0004 and the SF 1449. The contract will have one ordering period with no option periods; the contract will have multiple pricing periods. Please refer to the Price

Schedule in the solicitation.

End of Document