36C26325Q0797.pdf

PAGE 1 OF1. REQUISITION NO.

2. CONTRACT NO. 3. AWARD/EFFECTIVE DATE 4. ORDER NO. 5. SOLICITATION NUMBER 6. SOLICITATION ISSUE DATE

a. NAME b. TELEPHONE NO. (No Collect Calls) 8. OFFER DUE DATE/LOCAL

TIME

9. ISSUED BY CODE 10. THIS ACQUISITION IS UNRESTRICTED OR SET ASIDE: % FOR:

SMALL BUSINESS

HUBZONE SMALL

BUSINESS

SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

WOMEN-OWNED SMALL BUSINESS

(WOSB) ELIGIBLE UNDER THE WOMEN-OWNED

SMALL BUSINESS PROGRAM

EDWOSB

8(A)

NAICS:

SIZE STANDARD:

11. DELIVERY FOR FOB DESTINA-

TION UNLESS BLOCK IS

MARKED

SEE SCHEDULE

12. DISCOUNT TERMS

13a. THIS CONTRACT IS A

RATED ORDER UNDER

DPAS (15 CFR 700)

13b. RATING

14. METHOD OF SOLICITATION

RFQ IFB RFP

15. DELIVER TO CODE 16. ADMINISTERED BY CODE

17a. CONTRACTOR/OFFEROR CODE FACILITY CODE 18a. PAYMENT WILL BE MADE BY CODE

TELEPHONE NO. UEI: EFT:

PHONE: FAX:

17b. CHECK IF REMITTANCE IS DIFFERENT AND PUT SUCH ADDRESS IN OFFER

18b. SUBMIT INVOICES TO ADDRESS SHOWN IN BLOCK 18a UNLESS BLOCK BELOW IS CHECKED

SEE ADDENDUM

19. 20. 21. 22. 23. 24.

ITEM NO. SCHEDULE OF SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

(Use Reverse and/or Attach Additional Sheets as Necessary)

25. ACCOUNTING AND APPROPRIATION DATA 26. TOTAL AWARD AMOUNT (For Govt. Use Only)

27a. SOLICITATION INCORPORATES BY REFERENCE FAR 52.212-1, 52.212-4. FAR 52.212-3 AND 52.212-5 ARE ATTACHED. ADDENDA ARE ARE NOT ATTACHED.

27b. CONTRACT/PURCHASE ORDER INCORPORATES BY REFERENCE FAR 52.212-4. FAR 52.212-5 IS ATTACHED. ADDENDA ARE ARE NOT ATTACHED

28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN _______________ 29. AWARD OF CONTRACT: REF. ___________________________________ OFFER COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND DATED ________________________________. YOUR OFFER ON SOLICITATION DELIVER ALL ITEMS SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY (BLOCK 5), INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE ADDITIONAL SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED SET FORTH HEREIN IS ACCEPTED AS TO ITEMS:

30a. SIGNATURE OF OFFEROR/CONTRACTOR 31a. UNITED STATES OF AMERICA (SIGNATURE OF CONTRACTING OFFICER)

30b. NAME AND TITLE OF SIGNER (TYPE OR PRINT) 30c. DATE SIGNED 31b. NAME OF CONTRACTING OFFICER (TYPE OR PRINT) 31c. DATE SIGNED

AUTHORIZED FOR LOCAL REPRODUCTION (REV. NOV 2021)

PREVIOUS EDITION IS NOT USABLE Prescribed by GSA - FAR (48 CFR) 53.212

7. FOR SOLICITATION

INFORMATION CALL:

STANDARD FORM 1449

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES

OFFEROR TO COMPLETE BLOCKS 12, 17, 23, 24, & 30

36C26325Q0797 06-12-2025

Cameron Rick 651-293-3036 06-26-2025 12:00pm CDT

36C263 Department of Veterans Affairs

NETWORK 23 CONTRACTING OFFICE

316 Robert Street N. STE. 506 St. Paul MN 55101

X

334510

1250 Employees

N/A

X

36C618

Department of Veterans Affairs Minneapolis VAMC

1 Veterans Dr.

Minneapolis MN 55417

36C263

Department of Veterans Affairs

NETWORK 23 CONTRACTING OFFICE

316 Robert Street N. STE. 506 St. Paul MN 55101

Y

Department of Veterans Affairs Financial Services Center PO Box 149971

Austin TX 78714-9971

See CONTINUATION Page

This solicitation is to provide equipment and services to the Minneapolis VA Health Care System.

See SOW for Home Sleep Apnea Testing (HSAT) Equipment and Service requirements.

Note block 30 - This document must be signed and returned in order to be considered. Email all required and completed documents to: cameron.rick@va.gov.

Submit questions via email by 12:00PM, June 19, 2025.

**No telephonic questions will be accepted.**

Responses to questions will be posted as an amendment to the solicitation.

Solicitation will close at 12:00PM Central on June 26, 2025.

See CONTINUATION Page

X X

X 1

Cameron Rick Contracting Officer

36C26325Q0797

Table of Contents

SECTION A

A.1 SF 1449 SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL PRODUCTS

AND COMMERCIAL SERVICES

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

Performance Work Statement

B.2 PRICE/COST SCHEDULE

ITEM INFORMATION

SECTION C - CONTRACT CLAUSES

C.1 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL PRODUCTS

AND COMMERCIAL SERVICES (NOV 2023)

C.2 52.217-8 OPTION TO EXTEND SERVICES (NOV 1999)

C.3 52.217-9 OPTION TO EXTEND THE TERM OF THE CONTRACT (MAR 2000) ...25

C.4 52.225-5 TRADE AGREEMENTS (NOV 2023)

C.5 52.225-6 TRADE AGREEMENTS CERTIFICATE (FEB 2021)

C.6 VAAR 852.211-76 LIQUIDATED DAMAGES – REIMBURSEMENT FOR DATA

BREACH COSTS (FEB 2023) ALTERNATE I (FEB 2023)

C.7 VAAR 852.232-72 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS (NOV

2018)

C.8 VAAR 852.237-75 KEY PERSONNEL (OCT 2019)

C.9 VAAR 852.242-71 ADMINISTRATIVE CONTRACTING OFFICER (OCT 2020)

C.10 VAAR 852.247-73 PACKING FOR DOMESTIC SHIPMENT (OCT 2018)

C.11 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

C.12 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT

STATUTES OR EXECUTIVE ORDERS—COMMERCIAL PRODUCTS AND

COMMERCIAL SERVICES (JAN 2025) (DEVIATION FEB 2025)

SECTION E - SOLICITATION PROVISIONS

E.1 52.212-1 INSTRUCTIONS TO OFFERORS—COMMERCIAL PRODUCTS AND

COMMERCIAL SERVICES (SEP 2023)

ADDENDUM to FAR 52.212-1 INSTRUCTIONS TO OFFERORS—COMMERCIAL

ITEMS

E.2 52.212-2 EVALUATION—COMMERCIAL ITEMS (NOV 2021)

E.3 52.201-1 ACQUISITION 360: VOLUNTARY SURVEY (SEP 2023)

E.4 52.204-24 REPRESENTATION REGARDING CERTAIN TELECOMMUNICATIONS

AND VIDEO SURVEILLANCE SERVICES OR EQUIPMENT (NOV 2021)

E.5 52.204-29 FEDERAL ACQUISITION SUPPLY CHAIN SECURITY ACT

ORDERS—REPRESENTATION AND DISCLOSURES (DEC 2023)

E.6 52.209-7 INFORMATION REGARDING RESPONSIBILITY MATTERS (OCT 2018)

E.7 52.233-2 SERVICE OF PROTEST (SEP 2006)

E.8 VAAR 852.233-71 ALTERNATE PROTEST PROCEDURE (OCT 2018)

E.9 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB

1998)

E.10 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—

COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (MAY 2024) (DEVIATION

FEB 2025)

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

1. Contract Administration: All contract administration matters will be handled by the following individuals:

a. CONTRACTOR:

b. GOVERNMENT: Contracting Officer 36C263 Cameron Rick

Department of Veterans Affairs

NETWORK 23 CONTRACTING OFFICE

316 Robert Street N. STE. 506

St. Paul MN 55101

2. CONTRACTOR REMITTANCE ADDRESS: All payments by the Government to the contractor will be made in accordance with:

[X] 52.232-33, Payment by Electronic Funds Transfer—System For Award Management, or

[] 52.232-36, Payment by Third Party

3. INVOICES: Invoices shall be submitted in arrears:

a. Quarterly []

b. Semi-Annually []

c. Other [X] Monthly

4. GOVERNMENT INVOICE ADDRESS: All Invoices from the contractor shall be submitted electronically in accordance with VAAR Clause 852.232-72 Electronic Submission of Payment Requests.

ACKNOWLEDGMENT OF AMENDMENTS: The offeror acknowledges receipt of amendments to the Solicitation numbered and dated as follows:

AMENDMENT NO DATE

Performance Work Statement Home Sleep Apnea Testing (HSAT) for Veteran Beneficiaries of the Minneapolis VA Healthcare System (MVAHCS)

Purpose

The purpose of this document is to communicate the Government requirements of potential contractors with regards to Home Sleep Apnea Testing devices and services. This document details requirements of the device, the service, and the potential contractor.

Background

MVAHCS currently makes use of disposable HSAT devices from Zoll Itamar WatchPAT One Direct program. Devices are ordered from a manufacturer, who ships them directly to the Veteran beneficiary. The manufacturer contacts the beneficiary to provide instructions and support and uploads the test results to the Somnoware software platform where they are available to MVAHCS staff.

The Government wishes to continue it’s current, established process for HSAT, as this process has proven to benefit MVAHCS Veteran patients and reduce the cost of providing Sleep Clinic services at MVAHCS.

MVAHCS is currently limited in its ability to purchase HSATs due to Government Purchase Card (GPC) limits. Current purchases must be timed to meet the availability of purchase card funds rather than the needs of the Veteran. Pursuing the process under contract will allow the Government more flexibility in managing Sleep Clinic HSAT purchases and reduce the burden on Government purchase cards. We believe that this request is in line with the VA’s mission by placing the Veteran first.

Scope

Quantities, costs, or amounts shown hereafter are estimates only and not guaranteed. Post-award Task Orders shall contain the final cost determination as agree upon by the Government and the Contractor.

The Contractor will ship Zoll Itamar WatchPAT One Direct or equal disposable HSATs to Veteran beneficiaries’ home address, provide tracking and proof of delivery, and provide Veteran beneficiaries with pre-paid shipping for the return of the disposable HSAT to the Contractor.

The Contractor will contact the Veteran beneficiary to provide instructions and support for operating the disposable HSAT. The Contractor will make multiple attempts to contact the Veteran beneficiary if the initial attempt is unsuccessful.

The Contractor’s disposable HSAT device shall include a web-based or mobile application for the retrieval of test scores and results.

The Contractor shall provide, at no additional cost to the Government, a non-disposable alternative HSAT for Veteran beneficiaries unable to use the Contractor’s web-based or mobile application or are otherwise not able to satisfactorily use a disposable HSAT.

The non-disposable HSATs shall be returned to the Contractor. The Contractor shall make test scores and results available to MVAHCS staff via the Somnoware software platform. Test scores and results shall be timely and complete.

The Contractor shall provide, for the life of the contract and at no charge to the government, HSATs that are compatible with the Somnoware software platform. HSATs must include a user’s manual and instructions for troubleshooting.

The Contractor shall repeat the Veteran beneficiary’s sleep apnea test for at no cost to the Government if:

HSAT provides unsatisfactory results.

HSAT fails to transmit or download information.

Information is not retrievable through the Contractor’s web-based or mobile application.

The Government, in good faith, deems the device damaged, defective, or substandard.

The Contractor shall provide reports of normal ranges in accordance with the American Academy of Sleep to MVAHCS suitable for the following audiences:

Executive leadership Clinic providers and staff Management and program analysts Finance and billing specialists

All costs for the devices and services covered in this PWS shall be included as a single invoiced line item and shall not be separately priced.

Equipment and supplies remain the property of Contractor; the Government shall neither stock nor store items on behalf of the Contractor.

The contract period of performance shall be one base period followed by three option periods.

Place of Performance

The contractor shall ship HSATs to the Veteran beneficiary’s home address. Test scores and results shall be retrieved remotely by the Contractor for disposable HSAT and upon return of the non-disposable HSAT. Test scores and results shall be made available to the Government via the Somnoware software platform.

Equipment and Service Specifications

Equipment Requirements

Contractors shall provide the Zoll Itamar WatchPAT One Direct (product code CS2117002) or equal.

o Estimated yearly quantity is 2,250 disposable and 250 non-disposable HSATs:

2,500 total estimated quantity.

Shall be lightweight and easy for Veteran beneficiaries to use.

Captured sleep apnea results shall be available to be reviewed remotely in report form and raw data form.

Shall be available as a disposable type IV peripheral arterial tone based home sleep apnea monitoring system AND a non-disposable returnable equivalent device for patients without access to an internet-connected smart device.

Shall have U.S. Food and Drug Administration (FDA) approval.

Shall be compatible with the Somnoware software platform.

Shall provide date and timestamps on clinical reports.

Shall have the capability of monitoring and recording central sleep apnea, obstructive sleep apnea, hypopnea, oximetry, heart rate, body position, and snoring.

Shall not require respiratory belts, airflow sensor, or need of additional monitoring sensors.

Test Scores and Results Requirements

Following are the minimum acceptable requirement for scoring and results:

Respiratory abnormalities Oxygen desaturations Snoring Body position Heart rate

Results shall be compared against the normal range in accordance with the American Academy of Sleep.

Contractor Requirements

Shall receive orders from MVAHCS clinicians through Somnoware sleep and respiratory care diagnostics software.

Shall drop ship orders placed through Somnoware to the patient’s residence.

Shall send veteran a disposable type IV peripheral arterial tone-based HSAT. If the veteran does not have an internet-connected smart device, shall send veteran a non-disposable equivalent and prepaid return shipping.

Shall provide all leads, probes, attachments, and batteries needed for HSAT to properly perform its intended function.

Shall provide for all cleaning and maintenance of any reusable type IV peripheral arterial tone-based HSATs.

Shall provide 24/7 troubleshooting and customer support. Support number shall be included with shipment to each veteran.

Shall notify the Veteran beneficiary of the delivery date and time (e.g. four-hour window).

Shall establish a sleep study date and time by contacting the Veteran beneficiary directly.

Shall provide veteran written and video instructions on how to complete Type IV peripheral arterial tone-based HSAT using either the disposable or non-disposable device.

Shall provide patient with return mailing instructions, shipping label, and packaging for any non-disposable HAST.

Shall make test scores and results available through Somnoware platform upon completion of disposable HSAT or return of reusable HSAT.

Shall follow up with multiple attempts with veteran to retrieve non-returned HSATs.

Shall assume fiscal responsibility for lost/damaged/unreturned devices prior to delivery receipt provided by the carrier.

Shall replace defective devices at no cost to the Government.

Shall provide tracking information to authorized individuals.

Shall invoice the Government via the Inpatient Prospective Payment System (IPPS) where the HSAT device and service shall be submitted as a single line item.

Shall proactively provide regular reports and analysis suitable for monitoring at both a patient and device level.

Shall proactively provide data in raw format (for example, .csv or .exls) to the COR or the

COR’s alternative. This data should be sufficient to demonstrate at minimum, for each device, when it was ordered, shipped, received, returned with results, whether the results were valid.

Shall proactively provide notification to the COR and manager of the remaining available HSTs for the ordering period.

Procedure and Workflow

1. MVAHCS staff place a consultation order using the Somnoware platform.

2. MVAHCS staff assigns the consultation for scheduling with the Contractor.

3. Contractor schedules delivery appointment with Veteran beneficiary.

Prior to delivery, Contractor inspects HSAT to be in good condition and sanitized according to the Centers for Disease Control and Prevention (CDC) Guidelines for Disinfection and Sanitization.

At the time of the appointment, the Contractor shall provide training on the use of the HSAT device, connection, operation, and web-based or mobile application.

4. Veteran beneficiary completes sleep apnea test and returns any non-disposable HSAT device using the pre-paid return shipping label.

5. Contractor completes report and records results in Somnoware.

Deliverables

Contractor shall provide the following deliverables through the life of the contract:

Integration Management Control Plan (IMCP) shall be provided prior to the commencement of services by the Contractor. The IMCP shall provide details demonstrating how the Contractor will integrate with the Government’s current sleep study procedures. Topics shall include, at a minimum, quality assurance, reporting, administrating and clerical functions, and documentation.

Contract Management Plan (CMP) shall be provided prior to the commencement of services by the Contractor. The CMP shall provide details demonstrating the technical, organizational, and managerial controls that will be employed to meet the cost, schedule, and performance requirements of the contract.

Financial Management Report (FMR) shall be provided monthly directly to the Contracting Officer’s Representative (COR). Shall be in raw format (e.g. .csv or .xlsx) and shall contain all data required for the reconciling of payment to the device-level detail.

Clinician Status Report (CSR) shall be provided to MVAHCS Sleep Clinic staff monthly and as requested. Shall allow clinicians to understand the status of the program, as well as that of individual Veteran beneficiaries, in terms of their HSAT.

Test Scores and Results (TSR) shall be uploaded to Somnoware software platform upon the completion of the Veteran beneficiary’s HSAT.

Invoices shall be submitted through IPPS.

Training and Technical Support

Contractor shall provide training to each Veteran beneficiary. Training shall be conducted through written and video demonstration. Training material shall be in English and/or the primary language of the Veteran beneficiary. In the case where non-English material is required, the Contractor shall work with the Government in providing adequate instruction material.

Contractor shall provide troubleshooting and technical support for Contractor-supplied devices and services. Such support must be available 24 hours per day, 7 days per week via telephone.

Quality Measurement

Quality assurance and surveillance will assess the following areas: Maintenance, Quality, and Staff Qualifications, and Patient Safety.

QUALITY ASSURANCE SURVEILLANCE PLAN

For: Clinical Sleep Lab Home Services

Contract Number:

Contract Description: Home Sleep Apnea Testing (HSAT) for Veteran Beneficiaries of the Minneapolis VA Healthcare System (MVAHCS)

Contractor’s name:

1. PURPOSE

This Quality Assurance Surveillance Plan (QASP) provides a systematic method to evaluate performance for the stated contract. This QASP explains the following:

What will be monitored.

How monitoring will take place.

Who will conduct the monitoring.

How monitoring efforts and results will be documented.

This QASP does not detail how the contractor accomplishes the work. Rather, the QASP is created with the premise that the contractor is responsible for management and quality control actions to meet the terms of the contract. It is the Government’s responsibility to be objective, fair, and consistent in evaluating performance.

This QASP is a “living document” and the Government may review and revise it on a regular basis. However, the Government shall coordinate changes with the contractor. Copies of the original QASP and revisions shall be provided to the contractor and Government officials implementing surveillance activities.

2. GOVERNMENT ROLES AND RESPONSIBILITIES

The following personnel shall oversee and coordinate surveillance activities.

a. Contracting Officer (CO) - The CO shall ensure performance of all necessary actions for effective contracting, ensure compliance with the contract terms, and shall safeguard the interests of the United States in the contractual relationship.

The CO shall also assure that the contractor receives impartial, fair, and equitable treatment under this contract. The CO is ultimately responsible for the final determination of the adequacy of the contractor’s performance.

Assigned CO:

Organization or Agency: Department of Veterans Affairs, VISN 23 Contracting Office

b. Contracting Officer’s Representative (COR) - The COR is responsible for technical administration of the contract and shall assure proper Government surveillance of the contractor’s performance. The COR shall keep a quality assurance file. The COR is not empowered to make any contractual commitments or to authorize any contractual changes on the Government’s behalf.

Assigned COR: Matthew D Murphy, Program Analyst/ COR, MVAHCS Primary Care and Specialty Medicine ICC

3. CONTRACTOR REPRESENTATIVES

The following employees of the contractor serve as the contractor’s program manager for this contract.

a. Program Manager:

4. PERFORMANCE STANDARDS

Performance standards define desired services. The Government performs surveillance to determine if the contractor exceeds, meets or does not meet these standards.

The Performance Requirements Summary Matrix (attached) includes performance standards. The Government shall use these standards to determine contractor performance and shall compare contractor performance to the Acceptable Quality Level (AQL).

5. INCENTIVES

The Government shall use Exercise of Option Period and past performance as incentives. Incentives shall be based on exceeding, meeting, or not meeting performance standards.

6. METHODS OF QA SURVEILLANCE

Various methods exist to monitor performance. The COR shall use the surveillance methods listed below in the administration of this QASP.

Title ID Task

Standard

Acceptable Quality Level

Method of Surveillance Incentive

Quality Care

Contractor initial patient contact timeliness

Contractor should complete initial contact within 3 business days of order

90% Random inspection (auditing).

Exercise of Option Period and past performance

Patient Safety

Patient safety incidents must be reported using Patient

All incidents reported immediately (within 24 hours.)

95% Direct Observation

Exercise of Option Period and past

Safety Report. performance

Patient Satisfaction

Patient complaints about the quality of care are reported to the Medical Center Patient Advocate, the

COR, and the Contractor

All patient complaints are reported immediately (within 24 hours) and resolved within 7 days

90% Random inspection (auditing).

Exercise of Option Period and past performance

Support and Maintenance 4

Initiates repeat testing for failed studies

Contractor provides weekly reports

90%

Random inspection (auditing).

Exercise of Option Period and past performance

a. DIRECT OBSERVATION. 100% surveillance

b. RANDOM INSPECTION. 3 randomly selected files per 3-month contract quarter.

c. VALIDATED USER/CUSTOMER COMPLAINTS. Customer complaint data is compiled quarterly and reviewed by Supervisor – any validated complaints against a contractor that are not resolved within the required seven-day period will be further investigated.

d. RANDOM SAMPLING. Patient documentation to be reviewed will be randomly selected and cover the period of service.

7. RATINGS

Metrics and methods are designed to determine if performance exceeds, meets, or does not meet a given standard and acceptable quality level. A rating scale shall be used to determine a positive, neutral, or negative outcome. The following ratings shall be used:

8. DOCUMENTING PERFORMANCE

a. ACCEPTABLE PERFORMANCE

The Government shall document positive performance. Any report may become a part of the supporting documentation for any contractual action.

b. UNACCEPTABLE PERFORMANCE

When unacceptable performance occurs, the COR/designee shall inform the contractor. This will normally be in writing unless circumstances necessitate verbal communication. In any case the COR/designee shall document the discussion and place it in the COR file.

When the CO determines formal written communication is required, the CO shall prepare a Contract Discrepancy Report (CDR) and present it to the contractor's program manager.

The contractor shall acknowledge receipt of the CDR in writing. The CDR will specify if the contractor is required to prepare a corrective action plan to document how the contractor shall correct the unacceptable performance and avoid a recurrence. The CDR will also state how long after receipt the contractor has to present this corrective action plan to the CO. The Government shall review the contractor's corrective action plan to determine acceptability.

Any CDRs may become a part of the supporting documentation for any contractual action deemed necessary by the CO.

9. FREQUENCY OF MEASUREMENT

a. Frequency of Measurement.

During contract performance, the COR will periodically analyze whether the negotiated frequency of surveillance is appropriate for the work being performed.

b. Frequency of Performance Assessment Meetings.

The COR/designee shall meet with the contractor semi-annually to assess performance and shall provide a written assessment.

ADDENDUM

PERFORMANCE REQUIREMENTS SUMMARY MATRIX

1. CPAR RATINGS ASSIGNED TO QASP ITEMS:

Metrics and methods are designed to determine rating for a given standard and acceptable quality level. The following ratings shall be used (Reference: CPARS User Manual: https://www.cpars.gov/documents/CPARS-Guidance.pdf.

EXCEPTIONAL: Performance meets contractual requirements and exceeds many to the Government’s benefit. The contractual performance of the element or sub-element being assessed was accomplished with few minor problems for which corrective actions taken by the contractor were highly effective.

Note: To justify an Exceptional rating, you should identify multiple significant events in each category and state how it was a benefit to the GOVERNMENT. However, a singular event could be of such magnitude that it alone constitutes an Exceptional rating.

Also, there should have been NO significant weaknesses identified.

Performance meets contractual requirements and exceeds some to the Government’s benefit. The contractual performance of the element or sub-element being assessed was accomplished with some minor problems for which corrective actions taken by the contractor were effective.

Note: To justify a Very Good rating, you should identify a significant event in each category and state how it was a benefit to the GOVERNMENT. Also, there should have been NO significant weaknesses identified.

VERY GOOD:

Performance meets contractual requirements. The contractual performance of the element or sub-element contains some minor problems for which corrective actions taken by the contractor appear or were satisfactory.

Note: To justify a Satisfactory rating, there should have been only minor problems, or major problems the contractor recovered from without impact to the contract. Also, there should have been NO significant weaknesses identified.

SATISFACTORY:

Performance does not meet some contractual requirements. The contractual performance of the element or sub-element being assessed reflects a serious problem for which the contractor has not yet identified corrective actions. The contractor’s proposed actions appear only marginally effective or were not fully implemented.

Note: To justify Marginal performance, you should identify a significant event in each category that the contractor had trouble overcoming and state how it impacted the GOVERNMENT. A Marginal rating should be supported by referencing the management tool that notified the contractor of the contractual deficiency (e.g.

Management, Quality, Safety or Environmental Deficiency Report or letter).

MARGINAL:

UNSATISFACTORY:

Performance does not meet most contractual requirements, and recovery is not likely in a timely manner. The contractual performance of the element or sub-element being assessed contains serious problem(s) for which the contractor’s corrective actions appear or were ineffective.

Note: To justify an Unsatisfactory rating, you should identify multiple significant events in each category that the contractor had trouble overcoming and state how it impacted the GOVERNMENT. However, a singular problem could be of such serious magnitude that it alone constitutes an unsatisfactory rating. An Unsatisfactory rating should be supported by referencing the management tools used to notify the contractor of the contractual deficiencies (e.g. Management, Quality, Safety or Environmental Deficiency Reports, or letters).

DOCUMENTING PERFORMANCE

a. The Government shall document positive and/or negative performance. Any report may become a part of the supporting documentation for any contractual action and preparing annual past performance using CONTRACTOR PERFORMANCE

ASSESSMENT REPORT (CPAR).

b. If contractor performance does not meet the Acceptable Quality level, the CO shall inform the contractor. This will normally be in writing unless circumstances necessitate verbal communication. In any case the CO shall document the discussion and place it in the contract file. When the COR and the CO determines formal written communication is required, the COR shall prepare a Contract Report (CR), and present it to CO. The CO will in turn review and will present to the contractor's program manager for corrective action.

The contractor shall acknowledge receipt of the CR in writing. The CR will specify if the contractor is required to prepare a corrective action plan to document how the contractor shall correct the unacceptable performance and avoid a recurrence. The CR will also state how long after receipt the contractor has to present this corrective action plan to the CO.

The Government shall review the contractor's corrective action plan to determine acceptability. The CO shall also assure that the contractor receives impartial, fair, and equitable treatment. The CO is ultimately responsible for the final determination of the adequacy of the contractor’s performance and the acceptability of the Contractor’s corrective action plan.

Any CRs may become a part of the supporting documentation for any contractual action deemed necessary by the CO.

2. COR AND CONTRACTOR ACKNOWLEDGEMENT OF QASP

SIGNED:

COR NAME/TITLE DATE

SIGNED:

CONTRACTOR NAME/TITLE DATE

B.2 PRICE/COST SCHEDULE

ITEM INFORMATION

ITEM

NUMBE

R

DESCRIPTION OF

SUPPLIES/SERVIC

ES

QUANTIT

Y

UNI

T UNIT PRICE AMOUNT

0001 63.00 EA ________________

HSAT Reusable Device Contract Period: Base POP Begin: 07-15-2025 POP End: 09-30-2025 PRINCIPAL NAICS CODE: 334510 - Electromedical and Electrotherapeutic Apparatus Manufacturing PRODUCT/SERVICE CODE: 6515 - Medical and Surgical Instruments, Equipment, and Supplies

0002 563.00 EA ________________

HSAT Disposable Device Contract Period: Base POP Begin: 07-15-2025 POP End: 09-30-2025 PRINCIPAL NAICS CODE: 334510 - Electromedical and Electrotherapeutic Apparatus Manufacturing PRODUCT/SERVICE CODE: 6515 - Medical and Surgical Instruments, Equipment, and Supplies

1001 250.00 EA ________________

HSAT Reusable Device Contract Period: Option 1 POP Begin: 10-01-2025 POP End: 09-30-2026 PRINCIPAL NAICS CODE: 334510 - Electromedical and Electrotherapeutic Apparatus Manufacturing PRODUCT/SERVICE CODE: 6515 - Medical and Surgical Instruments, Equipment, and Supplies

1002 2,250.00 EA ________________

HSAT Disposable Device Contract Period: Option 1 POP Begin: 10-01-2025 POP End: 09-30-2026 PRINCIPAL NAICS CODE: 334510 - Electromedical and Electrotherapeutic Apparatus Manufacturing PRODUCT/SERVICE CODE: 6515 - Medical and Surgical Instruments, Equipment, and Supplies

2001 250.00 EA ________________

HSAT Reusable Device Contract Period: Option 2 POP Begin: 10-01-2026 POP End: 09-30-2027 PRINCIPAL NAICS CODE: 334510 - Electromedical and Electrotherapeutic Apparatus Manufacturing PRODUCT/SERVICE CODE: 6515 - Medical and Surgical Instruments, Equipment, and Supplies

2002 2,250.00 EA ________________

HSAT Disposable Device Contract Period: Option 2 POP Begin: 10-01-2026 POP End: 09-30-2027 PRINCIPAL NAICS CODE: 334510 - Electromedical and Electrotherapeutic Apparatus Manufacturing PRODUCT/SERVICE CODE: 6515 - Medical and Surgical Instruments, Equipment, and Supplies

3001 187.00 EA ________________

HSAT Reusable Device Contract Period: Option 3 POP Begin: 10-01-2027 POP End: 07-14-2028 PRINCIPAL NAICS CODE: 334510 - Electromedical and Electrotherapeutic Apparatus Manufacturing PRODUCT/SERVICE CODE: 6515 - Medical and Surgical Instruments, Equipment, and Supplies

3002 1,688.00 EA ________________

HSAT Disposable Device Contract Period: Option 3 POP Begin: 10-01-2027 POP End: 07-14-2028 PRINCIPAL NAICS CODE: 334510 - Electromedical and Electrotherapeutic Apparatus Manufacturing

PRODUCT/SERVICE CODE: 6515 - Medical and Surgical Instruments, Equipment, and Supplies

GRAND TOTAL ________________

SECTION C - CONTRACT CLAUSES

C.1 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL

PRODUCTS AND COMMERCIAL SERVICES (NOV 2023)

(a) Inspection/Acceptance. The Contractor shall only tender for acceptance those items that conform to the requirements of this contract. The Government reserves the right to inspect or test any supplies or services that have been tendered for acceptance. The Government may require repair or replacement of nonconforming supplies or reperformance of nonconforming services at no increase in contract price. If repair/replacement or reperformance will not correct the defects or is not possible, the Government may seek an equitable price reduction or adequate consideration for acceptance of nonconforming supplies or services. The Government must exercise its post-acceptance rights—

(1) Within a reasonable time after the defect was discovered or should have been discovered;

and

(2) Before any substantial change occurs in the condition of the item, unless the change is due to the defect in the item.

(b) Assignment. The Contractor or its assignee may assign its rights to receive payment due as a result of performance of this contract to a bank, trust company, or other financing institution, including any Federal lending agency in accordance with the Assignment of Claims Act (31 U.S.C. 3727). However, when a third party makes payment (e.g., use of the Governmentwide commercial purchase card), the Contractor may not assign its rights to receive payment under this contract.

(c) Changes. Changes in the terms and conditions of this contract may be made only by written agreement of the parties.

(d) Disputes. This contract is subject to 41 U.S.C. chapter 71, Contract Disputes. Failure of the parties to this contract to reach agreement on any request for equitable adjustment, claim, appeal or action arising under or relating to this contract shall be a dispute to be resolved in accordance with the clause at Federal Acquisition Regulation (FAR) 52.233-1, Disputes, which is incorporated herein by reference. The Contractor shall proceed diligently with performance of this contract, pending final resolution of any dispute arising under the contract.

(e) Definitions. The clause at FAR 52.202-1, Definitions, is incorporated herein by reference.

(f) Excusable delays. The Contractor shall be liable for default unless nonperformance is caused by an occurrence beyond the reasonable control of the Contractor and without its fault or negligence such as, acts of God or the public enemy, acts of the Government in either its sovereign or contractual capacity, fires, floods, epidemics, quarantine restrictions, strikes, unusually severe weather, and delays of common carriers. The Contractor shall notify the Contracting Officer in writing as soon as it is reasonably possible after the commencement of any excusable delay, setting forth the full particulars in connection therewith, shall remedy such occurrence with all reasonable dispatch, and shall promptly give written notice to the Contracting Officer of the cessation of such occurrence.

(g) Invoice.

(1) The Contractor shall submit an original invoice and three copies (or electronic invoice, if authorized) to the address designated in the contract to receive invoices. An invoice must include—

(i) Name and address of the Contractor;

(ii) Invoice date and number;

(iii) Contract number, line item number and, if applicable, the order number;

(iv) Description, quantity, unit of measure, unit price and extended price of the items delivered;

(v) Shipping number and date of shipment, including the bill of lading number and weight of shipment if shipped on Government bill of lading;

(vi) Terms of any discount for prompt payment offered;

(vii) Name and address of official to whom payment is to be sent;

(viii) Name, title, and phone number of person to notify in event of defective invoice; and

(ix) Taxpayer Identification Number (TIN). The Contractor shall include its TIN on the invoice only if required elsewhere in this contract.

(x) Electronic funds transfer (EFT) banking information.

(A) The Contractor shall include EFT banking information on the invoice only if required elsewhere in this contract.

(B) If EFT banking information is not required to be on the invoice, in order for the invoice to be a proper invoice, the Contractor shall have submitted correct EFT banking information in accordance with the applicable solicitation provision, contract clause (e.g., 52.232-33, Payment by Electronic Funds Transfer—System for Award Management, or 52.232-34, Payment by Electronic Funds Transfer—Other Than System for Award Management), or applicable agency procedures.

(C) EFT banking information is not required if the Government waived the requirement to pay by EFT.

(2) Invoices will be handled in accordance with the Prompt Payment Act (31 U.S.C. 3903) and Office of Management and Budget (OMB) prompt payment regulations at 5 CFR part 1315.

(h) Patent indemnity. The Contractor shall indemnify the Government and its officers, employees and agents against liability, including costs, for actual or alleged direct or contributory infringement of, or inducement to infringe, any United States or foreign patent, trademark or copyright, arising out of the performance of this contract, provided the Contractor is reasonably notified of such claims and proceedings.

(i) Payment.—

(1) Items accepted. Payment shall be made for items accepted by the Government that have been delivered to the delivery destinations set forth in this contract.

(2) Prompt payment. The Government will make payment in accordance with the Prompt Payment Act (31 U.S.C. 3903) and prompt payment regulations at 5 CFR part 1315.

(3) Electronic Funds Transfer (EFT). If the Government makes payment by EFT, see 52.212- 5(b) for the appropriate EFT clause.

(4) Discount. In connection with any discount offered for early payment, time shall be computed from the date of the invoice. For the purpose of computing the discount earned, payment shall be considered to have been made on the date which appears on the payment check or the specified payment date if an electronic funds transfer payment is made.

(5) Overpayments. If the Contractor becomes aware of a duplicate contract financing or invoice payment or that the Government has otherwise overpaid on a contract financing or invoice payment, the Contractor shall—

(i) Remit the overpayment amount to the payment office cited in the contract along with a description of the overpayment including the—

(A) Circumstances of the overpayment (e.g., duplicate payment, erroneous payment, liquidation errors, date(s) of overpayment);

(B) Affected contract number and delivery order number, if applicable;

(C) Affected line item or subline item, if applicable; and

(D) Contractor point of contact.

(ii) Provide a copy of the remittance and supporting documentation to the Contracting Officer.

(6) Interest.

(i) All amounts that become payable by the Contractor to the Government under this contract shall bear simple interest from the date due until paid unless paid within 30 days of becoming due. The interest rate shall be the interest rate established by the Secretary of the Treasury as provided in 41 U.S.C. 7109, which is applicable to the period in which the amount becomes due, as provided in (i)(6)(v) of this clause, and then at the rate applicable for each six-month period as fixed by the Secretary until the amount is paid.

(ii) The Government may issue a demand for payment to the Contractor upon finding a debt is due under the contract.

(iii) Final decisions. The Contracting Officer will issue a final decision as required by 33.211 if—

(A) The Contracting Officer and the Contractor are unable to reach agreement on the existence or amount of a debt within 30 days;

(B) The Contractor fails to liquidate a debt previously demanded by the Contracting Officer within the timeline specified in the demand for payment unless the amounts were not repaid because the Contractor has requested an installment payment agreement; or

(C) The Contractor requests a deferment of collection on a debt previously demanded by the Contracting Officer (see 32.607-2).

(iv) If a demand for payment was previously issued for the debt, the demand for payment included in the final decision shall identify the same due date as the original demand for payment.

(v) Amounts shall be due at the earliest of the following dates:

(A) The date fixed under this contract.

(B) The date of the first written demand for payment, including any demand for payment resulting from a default termination.

(vi) The interest charge shall be computed for the actual number of calendar days involved beginning on the due date and ending on—

(A) The date on which the designated office receives payment from the Contractor;

(B) The date of issuance of a Government check to the Contractor from which an amount otherwise payable has been withheld as a credit against the contract debt; or

(C) The date on which an amount withheld and applied to the contract debt would otherwise have become payable to the Contractor.

(vii) The interest charge made under this clause may be reduced under the procedures prescribed in FAR 32.608-2 in effect on the date of this contract.

(j) Risk of loss. Unless the contract specifically provides otherwise, risk of loss or damage to the supplies provided under this contract shall remain with the Contractor until, and shall pass to the Government upon:

(1) Delivery of the supplies to a carrier, if transportation is f.o.b. origin; or

(2) Delivery of the supplies to the Government at the destination specified in the contract, if transportation is f.o.b. destination.

(k) Taxes. The contract price includes all applicable Federal, State, and local taxes and duties.

(l) Termination for the Government's convenience. The Government reserves the right to terminate this contract, or any part hereof, for its sole convenience. In the event of such termination, the Contractor shall immediately stop all work hereunder and shall immediately cause any and all of its suppliers and subcontractors to cease work. Subject to the terms of this contract, the Contractor shall be paid a percentage of the contract price reflecting the percentage of the work performed prior to the notice of termination, plus reasonable charges the Contractor can demonstrate to the satisfaction of the Government using its standard record keeping system, have resulted from the termination. The Contractor shall not be required to comply with the cost accounting standards or contract cost principles for this purpose. This paragraph does not give the Government any right to audit the Contractor's records. The Contractor shall not be paid for any work performed or costs incurred which reasonably could have been avoided.

(m) Termination for cause. The Government may terminate this contract, or any part hereof, for cause in the event of any default by the Contractor, or if the Contractor fails to comply with any contract terms and conditions, or fails to provide the Government, upon request, with adequate assurances of future performance. In the event of termination for cause, the Government shall not be liable to the Contractor for any amount for supplies or services not accepted, and the Contractor shall be liable to the Government for any and all rights and remedies provided by law. If it is determined that the Government improperly terminated this contract for default, such termination shall be deemed a termination for convenience.

(n) Title. Unless specified elsewhere in this contract, title to items furnished under this contract shall pass to the Government upon acceptance, regardless of when or where the Government takes physical possession.

(o) Warranty. The Contractor warrants and implies that the items delivered hereunder are merchantable and fit for use for the particular purpose described in this contract.

(p) Limitation of liability. Except as otherwise provided by an express warranty, the Contractor will not be liable to the Government for consequential damages resulting from any defect or deficiencies in accepted items.

(q) Other compliances. The Contractor shall comply with all applicable Federal, State and local laws, executive orders, rules and regulations applicable to its performance under this contract.

(r) Compliance with laws unique to Government contracts. The Contractor agrees to comply with 31 U.S.C. 1352 relating to limitations on the use of appropriated funds to influence certain Federal contracts; 18 U.S.C. 431 relating to officials not to benefit; 40 U.S.C. chapter 37, Contract Work Hours and Safety Standards; 41 U.S.C. chapter 87, Kickbacks; 49 U.S.C. 40118, Fly American; and 41 U.S.C. chapter 21 relating to procurement integrity.

(s) Order of precedence. Any inconsistencies in this solicitation or contract shall be resolved by giving precedence in the following order:

(1) The schedule of supplies/services.

(2) The Assignments, Disputes, Payments, Invoice, Other Compliances, Compliance with Laws Unique to Government Contracts, and Unauthorized Obligations paragraphs of this clause;

(3) The clause at 52.212-5.

(4) Addenda to this solicitation or contract, including any license agreements for computer software.

(5) Solicitation provisions if this is a solicitation.

(6) Other paragraphs of this clause.

(7) The Standard Form 1449.

(8) Other documents, exhibits, and attachments

(9) The specification.

(t) [Reserved]

(u) Unauthorized Obligations.

(1) Except as stated in paragraph (u)(2) of this clause, when any supply or service acquired under this contract is subject to any End User License Agreement (EULA), Terms of Service (TOS), or similar legal instrument or agreement, that includes any clause requiring the Government to indemnify the Contractor or any person or entity for damages, costs, fees, or any other loss or liability that would create an Anti-Deficiency Act violation (31 U.S.C. 1341), the following shall govern:

(i) Any such clause is unenforceable against the Government.

(ii) Neither the Government nor any Government authorized end user shall be deemed to have agreed to such clause by virtue of it appearing in the EULA, TOS, or similar legal instrument or agreement. If the EULA, TOS, or similar legal instrument or agreement is invoked through an “I agree” click box or other comparable mechanism (e.g., “click-wrap” or “browse-wrap” agreements), execution does not bind the Government or any Government authorized end user to such clause.

(iii) Any such clause is deemed to be stricken from the EULA, TOS, or similar legal instrument or agreement.

(2) Paragraph (u)(1) of this clause does not apply to indemnification by the Government that is expressly authorized by statute and specifically authorized under applicable agency regulations and procedures.

(v) Incorporation by reference. The Contractor’s representations and certifications, including those completed electronically via the System for Award Management (SAM), are incorporated by reference into the contract.

(End of Clause)

ADDENDUM to FAR 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL

PRODUCTS AND COMMERCIAL SERVICES

Clauses 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 clauses are incorporated into 52.212-4 as an addendum to this contract:

C.2 52.217-8 OPTION TO EXTEND SERVICES (NOV 1999)

The Government may require continued performance of any services within the limits and at the rates specified in the contract. These rates may be adjusted only as a result of revisions to prevailing labor rates provided by the Secretary of Labor. The option provision may be exercised more than once, but the total extension of performance hereunder shall not exceed 6 months. The Contracting Officer may exercise the option by written notice to the Contractor within 30 days from the end of the period of performance.

(End of Clause)

C.3 52.217-9 OPTION TO EXTEND THE TERM OF THE CONTRACT (MAR

2000)

(a) The Government may extend the term of this contract by written notice to the Contractor within 30 days from the end of the period of performance; provided that the Government gives the Contractor a preliminary written notice of its intent to extend at least 60 days before the contract expires. The preliminary notice does not commit the Government to an extension.

(b) If the Government exercises this option, the extended contract shall be considered to include this option clause.

(c) The total duration of this contract, including the exercise of any options under this clause, shall not exceed three (3) years.

(End of Clause)

C.4 52.225-5 TRADE AGREEMENTS (NOV 2023)

(a) Definitions. As used in this clause.

"Caribbean Basin country end product"—

(1) Means an article that—

(i)(A) Is wholly the growth, product, or manufacture of a Caribbean Basin country; or

(B) In the case of an article that consists in whole or in part of materials from another country, has been substantially transformed in a Caribbean Basin country into a new and different article of commerce with a name, character, or use distinct from that of the article or articles from which it was transformed; and

(ii) Is not excluded from duty-free treatment for Caribbean countries under 19 U.S.C.

2703(b).

(A) For this reason, the following articles are not Caribbean Basin country end products:

(1) Tuna, prepared or preserved in any manner in airtight containers;

(2) Petroleum, or any product derived from petroleum;

(3) Watches and watch parts (including cases, bracelets, and straps) of whatever type including, but not limited to, mechanical, quartz digital, or quartz analog, if such watches or watch parts contain any material that is the product of any country to which the Harmonized Tariff Schedule of the United States (HTSUS) column 2 rates…