Solicitation 36C25025Q4480.pdf

PAGE 1 OF 1. 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

Not Applicable

36C25025Q4480 03-17-2025

Brad Burhite (513) 692-7340 03-27-2025

10:00 EDT

36C250

Department of Veterans Affairs Network Contracting Office (NCO) 10 260 E. University Avenue Cincinnati OH 45219

X 100

X

621610

$19 Million

X

N/A

X

See PWS and COST/PRICE SCHEDULE

36C250

Department of Veterans Affairs Network Contracting Office (NCO) 10 260 E. University Avenue Cincinnati OH 45219

Department of Veterans Affairs

FMS-VA-2(101)

Financial Services Center PO Box 149971 Austin TX 78714-9971

See CONTINUATION Page

The contractor shall provide all personnel, equipment, supplies, facilities, transportation, tools, materials, supervision, and other items necessary to provide Home-Based Sleep Study Services for Dayton VA Medical Center (VAMC) in accordance with the PWS and terms and conditions established herein with performance period as follows:

- Base Period (8-months) from 4/08/2025 to 12/07/2025

- Option Year One (OY1) from 12/08/2025 to 12/07/2026

- Option Year Two (OY2) from 12/08/2026 to 12/07/2027

- Option Year Three (OY3) from 12/08/2027 to 12/07/2028

- Option Year Four (OY4) from 12/08/2028 to 12/07/2029

This solicitation shall be conducted in accordance with FAR Subpart 13.5 and is anticipated to result in the award of an Indefinite-Delivery type contract as defined in FAR Subpart 16.5. The performance of services under this contract shall only be authorized though the award of funded task order(s) by the cognizant government contracting.

See CONTINUATION Page Subject to FAR 52.232-18 (Availability of Funds)

X X

X 1

Bradley Burhite

VA-VHA-2020-230A0A03

BRADLEY

BURHITE

Digitally signed by BRADLEY

BURHITE

Date: 2025.03.17 15:44:31 -04'00'

36C25025Q4480

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

B.2 PRICE/COST SCHEDULE

ITEM INFORMATION

B.3 PERFORMANCE WORK STATEMENT dated 5 March 2025

B.4 IT CONTRACT SECURITY

SECTION C - CONTRACT CLAUSES

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

AND COMMERCIAL SERVICES (NOV 2023)

C.2 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT

STATUTES OR EXECUTIVE ORDERS—COMMERCIAL PRODUCTS AND

COMMERCIAL SERVICES (JAN 2025)

C.3 52.215-22 LIMITATIONS ON PASS-THROUGH CHARGES—IDENTIFICATION OF

SUBCONTRACT EFFORT (OCT 2009)

C.4 52.215-23 LIMITATIONS ON PASS-THROUGH CHARGES (JUN 2020)

C.5 52.216-18 ORDERING (AUG 2020)

C.6 52.216-19 ORDER LIMITATIONS (OCT 1995)

C.7 52.216-22 INDEFINITE QUANTITY (OCT 1995)

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

C.9 52.217-9 OPTION TO EXTEND THE TERM OF THE CONTRACT (MAR 2000) ... 47

C.10 52.219-14 LIMITATIONS ON SUBCONTRACTING (OCT 2022)

C.11 52.224-2 PRIVACY ACT (APR 1984)

C.12 52.224-3 PRIVACY TRAINING (JAN 2017)

C.13 52.232-19 AVAILABILITY OF FUNDS FOR THE NEXT FISCAL YEAR (APR

1984)

C.14 52.242-15 STOP-WORK ORDER (AUG 1989)

C.15 SUPPLEMENTAL INSURANCE REQUIREMENTS

C.16 VAAR 852.204-71 INFORMATION AND INFORMATION SYSTEMS SECURITY

(FEB 2023)

C.17 VAAR 852.219-75 VA NOTICE OF LIMITATIONS ON SUBCONTRACTING—

CERTIFICATE OF COMPLIANCE FOR SERVICES AND CONSTRUCTION (JAN 2023)

(DEVIATION)

C.18 VAAR 852.232-72 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS

(NOV 2018)

C.19 VAAR 852.237-75 KEY PERSONNEL (OCT 2019)

C.20 VAAR 852.242-71 ADMINISTRATIVE CONTRACTING OFFICER (OCT 2020) . 65

C.21 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS

D.1 WAGE DETERMINATION (WD) 2015-4731-R25 MONTGOMERY COUNTY, OHIO

DATED 12/23/2024 (see attached)

SECTION E - SOLICITATION PROVISIONS

E.1 52.204-24 REPRESENTATION REGARDING CERTAIN TELECOMMUNICATIONS

AND VIDEO SURVEILLANCE SERVICES OR EQUIPMENT (NOV 2021)

E.2 52.204-29 FEDERAL ACQUISITION SUPPLY CHAIN SECURITY ACT

ORDERS—REPRESENTATION AND DISCLOSURES (DEC 2023)

E.3 52.209-7 INFORMATION REGARDING RESPONSIBILITY MATTERS (OCT 2018)

E.4 52.212-1 INSTRUCTIONS TO OFFERORS—COMMERCIAL PRODUCTS AND

COMMERCIAL SERVICES (SEP 2023)

E.5 52.212-2 EVALUATION—COMMERCIAL PRODUCTS AND COMMERCIAL

SERVICES (NOV 2021)

E.6 52.212-2 (Addendum A) – Past Performance Questionnaire E.7 52.212-2 (Addendum B) – Statement of FAR 52.219-14 Limitations on Subcontracting Compliance

E.8 VAAR 852.219-75 VA NOTICE OF LIMITATIONS ON SUBCONTRACTING—

CERTIFICATE OF COMPLIANCE FOR SERVICES AND CONSTRUCTION (NOV 2022)

E.9 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—

COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (MAY 2024)

E.10 52.216-1 TYPE OF CONTRACT (APR 1984)

E.11 52.217-5 EVALUATION OF OPTIONS (JUL 1990)

E.12 52.233-2 SERVICE OF PROTEST (SEP 2006)

E.13 VAAR 852.233-71 ALTERNATE PROTEST PROCEDURE (OCT 2018)

E.14 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE

(FEB 1998)

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 36C250

Network Contracting Office (NCO) 10 260 E. University Avenue Cincinnati OH 45219

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

[X] 52.232-36, Payment by Third Party

3. INVOICES: Invoices shall be submitted in arrears:

a. Quarterly []

b. Semi-Annually []

c. Other [X] Invoices shall be submitted monthly in the arrears upon completion of authorized services.

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

B.2 PRICE/COST SCHEDULE

ITEM INFORMATION

ITEM

NUMBER

DESCRIPTION OF

SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

550.00 EA $____________ $______________

BASE PERIOD (8-MONTHS) | HOME-BASED SLEEP STUDY

SERVICES FOR DAYTON VAMC: The contractor shall provide home-based sleep study services for Dayton VA Medical Center (VAMC) in accordance with the PWS and terms and conditions established in the contract. This service shall be provided on a turn-key basis. In addition, the individual unit price provided herein shall be fully inclusive of all costs associated with providing patient home-based sleep study services such as provide all personnel, equipment, supplies, facilities, transportation, tools, materials, supervision and other items necessary to provide this required service.

INVOICING: The contractor shall invoice on a monthly basis in the arrears upon completion of services in accordance with the Federal Acquisition Regulation (FAR) not-to-exceed the total quantity established within this contract line-item number (CLIN).

IDIQ MINIMUM AND MAXIMUM: The minimum IDIQ amount shall be a quantity of ten (10) which shall be applied to the Base Period. The maximum IDIQ amount shall not exceed the pre-established total quantity for this contract line-item number (CLIN) within the PRICE/COST

SCHEDULE.

Contract Period: Base POP Begin: 04-08-2025 POP End: 12-07-2025

PRINCIPAL NAICS CODE: 621610 - Home Health Care Services PRODUCT/SERVICE CODE: Q521 - Medical - Pulmonary

800.00 EA $____________ $______________

OPTION YEAR ONE (OY1) | HOME-BASED SLEEP STUDY

based sleep study services for Dayton VA Medical Center (VAMC) in accordance with the PWS and terms and conditions established in the contract. This service shall be provided on a turn-key basis. In addition, the individual unit price provided herein shall be fully inclusive of all costs associated with providing patient home-based sleep study services such as provide all personnel, equipment, supplies, facilities, transportation, tools, materials, supervision and other items necessary to provide this required service.

INVOICING: The contractor shall invoice on a monthly basis in the arrears upon completion of services in accordance with the Federal Acquisition Regulation (FAR) not-to-exceed the total quantity established within this contract line-item number (CLIN).

IDIQ MINIMUM AND MAXIMUM: The minimum IDIQ amount shall be a quantity of ten (10) which shall be applied to the Base Period. The maximum IDIQ amount shall not exceed the pre-established total quantity for this contract line-item number (CLIN) within the PRICE/COST

SCHEDULE.

Contract Period: Option 1 POP Begin: 12-08-2025 POP End: 12-07-2026

OPTION YEAR TWO (OY2) | HOME-BASED SLEEP STUDY

based sleep study services for Dayton VA Medical Center (VAMC) in accordance with the PWS and terms and conditions established in the contract. This service shall be provided on a turn-key basis. In addition, the individual unit price provided herein shall be fully inclusive of all costs associated with providing patient home-based sleep study services such as provide all personnel, equipment, supplies, facilities, transportation, tools, materials, supervision and other items necessary to provide this required service.

INVOICING: The contractor shall invoice on a monthly basis in the arrears upon completion of services in accordance with the Federal Acquisition Regulation (FAR) not-to-exceed the total quantity established within this contract line-item number (CLIN).

IDIQ MINIMUM AND MAXIMUM: The minimum IDIQ amount shall be a quantity of ten (10) which shall be applied to the Base Period. The maximum IDIQ amount shall not exceed the pre-established total quantity for this contract line-item number (CLIN) within the PRICE/COST

SCHEDULE.

Contract Period: Option 2 POP Begin: 12-08-2026 POP End: 12-07-2027

OPTION YEAR THREE (OY3) | HOME-BASED SLEEP STUDY

based sleep study services for Dayton VA Medical Center (VAMC) in accordance with the PWS and terms and conditions established in the contract. This service shall be provided on a turn-key basis. In addition, the individual unit price provided herein shall be fully inclusive of all costs associated with providing patient home-based sleep study services such as provide all personnel, equipment, supplies, facilities, transportation, tools, materials, supervision and other items necessary to provide this required service.

INVOICING: The contractor shall invoice on a monthly basis in the arrears upon completion of services in accordance with the Federal Acquisition Regulation (FAR) not-to-exceed the total quantity established within this contract line-item number (CLIN).

IDIQ MINIMUM AND MAXIMUM: The minimum IDIQ amount shall be a quantity of ten (10) which shall be applied to the Base Period. The maximum IDIQ amount shall not exceed the pre-established total quantity for this contract line-item number (CLIN) within the PRICE/COST

SCHEDULE.

Contract Period: Option 3 POP Begin: 12-08-2027 POP End: 12-07-2028

OPTION YEAR FOUR (OY4) | HOME-BASED SLEEP STUDY

based sleep study services for Dayton VA Medical Center (VAMC) in accordance with the PWS and terms and conditions established in the contract. This service shall be provided on a turn-key basis. In addition, the individual unit price provided herein shall be fully inclusive of all costs associated with providing patient home-based sleep study services such as provide all personnel, equipment, supplies, facilities, transportation, tools, materials, supervision and other items necessary to provide this required service.

INVOICING: The contractor shall invoice on a monthly basis in the arrears upon completion of services in accordance with the Federal Acquisition Regulation (FAR) not-to-exceed the total quantity established within this contract line-item number (CLIN).

IDIQ MINIMUM AND MAXIMUM: The minimum IDIQ amount shall be a quantity of ten (10) which shall be applied to the Base Period. The maximum IDIQ amount shall not exceed the pre-established total quantity for this contract line-item number (CLIN) within the PRICE/COST

SCHEDULE.

Contract Period: Option 4 POP Begin: 12-08-2028 POP End: 12-07-2029

GRAND TOTAL

B.3 PERFORMANCE WORK STATEMENT dated 5 March 2025

PERFORMANCE WORK STATEMENT (PWS)

Home Based Sleep Study Services for Dayton VA Medical Center (VAMC)

5 March 2025

1. GENERAL. The contractor shall provide HOME BASED SLEEP STUDY SERVICES in support of Dayton VA Medical Center (VAMC) for this non-personal services requirement. The government shall not exercise any supervision or control over the contractor in providing services as specified herein.

The contractor shall provide all personnel, equipment, supplies, facilities, transportation, tools, materials, supervision and other items necessary to provide HOME BASED SLEEP STUDY SERVICES for DAYTON VAMC which are FDA cleared, FedRAMP approved (if cloud based) and VA Technical Reference Model (TRM) authorized as compatible with the VA IT system as a turn-key deliverable. Please note the definition of “turn-key deliverable” is that the contractor shall provide all personnel, equipment, supplies, facilities, transportation, tools, materials, supervision and other items necessary to provide home-based sleep study services for Dayton VAMC in which the final deliverable is an actionable sleep study for each patient as defined herein.

The contractor shall utilize either reusable or disposable FDA cleared sleep study devices as appropriate as the primary means of conducting home based sleep studies which are VHA TRM authorized as compatible. In addition, the contractor shall ensure that a sufficient quantity of the reusable type of sleep study devices are available at all times for patients who do not have a personal smart phone capable of transmitting sleep study data for the disposable type of sleep study devices. Lastly, the contractor shall utilize a FedRAMP approved capability to securely transmitting sleep study results from the patient’s personal cell phone at home to the Pulmonary Department at the VA Medical Center as a turn-key deliverable.

In addition, the contractor shall provide the raw data and final report in FDA cleared format which shall include all necessary software tools for turn-key utilization of the data the government requiring office for all sleep studies.

The contractor shall ensure that all sleep study report and related raw data are transmitted electronically in a format that is compliant with the pre-existing IT infrastructure and IT security protocols for secure transmission of data at no additional cost to the government in excess of the established PRICE/COST SCHEDULE. In addition, all sleep study reports shall follow the basic guidelines provided in the American Academy of Sleep Medicine (AASM) manual for tabulating and scoring of sleep related events.

The requirement and demand for Veteran access dictates the necessity of providing a service that includes the entire catchment are for The VA Central Ohio Healthcare System. This requirement is intended to address this need by providing HOME BASED SLEEP STUDY SERVICES with minimal life cycle costs. In order to meet this requirement, the contractor shall provide portable sleep studies to the Veteran population at their home of residence.

This effort shall ensure a continuation of high-quality sleep apnea testing and care. Furthermore, this service will allow Veterans with a traveling hardship to have easy access to quality sleep care.

IMPORTANT NOTE: The contractor is NOT required to interpret the sleep studies generated herein. The government will be responsible for interpreting all home-based sleep studies completed by the contractor during the performance of this entire contract requirement.

1.1 SCOPE SUMMARY. The contractor shall provide all personnel, equipment, supplies, facilities, transportation, tools, materials, supervision, and other items necessary to provide HOME BASED SLEEP STUDY SERVICES for Dayton VA Medical Center (VAMC) in Ohio as established in this Performance Work Statement (PWS) and in accordance with terms and conditions established in the contract for the following location:

Dayton VA Medical Center

4100 West Third Street Dayton, Ohio 45428-0004

1.2 PERIOD OF PEFORMANCE. The period of performance for this requirement is summarized as follows:

Base Period (8-Months) from 4/08/2025 to 12/07/2025 Option Year One (OY1) from 12/08/2025 to 12/07/2026 Option Year Two (OY2) from 12/08/2026 to 12/07/2027 Option Year Three (OY3) from 12/08/2027 to 12/07/2028 Option Year Four (OY4) from 12/08/2028 to 12/07/2029

1.3 GENERAL REQUIREMENTS

1.3.1 Quality Control: The contractor shall develop and maintain an effective quality control program to ensure services are performed in accordance with this PWS. The contractor shall identify and define the management concept for ensuring compliance with all contract requirements. The contractor shall develop and implement procedures to identify, prevent, and ensure non-recurrence of defective services. The contractor will have an on-going quality assurance and /or quality improvement program designed to objectively and systematically measure, assess, and improve performance to enhance patient care and all patient care services. The contractor’s quality control program is the means by which the contractor assures that all work complies with the requirement of the contract. The contractor shall provide a copy of the QCP with their offeror as specified by the Contracting Officer and upon request thereafter. After acceptance of the quality control plan, the contractor shall immediately notify the contracting officer of any proposed changes to their quality control program and submit a change request in writing to the contracting officer. The contractor shall furnish copies of these records if requested by the Contracting Officer, GOVERNMENT PM or individual(s) designated by the GOVERNMENT PM and/or CO in writing. The contractor’s quality control program shall include the following:

1.3.2 Quality Assurance. The government shall evaluate the contractor’s performance under this contract in accordance with the Quality Assurance Surveillance Plan. This plan is primarily focused on what the Government must do to ensure that the contractor has performed in accordance with the performance standards. It defines how the performance standards will be applied, the frequency of surveillance, and the minimum acceptable defect rate(s):

1.3.3 Federally Recognized Holidays. The contractor is not anticipated but may be required to provide service on Federally recognized holidays in accordance with the terms and conditions established in this PWS to include but not limited to the following:

New Year’s Day Labor Day Martin Luther King Jr.’s Birthday Columbus Day President’s Day Veteran’s Day Memorial Day Thanksgiving Day Juneteenth Christmas Day Independence Day

1.3.4 Hours of Operation. The business hours of operation for Dayton VA Medical Center (VAMC) in Ohio is Monday through Friday from 0800-EST to 1630-EST, except on Federally recognized holidays.

1.3.5 Place of Performance. The contractor shall furnish provide services in accordance with the terms and conditions of this contract as requested by the authorized government representative(s) designated in writing by the GOVERNMENT PM and/or CO in accordance with the procedures specified within this PWS for the following location:

Department of Veterans Affairs Dayton VA Medical Center 4100 West Third Street Dayton, Ohio 45428-0004

1.3.6 Type of Contract. The government intends to award a single-award firm-fixed price (FFP) contract for the effort specified herein. The IDIQ quantities established in the PRICE/COST SCHEDULE are not-to-exceed in accordance with the terms and conditions of the contract. The base and option periods (if any) specified in the

PRICE/COST SCHEDULE shall be exercised at the discretion of the government. The authority that will be utilized to award this effort is FAR Part 13.5 (Simplified Procedures for Certain Commercial Items).

1.3.7 Security Requirements and Background Checks. All contractor employees shall comply with the security and background check requirements required by Federal, State, Local and the Department of Veterans Affairs to perform service in support of this VA medical facility in the state of Ohio. The contractor shall perform the services in compliance with the terms and conditions of this contract at the contractor’s facility unless a meeting and/or site visit is required which shall be coordinated with the government program manager.

1.4.12.1 VAMC/VAACC Identification Badges: The contractor shall ensure that all personnel obtain VAMC/VAACC identification badges from the each VAMC/VAACC security personnel office as appropriate in compliance with all federal and local VAMC/VAACC facility policies in coordination with the government program manager if required.

1.4.12.2 PHYSICAL Security: Not Applicable.

1.4.12.3 Key Control: Not Applicable.

1.4.12.4 Lock Combinations: Not Applicable.

1.3.9 Post Award Conference/Periodic Progress Meetings. The contractor agrees to attend any post award conference convened by the contracting activity or contract administration office in accordance with Federal Acquisition Regulation Subpart 42.5. The contracting officer, government program manager, and other government personnel, as appropriate, may meet periodically with the contractor to review the contractor's performance. At these meetings the contracting officer will apprise the contractor of how the government views the contractor's performance and the contractor will apprise the government of problems, if any, being experienced. Appropriate action shall be taken to resolve outstanding issues. These meetings shall be at no additional cost to the government.

1.3.10 Government Program Manager (Government PM). The government PM will be identified by the cognizant government Contracting Officer in writing. The PM monitors all technical aspects of the contract and assists in contract administration. The PM is authorized to perform the following functions: assure that the contractor performs the technical requirements of the contract: maintain written and oral communications with the contractor concerning technical aspects of the contract that are within scope: monitor contractor's performance and notifies both the contracting officer and contractor of any deficiencies; coordinate availability of government furnished property, and provide site entry of contractor personnel. The PM shall be specified in writing by the CO and is not authorized to change any of the terms and conditions of the resulting contract.

1.3.11 Key Personnel. The following personnel are considered key personnel by the government: Project Manager/Alternate Project Manager and Officer in Charge. The contractor shall provide a contract manager who shall be responsible for the performance of the work. The name of this person and an alternate who shall act for the contractor when the manager is absent shall be designated in writing to the contracting officer. The contract manager or alternate shall have full authority to act for the contractor on all contract matters relating to daily operation of this contract.

1.3.12 Identification of Contractor Employees: All contract personnel attending meetings, answering Government telephones, and working in other situations where their contractor status is not obvious to third parties are required to identify themselves as such to avoid creating an impression in the minds of members of the public that they are Government officials. They must also ensure that all documents or reports produced by contractors are suitably marked as contractor products or that contractor participation is appropriately disclosed.

1.3.13 Contractor Travel: Not Applicable

1.3.14 Other Direct Costs: Not Applicable

1.3.15 Data Rights: Not Applicable

1.3.16 Organizational Conflict of Interest: Not Applicable

1.3.17 Phase-In /Phase-Out Period: Not Applicable

2. DEFINITIONS AND ACRONYMS

2.1. DEFINITIONS

BENEFICIARY. Veterans and other members determined to be eligible for benefits by the VA.

COMMUNITY LIVING CENTER (CLC). The Community Living Centers (CLCs) are inpatient units for

VAMC nursing homes.

CONTRACT TASK ORDERS. Award of a funded contract task order for the appropriate period of performance is required prior to the commencement of any/all work in accordance with FAR part 16.506 as specified herein.

CONTRACTOR. A vendor awarded a contract to provide specific supplies or service to the government. The term used in this contract refers to the prime contractor and its employees. The contractor is fully responsible for performance of their sub-contractor(s) and shall ensure that their subcontractor(s) are fully compliant with the terms and conditions of this contract at all-times.

CONTRACTING OFFICER. A person with authority to enter into, administer, and or terminate contracts, and make related determinations and findings on behalf of the government. Note: The only individual who can legally bind the government.

CONTRACTING OFFICER'S REPRESENTATIVE (COR). An employee of the U.S. Government appointed by the Contracting Officer to administer the contract. Such appointment shall be in writing and shall state the scope of authority and limitations. This individual has authority to provide technical direction to the contractor as long as that direction is within the scope of the contract, does not constitute a change, and has no funding implications. This individual does NOT have authority to change the terms and conditions of the contract.

DEFECTIVE SERVICE. A service output that does not meet the standard of performance associated with the Performance Work Statement.

DELIVERABLE. Anything that can be physically delivered but may include non-manufactured things such as meeting minutes or reports.

GOVERNMENT PROGRAM MANAGER (PM): An individual specified by the contracting officer in writing to provide technical guidance for work within the scope of this contract. This individual has authority to provide technical direction to the contractor as long as that direction is within the scope of the contract, does not constitute a change, and has no funding implications.

KEY PERSONNEL. Contractor personnel that are evaluated in a source selection process and that may be required to be used in the performance of a contract by the Key Personnel listed in the PWS. When key personnel are used as an evaluation factor in best value procurement, an offer can be rejected if it does not have a firm commitment from the persons that are listed in the proposal.

NOT TO EXCEED (NTE). The price and/or quantity that the contract or purchase order shall not exceed.

PATIENT BUSINESS SERVICES. An administrative department which processes patients’ medical records, appointments, etc.

PHYSICAL SECURITY. Actions that prevent the loss or damage of Government property.

QUALITY ASSURANCE. The government procedures to verify that services being performed by the contractor are performed according to acceptable standards.

QUALITY CONTROL. All necessary measures taken by the Contractor to assure that the quality of an end product or service shall meet contract requirements.

QUALITY ASSURANCE. Those actions taken by the Government to assure services meet the requirements of this contract.

QUALITY ASSURANCE EVALUATOR(S): Government personnel responsible for surveillance of contractor performance.

QUALITY ASSURANCE SURVEILLENCE PLAN (QASP). An organized written document specifying the surveillance methodology to be utilized by the government for surveillance of contractor performance.

QUALITY CONTROL PLAN (QCP): The QCP is the contractor's management plan for executing the contract which shall be provided to the government upon request and whenever updated by the contractor. The contractor QCP describes the way in which the contractor will produce the deliverables, and the step-by-step approach that will be taken to ensure the quality of service provided to the government.

SUBCONTRACTOR(S). A subcontractor is one who enters into a contract with a contractor (or prime contractor).

THE JOINT COMMISSION (TJC). A national not-for-profit organization dedicated to administering accreditation programs that improve the care, safety and treatment of patients in a health care facility and environment.

TURN-KEY DELIVERABLE: The contractor shall provide all personnel, equipment, supplies, facilities, transportation, tools, materials, supervision and other items necessary to provide home-based sleep study services for Dayton VAMC in which the final deliverable is an actionable sleep study for each patient as defined in this PWS.

UNIVERSAL PRECAUTIONS. The standard precautions which shall be taken by the contractor when it is anticipated that an individual may encounter blood or body fluid while performing normal duties which require the use of personal protective equipment (e.g., gloves).

2.2. ACRONYMS:

AQL Access Control List CBOC Community Based Outpatient Clinic CFR Code of Federal Regulations CLC Community Living Centers CO Contracting Officer CONUS Continental United States (excludes Alaska and Hawaii) COR Contracting Officer’s Representative COTR Contracting Officer's Technical Representative COTS Commercial-Off-the-Shelf FAR Federal Acquisition Regulation HIPAA Health Insurance Portability and Accountability Act of 1996 NHCU Nursing Home Care Unit NTE Not to Exceed OCI Organizational Conflict of Interest OCONUS Outside Continental United States (includes Alaska and Hawaii) ODC Other Direct Costs OAC Ohio Administrative Code ORC Ohio Revised Code PBS Patient Business Services PIPO Phase In/Phase Out PACS Physical Access Control System POC Point of Contact PM Program Manager PRS Performance Requirements Summary PWS Performance Work Statement QA Quality Assurance QAP Quality Assurance Plan QASP Quality Assurance Surveillance Plan QC Quality Control QCP Quality Control Program SaaS Software as a Service SMS Security Management System SSA Site Support Agreement TE Technical Exhibit VAAR Veteran’s Administration Acquisition Regulation VAPS VA Police System VISTA Veteran’s Health Information Systems and Technology Architecture VSC VHA Service Center VAACC Veteran’s Administration Ambulatory Care Clinic VAMC Veteran’s Administration Medical Center VHA Veteran’s Health Administration VHA PM Veteran’s Health Administration Procurement Manual

3. GOVERNMENT FURNISHED ITEMS AND SERVICES: No government furnished equipment (GFE) will be provided for this requirement.

3.1. Services: Not applicable

3.2 Facilities: Not applicable.

3.3 Utilities: Not applicable.

3.4 Equipment: Not applicable.

3.5 Materials: Not applicable.

4. CONTRACTOR FURNISHED ITEMS AND RESPONSIBILITIES:

4.1 General: The contractor shall provide all personnel, equipment, supplies, facilities, transportation, tools, materials, supervision, and other items necessary to perform all services under this contract as defined in this PWS and in accordance with the terms and conditions of this contract.

4.2. Materials, Supplies and Equipment: The contractor shall provide the supplies as specified in this PWS.

5. REQUIREMENTS – SPECIFIC TASKS:

5.1 GENERAL: The contractor shall provide portable sleep studies to the Veteran population at their home of residence. This effort shall ensure a continuation of high-quality sleep apnea testing and care. Furthermore, this service will allow Veterans with a traveling hardship to have easy access to quality sleep care.

5.1.1 ORDERING: The units ordered by the government shall be shipped directly from the contractor to each patient at their home of residence which shall include 24/7 customer support service.

5.1.2 The contractor shall ensure all reusable and/or disposable sleep study devices are provided in compliance with the following salient characteristics:

5.1.2.1 The contractor shall ensure that all necessary equipment and/or supplies are provided to the VA patient at their home of residence for turn-key use in a kit with instructions.

5.1.2.2 Equipment and/or supplies shall be FDA-cleared portable diagnostic device that monitors, tracks, and records respiratory, cardiac, and blood oxygen levels to enable Obstructive Sleep Apnea (OSA) testing approach.

5.1.2.3 Equipment and/or supplies shall be high compliance with a minimal failure rate of (< =3%) for the device only which does include patient caused failures.

5.1.2.4 Provides non-EEG HST measures “True Sleep Time” (rather than total recording time) and provides complete sleep architecture.

5.1.2.5 Supplies shall require minimal cleaning, preparation or handling before and after patient use.

5.1.2.6 The contractor shall provide a portable in-home capability that meets the needs of VA by providing a service that helps VA manage a growing patient population by ensuring all specialty services are available for our Veteran patients to able to have complete care in one place.

5.1.2.7 The Pulmonary Department needs a quick turnaround of results that allows the provider to make a diagnosis and treatment plan quickly and service more veterans at the same time within a reasonable amount of time.

5.1.2.8 The contractor shall ensure all services are provided as turnkey to the government requiring activity. The contractor shall provide the government requiring activity for each sleep study the raw data and final report in FDA cleared format which shall include all necessary software tools for turn-key utilization of the data.

5.1.2.9 The contractor shall ensure that all required equipment with instructions for use and disposal be shipped to the patient at their home of residence within 10 business days of any given request by an authorized government representative specified by the government contracting officer.

Instructions for the patient shall include how to return a reusable unit back to the contractor via the pre-paid postage box/envelope. The instructions for patient use shall also include how to upload the required sleep study report and instructions for disposal if using a disposal device.

5.1.2.10 The contractor shall provide a secure, digital reporting structure for all patient sleep study reports and shall be accessible by only the authorized government representative(s) specified by the government contracting officer in writing. Furthermore, the contractor shall ensure that all reports and data is compliant with HIPPA, Privacy Act of 1974 and all VA policies and procedures. The contractor shall ensure that all patient sleep study reports are accessible by all authorized government representative(s) for the entire life of the contract.

5.1.2.11 The contractor shall provide for each sleep study the raw data and final report in the FDA cleared format to the government requiring activity.

5.1.2.12 The contractor shall ensure that the sleep study report for each patient is available for download by the government requiring activity within 5 minutes of any sleep study report being uploaded by any given patient. Furthermore, the contractor shall send an email notification to the authorized government representative(s) within 1 hour of any given sleep study report being uploaded by any given patient as available for download by the government. The sleep study report shall include heart rate, O2 saturation, hypnogram, complete sleep architecture, respiratory analysis, and provide a non-EEG HST measures “True Sleep Time” (rather than total recording time).

5.1.2.13 If utilizing sleep study devices that require hosting and transmission on the cloud, the contractor shall provide documentation to evidence VA Technical Reference Model (TRM), VA Authority- To-Operate (ATO), and VA FedRAMP and FDA approval for software and devices as applicable.

5.1.2.14 The definition of a billable sleep study is any test that includes the minimum amount of data required by the VA Medical Center which is anticipated to be 4 hours of contiguous usable data (may be subject to change).

5.1.3 ORDERING QUANTITIES. This contract is an indefinite quantity contract with maximum not-to-exceed (NTE) amounts which are established in the PRICE/COST SCHEDULE. The contractor shall not exceed the maximum NTE amounts established in the PRICE/COST SCHEDULE unless authorized via a bilateral contract modification that is full funded, justified and signed by the government contracting officer.

5.1.4 PACKAGING, PACKING AND SHIPPING INSTRUCTIONS. Direct shipping to the patient is implicit. It is what this service is revolved around.

5.1.5 INSPECTION AND ACCEPTANCE CRITERIA. The Veteran will receive the package from contractor with packing slip. Once the overnight sleep study has been completed the VA personnel will ensure transmission occurred to reflect findings of the study. The government technical POCs specified by the contracting officer in writing will be responsible for confirming that inspection and acceptance of the wristband sleep study device have been received by the patient from the contractor. A demo period or trial is not deemed as an inspection of a product.

The contractor shall ensure the patient understands its usage and what to do once the test is complete. The results will be provided to the patient once they are read at VA.

5.1.6 TIMELINESS. The contractor shall provide sleep study supplies and services as needed in a timely fashion as mutually agreed in accordance with the terms and conditions of this contract which shall not exceed the maximum not-to-exceed (NTE) amounts established in the PRICE/COST SCHEDULE.

5.1.7 DELIVERABLES. The contractor shall treat all deliverables under the contract as the property of the U.S.

government for which the government agency shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest.

5.1.8 RECORDS. The contractor shall not create or maintain any records that are not specifically tied to or authorized by the contract using government ‘IT’ equipment and/or Government records.

5.1.9 The contractor shall not retain, use, sell, or disseminate copies of any deliverable that contains information covered by the Privacy Act of 1974 or that which is generally protected by the Freedom of Information Act.

5.1.10 The contractor shall not create or maintain any records containing any government agency records that are not specifically tied to or authorized by the contract.

5.1.11 The government agency owns the rights to all data/records produced as part of this contract.

5.1.12 The government agency owns the rights to all electronic information (electronic data, electronic information systems, electronic databases, etc.) and all supporting documentation created as part of this contract. Contractor must deliver sufficient documentation with all deliverables to permit the agency use.

5.1.13 The contractor agrees to comply with Federal and agency records management policies, including those policies associated with the safeguarding of records covered by the Privacy Act of 1974. These policies include the preservation of all records created or received regardless of format [paper, electronic, etc.] or mode of transmission [e-mail, fax, etc.] or state of completion [draft, final, etc.].

5.1.14 No disposition of documents will be allowed without the prior written consent of the Contracting Officer.

The Agency and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701. Records may not be removed from the legal custody of the Agency or destroyed without regard to the provisions of the agency records schedules.

5.1.15 The contractor is required to obtain the Contracting Officer's approval prior to engaging in any contractual relationship (sub-contractor) in support of this contract requiring the disclosure of information, documentary material and/or records generated under or relating to this contract. The Contractor (and any sub-contractor) is required to abide by Government and Agency guidance for protecting sensitive and proprietary information.

5.2 VA INFORMATION CUSTODIAL LANGUAGE.

5.2.1 Information made available to the prime contractor or their subcontractors through the prime contractor by VA for the performance or administration of this contract or information developed by the contractor and their subcontractors in performance or administration of the contract shall be used only for those purposes and shall not be used in any other way without the prior written agreement of the VA. This clause expressly limits the contractor/subcontractor's rights to use data as described in Rights in Data - General, FAR 52.227-14(d) (1).

5.2.2 The prime contractor and their subcontractor(s) shall store, transport, or transmit VA sensitive information in an encrypted form, using VA-approved encryption tools that are, at a minimum, FIPS 140-2 validated.

5.3 SECURITY INCIDENT INVESTIGATION

5.3.1 The term “security incident” means an event that has, or could have, resulted in unauthorized access to, loss or damage to VA assets, or sensitive information, or an action that breaches VA security procedures. The contractor/subcontractor shall immediately notify the GOVERNMENT PM and simultaneously, the designated ISO and Privacy Officer for the contract of any known or suspected security/privacy incidents, or any unauthorized disclosure of sensitive information, including that contained in system(s) to which the contractor/subcontractor has access.

5.3.2 To the extent known by the contractor/subcontractor, the contractor/subcontractor’s notice to VA shall identify the information involved, the circumstances surrounding the incident (including to whom, how, when, and where the VA information or assets were placed at risk or compromised), and any other information that the contractor/subcontractor considers relevant.

5.4 INVOICING PROCEDURES, BILLING RATES AND MANDATORY REPORTS. The contractor shall comply with the terms and conditions established in this contract for invoicing procedures, billing rates and mandatory reports which shall include the following:

5.4.1 Invoicing Procedures. The contractor shall submit invoices only upon completion of work authorized by a government representative designated by the contracting officer in writing. The contractor shall only invoice for authorized work completed not-to-exceed (NTE) the amounts established in PRICE/COST SCHEDULE for this contract. The contractor shall ensure all invoices reference the following information to be considered for payment by the government:

Contract Number (and task order Number if applicable) Funding PO Number Actual quantity of authorized work completed by Contract Line-Item Number (CLIN) Other information requested by the CO or authorized government representative(s) designated in writing by the CO.

5.4.2 Billing Rates. The contractor shall submit all invoices in accordance with the terms and conditions of this contract at the rates specified in the– PRICE/COST SCHEDULE which shall be priced as all-inclusive of all costs required to perform services under this contract summarized as follows:

5.4.2.1 All Inclusive Pricing | Fully Burdened. All services and supplies established in the PRICE/COST SCHEDULE shall be priced by the contractor as fully burdened (or fully inclusive) of all costs required to perform services under this contract such as overhead, general and administrative (G&A) costs, indirect costs, and other direct costs (ODCs).

5.4.2.2 No Long-Distance Phone Charges Authorized. If the contractor’s place of business is located beyond the local telephone call zone of the VA Medical Center, the contractor ensure that a toll-free number is available at all times for accepting the VA phone calls and faxes.

5.4.3 Mandatory Reports | Ad Hoc Reports and Data Calls. The contractor shall provide ad hoc reports and respond to data calls on an as needed basis as requested by either the GOVERNMENT PM or CO.

5.5 EMPLOYEE STANDARDS AND CERTIFICATION REQUIREMENTS. All services performed by contractor employees under this contract shall comply with all applicable Federal, State, Local and Department of Veterans Affairs requirements.

5.6 DISASTER PLANS. In case of a disaster, natural or man-made, the contractor shall utilize maximum available resources to assist in providing services to government.

5.7 WAGE RATES AND SERVICES CONTRACT ACT.

5.7.1 Wage Rates. The contractor shall provide services which comply with the Department of Labor wage rate determinations as applicable in the county in which the services are provided.

5.7.2 Services Contract Act. The contractor shall ensure full compliance with all requirements of the Services Contract Act (SCA) during the performance of the resultant contract (if any) to include any task orders issued under the resultant contract.

5.8 APPLICABLE PUBLICATIONS, CERTIFICATIONS AND OTHER REQUIREMENTS. The contractor must abide by all applicable regulations, publications, manuals, and local policies and procedures to include Federal, State, Local and Department of Veterans Affairs policies.

5.9 TRAINING. All contractor employees shall comply with the training requirements required by Federal, State, Local and Department of Veterans Affairs policies and procedures.

5.10 CONTRACTOR PERFORMANCE ASSESSMENT RATING SYSTEM (CPARS). The contractor is required to register in the Contractor Performance Assessment Rating System (CPARS). As prescribed in Federal Acquisition Regulation (FAR) Part 42.15, the Department of Veterans Affairs (VA) evaluates contractor past performance on all contracts that exceed the dollar threshold specified in the FAR and may share those evaluations with other Federal Government contract specialists and procurement officials. The FAR requires that the contractor be provided an opportunity to comment on past performance evaluations prior to each report closing. To fulfill this requirement VA uses an online database. The CPARS database information is shared with the Past Performance Information Retrieval System (PPIRS) database, which is available to all Federal Agencies.

5.10.2.1 Each contractor whose contract award is estimated to exceed the dollar threshold specified in the FAR shall be required to register with the Contractor Performance Assessment Rating System (CPARS) database at the following https://www.cpars.gov/ or by calling (207) 438-1690. Registration should occur no later than thirty days after contract award and must be kept current should there be any change to the contractor’s registered representative.

5.10.2.2 For contracts with a period of one year or less, the contracting officer will perform a single evaluation when the contract is complete. For contracts exceeding one year, the contracting officer will evaluate the contractor’s performance annually. Interim reports will be filed each year until the last year of the contract when the final report will be completed. The report shall be assigned in CPARS to the contractor’s designated representative for comment. The contractor representative will have thirty days to submit any comments and re-assign the report to the VA contracting officer.

5.10.2.3 For contracts with a period of one year or less, the contracting officer will perform a single evaluation when the contract is complete. For contracts exceeding one year, the contracting officer will evaluate the contractor’s performance annually. Interim reports will be filed each year until the last year of the contract when the final report will be completed. The report shall be assigned in CPARS to the contractor’s designated representative for comment.