Description of Services Perfusion-Autotransfusion.pdf

PERFORMANCE WORK STATEMENT

PERFUSION/AUTOTRANSFUSION SERVICES

1. GENERAL:

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

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

1.3. Authority: Title 38 USC 8153, Health Care Resources (HCR) sharing Authority and FAR parts used (FAR 12 in combination with 15)

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

1.1.1. VA Directive 1663: Health Care Resources (HCR) Contracting – Buying Title 38 U.S.C. 8153 https://www1.va.gov/vapubs/viewPublication.asp?Pub_ID=969&FType=2

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 https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=1364

1.4.6. VHA Directive 1100.20: Credentialing of Health Care Providers https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=2910

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 https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=3088

1.4.12. VHA Handbook 1100.17: National Practitioner Data Bank (NPDB) Reports https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=2135

1.4.13. VHA Handbook 1400.04: Supervision of Associated Health Trainees

VHANHMCarteS Cross-Out

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

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

1.4.15. Joint Commission:

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

1.4.16. HHS OIG Website:

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

1.4.17. 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 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

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 perfusion service coverage for the Open-Heart Surgery Program and the Liver Transplant Program at the VA Pittsburgh Healthcare System (VAPHS), University Drive Division, Pittsburgh, PA 15240. Up to two (2) Board Certified Perfusionists will be available for all perfusion-related duties or any other procedure requiring perfusion services.

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

2.2.1. License - All licenses held by the personnel working on this contract shall be full and unrestricted license to the services covered by this contract issued in any State, Territory, or Commonwealth of the United States or the District of Columbia. Contract personnel shall submit evidence of current, full, and unrestricted licenses, registration, certification, and/or other relevant credentials for verification prior to appointment and throughout the employment process, as requested by the COR. Contractor is responsible for immediate notification of the COR regarding any matter that might adversely affect or otherwise limit their clinical privileges. Failure to meet this requirement may result in termination of the contract.

2.2.2. Board Certification – The contractor’s employees and any subcontractors shall have all licenses, permits, and certifications as required by law and this contract. All Perfusionists shall be certified with at least a minimum of one year of experience. All Perfusionists shall be a graduate of an accredited Allied Health Education Program School of Perfusion Technology and shall be certified by the American Board of Cardiovascular Perfusion, demonstrate evidence of meeting continuing education requirements, and shall have performed a minimum of 40 clinical cases per year.

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

2.2.3. Credentialing and Privileging - Contract Perfusionists fulfilling the conditions of the contract shall be subject to all bylaws, rules, and regulations of the VAMC. Each Perfusionist shall be credentialed and privileged prior to providing services and must be found acceptable by the Medical Executive Board. Credentialing and privileging are to be completed in accordance with VHA Handbook 1100.19 referenced above. The ability for an individual Perfusionist to continue to render services under the contract shall be dependent upon demonstration of clinical competence. Clinical competency shall be assessed on an ongoing basis, applicable to all Perfusionists, and to be reported as provider specific practice information at the time or an accreditation body with equal or better standards Joint Commission.

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

2.2.4. Technical Proficiency - The assigned Perfusionist(s) must be competent to support percutaneous cannulation for minimally invasive and robotic surgery and must have experience in liver transplant perfusion. The Perfusionist(s) must be capable of managing ventricular assist device (VAD) methodologies and must work closely with the VAPHS team with respect to management of complex Congestive Heart Failure (CHF) cases and redo cardiac bypass surgery, as well as aortic surgery and extracorporeal membrane oxygenation (ECMO). Contract personnel (s) shall be technically proficient in the skills necessary to fulfill the government’s requirements, including the ability to speak, understand, read, and write English fluently. Contractor shall provide documents upon request of the CO/COR to verify current and ongoing competency, skills, certification and/or licensure related to the provision of care, treatment and/or services performed. Contractor shall provide verifiable evidence of all educational and training experiences including any gaps in educational history for all contract personnel(s) and contract personnel (s) shall be responsible for abiding by the Facility's Medical Staff By-Laws, rules, and regulations (referenced herein) that govern medical staff behavior.

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

2.2.6. Training (BLS and VA MANDATORY): Contractor shall meet all VA educational requirements and mandatory course requirements defined herein; all training must be completed by the Contractor’s cardiac Perfusionist(s) as required by the VA.

Training (The following training is mandatory per VHACO for Contracted Physicians and clinicians)

Frequency (once a year, etc)

Annual Hours

Active Threat Training Once a Year 1 Blood Administration:

Complications

Once a Year 1

Blood Administration:

Administration (all contract employees who administer blood components)

Once a Year 1

Government Ethics Once a Year 1 Hospice and Palliative Care for VA Clinicians

Once a Year 1

Military Sexual Trauma (MST) for Medical Providers

Once a Year 1

Moderate Sedation In- Service Training

Once a Year 1

Prevention of Workplace Harassment/No Fear Act

Once a Year 1

VA Core Values Training (ICARE Recommitment)

Once a Year 1

VA Privacy and Information Security Awareness and Rules of Behavior

Once a Year 1

VHA Privacy and HIPAA Focused Training

Once a Year 1

BLS Once a Year 1 Patient Safety Once a Year 1 Patient Rights Once a Year 1 Patient Abuse Once a Year 1 Prevention/Managem ent of Disruptive Behavior/Violence Prevention Level I

Once a Year 1

Suicide Prevention:

Suicide Risk Management Training for Clinicians

Once a Year 1

SUX Infection Control and Bood Borne Pathogens

Once a Year 1

Opioid Overdose and Naloxone/Narcan Administration

Once a Year 1

CPRS Once a Year 1 VISTA Imaging Once a Year 1

2.2.7. Standard Personnel Testing (PPD, etc.): Contractor shall provide proof of the following tests for physicians within five (5) calendar days after contract award and prior to the first duty shift to the COR and Contracting Officer. Tests shall be current within the past year.

2.2.7.1. TUBERCULOSIS TESTING: Contractor shall provide proof of a negative Tuberculosis Skin Test (TST) or interferon-gamma release assays (IGRA) for all Contractor’s physician (s) {This is applicable to all health care workers}. A negative chest radiographic report for active tuberculosis shall be provided in cases of positive TST or IGRA results. The TST or IGRA testing shall be repeated annually.

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

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

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

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

2.2.7.6. OSHA REGULATION CONCERNING OCCUPATIONAL EXPOSURE TO BLOODBORNE PATHOGENS: Contractor shall provide evidence of completing and passing generic self-study blood-borne pathogen training for all Contractor’s physician (s) {This is applicable to all health care workers}; provide their own Hepatitis B vaccination series and hepatitis B surface antigen test results following the hepatitis B vaccination series; maintain an exposure determination and control plan; maintain required records; and ensure that proper follow-up evaluation is provided following an exposure incident.

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

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

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

2.2.10. Citizenship related Requirements:

2.2.10.1. The Contractor certifies that the Contractor shall comply with any and all legal provisions contained in the Immigration and Nationality Act of 1952, As Amended; its related laws and regulations that are enforced by Homeland Security, Immigration and Customs Enforcement and the U.S Department of Labor as these may relate to non-immigrant foreign nationals working under contract or subcontract for the Contractor while providing services to Department of Veterans Affairs patient referrals;

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

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

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

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

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

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

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

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

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

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

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

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

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

2.8.1. Workers’ compensation

2.8.2. Professional liability insurance

2.8.3. Health examinations to include:

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

2.8.5. Evidence of Hepatitis B immunity (hepatitis immune titer, if the individual has had the series of shots; if no immunity, evidence that the individual has started the Hepatitis B vaccination series

2.8.6. Evidence of a Hepatitis C titer

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

2.8.8. Income tax withholding, and

2.8.9. Social security payments

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

2.10. Key Personnel:

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

2.10.2. The Contractor shall be responsible for providing coverage to the VA during periods of vacancies of the Contractor’s personnel due to sick leave, personal leave, vacations, and additional coverage as required. In the event a scheduled provider is unable to complete an assigned shift, the contractor shall provide replacement provider coverage within 2 hours and notify the Operating Room Program Support Clerk at the VA Pittsburgh Healthcare System, University Drive Division immediately of the schedule change.

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

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

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

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

2.11.3. The Government reserves the right to refuse acceptance of any Contractor personnel at any time after performance begins, if personal or professional conduct jeopardizes patient care or interferes with the regular and ordinary operation of the facility. Breaches of conduct include intoxication or debilitation resulting from drug use, theft, patient abuse, dereliction, or negligence in performing directed tasks, or other conduct resulting in formal complaints by patient or other staff members to designated Government representatives. Standards for conduct shall mirror those prescribed by current federal personnel regulations. Should the VA COS or designee show documented clinical problems or continual unprofessional behavior/actions with any contract personnel (s), s/he may request, without cause, immediate replacement of said contract personnel (s).

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

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

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

3. VA HOURS OF OPERATION/SCHEDULING:

3.1. VA Business Hours: VA business hours/hours of operation are 6:30 am – 7:00 pm Monday – Friday.

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

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

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

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

3.5. Federal Holidays:

• • New Year’s Day

• • Martin Luther King’s Birthday

• • President’s Day

• • Memorial Day

• • Independence Day

• • Labor Day

• • Columbus Day

• • Veterans Day

• • Thanksgiving Day

• • Christmas Day

• • Any day specifically declared by the President of the United States to be a national holiday.

4. CONTRACTOR RESPONSIBILITIES:

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

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

4.2. Standards of Care: The contract personnel(s)’ care shall cover the range of Perfusionist services as would be provided in a state-of-the-art civilian medical treatment facility, and the standard of care shall be of a quality, meeting or exceedingly currently recognized national standards as established by 4.2.1. American Board of Cardiovascular Perfusion: http://www.abcp.org

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

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

4.2.5. The requirements contained in this PWS.

4.3. MEDICAL RECORDS

4.3.1. Authorities: Contract personnel (s) providing healthcare services to VA patients shall be considered as part of the Department Healthcare Activity and shall comply with the U.S.C.551a (Privacy Act), 38 U.S.C. 5701 (Confidentiality of claimants records), 5 U.S.C. 552 (FOIA), 38 U.S.C.

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

4.3.2. HIPAA: This contract and its requirements meet exception in 45 CFR 164.502(e), and do not require a BAA for Covered Entity to disclose Protected Health Information to: a Health Care provider for treatment. Based on this exception, a BAA is not required for this contract. Treatment and administrative patient records generated by this contract or provided to the Contractors by the VA are covered by the VA system of records entitled ‘Patient Medical Records-VA’ (24VA19). Contractor generated VA Patient records are the property of the VA and shall not be accessed, released, transferred, or destroyed except in accordance with applicable laws and regulations. Contractor shall ensure that all records pertaining to medical care and services are available for immediate transmission when requested by the VA. Records identified for review, audit, or evaluation by VA representatives and authorized federal and state officials, shall be accessed on-site during normal business hours or mailed by the Contractor at his expense. Contractor shall deliver all final patient records, correspondence, and notes to the VA within twenty-one (21) calendar days after the contract expiration date.

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

4.3.4. Professional Standards for Documenting Care: Care shall be appropriately documented in medical records in accordance with standard commercial practice and guidelines established by VHA Handbook 1907.01 Health Information Management and Health Records:

http://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=2791 and all guidelines provided by the VAMC.

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

Additionally, the Contractor shall use VA Form 10-5345, Request for and Authorization to Release Medical Records or Health Information, when releasing records protected by 38 U.S.C. 7332. Treatment and release records shall include the patient’s consent form. Completed Release of Information requests will be forwarded to the consent form. Completed Release of Information requests will be forwarded to the VA Pittsburgh Healthcare System Release of Information Department 136H4-A at the following address:

1010 Delafield Road Pittsburgh, PA 15215

Phone number: (412) 822-1143 Fax number: (412) 822-1161

4.3.6. 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.

4.3.7. 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.

4.3.8. 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.

4.3.9. Records created by contract personnel (s) while 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 CPRS system for review.

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

4.3.10.1. 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, 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 CPRS and will not be utilizing the VISTA system.

4.3.10.2. 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.

4.3.10.3. 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.

4.3.10.4. VA will provide the necessary training to contract personnel (s) on the proper use and operation of the computerized medical records system (Computerized Patient Recordkeeping System - VA CPRS). 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 % of the time involved in direct patient care. The Perfusionists role will be 99% 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 Cardiac/Liver Perfusion care as well as other modalities such as ventricular assist device support and extracorporeal membrane oxygenation (ECMO) support, including, but not limited to:

4.4.1.1. All Perfusionists shall assist the Cardiac Surgery service with by-pass surgical cases and valve replacement of various types. The contractor shall perform onsite Cardiac/Liver Perfusion Services in the treatment of care for eligible veteran beneficiaries as referred and authorized by the VA Pittsburgh Healthcare System, University Drive 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, cleaning, 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 Cardiac surgeon attending will oversee the activity of the Perfusionists during cardiac surgery.

4.4.1.3. The contractor will assign Perfusionists who have knowledge of Cobe, Haemonetics, BioMedicus, Sarns and Datascope equipment, as well as the ability to adapt additional equipment as necessary. Perfusionists will be familiar with the operation of cardiopulmonary bypass equipment so that minor repairs may be made on an emergent basis in the event of equipment failure during a procedure. The VA Pittsburgh Healthcare System Biomedical Department is responsible for major and non-procedure occurrence repair and maintenance (other than cleaning) for all VAMC-owned cardiopulmonary and perfusion-related equipment.

4.4.1.4. The contractor will designate a Perfusionist to act in the capacity as Charge Perfusionist for the administrative services provided by the contractor.

4.4.1.5. Perfusionists assigned by the contractor will have the ability to:

4.4.1.5.1. Set up and operate cardiopulmonary bypass equipment, conduct cardiopulmonary bypass, monitor, and document all patient perfusion parameters, and make necessary adjustments for routine and emergent procedures requiring cardiopulmonary support.

4.4.1.5.2. Operate all associated perfusion equipment including cardioplegia, cell saver, intra-aortic balloon device (IABD), femoral-femoral cardiopulmonary support (emergency bypass), extracorporeal membrane oxygenation (ECMO) as necessary.

4.4.1.5.3. Administer medications and blood components via bypass as necessary after consultation with the attending cardiac surgeon or anesthesiologists.

4.4.1.5.4. Assist in trouble shooting IABD problems.

4.4.1.5.5. Operate veno-venous bypass machine for liver transplant procedures.

4.4.1.5.6. Clean all perfusion equipment at the end of the procedure.

4.4.1.5.7. Arteriocyte-Magellan Bone Marrow Aspirate Concentrate (BMAC). Coverage Period 24 hours per day 7 days per week with response time commitment 1 hour. 4.4.1.5.7.1. Set up and confirmation of device function.

4.4.1.5.7.2. Assist anesthesia provider with whole blood phlebotomy.

4.4.1.5.7.3. Assist surgical technologist and surgeon with bone marrow aspirate draw.

4.4.1.5.7.4. Prepare BMAC

4.4.1.5.7.5. Dispense and support surgical technologist and surgeon with applicator preparation and administration of BMAC.

4.4.1.5.7.6. Provide patient record of procedure.

4.4.1.5.7.7. Pending VA administration decision, support quality improvement program to include lab sampling and reporting of performance indicators.

4.4.1.5.8. Ensure adequate inventory levels are maintained by coordinating the request for supply replacements with VAMC Operating Room Staff through VAPHS Logistics personnel as may be needed.

4.4.1.5.9. Promote patient safety before, during, and after the operation.

4.4.1.5.10. Maintain aseptic technique.

4.4.1.5.11. Assist in the evaluation of new products and procedures.

4.4.1.5.12. Develop troubleshooting algorithms for all low flow emergencies. Utilizing the same equipment set up that would be used at this facility.

Including but not limited to: Decoupling, inadvertently pulling cannula out, Loss of power, Machine shut-off, Clots in oxygenator, Cardiotomy clots off, Kinking or >90angle hand crank tubing.

4.4.1.5.13. Attend annual open-heart surgery training and simulation on troubleshooting low flow emergencies utilizing the same equipment set up that would be used at this facility where they learn and practice using the emergency algorithm.

4.4.1.5.14. Once identified by the service line which configuration (Terumo/Sorin or Sorin/Sorin) will be utilized appropriate training will be required.

4.4.1.6. It is the Perfusionists responsibility to view the patient record within CPRS prior to the surgery to review the surgeon’s plan of care.

4.4.1.7. Contractor will assign Perfusionists to provide continuing education for VA Pittsburgh Healthcare System Operating Room Staff as necessary, i.e., as technology changes, techniques change, etc.

4.5. ADMINISTRATIVE: estimated 1% 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, training, 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.

Meeting Frequency (once a year, etc.)

Annual Hours

Transfusion Committee Meeting

Quarterly 8

Present annual ECMO training and assist VA staff with competency validation

Annual 8-16 hours total

4.5.2. Staff Meetings: The Contractor’s Perfusionist(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.

Meeting Frequency (once a year, etc.)

Annual Hours

Staff Meetings Weekly 52

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

4.5.3.1. Perfusionists will contribute to the ongoing quality improvement programs in the organization as described in Medical Center Memorandum No. PI-3, Improving Organizational Performance, and any updates. Contractor will ensure that a Quality Improvement Report is submitted quarterly to the Vice President, Surgery Service Line. This report is to include the review of two (2) indicators – (1) Blood product usage for CABG (Coronary Artery Bypass Graft) surgery cases (2) Cell Saver accuracy for CABG surgery cases that reflects an aspect of care provided by the Perfusionists at the VA Pittsburgh Healthcare System. The report will include an action plan to correct deficiencies identified during the review.

Perfusionists will complete an Intraoperative Autologous Blood Salvage QA/QC Worksheet for all cases involving intraoperative blood salvage. The Perfusionist shall attend the Transfusion Committee meetings which are held once a quarter. It is estimated that approximately seven (7) hours per year will be required for quality assurance activities, including the Transfusion Committee meetings.

4.5.4. Patient Safety Compliance and Reporting: Contractor’s Perfusionist(s) shall follow all established patient safety and infection control standards of care. Contractor’s Perfusionist(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.

4.5.5. Perfusion duties that will be performed only at the specific request of the attending cardiac surgeon or critical care medicine physician are:

Ventricular Assist Device (VAD) and Extracorporeal Membrane Oxygenation (ECMO). These long-term life supports, usually 3-14 days in length, require skilled perfusion coverage 24 hours a day (four shifts of six…