S06 36C26225Q0562 0001-Amendment 1 QA Responds.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 12

0001 03-13-2025

664-25-2-425-0009

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

TBD

36C26225Q0562

02-27-2025

X

X X

See CONTINUATION Page

X 1

The purpose of this amendment is to respond to questions received.

All offers are due NLT March 19, 2025, at 1:00 PM MST. Offerors shall be submitted via email to: Felicia Simpson, Contract Specialist at Felicia.Simpson@va.gov.

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.

A.1 PRICE/COST SCHEDULE

ITEM INFORMATION

ITEM

NUMBER

DESCRIPTION OF

SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

2,000.00 EA __________________ __________________

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

Contract Period: Base POP Begin: 04-01-2025 POP End: 09-30-2025 PRINCIPAL NAICS CODE: 621610 - Home Health Care Services PRODUCT/SERVICE CODE: Q521 - Medical - Pulmonary

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

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

Home Sleep Apnea contract, POP October 1, 2027, to September

30, 2028.

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

Home Sleep Apnea contract, POP October 1, 2028, to September

30, 2029.

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

GRAND TOTAL __________________

A.2 DELIVERY SCHEDULE

ITEM

NUMBER SHIPPING INFORMATION QUANTITY

DELIVERY

DATE

0001 SHIP TO: Phoenix VA Health Care System Cart T. Hayden Medical Center 650 E. Indian School RD.

Phoenix, AZ 85012

USA

2,000.00 4/1/2025- 9/30/2025

MARK FOR: Micheal Sierra

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

FOB: DESTINATION

1001 SHIP TO: Phoenix VA Health Care System Cart T. Hayden Medical Center 650 E. Indian School RD.

2,000.00 10/1/2025- 9/30/2026

MARK FOR: Micheal Sierra

2001 SHIP TO: Phoenix VA Health Care

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

2,000.00 10/1/2026- 9/30/2027

MARK FOR: Micheal Sierra

3001 SHIP TO: Phoenix VA Health Care

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

2,000.00 10/1/2027- 9/30/2028

MARK FOR: Micheal Sierra

4001 SHIP TO: Phoenix VA Health Care

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

2,000.00 10/1/2028- 9/30/2029

MARK FOR: Micheal Sierra

CONTINUATION PAGE

D.1 STATEMENT OF WORK-BRAND NAME OR EQUAL

1. Background: The Phoenix VA Health Care System (PVAHCS) anticipates continued and increased emphasis for home sleep testing as we transition clinical programs to tele sleep medicine service with virtual or phone appointment to diagnose and treat sleep disorder. Our tele sleep medicine service will provide a convenience, time saving and access to care to our veterans. Due to limited number of laboratory sleep testing with only 2 beds sleep lab at Phoenix VA, we relied mainly on home sleep study which allow veteran to have sleep apnea test in his or her own bed.

To assist as we shift to tele sleep medicine service with home sleep testing, the contractor shall provide the PVAHCS as ordered, direct to home disposable sleep studies to our Veteran population through a mail order service known as WatchPAT Direct or equal. The contractor shall prepare a brand name or equal WatchPATOne kit Product code CS2117002 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 WatchPAT kit or equal on the scheduled test day in order to review test instructions. After the patient completes the test in their own home, the Veteran will ship the device back to Contractor the next day a label for the return of the product if a reusable substitution must be provided in the event that a patient cannot use the primary product. The single use devices should have access to a label through a recycling program. Once the device is returned, 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 National Somnoware program used for the VA for the interpretation by the reading providers. The Item is needs to be completely disposable.

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

2. 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.

3. Minimum Salient Characteristics: WATCHPATONE via WATCHPAT DIRECT It is a diagnostic home sleep apnea (HSAT) test 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.

4. 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.

4.1. Task 1 - Enterprise Management Controls.

4.1.1. 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.

4.1.2. 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.

4.2. 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 – see deliverable schedule details at bottom of statement of work.

4.2.1. Subtask 1 – VA address listing provided to Contractor to send wristband (WatchPATOne Direct or brand name or equal) to patient with instructions for proper usage.

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

5. 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

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

7. 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.

8. Government-Furnished Equipment (GFE)/Government-Furnished Information

(GFI):

VA logs into contractor WATCHPAT One Direct Database or equal – 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.

9. 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.

10. Delivery Schedule:

SOW TASK #

Deliverable Title

Format

Number

Calendar Days after CO Start

1 Sleep Study Interpretations

Digital 1 Per Patient; various count per month

Immediately upon completion study

2 Monthly Itemized Invoice

OB 10 Tungsten

- IPPS

Once month billing Within 5 Days end of month

11. 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.

Date Holiday

Monday, January 01 New Year’s Day

Monday, January 15 Birthday of Martin Luther King, Jr.

Monday, February 19 * Washington’s Birthday

Monday, May 27 Memorial Day

Wednesday, June 19 Juneteenth National Independence Day

Thursday, July 04 Independence Day

Monday, September 02 Labor Day

Monday, October 14 Columbus Day

Monday, November 11 Veterans Day

Thursday, November 28 Thanksgiving Day

Wednesday, December 25 Christmas Day

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.

12. 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.

Questions for Sleep Apnea Test 36C26225Q0562 BRAND NAME OR EQUAL REQUIREMENT PAGE 41 of solicitation.

1. RFP requires the proposed device to track a patient’s snoring activities. What is the purpose of the requirement that the device measure snoring? Please identify the medical or diagnostic requirement associated with this feature that would not otherwise be captured by the other six features. Absent a specific medical or diagnostic reason for it, we request the removal of this requirement to allow a broader range of devices to proposed by offerors. To that end, this requirement can be read to limit competition to a single manufacturer without reasonable need for such requirement.

ANSWER: American Academy of Sleep Medicine clinical practice guideline 2017 require evaluation for snoring as part of clinical evaluation of patient with sleep apnea. Detecting snoring activities during sleep testing helps to detect and quantify snoring which is a common sleep symptom and potential indicator of sleep apnea. There is a subgroup of patients called habitual snoring who have normal AHI but snore and have daytime sleepiness symptoms. Habitual snoring is an extremely prevalent condition affecting 22% to 44% of middle-aged males and 13% to 28% of middle-aged females. Habitual snoring is readily affected by body position and weight and sometimes needs intervention by a sleep provider and often referral to ENT to rule out upper airway pathology.

2. The RFP requires the proposed device to maintain three points of contact with a patient.

Please identify the medical or diagnostic requirement associated with this requirement.

Absent a specific medical or diagnostic reason for it, we request the removal of this requirement to allow a broader range of devices to be proposed by offerors.

To that end, this requirement can be read to limit competition to a single manufacturer without reasonable need for such requirement.

ANSWER: Three points of contacts is optimal to increase the probability of successful data capture form sleep testing and at same time will provide simple and easy device for elderly veteran to use at home without difficulty. Fewer points of contacts less than 3 will not provide reliable data. Higher points of contacts more than 3 will make sleep testing device difficult for veteran to use at home.

3. The RFP requires the proposed device includes a wristband, through which the patient can wear the device. Please identify the medical or diagnostic requirement associated with this requirement. Absent a specific medical or diagnostic reason for it, we request the removal of this requirement to allow a broader range of devices to be proposed by offerors. To that end, this requirement can be read to limit competition to a single manufacturer without reasonable need for such requirement.

ANSWER: We found the wristband is a simple and easy device to use by our elderly veterans over the last 5 years. Some of our veterans experienced challenges and difficulty using our inhouse device like NOX T3 device with chest wall belt and nasal cannula.

4. The RFP requires the provision of a “brand name or equal WatchPATOne kit Product code CS2116045.” Please confirm why the RFP requires the use of “WatchPATOne kit Product code CS2116045” or an equal device?

ANSWER: The current code provided by the manufacturer is CS2117002. As per national sleep leadership, VA SOMNOWARE software is compatible only with Noxturnal’s T3 HSAT device and the WatchPAT devices using the ZZPAT software.

5. Can the VA identify an equal HST devices known by the VA?

ANSWER: There are several HST devices that meet the needs of the VA that can be substituted for this including the WatchPAT 300, Noxturnal’s T3 HSAT device and sooner Noxturnal A1 HSAT device will be added to SOMNOWARE.

6. The RFP lists the quantity for each CLIN as “1.0.” Please confirm the actual number of devices anticipated by the VA under each contract year and whether the VA intends for this award to constitute a requirements contract. This may affect the pricing that an offeror is able to provide to the government.

ANSWER: The quantity of (1) is incorrect for the testing needs required. We proposed 2000 device per year.

7. Section D.1 of the RFP provides that the shipped devices must include a return label, although that same section provides that the devices must be completely disposable.

Please confirm why a return label is necessary when the device must be completely disposable and is not intended for multiple uses.

ANSWER: This section should be changed to read that the testing company will provide a label for the return of the product if a reusable substitution must be provided in the event that a patient cannot use the primary product. The single use devices should have access to a label through a recycling program.

8. 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 Dr. Nadia at PVAHC? Please confirm and clarify.

ANSWER: The initial report will be automatically scored (autoscored) by the providing company then sent to PVAHC via the secure software SOMNOWARE. Then, sleep provider interpreting team at VA has the option and ability to manually score the test if necessary and finalize sleep reports and call patients to discuss sleep study results and treatment plans.

9. RFP indicates that the offeror is responsible for protecting all VA data and specifies that only "read-only" access should be provided to PVAHC staff. Is this interpretation correct? If not, please clarify what is expected of the offeror regarding data access and security requirements.

ANSWER: The selecting testing company will need to use SOMNOWARE for the secure transmission of their test results. Access of the SOMNOWARE software will need to meet the guidelines determined by the VA.

10. The RFP 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? For example, we have already completed the registration process through the Austin office.

Please confirm if these forms are necessary in such cases.

ANSWER: This will be dictated by VA policy. In addition, if the vendor is registered in the Tungsten network, on my end I will get the invoices to pay associated with the P.O.

Number. It’s an easy process once set up.

11. Per RFP, we understand that the VA is not requiring offerors to propose the WatchPAT device but is instead agnostic from a brand perspective as to what device a contractor will use to perform Home Sleep Testing services. Please confirm this understanding.

ANSWER: The VA prefers to continue with the type of device currently in use at this VA site and compatible with SOMNOWARE software which can be sourced by multiple vendors. Currently we are using Noxturnal’s T3 HSAT device and the WatchPAT devices because they are only devices compatible with VA SOMNOWARE software for now.

12. Why is the NAICS code of 621498 being used? The requirements of this code are “industry comprises establishments with medical staff primarily engaged in providing general or specialized outpatient care”. With the mail out home sleep apnea testing, medical staff is not directly involved in the care of the patient and the patient has telephone access to specialists to assist with the testing devices provided and ordered by the VA medical staff. Other codes previously used are 621610 and manufacturer codes of 33XXXX.

ANSWER: NAICS code 621610 Home Health Care Services will replace the current code of 621498.

13. Why is there a 100% set aside for small business and not “Unrestricted” or SDVOSB?

ANSWER: During the market research and the request for information under the brand name or equal, small business were the majority that had responded to the request.

14. The B.3 Delivery schedule requires a quantity of (1) delivered. What is expected in this delivery?

ANSWER: Quantity per year will be 2000 and have been updated to reflect the change.

15. The SOW species a “WatchPATOne kit Product code CS2116045” which is a code no longer in use by the manufacturer. Will this be updated to “CS2117002 WatchPAT ONE Direct”, which is the current code and product used by the manufacturer?

ANSWER: The current code provided by the manufacturer is CS2117002,

16. Why is there not standard contracting language in the solicitation is to ensure all items are OEM items distributed through an authorized distributor and the supply chain of custody prevents the receipt of Grey Market Items? This expressed in VAAR Clause 852.212-71/72 Gray Market Items.

ANSWER: The solicitation is for name brand or equal and this is a service requirement and not a supply requirement.

Per FAR 52.211-6

BRAND NAME OR EQUAL (AUG 1999)

(a) If an item in this solicitation is identified as "brand name or equal," the purchase description reflects the characteristics and level of quality that will satisfy the Government’s needs. The salient physical, functional, or performance characteristics that "equal" products must meet are specified in the solicitation.

(b) To be considered for award, offers of "equal" products, including "equal" products of the brand name manufacturer, must-

(1) Meet the salient physical, functional, or performance characteristic specified in this solicitation;

(2) Clearly identify the item by-

(i) Brand name, if any; and

(ii) Make or model number;

(3) Include descriptive literature such as illustrations, drawings, or a clear reference to previously furnished descriptive data or information available to the Contracting Officer; and

(4) Clearly describe any modifications the offeror plans to make in a product to make it conform to the solicitation requirements. Mark any descriptive material to clearly show the modifications.

(c) The Contracting Officer will evaluate "equal" products on the basis of information furnished by the offeror or identified in the offer and reasonably available to the Contracting Officer. The Contracting Officer is not responsible for locating or obtaining any information not identified in the offer.

(d) Unless the offeror clearly indicates in its offer that the product being offered is an "equal" product, the offeror shall provide the brand name product referenced in the solicitation.

(End of provision)

AMENDMENT ONE TO RESPOND TO QUESTION AND TO UPDATE THE QUANTITY.