36C25020Q0311-001.docx

36C25020Q0311 In-Home Sleep Study

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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.

DUNS:

DUNS+4:

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. 2/2012)

PREVIOUS EDITION IS NOT USABLE

Prescribed by GSA - FAR (48 CFR) 53.212

7. FOR SOLICITATION

INFORMATION CALL:

STANDARD FORM 1449

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

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS

36C25020Q0311 03-30-2020 Michelle C. Ford 734-222-7151 04-17-2020 4pm (Eastern) 36C250 Department of Veterans Affairs Network Contracting Office 10 PO Box 492 Ann Arbor MI 48106 X X N 621610 $16.5 Million N/A X 36C250 Department of Veterans Affairs VA Ann Arbor Healthcare System 2215 Fuller Road Ann Arbor MI 48105 36C250 Department of Veterans Affairs Network Contracting Office 10 PO Box 492 Ann Arbor MI 48106

Department of Veterans Affairs Financial Management System PO Box 149971 Austin TX 78714-9971 877-353-9791 512-460-5540 In-Home Sleep Monitoring services that include equipment and a Board-Certified Sleep Medicine Physician (BCSMP) who will review and interpret the raw data of the sleep study epoch for the Ann Arbor, VAMC in Ann Arbor, MI and Aleda E. Lutz, VAMC and all CBOCs in Saginaw, MI. In accordance with the Performance Work Statement (PWS). Please see "Price Schedule" starting on Page 7.

This acquisition will be conducted using the procedures in FAR Part 12, Acquisition of Commercial Items and FAR Part 13, Simplified Acquisition Procedures.

This will be a Firm Fixed Price, Indefinite Delivery, Indefinite Quantity (IDIQ) Contract.

X X Lisa D. Bailey Contracting Officer Table of Contents

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

(continuation from Standard Form 1449, block 18A.)

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

Lisa D. Bailey, Contracting Officer

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. Invoicing shall be in accordance with the requirements of the Department of Veterans Affairs (VA) Financial Services Center (VAFSC). The latest information shall be used for invoicing and payments may change during the period of performance of this acquisition. Therefore, current invoicing information is located at: http://www.fsc.va.gov/einvoice.asp.

See Section 11, Billing, of the Performance Work Statement for Invoice submission information.

All invoices shall include the following (see Section C1. 52.212-4, paragraph g, Invoice, of clause 52.212-4, Contract Terms and Conditions for additional Invoice Requirements and Supporting Documentation necessary for billing purposes).

1. Invoice Number

1. Invoice Date

1. Purchase Order Number (will always begin with 515)

5. CHANGES/MODIFICATIONS TO THE CONTRACT: The Contracting Officer will be the only person authorized to approve changes or modify any of the requirements under this resultant contract. The Contractor shall communicate with the Contracting Officer on all matters pertaining to contract administration. Only the Contracting Officer will be authorized to make commitments or issue changes that affect price, quantity, delivery or quality of performance of this resultant contract. In the event the Contractor effects any such change at the direction of any person other than the Contracting Officer, the change shall be considered unauthorized by the local VAMC and no adjustment will be made in the contract price to cover any increase in cost incurred as a result thereof.

The Contracting Officer’s Representative (COR) will be responsible for the overall technical administration of this contract as outlined in the COR Delegation of Authority.

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

9. SECURE FAX: In accordance with VA Handbook 6500, the following statement is required on all fax cover sheets; if it is determined the ordering process will include a fax: “This fax is intended only for the use of the person or office to which it is addressed and may contain information that is privileged, confidential or protected by law. All others are hereby notified that the receipt of this fax does not waive any applicable privilege or exemption for disclosure and that any dissemination, distribution or copying of this communication is prohibited. If you have received this fax in error, please notify this office immediately at the telephone number listed above.”

36C25020Q0311 In-Home Sleep Study

10. POST-AWARD ORIENTATION: The Contracting Officer will schedule a post-award orientation conference for contract orientation purposes.

B.2 REVIEW REQUIRED REGISTRATION WITH CONTRACTOR PERFORMANCE ASSESSMENT SYSTEM (CPARS)

(a) 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 $250,000 and shares 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, CPARS, which is maintained by the Naval Seal Logistics Center in Portsmouth, Virginia. CPARS has connectivity with the Past Performance Information Retrieval System (PPIRS) database, which is available to all Federal agencies. PPIRS is the system used to collect and retrieve performance assessment reports used in source selection determinations and completed CPARS report cards transferred to PPIRS. CPARS also includes access to the federal awardee performance and integrity information system (FAPIIS). FAPIIS is a web-enabled application accessed via CPARS for contractor responsibility determination information.

(b) Each contractor whose contract award is estimated to exceed $250,000 is required to register with CPARS database at the following web address: www.cpars.csd.disa.mil. Help in registering can be obtained by contacting Customer Support Desk @ DSN: 684-1690 or COMM: 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.

(c) 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 sixty days to submit any comments and re-assign the report to the VA contracting officer.

(d) Failure to have a current registration in the CPARS database, or to re-assign the report to the VA contracting officer within those sixty days, will result in the Government's evaluation being placed on file in the database with a statement that the contractor failed to respond.”

B.3 PRICE SCHEDULE

The quantities stated in this price schedule represent the Government’s best estimate, based on historical usage and projected need. Please note that they are only estimates and are not a guarantee of future orders. The contract minimum of any resultant Firm Fixed Price, Indefinite Delivery, Indefinite Quantity (IDIQ) contract will be ten (10) sleep studies. If no services are utilized, the cost of ten (10) studies will be paid at the CLIN 001 rate. The contract maximum will not exceed 9,100 Sleep Studies.

Note: This contract is firm fixed price and does not include an economic price adjustment mechanism. In lieu of an EPA clause, the following price schedule contains five distinct price list. Offerors shall price out base year and all option years.

Base Ordering Period: May 1, 2020 through April 30, 2021

Ordering Period 1: May 1, 2021 through April 30, 2022

Ordering Period 2: May 1, 2022 through April 30, 2023

Ordering Period 3: May 1, 2023 through April 30, 2024

Ordering Period 4: May 1, 2024 through April 30, 2025

Aggregate Total to include base and all option years: $_____________________

B.4 PERFORMANCE WORK STATEMENT

In Home Sleep Study Monitoring

1. SCOPE OF CONTRACT. The intent is to establish a contract where the contractor shall provide Sleep Monitoring services that include equipment, monitoring, a Board-Certified Sleep Medicine Physician (BCSMP) to interpret the results and training for the Ann Arbor Healthcare System (VAAAHS), Aleda E. Lutz VAMC and all of its Community Based Outpatient Centers (CBOC). The Period of performance will be 12 months from the effective date of award with four (4), one-year option periods.

2. GENERAL. The contractor shall show that their mode and method of patient training addresses a variety of appropriate methodologies (e.g., verbal, written, video).

2.1. For sleep monitoring devices, the Contractor shall supply the monitoring equipment to be used in the patient’s home with all supplies needed to complete the test.

2.2. The Contractor shall contact each patient and provide assistance (over the telephone or in person) required for each night’s set-up.

2.3. Once the test is complete the contractor shall provide a method for retrieving the device, such as providing a self-addressed stamped package for the patient to return the equipment to the contractor.

2.4. The contractor shall provide a Board-Certified Sleep Medicine Physician (BCSMP), who shall review and interpret the raw data of the sleep study epoch by epoch and provide a report to the ordering physician at the VA.

3. EQUIPMENT.

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

3.1.1. Personal sleep monitors and equipment

3.1.2. Current operator’s manual(s)

3.2. The system shall have an on-board manual to include system operation and troubleshooting.

The contractor shall repeat the monitoring study within 72 hours at no additional costs to the government for reasons including, but not limited to, device provides unsatisfactory results, device fails to transmit or download information, information is not retrievable through the use of the web-based system, or there is an imaging defect or artifact determined by the VA to be substandard.

3.3. All equipment offered shall be FDA approved.

3.4. All sleep monitors shall be provided by the contractor for VA use and must be State-Of-The-Art equipment, lightweight and simple for patients to use. Patients will use the monitor as specified by the VA provider.

3.5. Samples shall be provided to the site during the training or orientation process throughout the life of the contract.

3.6. The contractor shall always maintain an equipment inventory level to support a surge of 35 studies per week.

3.7. This equipment inventory shall be adequately restocked at all times to ensure that the facility can always meet the daily patient demand.

3.8. All equipment remains the sole property of the contractor including the initial deliver of the units.

3.9. The contractor is responsible for all service maintenance and repairs for the equipment and hardware.

3.10. The contractor will supply a postage-paid return container for the sleep monitoring equipment.

3.11. If monitoring equipment or manuals are not returned to the vendor by the patient, the contractor shall bear the costs of replacing the monitor/equipment at no additional cost to the patient or government.

4. MONITORING SERVICE.

4.1. Equipment that is assigned to patients shall require monitoring during the patient’s usual sleep period.

4.2. The contractor shall provide On-Call services for patients and shall be available 24 hours a day, 7 days a week.

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

4.4. For Sleep Monitoring: Contractor shall have a Board-Certified Sleep Specialist on Staff and be available at all times to perform interpretations that are of an acute nature.

4.5. Contractor report turnaround to the requesting provider shall be within 72 hours after receiving the monitor from the patient.

4.6. Contractor shall initiate sleep procedure within 24 hours of receiving consult request from the VA facility and shall provide a completed report within 14 days of the initial consult request.

4.7. Contractor shall transmit the data, analysis, and interpretation electronically to the VA facility that requested the study for review within 72 hours, as noted above, unless a potentially life-threatening arrhythmia and/or event is found during review of the study. In the event of a life-threatening arrhythmia and/or event, the contractor shall notify the requesting VA facility within 4 hours of review of the study, and this transmission shall be clearly identified as high priority.

4.8. The contractor shall provide a detailed monthly report for all Veteran patients receiving full services to the COR at the end of the current billing period. Full services are defined as patients that have been identified by a VA provider as requiring monitoring services, have been assigned a monitor that has been returned to the contractor for interpretation, the interpretation has been reported back to the VA, and the interpretation report is determined to be without technical error. Full service shall be completed within 14 days.

4.9. The contractor shall provide a monthly report that details at a minimum: the date consult was received, date patient was contacted, date equipment was sent to patient, date equipment was returned to the contractor, date final report and completed questionnaires were sent to the VA provider.

5. INSTRUMENT CAPABILITIES.

5.1. The contractor shall have a Sleep Study Type 3 Recording device.

5.2. Equipment used for home sleep testing must comply with the accreditation standards set for Out of Center Sleep Testing (OCST) equipment by the American Academy of Sleep Medicine (AASM). https://aasm.org/resources/pdf/accred/outofcenteraccreditationstandardsfeb2013.pdf

5.3. The contractor shall be certified as an Approved Out of Center Sleep Testing Providers (AOCSTP) or develop a process for attaining credentialing as an AOCSTP by completing specified technical components of OCST in accordance with AASM OCST standards. In order to attain AOCSTP status, the contractor will need to complete an online application to indicate compliance with all of the AASM standards. https://aasm.org/aasm-introduces-accreditation-for-out-of-center-sleep-testing/

5.4. Sleep monitors must be easy to use with various diagnostic parameters including a minimum of airflow, breathing effort, pulse oximetry, snore/audio, position, and ECG or heart rate channels.

5.5. Sleep monitors shall also have additional measurement channels available for analysis (such as, but not limited to, snoring, body position, additional airflow, etc.) if requested by the ordering facility.

5.6. Equipment shall be portable with a lightweight design.

5.7. All consumable items (batteries, patches) are provided by the contractor to patient who returns the item within one week.

5.8. Contractor shall provide a minimum of 3 days of battery life, using standard size batteries readily available, and easily changed by patient.

5.9. Raw data shall be stored and archived for three (3) years, as required by the AASM.

5.10. The study reports must include following data at a minimum: time in bed/recording time, position data, definitions for hypopnea and apnea, estimated apnea hypopnea index or respiratory disturbance index, pulse rate, detailed oximetry data, and snore/audio channel.

5.11. The study reports shall also include additional parameters if additional parameters are available on the testing.

5.12. To determine patient eligibility and safety for home sleep testing, all consults for home sleep test will be reviewed by a VA sleep provider, as per AASM guidelines, prior to undergoing the study.

5.13. All patients undergoing a home sleep test must complete a comprehensive sleep questionnaire that is evaluated by a board-certified sleep medicine physician prior to the testing, which is also made available to the VA with the interpreted report. Any contractor provided questioner will need to be approved by VA COR or designee before distribution to patients.

6. TRAINING.

6.1. The contractor shall provide comprehensive training to the VA Medical Center staff. Multiple training Sessions may be required for numerous staff members. 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.

6.2. 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 needs to contact the contractor 24/7.

7. TECHNICAL SUPPORT.

7.1. Technical Support is required by the contractor via telephone for troubleshooting of method and/or problems 24/7. The response time for telephone technical assistance shall be within one (1) hour from the time of the initial call for technical support.

7.2. Contractor shall also show availability 24/7 for patient support. Contractor must have appropriately trained personnel available by phone throughout the duration of all sleep tests for patient support.

8. MAINTENANCE. All monitors at each location will be kept at OEM specs. All portable sleep monitoring equipment shall be cleaned, disinfected, and decontaminated according to manufacturing guidelines, VA Reusable Medical Equipment (RME), and/or AASM accreditation standards, each time before it is sent to patients. Unclean equipment shall be stored in an area separate from cleaned equipment to prevent cross contamination.

8.1. Contractor shall demonstrate set procedures for proper inspection and maintenance of the portable monitoring equipment and shall provide each location as defined above a copy of the inspection checklist.

8.2. A visual inspection shall be performed prior to distributing equipment to patients and equipment maintenance shall occur on a regular basis following AASM accreditation standards.

8.3. The contractor shall have a formal procedure to validate the functional integrity of any device before it is provisioned 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. Contactor shall report on the failure rate of the equipment and supply maintenance records.

8.4. When upgrade to the analytical software or hardware are available that is designed to improve the performance of the analytical system; those upgrades shall be made available to the medical center at no additional costs.

8.5. The contractor, along with the COR shall coordinate installation of upgrades.

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

9. QUALITY PROGRAM. The contractor shall maintain a quality system that ensures conformance to contractual requirements and meets the requirements of ISO 9001, or an equivalent quality system during performance of this contract.

9.1. Contractor shall follow all AASM guidelines for out of center sleep testing as they exist today as well as continue to follow all future modifications by the AASM as they occur. Contractor shall provide written policies and procedures that closely follow AASM requirements and updates. Any changes in policies and procedures should be furnished to the Medical Center for approval.

9.2. Contractor shall have a clearly defined process by which it collects data, performs root cause analysis, and can supply easily understandable reports.

9.3. Contractor shall provide reports about the reliability of the tests, scoring reliabilities, and the adequacy of the data on a quarterly basis.

9.4. All VA Sleep Medicine physicians shall have option for a full interpretation or ability to interpret independently with access to epoch by epoch raw data scored by a registered sleep technologist.

9.5. VA Sleep Medicine physicians shall have access to raw data from ten random studies on VA patients on a quarterly basis for quality and assurance purposes. The contractor shall provide to the VA the Software (and any updates when available) needed to evaluate and interpret the raw data.

9.6. Contractor shall demonstrate that their information systems are HIPPA compliant and that the raw data can be transferred securely and with accuracy to the VA.

10. FEDERAL HOLIDAYS.

11. BILLING:

11.1. Invoice requirements and supporting documentation: The Contractor shall submit an original monthly invoice and supporting documentation for the previous month’s services Invoices no later than the 15th workday of the month. Invoices without proper documentation shall be returned, and no advance payments shall be authorized.

11.2. Contractor shall submit payment requests electronically to each COR designated Point of Contact (POC) through the use of the Tungsten system. Payments will be made based on the following:

11.2.1. the contractor adequately provided equipment to users or patient;

11.2.2. the equipment functioned properly, and a study was successfully transmitted or sent back to the contractor for interpretation;

11.2.3. the interpretation was completed and sent to the VA Medical Center or ordering facility;

11.2.4. the report was determined to be of diagnostic value and;

11.2.5. an accurate invoice sent through the Tungsten system will serve as the trigger to initiate payment to the contractor.

11.3. Subsequent changes or corrections shall be submitted by separate invoice. In addition to information required for submission of a “proper” invoice in accordance with FAR 52.212-4 (g), all invoices must include:

11.3.1. Name and Address of Contractor

11.3.2. Invoice Date and Invoice Number

11.3.3. Contract Number, Purchase Order and Task Order Number

11.3.4. Date of Service

11.3.5. Quantity of Studies performed

11.3.6. Include the month that services were performed (i.e. January 1st through January 31st and year)

11.3.7. Cost per study

11.3.8. Total price

11.3.9. Facsimile, e-mail and scanned documents are not acceptable forms of submission for payment requests. Invoicing shall be done via the VA Electronic Presentment and Payment System used by VA FSC. This system involves usage of a third-party contractor, OB10. Invoices may be submitted free of charge at the following website: http://ob10.com/us/en/veterans-affairs-us/. Contact information for invoicing assistance is as follows:

OB10 e-Invoice Setup Information: 877-489-6135 OB10 e-Invoice email: va.registration@ob10.com FSC e-Invoice Contact Information: 877-353-9791 FSC e-Invoice Email: vafsccshd@va.gov

12. RECORDS MANAGEMENT.

12.1. Contractor shall comply with all applicable records management laws and regulations, as well as National Archives and Records Administration (NARA) records policies, including but not limited to the Federal Records Act (44 U.S.C. chs. 21, 29, 31, 33), NARA regulations at 36 CFR Chapter XII Subchapter B, and those policies associated with the safeguarding of records covered by the Privacy Act of 1974 (5 U.S.C. 552a). These policies include the preservation of all records, regardless of form or characteristics, mode of transmission, or state of completion.

12.2. In accordance with 36 CFR 1222.32, all data created for Government use and delivered to, or falling under the legal control of, the Government are Federal records subject to the provisions of 44 U.S.C. chapters 21, 29, 31, and 33, the Freedom of Information Act (FOIA) (5 U.S.C. 552), as amended, and the Privacy Act of 1974 (5 U.S.C. 552a), as amended and must be managed and scheduled for disposition only as permitted by statute or regulation.

12.3. In accordance with 36 CFR 1222.32, Contractor shall maintain all records created for Government use or created in the course of performing the contract and/or delivered to, or under the legal control of the Government and must be managed in accordance with Federal law. Electronic records and associated metadata must be accompanied by sufficient technical documentation to permit understanding and use of the records and data.

12.4. VA Medical Center and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Records may not be removed from the legal custody of VA Medical Center or destroyed except for in accordance with the provisions of the agency records schedules and with the written concurrence of the Head of the Contracting Activity. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701. In the event of any unlawful or accidental removal, defacing, alteration, or destruction of records, Contractor must report to the VA Medical Center. The agency must report promptly to NARA in accordance with 36 CFR 1230.

12.5. The Contractor shall immediately notify the appropriate Contracting Officer upon discovery of any inadvertent or unauthorized disclosures of information, data, documentary materials, records or equipment. Disclosure of non-public information is limited to authorized personnel with a need-to-know as described in the [contract vehicle]. The Contractor shall ensure that the appropriate personnel, administrative, technical, and physical safeguards are established to ensure the security and confidentiality of this information, data, documentary material, records and/or equipment is properly protected. The Contractor shall not remove material from Government facilities or systems, or facilities or systems operated or maintained on the Government’s behalf, without the express written permission of the Head of the Contracting Activity. When information, data, documentary material, records and/or equipment is no longer required, it shall be returned to VA Medical Center’s control or the Contractor must hold it until otherwise directed. Items returned to the Government shall be hand carried, mailed, emailed, or securely electronically transmitted to the Contracting Officer or address prescribed in the [contract vehicle]. Destruction of records is EXPRESSLY PROHIBITED unless in accordance with Paragraph (12.4).

12.6. 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, contracts. The Contractor (and any sub-contractor) is required to abide by Government and VA Medical Centers guidance for protecting sensitive, proprietary information, classified, and controlled unclassified information.

12.7. The Contractor shall only use Government IT equipment for purposes specifically tied to or authorized by the contract and in accordance with VA Medical Centers policy.

12.8. The Contractor shall not create or maintain any records containing any non-public VA Medical Center information that are not specifically tied to or authorized by the contract.

12.9. 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 from public disclosure by an exemption to the Freedom of Information Act.

12.10. The VA Medical Center owns the rights to all data and records produced as part of this contract. All deliverables under the contract are the property of the U.S. Government for which VA Medical Center shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest. Any Contractor rights in the data or deliverables must be identified as required by FAR 52.227-11 through FAR 52.227-20.

12.11. Training. All Contractor employees assigned to this contract who create, work with, or otherwise handle records are required to take VHA-provided records management training, Talent Management System (TMS) Item #3873736, Records Management for Records Officers and Liaisons. The Contractor is responsible for confirming training has been completed according to agency policies, including initial training and any annual or refresher training.

13. PERFORMANCE STANDARDS, QUALITY ASSURANCE (QA) AND QUALITY IMPROVEMENT(QI).

Quality Management/Quality Assurance Surveillance: Contractor (s) shall be subject to Quality Management measures, such as patient satisfaction surveys, staffing and supportive services, timely completion of records and reports, and COR Reviews. Methods of Surveillance: Direct observation shall be performed periodically or through 100% surveillance. There will be periodic inspections to evaluate outcomes on a periodic basis. Inspections may be scheduled Daily, Weekly, Monthly, Quarterly, Annually or unscheduled, as required. There will be progress or status meetings.

Contractor performance will be monitored by the government using the standards as outlined in this Performance Work Statement (PWS) and methods of surveillance detailed in the Quality Assurance Surveillance Plan (QASP).

13.1. Measure: Personnel

Performance Requirement: Contractor shall provide a Board-Certified Sleep Medicine Physician (BCSMP) Standard: Review and interpret the raw data of the sleep study epoch by epoch and provide a report to the ordering physician.

Acceptable Quality Level: 100% during annual rating period Surveillance Method: Periodic Reviews and spot checks Frequency: Random

13.2. Measure: Equipment

Performance Requirement: The contractor shall provide personal sleep monitoring equipment and operator’s manual at no cost to the government.

Standard: Contractor shall have state of the art equipment that is FDA approved and shall always maintain an equipment inventory level to support a surge of 35 studies per week.

Acceptable Quality Level: 95% of referred cases Surveillance Method: Direct Observation Frequency: Quarterly

13.3. Measure: Monitoring Services

Performance Requirement: The contractor shall provide On-Call services for patients and VA staff shall be available 24 hours a day, 7 days a week.

Standard: Contractor shall have a Board-Certified Sleep Specialist on Staff and be available at all times (24/7) to perform interpretations that are of an acute nature. Also, in the event of questions or issues that may arise to both patient and VA staff.

Acceptable Quality Level: 95% of referred cases Surveillance Method: Periodic Reviews Frequency: Random

13.4. Measure: Instrument Capabilities

Performance Requirement: The contractor shall have a Sleep Study Type 3 Recording device.

Standard: Equipment used for home sleep testing must comply with the accreditation standards set for Out of Center Sleep Testing (OCST) equipment by the American Academy of Sleep Medicine (AASM) Acceptable Quality Level: 100% during annual rating period Surveillance Method: Periodic Reviews Frequency: Random

13.5. Measure: Training

Performance Requirement: The contractor shall provide comprehensive training to the VA Medical Center Staff. Multiple training Sessions may be required for numerous staff members Standard: 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.

Acceptable Quality Level: 95% of referred cases Surveillance Method: Periodic Reviews Frequency: Random

13.6. Measure: Technical Support

Performance Requirement: Technical Support is required by the contractor via telephone for troubleshooting of method and/or problems 24/7.

Standard: The response time for telephone technical assistance shall be within one (1) hour from the time of the initial call for technical support.

Acceptable Quality Level: 100% of referred cases Surveillance Method: Periodic Reviews Frequency: Random

13.7. Measure: Billing/Invoicing

Performance Requirement: The Contractor shall submit an original monthly invoice and supporting documentation Standard: Invoices shall be submitted no later than the 15th workday of the month. Invoices without proper Documentation shall be returned, and no advance payments shall be authorized.

Acceptable Quality Level: 95% of referred cases Surveillance Method: Quarterly Direct Observation Frequency: Quarterly

14. PATIENT AND VA EMPLOYEE COMPLAINTS.

14.1. The CO will resolve complaints concerning Contractor relations with the Government employees or patients. The CO is final authority on validating complaints. In the event that the Contractor is involved and named in a validated patient complaint, the Government reserves the right to refuse acceptance of the services of such personnel. This does not preclude refusal in the event of incidents involving physical or verbal abuse.

(End of Performance Work Statemen)

B.5 IT CONTRACT SECURITY

VA INFORMATION AND INFORMATION SYSTEM SECURITY/PRIVACY

1. 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.

2. ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS

a. A contractor/subcontractor 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.

b. All contractors, subcontractors, and third-party servicers and 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 must be in accordance with VA Directive and Handbook 0710, Personnel Suitability and Security Program. The Office for Operations, Security, and Preparedness is responsible for these policies and procedures.

c. Contract personnel who require access to national security programs must have a valid security clearance. National Industrial Security Program (NISP) was established by Executive Order 12829 to ensure that cleared U.S. defense industry contract personnel safeguard the classified information in their possession while performing work on contracts, programs, bids, or research and development efforts. The Department of Veterans Affairs does not have a Memorandum of Agreement with Defense Security Service (DSS). Verification of a Security Clearance must be processed through the Special Security Officer located in the Planning and National Security Service within the Office of Operations, Security, and Preparedness.

d. Custom software development and outsourced operations must be located in the U.S. to the maximum extent practical. If such services are proposed to be performed abroad and are not disallowed by other VA policy or mandates, the contractor/subcontractor must state where all non-U.S. services are provided and detail a security plan, deemed to be acceptable by VA, specifically to address mitigation of the resulting problems of communication, control, data protection, and so forth. Location within the U.S. may be an evaluation factor.

e. 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.

3. VA INFORMATION CUSTODIAL LANGUAGE

a. 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).

b. VA information should not be co-mingled, if possible, with any other data on the contractors/subcontractor's information systems or media storage systems in order to ensure VA requirements related to data protection and media sanitization can be met. If co-mingling must be allowed to meet the requirements of the business need, the contractor must ensure that VA's information is returned to the VA or destroyed in accordance with VA's sanitization requirements. VA reserves the right to conduct on-site inspections of contractor and subcontractor IT resources to ensure data security controls, separation of data and job duties, and destruction/media sanitization procedures are in compliance with VA directive requirements.

c. Prior to termination or completion of this contract, contractor/ subcontractor must not destroy information received from VA, or gathered/ created by the contractor in the course of performing this contract without prior written approval by the VA. Any data destruction done on behalf of VA by a contractor/subcontractor must be done in accordance with National Archives and Records Administration (NARA) requirements as outlined in VA Directive 6300, Records and Information Management and its Handbook 6300.1 Records Management Procedures, applicable VA Records Control Schedules, and VA Handbook 6500.1, Electronic Media Sanitization. Self-certification by the contractor that the data destruction requirements above have been met must be sent to the VA Contracting Officer within 30 days of termination of the contract.

d. The contractor/subcontractor must receive, gather, store, back up, maintain, use, disclose and dispose of VA information only in compliance with the terms of the contract and applicable Federal and VA information confidentiality and security laws, regulations and policies. If Federal or VA information confidentiality and security laws, regulations and policies become applicable to the VA information or information systems after execution of the contract, or if NIST issues or updates applicable FIPS or Special Publications (SP) after execution of this contract, the parties agree to negotiate in good faith to implement the information confidentiality and security laws, regulations and policies in this contract.

e. The contractor/subcontractor shall not make copies of VA information except as authorized and necessary to perform the terms of the agreement or to preserve electronic information stored on contractor/subcontractor electronic storage media for restoration in case any electronic equipment or data used by the contractor/subcontractor needs to be restored to an operating state. If copies are made for restoration purposes, after the restoration is complete, the copies must be appropriately destroyed.

f. If VA determines that the contractor has violated any of the information confidentiality, privacy, and security 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.

g. If a VHA contract is terminated for cause, the associated BAA must also be terminated and appropriate actions taken in accordance with VHA Handbook 1600.01, Business Associate Agreements. Absent an agreement to use or disclose protected health information, there is no business associate relationship.

h. The contractor/subcontractor must 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.

i. The contractor/subcontractor's firewall and Web services security controls, if applicable, shall meet or exceed VA's minimum requirements. VA Configuration Guidelines are available upon request.

j. Except for uses and disclosures of VA information authorized by this contract for performance of the contract, the contractor/subcontractor may use and disclose VA information only in two other situations: (i) in response to a qualifying order of a court of competent jurisdiction, or (ii) with VA's prior written approval. The contractor/subcontractor must refer all requests for, demands for production of, or inquiries about, VA information and information systems to the VA contracting officer for response.

k. Notwithstanding the provision above, the contractor/subcontractor shall not release VA records protected by Title 38 U.S.C. 5705, confidentiality of medical quality assurance records and/or Title 38 U.S.C. 7332, confidentiality of certain health records pertaining to drug addiction, sickle cell anemia, alcoholism or alcohol abuse, or infection with human immunodeficiency virus. If the contractor/subcontractor is in receipt of a court order or other requests for the above-mentioned information, that contractor/subcontractor shall immediately refer such court orders or other requests to the VA contracting officer for response.

l. For service that involves the storage, generating, transmitting, or exchanging of VA sensitive information but does not require C&A or an MOU-ISA for system interconnection, the contractor/subcontractor must complete a Contractor Security Control Assessment (CSCA) on a yearly basis and provide it to the COR.

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6. SECURITY INCIDENT INVESTIGATION

a. 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.