36C24919R0191-001.docx

36C24919R0191 – Attachment 1

PERFORMANCE WORK STATEMENT

PERFUSION SERVICES

1. GENERAL:

1.1. Services Provided: The contractor shall provide Perfusion Services on site in accordance with the terms and conditions contained herein to beneficiaries of the Department of Veterans Affairs (VA), Memphis, TN.

1.2. Place of Performance: Contractor shall furnish services at VAMC Memphis TN.

1.3. Authority: Title 38 U.S.C. 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=969

1.4.2. VHA Directive 1003, VHA’s Veteran Customer Service Program https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=268

1.4.3. VHA Handbook 1003.1, Key Elements of VHA’s Veteran Customer Service Program https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=422

1.4.4. VHA Handbook 1003.2, Service Recovery in the Veterans Health Administration https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=433

1.4.5. VHA Directive 1230, Outpatient Scheduling Processes and Procedures https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=3218

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

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

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

1.4.9. VHA Handbook 1907.01 Health Information Management and Health Records: http://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=3088

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

1.4.11. Joint Commission - http://www.jointcommission.org/standards/

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

1.4.13. 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. Vet-Pro: 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 Memphis TN VA Medical Center.

2. QUALIFICATIONS:

2.1. Staff/Facility – The contractor shall provide One Full Time Equivalency Employees (FTEEs), consisting of one____ Board Certified Perfusionist located at the VAMC Memphis, TN, (as needed).

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 (three) 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 250 clinical cases). Experience shall be demonstrated in the following areas: Open heart surgery, heart lung machine, membrane oxygenation, left/right heart bypass, intra-aortic balloon pumping, cell savaging 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 - Contract Perfusionist fulfilling the conditions of the contract shall be subject to all bylaws, rules and regulations of the VAMC. Each Perfusionist shall be credentialed and privileged prior to providing services and must be found acceptable by the Medical Executive committee and Governing Body. Credentialing and privileging is to be completed in accordance with VHA Handbook 1100.19 referenced above. The ability for an individual Perfusionist to continue to render services under the contract shall be dependent upon demonstration of clinical competence. Clinical competency shall be assessed on an ongoing basis, 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.

2.1.4. 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.

2.1.5. 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.

2.1.6. 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 (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).

2.1.7. Training (ACLS, BLS and VA MANDATORY): Contractor shall meet all VA educational requirements and mandatory course requirements defined herein: (1) All training must be completed by the Contractor’s perfusionist as required by the VA. The contractor will go to TMS website (www.tms.va.gov) to self-enroll for the following training listed below:

(2) Successfully complete the VA Privacy and Information Security Awareness and Rules of Behavior Training #10176 and Privacy and HIPPA Training #10203. See below link for instructions on completing required training.

List all training required, frequency and associated time Training

Frequency (once a year, etc.)

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.

2.1.9. TUBERCULOSIS TESTING: Contractor shall provide proof of a negative reaction to PPD testing for all contract personnel (s). A negative chest radiographic report for active tuberculosis shall be provided in cases of positive PPD results. The PPD test shall be repeated annually.

2.1.10. RUBELLA TESTING: Contractor shall provide proof of immunization for all contract personnel (s) for measles, mumps, rubella or a rubella titer of 1.8 or greater. If the titer is less than 1.8, a rubella immunization shall be administered with follow-up documentation to the COR.

2.1.11. OSHA regulation concerning occupational exposure to bloodborne pathogens: Contractor shall provide generic self-study training for all contract personnel (s); provide their own Hepatitis B vaccination series at no cost to the VA if they elect to receive it; maintain an exposure determination and control plan; maintain required records; and ensure that proper follow-up evaluation is provided following an exposure incident. 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.

2.1.12. 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.

2.1.13. Citizenship related Requirements:

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;

2.1.14. 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.

2.1.15. 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.

2.1.16. 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.

2.1.17. 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.

2.1.18. 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.

2.1.19. 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.

2.1.20. 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.

2.1.21. 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.

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

3. 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.

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

5. 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.

6. 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:

6.1.1. Workers’ compensation

6.1.2. Professional liability insurance

6.1.3. Health examinations to include:

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

6.1.5. 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

6.1.6. Evidence of a Hepatitis C titer

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

6.1.8. Income tax withholding, and

6.1.9. Social security payments

6.2. 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.

6.3. Key Personnel:

6.3.1. The VA Full Time Equivalency (FTE) for the Perfusion services required is one (1) FTEE which consist of one (1) Perfusionist

6.3.2. The number of Board Certified Perfusionists required to be on site as needed are five as defined in paragraph Hours of Operation of this section.

6.3.3. 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 a scheduled procedure), the contractor shall provide replacement provider coverage within 2 hours and notify the Contracting Office Representative (COR) at the VAMC Memphis TN immediately of the schedule change.

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

Key Personnel/Substitute Name (s)

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

Substitutes

7. 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.

7.1.1. 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.

7.1.2. 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).

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

7.1.4. 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.

7.1.5. 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.

8. VA HOURS OF OPERATION:

8.1. VA Business Hours: VA business hours of operation Monday – Friday 8:00 a.m. to 4:30 p.m.

8.1.1. Work Schedule: Services required are on an as needed basis. Cases are normally scheduled for Tuesday and Thursday for eight (8) hours a day from 8:00 a.m. to 4:30 p.m.

8.1.2. Perfusionist services are required 24/7 for on call coverage on an as needed basis. The Perfusionists will provide services in the OR for the balloon pump during open-heart procedures. The requirement is for the contractor to provide one Board Certified Perfusionist. The Perfusionist will be used to support the emergency services as well as provide for coverage during vacation, illness, etc. It is required by the contractor that one (1) full time Perfusionist be in an on-call status for 24 hours a day and seven (7) days a week including all Federal Holidays and be within 30 minutes of the facility to support these emergent cases. On-call pay will not be paid while cases are being performed. Any hours worked during an on-call status for an emergency procedure shall be paid the same rate as regular tour hours.

8.2. 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 by the President of the United States to be a national holiday.

9. CONTRACTOR RESPONSIBILITIES:

9.1 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.

9.1.1 Contract personnel (s) shall be responsible for signing in and out when in attendance. Time sheets will be used by the COR to confirm hours/day and services provided against the contractor’s invoices. The signed timesheets should be placed in the locked timesheet box located in the doctor’s lounge on the 3rd floor Room CE304. This is in addition to the case log.

9.1.2. The contract personnel is responsible for maintaining their equipment. They need to provide service records and the equipment should be clean prior to bringing to the VAMC. (The Contractor will provide the heater/cooler pump for a limited period of time that will be subject to this requirement.)

9.1.3 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:

9.1.4. American Board of Cardiovascular Perfusion: http://www.abcp.org

9.1.5. VHA Directive 1003, VHA’s Veteran Customer Service Program https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=268

9.1.6. VHA Handbook 1003.1, Key Elements of VHA’s Veteran Customer Service Program https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=422

9.1.7. VHA Handbook 1003.2, Service Recovery in the Veterans Health Administration https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=433

9.1.8. VHA Directive 1230, Outpatient Scheduling Processes and Procedures https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=3218

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

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

9.2 The requirements contained in this PWS

9.3 MEDICAL RECORDS

9.3.1 Authorities: Contract personnel (s) providing healthcare services to VA patients shall be considered as part of the Department Healthcare Activity and shall comply with the U.S.C.551a (Privacy Act), 38 U.S.C. 5701 (Confidentiality of claimants records), 5 U.S.C. 552 (FOIA), 38 U.S.C. 5705 (Confidentiality of Medical Quality Assurance Records) 38 U.S.C. 7332 (Confidentiality of certain medical records), Title 5 U.S.C. § 522a (Records Maintained on Individuals) as well as 45 C.F.R. Parts 160, 162, and 164 (HIPAA).

9.3.2 HIPAA: This contract and its requirements meet exception in 45 CFR 164.502(e), and do not require a BAA in order for Covered Entity to disclose Protected Health Information to: a health care provider for treatment. Based on this exception, a BAA is not required for this contract. Treatment and administrative patient records generated by this contract or provided to the Contractors by the VA are covered by the VA system of records entitled ‘Patient Medical Records-VA’ (24VA19). Contractor generated VA Patient records are the property of the VA and shall not be accessed, released, transferred, or destroyed except in accordance with applicable laws and regulations. Contractor shall ensure that all records pertaining to medical care and services are available for immediate transmission when requested by the VA. Records identified for review, audit, or evaluation by VA representatives and authorized federal and state officials, shall be accessed on-site during normal business hours.

9.3.3 Disclosure: Contract personnel (s) may have access to patient medical records: however, Contractor shall obtain permission from the VA before disclosing any patient information. Subject to applicable federal confidentiality or privacy laws, the Contractor, or their designated representatives, and designated representatives of federal regulatory agencies having jurisdiction over Contractor, may have access to VA ‘s records, at VA’s place of business on request during normal business hours, to inspect and review.

9.3.4 Professional Standards for Documenting Care: Care shall be appropriately documented in medical records in accordance with standard commercial practice and guidelines established by VHA Handbook 1907.01 Health Information Management and Health Records: http://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=3088 and all guidelines provided by the VAMC.

9.3.5 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 will not be releasing any patient information. All completed release of information forms shall be forwarded to the Release of Information department to scan and upload into the patient’s medical record, if it is a VA patient.

9.3.6 Confidentiality - VA will provide the contract personnel (s) access to pertinent patient medical information, within the existing privacy rules and regulations, for the purpose of providing coordinated comprehensive primary care. Contract personnel (s) shall ensure the confidentiality of all patient information and shall be held liable in the event of the breach of confidentiality.

9.3.7 Personal Identity Verification (PIV) - Contract personnel (s) shall participate in computer security and documentation training as is all personnel practicing within the VA Medical Center. Contract personnel (s) shall comply with facility requirements to obtain personal security investigations, installation access and participate in the computer security and documentation training.

9.3.8 Contract personnel (s) shall provide medical record documentation in accordance with rules and regulations of the medical staff and medical staff by laws. Reference Policy Memorandum No. 136-1, Change 2 to Appendix B dated Sept. 29, 2000, Control of Medical Records and in accordance with Policy Memorandum 136-1, Change 2 to Appendix A dated September 29, 2000, Completion of Medical Records.

9.3.9 Records created by contract personnel (s) in the course of treating VA patients under this agreement are the property of the VA and shall not be accessed, released, transferred or destroyed except in accordance with applicable federal law and regulations.

9.4 Contract personnel will not access CPRS or VISTA.

9.4.1 Upon transfusion of components, the Perfusionists are responsible for completing the required information on the SF-518 form (Record of Transfusion on the Standard Form 518) to include pre-transfusion data and post-transfusion data. The completed original SF-518 shall be scanned into the patient's chart, and a copy of the SF-518 shall be placed in the designated location for return to the Blood Bank. Under no circumstances will the SF-518 be discarded.

9.5 Direct Patient Care: 90 % of the time involved in direct patient care. The Perfusionists’ role will be 90% to patient care related. The other 10% will be administrative.

9.5.1 Scope of Care: Contract personnel (s) (as appropriate and within scope of practice/privileging) shall be responsible for providing Perfusion care, including, but not limited to:

9.5.1.1 All Perfusionists shall assist the Cardio-Thoracic service with by-pass surgical cases and valve replacement of various types. The contractor shall perform onsite Perfusion Services in the treatment of care for eligible veteran beneficiaries as referred and authorized by the Memphis VAMC. The Perfusionists are responsible for preparation, and operation of the heart and lung machines/pumps in conjunction with maintaining a sterile environment for procedures maintaining blood volume in the patients preventing shock or air embolus. Assemble supplies and equipment in preparation to accept patient on extra corporeal circulation in cases of premature cardiac arrest or failure. Other services include preparation, maintenance and operation of VA owned equipment to include the heart lung machine, auto transfusion pump, intra-aortic balloon pump and centrifugal ventricular assist device. The Perfusionists will train the nurses to operate the auto transfusion pump and intra-aortic balloon pump, but the Contractor will not operate this equipment outside of open heart procedures.

9.5.1.2 The Perfusionists will be notified by phone or pager of upcoming cases.

9.5.2 Reporting Information for Perfusion. The Perfusionist should maintain a detailed record of the cardiopulmonary bypass for the open- heart case.

9.6 ADMINISTRATIVE: estimated_10__% of time not involved in direct patient care (should match information from needs assessment.) (NOTE: MUST BE TAILORED TO THE RESPONSIBILITIES REQUIRED: list tasks, call, etc. For meetings, list the name, frequency, length of each meeting. For other administrative tasks, ensure that a description of effort (scheduled time) is outlined for each task.).

9.6.1 Quality Improvement Meetings: The Contractor’s physician(s) shall participate in continuous quality improvement activities and meetings with committee participation as required by the VAMC Chief of Service, Chief of Staff, or designee. List all meetings, associated time and frequency.

None

9.6.2 Staff Meetings: The Contractor’s physician(s) shall attend staff meetings as required by the VAMC Chief of Service, Chief of Staff, or designee. Contractor to communicate with COR on this requirement and report any conflicts that may interfere with compliance with this requirement. List all meetings, associated time and frequency.

None

9.6.3 QA/QI documentation: The Contractor’s physician(s) shall complete the appropriate QM/PI documentation pertaining to all procedures, complications and outcome of examinations.

9.6.4 Patient Safety Compliance and Reporting: Contractor’s physician(s) shall follow all established patient safety and infection control standards of care. Contractor’s physician(s) shall make every effort to prevent medication errors, falls, and patient injury caused by acts of commission or omission in the delivery of care. All events related to patient injury, medication errors, and other breeches of patient safety shall be reported to the COR VA Safety Policy. As soon as practicable (but within 24 hours) Contractors shall notify COR of incident and submit to the COR the Patient Safety Report, following up with COR as required or requested.

9.7 PERFORMANCE STANDARDS, QUALITY ASSURANCE (QA) SURVEILLANCE PLAN AND QUALITY IMPROVEMENT(QI)

9.7.1 Quality Management/Quality Assurance Surveillance: Contract personnel shall be subject to Quality Management measures, such as patient satisfaction surveys, timely completion of medical records, and Peer Reviews. Methods of Surveillance: Focused Provider Practice Evaluation (FPPE) and Ongoing Provider Practice Evaluation (OPPE). Contractor performance will be monitored by the government using the standards as outlined in this Performance Work Statement (PWS) and methods of surveillance detailed in the Quality Assurance Surveillance Plan (QASP). The QASP shall be attached to the resultant contract and shall define the methods and frequency of surveillance conducted. Contract monitoring will be accomplished through a record keeping system (attendance log) maintained by the Chief, Surgical Service in order to reconcile payments. Contractor’s employees shall sign in and sign out of the attendance log indicating the dates and times worked. Procedure documentation shall be maintained by the contractor and shall be signed by the contractor’s employee(s). The Chief, Cardio-Thoracic Section shall certify the actual number of procedures completed. Copies of the procedure documentation sheets shall be forwarded to the Chief, Surgical Service for review and concurrence. The Chief, Surgical Service is responsible for monitoring the professional components of the contract. All adverse actions shall be reported to the Contracting Officer immediately. The Contracting Officer and COR shall examine methodologies and quality control procedures during the contract term. All activities shall comply with Joint Commission standards and the policies and procedures of the VAMC.

9.7.2 Patient Complaints: The CO will resolve complaints concerning Contractor relations with the Government employees or patients. The CO is final authority on validating complaints. In the event that the Contractor is involved and named in a validated patient complaint, the Government reserves the right to refuse acceptance of the services of such personnel. This does not preclude refusal in the event of incidents involving physical or verbal abuse.

9.7.3 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. The CO and COR shall deal with issues raised concerning Contractor’s conduct. The final arbiter on questions of acceptability is the CO.

9.7.4 Performance Standards:

9.7.4.1 Measure: Provider Quality Performance

Performance Requirement: Ongoing Provider Performance Evaluation (OPPE) shall perform in accordance with clinical standards

Surveillance Method: OPPE a. Patience Care Performance b. Medical/Clinical knowledge c. Practiced Based Learning & Improvement, d. Interpersonal & Communication Skills, e. Professionalism f. System Based Practice

9.7.4.2 Measure: Qualifications of Key Personnel

Performance Requirement: All contract Perfusionists shall have current certification in accordance with American Board of Cardiovascular Perfusion and maintain license, registration and/or certification.

Autotransfusionist shall have only a certification as an Autotransfusionist.

Standard: All Perfusionists/Autotransfusionist shall be certified and compliant with all certifications Acceptable Quality Level: 95% Surveillance Method: Random Inspection of qualification documents

9.7.4.3 Measure: Scope of Practice/Privileging

Performance Requirement: Contract personnel (s) perform within their individual scopes of practice/privileging Standard: All (100%) contract personnel (s) perform within their scope of practice/privileges 100% of the time Acceptable Quality Level:95% Surveillance Method: Random Inspection of records

9.7.4.4 Measure: Patient Access (A)

Performance Requirement: Patient must receive treatment in a timely manner Standard: Perfusionists shall be onsite and available during all scheduled OR hours and within 30 minutes of the facility Acceptable Quality Level:95% Surveillance Method: Direct observation and random inspection

9.7.4.5 Measure: Patient Access (B)

Performance Requirement: Perfusionists/Autotransfusionist shall be available and be in location as needed to properly perform tasks as specified Standard: Perfusionists shall be onsite and available during all scheduled OR hours and within 30 minutes of the facility Acceptable Quality Level:95% Surveillance Method: Periodic Sampling of Time and Attendance Sheets

9.7.4.6 Measure: Patient Safety

Performance Requirement: Patient safety incidents shall be reported using Patient Safety Report All incidents shall be reported immediately (within 24 hours) Standard: All of patient safety incidents are reported using Patient Safety Report within 24 hours of incident Acceptable Quality Level:95% Surveillance Method: Direct Observation and periodic inspection

9.7.4.7 Measure: Maintains licensing, registration, and certification Performance Requirement: Updated Licensing, registration and certification shall be provided as they are renewed.

Licensing and registration information shall be kept current Standard: All licensing, registration(s) and certification(s) for contract personnel (s) shall be provided as they are renewed Licensing and registration information shall be kept current Acceptable Quality Level: 95% Surveillance Method: Periodic Sampling and Random Sampling

9.7.4.8 Measure: Mandatory Training, Privacy, Confidentiality and HIPAA Performance Requirement: Contractor personnel (s) shall complete all required training on time per VAMC policy. Contractor personnel (s) is aware of all laws, regulations, policies and procedures relating to Privacy, Confidentiality, and HIPAA and complies with all standards Zero breaches of privacy or confidentiality.

Standard: All contractor personnel (s) shall comply with all laws, regulations, policies and procedures relating to Privacy, Confidentiality, and HIPAA.

Acceptable Quality Level:95% Surveillance Method: Periodic sampling. Contractor personnel (s) shall provide evidence of annual training required by VAMC, reports violations per VA Directive 6500.6.

9.7.4.9 Measure: Clinical Information Return

Performance Requirement: Perfusionists shall be responsible to check and compute all calculations of perfusion, autotransfusion and cell saver treatments.

Standard: All cases Acceptable Quality Level:95% Surveillance Method: Direct observation and random sampling

9.7.4.10 Measure: Documentation/Timesheet

Performance Requirement: Time Sheet Documentation to be completed weekly and turned in to Section Chief for concurrence Standard: Weekly Acceptable Quality Level:95% Surveillance Method: Periodic inspection and random sampling

9.7.5 Registration with Contractor Performance Assessment Reporting System

9.7.6 As prescribed in Federal Acquisition Regulation (FAR) Part 42.15, the Department of Veterans Affairs (VA) evaluates contractor past performance on all contracts that exceed the simplified acquisition threshold and shares those evaluations with other Federal Government contract specialists and procurement officials. The FAR requires that the contractor be provided an opportunity to comment on past performance evaluations prior to each report closing. To fulfill this requirement VA uses an online database, CPARS, which is maintained by the Naval Seal Logistics Center in Portsmouth, Virginia. CPARS has connectivity with the Past Performance Information Retrieval System (PPIRS) database, which is available to all Federal agencies. PPIRS is the system used to collect and retrieve performance assessment reports used in source selection determinations and completed CPARS report cards transferred to PPIRS. CPARS also includes access to the federal awardee performance and integrity information system (FAPIIS). FAPIIS is a web-enabled application accessed via CPARS for contractor responsibility determination information.

9.7.7 Each contractor whose contract award is estimated to exceed the simplified acquisition threshold is required to register with CPARS database at the following web address: www.cpars.csd.disa.mil. Help in registering can be obtained by contacting Customer Support Desk @ DSN: 684-1690 or COMM: 207-438-1690. Registration should occur no later than thirty days after contract award, and must be kept current should there be any change to the contractor’s registered representative.

9.7.8 For contracts with a period of one year or less, the contracting officer will perform a single evaluation when the contract is complete. For contracts exceeding one year, the contracting officer will evaluate the contractor’s performance annually. Interim reports will be filed each year until the last year of the contract, when the final report will be completed. The report shall be assigned in CPARS to the contractor’s designated representative for comment. The contractor representative will have thirty days to submit any comments and re-assign the report to the VA contracting officer.

9.7.9 Failure to have a current registration in the CPARS database, or to re-assign the report to the VA contracting officer within those thirty days, will result in the Government’s evaluation being placed on file in the database with a statement that the contractor failed to respond.

10. GOVERNMENT RESPONSIBILITIES:

10.1. VA Support Personnel, Services or Equipment: VA owned equipment list:

· Heart lung machine

· Auto transfusion pump

· Intra-aortic balloon pump

· Centrifugal ventricular assist device

10.2. The Perfusionists are responsible for preparation, operation and maintenance of the heart and lung machines/pump, auto transfusion pump, intra-aortic balloon pump and centrifugal ventricular assist device.

10.3. The Perfusionists is responsible for coordinating scheduled periodic preventative maintenance and repair calls for VA owned equipment and maintain record as such. Perfusionist will train nurses to set up and operates autotransfusion pump for other surgical procedures and help with troubleshooting.

Contract Administration/Performance Monitoring: After award of contract, all inquiries and correspondence relative to the administration of the contract shall be addressed to:

10.4. CO RESPONSIBILITIES:

10.4.1. The Contracting Officer is the only person authorized to approve changes or modify any of the requirements of this contract. The Contractor shall communicate with the Contracting Officer on all matters pertaining to contract administration. Only the Contracting Officer is authorized to make commitments or issue any modification to include (but not limited to) terms affecting price, quantity or quality of performance of this contract.

10.4.2. The Contracting Officer shall resolve complaints concerning Contractor relations with the Government employees or patients. The Contracting Officer is final authority on validating complaints. In the event the Contractor effects any such change at the direction of any person other than the Contracting Officer without authority, no adjustment shall be made in the contract price to cover an increase in costs incurred as a result thereof.

10.4.3. In the event that contracted services do not meet quality and/or safety expectations, the best remedy will be implemented, to include but not limited to a targeted and time limited performance improvement plan; increased monitoring of the contracted services; consultation or training…