36C26225Q0220 0002.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) 12-19-2024 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

36C26225Q0220

X X X X ** HOUR & DATE for Receipt of Offers is EXTENDED to: 01-06-2025 1:00PM MST See CONTINUATION Page X The purpose of this amendment is to extend the due date of quotes from 12/23/2025 to 1/6/2025 1:00 PM MST and questions, are due by 12/30/2024 at 1:00 PM MST.

Updated the Statement of Work and instructions to offers.

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 to not be acceptable and will not be evaluated.

CONTINUATION PAGE

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.

Providers should consider empiric treatments and alternative diagnostic modalities that do not require in-person visits (e.g., home sleep apnea 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, direct to home disposable sleep studies to our Veteran population through a mail order service. The contractor shall prepare the disposable 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 home sleep study device on the scheduled test day in order 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. Once the device is uploaded, 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. The testing device needs to be disposable.

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 on the wrist 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. The device is disposable per contractor.

4. Minimum Salient Characteristics: The home sleep testing device is diagnostic testing equipment that utilizes the Peripheral Arterial Tone (PAT) signal. It measures up to 7 channels (PAT signal, heart rate, oximetry, actigraphy, body position, snoring and chest motion) via three points of contact. Within one‐minute post‐study the raw data is downloaded and auto‐scored identifying all types of apnea events. Sending the HSATs to patients’ home, providing 24‐hour assistance, also will provide help with scoring the studies. These disposable systems will allow the VA to decrease the waiting time and will ease the Veterans that live far away by having them shipped to their homes.

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 Nadia Hasaneen, 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 contractor point of contact Mr. Matthew Plummer. Results will go to Nadia Hasaneen, 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. Pulmonary Department - Pulmonologist – Nadia Hasaneen, 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.

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 quote. 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 quotation submitted in hard copy format shall include one copy of the quote. If an alternative quote is submitted, the Contractor shall submit one copy of the alternative quotation.

IAW FAR 13.106-2(b)(3), a Comparative Evaluation will be performed to evaluate all quotes.

Evaluation Approach. The Government will evaluate quotations using the comparative evaluation process outlined in FAR 13.106-2 (b) (3), where quotations will be compared to one another to determine which provides the best benefit to the Government. The Government reserves the right to consider a quotation other than the lowest price that provides additional benefit(s). Quotations may exceed minimum requirements of the solicitation. The Government reserves the right to select a quotation that provides benefit to the Government that exceeds the minimum requirements of the solicitation but is not required to do so. Each response must meet the minimum requirements of the solicitation.

Required Submittals: In order to evaluate the vendor’s experience and qualifications, the following documentation shall be submitted with their quote:

1. File #1: General Information/Technical Approach:

The quotation will be evaluated to the extent to which it can meet and/or exceed the Government’s requirements as outlined in the solicitation and based on the information requested in the instructions to quoters section of the solicitation.

Contractor shall obtain all necessary licenses required to perform this work. Contractor shall take all precautions necessary to protect persons and property from injury or damage during the performance of this contract. Contractor shall be responsible for any injury to himself/herself, his/her employees, or others, as well as for any damage to personal or public property that occurs during the performance of this contract that is caused by him/her or his/her employees’ fault or negligence. Contractor shall maintain personal liability and property damage insurance prescribed by the laws of the Federal Government. Statement of Work (SOW) shall not be used as your TECHNICAL APPROACH for the requirement of Portable Sleep Studies. Technical Approach shall consist of how you will achieve the work and how it will be completed.

FACTOR 1: Contractor must be able to mail directly to the patient the device per the SOW.

FACTOR 2: Contractor must be able to provide the technical and functional activities at the required level for integration of all tasks specified within this SOW.

FACTOR 3: Contractor must be able to 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.

FACTOR 4: Contractor must provide the deliverables per the SOW.

FACTOR 5: Contractor must be Technical Reference Model (TRM) approved with the VA. Verification of submittal must be with offer and link is provided for all approved IT capabilities VA Technical Reference Model.

2. File #2: Price/Cost Schedule:

The offeror 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.

3. File #3: Previous Experience: Offeror must provide technical narrative demonstrating, completion of three or more projects compatible cost within the last five (5) years similar in scope, magnitude, and complexity of the current action.

4. File #4: Past Performance

a. No Price information shall be included in the technical proposal (File #2).

b. Past Performance: Past Performance as pertains to Contractor Performance Assessment Report (CPARS) or list of past jobs which specialist may verify performance.

Provide evidence of satisfactory past performance within the last (5) five years from the date of issuance of this RFQ for (2) two projects of a similar scope to that described by the Performance Work Statement associated with this solicitation. Include in the past performance contact information, including e-mail address(es), for the provided examples.

5. File #5: Other Requirements:

The offeror shall submit the required information listed below as part of their quote:

a. Verification of submitted VA Form 10091 and confirmation of W-9 faxed to Austin, TX.

b. FMS Vendor File Update Form

c. Verification of Registration in System for Award Management (SAM)

d. VAAR 852.219-75 and -76 certifications shall be signed and filled out at the time of bid/quote/offer submission. If VAAR 852.219-75 and -76 certifications is not signed nor filled out, then your offeror shall not be evaluated.

Options:

The Government will evaluate quotations for award purposes by adding the total price for all options to the total price for the basic requirement. This includes options under FAR 52.217-8, Option to Extend Services. The Government intends to evaluate the option to extend services under FAR 52.217-8 as follows: The evaluation will consider the possibility that the option can be exercised at any time and can be exercised in increments of one to six months, but not for more than a total of six months during the life of the contract. The evaluation will assume that the prices for any option exercised under FAR 52.217-8 will be those rates in effect under the contract each time an option is exercised under this clause. The evaluation will therefore assume that the addition of the price or prices of any possible extension or extensions under FAR 52.217-8 to the total price for the basic requirement and the total price for the priced options has the same effect on the total price of all quotes relative to each other and will not affect the ranking of quotes based on price, unless, after reviewing the quotes, the Government determines that there is a basis for finding otherwise. This evaluation will not obligate the Government to exercise any option under FAR 52.217-8.

Quotes 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 Government email server. Quotes must also be in PDF, and compatible with Microsoft Office Software to be accepted. The Contractor submitting a quote is responsible for ensuring that the contract specialist has received the quote before the deadline for receipt of quotes, 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.

System for Award Management: IAW FAR 52.212-4 (t) Contractors submitting quotes are encouraged to go to the SAM database at https://www.sam.gov/portal/public/SAM and start the registration process as soon as possible to avoid possible delays should the contractor be selected as a prospective awardee. After initial registration, the contractor is required to update registration data as changes occur and must re-register annually to ensure all data remains current. Noncompliance with this requirement will preclude the exercising of any option periods that may be included herein and will be cause for termination of the contract at such time noncompliance is discovered. Refer to cited Clause for more details.

GENERAL INSTRUCTIONS FOR QUOTATION SUBMISSION

Format of Quotation: In order to be considered for selection, the Contractor must submit a complete response to this solicitation using the sequence and format instructions provided. Quotes 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 Quotation, as appropriate. To reduce quote size, the Contractor submitting a quote shall confine submission to essential matters sufficient to define the quotation and provide an adequate basis for evaluation. The Quotation shall not contain classified data. NO ZIPPED FILES are permitted.

The Contractor submitting a quote may be asked to clarify certain aspects of their quotation. Communication conducted to resolve minor or clerical errors will not be constituted as discussions. Although the government intends to award the contract without discussions with respective Contractors, the government reserves the right to conduct discussions if deemed in its best interest.

Submittal Instructions: The Contractor’s quotation must be labeled with the Contractor’s name and business address of the firm, the solicitation number 36C26225Q220_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# 36C26225Q220_1, - Portable Sleep Studies”. All information submissions must be received no later than 1:00 pm MST on January 6, 2025.

The Contractor is advised that all submissions and related materials become the property of the U.S. Government and will not be returned. Quotations, if accepted by the Government, will form binding parts of the contract that results from this solicitation. Therefore, care must be taken to properly address the requirements set forth in this RFQ.

Questions: All questions must be submitted by email to felicia.simpson@va.gov no later than 1PM (MST) on December 30, 2024. The Government reserves the right to not answer questions not meeting this timeline if doing so would result in an amendment requiring and extension of the solicitation and the extension would not be in the best interest of the Government. All responses to questions will be provided on the spot or posted on Federal Business Opportunities no later than January 2, 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.

The following provisions are incorporated into 52.212-1 as an addendum to this solicitation:

AMENDMENT TWO IS TO EXTEND THE OFFER DUE DATE AND UPDATE THE INSTRUCTIONS TO OFFERS AND SOW.

A.1 PRICE/COST SCHEDULE

ITEM INFORMATION

Base Year Funding for Home Sleep Apnea contract, POP January 20, 2025, to September 30, 2025.

Contract Period: Base POP Begin: 01-20-2025 POP End: 09-30-2025 PRINCIPAL NAICS CODE: 621498 - All Other Outpatient Care Centers PRODUCT/SERVICE CODE: Q521 - Medical - Pulmonary

Base Year Funding for Home Sleep Apnea contract, POP October 1, 2025, to September 30, 2026.

Contract Period: Option 1 POP Begin: 10-01-2025 POP End: 09-30-2026

Base Year Funding for Home Sleep Apnea contract, POP October 1, 2026, to September 30, 2027.

Contract Period: Option 2 POP Begin: 10-01-2026 POP End: 09-30-2027

Base Year Funding for Home Sleep Apnea contract, POP October 10, 2027, to September 30, 2028.

Contract Period: Option 3 POP Begin: 10-01-2027 POP End: 09-30-2028

Base Year Funding for Home Sleep Apnea contract, POP October 10, 2028, to September 30, 2029.

Contract Period: Option 4 POP Begin: 10-01-2028 POP End: 09-30-2029

A.2 DELIVERY SCHEDULE

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

Phoenix, AZ 85012

USA

(602) 277-5551 7780 michael.sierra@va.gov