S02 36C25724Q0471 - Neuromonitoring Services.pdf

36C25724Q0471

RFQ#36C25724Q0471

Neuromonitoring Equipment and Technicians

SEE BELOW:

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

36C257-24-AP-1978

36C25724Q0471 10-03-2024

Brandy Riha, Contracting Officer 254-778-4811 10-23-2024 12:00 pm CDT

36C257 Department of Veterans Affairs VHA RPO West - NCO 17 Healthcare Resources Branch 11495 Turner Road El Paso TX 79936

X 100

X

621399

$10 Million

N/A

X

36C549

Department of Veterans Affairs North Texas Veterans HCS 4500 S. Lancaster Road

Dallas TX 75216

36C257

SEE BLOCK 9

36C104

This is accomplished through the Tungsten Network located at:

http://www.fsc.va.gov/einvoice.asp This is mandatory and the sole method for submitting invoices.

(877) 353-9791 (512) 460-5540

See CONTINUATION Page

The contractor shall provide On-Site Neuromonitoring Services on an as-needed basis to Veteran beneficiaries at the Department of Veterans Affairs (VA), North Texas Veterans Health Care System (VANTHCS).

Services shall include Neuromonitoring Equipment and Technicians.

This requirement is being procured as a 100% Total Service- Disabled Veteran-Owned Small Business Set-Aside. Only SDVOSBs certified by SBA in VetCert and registered in Sam.gov at the time of offer submissions will be considered for award. Firms not classified as SDVOSBs in SBA's VetCert and not registered in Sam.gov will be considered non-responsive and ineligible for award.

See CONTINUATION Page

X 1

Elsa Gomez

Table of Contents

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

B.2 SCHEDULE OF SERVICES

B.3 PERFORMANCE WORK STATEMENT

SECTION C - CONTRACT CLAUSES

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

AND COMMERCIAL SERVICES (NOV 2023)

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

C.6 52.217-8 OPTION TO EXTEND SERVICES (NOV 1999)

C.7 52.217-9 OPTION TO EXTEND THE TERM OF THE CONTRACT (MAR 2000)... 32

C.8 SUPPLEMENTAL INSURANCE REQUIREMENTS

C.10 VAAR 852.201-70 CONTRACTING OFFICER'S REPRESENTATIVE (DEC 2022)

C.11 VAAR 852.203-70 COMMERCIAL ADVERTISING (MAY 2018)

C.12 VAAR 852.211-76 LIQUIDATED DAMAGES – REIMBURSEMENT FOR DATA

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

C.13 VAAR 852.219-73 VA NOTICE OF TOTAL SET-ASIDE FOR CERTIFIED

SERVICE-DISABLED VETERAN-OWNED SMALL BUSINESSES (JAN 2023)

(DEVIATION)

C.14 VAAR 852.219-75 VA NOTICE OF LIMITATIONS ON SUBCONTRACTING—

CERTIFICATE OF COMPLIANCE FOR SERVICES AND CONSTRUCTION (JAN 2023)

(DEVIATION)

C.15 VAAR 852.232-72 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS

(NOV 2018)

C.16 VAAR 852.237-70 INDEMNIFICATION AND MEDICAL LIABILITY INSURANCE

(OCT 2019)

C.17 VAAR 852.237-72 CRIME CONTROL ACT—REPORTING OF CHILD ABUSE

(OCT 2019)

C.18 VAAR 852.237-74 NON-DISCRIMINATION IN SERVICE DELIVERY (OCT 2019)

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

C.20 VAAR 852.242-71 ADMINISTRATIVE CONTRACTING OFFICER (OCT 2020) . 43

C.21 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT

STATUTES OR EXECUTIVE ORDERS—COMMERCIAL PRODUCTS AND

COMMERCIAL SERVICES (MAY 2024)

SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS

See attached document: D.1 PAST PERFORMANCE SURVEY See attached document: D.2 CONTRACTOR RULES OF BEHAVIOR See attached document: D.3 CONTRACTOR CERTIFICATION OF IMMIGRATION See attached document: D.4 ORGANIZATIONAL CONFLICTS OF INTEREST See attached document: D.5 QASP - NEUROMONITORING See attached document: D.6 WAGE DETERMINATION

SECTION E - SOLICITATION PROVISIONS

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

E.2 52.212-1 INSTRUCTIONS TO OFFERORS—COMMERCIAL PRODUCTS AND

COMMERCIAL SERVICES (SEP 2023)

E.3 ADDENDUM to FAR 52.212-1 INSTRUCTIONS TO OFFERORS—COMMERCIAL

PRODUCTS AND COMMERCIAL SERVICES

E.4 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB

1998)

E.5 52.204-24 REPRESENTATION REGARDING CERTAIN TELECOMMUNICATIONS

AND VIDEO SURVEILLANCE SERVICES OR EQUIPMENT (NOV 2021)

E.6 52.204-29 FEDERAL ACQUISITION SUPPLY CHAIN SECURITY ACT

ORDERS—REPRESENTATION AND DISCLOSURES (DEC 2023)

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

E.8 52.233-2 SERVICE OF PROTEST (SEP 2006)

E.9 VAAR 852.233-70 PROTEST CONTENT/ALTERNATIVE DISPUTE RESOLUTION

(OCT 2018)

E.10 VAAR 852.233-71 ALTERNATE PROTEST PROCEDURE (OCT 2018)

E.11 VAAR 852.252-70 SOLICITATION PROVISIONS OR CLAUSES

INCORPORATED BY REFERENCE (JAN 2008)

E.14 52.212-2 EVALUATION—COMMERCIAL PRODUCTS AND COMMERCIAL

SERVICES (NOV 2021)

E.15 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—

COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (MAY 2024)

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

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

a. CONTRACTOR:

Contractor Name:

Address:

Point of Contact:

Title:

Phone:

Email:

Tax ID Number:

SAM Unique Entity ID:

b. GOVERNMENT: Contracting Officer 36C257 Elsa Gomez

Department of Veterans Affairs

VHA RPO West - NCO 17

Healthcare Resources Branch

11495 Turner Road

El Paso TX 79936

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

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

[] 52.232-36, Payment by Third Party

3. INVOICES: Invoices shall be submitted in arrears:

a. Quarterly []

b. Semi-Annually []

c. Other [x] Monthly

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

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

AMENDMENT NO DATE

B.2 SCHEDULE OF SERVICES

The contractor shall provide all personnel and equipment required to provide Neuromonitoring Equipment and Technician services for surgical procedures at North Texas Veterans Health Care System (VANTHCS), 4500 South Lancaster Road, Dallas, Texas 75216. The Contractor shall only invoice for actual work performed.

As part of price evaluation, the Government will evaluate its option to extend services (see FAR Clause 52.217-8). The evaluation will assume that the prices for any option exercised under FAR 52.217-8 will be at the same rates as those in effect under the contract at the time the option is exercised. The evaluation will therefore assume that the addition of the price or prices of any possible extension or extensions under FAR 52.217-8 to the total price for the basic requirement and the total price for the priced options has the same effect on the total price of all proposals relative to each other, and will not affect the ranking of proposals based on price, unless, after reviewing the proposals, the Government determines that there is a basis for f inding otherwise. This evaluation will not obligate the Government to exercise any option under

FAR 52.217-8.

ITEM INFORMATION

ITEM

NUMBER

DESCRIPTION OF

SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

160.00 EA ____________ _____________

Provide Neuromonitoring Equipment and Technician Services to include intraoperative, preoperative, postoperative, and operating room neurophysiologic monitoring procedures.

Contract Period: Base POP Begin: 01-01-2025 POP End: 12-31-2025 PRINCIPAL NAICS CODE: 621399 - Offices of All Other Miscellaneous Health Practitioners PRODUCT/SERVICE CODE: Q523 - Medical - Surgery

7.00 EA ___________ ____________

Hourly rate for each additional hour of surgery beyond initial 7 hours.

Contract Period: Base POP Begin: 01-01-2025 POP End: 12-31-2025 PRINCIPAL NAICS CODE: 621399 - Offices of All Other

7.00 EA ___________ _____________

Late scheduling fee for surgeries scheduled after 3 p.m. of the day preceding surgery.

Contract Period: Base POP Begin: 01-01-2025 POP End: 12-31-2025 PRINCIPAL NAICS CODE: 621399 - Offices of All Other

Cancellation fee if services are cancelled after 5 p.m. of the day preceding surgery and before surgery time.

Contract Period: Base POP Begin: 01-01-2025 POP End: 12-31-2025 PRINCIPAL NAICS CODE: 621399 - Offices of All Other

Cancellation fee if services are cancelled after the boarded surgery time.

Contract Period: Base POP Begin: 01-01-2025 POP End: 12-31-2025 PRINCIPAL NAICS CODE: 621399 - Offices of All Other

160.00 EA ___________ _____________

Services to include intraoperative, preoperative, postoperative, and operating room neurophysiologic monitoring procedures.

Contract Period: Option 1 POP Begin: 01-01-2026 POP End: 12-31-2026 PRINCIPAL NAICS CODE: 621399 - Offices of All Other initial 7 hours.

Contract Period: Option 1 POP Begin: 01-01-2026 POP End: 12-31-2026 PRINCIPAL NAICS CODE: 621399 - Offices of All Other the day preceding surgery.

Contract Period: Option 1 POP Begin: 01-01-2026 POP End: 12-31-2026 PRINCIPAL NAICS CODE: 621399 - Offices of All Other the day preceding surgery and before surgery time.

Contract Period: Option 1 POP Begin: 01-01-2026 POP End: 12-31-2026 PRINCIPAL NAICS CODE: 621399 - Offices of All Other

Cancellation fee if services are cancelled after the boarded surgery time.

Contract Period: Option 1 POP Begin: 01-01-2026 POP End: 12-31-2026 PRINCIPAL NAICS CODE: 621399 - Offices of All Other

Services to include intraoperative, preoperative, postoperative, and operating room neurophysiologic monitoring procedures.

Contract Period: Option 2 POP Begin: 01-01-2027 POP End: 12-31-2027 PRINCIPAL NAICS CODE: 621399 - Offices of All Other initial 7 hours.

Contract Period: Option 2 POP Begin: 01-01-2027 POP End: 12-31-2027 PRINCIPAL NAICS CODE: 621399 - Offices of All Other the day preceding surgery.

Contract Period: Option 2 POP Begin: 01-01-2027 POP End: 12-31-2027 PRINCIPAL NAICS CODE: 621399 - Offices of All Other the day preceding surgery and before surgery time.

Contract Period: Option 2 POP Begin: 01-01-2027 POP End: 12-31-2027 PRINCIPAL NAICS CODE: 621399 - Offices of All Other boarded surgery time.

Contract Period: Option 2 POP Begin: 01-01-2027 POP End: 12-31-2027 PRINCIPAL NAICS CODE: 621399 - Offices of All Other

Services to include intraoperative, preoperative, postoperative, and operating room neurophysiologic monitoring procedures.

Contract Period: Option 3 POP Begin: 01-01-2028 POP End: 12-31-2028 PRINCIPAL NAICS CODE: 621399 - Offices of All Other initial 7 hours.

Contract Period: Option 3 POP Begin: 01-01-2028 POP End: 12-31-2028 PRINCIPAL NAICS CODE: 621399 - Offices of All Other the day preceding surgery.

Contract Period: Option 3 POP Begin: 01-01-2028 POP End: 12-31-2028 PRINCIPAL NAICS CODE: 621399 - Offices of All Other the day preceding surgery and before surgery time.

Contract Period: Option 3 POP Begin: 01-01-2028 POP End: 12-31-2028 PRINCIPAL NAICS CODE: 621399 - Offices of All Other boarded surgery time.

Contract Period: Option 3 POP Begin: 01-01-2028 POP End: 12-31-2028 PRINCIPAL NAICS CODE: 621399 - Offices of All Other

Services to include intraoperative, preoperative, postoperative, and operating room neurophysiologic monitoring procedures.

Contract Period: Option 4 POP Begin: 01-01-2029 POP End: 12-31-2029 PRINCIPAL NAICS CODE: 621399 - Offices of All Other initial 7 hours.

Contract Period: Option 4 POP Begin: 01-01-2029 POP End: 12-31-2029 PRINCIPAL NAICS CODE: 621399 - Offices of All Other the day preceding surgery.

Contract Period: Option 4 POP Begin: 01-01-2029 POP End: 12-31-2029 PRINCIPAL NAICS CODE: 621399 - Offices of All Other the day preceding surgery and before surgery time.

Contract Period: Option 4 POP Begin: 01-01-2029 POP End: 12-31-2029

PRINCIPAL NAICS CODE: 621399 - Offices of All Other

7.00 EA __________ _____________

boarded surgery time.

Contract Period: Option 4 POP Begin: 01-01-2029 POP End: 12-31-2029 PRINCIPAL NAICS CODE: 621399 - Offices of All Other

GRAND

TOTAL

B.3 PERFORMANCE WORK STATEMENT

Performance Work Statement

Neuromonitoring Equipment and Technician Services PWS

B.3.1 SCOPE OF WORK

B.3.1.1. The Contractor shall provide Neuromonitoring Equipment and Technician Services for surgical procedures at North Texas Veterans Health Care System (VANTHCS), 4500 South Lancaster Road, Dallas, Texas 75216 on an as needed basis.

Services shall include intraoperative, preoperative, postoperative neurophysiologic monitoring services and evoked potential testing for neurosurgery patients. Services are to be conducted in the operating room and associated areas of the Dallas VA Medical Center on a per case basis as determined by the Chief of Surgical Service and Chief of Neurosurgery. The Chief of Neurosurgery shall notify the Administrative Officer or appropriate designee in Surgical Service when monitoring services are needed for a neurosurgical patient. The Administrative Officer or appropriate designee will contact the Contractor with the request for monitoring. All changes to the proposed monitoring, to include date/time, type of monitoring, etc., will be conveyed by the Administrative Office or appropriate designee to the Contractor.

B.3.1.2. The Contractor shall provide the equipment and services as described herein in a manner consistent with the standards of the Joint Commission for the Accreditation of Healthcare Organization (JC) requirements for this type of equipment and services.

B.3.2 HOURS/SCHEDULING OF SERVICE

B.3.2.1.Except by special alternative arrangement, scheduled services shall be rendered by the Contractor on a 24-hour bases. Upon contract award the contractor shall be available to provide Neurosurgery monitoring services as specified here in 24 / 7 365 days a year.

B.3.2.2. Federal Holidays. The eleven (11) holidays observed by the Federal Government are as follows:

New Years Day Labor Day Martin Luther King’s Birthday Columbus Day Presidents Day Veterans Day Memorial Day Thanksgiving Day Juneteenth National Independence day Christmas Day Independence Day

And any other day specifically declared by the President of the United States to be a National Holiday.

B.3.3. CONTRACTING OFFICER’S REPRESENTATIVE (COR): VANTHCS shall appoint one

(1) COR for this contract. When service is requested, the Contractor shall always contact the COR, Betty Campbell, at 214-857-1836, or her designee.

B.3.4. CONTRACT REQUIREMENTS:

Upon arrival at the VA on each schedule day of service the Contractor shall report to the VA Human Resources (HR) Service to obtain a temporary VA Contractor badge.

B.3.4.1. EQUIPMENT SET UP/INSPECTION: Delivery activities shall consist of the following:

B.3.4.1.1. Upon arrival at the VA the Contractor shall take all equipment to BioMed Service for preoperative electrical safety check.

B.3.4.1.2. Equipment Set Up: All necessary preparation required to ready the Neuromonitoring Equipment for operation/service.

B.3.4.1.3. Maintenance: The Contractor shall maintain equipment in accordance with manufacture’s specifications. The Contractor shall provide written documentation of Preventive Maintenance Services (PMS)/Maintenance has been performed as required for verif ication by the COR or his/her designee for all scheduled services.

Documentation shall describe the maintenance and repair service performed on the equipment in sufficient detail to be acceptable by field inspectors of the Joint Commission and other inspecting bodies. This shall include a list of all parts replaced, all service performed as well as a statement that the equipment is operating per manufacturer’s specifications after repair. The service report will be signed by the Contractor’s service technician, and by designated VANTHCS personnel.

B.3.4.1.4. Specifications for Neuromonitoring Intraoperative Monitoring (IOM) system:

• Camera- The camera should be mounted at least 22 inches (1.83 feet) but no more than 52 inches(4.33 feet) away from the patient and orthogonal to the patient’s spine’s long axis. The camera can be mounted on an IV pole or stand using the locking clamp that’s attached to it.

• Control Unit- The control unit should be plugged into a wall outlet and the power should be confirmed to be clean and grounded.

• Monitoring professional – The monitoring professional should be dedicated to monitoring in real-time and can be always in contact with the operating room. When monitoring remotely, they can only bill for the time spent monitoring a Medicare patient in 15-minute increments.

• Billing- The monitoring professional can only bill for time spent exclusively on a single patient. They can add up non-continuous time spent5 with a patient to determine how many units can be billed.

• The IOM system uses electromyography (EMG), motor evoked potentials (MEP), and somatosensory evoked potentials (SSEP) to monitor nerve and spinal cord activity during surgical procedures. This helps with implant placement and surgical technique. The IOM system platform can be used for surgeries in the following regions: Cervical, Thoracic, Lumbar, Scoliosis, and Thoracic vertebroplasty. The primary responsibility a Certif ied Intraoperative Neuromonitoring (IONM) Technologist is to collect and analyze, or to oversee the collection and analysis of multiple types of recordings and measurements of the electrical activity of the central and/or peripheral nervous system. The most used intraoperative neurophysiological monitoring (IONM) techniques for surgical procedures i:

Somatosensory sensory evoked potential (SSEP) Motor-evoked potential (MEP) Spontaneous and triggered electromyography (EMG)

B.3.4.2. CONTRACTOR PROVIDED RESPONSIBILITIES:

• Provides 24/7 onsite case coverage and scheduling 365 days/year with fully credentialed Neurophysiologists available for onsite coverage before and during surgery, (up to 3 if required).

• Neuromonitoring teams accredited by ABRET, (American Board of Registration of Electroencephalographic and Evoked Potential Technologist).

• Oversight of neuromonitoring done by board certif ied Neurologists.

• Certif icate of Neurophysiologic intraoperative monitoring (CNIM) 80% of techs or more.

• Intraoperative monitoring modalities needed include: SSEPS, TcMEP, S-

EMG, T-EMG, spinal cord mapping including D-Waves, DNEPs, NMEPs, Cortical, motor, sensory, language mapping, white matter tract and brainstem nuclei mapping, brainstem auditory evoked responses, visual evoked potentials, cranial nerve monitoring, and intraoperative EEG.

• Meets joint commission clinical quality standards for intraoperative monitoring.

• Establish communication protocols with the surgical team to report monitoring activity.

• Accurately apply all recording and stimulating electrodes.

• Perform monitoring procedures and documentation according to established protocols.

• Identify monitored waveforms and any variation from baseline.

• Understand anesthetic techniques and physiologic changes that can affect the waveforms being monitored.

• Be competent in the operating of monitoring equipment, including troubleshooting and electrical safety.

• Interpret the intraoperative monitoring recording and make recommendations regarding action or consequence to the attending Neurosurgeon.

• The Neuromonitoring team will provide all resources required to ensure a smooth transition in accordance with the contract requirements.

• FPIS compliant

• Quality reports required for quality assurance needs to be JHACO certif ied.

• Have a diplomat of American Board of Neuromonitoring on the team.

• Provides a list of all active surgeons receiving payments in consulting arrangements, advisors, and board members.

• Provides a list of all clients served in the past 12 months to permit

VANTHCS to contact any reference of our choosing.

B.3.4.2.1. CONTRACTOR PERSONNEL/QUALIFICATIONS/EXPERIENCE CRITERIA:

The Contractor’s Technician(s) shall be certif ied to operate the required equipment.

The Contractor shall be required to maintain following documentation for each Technician working under the contract. The Offeror shall provide the following documentation with their offer.

• Qualif ications, Certif ications, record of credentials and competencies

• Applicable License(s), including number and expiration date.

• Documentation of education and training

B.3.4.3. RECORD KEEPING/CONTRACT MONITORING

B.3.4.3.1. VANTHCS shall establish and maintain a record keeping system that shall record the services performed by the Contractor.

B.3.4.3.2. The Contractor shall perform services under the direction of the VANTHCS, Chief, Surgical Service and Chief, Neurosurgery Service.

B.3.4.4. CONFIDENTIALITY OF PATIENT RECORDS

B.3.4.4.1. The Contractor, as a VA provider, will assist in the provision of health care to patients seeking such care from or through VA. As such, the Contractor is considered as being part of the Department health care activity. Contractor is a VA provider for purposes of the Privacy Act, Title 5 U.S.C. 552a. Further, for the purpose of VA records access and patient confidentiality, Contractor is a VA contractor for the following provisions: Title 38 U.S.C. 5701, 5705, and 7362. Therefore, Contractor may have access, as would other appropriate components of VA, to patient medical records, including patient treatment records pertaining to drug and alcohol abuse, HIV, and sickle cell anemia, to the extent necessary to perform its contractual responsibilities.

However, like other components of the Department, and not withstanding any other provisions of the contract, the Contractor is restricted from making disclosures of VA records, or information contained in such records, to which it may have access, except to the extent that explicit disclosure authority from VA has been received. The Contractor is subject to the same penalties and liabilities for unauthorized disclosures of such records as VA.

B.3.4.4.2. The records referred to above shall be and remain the property of VA and shall not be removed or transferred from VA except in accordance with U.S.C.551a (Privacy Act), 38 U.S.C. 5701 (Confidentiality of Claimants Records), 5 U.S.C. 552 (FOIA), 38 U.S.C. 5705 (Confidentiality of Medical Quality Assurance Records) 38 U.S.C. 7332 (Confidentiality of Certain Medical Records), and federal laws, rules, and regulations. Subject to applicable federal confidentiality or privacy laws, the Contractor, or their designated representatives, and designated representatives of Federal regulatory agencies having jurisdiction over Contractor, may have access to VA ‘s records, at VA’s place of business on request during normal business hours, to inspect and review and make copies of such records.

B.3.4.5. HEALTH INSURANCE PORTABILITY AND ACCOUNTABILITY ACT OF 1996

(HIPAA):

Contractor must adhere to the provisions of Public Law 104-191, Health Insurance Portability and Accountability Act (HIPAA) of 1996 and the National Standards to Protect the Privacy and Security of Protected Health Information (PHI). As required by HIPAA, the Department of Health, and Human Services (HHS) has promulgated rules governing the security and use and disclosure of protected health information. by covered entities, including the Department of Veterans Affairs (VA). In accordance with HIPAA, the Contractor may be required to enter into a Business Associate Agreement (BAA) with VA.

B.3.4.6. LIABILITY AND INSURANCE REQUIREMENTS:

B.3.4.6.1. The Contractor shall provide insurance coverage in accordance with Federal Acquisition Regulation (FAR) Clause 52.228-5, Insurance – Work on a Government Installation (Jan 1997), VA Acquisition Regulation (VAAR) Clause 852.237-7, Indemnification and Medical Liability Insurance (Jan 2008), and Supplemental Insurance Requirements incorporated herein under the Clauses Section.

B.3.4.6.2. Before commencing work under the contract, the Contractor shall furnish to the Contracting Officer a certif icate of insurance indicating the coverage outlined herein and containing an endorsement to the effect that cancellation of, or any material change in the policies which adversely affect the interests of the Government in such insurance shall not be effective unless a 30-day advance written notice of cancellation or change is furnished the Government.

B.3.4.7. ID BADGES/PARKING/SMOKING POLICY:

B.3.4.7.1. BADGES. All Contractor personnel are required to wear Contractor issued identif ication (ID) badges during the entire time they are on the VA grounds. Upon arrival at the VA on each schedule day of service the contractor shall report the VA Human Resources (HR) Service to obtain a temporary VA Contractor badge.

B.3.4.7.2. PARKING. It is the responsibility of Contractor personnel to park only in designated parking areas. Parking information is available from the VA Security Service. The VA will not invalidate or make reimbursement for parking violations of the Contractor's personnel under any circumstances.

B.3.4.7.3. SMOKING. Smoking is not permitted within or around the VA Healthcare System facilities, except in designated areas.

B.3.4.8. RECORDS MANAGEMENT: All records (administrative and program specific) created during the period of the contract belong to VA North Texas Health Care System(VANTHCS) and must be returned to VANTHCS at the end of the contract or destroyed in accordance with the VHA Record Control Schedule (RCS)10-1. NARA RM Language Clause to be included in contracts:

B.3.4.9.1 Citations to pertinent laws, codes, and regulations such as 44 U.S.C Chapter 21 , 29, 31and 33; Freedom of Information Act (5 U.S.C. 552); Privacy Act (5 U.S.C. 552a); 36 CFR Part 1222 and Part 1228.

B.3.4.9.2. Contractor shall treat all deliverables under the contract as the property of the U.S. Government for which the Government Agency shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest.

B.3.4.9.3. Contractor shall not create or maintain any records that are not specifically tied to or authorized by the contract using Government ‘IT’ equipment and/or Government records.

B.3.4.9 4. Contractor shall not retain, use, sell, or disseminate copies of any deliverable that contains information covered by the Privacy Act of 1974 or that which is generally protected by the Freedom of Information Act.

B.3.4.9.5. Contractor shall not create or maintain any records containing any Government Agency records that are not specifically tied to or authorized by the contract or identif ied in the RCS 10-1.

B.3.4.9.6. The Government Agency owns the rights to all data/records produced as part of this contract.

B.3.4.9.7. The Government Agency owns the rights to all electronic information

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

B.3.4.9.8. Contractor agrees to comply with Federal and Agency records management policies, including those policies associated with the safeguarding of records covered by the Privacy Act of 1974. These policies include the preservation of all records created or received regardless of format [paper, electronic, etc.] or mode of transmission [e-mail, fax, etc.] or state of completion [draft, f inal, etc.].

B.3.4.9.9. No disposition of documents will be allowed without the prior written consent of the Contracting Officer. The Agency and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701. Records may not be removed from the legal custody of the Agency or destroyed without regard to the provisions of the agency records schedules.

B.3.4.9.10. Contractor is required to obtain the Contracting Officer's approval prior to engaging in any contractual relationship (sub-contractor) in support of this contract requiring the disclosure of information, documentary material and/or records generated under or relating to this contract. The Contractor (and any sub-contractor) is required to abide by Government and Agency guidance for protecting sensitive and proprietary information.

(End of Performance Work Statement)

B.4 IT CONTRACT SECURITY – VA INFORMATION AND INFORMATION SYSTEM

SECURITY/PRIVACY

B.4.1. GENERAL: Contractors, contractor personnel, subcontractors, and subcontractor personnel shall be subject to the same Federal laws, regulations, standards, and VA Directives and Handbooks.

B.4.2. CONTRACTOR PERSONNEL SECURITY REQUIREMENTS:

B.4.2.1. All Contractor employees having or requiring access to the Department of Veterans Affairs' computer systems or to sensitive data (to include patient or beneficiary records), shall be the subject of a background investigation and must receive a favorable adjudication from the VA Office of Security and Law Enforcement prior to contract performance. This requirement is applicable to all subcontractor personnel requiring the same access.

B.4.2.2. The Contracting Officer will provide the appropriate Background Investigation information to the Contractor for completion. Required background investigation initiation documentation must be completed and returned to the Contracting Office within five (5) calendar days after receipt.

B.4.2.3. Contractor staff shall not begin performance until notification is received from the Contracting Officer that the Security Package has been received and is considered a complete package. It is not necessary that the full Investigation be complete prior to commencement of work. However, if the investigation is not completed prior to the start date of the contract, the Contractor shall be responsible for the actions of those individuals they provide to perform work for VA.

B.4.2.3.1. Position Sensitivity - The position sensitivity has been designated as Low Risk.

B.4.2.3.2. Background Investigation - The level of background investigation commensurate with the level of access is National Agency Check with Written Inquiries (NACI).

B.4.2.3.3. Contractor Responsibilities –

B.4.2.3.3.1. The Contractor shall bear the expense of obtaining background investigations. The VA Is responsible for payment to the Security Investigations Center;

however, upon final payment, the VA will submit a Bill of Collections to the Contractor.

The Contractor is responsible for reimbursement to the VA within 30 calendar days.

The current cost for a low-risk background investigation is $231 per case.

B.4.2.3.3.2. Contractor, when notif ied of an unfavorable determination by the Government, shall withdraw the employee from consideration from working under the contract.

B.4.2.3.3.3. Failure to comply with the Contractor personnel security requirements may result in termination of the contract for default.

B.4.2.3.4. Fingerprinting Requirements - Contractor/subcontractor employees will be required to have fingerprints taken as part of the background Investigation process.

The preferred method of obtaining fingerprints is to have them taken electronically at the Human Resources Service at a VA facility. If f ingerprints cannot be obtained at a VA facility the Contracting Officer will provide the Contractor with a Form FD258 fingerprint chart, which can be taken to any local police station for f ingerprints.

However, local entities may assess a fee for this service.

B.4.3. ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS:A

Contractor/subcontractor shall be granted 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.4.3.2. All Contractors/subcontractors 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.

B.4.3.3. 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 notif ied immediately by the Contractor or subcontractor prior to an unfriendly termination.

B.4.4. VA INFORMATION CUSTODIAL LANGUAGE:Information made available to the contractor or subcontractor by VA for the performance or administration of this contract or information development 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.4.4.2. Prior to termination or completion of this contract, Contractor/subcontractor must not destroy information received from VA, or gathered/created by the Contractor while 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-certif ication 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 or completion of the contract.

B.4.4.3. 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 into this contract.

B.4.4.4. The Contractor/subcontractor shall not make copies of VA information except as authorized and necessary to perform the terms of the agreement.

B.4.4.5. If VA determines that the Contractor has violated any of the information confidentiality, privacy, and security provision 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.

B.4.4.6. 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.

B.4.4.7. 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.

B.4.5. 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 procedure. The Contractor/subcontractor shall immediately notify the COTR 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.

B.4.5.2. To the extent known by the Contractor/subcontractor, the Contractor/subcontractor's notice to VA shall identify the Information involved, the circumstances surrounding the incident (including to whom, how, when, and where the VA information or assets were placed at risk or compromised), and any other information that the Contractor/subcontractor considers relevant.

B.4.5.3. With respect to unsecured protected health information, the Contractor/subcontractor is deemed to have discovered a data breach when the Contractor/subcontractor knew or should have known of a breach of such information.

Upon discovery, the Contractor/ subcontractor must simultaneously notify the COTR, ISO and Privacy Officer.

B.4.5.4. 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 010 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 the 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.

B.4.6. LIQUIDATED DAMAGES FOR DATA BREACHConsistent 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.

B.4.6.2. 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.

B.4.6.3. Each risk analysis shall address all relevant information concerning the data breach, including the following:

B.4.6.3.1. Nature of the event (loss, theft, unauthorized access).

B.4.6.3.2 Description of the event, including:

B.4.6.3.2.1. date of occurrence.

B.4.6.3.2.2. data elements involved, including any PII, such as full name, social security number, date of birth, home address, account number, disability code.

B.4.6.3.2.3. Number of individuals affected or potentially affected; B.4.6.3.2.4. Names of individuals or groups affected or potentially affected.

B.4.6.3.2.5. Ease of logical data access to the lost, stolen or improperly accessed data considering the degree of protection for the data, e.g., unencrypted, plain text.

B.4.6.3.2.6. Amount of time the data has been out of VA control.

B.4.6.3.2.7. The likelihood that the sensitive personal information will or has been compromised (made accessible to and usable by unauthorized persons).

B.4.6.3.2.8. Known misuses of data containing sensitive personal information, if any; B.4.6.3.2.9. Assessment of the potential harm to the affected individuals.

B.4.6.3.2.10. Data breach analysis as outlined in 6500.2 Handbook, Management of Security and Privacy Incidents, as appropriate; and B.4.6.3.2.11. Whether credit protection services may assist record subjects in avoiding or mitigating the results of identity theft based on the sensitive personal information that may have been compromised.

B.4.6.4. Based on the determinations of the independent risk analysis, the contractor shall be responsible for paying to the VA liquidated damages in the amount of $37.50 per affected individual to cover the cost of providing credit protection services to affected individuals consisting of the following:

B.4.6.4.1. Notif ication.

B.4.6.4.2. One year of credit monitoring services consisting of automatic daily monitoring of at least 3 relevant credit bureau reports.

B.4.6.4.3. Data breach analysis.

B.4.6.4.4. Fraud resolution services, including writing dispute letters, initiating fraud alerts and credit freezes, to assist affected individuals to bring matters to resolution.

B.4.6.4.5. One year of identity theft insurance with $20,000.00 coverage at $0 deductible;

and B.4.6.4.6. Necessary legal expenses the subjects may incur to repair falsif ied or damaged credit records, histories, or f inancial affairs.

B.4.7 SECURITY CONTOLS COMPLIANCE TESTING: On a periodic basis, VA, including the Office of Inspector General, reserves the right to evaluate any or all the security controls and privacy practices implemented by the Contractor under the clauses contained within the contract. With 10 working- days’ notice, at the request of the Government, the Contractor must fully cooperate and assist in a government-sponsored security controls assessment at each location wherein VA information is processed or stored, or information systems are developed, operated, maintained, or used on behalf of VA, including those initiated by the Office of Inspector General. The Government may conduct a security control assessment on shorter notice (to include unannounced assessments) as determined by VA in the event of a security incident or at any other time.

B.4.8 TRAINING:

B.4.8.1. 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:

B.4.8.1.1. Sign and acknowledge (either manually or electronically) understanding of and responsibility for compliance with the Contractor Rules of Behavior, attached, relating to access to VA information and information systems.

B.4.8.1.2. Successfully complete the VA Cyber Security Awareness and Rules of Behavior training and annually complete required security training.

B.4.8.1.3. Successfully complete the appropriate VA privacy training and annually complete required privacy training; and

B.4.8.1.4. Successfully complete any additional cyber security or privacy training, as required for VA personnel with equivalent information system access [to be defined by the VA program official and provided to the contracting officer for inclusion in the solicitation document – e.g., any role-based information security training required in accordance with NIST Special Publication 800-16, Information Technology Security Training Requirements.]

B.4.8.2. The Contractor shall provide the Contracting Officer and/or the COTR a copy of the training certificates and certification of signing the Contractor Rules of Behavior for each applicable employee within one week of the initiation of the contract and annually thereafter, as required.

B.4.8.3. Failure to complete the mandatory annual training and sign the Rules of Behavior annually, 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 documents are completed.

SECTION C - CONTRACT CLAUSES

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

PRODUCTS AND COMMERCIAL SERVICES (NOV 2023)

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

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

and

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

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

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

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

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

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

(g) Invoice.

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

(i) Name and address of the Contractor;

(ii) Invoice date and number;

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

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

(v) Shipping number and date of shipment, including the bill of lading number and weight of shipment if…