36C26226Q0658 0004.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) 06-09-2026 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 4135 S. Power Rd #103 RM 116 Mesa AZ 85212 To all Offerors/Bidders

36C26226Q0658 05-13-2026

X X X X The purpose for this amendment is to respond to additional questions received for the sleep apnea testing.

All offers are due NLT June 15, 2026, at 1:00 PM MST. Offerors shall be submitted via email to: Felicia Simpson, at Felicia.Simpson@va.gov.

Contractor shall sign clause 852.219-75 VA NOTICE OF LIMITATIONS ON SUBCONTRACTING-CERTIFICATE OF COMPLIANCE FOR SERVICE AND CONSTRUCTION (JAN 2023) (DEVIATION) pg 28 of the solicitation.

ALL OFFERS SHALL SUBMIT ALL DOCUMENTATION UNDER SECTION E and all AMENDMENTS, failure to provide any required document and acknowledgment of all amendments will result in the offer not being accepted and will not be evaluated.

CONTINUATION PAGE

36C26226Q0658 Portable Sleep Home Apnea Testing

1. Could you please provide the approximate historical volume of completed Type III Home Sleep Apnea Tests (HSAT) ordered by PVAHCS Sleep Medicine per contract year (or per fiscal year) under the prior contract for this requirement? Alternatively, if exact figures are not available, an estimated annual range of studies expected under the resulting contract would be helpful.

ANSWER:

Previous HAST Contract:

Itamar Medical, Inc. 36C25821F0073. 07/08/2021-12/30/2024 Grand Total for all Contract Years: 4060 Base Period of Performance 07/08/2021-06/30/202 PO 644C103142, Amount: 261 Option Year 1, 07/01/2022-06/30/2023, PO 644C20149, Amount: 613 Option Year 2, 07/01/2023-06/30/2024, PO 644C30263, Amount: 2056 6 Month Extension. 07/01/2024- 12-30-2024, PO 644C40261, Amount: 1130

2. Is the quantity in the price/schedule of 1, is this correct quantity?

ANSWER: We are asking for 3000 HSATs for the base year and 3000 HSATs for each option year.

3. Are WatchPAT devices considered compliant with the requirement that the HSAT device be a Type III device with at least 7 channels?"

ANSWER: No, we need a device that can be used on all veterans with no limitations on who it can be used on. No. WatchPAT devices are not compliant with our request. We are not requesting devices that utilize PPG or PAT technology.

4. Shall the offer include cost for physician interpretations provided for each test?

ANSWER: No, the cost should not, the VA sleep providers will be doing the interpretations.

5. The amended solicitation indicates an estimated quantity of 3,000 tests per contract year. Is this quantity an estimate only, or is there a minimum guaranteed quantity under the contract? Additionally, is there an anticipated monthly average order volume, seasonal fluctuation pattern, or projected mix of disposable versus reusable devices?

ANSWER: Previous contract we were capitated by the limit on test. We had to ask for more test to meet the need. The previous device used for testing was not able to be used on patients and had limitations. We average at a minimum of 200 going out to contract monthly. The volume does spike in the fall and winter months due to seasonal visitors that transfer care while they stay in Arizona during the winter months.

6. Will the Government provide a test environment, validation process, or implementation period to confirm compatibility with VA Somnoware, VA EHR systems, and any applicable cybersecurity, interoperability, TRM, or integration requirements? If not, must full integration be operational at award?

ANSWER: Full integration or a platform that already integrates and is approved TRM and only requires setting up the new site for use is needed immediately.

7. Does the Government require scored studies only, or must offerors also provide raw data files? Are physician interpretations performed exclusively by VA providers, and are there required report formats, templates, or data fields for transmitting results through Somnoware? Would the VA provide a prior report for example?

ANSWER: If a device is used the Phoenix VA that does not have software for studies needs to be scored. Raw data files for software we currently use are fine as they will be overscored by sleep technicians at Phoenix VA. Finalized reports that go for interpretation are generated by Phoenix VA Staff using the approved formats the National Sleep program for VA has authorized. Data will be imported to these files. Only VA sleep providers will be doing interpretation.

8. What are the required service levels for order fulfillment, including shipment turnaround times, overnight delivery requirements, acknowledgment of orders, and geographic coverage (CONUS, OCONUS, APO/FPO, territories)?

ANSWER: Please refer to SOW for information as it outlines when results should be available once testing is complete based on the device. The government is aware some of these timelines are dictated of the timely performing and possible shipping back of the device by the patient. The delivery area will be areas serviced by the Phoenix VA in Arizona. Orders will be sent through the dropship feature in Somnoware to the vendor for processing and fulfillment. There is no overnight delivery requirement.

9. The solicitation states that the Government assumes no responsibility for lost, unreturned, or damaged devices. Can the Government provide historical loss-rate data from the incumbent contract, and may offerors include anticipated replacement costs within their pricing?

ANSWER: Previous contracts were single use disposable devices, however the in-house testing done by the VA has 3 to 4 at a minimum loss every year. Lost or damaged equipment is at the vendor’s expense.

10. Does the required 24/7 patient support require live personnel at all times, or may after-hours support be provided through an escalation process? Are there minimum response time requirements or multilingual support requirements?

ANSWER: The level of support is determined by the patient’s need. Previous history has shown that patients needed to be able to speak with someone when they needed to trouble shoot or were having difficulty with the device. Having someone on call that calls back to assist is an option, however the call back needs to be timely (no more than 10 to 15 minutes) since the veteran is trying to use the device for testing and is preparing to go to sleep.

11. Will orders be transmitted exclusively through Somnoware, or may secure email or other ordering methods also be utilized?

ANSWER: Orders will be sent through Somnoware exclusively.

12. For pricing purposes, should offerors assume all tests are completed successfully, or should anticipated incomplete studies, failed studies, and retests be incorporated into pricing? Will the Government reimburse costs associated with devices that are shipped but never completed by the Veteran?

ANSWER: The SOW of defines that it is based on completed valid studies.

13. Should pricing include all associated costs, including outbound shipping, return shipping, consumables, device replacement, software licensing, technical support, data hosting, and integration services, or will any of these items be reimbursed separately?

ANSWER: Pricing should be an all-inclusive price incorporating all the components needed to fulfill the contract as outlined in the SOW.

14. For evaluation purposes, will experience providing home sleep testing services to commercial healthcare organizations be considered comparable to Federal or VA experience?

ANSWER: If it is a like kind experience similar to VA or federal agency.

15. Will the Government permit submission of product samples before proposal submission or with proposals, and does the Government anticipate conducting product demonstrations, oral presentations, technical discussions, or evaluator reviews of demonstration units during the evaluation process?

ANSWER: No proposal should include device planned to be used, logistics, and customer service plan.

16. If demonstrations are permitted, may offerors provide demonstration devices for review by clinical stakeholders, sleep medicine personnel, or technical evaluators?

ANSWER: Demonstrations are not needed at this time due to extensive research and use of devices that are on the market by involved stakeholders, sleep providers, and sleep staff.

17. Will the Government identify the composition of the evaluation team, including whether sleep physicians, respiratory therapists, sleep technologists, biomedical personnel, information technology personnel, and/or contracting personnel will participate in the evaluation? Will evaluators include clinical subject matter experts with direct experience utilizing Type III Home Sleep Apnea Testing devices?

ANSWER: The evaluation team will consist of sleep providers, Respiratory therapists, Sleep technologists that are all well versed in the use of type III home sleep testing devices and are clinical subject matter experts.

18. Beyond the minimum salient characteristics, what product attributes, performance outcomes, or differentiators will be considered most important in determining best value?

ANSWER: Ease of use for the patient, quality of instruction given to the patient on use of device and testing process. The contingency plan for malfunctioning device and the process the patient needs to do to get a working device for testing.

19. What are the scores and evaluation process for proposal evaluation: Among the following areas, which will carry the greatest weight during technical evaluation:

• Clinical performance and diagnostic accuracy

• Ease of patient use

• Patient compliance and completion rates

• Data quality

• Somnoware and VA integration

• Customer support

• Logistics and fulfillment

• Cost effectiveness

• Environmental sustainability ANSWER: Refer to page 46 of the solicitation Instruction to offers.

20. Will the Government place value on demonstrated reductions in failed studies, repeat studies, patient abandonment rates, improved patient compliance, improved patient experience, or improved overall health outcomes?

ANSWER: There are values to all these components. These factors help demonstrate a quality testing program.

21. The solicitation permits either disposable or reusable Type III Home Sleep Testing devices. Will the Government consider the environmental, operational, and cost benefits of a fully reusable, recyclable, and completely sanitizable device solution as a positive discriminator during evaluation? If reusable devices are proposed, are there specific cleaning, disinfection, or infection-control requirements beyond manufacturer recommendations?

ANSWER: There will be no discrimination against proposals that are using reusable equipment. The cleaning of the equipment must abide and follow manufacturing instructions for the device. There should be a system in place that can verify the equipment was cleaned before being sent out to another veteran.

22. Does the Government have any preference for disposable versus reusable devices provided all minimum requirements are satisfied?

ANSWER: There is not preference at this time. A device that meets the testing requirements is the preferred device.

23. Is the Government's primary objective to increase patient access, improve clinical outcomes, reduce time to diagnosis, reduce operational burden on VA staff, or achieve a combination of these objectives?

ANSWER: It is a combination of these factors.

24. Does the Government seek a strategic long-term sleep testing solution focused on continuity of Veteran care and improved outcomes, or is the primary focus fulfillment of individual testing requirements on an as-needed basis?

ANSWER: It is to fulfill the individual need of these locations testing requirements.

25. Can the Government provide any information regarding the current contract structure, incumbent performance challenges, lessons learned, or areas where the Government is seeking improvement under the new contract?

ANSWER: This is a new requirement, and no incumbent information is available.

AMENDMENT FOUR TO RESPOND TO ADDITIONAL QUESTIONS.