36C25524Q0092_1.docx

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

TBD

36C25524Q0092 12-20-2023 Courtney Chattman 913-946-1975 01-04-2024 10:00

CST

36C255 Department of Veterans Affairs Network Contracting Office (NCO) 15 3450 S 4th Street Trafficway

Leavenworth KS 66048

X

621610 $19 Million

N/A

Department of Veterans Affairs St. Louis Veterans Hospital 915 N Grand Blvd St. Louis MO 63108 36C255 Department of Veterans Affairs Network Contracting Office (NCO) 15 3450 S 4th Street Trafficway

Leavenworth KS 66048

36C255

Financial Services Center http://www.fsc.va.gov/einvoice.asp

Austin TX 877-353-9791 512-460-5429

See CONTINUATION Page Home Sleep Apnea Testing - St. Louis VA Medical Center.

The purpose of this solicitation is to establish a Indefinite Delivery Indefinite Quantity (IDIQ) Contract for the St. Louis VA Medical Center.

The anticipated Period of Performance is Base plus Three (3) Option Years.

Pricing will be Firm Fixed Price (FFP) for each order.

See Section B.2 Performance Work Statement for full details.

Service Contract Act WD # 2015-5075, Rev 24 does apply.

CO POC: Courtney Chattman; Courtney Chattman@va.gov.

All questions are due no later than December 28, 2023, at 10AM CST and shall be emailed to courtney.chattman@va.gov.

See CONTINUATION Page

TBD

One

Courtney Chattman

Table of Contents

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

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

a. CONTRACTOR:

Contractor SAM UEI#:

Company Name and Address:

Point of Contact:

Phone Number:

Email Address:

b. GOVERNMENT: Contracting Officer 36C255 Courtney Chattman

Network Contracting Office (NCO) 15 3450 S 4th Street Leavenworth, KS 66048

2. CONTRACTOR REMITTANCE ADDRESS: All payments by the Government to the contractor will be made in accordance with 52.232-33, Payment by Electronic Funds Transfer—System for Award Management.

3. INVOICES: Invoices shall be submitted in arrears 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:

B.2 PERFORMANCE WORK STATEMENT

DEPARTMENT OF VETERANS AFFAIRS

ST. LOUIS VA HEALTHCARE SYSTEM

FOR

HOME SLEEP TESTING SERVICES

1. Introduction: The purpose of this Performance Work Statement (PWS) is to outline the need for Home Sleep testing services for diagnosing patients located at the St. Louis Veterans Hospital (STL VA ) in St. Louis, MO. Home Sleep Study Testing: The contractor shall provide home sleep studies for patients experiencing sleep apnea symptoms, such as snoring, daytime sleepiness, poor memory, cognitive impairment and witnessed apneas. The device(s) is given to patients to use for up to 3 nights. After the evaluation period, the patient returns the device(s) to the company in packaging provided by the company.

2. Scope of Work: The contractor will provide home sleep study services for patients who qualify for home sleep apnea testing. They will provide the following:

a. The contractor shall furnish, for the life of the contract, the following equipment at no additional costs to the Government:

1) Home sleep study equipment.

2) Current operator’s manual(s) as well as hands on training by local representative.

b. The system shall have an operator’s manual to include system operation and troubleshooting. The contractor shall repeat the sleep study at no additional costs to the Government for the following reasons or other unforeseen issues:

1) Device(s) provides unsatisfactory results.

2) Device(s) fails to transmit or download information.

3) Information is not retrievable through the use of the web-based system.

4) There is a defect or artifact determined by the VA to be substandard.

3. Place of Performance: The selected contractor shall be providing equipment and off-site scoring. No travel fees will apply. All delivery, disposable items, and equipment are included in the item price. Location: St. Louis Veterans Hospital, 915 N Grand Blvd, St. Louis, MO 63108. Devices shall be provided to patients directly from the contractor. Upon completion of the sleep study, device(s) shall be mailed directly back to contractor at no expense to patient or VA.

4. Performance Period: Base year with two (2) Option Years. Anticipated Start Date: 2023

5. Procedure: The vendor contacts the patient to schedule the patient’s study and set up a time to deliver the equipment. The device(s) is given to patients to use for 1 to 3 days depending on the indication for the sleep study. Upon receipt of order, contractor shall contact patient within 24 hours by phone, and polysomnography technicians will instruct and explain to the patients about what the device is, how to hook it up, and how to use the equipment. They will then hook up the device(s) to the patient, with specific instruction in order to continue to have the device(s) on for the duration of evaluation. After the evaluation period, the patient returns the device(s) to the contractor in the envelopes provided or to the healthcare facility.

6. General Requirements:

a. Home Sleep Study: The contractor will provide home testing equipment that can perform home sleep studies for patient care. The equipment will provide the following:

1) Equipment that is ordered for the patients’ specific needs.

2) Education regarding the set-up and use of the devices along with 24/7 technical support that will be offered on the phone.

3) The device to have at least 7 channels (a type 3 device).

4) Captured sleep study data is reviewed and manually scored by a Registered Polysomnography Technician.

5) The ability to provide data from each night of the study, as well as the cumulative data, if multiple nights.

6) Scoring of the sleep study along with the raw data of the sleep study will be made available online and will be interpreted by the sleep physicians at St. Louis VA.

7) Both patients and VA staff shall have unlimited 24/7 telephone access to contractor’s support staff that are knowledgeable and shall supply help in resolving any monitoring problems.

8) Contractor shall electronically post the data and scoring for immediate review by the appropriate St. Louis VA staff within 72 hours of sleep study completion.

9) Contractor shall post an all-results-data export file to VA staff within 24 hours of scoring completion.

10) The contractor shall provide detailed reports for all Veteran patients receiving full services to the COR (Contracting Officer Representative) at the end of the current billing period. Full services are defined as patients that have been identified by a VA provider as requiring a home sleep study, have been assigned equipment that has been returned to the contractor for scoring, the scoring has been reported back to the appropriate medical center, and the sleep study report is determined to be without technical error.

b. Scoring Reports: All scoring information will be collected and communicated to the physician at the VAMC. The scoring report shall include at minimum:

1) Respiratory abnormalities

2) Oxygen desaturations

3) Snoring

4) Body position

5) Heart rate

7. Data Management: While patient is using the equipment, the scored study will be made available online. The VA shall have access to patient reporting 24 hours a day at the physician’s or authorized representative’s convenience through password protection.

8. Workflow: The device is given to patients to use for 1 to 3 days depending on the indication for the sleep study. The monitor will be delivered directly to the patient, and the patient will be hooked up at home with instructions from the vendor. The contractor staff will instruct and explain to the patients what the device is, how to hook it up, and how the patient will use it. The patient will complete the study as directed and will send the equipment back to the vendor once the study is completed. An end of sleep study, the sleep study data and scoring will be made available within 72 hours after the service is completed (Access to the data from the website is limited to the physicians and/or any other authorized representative responsible for evaluating the data). Once the sleep study has been scored, the contractor shall post it for the VAMC physicians to review and interpret.

9. Equipment:

a. All equipment offered shall be U.S. Food and Drug Administration (FDA) approved.

b. All home sleep testing equipment shall be provided by the contractor for VA patient use and shall be state-of-the-art equipment, lightweight, and simple for patients to use. Patients will use the equipment for 1 to 3 days, or as specified by the VA provider. Samples shall be provided to each site during the training or orientation process.

c. All equipment remains the sole property of the contractor including the initial delivery of the units. The contractor is responsible for all service maintenance and repairs of the equipment and hardware.

d. The contractor shall supply a postage-paid return container for all equipment.

10. Instrument Capabilities:

a. Lightweight and easy to use design.

b. Have at least 7 channels (type 3 device).

c. Must be compatible with the sleep study system that is utilized for patient care at the St. Louis VA, which is the Alice 6 system.

d. Instrument/Monitor has a date and time stamp for clinical reports.

e. All consumable items are provided to patient by contractor who returns the item after sleep study.

11. Training: The contractor shall provide comprehensive training to the St. Louis VA staff. This may require multiple training sessions for numerous staff. The training shall consist of proper use of the monitoring devices, instructions on how to upload patient information into contractor provided software and/or websites, and how to maintain or provide basic quality assurance tests. Contractor shall also provide each participant at each facility copies of manuals, equipment checklists, surveys, and specific contact information in the event that a medical center staff person needed to contact the contractor 24/7.

12. Technical Support: Technical support is required via telephone for troubleshooting of method and/or problems. The response time for telephone technical assistance shall be within one (1) hour from the time of the initial call for technical support. Contractor must also show availability 24/7 for patient support. Contractor must have appropriately trained personnel available by phone throughout the duration of all tests for patient support.

13. Quality:

a. Maintenance:

1) All home sleep study equipment shall be cleaned, disinfected, and decontaminated according to accreditation standards, before it is sent to the patients. Unclean equipment should be stored in an area separate from cleaned equipment to prevent cross contamination.

2) Contractor shall demonstrate set procedures for proper inspection and maintenance of the home sleep study equipment and shall provide each location a copy of the inspection checklist.

3) Contractor shall be responsible for the configuration and calibration of the devices

4) The contractor shall have a formal procedure to validate the functional integrity of any device before it is provided to a patient, and shall, at a minimum, complete and document such validation procedure whenever a device is returned with non-diagnostic or unsatisfactory results, or when visual inspection suggests the possibility of device damage.

5) Contractor shall report on the failure rate of their equipment and supply maintenance records.

6) When upgrades to the analytical software or hardware are available that are designed to improve the performance of the analytical system, those upgrades shall be made available to the St. Louis VA at no additional costs.

7) The contractor shall coordinate installation of upgrades with the COR.

8) The contractor shall provide customer notifications and latest operator’s manual within 10 days after their release/publication.

b. Quality Program:

1) The contractor shall maintain a quality system that ensures conformance to contractual requirements and meets the requirements of ISO 9001 and/or CMS requirements for equivalent home sleep testing, or an equivalent quality system during performance of this contract.

2) Contractor must have a clearly defined process by which it collects the required data, performs root cause analysis, and can supply easily understandable reports.

3) Contractor must demonstrate that their information systems are HIPAA compliant and that the raw data can be transferred securely and with accuracy to the VA.

14. Government holidays: The contractor is not required to provide service on the following National holidays, nor shall the contractor be paid for these holidays.

The following national holidays observed by the Federal Government:

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

15. Overtime and holidays: Any overtime or holiday pay that may be entitled to contractor personnel performing under this contract shall be the sole responsibility of the contractor and shall not be billed to nor reimbursed by the Government.

16. Ordering activity: Contractor shall not accept any instructions issued by any person other than the CO or COR acting within the limits of his/her authority.

17. Changes to Contract: Only those services specified herein are authorized. Before performing any service of a non-contractual nature, contractor shall advise the CO of the reason(s) for the additional work and/or service. Prior authorization shall be obtained from the CO before performing the services.

18. Complaints: Contractor shall promptly and courteously respond to complaints within three (3) working days. Including complaints brought to contractor’s attention by the CO. Contractor shall maintain a written record of all complaints, both written and oral showing the identity of the individual, the nature of the complaint, and contractor’s response. Contractor shall permit the Government to inspect such records upon reasonable notice.

19. Badges: All contractor personnel shall be required to wear VA provided identification (I.D.) badges above the waist at all times while on the VA grounds. Contractors shall be required to coordinate with COR in order to obtain the VA provided I.D. badges for all staff. All VA provided I.D. badges shall be returned at the end of the contract or upon completion of service. Failure to wear ID badges may result in removal from any of the VA facilities and/or otherwise referred to federal property.

20. VA INFORMATION AND INFORMATION SYSTEM SECURITY/PRIVACY

a. GENERAL: Contractors, contractor personnel, subcontractors, and subcontractor personnel shall be subject to the same Federal laws, regulations, standards, and VA Directives and Handbooks as VA and VA personnel regarding information and information system security.

b. ACCESS to VA INFORMATION AND VA INFORMATION SYSTEMS: A contractor/subcontrator shall request logical (technical) or physical access to VA information and VA information systems for their employees, subcontractors, and affiliates only to the extent necessary to perform the services specified in the contract, agreement, or task order.

The contractor or subcontractor must notify the Contracting Officer immediately when an employee working on a VA system or with access to VA information is reassigned or leaves the contractor or subcontractor’s employ. The Contracting Officer must also be notified immediately by the contractor or subcontractor prior to an unfriendly termination.

c. VA INFORMATION CUSTODIAL Language: Information made available to the contractor or subcontractor by VA for the performance or administration of this contract or information developed by the contractor/subcontractor 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).

If VA determines that the contractor has violated any of the information confidentiality, privacy, security, and other provisions of the contract, it shall be sufficient grounds for VA to withhold payment to the contractor or third party or terminate the contract for default or terminate for cause under Federal Acquisition Regulation (FAR) part 12.

d. SECURITY INCIDENT INVESTIGATION: 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 COR 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.

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.

With respect to unsecured protected health information, the business associate is deemed to have discovered a data breach when the business associate knew or should have known of a breach of such information. Upon discovery, the business associate must notify the covered entity of the breach. Notifications need to be made in accordance with the executed business associate agreement.

In instances of theft or break-in or other criminal activity, the contractor/subcontractor must concurrently report the incident to the appropriate law enforcement entity (or entities) of jurisdiction, including the VA OIG and Security and Law Enforcement. The contractor, its employees, and its subcontractors and their employees shall cooperate with VA and any law enforcement authority responsible for the investigation and prosecution of any possible criminal law violation(s) associated with any incident. The contractor/subcontractor shall cooperate with VA in any civil litigation to recover VA information, obtain monetary or other compensation from a third party for damages arising from any incident, or obtain injunctive relief against any third party arising from, or related to, the incident.

e. LIQUIDATED DAMAGES FOR DATA BREACH: Consistent with the requirements of 38 U.S.C. §5725, a contract may require access to sensitive personal information. If so, the contractor is liable to VA for liquidated damages in the event of a data breach or privacy incident involving any SPI the contractor/subcontractor processes or maintains under this contract.

The contractor/subcontractor shall provide notice to VA of a “security incident” as set forth in the Security Incident Investigation section above. Upon such notification, VA must secure from a non-Department entity or the VA Office of Inspector General an independent risk analysis of the data breach to determine the level of risk associated with the data breach for the potential misuse of any sensitive personal information involved in the data breach. The term 'data breach' means the loss, theft, or other unauthorized access, or any access other than that incidental to the scope of employment, to data containing sensitive personal information, in electronic or printed form, that results in the potential compromise of the confidentiality or integrity of the data. Contractor shall fully cooperate with the entity performing the risk analysis. Failure to cooperate may be deemed a material breach and grounds for contract termination.

f. TRAINING: All contractor employees and subcontractor employees requiring access to VA information and VA information systems shall complete the following before being granted access to VA information and its systems:

Successfully complete the appropriate VA privacy training and annually complete required privacy training (See below training); and successfully complete any additional cyber security or privacy training, as required for VA personnel with equivalent information system access.

The contractor shall provide to the contracting officer and/or the COR a copy of the training certificates for each applicable employee within 1 week of the initiation of the contract and annually thereafter, as required.

Failure to complete the mandatory annual training, within the timeframe required, is grounds for suspension or termination of all physical or electronic access privileges and removal from work on the contract until such time as the training and documents are complete.

g. What is VA Sensitive Information/Data? All Department information and/or data on any storage media or in any form or format, which requires protection due to the risk of harm that could result from inadvertent or deliberate disclosure, alteration, or destruction of the information. The term includes not only information that identifies an individual but also other information whose improper use or disclosure could adversely affect the ability of an agency to accomplish its mission, proprietary information, and records about individuals requiring protection under applicable confidentiality provisions.

h. What is Protected Health Information? The HIPAA Privacy Rule defines protected health information as Individually Identifiable Health Information transmitted or maintained in any form or medium by a covered entity, such as VHA.

i. What is an “Incidental” Disclosure? An incidental disclosure is one where an individual’s information may be disclosed incidentally even though appropriate safeguards are in place. Due to the nature of VA communications and practices, as well as the various environments in which Veterans receive healthcare or other services from VA, the potential exists for a Veteran’s protected health information or VA sensitive information to be disclosed incidentally.

For example:

• You overhear a healthcare provider’s conversation with another provider or patient even when the conversation is taken place appropriately.

• You may see limited Veteran information on sign-in sheets or white boards within a treating area of the facility.

• Hearing a Veteran’s name being called out for an appointment or when the Veteran is being transported/escorted to and from an appointment.

j. Safeguards You Must Follow to Secure VA Sensitive Information:

• Secure any VA sensitive information found in unsecured public areas (parking lot, trash can, or vacated area) until information can be given to your supervisor or Privacy Officer. You must report such incidents to your Privacy Officer timely.

• Don’t take VA sensitive information off facilities grounds without VA permission unless the VA information is general public information, i.e., brochures/pamphlets.

• Don’t take pictures using a personal camera without the permission from the Medical Center Director.

• Any protected health information overheard or seen in VA should not be discussed or shared with anyone who does not have a need to know the information in the performance of their official job duties, this includes spouses, employers or colleagues.

• Do not share VA access cards, keys, or codes to enter the facility.

• Immediately report lost or stolen Personal Identity Verification (PIV) or Veteran Health Identification Cards (VHIC), any VA keys or keypad lock codes to your supervisor or VA police.

• Do not use a VA computer using another VA employee’s access and password.

• Do not ask another VA employee to access your own protected health information. You must request this information in writing from the Release of Information section at your facility.

k. What are the Six Privacy Laws and Statutes Governing VA?

1. Freedom of Information Act (FOIA) compels disclosure of reasonably described VA records or a reasonably segregated portion of the records to any person upon written request unless one or more of the nine exemptions apply.

2. Privacy Act of 1974 provides for the confidentiality of personal information about a living individual who is a United States citizen, or an alien lawfully admitted to U.S. and whose information is retrieved by the individual’s name or other unique identifier, e.g., Social Security Number.

3. Health Insurance Portability and Accountability Act (HIPAA) provides for the improvement of the efficiency and effectiveness of health care systems by encouraging the development of health information systems through the establishment of standards and requirements for the electronic transmission, privacy, and security of certain health information.

4. 38 U.S.C. 5701 provides for the confidentiality of all VA patient and claimant information, with special protection for their names and home addresses.

5. 38 U.S.C. 7332 provides for the confidentiality of drug abuse, alcoholism and alcohol abuse, infection with the human immunodeficiency virus (HIV) and sickle cell anemia medical records and health information.

6. 38 U.S.C. 5705 provides for the confidentiality of designated medical-quality assurance documents.

l. What are the Privacy Rules Concerning Use and Disclosure?

You are not authorized to use or disclose protected health information. In general, VHA personnel may only use information for purposes of treatment, payment or healthcare operations when they have a need-to-know in the course of their official job duties. VHA may only disclose protected health information upon written request by the individual who is the subject of the information or as authorized by law.

m. How is Privacy Enforced?

There are both civil and criminal penalties, including monetary penalties that may be imposed if a privacy violation has taken place. Any willful negligent or intentional violation of an individual’s privacy by VA personnel, contract staff, volunteers, or others may result in such corrective action as deemed appropriate by VA including the potential loss of employment, contract, or volunteer status.

Know your VA/VHA Privacy Officer and Information Security Officer. These are the individuals to whom you can report any potential violation of protected health information or VA sensitive information, or any other concerns regarding privacy of VA sensitive information.

(End of Performance Work Statement)

B.3 PRICE/COST SCHEDULE

ITEM INFORMATION

Multi-Night Home Sleep Study + Scoring by RPSGT -Home sleep apnea testing, to include deployment, education, retrieval, and scoring by TPV.

Contract Period: Base POP Begin: 01-03-2024 POP End: 01-02-2025 PRINCIPAL NAICS CODE: 621610 - Home Health Care Services PRODUCT/SERVICE CODE: Q403 - Medical - Evaluation/Screening

Multi-Night Home Sleep Study + Scoring by RPSGT

Contract Period: Option 1 POP Begin: 01-03-2025 POP End: 01-02-2026

Multi-Night Home Sleep Study + Scoring by RPSGT

Contract Period: Option 2 POP Begin: 01-03-2026 POP End: 01-02-2027

Multi-Night Home Sleep Study + Scoring by RPSGT

Contract Period: Option 3 POP Begin: 01-03-2027 POP End: 01-02-2028

36C25524Q0092

Page 1 of Page 1 of

SECTION C - CONTRACT CLAUSES

C.1 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 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this/these address(es):

https://www.acquisition.gov/browse/index/far https://www.va.gov/oal/library/vaar/

(End of Clause)

C.3 52.216-18 ORDERING (AUG 2020)

(a) Any supplies and services to be furnished under this contract shall be ordered by issuance of delivery orders or task orders by the individuals or activities designated in the Schedule. Such orders may be issued from 01-03-2024 through 01-02-2028.

(b) All delivery orders or task orders are subject to the terms and conditions of this contract. In the event of conflict between a delivery order or task order and this contract, the contract shall control.

(c) A delivery order or task order is considered "issued" when—

(1) If sent by mail (includes transmittal by U.S. mail or private delivery service), the Government deposits the order in the mail;

(2) If sent by fax, the Government transmits the order to the Contractor’s fax number; or

(3) If sent electronically, the Government either—

(i) Posts a copy of the delivery order or task order to a Government document access system, and notice is sent to the Contractor; or

(ii) Distributes the delivery order or task order via email to the Contractor’s email address.

(d) Orders may be issued by methods other than those enumerated in this clause only if authorized in the contract.

(End of Clause)

C.4 52.216-19 ORDER LIMITATIONS (OCT 1995)

(a) Minimum order. When the Government requires supplies or services covered by this contract in an amount of less than 50, the Government is not obligated to purchase, nor is the Contractor obligated to furnish, those supplies or services under the contract.

(b) Maximum order. The Contractor is not obligated to honor—

(1) Any order for a single item in excess of 10;

(2) Any order for a combination of items in excess of 300; or

(3) A series of orders from the same ordering office within 20 days that together call for quantities exceeding the limitation in paragraph (b)(1) or (2) of this section.

(c) If this is a requirements contract (i.e., includes the Requirements clause at subsection 52.216-21 of the Federal Acquisition Regulation (FAR)), the Government is not required to order a part of any one requirement from the Contractor if that requirement exceeds the maximum-order limitations in paragraph (b) of this section.

(d) Notwithstanding paragraphs (b) and (c) of this section, the Contractor shall honor any order exceeding the maximum order limitations in paragraph (b), unless that order (or orders) is returned to the ordering office within 5 days after issuance, with written notice stating the Contractor's intent not to ship the item (or items) called for and the reasons. Upon receiving this notice, the Government may acquire the supplies or services from another source.

(End of Clause)

C.5 52.216-22 INDEFINITE QUANTITY (OCT 1995)

(a) This is an indefinite-quantity contract for the supplies or services specified, and effective for the period stated, in the Schedule. The quantities of supplies and services specified in the Schedule are estimates only and are not purchased by this contract.

(b) Delivery or performance shall be made only as authorized by orders issued in accordance with the Ordering clause. The Contractor shall furnish to the Government, when and if ordered, the supplies or services specified in the Schedule up to and including the quantity designated in the Schedule as the "maximum." The Government shall order at least the quantity of supplies or services designated in the Schedule as the "minimum."

(c) Except for any limitations on quantities in the Order Limitations clause or in the Schedule, there is no limit on the number of orders that may be issued. The Government may issue orders requiring delivery to multiple destinations or performance at multiple locations.

(d) Any order issued during the effective period of this contract and not completed within that period shall be completed by the Contractor within the time specified in the order. The contract shall govern the Contractor's and Government's rights and obligations with respect to that order to the same extent as if the order were completed during the contract's effective period; provided, that the Contractor shall not be required to make any deliveries under this contract after 01-02-2028.

(End of Clause)

C.6 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; provided that the Government gives the Contractor a preliminary written notice of its intent to extend at least 30 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 four (4) years.

(End of Clause)

C.7 52.232-19 AVAILABILITY OF FUNDS FOR THE NEXT FISCAL YEAR (APR 1984)

Funds are not presently available for performance under this contract beyond 01/02/2025. The Government's obligation for performance of this contract beyond that date is contingent upon the availability of appropriated funds from which payment for contract purposes can be made. No legal liability on the part of the Government for any payment may arise for performance under this contract beyond 01/02/2025, until funds are made available to the Contracting Officer for performance and until the Contractor receives notice of availability, to be confirmed in writing by the Contracting Officer.

(End of Clause)

C.8 VAAR 852.201-70 CONTRACTING OFFICER'S REPRESENTATIVE (DEC 2022)

The Contracting Officer reserves the right to designate representatives to act for him/her in furnishing technical guidance and advice or generally monitor the work to be performed under this contract. Such designation will be in writing and will define the scope and limitation of the designee’s authority. A copy of the designation letter shall be furnished to the Contractor.

(End of Clause)

C.9 VAAR 852.203-70 COMMERCIAL ADVERTISING (MAY 2018)

The Contractor shall not make reference in its commercial advertising to Department of Veterans Affairs contracts in a manner that states or implies the Department of Veterans Affairs approves or endorses the Contractor’s products or services or considers the Contractor’s products or services superior to other products or services.

(End of Clause)

C.10 VAAR 852.204-71 INFORMATION AND INFORMATION SYSTEMS SECURITY (FEB 2023)

(a) Definitions. As used in this clause—Business Associate means an entity, including an individual (other than a member of the workforce of a covered entity), company, organization or another covered entity, as defined by the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule, that performs or assists in the performance of a function or activity on behalf of the Veterans Health Administration (VHA) that involves the creating, receiving, maintaining, transmitting of, or having access to, protected health information (PHI). The term also includes a subcontractor of a business associate that creates, receives, maintains, or transmits PHI on behalf of the business associate.

Business Associate Agreement (BAA) means the agreement, as dictated by the Privacy Rule, between VHA and a business associate, which must be entered into in addition to the underlying contract for services and before any release of PHI can be made to the business associate, in order for the business associate to perform certain functions or activities on behalf of VHA.

Information system means a discrete set of information resources organized for the collection, processing, maintenance, use, sharing, dissemination, or disposition of information whether automated or manual.

Information technology (see FAR 2.101) also means Information and Communication Technology (ICT).

Information technology-related contracts means those contracts which include services (including support services), and related resources for information technology as defined in 802.101.

Privacy officer means the VA official with responsibility for implementing and oversight of privacy related policies and practices that impact a given VA acquisition.

Sensitive personal information means, with respect to an individual, any information about the individual maintained by VA, including but not limited to the following:

(1) Education, financial transactions, medical history, and criminal or employment history.

(2) Information that can be used to distinguish or trace the individual’s identity, including but not limited to name, social security number, date and place of birth, mother’s maiden name, or biometric records.

Security plan means a formal document that provides an overview of the security requirements for an information system or an information security program and describes the security controls in place or planned for meeting those requirements.

VA Information Security Rules of Behavior for Organizational Users (VA National Rules of Behavior) means a set of VA rules that describes the responsibilities and expected behavior of users of VA information or information systems.

VA sensitive information means all VA data, on any storage media or in any form or format, which requires protection due to the risk of harm that could result from inadvertent or deliberate disclosure, alteration, or destruction of the information and includes sensitive personal information. The term includes information where improper use or disclosure could adversely affect the ability of VA to accomplish its mission, proprietary information, records about individuals requiring protection under various confidentiality provisions such as the Privacy Act and the HIPAA Privacy Rule, and information that can be withheld under the Freedom of Information Act. Examples of VA sensitive information include the following:

individually-identifiable medical, benefits, and personnel information; financial, budgetary, research, quality assurance, confidential commercial, critical infrastructure, investigatory, and law enforcement information; information that is confidential and privileged in litigation such as information protected by the deliberative process privilege, attorney work-product privilege, and the attorney-client privilege; and other information which, if released, could result in violation of law or harm or unfairness to any individual or group, or could adversely affect the national interest or the conduct of Federal programs.

(b) General. Contractors, subcontractors, their employees, third-parties, and business associates with access to VA information, information systems, or information technology (IT) or providing and accessing IT-related goods and services, shall adhere to VA Directive 6500, VA Cybersecurity Program, and the directives and handbooks in the VA 6500 series related to VA information (including VA sensitive information and sensitive personal information and information systems security and privacy), as well as those set forth in the contract specifications, statement of work, or performance work statement. These include, but are not limited to, VA Handbook 6500.6, Contract Security; and VA Directive and Handbook 0710, Personnel Security and Suitability Program, which establishes VA’s procedures, responsibilities, and processes for complying with current Federal law, Executive Orders, policies, regulations, standards and guidance for protecting VA information, information systems (see 802.101, Definitions) security and privacy, and adhering to personnel security requirements when accessing VA information or information systems.

(c) Access to VA information and VA information systems.

(1) Contractors are limited in their request for logical or physical access to VA information or VA information systems for their employees, subcontractors, third parties and business associates to the extent necessary to perform the services or provide the goods as specified in the contracts, agreements, task, delivery or purchase orders.

(2) All Contractors, subcontractors, third parties, and business associates working with VA information are subject to the same investigative requirements as those of VA appointees or employees who have access to the same types of information. The level and process of background security investigations for contractors to access VA information and VA information systems shall be in accordance with VA Directive and Handbook 0710, Personnel Security and Suitability Program.

(3) Contractors, subcontractors, third parties, and business associates who require access to national security programs must have a valid security clearance.

(4) HIPAA Business Associate Agreement requirement. Contractors shall enter into a Business Associate Agreement (BAA) with VHA, VA’s Covered Entity, when contract requirements and access to protected health information is required and when requested by the Contracting Officer, or the Contracting Officer’s Representative (COR) (see VAAR 824.103–70). Under the HIPAA Privacy and Security Rules, a Covered Entity (VHA) must have a satisfactory assurance that its PHI will be safeguarded from misuse. To do so, a Covered Entity enters into a BAA with a contractor (now the business associate), which obligates the business associate to only use the Covered Entity’s PHI for the purposes for which it was engaged, provide the same protections and safeguards as is required from the Covered Entity, and agree to the same disclosure restrictions to PHI that is required of the Covered Entity in situations where a contractor—

(i) Creates, receives, maintains, or transmits VHA PHI or that will store, generate, access, exchange, process, or utilize such PHI in order to perform certain health care operations activities or functions on behalf of the Covered Entity; or

(ii) Provides one or more of the services specified in the Privacy Rule to or for the Covered Entity.

(A) Contractors or entities required to execute BAAs for contracts and other agreements become VHA business associates. BAAs are issued by VHA or may be issued by other VA programs in support of VHA. The HIPAA Privacy Rule requires VHA to execute compliant BAAs with persons or entities that create, receive, maintain, or transmit VHA PHI or that will store, generate, access, exchange, process, or utilize such PHI in order to perform certain activities, functions or services to, for, or on behalf of VHA. There may be other VA components or staff offices which also provide certain services and support to VHA and must receive PHI in order to do so. If these components award contracts or enter into other agreements, purchase/delivery orders, modifications and issue governmentwide purchase card transactions to help in the delivery of these services to VHA, they will also fall within the requirement to obtain a satisfactory assurance from these contractors by executing a BAA.

(B) BAA requirements flow down to subcontractors.