36C26226Q1066 0001.docx

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) 07-15-2026 644-26-3-425-0060

VA-26-00053767

36C262

NCO 22

Department of Veterans Affairs NCO 22 - Mesa Annex 4135 S. Power Rd #103 RM 116 Mesa AZ 85212 36C262

NCO 22

Department of Veterans Affairs NCO 22 - Mesa Annex 4135 S. Power Rd #103 RM 116 Mesa AZ 85212 To all Offerors/Bidders

36C26226Q1066 07-06-2026

X X X ** HOUR & DATE for Receipt of Offers is EXTENDED to: 07-20-2026 1:00PM MDT See CONTINUATION Page X The purpose for this amendment is to respond to questions and to extend the closing due date for offers.

All offers are due NLT July 20, 2026, at 1:00 PM MST. Offerors shall be submitted via email to: Felicia Simpson, Contract Specialist at Felicia.Simpson@va.gov.

A.1 PRICE/COST SCHEDULE

ITEM INFORMATION

Base Year Funding for Portable Home Sleep Apnea Testing.

Contract Period: Base POP Begin: 08-01-2026 POP End: 07-31-2027 PRINCIPAL NAICS CODE: 339112 - Surgical and Medical Instrument Manufacturing PRODUCT/SERVICE CODE: Q521 - Medical - Pulmonary

Option Year One Funding for Portable Home Sleep Apnea Testing.

Contract Period: Option 1 POP Begin: 08-01-2027 POP End: 07-31-2028

Option Year Two Funding for Portable Home Sleep Apnea Testing.

Contract Period: Option 2 POP Begin: 08-01-2028 POP End: 07-31-2029

Option Year Three Funding for Portable Home Sleep Apnea Testing.

Contract Period: Option 3 POP Begin: 08-01-2029 POP End: 07-31-2030

Option Year Four Funding for Portable Home Sleep Apnea Testing.

Contract Period: Option 4 POP Begin: 08-01-2030 POP End: 07-31-2031

A.2 DELIVERY SCHEDULE

Cart T. Hayden Medical Center 650 E. Indian School RD.

Phoenix, AZ 85012

USA

602-277-5551 x1115 Danette Venegas@va.gov

CONTINUATION PAGE

Question and Answers 36C26226Q1066

1. Pricing/Quantity: Section B lists each annual CLIN as 1 EA. Should Offerors provide an all-inclusive unit price per completed valid HSAT? If so, what estimated annual quantity should be used to calculate the CLIN total?

ANSWER: CLINs have been updated from 1 to 3000.

2. Prior RFQ Clarifications: Do any technical or operational clarifications issued under prior RFQ 36C26226Q0658 apply to this reissued requirement?

ANSWER: Yes, previous clarifications from RFQ 36C26226Q0658 apply.

3. VAAR Certifications: For a non-SDVOSB/non-VOSB small business Offeror, VAAR 852.219-75 and 852.219-76 should be marked Not Applicable, omitted, or supported by a statement of non-applicability?

ANSWER: This is not required nor is it in solicitation 36C26226Q1066.

4. Solicitation Identifier: Please confirm the correct RFQ number and required email subject line for proposal submission, as variations of the solicitation identifier appear within the RFQ.

ANSWER: The solicitation is 36C26226Q1066 and the email address is felicia.simpson@va.gov.

5. Equal/Alternative Technology: May an Offeror propose an FDA-cleared Type III HSAT solution that meets the required physiological measurements and clinical objectives using alternative sensing technology in place of traditional respiratory belts and a nasal airflow/pressure sensor, provided the Offeror demonstrates equal or superior functional and clinical performance?

ANSWER: No, please submit devices that meet the salient characteristics as outlined in the SOW.

6. Somnoware Integration: Would the Government consider a secure, functionally equivalent interoperability approach that provides required raw and/or scored study data for VA clinical review, rather than requiring existing native Somnoware integration?

ANSWER: Somnoware integration and capability is required.

7. Does this RFP require boarded sleep physician interpretation or are the VA physicians completing the interpretations? On page 35 under Patient Study Processing (Task 5.2 Task 2) “Capability to deliver Sleep Study Interpretations (digital).” However, on the top of page 29 it states “upon completion of the tests….to a secure portal for VA physician review….to be sent to a VA secure portal for Physician review.” Further, page 30 under 6. Deliverables states “ Sleep study report per patient” which would typically indicate the raw data report rather than an interpretation. Please clarify if the final product is the sleep study data report or a fully interpreted sleep study.

ANSWER: VA sleep providers will be doing the final interpretation.

8. In order for any type III sleep study devices to “interface with the VA’s Somnoware system” as required on page 29 under 4. Minimum salient characteristics, this type of medical device requires being initialized/connected to a VA computer. However, on page 30 9. Government Furnished Equipment (GFE), it clearly states that “there will be no GFE or GFI based on contractor sending disposable sleep study device via direct mail to patient.” Further, there are no disposable Type III sleep study devices on the market. Therefore,

a. Are type IV disposable devices allowed to be used that do not meet all of the minimum salient characteristics on page 29 that could be connected remotely to the VA’s Somnoware system?

ANSWER: The Type IV device needs to meet the salient characteristics. There needs to be a way to pull the information into the VA Somnoware platform, it can be through a portal or cloud base system that works with Somnoware and meets TRM requirements.

b. Also under this section, it states “VA logs into contractor’s Database.” Could our proposal use our own secure instance of Somnoware instead of the VA’s Somnoware instance to initialize Type III devices that meets all other minimum salient characteristics on page 29.

ANSWER: The VA must be able to pull the data into VA Somnoware for VA sleep Interpretation.

c. Page 35 indicates “the vendor shall have capability of sending Veteran disposable OR reusable type III home sleep testing equipment”—are there any specifications for the disposable devices?

ANSWER: The disposables device proposed must meet the salient characteristics.

9. Given the short interval between question submission and response date, would it be possible to extend the submission date by a few days?

ANSWER: Yes, this will be extended to July 20, 2026

10. Since the contractor is responsible for replacing units that are lost or not returned, is it permissible offer a gift card to the veterans as a thank you for returning the units?

This would benefit both the VA - more test results and the contractor - less units lost.

ANSWER: Per FAR 31.205‑13 – Employee Morale, Health, Welfare, Food Service, and Dormitory Costs This cost principle states that “costs of gifts are unallowable.” Gift cards fall squarely under “gifts,” making them unallowable costs for contractors charging the Government under a contract.

This applies whether the contractor or the Government is considering providing gift cards to veterans.

11. Is this the first time the Department of Veterans Affairs has solicited this requirement, or is this a follow-on procurement?

ANSWER: No, this is not the first time it was solicited, and no award was made from the previous solicitation.

12. If this is a follow-on procurement, could you identify the incumbent contractor and, if available, the value of the previous contract?

ANSWER: N/A

13. Could you provide the historical workload associated with this requirement, such as the approximate monthly or annual volume of home sleep apnea tests or devices utilized?

ANSWER: Previous contract was 200-300 per month. This was limited by the amount of tests that were contracted.

14. Beyond the evaluation criteria identified in the solicitation, are there any technical capabilities or performance considerations that the Government views as particularly important when evaluating proposals?

ANSWER: Read Section E of the solicitation.

15. An SBA Nonmanufacturer Rule waiver applies to this procurement or product category ANSWER: No, this does not apply to the Portable Home Sleep Apnea Device Testing

16. Foreign-manufactured devices are permissible under this set-aside.

ANSWER: Devices used must be FDA approved to be used the United States. Device Software must meet the federal TRM requirements.

AMENDMENT ONE IS FOR RESPONDING TO QUESTIONS AND EXTENDING CLOSING DATE.