36C26318R0480-001.docx

36C26318R0480

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1. REQUISITION NO.

2. CONTRACT NO.

3. AWARD/EFFECTIVE DATE

4. ORDER NO.

5. SOLICITATION NUMBER

6. SOLICITATION ISSUE DATE

a. NAME

b. TELEPHONE NO. (No Collect Calls)

8. OFFER DUE DATE/LOCAL

TIME

9. ISSUED BY

CODE

10. THIS ACQUISITION IS

UNRESTRICTED OR

SET ASIDE:

% FOR:

SMALL BUSINESS

HUBZONE SMALL

BUSINESS

SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

WOMEN-OWNED SMALL BUSINESS

(WOSB) ELIGIBLE UNDER THE WOMEN-OWNED

SMALL BUSINESS PROGRAM

EDWOSB

8(A)

NAICS:

SIZE STANDARD:

11. DELIVERY FOR FOB DESTINA-

TION UNLESS BLOCK IS

MARKED

SEE SCHEDULE

12. DISCOUNT TERMS

13a. THIS CONTRACT IS A

RATED ORDER UNDER

DPAS (15 CFR 700)

13b. RATING

14. METHOD OF SOLICITATION

RFQ

IFB

RFP

15. DELIVER TO

CODE

16. ADMINISTERED BY

CODE

17a. CONTRACTOR/OFFEROR

CODE

FACILITY CODE

18a. PAYMENT WILL BE MADE BY

CODE

TELEPHONE NO.

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

36C26318R0480 06-05 -2018 Daniel Vagts 651-293-3040 06-30 -2018

10 AM EST

Department of Veterans Affairs NCO 23 - St Paul 316 Robert Street N.

Attention: Daniel Vagts St Paul MN 55101 X X 621111 $11 Million X N/A X Department of Veterans Affairs NCO 23 - Minneapolis One Veterans Drive, Building 70 Minneapolis MN 55417 Department of Veterans Affairs NCO 23 - St Paul Attention: Daniel Vagts 316 Robert Street N.

Minneapolis MN 55415

Y Department of Veterans Affairs Financial Services Center PO Box 149971 Austin TX 78714-9971 See CONTINUATION Page

1.0 Full-Time Equivalent (FTE) Perfusionist Services

for the Minneapolis VA Health Care System.

See Section B.4 Schedule of Services (pg.7 See Section B.5 Performance Work Statement (pg.11 See CONTINUATION Page X X X

ONE

Daniel Vagts Contract Officer Table of Contents

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

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

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

a. CONTRACTOR:

b. GOVERNMENT: Contracting Officer Contracting Officer is Daniel Vagts at daniel.vagts@va.gov Department of Veterans Affairs NCO 23 – St. Paul 316 Robert Street N.

St. Paul MN 55101

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.

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

6. TYPE OF CONTRACT: Resultant contracts shall be a Firm Fixed Price (FFP) contract effective for the period stated in the Schedule of Services.

7. TERM OF CONTRACT: The contract period is effective August 1, 2018 through July 31, 2019.

8. POINT OF CONTACT: The Contractor shall provide a point of contact (POC) who shall be responsible for the performance of the work under this contract. The POC shall have full authority to act for the Contractor on all matters relating to the daily operation of this contract. The POC may be a contract health care provider performing under this contract. An alternate may be designated, but the Contractor shall identify, in writing, those times when the alternate shall act as the POC. The Contractor shall identify the POC and alternate in writing to the Contracting Officer’s Representative (COR) and Contracting Officer (CO). The Contractor shall give written notification to the COR and CO of the time when the alternate will act as the POC. The POC shall be available by telephone Monday through Friday, 8:00 AM through 4:30 PM, excluding Federal holidays.

9. SECURE FAX: VA Handbook 6500 requires the following statement on all fax cover sheets be included: “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, distribute on, 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.”

10. POST AWARD ORIENTATION: The Contracting Officer shall follow the guidance in FAR Subpart 42.5 and note Information Letter (IL) 003A3-12-04 that provides documentation requirements for orientation conducted for such awards. A hyperlink to the IL is provided for your information. http://www.va.gov/oal/docs/library/ils/il12-04.pdf

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

This solicitation includes FAR 52.219-14 Limitations on Subcontracting. Accordingly, any contract resulting from this solicitation will include this clause. The contractor is advised in performing contract administration functions, the CO may use the services of a support contractor(s) retained by VA to assist in assessing the contractor's compliance with the limitations on subcontracting or percentage of work performance requirements specified in the clause. To that end, the support contractor(s) may require access to contractor's offices where the contractor's business records or other proprietary data are retained and to review such business records regarding the contractor's 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's compliance with the limitations on subcontracting or percentage of work performance requirement.

B.3 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.

B.4 SCHEDULE OF SERVICES

The Contractor shall furnish all personnel to provide services necessary to perform Perfusionist Services to eligible beneficiaries of the Department of Veterans Affairs Medical Center, Minneapolis (hereinafter referred to as VAMC).

Place of Performance: Services shall be provided on site, VAMC Minneapolis VA Medical Center, One Veterans Drive, Minneapolis, Minnesota 55417.

Instructions:

The contractor shall be required to provide as a minimum, enough appropriately qualified physicians to be credentialed and privileged that meet or exceed twice the number of FTE required to fulfill this obligation.

On-call coverage is all inclusive within the CLIN structure listed below.

BASE PERIOD: August 1, 2018 to July 31, 2019

Annual Cost

1.0 Full-Time Equivalent (FTE) Board Certified Clinical Perfusionists Services. On-call coverage is all inclusive within this CLIN.

KEY PERSONNEL

NAME:____________

TITLE/LEVEL OF EXPERIENCE:____________

36C26318R0480

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B.5 PERFORMANCE WORK STATMENT

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), MVAHCS

1.2. Place of Performance - Contractor shall furnish services at the Minneapolis, VA Health Care System, Minneapolis, MN.

1.3. Authority: Title 38 USC 8153, Health Care Resources (HCR) sharing Authority.

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 http://www1.va.gov/vapubs/viewPublication.asp?Pub_ID=347

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”

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

1.4.4. VHA Directive 1192 “Seasonal Influenza Prevention Program” https://www.publichealth.va.gov/docs/flu/VHA_Directive_1192_Sep

1.4.5. VHA Handbook 1100.17: National Practitioner Data Bank Reports - http://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=2135

1.4.6. VHA Handbook 1100.18 Reporting and Responding to State Licensing Boards - http://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=1364

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

1.4.8. VHA Handbook 1907.01 Health Information Management and Health Records: http://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=2791

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. 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. CDR: Contract Discrepancy Report

1.5.7. CEU: Certified Education Unit

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

1.5.16. DEA: Drug Enforcement Agency

1.5.17. ED: Emergency Department

1.5.18. ECMO: Extracorporeal Membrane Oxygenation

1.5.19. EMR: Electronic Medical Record

1.5.20. FSMB: Federation of State Medical Boards

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

1.5.22. HHS: Department of Health and Human Services

1.5.23. HIPAA: Health Insurance Portability and Accountability Act

1.5.24. HR: Human Resources

1.5.25. ISO: Information Security Officer

1.5.26. 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).

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

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. OIT: Office of Information and Technology

1.5.33. OPM: Office of Personnel Management

1.5.34. OPPE: Ongoing Provider Practice Evaluation

1.5.35. OR: Operating Room

1.5.36. PA: Physician Assistant

1.5.37. PIV: Personal Identity Verification

1.5.38. POP: Period of Performance

1.5.39. PPD: Purified Protein Derivative

1.5.40. PWS: Performance Work Statement

1.5.41. QASP: Quality Assurance Surveillance Plan

1.5.42. RFP: Request for Proposal

1.5.43. VAMC: Veterans Affairs Medical Center

1.5.44. 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.

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

1.5.46. 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.

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

1.5.48. Veterans Affairs Medical Center (VAMC): Unless identified with the name of a different VA Medical Center, for the purpose of this contract, this term shall mean the MVAHCS.

2. QUALIFICATIONS:

2.1. Staff/Facility –

The contractor shall provide Board Certified Perfusionists to work at the MVAHCS as follows:

Perfusionist services are required for 1.0 FTE perfusionist working Monday – Friday with onsite and on-call coverage every 3rd week. Duties include: management of physiological and metabolic needs of surgical patients during cardiovascular surgical procedures; extracorporeal support functions; heart failure therapy and support; blood management; other clinical perfusion procedures as required; and on-call coverage.

2.1.1. 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 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.

2.1.2.1. All continuing education courses required for maintaining certification must be kept up to date at all times. Documentation verifying current certification shall be provided by the Contractor to the VA COR on an annual basis for each year of contract performance. A folder with the stated qualifications will be maintained by the COR.

2.1.3. Credentialing and Privileging – Reserved. Credentialing and Privileging is not required per Human Resources.

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, is true for all Perfusionist and to the reported as provider specific practice information at the time or an accreditation body with equal or better standards Joint Commission.

2.1.3.1.1. 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 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).

2.1.6. Training (ACLS, BLS, CPRS 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

· As the VA routinely reviews and updates policies and procedures covering contractor training, requirements may change during the term of this contract and additional training may be implemented unilaterally during the term of this agreement.

2.1.7. Standard Personnel Testing (PPD, etc.): Contractor shall provide proof of the following tests 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) {This is applicable to all health care workers}. A negative chest radiographic report for active tuberculosis shall be provided in cases of positive TST or IGRA results. The TST or IGRA testing shall be repeated annually.

2.1.7.2. 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. 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.

2.1.7.7. 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.

2.1.8. 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 (Jan 2008) 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 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.

2.3. 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:

2.7.4. 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 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.

2.9. Key Personnel:

2.9.1. The VA Full Time Equivalency (FTE): FTE is defined by VA as a minimum of 80 hours every two weeks and does not include holidays.

2.9.2. The number of Board Certified Perfusionists required to be on site on a daily basis is 1.0 FTE 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) at the MVAHCS immediately of the schedule change.

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

(i.e.; 1.0, .5,) National Provider Identifier Number

Substitutes

2.10. 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.

2.10.1. 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 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.

2.10.3. 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 VAMC’s medical services, The Contractor shall have a contingency plan in place to be utilized if the contract personnel (s) leaves Contractor’s employment or is unable to continue performance in accordance with the terms and conditions of the resulting contract.

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. HOURS OF OPERATION:

3.1. VA Business Hours:

The VA Medical Center is open 24 hours per day 7 days a week (24/7), 365 days per year.

Administrative offices, clinics and the OR general hours of operation are Monday through Friday 7:00 AM – 4:30 PM.

3.1.1. Work Schedule: Regular work hours are Monday through Friday for (10) hours a day from 6:30 a.m. to 5:00 p.m. or until all patient care is completed. Contract Staff are to remain in the Surgery Suite or at the Medical Center until released Attending Staff. The 6:30 am – 5:00 pm tour of duty includes a 30-minute unpaid lunch.

3.1.2. The Perfusionist is required onsite for up to 3,068 hours per year on a Monday through Friday, a ten-hour shift to support these procedures and patients that are in the Intensive Care Unit requiring balloon pump/Extracorporeal Membrane Oxygenation (ECMO) support.

3.1.2.1. The requirement is for the contractor to provide a minimum of two Board Certified Perfusionists.

3.1.2.2. One perfusionist will work Monday – Friday at a 1.0 FTEE. The additional FTE will be used to support coverage for emergency services as well as provide coverage during vacation, illness, etc for either the Contractor or VA Perfusion Staff.

3.1.2.3. OR Schedule: The Minneapolis VA performs an average of 2 cardiac bypass cases per day, Monday through Friday, typically between the hours of 6:30 a.m. to 5:00 p.m. or until all patient care is completed. The contractor will provide 1.0 FTE to staff the VA operating room for cardiovascular surgical procedures Monday through Friday, excluding federal holidays.

3.1.2.4. The VA requires additional contractor coverage above the 1.0 FTE to provide vacation coverage for VA Staff Perfusionist. The Contractor will be notified a minimum of two weeks in advance of need for services. In the event of an emergency, Contractor may receive less than 24-hour notice.

3.1.2.5. The schedule and tour of duty is defined by the Clinical Service Chief and may vary based on the nature of the workload, needs of the service, and patient care requirements

3.1.2.6. On-Call is required during off-duty hours and the contractor shall be available 24 hours a day, 7 days per week every 3rd week of the contract. Contractor will respond to call within 15 minutes of receipt of call by phone and within 60 minutes in person. Concurrent call is not allowed. Call coverage hours are as follows:

3.1.2.6.1. Weekdays (Monday-Friday) call coverage starts at 3:00 p.m., and goes until 6:30 a.m. the following morning, unless the weekday perfusionist is still in house. When the perfusionist is still in house at 3:00 p.m., call will start when all cases are complete and the perfusionist leaves for the day.

3.1.2.6.2. Weekend call coverage is from 6:30 a.m. on Saturday to 6:30 a.m. on Monday.

3.1.2.6.3. Holiday call coverage is from 6:30 a.m. to 6:30 a.m. the following day.

3.1.2.6.4. When call results in contractor being called on-site to the VA Medical Center for services, call coverage will be compensated at the contractor’s hourly rate.

3.1.2.6.5. Contractor will be compensated only for actual onsite time providing services for the MVAHCS. Contractor may not work at another facility during his VA scheduled tour of duty.

3.1.2.6.6. 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

· Independence Day

· Labor Day

· Columbus Day

· Veterans Day

· Thanksgiving Day

· Christmas Day

· Any day specifically declared to be a national holiday.

4. CONTRACTOR RESPONSIBILITIES:

4.1.1. 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.

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

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

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

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

4.2.5 The contractor duties include, but are not limited to:

4.2.5.1. Contractor shall provide clinical perfusion services for cardiac bypass, Cell Saver, Platelet Gel Production and Intra-Aortic Balloon Pump (IABP) monitoring. Perfusionist must stay in-house when providing IABP monitoring. Services shall be provided in collaboration with the Cardio/Thoracic Surgeon and Anesthesiologist.

4.2.5.2. Perfusionist shall have the ability to plan, organize, coordinate and evaluate the clinical perfusion requirements for each patient’s cardiopulmonary surgical procedure and are responsible for the physiologic monitoring, analysis, intervention and hemodynamic stability of patients in the most complex types of surgical procedures.

4.2.5.3. Must have expert knowledge of cardio-pulmonary bypass methods, equipment and procedures.

4.2.5.4. Extracorporeal support: The Clinical Perfusionist is responsible to manage the physiologic and metabolic needs of the cardiac surgical patient. They are responsible for conducting extracorporeal circulation and ensuring the safe management of cardio-respiratory functions during any medical situation where it is necessary to support the patient’s cardio-respiratory function including but not limited to: cardiopulmonary bypass; extracorporeal resuscitation; and extracorporeal circulation for long term support of failing respiratory and/or cardiac function.

4.2.5.5. Associated extracorporeal support functions provided by the Clinical Perfusionist will include: myocardial protection through administration of prescribed cardioplegia solutions via the coronary blood supply anatomical systems; hemofiltration/renal replacement therapy; anticoagulation and hemostatsis management, analysis and intervention; thermal regulation; blood gas and blood chemistry monitoring; Physiologic monitoring, analysis and intervention; administration of blood components, pharmaceuticals and anesthetic agents.

4.2.5.6. Heart failure therapy and clinical support services to include: ventricular assist device management; external counterpulsation and intra-aortic counterpulsation device oversight and management including device insertion and monitoring for patient balloon pump operation in the Intensive Care Units; temporary pacemaker management; external counterpulsation; management of transportation of extracorporeal supported patients for safe transport; hemofiltration and aquapheresis; periodic flow augmentation therapy.

4.2.5.7. Provide blood management services to include: autotransfusion oversight for autologous blood and cell salvage techniques; platelet gel therapies; non-differential progenitor cell harvest; acute normovolemic hemodilution; phlebotomy;…