Performance Work Statement.pdf

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?.## PERFORMANCE WORK STATEMENT – Perfusion/Autotransfusion

Physician Services

1. GENERAL:

1.1. Services Provided: The contractor shall provide Perfusion/Autotransfusion Services on site in accordance with the terms and conditions contained herein to beneficiaries of the Department of Veterans Affairs (VA), San Francisco Health Care System

(SFVAHCS).

1.2. Place of Performance: Contractor shall furnish services at the San Francisco Veterans Affairs Health Care System, 4150 Clement Street, SF, CA 94121 and/or within 45 minutes from the facility.

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

1.4. Policy/Directives/Handbooks. The contractor shall be subject to the following policies, including any subsequent updates during the period of performance. The policies listed below can be accessed electronically at the following: VA Publications VHA Publications

1.4.1. VA Directive 1663: Health Care Resources (HCR) Contracting – Buying Title 38 U.S.C. 8153.

1.4.2. VHA Directive 1003.04: VHA Patient Advocacy

1.4.3. VHA Directive 1065: Productivity and Staffing Guidance for Specialty Provider Group Practice

1.4.4. VHA Directive 1088(1): Communicating Test Results to Providers and Patients

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

1.4.6. VHA Directive 1100.20: Credentialing of Health Care Providers

1.4.7. VHA Directive 1100.21: Privileging

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

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

1.4.10. VHA Directive 1605.01: Privacy and Release of Information

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

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

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

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

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

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

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

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

1.5. Acronyms/Definitions: Terms used in this contract shall be interpreted as follows unless the context expressly requires a different construction and/or interpretation. In case of a https://www.va.gov/vapubs/ https://www.va.gov/vhapublications/index.cfm https://www.va.gov/vhapublications/index.cfm http://www.justice.gov/oip/foia_updates/Vol_XVII_4/page2.htm http://www.jointcommission.org/standards/ http://www.cdc.gov/hicpac/pdf/InfectControl98.pdf

Revision 04/01/2025 Page 2 of 38 conflict in language between the Definitions and other sections of this contract, the language in this section shall govern.

1.5.1. ABCP: American Board of Cardiovascular Perfusion

1.5.2. ACGME: Accreditation Council for Graduate Medical Education

1.5.3. ACLS: Advanced Cardiac Life Support

1.5.4. BLS: Basic Life Support

1.5.5. CDC: Centers for Disease Control and Prevention

1.5.6. CEU: Certified Education Unit

1.5.7. Clinical Privileging: Clinical Privileging is the process by which a practitioner, licensed for independent practice; e.g., without supervision, direction, required sponsor, preceptor, mandatory collaboration, etc.; is permitted by law and the facility to practice independently, to provide specific medical or other patient care services within the scope of the individual’s license, based upon the individual’s clinical competence as determined by peer references, professional experience, health status, education, training and licensure. Clinical privileges must be facility-specific and provider-specific, and within available resources.

1.5.8. CME: Continuing Medical Education

1.5.9. CMP: Civil Monetary Penalty

1.5.10. CMS: Centers for Medicare and Medicaid Services

1.5.11. CO: Contracting Officer: The person executing this contract on behalf of the Government with the authority to enter into and administer contracts and make related determinations and findings.

1.5.12. COR: Contracting Officer’s Representative: A person appointed by the CO to take necessary action to ensure the Contractor performs in accordance with and adheres to the specifications contained in the contract and to protect the interest of the Government. The COR shall report to the CO promptly any indication of non-compliance in order that appropriate action can be taken.

1.5.13. COS: Chief of Staff

1.5.14. CPARS: Contractor Performance Assessment Reporting System

1.5.15. Credentialing: Credentialing is the process of obtaining, verifying, and assessing the qualifications of a health care provider to provide care or services in or for the VA health care system. Credentials are documented evidence of licensure, education, training, experience, or other qualifications.

1.5.16. DEA: Drug Enforcement Agency

1.5.17. ED: Emergency Department

1.5.18. ECMO: Extracorporeal Membrane Oxygenation

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

1.5.20. EMR: Electronic Medical Record

1.5.21. FSMB: Federation of State Medical Boards

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1.5.22. FTE: Full Time Employee VA’s standard definition is for full time working the equivalent of 80 hours every two weeks, 2080 hours per year. However, providers may propose using their standard FTE definition.

1.5.23. HHS: Department of Health and Human Services

1.5.24. HIPAA: Health Insurance Portability and Accountability Act

1.5.25. ISO: Information Security Officer

1.5.26. Key Personnel: The individuals specified in this contract who are essential to work performance.

1.5.27. National Provider Identifier (NPI): NPI is a standard, unique 10-digit numeric identifier required by HIPAA. The Veterans Health Administration must use NPIs in all HIPAA-standard electronic transactions for individual (health care practitioners) and organizational entities (medical centers).

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

1.5.29. NP: Nurse Practitioner

1.5.30. NPPES: National Plan and Provider Enumeration System

1.5.31. OSHA: Occupational Safety and Health Administration

1.5.32. OPPE: Ongoing Provider Practice Evaluation

1.5.33. OR: Operating Room

1.5.34. PA: Physician Assistant

1.5.35. PIV: Personal Identity Verification

1.5.36. POP: Period of Performance

1.5.37. PPD: Purified Protein Derivative

1.5.38. PWS: Performance Work Statement

1.5.39. QASP: Quality Assurance Surveillance Plan

1.5.40. VHA: Veterans Health Administration

1.5.41. VetPro: Is VHA’s mandatory credentialing software platform to document the credentialing of VHA health care providers. This system facilitates completion of a uniform, accurate, and complete credentials file.

1.5.42. VISN: Veterans Integrated Services Network

1.5.43. VISTA: Veterans Integrated Systems Technology Architecture

2. QUALIFICATIONS:

2.1. Staff/Facility – The contractor shall provide 2 Full Time Equivalency Employees (FTEEs), and 1 on-call employee consisting of 3 Board Certified Perfusionists/Certified Auto transfusionist located at the SFVAHCS.

2.1.1. License: All licenses held by the key personnel working on this contract shall be full and unrestricted license to the services covered by this contract issued in any State, Territory, or Commonwealth of the United States or the District of

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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 and Autotransfusionist shall be certified with at least a minimum of ten (10) years of experience. All Perfusionists shall be a graduate of an accredited Allied Health Education Program School of Perfusion Technology and shall be certified by the American Board of Cardiovascular Perfusion, demonstrate evidence of meeting continuing education requirements and shall have performed a minimum of 1000 clinical cases. Experience shall be demonstrated in the following areas: Open heart surgery, autotransfusion, heart lung machine, membrane oxygenation, left/right heart bypass, intra-aortic balloon pumping and centrifugal ventricular assist device.

2.1.2.1. The Autotransfusionist shall have only a certification as an Autotransfusionist.

All continuing education courses required for maintaining certification must always be kept up to date. 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/Autotransfusionist fulfilling the conditions of the contract shall be subject to all bylaws, rules, and regulations of the VAMC. Each Perfusionist/Autotransfusionist shall be credentialed and privileged (if required) prior to providing services and must be found acceptable by the Facility Medical Executive Board and Medical Center Director (or designee). Credentialing and privileging is to be completed in accordance with VHA Directive 1100.20 and VHA Directive 1100.21 referenced above. The ability for an individual Perfusionist/Autotransfusionist to continue to render services under the contract shall be dependent upon demonstration of clinical competence. Clinical competency shall be assessed on an ongoing basis for all Perfusionists/Autotransfusionists and shall be reported as practitioner specific practice information, in compliance with an accreditation body with equal or better standards to The Joint Commission.

2.1.3.1. If a contract personnel(s) is not credentialed and privileged or has credentials/privileges suspended or revoked, the Contractor shall furnish an acceptable substitute without any additional cost to the government.

2.1.4. Technical Proficiency: Contract personnel(s) shall be technically proficient in the skills necessary to fulfill the government’s requirements, including the ability to speak, understand, read and write English fluently. Contractor shall provide documents upon request of the CO/COR to verify current and ongoing competency, skills, certification and/or licensure related to the provision of care, treatment and/or services performed. Contractor shall provide verifiable evidence of all educational and training experiences including any gaps in educational history for all contract personnel(s) and contract personnel(s) shall be

Revision 04/01/2025 Page 5 of 38 responsible for abiding by the Facility's Medical Staff By-Laws, rules, and regulations (referenced herein) that govern medical staff behavior.

2.1.5. Continuing Medical Education (CME)/ Certified Education Unit (CEU) Requirements: Contractor shall provide the COR copies of current CMEs as required or requested by the facility. Contract personnel(s) registered or certified by national/medical associations shall continue to meet the minimum standards for CME to remain current. Contractor shall report CME hours to the credential’s office for tracking. These documents are required for both privileging and re-privileging. Failure to provide shall result in loss of privileges for contract personnel(s).

2.1.6. Training (ACLS, BLS, EHR and VA MANDATORY): Contractor shall meet all VA educational requirements and mandatory course requirements defined herein; all training must be completed by the contractor’s physician(s) as required by the VA. Other training may become required. VA will communicate any changes to the training requirement to the contractor.

Training Frequency (once a year, etc.)

Annual Hours

Prevention of Workplace Harassment/No Fear Act

Annually 1.5

VA Privacy and Information Security Awareness and Rules of Behavior

Annually 1

VHA Privacy and HIPAA Focused Training

Annually 1

2.1.7. STANDARD INFECTION CONTROL MEASURES (PPD, IMMUNIZATIONS,

ETC.): Contractor shall provide proof of the following for physicians within five (5) calendar days after contract award and prior to the first duty shift to the COR and Contracting Officer. Tests shall be current within the past year.

2.1.7.1. TUBERCULOSIS TESTING: Contractor shall provide proof of a negative Tuberculosis Skin Test (TST) or interferon-gamma release assays (IGRA) for all Contractor’s physician(s) upon hire in accordance with CDC guidance.

(This is applicable to all health care workers). A negative chest radiographic report for active tuberculosis shall be provided in cases of positive TST or IGRA results.

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

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

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

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2.1.7.5. INFLUENZA: Contractors shall provide proof that all Contractor physicians have received the annual Influenza vaccine unless it is contraindicated. If the Contractor physician has a medical contraindication to the vaccine, they shall be required to wear a mask during the Influenza season. {This is applicable to all health care workers}.

2.1.7.6. OSHA REGULATION CONCERNING OCCUPATIONAL EXPOSURE TO

BLOODBORNE PATHOGENS: Contractor shall provide evidence of completing and passing generic self-study blood-borne pathogen training for all Contractor’s physician (s) {This is applicable to all health care workers};

provide their own Hepatitis B vaccination series and hepatitis B surface antigen test results following the hepatitis B vaccination series; maintain an exposure determination and control plan; maintain required records; and ensure that proper follow-up evaluation is provided following an exposure incident.

2.1.7.7. The facility shall notify the Contractor of any significant communicable disease exposures as appropriate. Contractor shall adhere to current CDC/HICPAC Guideline for Infection Control in health care personnel (as published in American Journal for Infection Control- AJIC 1998; 26:289-354 http://www.cdc.gov/hicpac/pdf/InfectControl98.pdf) for disease control.

Contractor shall provide follow up documentation of clearance to return to the workplace prior to their return.

2.1.8. National Provider Identification (NPI): NPI is a standard, unique 10-digit numeric identifier required by HIPAA. The Veterans Health Administration must use NPIs in all HIPAA-standard electronic transactions for individual (health care practitioners) and organizational entities (medical centers). The Contractor shall have or obtain appropriate NPI and if pertinent the Taxonomy Code confirmation notice issued by the Centers for Medicare and Medicaid Services (CMS) National Plan and Provider Enumeration System (NPPES) be provided to the Contracting Officer with the proposal.

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

2.1.10. Citizenship related Requirements:

2.1.10.1. The Contractor certifies that the Contractor shall comply with any and all legal provisions contained in the Immigration and Nationality Act of 1952, As Amended; its related laws and regulations that are enforced by Homeland http://www.cdc.gov/hicpac/pdf/InfectControl98.pdf

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Security, Immigration and Customs Enforcement and the U.S Department of Labor as these may relate to non-immigrant foreign nationals working under contract or subcontract for the Contractor while providing services to Department of Veterans Affairs patient referrals.

2.1.10.2. While performing services for the Department of Veterans Affairs, the Contractor shall not knowingly employ, contract or subcontract with an illegal alien; foreign national non-immigrant who is in violation their status, as a result of their failure to maintain or comply with the terms and conditions of their admission into the United States. Additionally, the Contractor is required to comply with all “E-Verify” requirements consistent with “Executive Order 12989” and any related pertinent Amendments, as well as applicable Federal Acquisition Regulations.

2.1.10.3. If the Contractor fails to comply with any requirements outlined in the preceding paragraphs or its Agency regulations, the Department of Veterans Affairs may, at its discretion, require that the foreign national who failed to maintain their legal status in the United States or otherwise failed to comply with the requirements of the laws administered by Homeland Security, Immigration and Customs Enforcement and the U.S Department of Labor, shall be prohibited from working at the Contractor’s place of business that services Department of Veterans Affairs patient referrals; or other place where the Contractor provides services to veterans who have been referred by the Department of Veterans Affairs; and shall form the basis for termination of this contract for breach.

2.1.10.4. This certification concerns a matter within the jurisdiction of an agency of the United States and the making of a false, fictitious, or fraudulent certification may render the maker subject to prosecution under 18 U.S.C. 1001.

2.1.10.5. The Contractor agrees to obtain a similar certification from its subcontractors. The certification shall be made as part of the offerors response to the RFP using the subject attachment in Section D of the solicitation document.

2.1.11. Annual Office of Inspector General (OIG) Statement: In accordance with HIPAA and the Balanced Budget Act (BBA) of 1977, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) has established a list of parties and entities excluded from Federal health care programs. Specifically, the listed parties and entities may not receive Federal Health Care program payments due to fraud and/or abuse of the Medicare and Medicaid programs.

2.1.11.1. Therefore, Contractor shall review the HHS OIG List of Excluded Individuals/Entities on the HHS OIG web site referenced above to ensure that the proposed contract physician (s) are not listed. Contractor should note that any excluded individual or entity that submits a claim for reimbursement to a Federal health care program, or causes such a claim to be submitted, may be subject to a Civil Monetary Penalty (CMP) for each item or service furnished during a period that the person was excluded and may also be subject to treble damages for the amount claimed for each item or service. CMP’s may also be imposed against the Contractor that employ or enter into contracts with excluded individuals to provide items or services to Federal program beneficiaries.

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2.1.11.2. By submitting their proposal, the Contractor certifies that the HHS OIG List of Excluded Individuals/Entities has been reviewed and that the Contractors are and/or firm is not listed as of the date the offer/bid was signed.

2.2. Clinical/Professional Performance: The qualifications of Contractor personnel are subject to review by VA Medical Center COS or his/her clinical designee and approval by the Medical Center Director as provided in VHA Directive 1100.20 and VHA Directive 1100.21. Clinical/Professional performance monitoring and review of all clinical personnel covered by this contract for quality purposes will be provided by the facility COS and/or the Chief of the Service or his designee. A clinical COR may be appointed, however, only the CO is authorized to consider any contract modification request and/or make changes to the contract during the administration of the resultant contract.

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

2.4. Indemnification: The Contractor shall be liable for, and shall indemnify and hold harmless the Government against, all actions or claims for loss of or damage to property or the injury or death of persons, arising out of or resulting from the fault, negligence, or act or omission of the Contractor, its agents, or employees.

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

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

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

2.7.1. Workers’ compensation

2.7.2. Professional liability insurance

2.7.3. Health examinations to include:

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

2.7.3.2. 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

2.7.3.3. Evidence of a Hepatitis C titer

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

2.7.4. Income tax withholding, and

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2.7.5. Social security payments

2.8. Tort Liability: The Federal Tort Claims Act does not cover Contractor or contract personnel(s). When Contractor or contract personnel(s) has been identified as a provider in a tort claim, the Contractor shall be responsible for notifying their legal counsel and/or insurance carrier. Any settlement or judgment arising from a Contractor’s (or contract provider (s)) action or non-action shall be the responsibility of the Contractor and/or insurance carrier.

2.9. Key Personnel:

2.9.1. The VA Full Time Equivalency (FTE) for the services required is 1.

2.9.2. The number of Board Certified Perfusionists required to be on site daily is 3 and the number of Certified Autotransfusionist is 1 as defined in paragraph Hours of Operation of this section.

2.9.3. The Contractor shall be responsible for providing coverage to the VA during periods of vacancies of the Contractor’s personnel due to sick leave, personal leave, vacations and additional coverage as required. In the event a scheduled provider is unable to complete an assigned shift, the contractor shall provide replacement provider coverage within 2 hours and notify the Contracting Office Representative (COR) immediately of the schedule change.

2.10. Personnel Substitutions: During the first ninety (90) calendar days of performance, the Contractor shall make NO substitutions of key personnel unless the substitution is necessitated by illness, death or termination of employment. The Contractor shall notify the CO, in writing, within 15 calendar days after the occurrence of any of these events and provide the information required below. After 90 days, the Contractor shall submit the information required below to the CO at least 15 calendar days prior to making any permanent substitutions.

2.10.1. The Contractor shall provide a detailed explanation of the circumstances necessitating the proposed substitutions, complete resumes for the proposed substitutes, and any additional information requested by the CO. Proposed substitutes shall have comparable qualifications to those of the persons being replaced. The CO will notify the Contractor within 15 calendar days after receipt of all required information of the decision on the proposed substitutes. The contract will be modified to reflect any approved changes of key personnel.

2.10.2. For temporary substitutions where the key person shall not be reporting to work for three (3) consecutive workdays or more, the Contractor shall provide a qualified replacement for the key person. The substitute shall have comparable qualifications to the key person. Any period exceeding two weeks will require the procedure as stated above.

2.10.3. The Government reserves the right to refuse acceptance of any Contractor personnel at any time after performance begins, if personal or professional conduct jeopardizes patient care or interferes with the regular and ordinary operation of the facility. Breaches of conduct include intoxication or debilitation resulting from drug use, theft, patient abuse, dereliction or negligence in performing directed tasks, or other conduct resulting in formal complaints by patient or other staff members to designated Government representatives.

Standards for conduct shall mirror those prescribed by current federal personnel

Revision 04/01/2025 Page 10 of 38 regulations. Should the VA COS or designee show documented clinical problems or continual unprofessional behavior/actions with any contract personnel(s), s/he may request, without cause, immediate replacement of said contract personnel(s).

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

2.10.5. Contingency Plan: Because continuity of care is an essential part of the Facility’s medical services, The Contractor shall have a contingency plan in place to be utilized if the contract personnel(s) leaves Contractor’s employment or is unable to continue performance in accordance with the terms and conditions of the resulting contract.

2.10.6. Note: Evidence of completion of required licensure, credentials, required training, current competencies and background investigations must be validated for all contractor personnel referred to perform services under this contract prior to providing direct patient care. Contractor shall not have any personnel report to duty until written notification is received from the Contracting Officer advising that the candidate (s) presented has met all requirements for contract performance.

3. VA HOURS OF OPERATION/SCHEDULING:

3.1. VA Business Hours: VA business hours/hours of operation are Monday through Friday, 8:00 a.m. – 4:30 p.m.

3.1.1. Work Schedule: Regular work hours are Monday through Friday for eight (8) hours a day from 8:00 a.m. to 4:30 p.m.

3.1.2. Off-hours Coverage: Contractor must make the Contractor’s perfusionist(s) available on- call during all hours when the VAPAHCS OR and Cath Lab are closed, including evenings, weekends and holidays.

3.1.2.1. On-call contractor’s perfusionist(s) must be available at all times to provide on-site perfusion services within 30 minutes of a page or call when medically indicated.

3.2. Federal Holidays:

• New Year’s Day

• Martin Luther King’s Birthday

• President’s Day

• Memorial Day

• Juneteenth

• Independence Day

• Labor Day

• Columbus Day

• Veterans Day

• Thanksgiving Day

• Christmas Day

• Any day specifically declared to be a national holiday.

4. CONTRACTOR RESPONSIBILITIES:

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

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

4.2. Standards of Care: The contract personnel(s)’ care shall cover the range of Perfusionist/Autotransfusion services as would be provided in a state-of-the-art civilian medical treatment facility and the standard of care shall be of a quality, meeting or exceeding currently recognized national standards as established by:

4.2.1. American Board of Cardiovascular Perfusion:

http://www.abcp.org

4.2.2. The professional standards of The Joint Commission (TJC):

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

4.2.3. The standards of the American Hospital Association (AHA):

http://www.hpoe.org/resources?show=100&type=8

4.2.4. The requirements contained in this PWS.

4.3. MEDICAL RECORDS

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

4.3.2. HIPAA: This contract and its requirements meet exception in 45 CFR 164.502(e), and do not require a BAA in order for Covered Entity to disclose Protected Health Information to: a health care provider for treatment. Based on this exception, a BAA is not required for this contract. Health records generated by this contract or provided to the Contractors by the VA are covered by the VA system of records entitled ‘Patient Medical Records-VA’ (24VA10A7). Contractor generated VA Patient records are the property of the VA and shall not be accessed, released, transferred, or destroyed except in accordance with applicable laws and regulations. Contractor shall ensure that all records pertaining to medical care and services provided to VA patients are captured in the VA electronic health record system as required by VA policy as discussed in 4.3.4.

4.3.3. Disclosure: Contract personnel(s) may have access to patient medical records for the purpose of providing medical care and services to VA patients and performing services under the contract; however, Contractor shall obtain permission from the VA before disclosing any patient information outside VA. VA authorizes the Contractor to discuss patient health information for coordination of care with community health care providers in compliance with VA regulations, HIPAA and VHA Directive 1605.01, Privacy and Release of Information. The VA will provide the Contractor with a copy of VHA Directive 1907.01, Health Information Management and Health Records and VHA Directive 1605.01, Privacy and Release of Information. The penalties and liabilities for the 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 https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=3088 https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=3088 https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=3233 https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=3233

Revision 04/01/2025 Page 12 of 38 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 Directive 1907.01 Health Information Management and Health Records:

https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=9235 and all guidelines provided by the Facility.

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. Contractor will not release or disclose copies of records and will refer all such requests to the Release of Information Department at the VA facility were assigned.

4.3.6. Management for Medical Records: National Archives and Records Administration record disposition requirements are found in RCS 10-1 Chapter 6, 6000 series.

4.3.7. 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.

4.3.8. 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.

4.3.9. 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.

4.3.10. 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. Contract personnel(s) shall maintain computer access and prepare for cases the following day by obtaining the patient information and record within the current electronic health record system for review.

4.3.11. Contract personnel(s) shall participate in quality improvement projects, initiatives, and reporting as requested.

4.3.11.1. VA utilizes a fully automated electronic medical record. The EMR consists of two primary components. The first is the Veterans Health Information System and Technology Architecture (VISTA), which consists of commercial hardware and software developed by the VA.

VISTA is a collection of over 100 applications that make up a comprehensive hospital information system. It includes both medical records and clinical applications or packages such as order entry, https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=9235

Revision 04/01/2025 Page 13 of 38 progress note, laboratory, radiology, and scheduling/admission-discharge-transfer and discharge summary. The present VISTA packages combined comprise an estimated 80 percent of the information maintained in the EMR. Contract personnel(s) shall be responsible for viewing the patient record within the EHR and will not be utilizing the VISTA system.

4.3.11.2. 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.

4.3.11.3. The second component uses optical disk imaging technology to meet the remaining 20 percent of the EMR information needs such as advance directive/guardianship papers, medical record documentation from non-VA facilities and informed consents.

4.3.11.4. VA will provide the necessary training to contract personnel(s) on the proper use and operation of the current computerized medical records system (Electronic Health Record - EHR). Contractor agrees and shall instruct their employees in signing computer security access agreements and is bound by confidentiality and release of information restrictions. For purposes of clarity, where the VA Forms reference “Contracted Employee Name” it shall mean “Contractor’s Employee Name.”

4.4. Direct Patient Care: 99.8% of the time involved in direct patient care. The Perfusionists and Autotransfusionist role will be 90% to patient care related.

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

4.4.1.1. 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/Autotransfusion Services in the treatment of care for eligible veteran beneficiaries as referred and authorized by the Malcom Randall 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.

4.4.1.2. The Autotransfusionist is responsible to check the OR schedule daily for surgical procedures requiring Autotransfusionist services; coordinate scheduled periodic preventative maintenance and repair calls for VA owned equipment and maintain a record of such; assure a minimum of four complete sets of supplies for open heart and Autotransfusion cases are available at any given time; sets up and operates Autotransfusion pump for surgical

Revision 04/01/2025 Page 14 of 38 procedures other than open heart. Also, generates a record during each surgical case to include the surgical time of the procedure and the amount of autotransfused blood given to Anesthesiology for delivery to the patient and handle breakdown of disposable within autotransfusion pump after completion of each procedure.

4.4.1.3. Reporting Information for Treatment: Access to the VA EHR shall be provided to the perfusionists/autotransfusionist, including the ability to printout a report of those services provided by the perfusionists/autotransfusionist. A detailed treatment plan which includes an initial assessment, recommended plan of treatment and expected outcomes will be entered in the patient's clinical record within twenty-four hours of initiating treatment and at a minimum contain the following information:

• Patient’s name and identification number

• Treating Physician's name and telephone number for follow-up questions

• Pertinent History

• Physical Findings

• Summary of the Recommended Treatment Plan

• Date treatment was initiated or is planned

• Anticipated or actual date that treatment was completed

• Follow-up Recommendations/Results of the Treatment

• Instructions given to the patient

4.4.1.4. It is the Perfusionists responsibility to view the patient record within the current electronic health record prior to the surgery to review the surgeon’s plan of care.

4.4.1.5. COMMUNICATING TEST RESULTS TO PROVIDERS AND PATIENTS: In accordance with VHA Directive 1088, Communicating Test Results to Providers and Patients, all test results requiring action must be communicated by the ordering provider, or designee, to patients no later than 7 calendar days from the date on which the results are available. For test results that require no action, results must be communicated by the ordering provider, or designee, to patients no later than 14 calendar days from the date on which the results are available. The Contractor shall provide the VA with the name, pager and telephone numbers of a LIP (physician, nurse practitioner, or physician assistant) at the Outpatient Site of Care to accept critical test results discovered on tests done by the VA.

For critical results, the LIP must respond back to the VA within forty-five

(45) minutes of the initial page or telephone call. The receiving LIP will document the results in the record and conduct a “read back” procedure to ensure accuracy of transmission and translation of all verbal results The contractor shall determine a plan to fulfill critical test result procedures, per VA policy. VA will not be responsible for the failure of the Contractor to receive critically abnormal test results. Critical results must be reported to the clinician by the radiologist by telephone. Documentation of this notification, “who, when” must appear in the radiology report. For critical

Revision 04/01/2025 Page 15 of 38 results that represent an imminent danger to the patient, the Contractor shall notify the patient immediately. See policy in section D (attachments) for additional requirements regarding communication of test results.

Mechanisms must be in-place to provide notification of test results for patients receiving care in accordance with VHA Directive 1088, Communicating Test Results to Providers and Patients.

4.5. ADMINISTRATIVE: estimated 0.2% of time not involved in direct patient care

4.5.1. Quality Improvement Meetings: The Contractor’s physician(s) shall participate in continuous quality improvement activities and meetings with committee participation as required by the facility Chief of Service, Chief of Staff, or designee.

Training Frequency Hours Prevention of Workplace Harassment/No Fear Annually 1.5 Privacy and HIPPA Training Annually 1

VA Privacy and Information Awareness and Rules of Behavior Annually 1

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

4.5.3. 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 documented in the medical record of those impacted and disclosed to the patient or surrogate. As soon as practicable (but within 24 hours) Contractors shall notify COR of incident and submit an entry in the Patient Safety Reporting System, following up with COR as required or requested.

4.6. PERFORMANCE STANDARDS, QUALITY ASSURANCE (QA) SURVEILLANCE

PLAN AND QUALITY IMPROVEMENT(QI)

4.6.1. 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

Revision 04/01/2025 Page 16 of 38 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.

4.6.2. 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.

4.6.3. 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.

4.6.4. Performance Standards:

4.6.4.1. Measure: Provider Quality Performance

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

Standard: OPPE documentation for all (100%) staff providing services under the contract

Acceptable Quality Level: 100% meets standards.

Surveillance Method: OPPE data pertinent to care performed for each provider working under this contract. OPPE data will review the following elements:

a. Patience Care Performance

b. Medical/Clinical knowledge

c. Practiced Based Learning & Improvement

d. Interpersonal & Communication Skills

e. Professionalism

f. System Based Practice

Frequency: Quarterly

4.6.4.2. 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: 100% meets standards.

Revision 04/01/2025 Page 17 of 38

Surveillance Method: Random Sampling of qualification documents

Frequency: Annually

4.6.4.3. 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: 100% meets standards.

Surveillance Method: Random Sampling of records

Frequency: Annually

4.6.4.4. 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: 97% meets standards.

Surveillance Method: Periodic Inspection

Frequency: Quarterly

4.6.4.5. 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: 97% meets standards.

Surveillance Method: Random Sampling of Time and Attendance Sheets

Frequency: Quarterly

4.6.4.6. Measure: Patient Safety

Performance Requirement: Patient safety incidents shall be reported using VA Patient Safety Reporting System. All incidents shall be reported immediately (within 24 hours)

Standard: All of patient safety…