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This performance work statement outlines requirements for a yoga instructor to provide services as part of a research study being conducted by the Department of Veterans Affairs Veterans Health Administration Veterans Integrated Service Network 21. The study aims to evaluate alternative pain treatment methods for chronic low back pain among veterans. The yoga instructor will be required to lead up to 10 one-hour yoga sessions per week over a five-year base period plus four one-year options. Sessions will incorporate poses using props and include instruction for home practice. The instructor must be RYT-500 certified or have an RYT-200 with two years' relevant experience. Healthcare experience and CPR certification are also required. The contractor will be expected to complete notes, adhere to research protocols, and report any adverse events.

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PERFORMANCE WORK STATEMENT (PWS)

VETERANS AFFAIRS SOUTHERN NEVADA HEALTHCARE SYSTEM

VASNHS, 6900 North Pecos Rd, North Las Vegas, NV

CONTRACT TITLE: Yoga Provider for the CSP #2009: Sequential and Comparative Evaluation of Pain

Treatment Effectiveness Response (SCEPTER).

REQUIREMENTS/SCOPE: Chronic low back pain (cLBP) has become a common issue for veterans to seek medical care in the United States. Previous studies pointed out that over 80% of the veteran had experienced low back pain for more than one year, and the recurrence rate was between 24-80%. Pain medications, including opioids, are one of the treatment options for low back pain. However, the opioid crisis arouses people’s attention in the past two decades. Therefore, the purpose of our study is to find the best treatment option to treat low back pain for veterans without using medications. There are two steps in the study. Step one has a control group and two light treatment groups, including physical therapy. Step two offers veterans one of three advanced treatment groups: cognitive behavioral therapy

(CBT), spinal manipulative therapy (SMT), or yoga.

SCOPE

The purpose of the SCEPTER study is to find a better way to treat cLBP without using medications. Yoga intervention is one of the advanced treatment groups we will provide to Veterans. The treatment consists of up to 10 sessions, and each session is about one hour. The Yoga Instructor/Provider will lead the study participants through a series of yoga poses with the use of yoga straps and blocks in each treatment session, so that the study participants can also practice a 20-25 minute of yoga at home each non-session day. The yoga sessions will help to relieve low back pain by focusing on the improvement of circulation, flexibility, and balance. The study participants may temporarily experience mild muscle soreness and aching, the study emphasizes the long-term benefits and effectiveness of the yoga intervention for cLBP in veterans.

The Yoga Instructor/Provider must meet all the minimum qualifications.

MINIMUM QUALIFICATIONS:

a. The Yoga Instructor/Provider must be certificated at the Registered Yoga Teacher (RYT)-500-hour level.

or

(2) RYT-200 certifications with at least two years of experience teaching yoga to people with medical conditions.

b. Healthcare and medical experience of at least 1-year in the past 5 years is required. Contractor must reference previous experience. Experience within a medical facility.

SPECIFIC TASKS: The yoga provider must be able to:

a. Commit to an estimated 300 hours of instruction for each year of the term of the contract.

Hours could vary depending on the needs of the facility to meet the (SCEPTER) research study.

b. Answer specific Veterans’ questions regarding the (SCEPTER) study and how yoga applies as an alternative treatment to chronic low back pain.

c. Be able to consult with Veterans individually.

d. Follow SCEPTER study’s yoga protocol and manual.

e. Lead yoga session(s).

f. Complete Computerized Patient Record System (CPRS) notes and encounters after each session.

CPRS training and access will be provided pending credentialing and NARS approval.

g. Report any Serious Adverse Events (SAEs)

h. Instructor must arrive at least 15 minutes prior to instruction and be required to stay after instruction to complete (CPRS) notes for the (SCEPTER) Research Study.

PERFORMANCE STANDARDS:

a. 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. In addition, the contractor will be required to take:

• Talent Management System (TMS) training for Good Clinical Practices

• TMS training for VA Privacy and Information Security Awareness and Rules of Behavior

(WBT)

• TMS Privacy and HIPAA Training

• Research-required Veteran Affairs (VA) Collaborative Institutional Training Initiative (CITI)

Program training in Human Subjects Protection Program

• SCEPTER study trainings to include but not limited to the Yoga modules.

• CPRS training

• Basic Life Support BLS certification

• Read the Yoga Home Practice manual and watched two home practice yoga videos.

• Complete courses in Yoga for Chronic Pain and Trauma Informed Yoga and Adaptive Yoga

Certificates.

All training listed above shall be done within 60 days after the contractor is provided access to the VA IT system. The contractor is responsible for confirming training has been completed according to agency policies, including initial training and any annual or refresher training.

b. Yoga Instructor must reschedule yoga instruction in conflict and or due to sickness or leave.

Missing or rescheduling more than 5 sessions in one calendar year will be considered

“excessive” rescheduling. Excessive rescheduling will be considered issues with performance and corrective action will be taken.

c. Due to unforeseen circumstances such as extended leave or inability to continue yoga instruction, the contractor must find a valid replacement who can meet the minimum requirements and performance standards outlined in the performance work statement (PWS)

d. Quality Assurance Surveillance Plan (QASP) will be provided to the awarded contractor within 60 days of contract award. The QASP is the document government personnel use to assess the contractor performance. Performance will be evaluated on a yearly basis and performance standards outlined in the QASP will adhere to contractor performance standards specific to the

Yoga Instruction portion of the SPECTER Research Project. The QASP will be used to monitor the contractor’s performance and the contractor will use the QASP in reference to performance expectations of the contract.

PERIOD OF PERFORMANCE/SCHEDULE: Base plus 4 option year contract for services.

Base Year: September 30, 2023, to September 29, 2024

Option Year 1: September 30, 2024, to September 29, 2025

Option Year 2: September 30, 2025, to September 29, 2026

Option Year 3: September 30, 2026, to September 29, 2027

Option Year 4: September 30, 2027, to September 29, 2028

a. Normal daytime working hours will be adhered to. Normal daytime work hours are 0730 to

1600 Monday through Friday.

b. The contractor will be assigned to work 1 to 3 hours per day, two to three days per week.

c. If the contractor wishes to work at nighttime or during other unscheduled times, they must first get permission from the Contracting Officer.

PARTICIPATING FACILITY:

1. VA Southern Nevada Healthcare System (VASNHS) 6900 North Pecos Rd, North Las Vegas, NV, 2nd floor, Bldg 5, Community Living Center (CLC)

2. Virtual Instruction: VA Video Connect (VVC)/telehealth and some on-site. Contractor shall furnish their own equipment required to conduct VVC.

CONTRACTING OFFICER REPRESENTATIVE:

The Contracting Officer Representative (COR) shall provide general instructions and shall be responsible for administrating the contract and ensuring invoices are certified for payment in a timely manner.

CONTRACTOR POINT OF CONTACT:

a. Contractor shall designate one employee as the Point of Contact (POC) responsible for administrative matters in the performance of services under this contract. The POC shall have full authority to act for the Contractor on all matters relating to the daily performance of this contract.

b. The POC shall be available by telephone Monday through Friday, between 7:30 a.m. and 4:00 p.m.

excluding national holidays.

c. Contractor shall provide the name and telephone number of the person designated as Point of Contact, Alternate Point of Contact, and the name, location and telephone number of the office where normal and emergency service calls are to be placed:

Point of Contact (Full Name):

Telephone Number:

E-mail Address:

Alternate Point of Contact (Full Name):

Telephone Number:

E-mail Address:

Emergency Service Contact Information:

Emergency Service Telephone Number:

U.S. GOVERNMENT FURNISHED MATERIALS AND SERVICES:

a. The contractor shall be responsible for the receipt and handling of all equipment and materials. The contractor shall coordinate proposed delivery areas with the SCEPTER b.

c. Study Staff, Research & Development Service staff, Logistics Services, and/or Engineer.

d. VASNHS will provide the SCEPTER study-required book, yoga mats and blocks, and pedometers to the SCEPTER Study Veteran participants.

e. VASNHS will provide care to SCEPTER study Veteran participants in case of injury during the yoga session(s).

f. SCEPTER study protocol, forms, and documentation will be provided to the contractor once all Research-required training courses are completed.

CONTRACTOR FURNISHED ITEMS AND SERVICES:

a. The contractor shall furnish all necessary supplies, equipment, products, tools, and any other items and services to perform all duties outlined in the (PWS).

b. The contractor shall provide fully qualified on-site personnel who shall be responsible for the performance of the work. The name of the person and all alternates shall be designated in writing to the Contracting Officer.

c. Some Yoga sessions will be done through VA Video Connect (VVC)/telehealth and some on-site. Contractor shall furnish their own equipment required to conduct VVC.

CONTRACTOR RESPONSIBILITIES:

a. Contractor Employees. The contractor shall not employ personnel for work on this contract if such employee is identified to the contractor as a potential threat to the health, safety, security, general well-being or operational mission of the installation and its population.

b. All work shall be performed, and equipment shall function in conformance with all VA safety standards, manufacturer’s/industry standards, the latest published edition of NFPA-99, FDA, OSHA, Joint Commission, and other applicable national standards. The COR may facilitate a copy of VA safety standards to the Contractor upon request.

c. Contractor personnel shall present a neat appearance and be easily recognized as contractor employees. This may be accomplished by wearing distinctive clothing bearing the name of the company or company ID badge. Contractor field service personnel shall be dressed to present a clean, neat appearance at all times when performing under this contract.

d. Personnel performing maintenance and repair services must be fully qualified, competent, technicians. “Fully qualified and competent” is defined as factory trained and verified by Polar Leasing.

e. Contractor will be responsible in ensuring safe yoga sessions. Each session will have up to 10 SCEPTER study Veteran participants with various medical disabilities to include but not limited to back pain. Yoga sessions could be done through VVC or on site at the 2nd floor, Bldg. 5, Community Living Center (CLC), VASNHS, 6900 North Pecos Rd, North Las Vegas, NV.

NATIONAL HOLIDAYS:

The Contractor is not required to provide services on the following National Holidays.

New Year’s Day January 1

Martin Luther King‘s Birthday Third Monday in January

President’s Day Third Monday in February

Memorial Day Last Monday in May

Juneteenth June 19

Independence Day July 4

Labor Day First Monday in September

Columbus Day Second Monday in October

Veterans Day November 11

Thanksgiving Day Fourth Thursday in November

Christmas Day December 25

When a holiday falls on a Sunday, the following Monday shall be observed as a legal holiday by U.S.

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

PARKING POLICY:

It is the responsibility of Contractor personnel to park only in designated parking areas. Parking information is available from the VA Police. The VA shall not invalidate or make reimbursement for parking violations of Contractor's personnel under any circumstances.

SMOKING POLICY:

Contractor personnel may not smoke on VA property.

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.

CHANGES TO CONTRACT:

Only those services specified herein are authorized.

COMPLAINTS:

Contractor shall promptly and courteously respond to complaints within 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.

INVOICING:

All Contractor personnel shall be required to wear company ID badges. INVOICE REQUIREMENTS:

a. Payments will be monthly.

b. No advance payments will be authorized.

c. The Government shall pay the Contractor, upon the submission of a properly prepared invoice for prices stipulated in this contract for services and supplies delivered and accepted.

d. Payment of invoices may be delayed if appropriate field service reports are not completed and submitted as specified herein.

e. The invoice shall be itemized to include the following minimum information:

1. Invoice Number and Date.

2. Contract Number.

3. Purchase Order/Obligation Number (to be assigned upon task order award).

4. Date of service.

5. Line item from Schedule of Service associated with each charge.

POST-AWARD PERFORMANCE CONFERENCE: The CO may schedule a post-award performance conference with Contractor, if deemed necessary, for contract orientation purposes.

SECURITY REQUIRMENTS:

a. 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. A prohibition on unauthorized disclosure: "Information made available to the contractor or subcontractor by VA for the performance or administration of this contract or information developed by the contractor 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." See VA Handbook 6500.6, Appendix C, paragraph 3.a.

c. A requirement for data breach notification: Upon discovery 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, the contractor/subcontractor shall immediately and simultaneously notify the COR, the designated ISO, and Privacy Officer for the contract. 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. See VA Handbook 6500.6, Appendix C, paragraph 6.a.

d. A requirement to pay liquidated damages in the event of a data breach: "In the event of a data breach or privacy incident involving any SPI the contractor processes or maintains under this contract, the contractor shall be liable to VA for liquidated damages for a specified amount per affected individual to cover the cost of providing credit protection services to those individuals." See VA Handbook 6500.6, Appendix C, paragraph 7.a., 7.d.

e. A requirement for annual security/privacy awareness training: "Before being granted access to VA information or information systems, all contractor employees and subcontractor employees requiring such access shall complete on an annual basis either: (i) the VA security/privacy awareness training (contains VA's security/privacy requirements) within 1 week of the initiation of the contract, or (ii) security awareness training provided or arranged by the contractor that conforms to VA's security/privacy requirements as delineated in the hard copy of the VA security awareness training provided to the contractor.

f. If the contractor provides their own training that conforms to VA's requirements, they will provide the COR or CO, a yearly report (due annually on the date of the contract initiation) stating that all applicable employees involved in VA's contract have received their annual security/privacy training that meets VA's requirements and the total number of employees trained. See VA Handbook 6500.6, Appendix C, paragraph 9.

g. A requirement to sign VA's Rules of Behavior: "Before being granted access to VA information or information systems, all contractor employees and subcontractor employees requiring such access shall sign on an annual basis an acknowledgment that they have read, understand, and agree to abide by VA's Contractor Rules of Behavior which is attached to this contract." See VA Handbook 6500.6, Appendix C, paragraph 9, Appendix D. Note: If a medical device vendor anticipates that the services under the contract will be performed by 10 or more individuals, the Contractor Rules of Behavior may be signed by the vendor's designated representative. The contract must reflect by signing the Rules of Behavior on behalf of the vendor that the designated representative agrees to ensure that all such individuals review and understand the Contractor Rules of Behavior when accessing VA's information and information systems.

h. Bio-Medical devices and other equipment or systems containing media (hard drives, optical disks, etc.) with VA sensitive information must not be returned to the vendor at the end of lease, for trade-in, or other purposes." See VA Handbook 6500.6, Appendix C, paragraph 5.h., for the specific options.

RECORDS MANAGEMENT LANGUAGE

a. 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. Chapters. 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.

b. 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.

c. In accordance with 36 CFR 1222.32, the 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.

d. The VA Southern Nevada Healthcare System (VASNHS) 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 VASNHS 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.

e. In the event of any unlawful or accidental removal, defacing, alteration, or destruction of records, the contractor must report to VASNHS. The agency must report promptly to NARA in accordance with 36 CFR 1230.

f. The contractor shall immediately notify the appropriate Contracting Officer (CO) 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 documents. 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 VASNHS 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 CO or address prescribed in the contract documents. Destruction of records is EXPRESSLY PROHIBITED unless in accordance with Paragraph (4).

g. The contractor is required to obtain the CO'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

VASNHS guidance for protecting sensitive, proprietary information, classified, and controlled unclassified information.

h. The contractor shall only use Government IT equipment for purposes specifically tied to or authorized by the contract and in accordance with VASNHS policy.

i. The contractor shall not create or maintain any records containing any non-public VASNHS information that are not specifically tied to or authorized by the contract.

j. 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 FOIA.

k. VASNHS 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 VASNHS 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.

FLOWDOWN REQUIREMENT TO SUBCONTRACTORS:

a. The contractor shall incorporate the substance of the contract, its terms, and requirements, in all subcontracts under this contract document, and require written subcontractor acknowledgment of same.

b. Violation by a subcontractor of any provision set forth in the contract will be attributed to the contractor.

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