36C24923Q0017.docx

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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.

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 CONDITIO

NS 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

596-23-1-036-0001 36C24923Q0017 Jack Hagopian 615-225-3425 12-09-2022 15:00

CST

Department of Veterans Affairs Network Contracting Office 9 (90C) c/o Jack Hagopian, Contract Specialist 1639 Medical Center Parkway, Suite 400 Murfreesboro TN 37129 X 621999 $18 Million N/A X Department of Veterans Affairs Lexington VAMC 1101 Veterans Dr.

Lexington KY 40502 90C Network Contracting Office 9 Department of Veterans Affairs c/o Jack Hagopian, Contract Specialist 1639 Medical Center Parkway Suite 400 Murfreesboro TN 37129

90C FSC e-Invoicing Payment http://www.fsc.va.gov/fsc/einvoice.asp Invoice Setup Information 1-877-489-6135 Invoice must be submitted electronically

Setup 1-877-489-6135 See CONTINUATION Page Neuromonitoring Services (See Below) X X Roxie A. Keese

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Table of Contents 36C24923Q0017

Page 1 of Page 1 of Contents

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

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

a. CONTRACTOR:

b. GOVERNMENT: Contracting Officer 36C249 Department of Veterans Affairs Network Contracting Office 9 c/o Jack Hagopian, Contract Specialist 1639 Medical Center Parkway, Suite 400 Murfreesboro TN 37129

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

3. INVOICES: Invoices shall be submitted in arrears:

a. Quarterly []

b. Semi-Annually []

c. Other [X] Monthly in Arrears

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:

36C24923Q0017

B.2 SCHEDULE OF SERVICES

The contractor shall provide complete neurological monitoring services during neurosurgical procedures in the Operating Suites of the VA Medical Center, Lexington, Kentucky, which includes operating and maintaining neurological monitoring equipment. As equipment nor permanent staff are available to perform these services, the contract is necessary and mandatory in order to carry out the objectives of providing the VA Medical Center, Lexington, Kentucky, with complete neurological monitoring services suitable for a medical center without a Neurological Monitoring Program, as well as meet and comply with all JCAHO Safety and Quality Assurance guidelines and regulations. Estimated recurring need for this support surface for the Medical Center based on past requirements is approximately four hours per session, twice per week, for an estimated 15 weeks of the fiscal year. Hours of possible need shall be between 7:30 and 3:30 pm, and will always be during a normal workday. There shall not be a need for this service after regular hours of operation, weekends, or holidays.

Place of Performance: Services shall be provided on site, VAMC 1101 Veterans Dr., Lexington, KY 40502 Base Period: January 1, 2023 – December 31, 2023

CLIN

No.

Per Unit Total Estimated Cost

Total for Option Base Period

Ordering Period 1: January 1, 2024 – December 31, 2024

CLIN

No.

Per Unit Total Estimated Cost

Total for Option Base Period

Ordering Period 2: January 1, 2025 – December 31, 2025

CLIN

No.

Per Unit Total Estimated Cost

Total for Option Base Period

Ordering Period 3: January 1, 2026 – December 31, 2026

CLIN

No.

Per Unit Total Estimated Cost

Total for Option Base Period

Ordering Period 4: January 1, 2027 – December 31, 2027

CLIN

No.

Per Unit Total Estimated Cost

Total for Option Base Period

Total for Period of Performance

A.1. ORDERS: This is a Fixed Price (FP) Indefinite Delivery/Indefinite Quantity (IDIQ) contract (see FAR 52.216-22). Task Orders shall be placed against this IDIQ contract at the time of contract award. Task Orders shall specify the estimated quantities of services during each period of performance and shall comply with FAR 52.216-18 and 52.216-19.

A.2. MINIMUM and MAXIMUM GUARANTEE: All quantities are estimates and all quoted prices shall be firm fixed prices. The Government’s guaranteed minimum during the life of the contract is $180,000.00. The Government’s contract ceiling amount during the life of the contract is $900,000. A funded Delivery/Task Orders (DO/TO) may only be awarded and issued by a warranted Contracting Officer (CO). Any changes to this contract may only be made by a written modification which is formally executed between the contractor and the CO.

B.3 PERFORMANCE WORK STATEMENT (PWS)

1. General:

1.1 Services Provided. The Contractor shall provide complete neurological monitoring services onsite in accordance with the specifications herein to the beneficiaries of the Department of Veterans Affairs (VA) and the Lexington VA Health Care System (LVAHCS). A contractor providing Neuromonitoring Services will meet or exceed the standards of the American Board of Electroencephalographic and Evoked Potential Technologists (ABRET). Services to the Operating Suites will begin January 1, 2023 – December 31, 2023 plus nine one year option years periods. The contractor will include operating and maintaining equipment (including monitoring devices), supplies, and labor of on-site qualified technician to perform intraoperative neurophysiologic monitoring (IONM) services in support of both neuro and vascular surgeries performed at the (LVAHCS). The Neuromonitoring service will require approximately four hours per session, twice per week, for 50 weeks per year. The Neuromonitoring service will be required during the standard business hours Monday – Friday between 7:00 am and 3:30 pm. There shall not normally be a need for this service after regular hours of operation, weekends, or holidays. There could be instances where a surgery is extended past regular hours due to unforeseen circumstances.

1.2 Place of Performance: The Contractor shall furnish services at the Lexington VA Health Care System (LVAHCS) at 1101 Veterans Drive, Lexington, KY 40502.

1.3 Authority: Title 38 USC 8153, Health Care Resources (HCR) and FAR parts 12 and 15.

1.4 Policy/Handbooks: the contractor shall be subject to the following policies, including any subsequent updates during the period of performance:

1.4.1 VHA Handbook 1100.17: National Practitioner Data Bank Reports:

https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=2135

1.4.2 VHA Handbook 1100.18: Reporting And Responding To State Licensing Boards:

https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=1364

1.4.3 VHA Handbook 1100.19: Credentialing and Privileging:

http://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=2910

1.4.4 VHA Directive 1003.04: VHA Patient Advocacy:

https://vaww.va.gov/vhapublications/ViewPublication.asp?pub_ID=5970

1.4.5 VHA Directive 1088: Communicating Test Results to Providers and Patients:

https://vaww.va.gov/vhapublications/ViewPublication.asp?pub_ID=3148

1.4.6 VHA Directive 1192.01: Seasonal Influenza Prevention Program:

https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=8948

1.4.7 VHA Directive 1220(1): Facility Procedure Complexity Designation Requirements to Perform Invasive Procedures In Any Clinical Setting: https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=8365

1.4.8 VHA Directive 1907.01: VHA Health Information Management and Health Records:

https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=9235

1.4.9 VHA Directive 1100.20 Credentialing of Health Care Providers:

https://vaww.va.gov/vhapublications/ViewPublication.asp?pub_ID=9444

1.4.10 Joint Commission:

http://www.jointcommission.org/standards/

1.4.11 HHS OIG Website: http://oig.hhs.gov/exclusions/index.asp

1.4.12 American Journal for Infection Control - AJIC 1998; 26:289-354:

1.4.13 http://www.cdc.gov/hicpac/pdf/InfectControl98.pdf

1.4.14 VA Directive 1663: Health Care Resources Contracting – Buying:

https://www.va.gov/vapubs/viewPublication.asp?Pub_ID=969&FType=2

1.4.15 Privacy Act of 1974 (5 U.S.C. 552a) as amended:

http://www.justice.gov/oip/foia_updates/Vol_XVII_4/page2.htm

1.4.16 VHA Directive 1088 Communicating Test Results to Providers and Patients, https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=3148

1.5 Definitions/Acronyms: Terms used in this contract shall be interpreted as follows unless the context expressly requires a different construction and/or interpretation. In case of a conflict in language between the Definitions and other sections of this contract, the language in this section shall govern.

1.5.1. ACEP: American College of Emergency Physicians

1.5.2. ACGME: Accreditation Council for Graduate Medical Education

1.5.3. AOD: Admitting Officer of the Day

1.5.4. BLS: Basic Life Support

1.5.5. Case: Elements of the covered surgeries anticipated (spinal) are expressed via Current Procedural Terminology (CPT) Code’s representative of a “typical case” and are delineated below. A case is estimated to be five (5) hours in duration, regardless of nature of the surgery.

1.5.6. CDC: Centers for Disease Control and Prevention

1.5.7. CDR: Contract Discrepancy Report

1.5.8. CEU: Certified Education Unit

1.5.9. CME: Continuing Medical Education

1.5.10. CMS: Centers for Medicare and Medicaid Services

1.5.11. Contracting Officer (CO): The person executing this contract on behalf of the Government with the authority to enter into and administer contracts and make related determinations and findings.

1.5.12. Contracting Officer’s Representative (COR): A person appointed by the CO to take necessary action to ensure the Contractor performs in accordance with and adheres to the specifications contained in the contract and to protect the interest of the Government. The COR shall report to the CO promptly any indication of non- compliance in order that appropriate action can be taken.

1.5.13. COS: Chief of Staff

1.5.14. Covered Surgeries: Any surgery for which VA surgeon requests scheduling of IONM service support. Surgeries covered under this contract include but not all inclusive:

a. Spinal

b. Cranial

c. Vascular

d. Peripheral nerve

1.5.15. COVID-19: Coronavirus Disease 2019

1.5.16. CPARS: Contractor Performance Assessment Reporting System

1.5.17. Credentialing: Credentialing is the systematic process of screening and evaluating qualification and other credentials, including licensure, required education, relevant training and experience and current competence and health status.

1.5.18. Contracting Specialist (CS): Prepares proposal packages, negotiates the contract, and awards the contract. Only the Contracting Officer is authorized to sign for the Federal Government.

1.5.19 DEA: Drug Enforcement Agency

1.5.20 EHR: Electronic Health Record - electronic health record system used by the VA

1.5.21 EMR: Electronic Medical Record

1.5.22 FSMB: Federation of State Medical Boards

1.5.23 HHS: Department of Health and Human Services

1.5.24 HIPAA: Health Insurance Portability and Accountability Act

1.5.25 HR: Human Resources

1.5.26 ISO: Information Security Officer

1.5.27 MOD: Medical Officer of the Day

1.5.28 National Provider Identifier (NPI): NPI is a standard, unique 10-digit numeric identifier required by HIPAA. The Veterans Health Administration must use NPIs in all HIPAA- standard electronic transactions for individual (health care practitioners) and organizational entities (medical centers).

1.5.29 NPPES: National Plan and Provider Enumeration System

1.5.30 POP: Period of Performance

1.5.31 PPD: Purified Protein Derivative

1.5.32 PWS: Performance Work Statement

1.5.33 Privileging (Clinical Privileging): Privileging is the process by which a practitioner, licensed for independent practice; e.g., without supervision, direction, required sponsor, preceptor, mandatory collaboration, etc.; is permitted by law and the facility to practice independently, to provide specific medical or other patient care services within the scope of the individual’s license, based upon the individual’s clinical competence as determined by peer references, professional experience, health status, education, training and licensure. Clinical privileges must be facility-specific and provider- specific.

1.5.34 QA/QI: Quality Assurance/Quality Improvement

1.5.35 QM/PI: Quality Management/Performance Improvement

1.5.36 QASP: Quality Assurance Surveillance Plan

1.5.37 Reports and Documentation: The hard copy record of real time neurological monitoring data captured throughout the surgery and printed from contractor equipment for inclusion in patient’s medical record.

1.5.38 Services: A list of intraoperative services that may require use of monitoring but not limited to are:

A. Transcranial Electrical Motor Evoked Potentials (TCeMEP) B. Upper and Lower Somatosensory Evoked Potentials (SEP) C. Auditory Brainstem Response (ABR) D. Electroencephalography (EEG) E. Electromyography (EMG) F. Cranial Nerve Electromyography (EMG)

1.5.39 Veterans Health Administration (VHA): The central office for administration of the VA medical centers through throughout the United States. The VHA is located in Washington, D.C.\

1.5.40 Unit Price: All-inclusive hourly rate for covered surgeries supported by intraoperative neurophysiologic monitoring (IONM) services. It includes qualified contractor technician utilizing contractor-owned and maintained IONM equipment specific to the covered surgery being supported.

1.5.41 Veterans Integrated Services Network (VISN): The regional oversight for the VA medical centers.

1.5.42 VISTA (Veterans Integrated Systems Technology Architecture): A PC based system that will capture and store clinical imagery, scanned documents and other non-textual data files and integrates them into patient’s medical record and with the hospital information system.

1.5.43 VetPro: a federal web-based credentialing program for healthcare providers.

1.5.44 Veterans Affairs Medical Center (VAMC): Unless identified with the name of a different VA medical Center, for purposes of this contract, this term shall mean the Lexington VA Healthcare System.

2. QUALIFICATIONS:

2.1 Staff / Facility

2.1.1 Personnel assigned by the contractor to perform the services covered by this contract must be employees of the contractor and meet basic minimum criteria/qualifications of contractor as well as the requirements identified below. The qualification of such personnel shall also be subject to review by the Chief of Surgery and Chief of Staff. Technicians must possess minimum qualifications specified below.

2.1.2 Recognition for Certification for Neurophysiological Intraoperative Monitoring (CNIM) from the American Board of Electroencephalographic and Evoked Potential Technologists (ABRET). All continuing education courses required for maintaining certification must be kept up to date at all times. Documentation verifying current certification shall be provided by the Contractor to the VA COR on an annual basis for each year of contract performance

2.1.3 Competency for/certification on equipment proposed by contractor for performance under this contract.

2.1.4 Three (3) years of recent clinical experience.

2.1.5 Fluent in written and spoken English.

2.1.6 Current certifications in Basic Life Support (BLS) is required. Certification in Advanced Life Support (ALS) is desirable.

2.1.7 Current Certificate of Liability Insurance for technicians submitted for performance under this contract.

2.1.8 Certification of successful completion of annual Privacy/HIPAA training. Training may be provided by contractor and validated by contractor written statement submitted to the Contracting Officer Representative (COR).

2.1.9 Timely completion of any new requirements for mandatory education and/or competency reassessment which occur during the contract performance period.

2.1.10 Certification of successful completion of annual Privacy/HIPAA Training and Information Security Training.

2.1.11 Contractor must provide documentation that demonstrates that all technicians named herein have a satisfactory health status including a current physical.

2.1.12 Standard Personnel Testing (PPD, etc.): Contractor shall provide proof of the following tests for physicians / technicians within five (5) calendar days after contract award and prior to the first duty shift to the COR and Contracting Officer. Tests shall be current within the past year.

2.1.12.1 TUBERCULOSIS TESTING: Contractor shall provide proof of a negative Tuberculosis Skin Test (TST) or interferon-gamma release assays (IGRA) for all Contractor’s technician(s) {This is applicable to all health care workers}. A negative chest radiographic report for active tuberculosis shall be provided in cases of positive TST or IGRA results. The TST or IGRA testing shall be repeated annually.

2.1.12.2 MEASLES, MUMPS, & RUBELLA TESTING: Contractors shall provide proof of immunity for all Contractor physicians {This is applicable to all health care workers}.

2.1.12.3 VARICELLA: Contractors shall provide proof of immunity for all Contractor technicians {This is applicable to all health care workers}.

2.1.12.4 ACELLULAR PERTUSSIS: Contractors shall provide proof of 1 dose of Tdap vaccination for all Contractor technicians {This is applicable to all health care workers}.

2.1.12.5 INFLUENZA: Contractors shall provide proof that all Contractor technicians have received the annual Influenza vaccine unless it is contraindicated. If the Contractor technician has a medical contraindication to the vaccine they shall be required to wear a mask during the Influenza season . {This is applicable to all health care workers}.

2.1.12.6 COVID-19: Contractors shall comply with VHA Supplemental Contract Requirements for Combatting COVID-19 {This is applicable to all health care workers}. – See Section D attachment.

2.1.12.7 OSHA REGULATION CONCERNING OCCUPATIONAL EXPOSURE TO

BLOODBORNE PATHOGENS: Contractor shall provide evidence of completing and passing generic self-study blood-borne pathogen training for all Contractor’s technicians(s) {This is applicable to all health care workers}; provide their own Hepatitis B vaccination series and hepatitis B surface antigen test results following the hepatitis B vaccination series; maintain an exposure determination and control plan; maintain required records; and ensure that proper follow-up evaluation is provided following an exposure incident.

2.1.12.8 The VAMC shall notify the Contractor of any significant communicable disease exposures as appropriate. Contractor shall adhere to current CDC/HICPAC Guideline for Infection Control in health care personnel ( as published in American Journal for Infection Control- AJIC 1998; 26:289-354 http://www.cdc.gov/hicpac/pdf/InfectControl98.pdf) for disease control. Contractor shall provide follow up documentation of clearance to return to the workplace prior to their return.

2.1.13 Conflict of Interest: The Contractor and all contractor’s personnel are responsible for identifying and communicating to the CO and COR conflicts of interest at the time of proposal and during the entirety of contract performance. At the time of proposal, the Contractor shall provide a statement which describes, in a concise manner, all relevant facts concerning any past, present, or currently planned interest (financial, contractual, organizational, or otherwise) or actual or potential organizational conflicts of interest relating to the services to be provided. The Contractor shall also provide statements containing the same information for any identified consultants or subcontractors who shall provide services. The Contractor must also provide relevant facts that show how it’s organizational and/or management system or other actions would avoid or mitigate any actual or potential organizational conflicts of interest. These statements shall be in response to the VAAR provision 852.209-70 Organizational Conflicts of Interest and fully outlined in response to the subject attachment in Section D of the solicitation document.

2.1.14 Citizenship related Requirements

2.1.14.1 The Contractor certifies that the Contractor shall comply with any and all legal provisions contained in the Immigration and Nationality Act of 1952, As Amended; its related laws and regulations that are enforced by Homeland Security, Immigration and Customs Enforcement and the U.S Department of Labor as these may relate to non-immigrant foreign nationals working under contract or subcontract for the Contractor while providing services to Department of Veterans Affairs patient referrals;

2.1.14.4 This certification concerns a matter within the jurisdiction of an agency of the United States and the making of a false, fictitious, or fraudulent certification may render the maker subject to prosecution under 18 U.S.C. 1001.

2.1.14.5 The Contractor agrees to obtain a similar certification from its subcontractors. The certification shall be made as part of the offerors response to the RFP using the subject attachment in Section D of the solicitation document

2.1.15 Annual Office of Inspector General (OIG) Statement: In accordance with HIPAA and the Balanced Budget Act (BBA) of 1977, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) has established a list of parties and entities excluded from Federal health care programs. Specifically, the listed parties and entities may not receive Federal Health Care program payments due to fraud and/or abuse of the Medicare and Medicaid programs.

2.1.15.1 Therefore, Contractor shall review the HHS OIG List of Excluded Individuals/Entities on the HHS OIG web site at http://oig.hhs.gov/exclusions/index.asp to ensure that the proposed contractor’s physician(s) are not listed. Contractor should note that any excluded individual or entity that submits a claim for reimbursement to a Federal health care program, or causes such a claim to be submitted, may be subject to a Civil Monetary Penalty (CMP) for each item or service furnished during a period that the person was excluded and may also be subject to treble damages for the amount claimed for each item or service. CMP’s may also be imposed against the Contractor that employs or enters into contracts with excluded individuals to provide items or services to Federal program beneficiaries.

2.1.15.2 By submitting their proposal, the Contractor certifies that the HHS OIG List of Excluded Individuals/Entities has been reviewed and that the Contractors are and/or firm is not listed as of the date the offer/bid was signed.

2.1.16 Clinical/Professional Performance: The qualifications of Contractor personnel are subject to review by VA Medical Center COS or his/her clinical designee and approval by the Medical Center Director as provided in VHA Handbook 1100.19 and VHA Directive 2012-030. Clinical/Professional performance monitoring and review of all clinical personnel covered by this contract for quality purposes will be provided by the VAMC COS and/or the Chief of the Service or his designee. A clinical COR may be appointed, however, only the CO is authorized to consider any contract modification request and/or make changes to the contract during the administration of the resultant contract.

2.1.17 Non Personal Healthcare Services: The parties agree that the Contractor and all contractor’s personnel shall not be considered VA employees for any purpose.

2.1.18 Indemnification: The Contractor shall be liable for, and shall indemnify and hold harmless the Government against, all actions or claims for loss of or damage to property or the injury or death of persons, arising out of or resulting from the fault, negligence, or act or omission of the Contractor, its agents, or employees.

2.1.19 Prohibition Against Self-Referral: Contractor’s personnel are prohibited from referring VA patients to contractor’s or their own practice(s)

2.1.20 Inherent Government Functions: Contractor and Contractor’s personnel shall not perform inherently governmental functions. This includes, but is not limited to, determination of agency policy, determination of Federal program priorities for budget requests, direction and control of government employees (outside a clinical context), selection or non-selection of individuals for Federal Government employment including the interviewing of individuals for employment, approval of position descriptions and performance standards for Federal employees, approving any contractual documents, approval of Federal licensing actions and inspections, and/or determination of budget policy, guidance, and strategy.

2.1.21 No Employee status: The Contractor shall be responsible for protecting Contractor’s personnel furnishing services. To carry out this responsibility, the Contractor shall provide or certify that the following is provided for all their staff providing services under the resultant contract:

2.1.21.1 Workers’ compensation

2.1.21.2 Professional liability insurance

2.1.21.3 Health examinations

2.1.21.4 Income tax withholding, and

2.1.21.5 Social security payments.

2.1.22 Tort Liability: The Federal Tort Claims Act does not cover Contractor or contractor’s personnel. When Contractor or contractor’s personnel have been identified as a provider in a tort claim, the Contractor shall be responsible for notifying their legal counsel and/or insurance carrier. Any settlement or judgment arising from a Contractor’s (or contractor’s personnel) action or non-action shall be the responsibility of the Contractor and/or insurance carrier.

2.1.23 Contractor shall be responsible to ensure that personnel providing work on this contract are fully trained and completely competent to perform the required work. Contractor will meet LVAHCS, Joint Commission, and the American Hospital Association standards.

2.1.24 Key Personnel:

2.1.24.1 The Contractor shall be responsible for providing coverage to the VA during periods of vacancies of the Contractor’s personnel due to sick leave, personal leave, vacations, and additional coverage as required. In the event a scheduled provider is unable to complete an assigned shift, the contractor shall provide replacement provider coverage within 2 hours and notify the Contracting Office Representative (COR) at the Lexington VAMC immediately of the schedule change.

2.1.24.2 The Contractor shall provide a detailed explanation of the circumstances necessitating the proposed substitutions, complete resumes for the proposed substitutes, and any additional information requested by the CO. Proposed substitutes shall have comparable qualifications to those of the persons being replaced. The CO will notify the Contractor within 15 calendar days after receipt of all required information of the decision on the proposed substitutes. The contract will be modified to reflect any approved changes of key personnel.

2.1.24.3 For temporary substitutions where the key person shall not be reporting to work for three (3) consecutive workdays or more, the Contractor shall provide a qualified replacement for the key person. The substitute shall have comparable qualifications to the key person. Any period exceeding two weeks will require the procedure as stated above.

2.1.24.4 The Government reserves the right to refuse acceptance of any Contractor personnel at any time after performance begins, if personal or professional conduct jeopardizes patient care or interferes with the regular and ordinary operation of the facility. Breaches of conduct include intoxication or debilitation resulting from drug use, theft, patient abuse, dereliction, or negligence in performing directed tasks, or other conduct resulting in formal complaints by patient or other staff members to designated Government representatives. Standards for conduct shall mirror those prescribed by current federal personnel regulations. Should the VA COS or designee show documented clinical problems or continual unprofessional behavior/actions with any contract personnel(s), s/he may request, without cause, immediate replacement of said contract personnel(s).

2.1.25 The CO and COR shall deal with issues raised concerning Contract personnel(s) conduct. The final arbiter on questions of acceptability is the CO.

2.1.26 Contingency Plan: Because continuity of care is an essential part of VAMC’s medical services, The Contractor shall have a contingency plan in place to be utilized if the contract personnel(s) leaves Contractor’s employment or is unable to continue performance in accordance with the terms and conditions of the resulting contract.

Note: Evidence of completion of required licensure, credentials, required training, current competencies and background investigations must be validated for all contractor personnel referred to perform services under this contract prior to providing direct patient care. Contractor shall not have any personnel report to duty until written notification is received from the Contracting Officer advising that the candidate (s) presented has met all requirements for contract performance.

3. SERVICES.

3.3 Maintenance. Contractor will perform all preventive maintenance, routine servicing, and quality control of all IONM equipment used in performance of this contract to ensure and maintain maximum accuracy and optimum performance. Proper documentation of maintenance results and corrective action taken, as necessary, must be available to the Government.

3.4 Medical Services. Contractor shall provide services of at least one (1) qualified technician proficient in set-up and use of intraoperative neurophysiologic monitoring equipment in an OR setting for each scheduled case.

3.5 Reports. Contractor technician shall print one (1) copy of all patient monitoring documentation generated during surgery for inclusion in the electronic record. Prior to leaving the premises, contractor technician shall submit one (1) copy to the OR front desk clerk.

3.6 Neuromonitoring Interpretation and Reporting. For neuromonitoring the contractor is responsible for interpretation and formal reporting of the complete neurological monitoring services. This includes providing an onsite qualified technician. The contractor shall provide immediately available resources, typically a physician, for study interpretation intraoperatively, for consultation to the surgeon(s) performing procedures, and to provide support to the “qualified technician” on site.

4 SCHEDULING/CUSTOMER SUPPORT

4.1. Contractor shall provide process/protocols for scheduling IONM services defined below. Contractor shall ensure 24/7/365 (including weekends and holidays) access to KEY PERSONNEL for performance under this contract.

4.1.1 Non-emergent: Contractor shall provide IONM services as requested by the facility 48 hours or more in advance of scheduled surgery(ies).

4.1.2 Emergent: Contractor shall provide IONM services to support emergency surgery(ies) within four (4) hours of request by the facility.

4.1.3 Concurrent: Contractor shall provide IONM services for up to three (3) concurrent cases during normal business hours.

4.2 Contractor shall have written contingency plans in place to cover emergencies, unexpected events, and assigned KEY PERSONNEL being located outside a 2-hour driving perimeter of Lexington VAMC.

4.3 Contractor shall provide direct line phone numbers bypassing menus, recorded messages, etc., providing authorized Government personnel immediate access to contractor scheduling and/or customer service personnel 24/7/365.

4.4 Federal Holidays:

· New Year’s Day

· Martin Luther King’s Birthday

· President’s Day

· Memorial Day

· Juneteenth Independence Day

· Independence Day

· Labor Day

· Columbus Day

· Veterans Day

· Thanksgiving Day

· Christmas Day

· Any day specifically declared to be a national holiday by the President of the United States.

5. CONTRACTOR RESPONSIBILITIES:

5.1 Clinical Personnel Required: The Contractor shall provide contract personnel(s) who are competent, qualified per this performance work statement and adequately trained to perform assigned duties.

5.2 Contract personnel(s) shall be responsible for signing in and out when in attendance. Time sheets will be used by the COR to confirm hours/day and services provided against the contractor’s invoices.

5.3 Standards of Care: The contract personnel(s)’ care shall cover the range of Neuromonitoring services as would be provided in a state-of-the-art civilian medical treatment facility and the standard of care shall be of a quality, meeting or exceeding currently recognized national standards as established by:

5.3.1 The professional standards of The Joint Commission (TJC):

http://www.jointcommission.org/standards_information/standards.aspx

5.3.2 The standards of the American Hospital Association (AHA):

http://www.hpoe.org/resources?show=100&type=8

5.3.3 The requirements contained in this PWS

6. MEDICAL RECORDS

6.1 Authorities: Contract personnel(s) providing healthcare services to VA patients shall be considered as part of the Department Healthcare Activity and shall comply with the 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), Title 5 U.S.C. § 522a (Records Maintained on Individuals) as well as 45 C.F.R. Parts 160, 162, and 164 (HIPAA).

6.2 HIPAA: This contract and its requirements meet exception in 45 CFR 164.502(e), and do not require a BAA in order for Covered Entity to disclose Protected Health Information to: a health care provider for treatment. Based on this exception, a BAA is not required for this contract. Health records generated by this contract or provided to the Contractors by the VA are covered by the VA system of records entitled ‘Patient Medical Records-VA’ (24VA10A7). Contractor generated VA Patient records are the property of the VA and shall not be accessed, released, transferred, or destroyed except in accordance with applicable laws and regulations. Contractor shall ensure that all records pertaining to medical care and services provided to VA patients are captured in the VA electronic health record system as required by VA policy as discussed in 4.3.4.

6.3 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 (National Institute of Standards and Technology) issues or updates applicable FIPS (Federal Information Processing Standards) 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.

6.4 Disclosure: Contract personnel(s) may have access to patient medical records for the purpose of providing medical care and services to VA patients and performing services under the contract; however, Contractor shall obtain permission from the VA before disclosing any patient information outside VA. VA authorizes the Contractor to discuss patient health information for coordination of care with community health care providers in compliance with VA regulations, HIPAA and VHA Directive 1605.01, Privacy and Release of Information. The VA will provide the Contractor with a copy of VHA Handbook 1907.01, Health Information Management and Health Records and VHA Directive 1605.01, Privacy and Release of Information. The penalties and liabilities for the unauthorized disclosure of VA patient information mandated by the statutes and regulations mentioned above, apply to the Contractor.

6.3 Professional Standards for Documenting Care: Care shall be appropriately documented in medical records in accordance with standard commercial practice and guidelines established by VHA Handbook 1907.01 Health Information Management and Health Records: https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=9235 and all guidelines provided by the VAMC.

6.4 Release of Information: The VA shall maintain control of releasing any patient medical information and will follow policies and standards as defined, but not limited to Privacy Act requirements. Contractor will not release or disclose copies of records and will refer all such requests to the Release of Information Department at the VA facility were assigned.

6.5 Management for Medical Records: National Archives and Records Administration record disposition requirements are found in RCS 10-1 Chapter 6, 6000 series.

6.6 Confidentiality: VA will provide the contract personnel(s) access to pertinent patient medical information, within the existing privacy rules and regulations, for the purpose of providing coordinated comprehensive primary care. Contract personnel(s) shall ensure the confidentiality of all patient information and shall be held liable in the event of the breach of confidentiality.

6.7 Personal Identity Verification (PIV): Contract personnel(s) shall participate in computer security and documentation training as is all personnel practicing within the VA Medical Center. Contract personnel(s) shall comply with facility requirements to obtain personal security investigations, installation access and participate in the computer security and documentation training.

6.8 Contract personnel(s) shall provide medical record documentation in accordance with rules and regulations of the medical staff and medical staff by laws. Reference Policy Memorandum No. 136-1, Change 2 to Appendix B dated Sept. 29, 2000, Control of Medical Records and in accordance with Policy Memorandum 136-1, Change 2 to Appendix A dated September 29, 2000, Completion of Medical Records.

6.9 Records created by contract personnel(s) in the course of treating VA patients under this agreement are the property of the VA and shall not be accessed, released, transferred or destroyed except in accordance with applicable federal law and regulations. Contract personnel(s) shall maintain computer access and prepare for cases the following day by obtaining the patient information and record within the current electronic health record system for review.

6.10 Contract personnel(s) shall participate in quality improvement projects, initiatives, and reporting as requested.

7. CO RESPONSIBILITIES:

7.1 The Contracting Officer is the only person authorized to approve changes or modify any of the requirements of this contract. The Contractor shall communicate with the Contracting Officer on all matters pertaining to contract administration. Only the Contracting Officer is authorized to make commitments or issue any modification to include (but not limited to) terms affecting price, quantity, or quality of performance of this contract.

7.2 The Contracting Officer shall resolve complaints concerning Contractor relations with the Government employees or patients. The Contracting Officer is final authority on validating complaints. In the event the Contractor effects any such change at the direction of any person other than the Contracting Officer without authority, no adjustment shall be made in the contract price to cover an increase in costs incurred as a result thereof.

7.3 In the event that contracted services do not meet quality and/or safety expectations, the best remedy will be implemented, to include but not limited to a targeted and time limited performance improvement plan; increased monitoring of the contracted services; consultation or training for Contractor personnel to be provided by the VA; replacement of the contract personnel and/or renegotiation of the contract terms or termination of the contract.

8. COR RESPONSIBILITIES:

8.1 The COR shall be the VA official responsible for verifying contract compliance. After contract award, any incidents of Contractor noncompliance as evidenced by the monitoring procedures shall be forwarded immediately to the Contracting Officer.

8.2 The COR will be responsible for monitoring the Contractor’s performance to ensure all specifications and requirements are fulfilled. Quality Improvement data that will be collected for ongoing monitoring includes but is not limited to: Entering data that may be collected.

8.3 The COR will maintain a record-keeping system of services by the use of the EHR computer system (Electronic health record system used by the VA). The COR will review this data monthly when invoices are received and certify all invoices for payment by comparing the hours documented on the VA record-keeping system and those on the invoices. Any evidence of the Contractor's non-compliance as evidenced by the monitoring procedures shall be forwarded immediately to the Contracting Officer.

8.4 The COR will review and certify monthly invoices for payment. If in the event the Contractor fails to provide the services in this contract, payments will be adjusted to compensate the Government for the difference.

8.5 Monitoring/Reporting Procedures: The service to be performed by the contractor will be under the direction of the Chief, Surgical Services of the VA Medical Center.