36C26225Q0902 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) 06-16-2025 644-25-2-425-0009 None 36C262

NCO 22

Department of Veterans Affairs NCO 22 - Network Contracting 650 East Indian School Road Phoenix AZ 85012 36C262

NCO 22

Department of Veterans Affairs NCO 22 - Network Contracting 650 East Indian School Road Phoenix AZ 85012 To all Offerors/Bidders

36C26225Q0902

X X X X

1. The purpose for this amendment is to respond to questions, update the SOW and to fix the wording in the instructions to offers.

2. All questions are due NLT June 24, 2025, at 1:00 PM MST. All offers are due NLT June 30, 2025, at 1:00 PM MST.

Offerors shall be submitted via email to: Felicia Simpson, Contract Specialist at Felicia.Simpson@va.gov.

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

CONTINUATION PAGE

E.1 ADDENDUM to FAR 52.212-1 INSTRUCTIONS TO OFFERORS—COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES

INSTRUCTIONS TO OFFERORS:

Offerors are notified that VA Form 10091, FMS Vendor File Request Form and W-9, Request for Taxpayer Identification Number and Certification (see SECTION D for attached documents) shall be faxed or emailed https://www.cep.fsc.va.gov directly to the VA Financial Service Center in Austin, Texas and be submitted with their offer. Failure to include this information can eliminate the offeror from award consideration or considerably delay the award.

How to Access CEP Access the CEP using this link: https://www.cep.fsc.va.gov The new Customer Engagement Portal meets AccessVA Security Protocol that requires Two-Factor Authentication/Verification (2-FA) for all users. AccessVA has partnered with ID.ME to provide the required 2-FA for all non-government users. Please register a new Customer Engagement Portal (CEP) user account. Once ID.Me has completed the 2-FS, you will be redirected to Customer Engagement Portal (CEP) us the 10091 webform link found on the welcome page.

Each OFFER submitted in hard copy format shall include one copy of the offer. If an alternative offer is submitted, the Contractor shall submit one copy of the alternative OFFER.

Offers submitted by email shall be sent to felicia.simpson@va.gov and will be accepted by the Government at the time the email is delivered to the contract specialist email box. Offers must also be in PDF, and compatible with Microsoft Office Software to be accepted. The Contractor submitting an offer is responsible for ensuring that the contract specialist has received the offer before the deadline for receipt of offers, and the government will not be responsible for delays or failures or either the contractor’s email system or the Government’s email system. Facsimile offers will not be accepted.

Quote Submittal Requirements: Offerors are required to include the following information with their quote submissions.

Factor 1 – Experience. This factor will be used to assess the Offeror’s experience providing sleep apnea testing. The Government will assess the Offeror’s experience, as well as the experience of the Offeror’s proposed subcontractor(s), if any are proposed. For each reference contract the Offeror submits as evidence of its offered experience providing sleep apnea testing, the Offeror’s narrative must clearly state the following information:

i. the legal name of entity with whom the Offeror (or the Offeror’s proposed subcontractor) held the contract;

ii. the contract number;

iii. a description providing details of the specific tasks the Offeror (or the Offeror’s proposed subcontractor) performed under that contract;

iv. in what geographic location the Offeror (or the Offeror’s proposed subcontractor) performed these services;

v. the dates during which the Offeror (or the Offeror’s proposed subcontractor) performed the contract;

vi. the number of buildings and height (number of stories of each building) for which the Offeror (or the Offeror’s proposed subcontractor) provided sleep apnea testing under that contract;

vii. whether the provided reference contract is for services provided by the Offeror or provided by a proposed subcontractor of the Offeror’s. If the claimed experience is for a proposed subcontractor, provide the full legal name of the proposed subcontractor;

viii. whether the Offeror (or the Offeror’s proposed subcontractor) was the prime contractor or a subcontractor for that contract; and

ix. the name, phone number, and email address of a person at the entity with whom the Offeror (or the Offeror’s proposed subcontractor) held the contract who can verify the information the Offeror provides in the narrative description for this factor.

The information requested above is required for the Government to evaluate proposals for the Experience evaluation factor. General statements claiming experience providing sleep apnea testing that do not include specific references to prior contract work, or that do not include the information required above, are not acceptable. FAILURE TO SUBMIT THE INFORMATION REQUIRED ABOVE TO SUPPORT THE OFFEROR’S CLAIMED EXPERIENCE MAY BE VIEWED BY THE GOVERNMENT AS EVIDENCE THAT THE OFFEROR (OR THE OFFEROR’S PROPOSED SUBCONTRACTOR) LACKS EXPERIENCE IN PROVIDING SLEEP APNEA TESTING WHEN EVALUATING PROPOSALS FOR THE EXPERIENCE EVALUATION FACTOR.

Factor 2 – Price. This factor will be used to assess the reasonableness of the Offeror’s proposed price. Offerors shall submit their pricing within the schedule, Section B, of the SF 1449. The offeror shall properly complete the solicitation document (SF 1449) along with any amendments (SF 30), if any are issued. Complete Blocks 12, 17a (please include Unique Entity Identifier (UEI), 30a, 30b, and 30c of the Standard Form SF1449.

GENERAL INSTRUCTIONS FOR OFFEROR SUBMISSION

Format of offer: In order to be considered for selection, the Contractor must submit a complete response to this solicitation using the sequence and format instructions provided. Offers shall be clear and concise, logically assembled (with all pages appropriately numbered) and indexed and cross-indexed to applicable parts of the Statement of Work (SOW) or Request for Offer, as appropriate. To reduce offer size, the Contractor submitting an offer shall confine submission to essential matters sufficient to define the offer and provide an adequate basis for evaluation.

Submittal Instructions: The Contractor’s offer must be labeled with the Contractor’s name and business address of the firm, the solicitation number 36C26225Q0902_1 and point of contact to include name, telephone, and email address. The Government is not responsible for identifying inconsistencies between the two and may rely on either version at its discretion.

All interested Offerors should submit information by e-mail to felicia.simpson@va.gov. All e-mails must have as the subject line “RFQ# 36C26225Q0902_1, - “Portable Sleep Apnea Test”. All information submissions must be received no later than 1:00 pm MST on June 30, 2025.

The Contractor is advised that all submissions and related materials become the property of the U.S. Government and will not be returned.

Questions: All questions must be submitted by email to felicia.simpson@va.gov no later than 1PM (MST) on June 24, 2025.

Provisions that are incorporated by reference (by Citation Number, Title, and Date), have the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available.

Questions and answers 36C26225Q0902 Sleep Apnea Test

1. The VA proposal appears to be structured in a way that results in a high-cost bid, limiting the equipment to a single unit type (Itamar WatchPAT One) and designating it as a set-aside for Veteran-Owned Small Businesses (VAOSB). Could the proposal be revised to include additional equipment types and open eligibility to a broader pool of small businesses? This approach could enhance governmental efficiency by balancing cost and quality, ensuring the best value for the government while maintaining high standards and increasing competition.

Answer: We are not designating that be solely offered to only VAOSB companies. Other devices that use different technology have more hardware that must be attached to the patient that often leads to patient not being able to put it on correctly as well as more items that can come off during the night making the study invalid, thus having to repeat the study or send them for in lab sleep study that costs considerably more to do. Minimizing the hardware that the veteran must wear and operate leads to more successful studies cutting down on cost. There are numerous devices that use PATsignal with some offering more than the required Minimum of 4 channels and have less hardware than the WatchPAT; Compumedics Somfit and Night Owl are examples of other devices both disposable and use PATsignal.

2. Are these services currently being provided under an existing contract?

Answer: No

3. If so, could you please share the contract/award number?

Answer: No contract has been awarded.

4. For ITEM NUMBER 0001, under "QUANTITY," the value is listed as 3, and under "UNIT," it is indicated as "MO." This does not match with the SOW where each device is being shipped, shouldn’t quantity be the total # of devices being requested for the contract year? Please clarify?

Answer: Quantity was 3000 testing devices for the year (Appears the quantities down the page are incorrect).

5. Interpretation and Diagnosis of Results: Is the interpretation and diagnosis of HST results expected to be provided by the offeror? Specifically, does a certified MD need to interpret the results and provide a diagnosis report, which will then be sent to PVAHC? Please confirm and clarify.

Answer: The VA sleep RPSGT will be doing the overscore and the VA providers will be doing the interpretations.

From section 3. Scope: The patient wears the device per the device manufacturer’s instructions and upon completion of the test the data is sent via the patients previously downloaded phone app to a secure portal for VA physician review or is shipped back to the contractor for download to be sent to a VA secure portal for Physician review.

From section 4: Results shall be immediately available through Somnoware if using disposable type IV peripheral arterial tone-based home sleep testing equipment for provider evaluation and review. The results should be available within 2-3 days if using reusable type IV peripheral arterial tone-based home sleep testing equipment pending timely return of the device from Veteran.

6. Required Forms for Proposal Submission: The solicitation requests submission of W-9, VA Form 10092, and the FMS Vendor File Update Request Forms, with proposals being deemed non-compliant if these forms are not provided. If the offeror is already registered and engaged in invoicing the VA for other contracts via the OB10 Tungsten-IPPS system, are these forms still required? This offeror has already completed the registration process through the Austin office.

Please confirm if these forms are necessary in such cases.

Answer: Yes, the vendor would be considered non-compliant if the forms were not provided. Yes, we must verify for each vendor that they are following the instructions to offers.

7. On page 32, Factor 1 – Experience, this is requesting experience regarding window washing services and not home sleep test. You may want to revisit and update to reflect the requested services in this solicitation (home sleep test). Also on page 33, Factor 1 – Experience also reference window washing services.

Answer: The experience will be updated to fit the sleep apnea test requirement.

8. Veteran Responsiveness and Study Completion: Based on prior experience providing similar services, we have observed that veterans are often unresponsive in completing their HST after receiving the devices, requiring multiple follow-ups. Section 11 of the delivery schedule specifies that the study must be completed within 45 days. For cases where veterans are unresponsive despite offeror outreach, will PVAHC provide support to the offeror to facilitate the completion of these studies?

Answer: No additional support will be provided. We initially contact the veteran making them aware of the company that will be contacting them for their HST.

9. Sam.gov says the due date is June 16 but the Solicitation says it is due June 30th. Can you please clarify?

Answer: All offers are due June 30, 2025, at 1:00 PM MST to Felicia Simpson, Contract Specialist at Felicia.Simpson@va.gov.

10. The problematic language is on page 25 under Minimum Salient Characteristics---"Minimum Salient Characteristics: The type IV home sleep testing device is diagnostic testing equipment that utilizes that shall use Peripheral Arterial Tone (PAT) signal.

The device shall measure at a minimum 4 channels or more (PAT signal, heart rate, oximetry, actigraphy, AHI) via points of contact on the device worn. The device shall have the following capability of monitoring and recording central apnea, obstructive apnea, hypopnea, oximetry, heart rate, and snore sensor. Device shall be void of respiratory belts, airflow sensor, or need of additional monitoring sensors.”

This is essentially the definition of a WatchPAT One device---there are numerous other FDA disposable home sleep tests on the market and there are some others that interface with Somnoware as well. Itamar only allows one or two vendors to provide their services to the VA so you are greatly limiting competition by writing it this way.

Answer: Please see response to question 1. The fewer sensor that a veteran needs to place on themselves results in less invalid studies, cutting down on the need to retest.

STATEMENT OF WORK

1. Contract Title: Portable Sleep Studies

2. Background: The Phoenix VA Health Care System (PVAHCS) anticipates continued and increased emphasis for home sleep testing as we transition clinical programs involving greater use of alternatives to face-to-face medicine. The pertinent excerpt of the referenced communication is below:

“Non-urgent pulmonary/sleep procedures should be deferred to minimize unnecessary risk to patients. These include, but are not limited to pulmonary function testing, 6-minute walk tests, methacholine challenge testing, surveillance bronchoscopy, in-person pulmonary rehabilitation, lung cancer screening, and polysomnography.

In addition, home sleep testing increases the access to care to rural and aging veterans that are unable to complete an in-lab sleep study as well as provide timely diagnosis and treatment of sleep disorders.

Providers should consider empiric treatments and alternative diagnostic modalities that do not require in-person visits (e.g., home sleep testing) while these procedures are deferred. To assist as we shift to alternatives to face-to-face clinical care, the contractor shall provide the PVAHCS as ordered, the type IV home sleep study testing devices to our Veteran population through a mail order service. The contractor shall prepare the type IV home sleep testing device per the instructions of the patient’s provider and then ship it to the patient. The contractor shall provide phone service to support the Veteran in the use of the type IV home sleep study device on the scheduled test day to review test instructions. After the patient completes the test in their own home, the Veteran will upload the device to the Contractor’s site the next day using the contractor’s application through Bluetooth or ship the device back to the contractor per their instruction for the device to be downloaded. Once the device is downloaded, the contractor shall upload the test results to a cloud-based server, where the referring physician can retrieve it for evaluation. The device and software need to be compatible with the VA National Somnoware program used for the VA for the interpretation by the reading providers and with VA EHR.

Amounts are provided for estimates only and are not guaranteed, quantities will be listed on funded task orders as needed.

3. Scope: The purchased units will be shipped directly from the vendor to the patient with 24/7 vendor support to the patient. The patient wears the device per the device manufacturer’s instructions and upon completion of the test the data is sent via the patients previously downloaded phone app to a secure portal for VA physician review or is shipped back to the contractor for download to be sent to a VA secure portal for Physician review.

4. Minimum Salient Characteristics: The type IV home sleep testing device is diagnostic testing equipment that utilizes that shall use Peripheral Arterial Tone (PAT) signal.

The device shall measure at a minimum 4 channels or more (PAT signal, heart rate, oximetry, actigraphy, AHI) via points of contact on the device worn. The device shall have the following capability of monitoring and recording central apnea, obstructive apnea, hypopnea, oximetry, and heart rate. Device shall be void of respiratory belts, airflow sensor, or need of additional monitoring sensors. The device shall interface with the VA’s Somnoware system, TRM Approved software, and VA EHR.

The vendor shall provide timely mailing services of the testing device to and from the user and notify veteran the device is enroute. Vendor shall provide 24/7 troubleshooting and customer support. Providers shall be able to drop ship orders through Somnoware to vendor. The vendor shall have capability of sending Veteran disposable OR reusable type IV peripheral arterial tone-based home sleep testing equipment. Vendor shall be responsible for all leads, probes, attachments, batteries, and needed consumables needed for the device to interface with the user. The vendor shall provide all cleaning and maintenance of all reusable equipment if used. Vendor shall provide patient with return mailing instructions, shipping label and packaging for reusable type IV peripheral arterial tone-based home sleep testing equipment. Results shall be immediately available through Somnoware if using disposable type IV peripheral arterial tone-based home sleep testing equipment for provider evaluation and review. The results should be available within 2-3 days if using reusable type IV peripheral arterial tone-based home sleep testing equipment pending timely return of the device from Veteran. The vendor shall be responsible for all defective equipment and all replacement parts on reusable devices. VA does not assume any fiscal responsibility for any lost, unreturned, or damaged devices. Vendor shall send an itemized invoice monthly of completed and resulted type IV peripheral arterial tone-based home sleep testing equipment. Vendor will only be reimbursed for completed type IV peripheral arterial tone-based home sleep testing.

5. Specific Tasks: This is to provide portable sleep studies. Direct mail to patient will be conducted from contractor. Address listings will be provided by Kyra Clark, M.D., PVAHCS Sleep Medicine Clinic Director; Morgan Kula, Supervisory RRT, RPSGT; or designee to the VA assigned Contract Officer Representative (COR). Assigned COR provides the VA address listings to awarded contractor. Results will go to Kyra Clark, M.D., PVAHCS Sleep Medicine Clinic Director; Morgan Kula, Supervisory RRT, RPSGT; or designee.

5.1. Task 1 - Enterprise Management Controls.

5.1.1. Subtask 1 - Integration Management Control Planning. Provide the technical and functional activities at the required level for integration of all tasks specified within this SOW. Include productivity and management methods such as quality assurance, progress/status reporting and program reviews. Provide the centralized administrative, clerical, documentation, and related functions.

5.1.2. Subtask 2 - Contract Management. Prepare a Contract Management Plan describing the technical approach, organizational resources, and management controls to be employed to meet the cost, performance, and schedule requirements throughout Contract execution. Provide a monthly status report monitoring the quality assurance, progress/status reporting and program reviews applied to this contract.

5.2. Task 2 - Consultation sheet of patient to Pulmonary Department for patient to be tested, 1) Sleep Study Interpretations – digital, 2) Monthly Itemized Invoice – OB 10 Tungsten IPPS, 3) Sleep Study Results - Verbal / Written CPRS – see deliverable schedule details at bottom of statement of work.

5.2.1. Subtask 1 – VA address listing provided to Contractor to send wristband HSAT devices to patient with instructions for proper usage.

5.2.2. Subtask 2 - Patient push button indicating sleep study complete to forward report to PVAHCS Pulmonary Department. Portable band is discarded by patient after test.

6. Deliverables: Sleep Study Report per patient with monthly invoicing for all Sleep Studies mailed out, returned by patient, and uploaded to the VA. Certifier of Invoices – Assigned VA CORs:

Primary COR - Michael Sierra, Administrative Officer/FAC-COR III Alternate COR - Danette Venegas, Program Specialist/FAC-COR I

7. Performance Monitoring: Each study will be reviewed by the local VA physician and inadequate function of the product shall be reported.

8. Security Requirements: From VA Project Special Forces: This acquisition has been reviewed and is categorized as a Software-as-a-Service (SaaS) by PSF. Additionally, VA Enterprise Center (VAEC) or Technical Reference Model (TRM) approval is required. Critical Decision 1 approved on 4/22/2020 VIPR #: V20-04292-001. This SaaS Product processes: No VA Data SaaS product has no direct connections or interfaces to VA systems or network Users consent to share their data (which may include PII and PHI) directly with the SaaS provider. SaaS provider must have published terms and conditions for user consent. VA providers access data in a view-only mode, or with limited functionality per the user’s consent. All data processed by SaaS provider shall be owned by SaaS provider/user.

9. Government-Furnished Equipment (GFE)/Government-Furnished Information (GFI):

VA logs into contractor’s Database – Hospital and Specialty Medicine Service Line, Pulmonary Department Sleep Study Administrative Staff, Morgan Kula, Supervisory RRT, RPSGT; or designee, gives information. Sleep Department Site Director–Kyra Clark, M.D., or designee gets the results. There will be no GFE or GFI based on contactor sending disposable sleep study device via direct mail to patient.

10. Packaging, Packing and Shipping Instructions: Direct shipping to the patient is implicit. The packing slip will be received by the patient. Must include return shipping instructions and postage.

11. Delivery Schedule:

SOW TASK #

Deliverable Title

Format

Number Calendar Days after CO Start

- IPPS

EHR

12. Holiday info:

The following Federal holidays are observed by the Federal Government: The Contractor is not required to provide services on the following National Holidays, nor shall the contractor employee be paid for those days.

When a holiday falls on a Sunday, the following Monday shall be observed as a legal holiday by U.S. Government agencies. When a holiday falls on a Saturday, the preceding Friday shall be observed as a legal holiday. Also, included would be any other day specifically declared by the President of the United States to be a National Holiday.

13. INVOICE and PAYMENTS:

Contractor shall submit monthly invoices in the arrears electronically via the Tungsten-Network System at the end of each month, for payment of the storage containers in that billing period. Contractor shall submit original invoice electronically to:

Department of Veterans Affairs Financial Services Center http://www.tungsten-network.com (Toll-free telephone number: (877) 489-6135)

Payment shall be made monthly in the arrears upon receipt of properly prepared invoice.

The invoice MUST be itemized to include the following information. Any information listed below that is not provided on an invoice, will render that invoice incomplete and the invoice will be returned for immediate correction.

a. Dates of service.

b. Description of services.

c. Invoice number, date.

d. Contract number.

e. Obligation number

Failure to comply with the above shall delay payment to the Contractor.

AMENDMENT ONE IS TO RESPOND TO QUESTIONS, UPDATE THE SOW AND UPDATE E.1 INSTRUCTIONS TO OFFERS.