S02 - RFQ 36C26226Q1411 0002.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 7

0002 09-03-2026

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

36C26226Q1411

X

X X

** HOUR & DATE for Receipt of Offers is EXTENDED to: 09-16-2026 07:00 PDT

X 1

VISN 22 Semen & Vasectomy Test Kits

The purpose of this amendment is to:

1) Extend the solicitation DUE DATE to 09/18/2026 at 07:00AM Pacific Daylight Time.

2) Answers to questions are posted in the following pages. Answers contain information regarding required licensing and other adjustments. READ CAREFULLY.

3) No other changes are made to this solicitation by this amendment.

Question 1 Special Standard of Responsibility SP1 requires the offeror to "provide evidence that the laboratory is licensed, accredited and issued by the College of American Pathologists (CAP)," and the SOW Licensures section states the laboratory "must be licensed/accredited by the College of American Pathologists (CAP). Is this required?

ANSWER: SP1: Special Licensure – The requirement for a CAP license or accreditation has been removed and is no longer necessary in the Statement of Work (SOW) or Special Standards of Responsibility. Please disregard any references to CAP licensure or accreditation.

However, CLIA certification remains required per the original solicitation.

Question 2 Will the Government consider direct-to-patient kit shipment, ordered by the VA facility and fulfilled by the contractor to the patient's address, either as the delivery model or as an acceptable alternative approach under Factor 1?

ANSWER: Yes the government will consider direct to patient shipment. The government prefers to hand the test kit directly to the patient to explain the collection process and answer any questions. Previous collection efforts have demonstrated that direct, in-person delivery by hospital or clinic staff, accompanied by an explanation, significantly improves kit return rates.

Additionally, kits mailed to patients have sometimes been discarded after being mistaken for junk mail, further supporting the preference for direct hand delivery. This direct to patient hand delivery also assists in keeping costs down.

Question 3 If bulk delivery to sites is required, what kit shelf life does the Government consider acceptable, and what storage conditions can participating sites provide and maintain?

ANSWER: The Government prefers a minimum shelf life of six months, with the product remaining stable at room temperature.

Question 4 If bulk delivery is required, will kits expired in VA site inventory be replaced at contractor expense, and how will the Government control site-held inventory levels to limit expiry?

ANSWER: Unused or expired kits will be replaced at government expense, as if purchasing new kits. According to the Statement of Work (SOW), each participating facility will order kits as needed; therefore, a one-time large quantity purchase is not anticipated. Each facility will independently coordinate with the vendor to order smaller batches based on their requirements.

This BPA contract will establish expected annual order quantities per site, and each site will schedule deliveries with the vendor to fulfill their needs. For example, a site may have an annual order of 40 kits, with 10 kits delivered every three months. Each facility will monitor usage and conduct routine inventory checks.

Question 5 Are the Attachment A quantities kits delivered to sites, or tests resulted?

ANSWER: TESTS REULTED

Question 6 Should the kit include a prepaid return mailer for the patient to return the specimen directly to our laboratory, and is that return shipping to be included in the unit price?

ANSWER: YES

Question 7 SOW Section B GENERAL states provides that post-vasectomy testing kits allow "unlimited retesting until azoospermia is confirmed. A full semen analysis will be performed after the third attempt." Attachment A prices Full Semen Analysis (CLIN 1, 1,104 annually) and Post Vasectomy Semen Analysis (CLIN 2, 636 annually) as separate line items.

When a post-vasectomy patient's course proceeds to a full semen analysis after the third attempt, is that analysis ordered and invoiced against CLIN 1, or included within the CLIN 2 unit price at no additional charge?

ANSWER: A minimum of two repeat Post Vasectomy Semen Analysis (PVSA) tests will be provided at no additional cost. This includes the initial PVSA test, plus up to two retests (a total of 3 tests).

Question 8 Does the CLIN 1 annual quantity of 1,104 include or exclude third-attempt analyses arising from CLIN 2 volume?

ANSWER: Excludes retest attempt

Question 9 Are the repeat post-vasectomy kits themselves - the second and subsequent attempts before the third - counted within the CLIN 2 quantity of 636, or are those 636 discrete patients?

ANSWER: DISCRETE PATIENTS

Question 10 The SOW requires 52 hours of room-temperature stability for Full Semen Analysis. Would the VA also consider a validated temperature-controlled transport method that uses a proprietary semen preservative and FedEx Priority Overnight delivery to minimize transit time and exposure to variable ambient temperatures?

ANSWER: YES but not required.

Question 11 SOW Section C item 4 states the requirement "Able to store kits at room temperature," and SOW Section B item 1 requires semen analysis kits "validated for a minimum of 52 hours of room temperature stability." We read these as addressing two different things and ask the Government to confirm:

Does the 52-hour minimum refer to the period from specimen collection to analysis, that is, the room-temperature stability of the collected specimen in return transit?

ANSWER: Yes, the minimum time requirement originally referred to the period from collection to analysis. However, as addressed in question 23, this timeframe has been reduced to 48 hours to promote maximum competition.

Question 12 Does "able to store kits at room temperature" refer to the assembled kit in the patient's possession during collection and return transit, or to unissued kit inventory held at a VA facility prior to issuance?

ANSWER: This refers to unissued or unused kit inventory, whether held at VA facilities or at a patient's home. For the purpose of this question, "assembled" refers to a kit that has been boxed with all supplies, consumables, and shipping materials, but has not yet had a specimen collected. This includes kits in a patient’s possession that remain sealed prior to specimen collection.

Question 13 If kits are to be delivered in bulk and held in site inventory, what shelf life and storage conditions does the Government require the contractor to guarantee for unissued kits held at VA facilities, and over what period does the Government expect sites to hold inventory?

ANSWER: Shelf life of at least 6 months stability at room temperature.

Question 14 The SOW states that a patient test report may be "a printed final copy ... or host-to-host VPN electronic transmission of test results," received "by VPN computer interfaced to the VistA Laboratory Package," and that the "Contractor shall make all results retrievable via a Secure Web Portal; in addition to providing the Web Portal, Contractor also send results via fax to a secure facsimile."

Is a secure web portal with clinician result retrieval sufficient to satisfy the reporting requirement at award, or is a host-to-host VistA HL7 interface required at award?

ANSWER: YES, a secure web portal with clinician result retrieval is acceptable. A highly desired but not mandatory feature is a secure web portal with patient access using a PIN or other security measure. VPN computer interface to VistA/ VistA HL7 Laboratory package is not required. A web portal with clinician access is the minimum requirement.

Question 15 Is secure fax capability mandatory in addition to the web portal, or provided at the site's election?

ANSWER: provided at site’s election.

Question 16 The SOW references "Section B.14 Technical Data Requirements B. Interface Telecommunication Requirements" for the VistA interface specification. That section is not included in the solicitation. May we request a copy?

ANSWER: Section B.14 not found. However, VistA is not required, disregard references in SOW to VistA.

Question 17 A VistA interconnection requires an approved MOU/ISA and VA Handbook 6500.6 Appendix C and D documentation, with a lead time typically measured in months, and materially affects pricing.

ANSWER: VistA not required. Disregard references in SOW to VistA

Question 18 Section B.2 paragraph 1 describes the Government as "establishing this single award Blanket Purchase Agreement (BPA) contract for Blood Bank Automation, Equipment Capital Purchase and CPT Solution." This appears carried over from an unrelated solicitation. Please confirm the BPA is for Semen Analysis and Post Vasectomy Semen Analysis mail-in test kits as described in the SOW.

ANSWER: “Blood Bank Automation, Equipment Capital Purchase and CPT Solution” reading was erroneously carried over. This solicitation for Semen Analysis and Post Vasectomy Semen Analysis mail-in test kits as described in the SOW and as corrected by this amendment’s answer to this question.

Question 19 The RFQ cover page item 4 states "This is a Small Business set-aside solicitation" and the clause list incorporates 52.219-6, Notice of Total Small Business Set-Aside, while the transmittal email of 27 August 2026 describes the acquisition as "full and open competition." Please confirm the solicitation is a total small business set-aside.

ANSWER: Please read the bottom of the original email, you will see the following statement:

“In the event of any discrepancies or errors in this message, the terms outlined in the attached documents as posted to SAM.gov shall prevail.”

THIS IS a Total Small Business Set-Aside. That being said, the email is a courtesy notification and not the official post. The official notices, files and or documents are posted on the SAM.gov website under this solicitation #.

Question 20 VAAR 852.215-70, SDVOSB and VOSB Evaluation Factors are among the clauses incorporated by reference. Please confirm whether any price evaluation preference or adjustment will be applied to SDVOSB or VOSB offerors under the lowest-price evaluation described in 52.212-2 and, if so, how it will be calculated?

ANSWER: VAAR 852.215-70, SDVOSB and VOSB Evaluation Factors, will not be applied for price evaluation purposes under this solicitation. No price evaluation preference or adjustment will be given to SDVOSB or VOSB offerors under the lowest-price evaluation method described in FAR 52.212-2.

Question 21

- Service Contract Labor Standards

The clause list incorporates 52.222-41, 52.222-43, 52.222-55 and 52.222-62. Please confirm whether a Wage Determination applies to this requirement and, if so, provide the applicable WD number, or confirm that this requirement is for commercial supplies not subject to SCLS.

ANSWER: A check of this requirement and services needed for this solicitation determined that NO wage determination will be necessary. Through this amendment, clauses 52.222-41, 52.222-43, 52.222-55 and 52.222-62 are removed from this solicitation.

Question 22 Please confirm the exact closing time and time zone for Government questions due August 31, 2026.

ANSWER: Stated directly on the solicitation, page 38, ADDENDUM to FAR 52.212-1, paragraph c. INQUIRY OR QUESTIONS. It clearly states questions are due “Monday, August 31, 2026, at 07:00 AM PDT”

Question 23 Is the 52-hour requirement intended to ensure specimens can tolerate extended transport delays, or must every acceptable system demonstrate 52 hours of room-temperature stability?

ANSWER: Update to SOW: Specimen needs to be stable for a minimum of 48 hours or more once collected to allow patients to have enough time to drop off and shipping. Taking into consideration delays in transportation from shipping companies even with overnight shipment label.