36C25025Q0020.docx

36C25025Q0020

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

36C25025Q0020 11-13-2024 Karen Williams 614-257-5220 12-04-2024 2:00 pm

EST

36C250 Department of Veterans Affairs Network Contracting Office (NCO) 10 Chalmers P. Wylie Ambulatory Care Center 420 North James Road Columbus OH 43219-1834 X X 621111 $16 Million N/A X Department of Veterans Affairs Northeast Ohio Healthcare System Louis Stokes VA Medical Center 10701 East Blvd Cleveland OH 44106 36C250 Department of Veterans Affairs Network Contracting Office (NCO) 10 Chalmers P. Wylie Outpatient Clinic 420 North James Road Columbus OH 43219-1834

36C250 Department of Veterans Affairs Financial Services Center Invoices to be Submitted Electronically https://www.tungstenautomation.com/

1-877-489-6135 See CONTINUATION Page Contractor to provide Perfusion Services onsite at the Louis Stokes VAMC.

THIS

PROCUREMENT IS SET-ASIDE 100% FOR VETERAN-OWNED, SMALL

BUSINESS CONCERNS (VOSB).

See the Schedule of Services beginning on Page 6 and the Performance Work Statement beginning on Page 12.

See CONTINUATION Page X X Karen Williams Table 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: (Please print or type):

Unique Entity Identifier (UEI): _____________________________

2. CONTRACTOR REMITTANCE ADDRESS: All payments by the Government to the contractor will be made in accordance with: 52.23233, Payment by Electronic Funds Transfer – System for Award Management

3. INVOICES: Invoices shall be submitted in arrears: Monthly

4. GOVERNMENT INVOICE ADDRESS: All invoices from the contractor shall be submitted electronically in accordance with VAAR Clause 852.232-72, Electronic Submission of Payment Requests. Invoicing shall be in accordance with the requirements of the Department of Veterans Affairs (VA) Financial Services Center (VAFSC). The latest information shall be used for invoicing and payments and may change during the period of performance of this acquisition. Current Invoicing information is located at: https://www.fsc.va.gov/einvoice.asp.

All invoices shall include the following:

· Invoice Number

· Invoice Date

· Purchase Order Number (will always begin with 583)

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

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

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

8. MANDATORY WRITTEN DISCLOSURES: Mandatory written disclosures required by 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/contacts/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.

B.2 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, Northeast Ohio Health Care System’s Louis Stokes Cleveland VA Medical Center. The Contractor’s perfusionists 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 as established by the American Board of Cardiovascular Perfusion http://www.abcp.org Place of Performance: Services shall be provided on site at the Louis Stokes Cleveland VA Medical Center, 10701 East Blvd., Cleveland, OH 44106 Period of Performance: 2/16/2025 – 2/15/2030 Pricing Instructions: The quoter is instructed to edit the Sub-Line Items (SLIN) to correspond with the number of key personnel submitted for the line item number (LIN).

The guaranteed minimum only applies to the fiscal year in which the contract is awarded. The total minimum amount is ten (10) hours. The maximum total value of the contract shall not exceed 50,000 hours.

The Contractor shall propose a minimum of four (4) key personnel to be credentialed and be available for scheduling to meet the requirements of the contract. This should consist of 1 Chief Perfusionist, 2 Staff Perfusionist, and 1 PRN Perfusionist.

One FTE is defined by the VA as a minimum of 80 hours every two weeks and does not include holidays.

ITEM INFORMATION

2,080.00

Board Certified Chief Perfusionist (to include on-call coverage)

Name: ______________________________________ Contract Period: Base POP Begin: 02-15-2025 POP End: 02-16-2026 PRINCIPAL NAICS CODE: 621111 - Offices of Physicians (except Mental Health Specialists) PRODUCT/SERVICE CODE: Q523 - Medical - Surgery

4,160.00

Not Separately Priced

Board Certified Staff Perfusionist (to include on-call coverage) Contract Period: Base POP Begin: 02-15-2025 POP End: 02-16-2026

0002A

0.00

Board Certified Staff Perfusionist (to include on-call coverage)

Name:___________________________________________ Contract Period: Base POP Begin: 02-15-2025 POP End: 02-16-2026

0002B

Board Certified Staff Perfusionist (to include on-call coverage)

Contract Period: Base POP Begin: 02-15-2025 POP End: 02-16-2026

1,040.00

Board Certified PRN Perfusionist (to include on-call coverage) Contract Period: Base POP Begin: 02-15-2025 POP End: 02-16-2026

Board Certified Chief Perfusionist (to include on-call coverage)

Contract Period: Option 1 POP Begin: 02-15-2026 POP End: 02-16-2027

Not Separately Priced

Board Certified Staff Perfusionist (to include on-call coverage) Contract Period: Option 1 POP Begin: 02-15-2026 POP End: 02-16-2027

1002A

Board Certified Staff Perfusionist (to include on-call coverage)

Contract Period: Option 1 POP Begin: 02-15-2026 POP End: 02-16-2027

1002B

Board Certified Staff Perfusionist (to include on-call coverage)

Contract Period: Option 1 POP Begin: 02-15-2026 POP End: 02-16-2027

Board Certified PRN Perfusionist (to include on-call coverage) Contract Period: Option 1 POP Begin: 02-15-2026 POP End: 02-16-2027

Board Certified Chief Perfusionist (to include on-call coverage)

Contract Period: Option 2 POP Begin: 02-15-2027 POP End: 02-16-2028

Not Separately Priced

Board Certified Staff Perfusionist (to include on-call coverage) Contract Period: Option 2 POP Begin: 02-15-2027 POP End: 02-16-2028

2002A

Board Certified Staff Perfusionist (to include on-call coverage)

Contract Period: Option 2 POP Begin: 02-15-2027 POP End: 02-16-2028

2002B

Board Certified Staff Perfusionist (to include on-call coverage)

Contract Period: Option 2 POP Begin: 02-15-2027 POP End: 02-16-2028

Board Certified PRN Perfusionist (to include on-call coverage) Contract Period: Option 2 POP Begin: 02-15-2027 POP End: 02-16-2028

Board Certified Chief Perfusionist (to include on-call coverage)

Contract Period: Option 3 POP Begin: 02-15-2028 POP End: 02-16-2029

Not Separately Priced

Board Certified Staff Perfusionist (to include on-call coverage) Contract Period: Option 3 POP Begin: 02-15-2028 POP End: 02-16-2029

3002A

Board Certified Staff Perfusionist (to include on-call coverage)

Contract Period: Option 3 POP Begin: 02-15-2028 POP End: 02-16-2029

3002B

Board Certified Staff Perfusionist (to include on-call coverage)

Contract Period: Option 3 POP Begin: 02-15-2028 POP End: 02-16-2029

Board Certified PRN Perfusionist (to include on-call coverage) Contract Period: Option 3 POP Begin: 02-15-2028 POP End: 02-16-2029

Board Certified Chief Perfusionist (to include on-call coverage)

Contract Period: Option 4 POP Begin: 02-15-2029 POP End: 02-16-2030

Not Separately Priced

Board Certified Staff Perfusionist (to include on-call coverage) Contract Period: Option 4 POP Begin: 02-15-2029 POP End: 02-16-2030

4002A

Board Certified Staff Perfusionist (to include on-call coverage)

Contract Period: Option 4 POP Begin: 02-15-2029 POP End: 02-16-2030

4002B

Board Certified Staff Perfusionist (to include on-call coverage)

Contract Period: Option 4 POP Begin: 02-15-2029 POP End: 02-16-2030

Board Certified PRN Perfusionist (to include on-call coverage) Contract Period: Option 4 POP Begin: 02-15-2029 POP End: 02-16-2030

Total for Base Year LINs 0001 – 0003:_____________________

Total for Option Year 1 LINs 1001 – 1003: _____________________

Total for Option Year 2 LINs 2001 – 2003: _____________________

Total for Option Year 3 LINs 3001 – 3003: _____________________

Total for Option Year 4 LINs 4001 – 4003: _____________________

36C25025Q0020 Grand Total for the Base and All Option Years: _____________________ Page 1 of Page 1 of

B.3 PERFORMANCE WORK STATEMENT

PERFUSION 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), Cleveland VAMC.

1.2. Place of Performance: Contractor shall furnish services at the VAMC Cleveland, 10701 East Blvd, Cleveland, OH 44106

1.3. Authority: Title 38 USC 8153, Health Care Resources (HCR) sharing Authority and FAR Part 12 in combination with FAR Part 13.

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

1.4.1. 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 1088(1): Communicating Test Results to Providers and Patients

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

1.4.5. VHA Directive 1100.20: Credentialing of Health Care Providers

1.4.6. VHA Directive 1100.21: Privileging

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

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

1.4.9. VHA Directive 1605.01: Privacy and Release of Information

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

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

1.4.12. VHA Handbook 1400.04: Supervision of Associated Health Trainees

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

1.4.14. Joint Commission:

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

1.4.15. HHS OIG Website:

http://oig.hhs.gov/exclusions/index.asp

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

Guideline for infection control in health care personnel, 1998 (cdc.gov)

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 3.5 Full Time Equivalency Employees (FTEEs) consisting of a Board Certified Chief Perfusionists (2080 hours), two (2) Board Certified Staff Perfusionists (4160 hours) and one (1) Board Certified PRN Perfusionists (1040 hours).

2.1.1. License: All licenses held by the key personnel working on this contract shall be full and unrestricted license to the services covered by this contract issued in any State, Territory, or Commonwealth of the United States or the District of Columbia. 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 five (5) 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 750 clinical cases. Experience shall be demonstrated in the following areas: Open heart surgery, 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 perfusionist(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 perfusionists 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 perfusionist(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 perfusionists {This is applicable to all health care workers}.

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

2.1.7.5. INFLUENZA: Contractors shall provide proof that all Contractor perfusionists have received the annual Influenza vaccine unless it is contraindicated. If the Contractor perfusionist 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: Contractor employees should adhere to the existing COVID-19 safety, and mitigation measures at their local VAMC.

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 perfusionist(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 (Guideline for infection control in health care personnel, 1998 (cdc.gov) for disease control. Contractor shall provide follow up documentation of clearance to return to the workplace prior to their return.

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 perfusionist(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 perfusionists 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. The C&A requirements do not apply, and a Security Accreditation Package is not required.

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:

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

2.7.5. 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

2.7.6. Evidence of a Hepatitis C titer

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

2.7.8. Income tax withholding, and

2.7.9. 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 3.5 FTE (7,280 hours) to include on-call coverage, which consist of one (1) Chief and two (2) Staff Perfusionists (2080 hrs. each) and one (1) PRN Perfusionist (estimated at 1040 hrs.)

2.9.2. The number of Board Certified Perfusionists required to be on site daily varies depending on the surgical schedule. It can be as low as 2 per day and as high as 4 per day to support patient needs.

2.9.2.1. Chief Perfusionist: In addition to staff perfusionist duties the Chief Perfusionist is also responsible for management and supervision of all contractor staff and PRN perfusionists that are approved and credentialed to work under the resultant contract. Ensure adequate staffing and support for scheduled and emergency cases. Delegates responsibilities. Acts as liaison with OR clinical staff. Ensures compliance with VA policies. Supervises and trains members of the perfusion team. Evaluates new procedures and equipment to maintain full clinical performance. Works with VA management to obtain new technology when available to ensure state of the art operations.

2.9.2.2. Staff and PRN Perfusionist: Operates the heart-lung machine and ECMO equipment. Manages physiological and metabolic demands of the patient during cardiac procedures. Responsible for performing required documentation for each case.

2.9.3. When a Perfusionist is supporting the care of an ECMO patient, the contractor will ensure a sufficient number of Certified Cardiac Perfusionists are available to handle the cardiac caseload. At a minimum, the expectation is one Certified Cardiac Perfusionist per surgery plus one available as a backup. If two surgeries are performed simultaneously, three staff are required to be on site.

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: VA business hours/hours of operation are Monday through Friday, 8:00am to 4:30pm.

3.1.1. Work Schedule: Regular work hours are 6:30am – 4:30pm Monday through Friday will be on an as needed basis to support scheduled surgeries. Occasional excursions from regular work hours will be required depending on the surgical schedule and patient care needs.

3.1.2. Perfusionist service is required for 7280 hours per year on a Monday through Friday, during regular operating room hours to support these procedures and patients that are in the Operating Room and Surgical Intensive Care Unit.

The requirement is for the contractor to provide one (1) Board Certified Chief Perfusionist, two (2) Board Certified Perfusionists, and one PRN 0.5 FTE Perfusionist. The PRN perfusionist 0.5 FTEE will be used to support the emergency services as well as provide for coverage during vacation, illness, etc.

3.1.3. Off-hours Coverage: The contractor shall provide one (1) full time Perfusionist for on-call services 24-hours a day and seven (7) days a week including all Federal Holidays. Contactor shall report to the facility within 30 minutes of notification of an unscheduled or emergency case. 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 stated in the appropriate LIN/SLIN in Section B.2 Schedule of Services.

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. 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.

4.1.1. 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.

4.2. Standards of Care: The contract personnel(s)’ care shall cover the range of Perfusionist 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:

4.2.1. American Board of Cardiovascular Perfusion:

http://www.abcp.org

4.2.2. The professional standards of The Joint Commission (TJC): http://www.jointcommission.org/standards_information/standards.aspx

4.2.3. The standards of the American Hospital Association (AHA): http://www.hpoe.org/resources?show=100&type=8

4.2.4. The requirements contained in this PWS

4.3. MEDICAL RECORDS

4.3.1. 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 5 U.S.C.552a (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).

4.3.2. 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.

4.3.3. 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.