Amendment 36C25726Q0787 0001.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 8

None

36C671

Department Of Veterans Affairs

Network Contracting Office 17

5441 Babcock Road Ste. 302

San Antonio TX 78240

36C671

Department Of Veterans Affairs

Network Contracting Office 17

5441 Babcock Road Ste. 302

San Antonio TX 78240

To all Offerors/Bidders

36C25726Q0787

07-22-2026

X

X X

** HOUR & DATE for Receipt of Offers is EXTENDED to: 09-21-2026 15:00 EDT

See CONTINUATION Page

The purpose of this amendment is to provide answers to vendor questions and provide an updated Schedule.

See Continuation Pages for answers to questions.

See the attached for the updated Schedule.

No further questions will be answered in relation to this solicitation. All responses are due to the point of contact, Delphia Schoenfeld, at delphia.schoenfeld@va.gov no later than 9/21/2026, 15:00 Eastern.

CONTINUATION PAGE

Vendor Questions

Answers are provided in red.

Vendor A:

1. Per the Instructions (p. 49) - If we use the spreadsheet provided “SCHEDULE

36C25726Q0797.xlsx”, vendors are required to provide the Subcontractor information (name, CLIA number, city and state), if applicable, in Column C (“Comment”), orderable test code in

Column O (“Manufacturer Part Number”), and CPT Code in Column Q (“Local Stock Number.”).

However, Column C (“Comment”) and Column O (“Manufacturer Part Number”) have already been populated. Do we write over the information that’s already in these columns? Or should we use different columns?

a. Vendors are not required to use the spreadsheet provided. Subcontractor information can be added in the cell below the existing information in Column C. The instructions for

Column O and Column Q are corrected to the following: Column O is corrected to CPT

Code, and Column Q is corrected to orderable test code.

2. Which column should we use to provide our test description/name?

a. If the name of a test is different, it should be added to the Description cell under the current name.

3. Per the instructions (p. 49), we are to provide pricing for all line items listed in B.3 Price/Cost

Schedule either by completing B.3 Price/Cost Schedule spreadsheet or by providing a quotation on a separate document. Do we also provide pricing and required information for the line items for the individual locations?

a. If the test price is different for each location, then a different price should be listed for each sub-line item (has letters). If the test price is the same for all locations, then the line item (does not have letters) should be filled in.

4. When reviewing “SCHEDULE 36C25726Q0797.xlsx”, we noticed approximately 40 base item numbers have volume discrepancies. Specifically, the individual location quantities do not match the overall test line-item level quantities.

Please update the quantities to accurately reflect the individual sites.

a. See the attached for the corrected schedule.

5. What is the true volume/quantity for each test? Is it only the quantity for the line items with a test name? As it appears the quantities for the Item Numbers ending in AA, AB, and AC are only to show how the overall test line-item level quantity is allocated between the sites. Please clarify.

a. This solicitation is intended to result in an IDIQ. The quantities are the best estimate that is able to be provided at this time. Testing volumes under order(s) for the IDIQ may vary.

Vendor B

1. If Contractor already has agreements in place with VA Medical Centers that are in VISN 17, how will those be affected by this award?

a. The existing contracts will continue until they expire then an order will be placed under this contract.

2. The solicitation notice indicates the following: “The items being requested are for urinalysis

CPRR for multiple locations within Veterans Integrated Service Network (VISN) 17.” Please clarify if the intent is to limit this contract to urinalysis testing.

a. This was an overlooked error. This requirement is for reference laboratory testing, using the testing methodology for the line items listed in the Schedule.

3. Please clarify what hazardous goods are being provided for the applicable testing.

a. Per the PWS, Section II, A, biomedical materials that include patient specimens and microbiology cultures and stocks, originating from Government facilities and destined to the contracted commercial reference laboratory. These items are classified as Hazard

Materials Class 6, Division 6.2 and are defined in 49 CFR Part 173.134 as those materials that contain or could contain etiologic agents.

4. Will any medico legal specimens be provided under this agreement?

a. Per the PWS, Section I, C, If a medico legal specimen is submitted, the Contractor shall provide its own special forms and special handling procedures to maintain a valid

“chain-of-custody possession” and develop the formal documentation necessary for that purpose.

5. If a Contractor does not possess a Business Partner Gateway ISA and Memorandum of

Understanding as required under the Telecommunications Interface Requirements, will

Contractor automatically be disqualified?

If this does not disqualify a Contractor, please clarify what a Generic Instrument Manager is in relation to this RFQ?

a. A vendor would not be automatically disqualified, however, having a Business Partner

Gateway ISA and Memorandum of Understanding already in place with the VA would be preferred. A Generic Instrument Manger is a middleware system acting as a bridge between the Laboratory Information System and hardware devices such as laboratory testing equipment, without specifying a particular name brand of middleware.

7. If a Contractor is unable to interface with the Government for ordering and delivery of results, will Contractor automatically be disqualified?

a. A vendor would not be automatically disqualified, however, having a Business Partner

Gateway ISA and Memorandum of Understanding already in place with the VA would be preferred. The vendor would also need to provide the method in which lab test results would be transmitted securely and the VA would have to find this method acceptable.

8. Contract Security Requirements

i. Does II. Contractor Personnel Security Requirements (including (3) Contractor

Responsibilities, (4) Government Responsibilities) apply if the Contractor does not access VA systems? If no, can it be removed from the award terms and conditions?

ii. If Contractor does not have access to VA systems, does Section III of the RFQ

(Requirements for Remote Access) apply and if yes, will Contractor automatically be disqualified if they cannot agree to these terms?

iii. If Contractor does not have access to VA systems, does Section IV(b) of the RFQ

(Security Training, Rules of Behavior) apply and if yes, will Contractor automatically be disqualified if they cannot agree to these terms?

iv. VII. VA Information Custodial language – if a Contractor comingles VA test results on the same lab information system with other patient results, will Contractor be disqualified?

a. Contract Security Requirements are standard and cannot be removed. If they do not apply, then the security steps are not sought. Vendors who do not agree will not be automatically disqualified, however, agreement is preferred.

b. Comingling – vendor will not be disqualified, however, VA information should not be co-mingled, if possible, with any other data on the contractors/subcontractor’s information systems or media storage systems in order to ensure VA requirements related to data protection and media sanitization can be met. If co-mingling must be allowed to meet the requirements of the business need, the contractor must ensure that VA’s information is returned to the VA or destroyed in accordance with VA’s sanitization requirements. VA reserves the right to conduct onsite inspections of contractor and subcontractor IT resources to ensure data security controls, separation of data and job duties, and destruction/media sanitization procedures are in compliance with VA directive requirements.

8. Please confirm whether offerors may submit their own pricing/matching document in lieu of completing the Government-provided spreadsheet, provided all required pricing and test-matching information is included.

a. Yes. The Addendum to the Instructions to Offerors allows for Vendor-generated pricing/matching documentation as long as the required information about test codes, subcontracting, and test locations are included.

9. If the Government-provided spreadsheet must be completed, please clarify the proper placement of offeror orderable codes, since the instructions indicate column O but that column appears to contain CPT code information.

a. The instructions for Column O and Column Q are corrected to the following: Column O is corrected to CPT Code, and Column Q is corrected to orderable test code.

10. Please confirm whether test volumes listed at the parent test-name level represent the sum of the volumes listed by individual testing site, and whether offerors should avoid duplicating those quantities in the response.

a. Yes, the parent line items (only containing numbers) are the sum of the annual estimate for “routine” locations (NTX, STX, and CTX).

11. For tests where the parent test-name line shows a quantity of zero, but one or more site-specific lines show volume, please clarify which quantity should be used for pricing and evaluation purposes.

a. This has been corrected. Please see the attached for the updated Schedule.

12. Please confirm whether the offeror should provide test matching and pricing by individual facility/site location, or whether a consolidated VISN-level response is acceptable.

a. It is preferred that pricing be provided at the VISN-level. If there are cases where STAT test is required for locations that do not have year-round testing, established pricing would allow for orders to be issued directly.

13. Please clarify whether reflex tests may be included when not listed in the utilization file. If allowed, should these be included at zero volume, on a separate tab, or in a separate supporting document?

a. Yes, if reflex testing can be included. It should be included on a separate tab.

14. Please clarify how offerors should respond to fields requesting local stock number, national stock number, or similar identifiers when such information is not applicable to laboratory testing services.

a. The Local Stock Number, based on the change described in question 9 above, should list the test code under which a facility would submit for ordering. The National Stock

Number can remain blank. The Manufacturer Part Number is to be the CPT Code(s) that apply to the test.

15. Page 51, Evaluation Criteria—Technical Capability, question 5: Please clarify the scope of the required performance improvement monitoring data for the previous 12 months. Should the submitted data be specific to services provided for VISN 17, or should it represent the Vendor’s organization-wide performance for the previous 12 months?

a. Organization-wide

16. For test 0094AA – Macro AST (CPT 84182), please provide the full test name and any associated details.

a. Macro-Aspartate Aminotransferase

Vendor C

1. Confirm that prime contractor and subcontractor testing facility locations are to be determined

(TBD) and may be located anywhere within the United States.

a. Yes. Per the Instructions to Offerors, vendors are to provide the location of each lab that will be performing tests as a prime or subcontracted vendor.

2. Confirm that the Government will provide the following administrative items:

• Pre-printed test request forms containing appropriate Shipping Section and account details.

• Specialized test request forms (e.g., cytogenetics, tissue, etc.).

a. No, contractor should provide all requisition forms needed.

3. Regarding the transport of biomedical materials (patient specimens, cultures, stocks) from

Government facilities to the commercial reference laboratory:

• Does this requirement also encompass the return of specimens to the originating Government facilities?

• Will the VA directly provide or reimburse the Contractor for shipping specimens from

Government facilities to the testing location?

a. Yes, for Histopathology specimens (i.e. blocks and slides) return is required.

b. No, Contractor will be responsible for all transportation and shipping costs.

4. To ensure accurate pricing and capability assessments, provide the historical or anticipated list of special tests, including specific tissue/specimen types and CPT codes, for:

• Histopathology

• Immunohistochemistry (IHC) Stains

• General Pathology Laboratory Services

a. The Schedule listed is the anticipated estimated quantities. The CPT Codes are listed in

Column AN.

5. Clarify the following operational responsibility:

• Will the VA provide or reimburse the Contractor for biohazard waste removal services?

a. No

6. Clarify the following operational responsibility:

• Confirm if the VA will supply the necessary tissue blocks required for positive laboratory controls?

a. No, this is not a typical practice for the VA.

Vendor D

1. Prime Contractor Eligibility: Is the prime contractor itself required to be a clinical/reference laboratory, or may a qualified service provider serve as the prime contractor while utilizing an appropriately licensed and accredited reference laboratory as a subcontractor?

a. Yes, vendors who respond must be able to perform testing. Additionally, if the vendor identifies as a small business through its SAM registration, the Limitations on

Subcontracting at FAR 52.219-14 for all small businesses and VAAR 852.219-75 for

SDVOSBs and VOSBs applies. So, any small business must perform at least 50% of the testing required.

2. CLIA Certification: Must the prime contractor independently hold the required CLIA certification, or may the CLIA certification of the laboratory actually performing the testing satisfy the solicitation requirement?

a. Yes, the prime contractor must have a CLIA certification.

3. CAP Accreditation: Similarly, must the prime contractor independently hold CAP accreditation for the required period, or may the accreditation and experience of a proposed subcontract/reference laboratory be used to satisfy this technical requirement?

a. Vendors who respond must have a CAP or similar accreditation.

4. Teaming/Subcontracting: Does the VA permit an offeror to submit a quotation using a prime contractor/subcontractor or teaming structure for this requirement?

a. Yes, subcontracting is allowed as long as all laboratories are identified, certified, and, in the case of small businesses, the prime contractor complies with the limitations on subcontracting.

5. Subcontracted Laboratory Services: Section III requires disclosure of secondary/subcontracted laboratory locations. Is there any limitation on the percentage or portion of laboratory testing that may be performed by an approved subcontract laboratory?

a. Small business vendors must be able to comply with the Limitations on Subcontracting at FAR 52.219-14.

6. Prime Contractor Responsibilities: If subcontracting is permitted, which portions of the

Performance Work Statement must be performed directly by the prime contractor?

a. A minimum of 50% of the work.

7. Specimen Collection: Does the requirement include actual specimen collection from

Veterans/patients, or will specimens be collected by VA personnel and provided to the contractor for transport and testing?

a. VA personnel will collect specimen.

8. Collection-Site Services: If specimen collection services are required, please identify the VA facilities or geographic locations where contractor-provided collection personnel would be required.

a. VA personnel will collect specimen.

9. Specimen Transportation/Courier Services: Is the contractor responsible for pickup and transportation of specimens from individual VISN 17 facilities to the performing laboratory? If so, please identify the anticipated pickup locations, required pickup frequency, and required courier/service levels.

a. Yes, see Places of Performance in SOW – specific pickup locations will be determined/ provided after contract is awarded.

10. Collection Supplies: Is the contractor responsible for furnishing specimen collection kits, containers, shipping materials, labels, requisitions, or other collection supplies to VA facilities?

a. Yes.

11. Chain of Custody: Are any tests under this requirement subject to forensic, employment, controlled-substance, or other specialized chain-of-custody requirements beyond normal clinical laboratory specimen handling?

a. No.

12. Electronic Results Integration: Is direct interface/integration with VA laboratory or electronic health record systems mandatory at contract start, or may secure electronic/web-based reporting be used while an interface is established?

a. If interface is not already established a secure electronic/ web-based reporting may be used while an interface is established, however, this does not mean starting the process to seek a Business Partner Gateway (BPG) Interconnection Security Agreement (ISA) and/ or Memorandum of Understanding (MOU) if one is not already in place.

13. Technical Experience: May the technical experience, certifications, accreditations, personnel, facilities, and testing capabilities of a proposed subcontract laboratory be considered in determining the technical acceptability of the prime contractor's quotation?

a. No. The vendor submitting the response must have technical expertise, certifications, accreditations, personnel, and testing capabilities.

14. Past Performance: May relevant past performance of a proposed major subcontractor or teaming partner be submitted and evaluated when the prime contractor does not independently possess equivalent reference-laboratory past performance?

a. No. Past performance must be from the potential contractor.

15. Key Personnel: Are there mandatory key-personnel positions, laboratory directors, medical directors, pathologists, technical supervisors, or other personnel that must be employees of the prime contractor rather than the performing laboratory?

a. Per the Special Requirements of the PWS, Section IV, C, 1 & 2, Contractor shall ensure all testing and supervisory personnel at all contractor-owned, affiliate, or subcontracted laboratories assigned to work under this contract meet and maintain the applicable personnel qualifications set forth under the Clinical Laboratory Improvement Amendments

(CLIA) of 1988 regulations. Contractor shall ensure its employees have the ability to perform the applicable duties consistent with their license and certification.

16. Testing Locations: May testing be performed at qualified laboratory facilities outside VISN 17's geographic area, provided all solicitation turnaround-time, specimen-integrity, reporting, accreditation, and shipping requirements are satisfied?

a. Yes.

17. Multiple Laboratory Locations: May a contractor utilize more than one qualified reference laboratory or specialty subcontract laboratory when necessary to provide the complete test menu?

a. Yes.

18. Pricing Responsibility: Should the offeror's proposed unit prices include all transportation, laboratory processing, supplies, reporting, subcontract laboratory fees, and related expenses, or are any of these costs reimbursed separately?

a. Yes.

19. IDIQ Minimum and Maximum: Please confirm the guaranteed minimum and maximum ordering amount/value applicable to the resulting contract and whether those amounts apply to the overall contract or individual ordering periods.

a. See B.3 Price/Cost Schedule for minimums and maximums for the IDIQ.

20. Estimated Volume: Is historical or estimated specimen/test volume by test code and VA facility available to offerors for purposes of developing accurate pricing and transportation capacity?

a. All testing listed are the estimated test quantities.

21. Historical Utilization: If available, would the VA please provide historical annual testing volume and expenditure information for the same or substantially similar specialty/reference laboratory services?

a. Expenditure information cannot be provided. The quantities listed are the historical annual estimates.

22. Incumbent/Predecessor Contract: If publicly releasable, please identify the incumbent contractor(s) currently providing the same or substantially similar services, along with the predecessor contract/BPA/IDIQ number(s).

a. The incumbent for STX and NTX is Mayo Clinic Laboratories.

23. Prior Award Information: If publicly releasable, please provide or identify where offerors may obtain the previous award amount, awarded pricing schedule, contract ceiling, period of performance, and number of offers received for the predecessor procurement.

a. The following information can be provided: STX: Contract 36C25722P0115, performance end date 2/28/2027; NTX: Contract 36C25722D0064, performance end date 9/22/2027.

24. Prior Solicitation: If there is a predecessor solicitation for substantially the same VISN 17 specialty testing requirement, would the VA please provide the solicitation number or direct offerors to the applicable public record?

a. Actions were not previously posted to the GPE.

25. Small-Business Prime / Large-Business Laboratory: Because this acquisition is unrestricted, may a small-business prime contractor propose a qualified large reference laboratory as a major subcontractor, assuming all solicitation requirements are otherwise satisfied?

a. Small business vendors must be able to comply with the Limitations on Subcontracting at FAR 52.219-14.

See attached document: SCHEDULE 36C25726Q0797 A0001.