36C24418R0541-002.docx

36C24418R0541

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.

DUNS:

DUNS+4:

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. 2/2012)

PREVIOUS EDITION IS NOT USABLE

Prescribed by GSA - FAR (48 CFR) 53.212

7. FOR SOLICITATION

INFORMATION CALL:

STANDARD FORM 1449

OFFEROR TO COMPLETE BLOCKS 12, 17, 23, 24, & 30

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS

36C24418R0541 06-10-2019 bethany.diaz@va.gov 412-822-3011 07-16-2019 00244 Department of Veterans Affairs Network Contracting Office 4

X 621399 $7.5 Million X N/A X 36C646 VA Pittsburgh Healthcare System University Drive C Pittsburgh PA 15240 00244 Department of Veterans Affairs Network Contracting Office 4

Austin Payment Center

PO Box 149971 Austin TX 78714-9971

(877) 353-9791

(512) 460-5429 See CONTINUATION Page Perfusionist Services in accordance with Performance of Work Statement and Price/Cost Schedule starting on Page 5 for complete details.

Supplemental instructions to offerors can be found in Section E, beginning on page 7 Please note, questions must be submitted in writing and are due NLT 12pm Noon EST on Tuesday June 18, 2019.

See CONTINUATION Page X X Mark Knorr Contracting Officer 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:

b. GOVERNMENT: Contracting Officer 36C244 Mark Knorr

Network Contracting Office 4

353 North Duffy Road Butler PA 16001

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

3. INVOICES: Invoices shall be submitted in arrears:

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.

Austin Payment Center Department of Veterans Affairs

PO Box 149971 Austin TX 78714-9971 ACKNOWLEDGMENT OF AMENDMENTS: The offeror acknowledges receipt of amendments to the Solicitation numbered and dated as follows:

B.2 SUBCONTRACTING COMMITMENTS--MONITORING AND COMPLIANCE (JUN 2011)

This solicitation includes VAAR 852.215-70, Service-Disabled Veteran-Owned and Veteran-Owned Small Business Evaluation Factors, and VAAR 852.215-71, Evaluation Factor Commitments. Accordingly, any contract resulting from this solicitation will include these clauses. The contractor is advised in performing contract administration functions, the CO may use the services of a support contractor(s) to assist in assessing contractor compliance with the subcontracting commitments incorporated into the contract. To that end, the support contractor(s) may require access to the contractor's business records or other proprietary data to review such business records regarding contract compliance with this requirement. All support contractors conducting this review on behalf of VA will be required to sign an “Information Protection and Non-Disclosure and Disclosure of Conflicts of Interest Agreement” to ensure the contractor's business records or other proprietary data reviewed or obtained in the course of assisting the CO in assessing the contractor for compliance are protected to ensure information or data is not improperly disclosed or other impropriety occurs. Furthermore, if VA determines any services the support contractor(s) will perform in assessing compliance are advisory and assistance services as defined in FAR 2.101, Definitions, the support contractor(s) must also enter into an agreement with the contractor to protect proprietary information as required by FAR 9.505-4, obtaining access to proprietary information, paragraph (b). The contractor is required to cooperate fully and make available any records as may be required to enable the CO to assess the contractor compliance with the subcontracting commitments.

36C24418R0541

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B.3 SCHEDULE OF SERVICES

The Contractor shall furnish all personnel to provide services necessary to perform onsite Cardiac/Liver Perfusion Services to eligible beneficiaries of the Department of Veterans Affairs Medical Center, VA Pittsburgh Healthcare System, University Drive, Pittsburgh, PA 15240 (hereinafter referred to as VAMC). The Contractor’s perfusionists care shall cover the range of Cardiac/Liver 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 (ABCP) http://www.abcp.org Place of Performance: Services shall be provided on site, VA Pittsburgh Healthcare System, University Drive C, Pittsburgh, PA 15240.

This is an IDIQ (Indefinite Delivery, Indefinite Quantity) type contract and, as such, a minimum and maximum must be established. The Minimum Requirement is represented by the dollar amount of $27,178.67 minimum for the total contract duration and may be met by a combination of any of the Contract Line Item Numbers (CLINS) as listed in the schedule below. The Maximum Requirement is represented by dollar amount of $2,115,312.23 for the total duration of the contract, and may be met by a combination of any of the following CLINs as listed in the schedule below. Task Orders will be issued against the IDIQ contract and will include quantities for the entirety of each ordering period. In the event such quantities begin to appear insufficient throughout the contract period, additional Task Orders may be completed to add quantities.

Pricing Instructions:

The Contractor shall propose a minimum of _2_ key personnel to be available for scheduling to meet the requirements of the contract for the following procedures:

Period of Performance:

BASE PERIOD: January 1, 2020 – December 31, 2020

Qty.

Annual Cost

BASE PERIOD TOTAL

OPTION YEAR 1: January 1, 2021 – December 31, 2021

Qty.

Annual Cost

OPTION YEAR 1 TOTAL

OPTION YEAR 2: January 1, 2022 – December 31, 2022

Qty.

Annual Cost

OPTION YEAR 2 TOTAL

OPTION YEAR 3: January 1, 2023 – December 31, 2023

Qty.

Annual Cost

OPTION YEAR 3 TOTAL

OPTION YEAR 4: January 1, 2024 – December 31, 2024

Qty.

OPTION YEAR 4 TOTAL

GRAND TOTAL (BASE PLUS OPTIONS)

B.4 Performance Work Statement for Onsite Cardiac/Liver Perfusionist Services

1. GENERAL:

1.1. Services Provided: The contractor shall provide Cardiac/Liver Perfusion Services on site in accordance with the terms and conditions contained herein to beneficiaries of the Department of Veterans Affairs (VA), VA Pittsburgh Healthcare System, University Drive Division.

1.2. Place of Performance: Contractor shall furnish services at VA Pittsburgh Healthcare System, University Drive C, Pittsburgh, PA 15240.

1.3. Authority (select) Title 38 U.S.C. 8153, Health Care Resources (HCR) sharing Authority, and FAR parts used (FAR 12 in combination with 15)

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

1.4.1. VA Directive 1663: Health Care Resources Contracting - Buying https://www1.va.gov/vapubs/viewPublication.asp?Pub_ID=969&FType=2

1.4.2. VHA Directive 2006-041 “Veterans’ Health Care Service Standards” (expired but still in effect pending revision) https://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=1443

1.4.3. VHA Directive 2010-018 “Facility Infrastructure”

https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=2227

1.4.4. VHA Directive 1192 “Seasonal Influenza Prevention Program” https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=5472

1.4.5. VHA Handbook 1100.17: National Practitioner Data Bank Reports - https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=2135

1.4.6. VHA Handbook 1100.18 Reporting And Responding To State Licensing Boards - https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=1364

1.4.7. VHA Handbook 1100.19 Credentialing and Privileging - https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=2910

1.4.8. VHA Handbook 1907.01 Health Information Management and Health Records: https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=3088

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

1.4.10. Joint Commission –

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

1.4.11. HHS OIG Website –

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

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

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

1.5.1. ABCP American Board of Cardiovascular Perfusion

1.5.2. ACGME: Accreditation Council for Graduate Medical Education

1.5.3. BLS: Basic Life Support

1.5.4. CDC: Centers for Disease Control and Prevention

1.5.5. CDR: Contract Discrepancy Report

1.5.6. CEU: Certified Education Unit

1.5.7. CME: Continuing Medical Education

1.5.8. CMP: Civil Monetary Penalty

1.5.9. CMS: Centers for Medicare and Medicaid Services

1.5.10. 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.

1.5.11. 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.

1.5.12. COS: Chief of Staff

1.5.13. CPARS: Contractor Performance Assessment Reporting System

1.5.14. CPRS: Computerized Patient Recordkeeping System- electronic health record system used by the VA.

1.5.15. DEA: Drug Enforcement Agency

1.5.16. ED: Emergency Department

1.5.17. ECMO: Extracorporeal Membrane Oxygenation

1.5.18. EMR: Electronic Medical Record

1.5.19. FSMB: Federation of State Medical Boards

1.5.20. FTEE: Full Time Equivalency Employee is defined by VA as a minimum of 80 hours every two weeks and does not include holidays

1.5.21. HHS: Department of Health and Human Services

1.5.22. HIPAA: Health Insurance Portability and Accountability Act

1.5.23. HR: Human Resources

1.5.24. ISO: Information Security Officer

1.5.25. 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).

1.5.26. NLNAC: National League for Nursing Accrediting Commission. www.nlnac.org

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

1.5.28. NP: Nurse Practitioner

1.5.29. NPPES: National Plan and Provider Enumeration System

1.5.30. OSHA: Occupational Safety and Health Administration

1.5.31. OIT: Office of Information and Technology

1.5.32. OPM: Office of Personnel Management

1.5.33. OPPE: Ongoing Provider Practice Evaluation

1.5.34. OR: Operating Room

1.5.35. PA: Physician Assistant

1.5.36. PIV: Personal Identity Verification

1.5.37. POP: Period of Performance

1.5.38. PPD: Purified Protein Derivative

1.5.39. PWS: Performance Work Statement

1.5.40. QASP: Quality Assurance Surveillance Plan

1.5.41. RFP: Request for Proposal

1.5.42. VAMC: Veterans Affairs Medical Center

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

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

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

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

1.5.47. VAPHS: This term shall mean the Pittsburgh VA Medical Center, University Drive Division.

2. QUALIFICATIONS:

2.1. Staff/Facility – The contractor shall provide perfusion service coverage for the Open Heart Surgery Program and the Liver Transplant Program at the VA Pittsburgh Healthcare System (VAPHS), University Drive Division, Pittsburgh, PA 15240. Board Certified Perfusionists will be available for all perfusion-related duties or any other procedure requiring perfusion services.

2.2. As assigned by the contractor, Perfusionist(s) will be available to the VA Pittsburgh Healthcare System Monday through Friday for perfusion related procedures such as open-heart surgical procedures, liver transplant procedures, intra-aortic balloon device troubleshooting and extracorporeal membrane oxygenation (ECMO). Perfusionist(s) will also be available, as assigned by the contractor, on an as-needed and/or emergency basis.

2.2.1. License - All licenses held by the 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 immediate notification of the COR regarding any matter that might adversely affect or otherwise limit their clinical privileges. Failure to meet this requirement may result in termination of the contract.

2.2.2. 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 one year 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 40 clinical cases per year. If a Perfusionist is unable to attain 40 primary clinical perfusion activities, a maximum of 15 activities may be documented as Secondary Clinical Perfusion Activities (SCPA) and will count towards the 40 case requirement. Only one SCPA case credit will be allowed during the conduction of one perfusion procedure. Experience shall be demonstrated in the following areas: Open heart surgery, heart lung machine, extracorporeal membrane oxygenation (ECMO), left/right heart bypass, intra-aortic balloon pumping and centrifugal ventricular assist device.

2.2.3. Credentialing and Privileging - Contract Perfusionists 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 prior to providing services and must be found acceptable by the Medical Executive Board. Credentialing and privileging is to be completed in accordance with VHA Handbook 1100.19 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, applicable to all Perfusionists, and to be reported as provider specific practice information at the time or an accreditation body with equal or better standards Joint Commission.

2.2.3.1. 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.

2.2.4. Technical Proficiency - The assigned Perfusionist(s) must be competent to support percutaneous cannulation for minimally invasive and robotic surgery and must have experience in liver transplant perfusion. The Perfusionist(s) must be capable of managing ventricular assist device (VAD) methodologies and must work closely with the VAPHS team with respect to management of complex Congestive Heart Failure (CHF) cases and redo cardiac bypass surgery, as well as aortic surgery and extracorporeal membrane oxygenation (ECMO). 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.

2.2.5. Continuing Medical Education (CME)/ Certified Education Unit (CEU) Requirements: Contractor shall provide the COR copies of current CMEs as required or requested by the VAMC. 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 credentials 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).

2.2.6. Training (BLS 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 cardiac Perfusionist(s) as required by the VA.

2.2.7. Standard Personnel Testing (PPD, etc.): Contractor shall provide proof of the following tests 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.

2.2.7.1. 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) {This is applicable to all health care workers}. A negative chest radiographic report for active tuberculosis shall be provided in cases of positive TST or IGRA results. The TST or IGRA testing shall be repeated annually.

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

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

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

2.2.7.5. 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}.

2.2.7.6. 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.

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

2.2.8. 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.

2.2.9. 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 (Jan 2008) and fully outlined in response to the subject attachment in Section D of the solicitation document.

2.2.10. Citizenship related Requirements:

2.2.10.1. 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;

2.2.10.2. 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.

2.2.10.3. 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.

2.2.10.4. 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.

2.2.10.5. 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.

2.2.11. 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.

2.2.12. 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.

2.2.12.1. 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.

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

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

2.5. 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.

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

2.7. 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.

2.8. 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:

2.8.1. Workers’ compensation

2.8.2. Professional liability insurance

2.8.3. Health examinations to include:

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

2.8.5. 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

2.8.6. Evidence of a Hepatitis C titer

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

2.8.8. Income tax withholding, and

2.8.9. Social security payments

2.9. Tort Liability: The Federal Tort Claims Act does not cover Contractor or contract personnel (s). When a 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.

2.10. Key Personnel:

2.10.1. The number of Board Certified Perfusionists required to be on site when cases are scheduled is two (2) as defined in paragraph Hours of Operation of this section.

2.10.2. 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 Operating Room Program Support Clerk at the VA Pittsburgh Healthcare System, University Drive Division immediately of the schedule change.

2.10.3. Contractor shall provide the names of the contracted employee(s) assigned to the performance:

Substitutes

2.11. Emergency 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.

2.11.1. 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.

2.11.2. For temporary substitutions where the key person shall not be reporting to work for three (3) consecutive work days 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.

2.11.3. 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).

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

2.11.5. Contingency Plan: Because continuity of care is an essential part of VAPHS’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.

2.11.6. 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 6:30 am – 7:00 pm Monday – Friday.

3.2. Work Schedule: 6:30 am – 7:00 pm Monday – Friday

3.3. Services Required: Cardiac/Liver Perfusionists Per-Case, with active “stand-by” hours authorized on a case-by-case basis as required to support active, cardiopulmonary surgery that may require perfusionists and Liver Transplant surgeries when notified of an imminent liver transplant case.

3.4. The VA Pittsburgh Healthcare System Operating Room Program Support Clerk will contact the contractor between the hours of 12:00 Noon and 3:00 P.M. Monday through Friday (or the contractor may contact the VAPHS Operating Room Program Support Clerk at (412) 360 – 6360), the day before scheduled procedure(s), to determine the need for perfusion services for scheduled cases. For emergent or unscheduled services outside of the normal operating room hours, approved VA personnel, (operating room personnel, patient care coordinators, critical care and surgery physicians and advanced practice personnel) will contact the on-call Perfusionist through the VA Charge Perfusionist’s beeper. Perfusionist shall be available “on-call” twenty-four hours per day, seven (7) days per week to provide perfusion services within one hour of actual contact by VA Pittsburgh Healthcare System, except where inclement weather, natural disaster or other force majeure prevents Perfusionist from responding within such time period. The operating hours may be revised, as deemed appropriate for patient care by the Chief of Staff (COS). Currently, normal operating room hours are 6:30 am – 7:00 pm.

3.4.1. The VA Pittsburgh Healthcare System will pay only for actual services performed at the VA facility and will not pay for availability ("on-call" or standby time) except for standby on site at the VA Pittsburgh Healthcare System. Standby services will be provided on site at the VA Pittsburgh Healthcare System for those procedures in which the surgeons determine that perfusion services might be needed during the course of the operation.

3.5. Federal Holidays:

· New Year’s Day

· Martin Luther King’s Birthday

· President’s Day

· Memorial Day

· Independence Day

· Labor Day

· Columbus Day

· Veterans Day

· Thanksgiving Day

· Christmas Day

· Any day specifically declared by the President of the United States 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 services provided and standby hours/day 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

4.2.3. VA Standards: VHA Directive 2006-041 “Veterans’ Health Care Service Standards” (expired but still in effect pending revision) https://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=1443

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

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

4.2.6. 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 U.S.C.551a (Privacy Act), 38 U.S.C. 5701 (Confidentiality of claimants records), 5 U.S.C. 552 (FOIA), 38 U.S.C. 5705 (Confidentiality of Medical Quality Assurance Records) 38 U.S.C. 7332 (Confidentiality of certain medical records), Title 5 U.S.C. § 522a (Records Maintained on Individuals) as well as 45 C.F.R. Parts 160, 162, and 164 (HIPAA).

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. Treatment and administrative patient 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’ (24VA19). 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 are available for immediate transmission when requested by the VA. Records identified for review, audit, or evaluation by VA representatives and authorized federal and state officials, shall be accessed on-site during normal business hours or mailed by the Contractor at his expense. Contractor shall deliver all final patient records, correspondence, and notes to the VA within twenty-one (21) calendar days after the contract expiration date.

4.3.3. Disclosure: Contract personnel (s) may have access to patient medical records: however, Contractor shall obtain permission from the VA before disclosing any patient information. Subject to applicable federal confidentiality or privacy laws, the Contractor, or their designated representatives, and designated representatives of federal regulatory agencies having jurisdiction over Contractor, may have access to VA ‘s records, at VA’s place of business on request during normal business hours, to inspect and review and make copies of such records. The VA will provide the Contractor with a copy of VHA Handbook 1907.1, Health Information management and Health Records and VHA Handbook 1605.1, Privacy and Release of Information. The penalties and liabilities for the unauthorized disclosure of VA patient information mandated by the statutes and regulations mentioned above, apply to the Contractor.

4.3.4. Professional Standards for Documenting Care: Care shall be appropriately documented in medical records in accordance with standard commercial practice and guidelines established by VHA Handbook 1907.01 Health Information Management and Health Records: http://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=2791 and all guidelines provided by the VAMC.

4.3.5. Release of Information: The VA shall maintain control of releasing any patient medical information and will follow policies and standards as defined, but not limited to Privacy Act requirements. In the case of the VA authorizing the Contractor to release patient information, the Contractor in compliance with VA regulations, and at his/her own expense, shall use VA Form 3288, Request for and Consent to Release of Information from Individual’s Records, to process “Release of Information Requests.” In addition,…