36C24926R0040.docx

36C24926R0040

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

XX

36C24926R0040 04-13-2026 Samantha Shackelford, CO 05-04-2026 17:00

EDT

Department of Veterans Affairs Network Contracting Office 9 (90C)

NCO 9

1639 Medical Center Parkway, Suite 204 Murfreesboro

TN

37129 X X 621999 $20.5 Million N/A X Department of Veterans Affairs

TVHS VAMC

1310 24th Avenue South Nashville

TN

37212-2637 90C Network Contracting Office 9 Department of Veterans Affairs Network Contracting Office (90C) 1639 Medical Center Parkway Suite 204 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 On-Site and On-Call Perfusionist services for the Tennessee Valley Healthcare System VAMC, Nashville, TN See Instructions for the Preparation of Proposal on page _______ for proposal guidance.

Schedule of Services is located on page ____.

Performance Work Statement is located on page ____.

$0.00 See CONTINUATION Page X X Samantha Shackelford Contracting Officer Table of Contents

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1. CONTRACT ADMINISTRATION DATA

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

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

1.1.1. CONTRACTOR (Offerors are required to designate a person for prompt contract administration):

1.1.2. GOVERNMENT: Contracting Officer 36C626

Same as above

1.2. CONTRACTOR REMITTANCE ADDRESS: All payments by the Government to the contractor will be made in accordance with Federal Acquisition Regulation (FAR) Clause 52. 232-33, Payment by Electronic Funds Transfer-System for Award Management.

1.3. SYSTEM FOR AWARD MANAGEMENT (SAM): Federal Acquisition Regulations require that federal contractors register in the System for Award Management (SAM) database at http://www.sam.gov and enter all mandatory information into the system. Award will be made to a Contractor who has completed this registration prior to award. Offerors are encouraged to ensure that they are registered in SAM prior to submitting an offer.

1.4. ONLINE REPRESENTATIONS AND CERTIFICATIONS APPLICATIONS (ORCA): Federal Acquisition Regulations (FAR 4.1201) require that federal contractors register in the Online Representations and Certifications at htt://sam.gov and enter all mandatory information into the system; and the SAM registrations must be kept current and updated at least annually. Award will not be made until Contractor has completed registration in SAM.

1.5. CONTRACT TERM: the contract terms for a base period of six months beginning the effective date of this contract. This contract also includes Federal Acquisition Regulation (FAR) clause 52.217-8 for a possible extension of up to six (6) months at the discretion of the Government.

1.6. SECURE FAX TRANSMISSIONS: All fax cover sheets shall state the following: This fax is intended only for the use of the person or office to which it is addressed and may contain information that is privileged, confidential, or protected by law. All others are hereby notified that the receipt of this fax does not waive any applicable privilege or exemption for disclosure and that any dissemination, distribution, or copying of this communication is prohibited. If you have received this fax in error, please notify this office immediately at the telephone number listed above.

1.7. INVOICES: Invoices shall be submitted in arrears:

a. Quarterly []

b. Semi-Annually [] c Other [X] Monthly in arrears

All invoices from the Contractor shall be submitted in accordance with Veterans Affairs Acquisition Regulation (VAAR) 852.232-72 – Electronic Submission of Payment Request (NOV. 2018).

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

1.9. MANDATORY WRITTEN DISCLOSURES: Mandatory written disclosures required by Federal Acquisition Regulation (FAR) clause 52.203-13 to the Department of Veterans Affairs, Office of Inspector General (OIG) must be made electronically through the VA OIG Hotline at http://www.va.gov/oig/contracts/hotline.asp and clicking on “FAR clause 52.203-13 Reporting.” If you experience difficulty accessing the website, call the Hotline at 1-800-488-8244 for further instructions.

1.10. POST AWARD ORIENTATION: Upon award, the Contracting Officer wills schedule a post award orientation for contract orientation purposes.

[End of Contract Administration Data] 36C24926R0040

Page 1 of Page 1 of

B.1 SCHEDULE OF SERVICES

The Contractor shall furnish all key personnel to provide services necessary to perform onsite Perfusion Services to eligible beneficiaries of the Department of Veterans Affairs, at Tennessee Valley Healthcare System (TVHS) VA Medical Center (VAMC). The Contractor’s physician(s) care shall cover the range of Perfusion 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.

Pre-priming an ECMO circuit and related activities are to be compliant with VA and TVHS established requirements for managing pre-primed systems based on evidence-based guidelines and accepted standards of practice. This would include compliance with instructions for use (IFU) for the machine, pump, circuit and fluid used for priming. Also included are VA and TVHS Infection Preventionist in establishing requirements.

ECMO circuits must be assembled and primed using strict, aseptic techniques. Advanced priming limits the length of time a circuit may be kept on standby. For example, a saline-primed circuit may be kept on standby for immediate deployment for a longer period of time than one primed with a hypertonic solution. The acceptable ‘standby’ timeframe based on all the above factors set by the VA and TVHS is five (5) days for open wet-primed circuits and six (6) weeks for closed wet-primed circuits and determined by TVHS.

Close monitoring for compliance is critical to reduce the risk of patient harm. Documenting the date, time and initials of the individual completing the priming process is required. Compliance with equipment cleaning is required to ensure standby timeframe for use are met.

Contractor’s Perfusionists shall meet or exceed guidelines set forth by the American Board of Cardiovascular Perfusion (ABCP): http://www.abcp.org; The professional standards of The Joint Commission (TJC): https://www.jointcommission.org/en-us/standards/standards-manuals; The standards of the American Hospital Association (AHA): http://www.hpoe.org/resources?show=100&type=8 and; VA and TVHS policies and procedures.

Place of Performance: Services shall be provided on site at the TVHS VAMC located at 1310 24th Avenue, South, Nashville, TN 37212.

Pricing Instructions: The offeror is instructed to edit the number of Sub Line-Item Number (SLIN) to correspond with the number of key personnel submitted for the Line-Item Number (LIN). Affiliate Offerors shall include the “title” of the personnel submitted. Other commercial health care Offerors shall identify by title/position or level of experience the key personnel submitted. Also, renumber SLINs if adding or removing Key Personnel.

The Contractor shall propose a minimum of two (2) key personnel to be credentialed and be available for scheduling to meet the requirements of the contract. It is desired that a third (3rd) key person be provided to assist with training and leave time for the one (1) FTE Perfusionist providers.

Period of Performance Base Year: Time of Award to 5/31/2027

Annual Cost

Perfusion Onsite Services – During Clinic Hours

Disposable Supplies – Manufacturer’s List Price minus 10%

TOTAL FOR BASE

Option Year 1: 6/1/2027 to 5/31/2028

Annual Cost

Perfusion Onsite Services – During Clinic Hours

Disposable Supplies – Manufacturer’s List Price minus 10%

TOTAL FOR OPTION YEAR 1

Option Year 2: 6/1/2028 to 5/31/2029

Annual Cost

Perfusion Onsite Services – During Clinic Hours

Disposable Supplies – Manufacturer’s List Price minus 10%

TOTAL FOR OPTION YEAR 2

Option Year 3: 6/1/2029 to 5/31/2030

Annual Cost

Perfusion Onsite Services – During Clinic Hours

Disposable Supplies – Manufacturer’s List Price minus 10%

TOTAL FOR OPTION YEAR 3

Option Year 4: 6/1/2030 to 5/31/2031

Annual Cost

Perfusion Onsite Services – During Clinic Hours

Disposable Supplies – Manufacturer’s List Price minus 10%

TOTAL FOR OPTION YEAR 4

Total for base performance period and all option years: $_________________________

B.2 PERFORMANCE WORK STATEMENT – Perfusion Physician Services

1. GENERAL:

1.1. Services Provided: The contractor shall provide Perfusion Services on site in accordance with the terms and conditions contained herein to beneficiaries of the Department of Veterans Affairs (VA), Tennessee Valley Healthcare System, Nashville Campus (hereinafter referred to as TVHS) on an as needed basis 24 hours a day, seven days a week, including holidays, in support of cardiovascular services. One (1) Contractor Perfusionist shall be onsite each workday, Monday through Friday, except Federal Holidays; and one (1) Contractor Perfusionist shall provide on-call coverage.

1.2. Place of Performance: Contractor shall furnish services at the Tennessee Valley Healthcare System (TVHS), Nashville Campus; 1310 24th Avenue South; Nashville, TN 37212-2637.

1.3. Authority: Title 38 USC 8153, Health Care Resources (HCR) sharing Authority and FAR parts 12 in combination with VAAR 873.

1.4. Policy/Directives/Handbooks. The contractor shall be subject to the following policies, including any subsequent updates during the period of performance. The policies listed below can be accessed electronically at the following: VA Publications VHA Publications 1.

1.1.

1.2.

1.3.

1.4.

1.4.1. VA Directive 1663: Health Care Resources (HCR) Contracting – Buying Title 38 U.S.C. 8153.

1.4.2. VHA Directive 1003.04: VHA Patient Advocacy

1.4.3. VHA Directive 2010-018 “Facility Infrastructure”

1.4.4. VHA Directive 1065: Productivity and Staffing Guidance for Specialty Provider Group Practice

1.4.5. VHA Directive 1088(1): Communicating Test Results to Providers and Patients

1.4.6. VHA Directive 1100.18: Reporting and Responding to State Licensing Boards

1.4.7. VHA Directive 1100.20: Credentialing of Health Care Providers

1.4.8. VHA Directive 1100.21: Privileging

1.4.9. VHA Directive 1192.01: Seasonal Influenza Vaccination Program for VHA Health Care Personnel

1.4.10. VHA Directive 1220(1): Facility Procedure Complexity Designation Requirements to Perform Invasive Procedures in Any Clinical Setting

1.4.11. VHA Directive 1605.01: Privacy and Release of Information

1.4.12. VHA Directive 1907.01: VHA Health Information Management and Health Records

1.4.13. VHA Handbook 1100.17: National Practitioner Data Bank (NPDB) Reports

1.4.14. Privacy Act of 1974 (5 U.S.C. 552a) as amended: http://www.justice.gov/oip/foia_updates/Vol_XVII_4/page2.htm

1.4.15. Joint Commission: http://www.jointcommission.org/standards/

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

1.4.17. American Journal for Infection Control - AJIC 1998; 26:289-354: http://www.cdc.gov/hicpac/pdf/InfectControl98.pdf

1.5. Acronyms/Definitions: 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. ABCP: American Board of Cardiovascular Perfusion

1.5.2. ACGME: Accreditation Council for Graduate Medical Education

1.5.3. ACLS: Advanced Cardiac Life Support

1.5.4. BLS: Basic Life Support

1.5.5. CDC: Centers for Disease Control and Prevention

1.5.6. CEU: Certified Education Unit

1.5.7. Clinical Privileging: Clinical 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, and within available resources.

1.5.8. CME: Continuing Medical Education

1.5.9. CMP: Civil Monetary Penalty

1.5.10. CMS: Centers for Medicare and Medicaid Services

1.5.11. CO: Contracting Officer: 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. COR: Contracting Officer’s Representative: 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. CPARS: Contractor Performance Assessment Reporting System

1.5.15. Credentialing: Credentialing is the process of obtaining, verifying, and assessing the qualifications of a health care provider to provide care or services in or for the VA health care system. Credentials are documented evidence of licensure, education, training, experience, or other qualifications.

1.5.16. DEA: Drug Enforcement Agency

1.5.17. ED: Emergency Department

1.5.18. ECMO: Extracorporeal Membrane Oxygenation

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

1.5.20. EMR: Electronic Medical Record

1.5.21. FSMB: Federation of State Medical Boards

1.5.22. FTE: Full Time Employee VA’s standard definition is for full time working the equivalent of 80 hours every two weeks, 2080 hours per year. However, providers may propose using their standard FTE definition.

1.5.23. HHS: Department of Health and Human Services

1.5.24. HIPAA: Health Insurance Portability and Accountability Act

1.5.25. ISO: Information Security Officer

1.5.26. Key Personnel: The individuals specified in this contract who are essential to work performance.

1.5.27. 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).

1.5.28. Non-Contract Provider: any person, organization, agency, or entity that is not directly or indirectly employed by the Contractor or any of its subcontractors.

1.5.29. NP: Nurse Practitioner

1.5.30. NPPES: National Plan and Provider Enumeration System

1.5.31. OSHA: Occupational Safety and Health Administration

1.5.32. OPPE: Ongoing Provider Practice Evaluation

1.5.33. OR: Operating Room

1.5.34. PA: Physician Assistant

1.5.35. PIV: Personal Identity Verification

1.5.36. POP: Period of Performance

1.5.37. PPD: Purified Protein Derivative

1.5.38. PWS: Performance Work Statement

1.5.39. QASP: Quality Assurance Surveillance Plan

1.5.40. VHA: Veterans Health Administration

1.5.41. VetPro: Is VHA’s mandatory credentialing software platform to document the credentialing of VHA health care providers. This system facilitates completion of a uniform, accurate, and complete credentials file.

1.5.42. VISN: Veterans Integrated Services Network

1.5.43. VISTA: Veterans Integrated Systems Technology Architecture

2. QUALIFICATIONS:

2.1. Staff/Facility – The contractor shall provide one (1) Full Time Equivalency Employees (FTEEs), consisting of two (2) Board Certified Perfusionists.

2.1.1. License: Each Contractor’s Perfusionist shall be licensed with the Tennessee Committee for Clinical Perfusion, State of Tennessee Department of Health. All licenses held by personnel working on this contract shall be full and unrestricted. Contract personnel shall submit evidence of current, full and unrestricted licenses, registration, certification, and/or other relevant credentials for verification prior to appointment and throughout the employment process, as requested by the COR. Contractor is responsible for keeping the COR informed of anything that would adversely affect or otherwise limit their clinical privileges. Failure to meet this requirement may result in termination of the contract.

2.1.2. Board Certification: The contractor’s employees and any subcontractors shall have all licenses, permits, and certifications as required by law and this contract. All Perfusionists shall be certified with at least a minimum of ten (10) years of experience. All Perfusionists shall be a graduate of an accredited Allied Health Education Program School of Perfusion Technology and shall be certified by the American Board of Cardiovascular Perfusion, demonstrate evidence of meeting continuing education requirements and shall have performed a minimum of 1000 clinical cases. Experience shall be demonstrated in the following areas: Open heart surgery, autotransfusion, heart lung machine, membrane oxygenation, left/right heart bypass, intra-aortic balloon pumping and centrifugal ventricular assist device.

2.1.3. Credentialing and Privileging: Contract Perfusionist fulfilling the conditions of the contract shall be subject to all bylaws, rules, and regulations of the VAMC. Each Perfusionist shall be credentialed and privileged (if required) prior to providing services and must be found acceptable by the Facility Medical Executive Board and Medical Center Director (or designee). Credentialing and privileging is to be completed in accordance with VHA Directive 1100.20 and VHA Directive 1100.21 referenced above. The ability for an individual Perfusionist to continue to render services under the contract shall be dependent upon demonstration of clinical competence. Clinical competency shall be assessed on an ongoing basis for all Perfusionists and shall be reported as practitioner specific practice information, in compliance with an accreditation body with equal or better standards to The Joint Commission.

2.1.3.1. If a contract personnel(s) is not credentialed and privileged or has credentials/privileges suspended or revoked, the Contractor shall furnish an acceptable substitute without any additional cost to the government.

2.1.4. Technical Proficiency: Contract personnel(s) shall be technically proficient in the skills necessary to fulfill the government’s requirements, including the ability to speak, understand, read and write English fluently. Contractor shall provide documents upon request of the CO/COR to verify current and ongoing competency, skills, certification and/or licensure related to the provision of care, treatment and/or services performed. Contractor shall provide verifiable evidence of all educational and training experiences including any gaps in educational history for all contract personnel(s) and contract personnel(s) shall be responsible for abiding by the Facility's Medical Staff By-Laws, rules, and regulations (referenced herein) that govern medical staff behavior.

2.1.5. Continuing Medical Education (CME)/ Certified Education Unit (CEU) Requirements: Contractor shall provide the COR copies of current CMEs as required or requested by the facility. Contract personnel(s) registered or certified by national/medical associations shall continue to meet the minimum standards for CME to remain current. Contractor shall report CME hours to the credential’s office for tracking. These documents are required for both privileging and re-privileging. Failure to provide shall result in loss of privileges for contract personnel(s).

2.1.6. Training (ACLS, BLS, EHR and VA MANDATORY): Contractor shall meet all VA educational requirements and mandatory course requirements defined herein; all training must be completed by the contractor’s physician(s) as required by the VA. Other training may become required. VA will communicate any changes to the training requirement to the contractor.

2.1.7. STANDARD INFECTION CONTROL MEASURES (PPD, IMMUNIZATIONS, ETC.): Contractor shall provide proof of the following for physicians 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.

2.1.7.1. TUBERCULOSIS TESTING: Contractor shall provide proof of a negative Tuberculosis Skin Test (TST) or interferon-gamma release assays (IGRA) for all Contractor’s physician(s) upon hire in accordance with CDC guidance. (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.

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

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

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

2.1.7.5. INFLUENZA: Contractors shall provide proof that all Contractor physicians have received the annual Influenza vaccine unless it is contraindicated. If the Contractor physician 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}.

2.1.7.6. COVID-19: The Vaccine Attestation Guidance for Contractors memorandum requires personnel working onsite VA facilities to complete an attestation form if they are fully vaccinated or provide evidence of a negative COVID-19 test 3 days prior to entering the facility. Contractors shall complete COVID-19 Vaccination information and Attestation FAQs in TMS. Complete and sign VA Form 10-263. COR/CO must ensure all contractors are complaint with mandatory COVID-19 vaccination requirements as outlined by VHA DIRECTIVE 1193 (Attachments 5, 6, and 7).

2.1.7.7. 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 physician (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.

2.1.7.8. The facility 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.

2.1.7.9. Contractor’s Perfusionist shall follow all established safety and infection control standards of care. All events related to patient injury, medication errors, and other breeches of patient safety shall be reported to the COR.

2.1.8. National Provider Identification (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). The Contractor shall have or obtain appropriate NPI and if pertinent the Taxonomy Code confirmation notice issued by the Centers for Medicare and Medicaid Services (CMS) National Plan and Provider Enumeration System (NPPES) be provided to the Contracting Officer with the proposal.

2.1.9. Conflict of Interest: The Contractor and all contract personnel(s) 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.

2.1.10. Citizenship related Requirements:

2.1.10.1. 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.

2.1.10.2. While performing services for the Department of Veterans Affairs, the Contractor shall not knowingly employ, contract or subcontract with an illegal alien; foreign national non-immigrant who is in violation their status, as a result of their failure to maintain or comply with the terms and conditions of their admission into the United States. Additionally, the Contractor is required to comply with all “E-Verify” requirements consistent with “Executive Order 12989” and any related pertinent Amendments, as well as applicable Federal Acquisition Regulations.

2.1.10.3. If the Contractor fails to comply with any requirements outlined in the preceding paragraphs or its Agency regulations, the Department of Veterans Affairs may, at its discretion, require that the foreign national who failed to maintain their legal status in the United States or otherwise failed to comply with the requirements of the laws administered by Homeland Security, Immigration and Customs Enforcement and the U.S Department of Labor, shall be prohibited from working at the Contractor’s place of business that services Department of Veterans Affairs patient referrals; or other place where the Contractor provides services to veterans who have been referred by the Department of Veterans Affairs; and shall form the basis for termination of this contract for breach.

2.1.10.4. 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.

2.1.10.5. 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.

2.1.11. 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.

2.1.11.1. Therefore, Contractor shall review the HHS OIG List of Excluded Individuals/Entities on the HHS OIG web site referenced above to ensure that the proposed contract 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 employ or enter into contracts with excluded individuals to provide items or services to Federal program beneficiaries.

2.1.11.2. 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.

2.2. 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 Directive 1100.20 and VHA Directive 1100.21. Clinical/Professional performance monitoring and review of all clinical personnel covered by this contract for quality purposes will be provided by the facility 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.

2.3. Non- Personal Healthcare Services: The parties agree that the Contractor and all contract personnel(s) shall not be considered VA employees for any purpose.

2.4. 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.

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

2.6. Inherent Government Functions: Contractor and Contract personnel(s) 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.

2.7. No Employee status: The Contractor shall be responsible for protecting Contract personnel(s) 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:

2.7.1. Workers’ compensation

2.7.2. Professional liability insurance

2.7.3. Health examinations to include:

2.7.3.1. Annual TB Skin Test and recent chest X-ray if there is a history of positive TB skin test.

2.7.3.2. Evidence of Hepatitis B immunity (hepatitis immune titer, if the individual has had the series of shots; if no immunity, evidence that the individual has started the Hepatitis B vaccination series

2.7.3.3. Evidence of a Hepatitis C titer

2.7.3.4. Varicella titer if contracted employee has not had chicken pox.

2.7.4. Income tax withholding, and

2.7.5. Social security payments

2.8. Tort Liability: The Federal Tort Claims Act does not cover Contractor or contract personnel(s). When Contractor or contract personnel(s) has 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 contract provider (s)) action or non-action shall be the responsibility of the Contractor and/or insurance carrier.

2.9. Key Personnel:

2.9.1. The VA Full Time Equivalency (FTE) for the services required is one (1) FTE.

2.9.2. The number of Board Certified Perfusionists required to be on site daily is one (1) as defined in paragraph Hours of Operation of this section.

2.9.3. 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) immediately of the schedule change.

2.10. Personnel Substitutions: During the first ninety (90) calendar days of performance, the Contractor shall make NO substitutions of key personnel unless the substitution is necessitated by illness, death or termination of employment. The Contractor shall notify the CO, in writing, within 15 calendar days after the occurrence of any of these events and provide the information required below. After 90 days, the Contractor shall submit the information required below to the CO at least 15 calendar days prior to making any permanent substitutions.

2.10.1. 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.

2.10.2. 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.

2.10.3. 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).

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

2.10.5. Contingency Plan: Because continuity of care is an essential part of the Facility’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.

2.10.6. 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. VA HOURS OF OPERATION/SCHEDULING:

3.1. VA Business Hours: Contractor shall provide Perfusionists on an as needed basis, twenty-four (24) hours a day, seven days a week, including holidays.

3.1.1. Work Schedule: Regular work hours are Monday through Friday for eight (8) hours a day from 7:00 a.m. to 3:30 p.m.

3.1.2. The Perfusionist service is required for 2080 hours per year on Monday through Friday, eight hours shift basis to support these procedures and patients that are in the Intensive Care Unit requiring balloon pump/Extracorporeal Membrane Oxygenation (ECMO) support. The requirement is for the contractor to provide one (1) Board Certified Perfusionists onsite during regular work hours. An additional perfusionist will be used to support the emergency services as well as provide for coverage during vacation, illness, etc.

3.1.3. Off-hours Coverage: It is required by the contractor that one (1) of the full time Perfusionist be in an on-call status for twenty-four (24) hours a day and seven (7) days a week including all Federal Holidays and be within thirty (30) minutes of the facility to support these emergent cases. On-call service is considered part of the Perfusionist services and will not be paid separately. Any hours worked during an on-call status for an emergency procedure shall be paid the same rate as regular tour hours.

3.2. Federal Holidays:

· New Year’s Day

· Martin Luther King’s Birthday

· President’s Day

· Memorial Day

· Juneteenth

· Independence Day

· Labor Day

· Columbus Day

· Veterans Day

· Thanksgiving Day

· Christmas Day

· Any day specifically declared to be a national holiday.

4. CONTRACTOR RESPONSIBILITIES:

4.1. Services Required: The Contractor shall provide on-site Cardiopulmonary Perfusionist coverage Monday through Friday during the normal workday, except Federal Holidays; and on-call services are to be provided on an as needed basis twenty-four (24) hours a day, seven days a week, including holidays, in support of cardiovascular services at TVHS, Nashville campus. Coverage will include the daily rounding and evaluation of long-term Ventricular Assist Devices if patient resides at the Nashville Campus of TVHS. The Contractor’s Perfusionist shall be present at TVHS Nashville campus and shall perform the required services for each cardiovascular procedure as requested by cardiovascular staff. The VA cardiovascular physician will notify the Contractor when perfusionist services are required. In emergency cases, the Contractor’s Perfusionist shall respond to a request for services at TVHS VAMC within thirty (30) minutes of notification by the attending physician, cardiovascular fellow, or designee. Perfusion services will be compensated on a per case basis. The Contractor shall be responsible for the payment of the Contractor’s Perfusionist’s holiday, weekend, overtime, leave including sick leave, and/or vacation time.

4.2. Clinical Personnel Required: The Contractor shall provide a licensed Perfusionist who is competent and qualified per this performance work statement and adequately trained to perform assigned duties. The Contractor’s Perfusionist shall be present for the duration of the procedure unless otherwise agreed upon by the requesting cardiovascular specialist. The Perfusionist shall be present in the patient care area until the patient leaves the patient care area unless otherwise agreed upon by the requesting cardiovascular specialist.

4.3. Duties/Responsibilities: The Contractor and Contractor’s Perfusionists shall include (but are not restricted to) the following:

4.3.1. Contractor shall only furnish disposables if specifically requested in writing by the TVHS VAMC.

4.3.2. Operate the cardiopulmonary bypass machine and other equipment as requested by the VA cardiovascular specialist.

4.3.3. Perfusionist, contract equipment end user will wipe down and disinfect surface prior to every case and shall document surface clean and disinfect on tracking sheet; and shall wipe off any “spills” that occur on the surface of the equipment during equipment use.

4.3.4. Contractor’s Perfusionist will clean and disinfect the equipment, to include connections and fittings, and water circulation system disinfection prior to an initial operation, and shall document on the tracking sheet.

4.3.5. Contractor’s Perfusionist will clean and disinfect the equipment after every operation, to include connections and fittings, and water circulation system disinfection after every operation, and shall document on tracking sheet.

4.3.6. Contractor’s Perfusionist service will change water in circulation system; add 3% hydrogen peroxide to the circulation system every seven (7) days.

4.3.7. Contractor’s Perfusionist will monitor water circulation system disinfection and replace MPS3 water tubing kit replacement every twenty-eight (28) days. Contractor’s Perfusionist will provide cleaning and disinfection of Hansen fittings and replace as needed.

4.3.8. TVHS Biomedical service, or product vendor at discretion of TVHS Biomedical service, will provide bi-annual or annual Preventive Maintenance.

4.3.9. A warm handoff between the Perfusionist and the cardiac surgeon or cardiologist already directly engaged in the patient’s care shall occur prior to exiting the patient care area and Veterans Administration Medical Center. The warm handoff shall be a face-to-face discussion, the surgeon or provider involved in the warm handoff, and any issues that need to be addressed. The Perfusionist shall remain in the patient care area until the clinician determines the Perfusionist is no longer required.

4.3.10. Contractor’s Perfusionist will monitor supplies and assist the VA to ensure adequate supplies are stocked as necessary for clinical requirements.

4.3.11. The Perfusionist shall be available in the patient care area with equipment/supplies are stocked as necessary for clinical requirements.

4.3.12. Provide autotransfusion, intro-aortic balloon pump, and other assist device services as determined by the VA cardiovascular specialist.

4.3.13. Perfusionists shall be responsible for signing in and out, when in attendance for OR procedures, in the vendor log located in the OR office.

4.3.14. The Perfusionist shall document perfusion and autotransfusion details on the Cardiopulmonary Perfusion Record for all performed services prior to leaving the patient label.