S02 - 36C26320R0148.pdf

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 109

36C26320R0143 06-17-2020

Daniel Vagts, Contract Officer 651-293-3040 07-10-2020

11:59 EST

36C263

Department of Veterans Affairs

Network 23 Contracting Office

Attention: Daniel Vagts

316 Robert Street N. STE. 506

St Paul MN 55101

X 100

X

621111

$12 Million

N/A

X

Department of Veterans Affairs

NCO 23

One Veterans Drive, Building 70

Minneapolis MN 55417

Network 23 Contracting Office

Attention: Daniel Vagts

316 Robert Street N. STE. 506

St. Paul MN 55415

Y

Financial Services Center

PO Box 149971

Austin TX 78714-9971

See CONTINUATION Page

1.6 Full-Time Equivalent (FTE) Perfusion Services for the

Minneapolis VA Health Care System.

See Section B.4 Schedule of Services (pg.6)

See Section B.5 Performance Work Statement (pg.12)

See CONTINUATION Page

X ONE

Daniel Vagts

Contract Officer

36C26320R0148

Table of Contents

SECTION A

A.1 SF 1449 SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

B.2 SCHEDULE OF SERVICES

B.3 PERFORMANCE WORK STATEMENT

SECTION C - CONTRACT CLAUSES

C.1 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL ITEMS (OCT 2018)

C.2 52.204-9 PERSONAL IDENTITY VERIFICATION OF CONTRACTOR PERSONNEL (JAN 2011)

C.3 52.204-21 BASIC SAFEGUARDING OF COVERED CONTRACTOR INFORMATION SYSTEMS (JUN

2016)

C.4 52.217-8 OPTION TO EXTEND SERVICES (NOV 1999)

C.5 52.217-9 OPTION TO EXTEND THE TERM OF THE CONTRACT (MAR 2000)

C.6 SUPPLEMENTAL INSURANCE REQUIREMENTS

C.7 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

C.8 VAAR 852.203-70 COMMERCIAL ADVERTISING (MAY 2018)

C.9 VAAR 852.219-74 LIMITATIONS ON SUBCONTRACTING—MONITORING AND COMPLIANCE

(JUL 2018)

C.10 VAAR 852.232-72 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS (NOV 2018)

C.11 VAAR 852.237-70 INDEMNIFICATION AND MEDICAL LIABILITY INSURANCE (OCT 2019)

C.12 VAAR 852.237-72 CRIME CONTROL ACT—REPORTING OF CHILD ABUSE (OCT 2019)

C.13 VAAR 852.237-74 NON-DISCRIMINATION IN SERVICE DELIVERY (OCT 2019)

C.14 VAAR 852.237-75 KEY PERSONNEL (OCT 2019)

C.15 VAAR 852.270-1 REPRESENTATIVES OF CONTRACTING OFFICERS (JAN 2008)

C.16 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT STATUTES OR

EXECUTIVE ORDERS—COMMERCIAL ITEMS (MAR 2020)

SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS

D.1 LIST OF ATTACHMENTS

Attachment 1 – D.1 - VA Rules of Behavior

Attachment 2 – D.2 - Background Investigation Procedure and Documents

Attachment 3 – D.3 – Quality Assurance Surveillance Plan (QASP)

Attachment 4 – D.4 - Immigration and Nationality Act Requirement

Attachment 5 – D.5 - VA Handbook 6500.6

Attachment 6 – D.6 - Organizational Conflict of Interest

Attachment 7 - D.7 - Past Performance Questionnaire

SECTION E - SOLICITATION PROVISIONS

E.1 52.212-1 INSTRUCTIONS TO OFFERORS—COMMERCIAL ITEMS (OCT 2018)

E.2 PROPOSAL SUBMITTAL INSTRUCTIONS

E.3 52.209-7 INFORMATION REGARDING RESPONSIBILITY MATTERS (OCT 2018)

E.4 52.216-1 TYPE OF CONTRACT (APR 1984)

E.5 52.233-2 SERVICE OF PROTEST (SEP 2006)

E.6 VAAR 852.209-70 ORGANIZATIONAL CONFLICTS OF INTEREST (JAN 2008)

E.7 VAAR 852.252-70 SOLICITATION PROVISIONS OR CLAUSES INCORPORATED BY REFERENCE

(JAN 2008)

E.8 VAAR 852.233-70 PROTEST CONTENT/ALTERNATIVE DISPUTE RESOLUTION (OCT 2018)

E.9 VAAR 852.233-71 ALTERNATE PROTEST PROCEDURE (OCT 2018)

E.10 52.212-2 EVALUATION—COMMERCIAL ITEMS (OCT 2014)

E.11 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—COMMERCIAL ITEMS (MAR

2020)

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:

[X] 52.232-33, Payment by Electronic Funds Transfer—System For Award Management, or [] 52.232-36, Payment by Third Party

3. INVOICES: Invoices shall be submitted in arrears:

a. Quarterly []

b. Semi-Annually []

c. Other [X] - Monthly

See Billing Instructions, PWS 6.2. Billing:

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:

AMENDMENT NO DATE

mailto:daniel.vagts@va.gov

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, 2019 through July 31, 2021 with four (4) available option periods.

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 will schedule a post award orientation for contract orientation purposes as required by Procurement Policy Memorandum (PPM) 2019-01.

B.2 SCHEDULE OF SERVICES

The contractor shall furnish all personnel to provide services necessary to perform onsite Perfusion

Services to eligible beneficiaries of the Department of Veterans Affairs Medical Center, Minneapolis VA

Health Care System (hereinafter referred to as VAMC). The contractor’s provider(s) care shall cover the range of Perfusion Services as would be provided in a state-of-the-art civilian medical treatment facility and the standard of care shall be of a quality, meeting or exceeding currently recognized national standards as established by the American Board of Cardiovascular Perfusion http://www.abcp.org

Place of Performance: Services shall be provided on site, Minneapolis VA Health Care System, One

Veterans Drive, Minneapolis, Minnesota 55417.

Pricing Instructions: The offeror is instructed to edit the number of sub-clins to correspond with the number of key personnel submitted for the contract line item number (CLIN).

The contractor shall propose a minimum of three (3) key personnel to be credentialed and be available for scheduling to meet the requirements of the contract.

Period of Performance: BASE PERIOD: August 1, 2020 to July 31, 2021

CLIN

No.

SUB-

Description Qty. Unit Unit Cost Total

Annual Cost

0001 None

1.6 FTE Perfusion Services and on-call

coverage

3,276 Hours DO NOT

PRICE

DO NOT PRICE

KEY PERSONNEL

None 0001a

Perfusion Services

NAME: ____________

EXPERIENCE:

Hours $__/hr $__

None 0001b

Perfusion Services

NAME: ____________

EXPERIENCE:

Hours $__/hr $__

None 0001c

Perfusion Services

NAME: ____________

EXPERIENCE:

Hours $__/hr $__

0002 None Perfusion On-Call Services 1,631.5 Hours $__/hr $__ http://www.abcp.org/

TOTAL FOR BASE PERIOD

Hours

OPTION PERIOD ONE: August 1, 2021 to July 31, 2022

No.

Annual Cost

1001 None

DO NOT PRICE

KEY PERSONNEL

None 1001a

Perfusion Services

NAME: ____________

EXPERIENCE:

Hours $__/hr $__

None 1001b

Perfusion Services

NAME: ____________

EXPERIENCE:

Hours $__/hr $__

None 1001c

Perfusion Services

NAME: ____________

EXPERIENCE:

Hours $__/hr $__

1002 None On-Call Perfusion Services 1,631.5 Hours $__/hr $__

TOTAL FOR OPTION PERIOD ONE

OPTION PERIOD TWO: August 1, 2022 to July 31, 2023

Annual Cost

2001 None

DO NOT PRICE

KEY PERSONNEL

None 2001a

Perfusion Services

NAME: ____________

EXPERIENCE:

Hours $__/hr $__

None 2001b

Perfusion Services

NAME: ____________

EXPERIENCE:

Hours $__/hr $__

None 2001c

Perfusion Services

NAME: ____________

EXPERIENCE:

2002 None On-Call Perfusion Services 1,631.5 Hours $__/hr $__

TOTAL FOR OPTION PERIOD TWO

OPTION PERIOD THREE: August 1, 2023 to July 31, 2024

Annual Cost

3001 None

DO NOT PRICE

KEY PERSONNEL

None 3001a

Perfusion Services

NAME: ____________

EXPERIENCE:

Hours $__/hr $__

None 3001b

Perfusion Services

NAME: ____________

EXPERIENCE:

Hours $__/hr $__

None 3001c

Perfusion Services

NAME: ____________

EXPERIENCE:

3002 None On-Call Perfusion Services 1,631.5 Hours $__/hr $__

TOTAL FOR OPTION PERIOD THREE

OPTION PERIOD FOUR: August 1, 2024 to July 31, 2025

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

Annual Cost

4001 None

DO NOT PRICE

KEY PERSONNEL

None 4001a

Perfusion Services

NAME: ____________

EXPERIENCE:

Hours $__/hr $__

None 4001b

Perfusion Services

NAME: ____________

EXPERIENCE:

Hours $__/hr $__

None 4001c

Perfusion Services

NAME: ____________

EXPERIENCE:

4002 None On-Call Perfusion Services 1,631.5 Hours $__/hr $__

TOTAL FOR OPTION PERIOD FOUR

B.3 PERFORMANCE WORK STATEMENT

1. GENERAL:

1.1. Services Provided: The contractor shall provide the Minneapolis VA Health Care System (MVAHCS) contractual services for an American Board of Cardiovascular Perfusionists to provide clinical perfusion services coverage to eligible veteran beneficiaries of the MVAHCS.

Perfusionist services are required on-site daily, Monday through Friday; On-call coverage is required. One key personnel is required to be onsite 52 weeks per year, Monday – Friday;

excluding federal holidays.

1.1.1. Scope of Services Provided: The MVAHCS requires the services of experienced, practicing Clinical Perfusionists to provide direct patient care for the management of physiological and metabolic needs of surgical patients during cardiovascular surgical procedures including coronary by-pass; extracorporeal support functions; heart failure therapy and support; blood management; other clinical perfusion procedures as required; and on-call coverage. It is estimated that contractor’s clinical perfusion services will be required for an estimated 3,276 hours of on-site services per year, and an estimated 1,632 hours of on-call coverage per year. Back-up coverage is required for MVAHCS staff vacation and leave coverage.

1.1.2. Period of Performance: Services required for a 12-month base period with four (4), 12-month options.

1.2. Place of Performance: Contractor shall furnish services on-site at the Minneapolis VA Health

Care System, One Veterans Drive, Minneapolis, Minnesota 55417.

1.3. Authority: Title 38 USC 8153, Health Care Resources (HCR) sharing Authority and 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. VHA Handbook 1100.17: National Practitioner Data Bank Reports https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=2135

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

1.4.3. VHA Handbook 1100.19: Credentialing and Privileging

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

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

1.4.5. VHA Directive 1220: Facility Procedure Complexity Designation Requirements to Perform Invasive Procedures In Any Clinical Setting https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=8365 https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=2135 https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=1364 https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=2910 https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=5472 https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=8365

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

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

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

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

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

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

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

1.4.12. Minneapolis VA Health Care System Policy: The Minneapolis VAHCS policies are only available on the Minneapolis VA Intranet site. This site is not available to the general public. Copies of these policies will be provided:

1.4.12.1. POL-05 PIV Card Policy (Personnel Identification Verification – ID Badge)

1.4.12.2. IC-01I Infection Precautions

1.4.12.3. IM-01M Medical Records (Management of Information)

1.4.12.4. IM-06F Information Security Policy/Procedures

1.4.12.5. MA-08C Vendors (Contractors)

1.4.12.6. PE-01G Assessment of Patients

1.4.12.7. PF-02N BLS and ACLS Requirements for Staff

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

https://www.va.gov/vapubs/viewPublication.asp?Pub_ID=969&FType=2 https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=3088 http://www.justice.gov/oip/foia_updates/Vol_XVII_4/page2.htm http://www.jointcommission.org/standards/ http://oig.hhs.gov/exclusions/index.asp http://www.cdc.gov/hicpac/pdf/InfectControl98.pdf

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. Contracting Officer (CO): The person executing this contract on behalf of the

Government with the authority to enter into and administer contracts and make related determinations and findings.

1.5.12. Contracting Officer’s Representative (COR): A person appointed by the CO to take necessary action to ensure the contractor performs in accordance with and adheres to the specifications contained in the contract and to protect the interest of the Government.

The COR shall report to the CO promptly any indication of non-compliance in order that appropriate action can be taken.

1.5.13. COS: Chief of Staff

1.5.14. CPARS: Contractor Performance Assessment Reporting System

1.5.15. DEA: Drug Enforcement Agency

1.5.16. ED: Emergency Department

1.5.17. ECMO: Extracorporeal Membrane Oxygenation

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

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 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.

http://www.nlnac.org/

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 Minneapolis VA Health Care System.

2. QUALIFICATIONS:

2.1. Staff/Facility:

2.1.1. License: Reserved

2.1.2. 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 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. Perfusionist(s) provided must be a Certified Clinical Perfusionist (CCP) as certified by the American Board of Cardiovascular Perfusion (ABCP) and must have graduated from an accredited clinical perfusion education program. Recognized accrediting agencies are: Accreditation Committee for Perfusion Education (AC-PE) in cooperation with the Commission on Accreditation of Allied Health Education Programs (CAAHEP), and the Conjoint Committee on Accreditation of the Canadian Medical Association (CMA).

2.1.2.1. The qualifications of contractor personnel are subject to review and approval by

Minneapolis VA Director of Surgery Specialty Care Patient Service Line. The VA reserves the right to approve the assignment of individual personnel furnished by the contractor to perform the functions specified in the contract. The VA Contracting

Officer must be notified prior to any changes in contract personnel.

2.1.2.2. Contractor must furnish copies of the perfusionist’s certification and evidence of completion of an accredited clinical perfusion education program. If a contract provider does not maintain certification, the contractor shall furnish an acceptable substitute without any additional cost to the government.

2.1.3. Experience: Perfusionist(s) must have a minimum of five-years recent experience providing clinical perfusion services for cardiac by-pass surgery.

2.1.3.1. Knowledge, Skills and Abilities: All Perfusionists provided must possess the following demonstrated knowledge, skills, and abilities:

2.1.3.1.1. Knowledge of equipment and supplies needed for safe conduct of cardiopulmonary by-pass surgery.

2.1.3.1.2. Knowledge of counter pulsation life support and insertion, maintenance, and removal of intra-aortic balloon pump.

2.1.3.1.3. Knowledge of blood sparing equipment (its uses, indications, and contraindications); blood banking procedures; blood storage and administration; and blood components, including platelet gel and sequestration.

2.1.3.1.4. Ability to operate ventricular assist devices (VAD) and assist with implantation, transportation, and removal of the device.

2.1.3.1.5. Knowledge of blood gases using alpha stat or Ph stat measures, and ability to analyze and apply lab results to patients under direct care on by-pass or VAD.

2.1.4. Credentialing and Privileging: Reserved

2.1.5. Technical Proficiency: Contract personnel 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.

2.1.6. 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 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 credentialing 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.

2.1.7. 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 personnel as required by the VA. Other training may become required. VA will communicate any changes to the training requirement to the contractor.

Training Frequency Annual Hours

VA Core Values Training (ICARE Recommitment)

Once a year 1 hour

VA Privacy and Information Security Awareness and Rules of Behavior

Once a year 1 hour

Mandatory Training for Transient Clinical Staff

Once a year 1.5 hours

BLS Every 24 months 3.5 hours

Suicide Prevention: Suicide Risk Management Training for Clinicians

Once a year 1 hour

CPRS Once 4 hours

VISTA Imaging Once 1 hour

ACLS Every 24 months 4 hours

Mandatory Training for Transient Clinical Staff – TMS course # 20152

Once a Year 1.5 hours

Prevention/Management of Disruptive Behavior/Violence Prevention Level 2 – TMS course # 23805

Every 24 months 2 hours

Prevention/Management of Disruptive Behavior/Violence Prevention Level 3 – TMS course # 12510

Every 24 months 4 hours

Additional training may be required per VA directives

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

2.1.8.1. TUBERCULOSIS TESTING: Contractor shall provide proof of a negative

Tuberculosis Skin Test (TST) or interferon-gamma release assays (IGRA) for all contractor’s personnel {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.

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

2.1.8.3. VARICELLA: Contractors shall provide proof of immunity for all contractor personnel {This is applicable to all health care workers}.

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

2.1.8.5. INFLUENZA: Contractors shall provide proof that all contractor personnel have received the annual Influenza vaccine unless it is contraindicated. If the contractor personnel have 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}.

2.1.8.6. 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 personnel {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.

2.1.8.7. 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.

2.1.9. National Provider Identification (NPI): Reserved

2.1.10. Conflict of Interest: The contractor and all contract personnel are responsible for identifying and communicating to the CO and COR conflicts of interest at the time of proposal and during the entirety of contract performance. At the time of proposal, the contractor shall provide a statement which describes, in a concise manner, all relevant facts concerning any past, present, or currently planned interest (financial, contractual, organizational, or otherwise) or actual or potential organizational conflicts of interest relating to the services to be provided. The contractor shall also provide statements containing the same information for any identified consultants or subcontractors who shall provide services. The contractor must also provide relevant facts that show how it’s organizational and/or management system or other actions would avoid or mitigate any actual or potential organizational conflicts of interest. These statements shall be in response to the VAAR provision 852.209-70 Organizational Conflicts of Interest (Jan 2008) and fully outlined in response to the subject attachment in Section D of the solicitation document.

2.1.11. Citizenship related Requirements:

2.1.11.1. 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;

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

2.1.11.2. 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.

2.1.11.3. 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.

2.1.11.4. 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.

2.1.11.5. 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.

2.1.12. 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.

2.1.12.1. 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 personnel 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.

2.1.12.2. 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 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 personnel are prohibited from referring VA patients to contractor’s or their own practice(s).

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

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

2.7.1. 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.

When contractor or contract personnel 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 personnel) action or non-action shall be the responsibility of the contractor and/or insurance carrier.

2.9. Key Personnel: Contractor will be responsible to ensure that the contractor personnel providing work on this contract are fully trained and fully competent to perform the required services for the duration of the contract period. Contractor’s personnel provided under this contract must meet the qualifications, training, and all requirements as stated in Section 2.1.

2.9.1. The contractor shall propose a minimum of three (3) key personnel be available for scheduling to meet the requirements of the contract.

2.9.2. The VA Full Time Equivalency (FTE) for the services required is 1.6 FTE. One FTE is defined by the VA as a person working a minimum of 80 hours every two weeks and does not include holidays.

2.9.3. Contractor’s Perfusionist is required to provide clinical perfusion services on-site an estimated 126 hours every two (2) weeks.

2.9.4. 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.

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 fifteen (15) calendar days after the occurrence of any of these events and provide the information required below. After ninety (90) days, the contractor shall submit the information required below to the CO at least fifteen (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 fifteen (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/he may request, without cause, immediate replacement of said contract personnel.

2.10.4. The CO and COR shall deal with issues raised concerning contract personnel 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 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 Minneapolis VA Health Care System 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 a.m. – 4:30 p.m. The services covered by this contract shall be furnished by the contractor as defined in the work schedule below. The contractor shall also be required to furnish on-call coverage and provide emergency services as needed including evenings, weekends and national holidays.

3.1.1. On-site Services/OR Schedule: The Minneapolis VA performs an average of two (2) cardiac bypass cases per day. The contractor will provide clinical perfusion staff in the VA operating room for cardiovascular surgical procedures Monday through Friday, excluding

Federal Holidays.

3.1.1.1. Tour of Duty: Monday – Friday, 6:30 a.m. to 3:00 p.m.

3.1.1.2. Key personnel are required to stay past their tour of duty until all patient care is complete. Patient care needs frequently require additional time.

3.1.1.3. Typically bypass cases may run between the hours of 6:30 a.m. to 5:00 p.m.

Perfusionists are required to remain in the surgical suite until surgical procedure is completed.

3.1.1.4. It is estimated that on-site services will be required up to 63 hours per week.

This includes Perfusionist’s regular O.R. work schedule, plus any hours spent on-site after regular tour of duty Monday through Friday, as well as call back hours on weeknights, weekends and holidays when the Perfusionist is called on-site to provide services.

3.1.1.5. 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. On-Call Coverage: Contractor is required to provide on-call coverage during hours when the medical center’s O.R. is typically closed. When Perfusionist is providing on-call coverage, they will carry a pager and services will be required during off-duty hours and shall be available 24 hours a day, 7 days per week on an “on-call” basis. Contractor will be required to provide seven (7) days of call coverage every three (3) weeks. It is estimated that contractor will be required to provide on-call coverage for approximately 1,632 hours per year.

Call coverage hours are as follows:

3.1.2.1. Weekday Call (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.

3.1.2.2. Weekend Call (Saturday & Sunday): Call coverage is from 6:30 a.m. on Saturday and goes to 6:30 a.m. on Monday.

3.1.2.3. Holiday Call: Coverage is from 6:30 a.m. to 6:30 a.m. the following day.

3.1.2.4. If call results in Perfusionist being called on-site to the Minneapolis VAHCS for services, the contractor will be compensated at the Perfusionist’s hourly on-site rate for services.

3.1.2.5. Concurrent call is not allowed. Perfusionist may not work at or for another facility during their VA scheduled hours.

3.1.2.6. Contractor’s Perfusionist will respond to call within 15 minutes of receipt of call by phone and within 60 minutes in person.

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

4.1.1. Contract personnel 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 and;

4.2.4. The requirements contained in this PWS.

4.3. Medical Records:

4.3.1. Authorities: Contract personnel 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’ (24VA10P2). Contractor generated VA Patient records are the property of the VA and shall not be accessed, released, transferred, or destroyed http://www.abcp.org/ http://www.jointcommission.org/standards_information/standards.aspx http://www.hpoe.org/resources?show=100&type=8 http://www.rms.oit.va.gov/SOR_Records/24VA19.asp 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 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 1907.01, Health Information Management and Health Records and VHA Directive 1605.01, Privacy and Release of Information. The penalties and liabilities for the unauthorized disclosure of

VA patient information mandated by the statutes and regulations mentioned above, apply to the contractor.

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: https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=3088 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. The contractor may respond to requests for records contained in their non-VA record system, but all requests for VA records will be forwarded to Minneapolis VA

Health Care System Release of Information Office (ROI) for response. The ROI office may be contacted via phone at 612-467-1992 extension 311992, and fax at 612-467-2197.

4.3.6. Confidentiality: VA will provide the contract personnel access to…