Page 1 of Page 20 of 20 Page 1 of THIS REQUEST FOR INFORMATION (RFI) SOURCES SOUGHT IS ISSUED SOLELY FOR MARKET RESEARCH AND PLANNING PURPOSES ONLY AND DOES NOT CONSTITUTE A SOLICITATION. 1. Responses to this Sources Sought must be in writing. The purpose of this Sources Sought Announcement is for market research only to make appropriate acquisition decisions and to gain knowledge of Small Business Capability, including Service-Disabled Veteran Owned Small Businesses and Veteran Owned Small Businesses (SDVOSB/VOSB) interested and capable of performing the work. 2. The NAICS for this requirement is NACIS 541990 All Other Professional, Scientific, and Technical Services 3. Interested and capable Contractors should respond to this notice not later than 3:00 PM (PST) on April 5, 2022, by providing the following via email only to Tashodra Rogers at Tashodra.Rogers@va.gov Please provide the following: a) company name b) address c) point of contact d) phone, fax, and email of primary point of contact e) DUNS number f) Type of small business, if applicable, (e.g. Services Disabled Veteran Owned Small Business (SDVOSB), Veteran-owned small business (VOSB), 8(a), HUB-Zone, Women Owned Small Business, Small disadvantaged business, or Small Business). g) A capability statement that addresses the organization s qualifications and ability to perform as a contractor specifically for the work described in the Performance Work Statement (PWS). Respondents are also encouraged to provide specific examples (e.g. contract number, point of contact information) of the Contractor s experience providing the same or similar services to that described in the DRAFT PWS. h) Respondents are also requested to include an informal quote. This informal quote is not binding but will assist the Government with its market research. Please include the quote for the base and four (4) option years. 4. SDVOSB/VOSB respondents. a) If respondent is VOSB or SDVOSB, respondent is encouraged to provide proof of www.vetbiz.gov certification. In addition, SDVOSB/VOSB Contractors are asked to acknowledge that they understand the limitations on sub-contracting pursuant to FAR 52.219-14, Limitations on Sub-Contracting, which will be included in the impending solicitation. Further SDVOSB/VOSB contractors are asked to respond that they are capable of providing the requested services keeping within the parameters of this clause. b) Small businesses, including SDVOSB/VOSBS are also advised that per 13 CFR, § 125.6 the prime contractor's limitations on subcontracting are as follows: 1) General. In order to be awarded a full or partial small business set-aside contract with a value greater than $150,000, an 8(a) contract, an SDVO SBC contract, a HUBZone contract, a WOSB or EDWOSB contract pursuant to part 127 of this chapter, a small business concern must agree that: 2) In the case of a contract for services (except construction), it will not pay more than 50% of the amount paid by the government to it to firms that are not similarly situated. Any work that a similarly situated subcontractor further subcontracts will count towards the 50% subcontract amount that cannot be exceeded. 5. Required Services. The Contractor shall provide Board Certified Cardiovascular Perfusionist Service as specified herein for eligible veterans on an as required basis. The contract perfusionist shall provide a full range of services in accordance with the terms and conditions contained herein to eligible VA beneficiaries. 6. Please note that if VA s pending market research establishes that two or more VOSB or SDVOSB, who are certified in VA s Vendor Information Pages (VIP) site https://www.vip.vetbiz.gov/, can provide the services, VA will set aside the underlying solicitation per 38 U.S.C. §8127. 7. All Offerors who provide goods or services to the United States Federal Government must be registered in the System for Award Management (SAM) database found at https://www.sam.gov. Registration must include Representations and Certifications. DRAFT PERFORMANCE WORK STATEMENT CERTIFIED CARDIOVASCULAR PERFUSIONIST SERVICES GENERAL: Services Provided: The Contractor shall provide Board Certified Cardiovascular Perfusionist Service as specified herein for eligible veterans on an as required basis. The contract perfusionist shall provide a full range of services in accordance with the terms and conditions contained herein to eligible VA beneficiaries. Place of Performance - Contractor shall furnish services at the VA San Diego Healthcare System (VASDHS), 3350 La Jolla Village Drive, San Diego, CA 92161 Authority: Title 38 USC 8153, Health Care Resources (HCR) sharing Authority Policy/Handbooks - The contractor shall be subject to the following policies, including any subsequent updates during the period of performance: VHA Handbook 1100.17: National Practitioner Data Bank Reports https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=2135 VHA Handbook 1100.18: Reporting And Responding To State Licensing Boards https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=1364 VHA Handbook 1100.19: Credentialing and Privileging https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=2910 VHA Directive 1192: Seasonal Influenza Prevention Program https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=5472 VHA Directive 1220: Facility Procedure Complexity Designation Requirements to Perform Invasive Procedures In Any Clinical Setting https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=8365 VA Directive 1663: Health Care Resources Contracting - Buying https://www.va.gov/vapubs/viewPublication.asp?Pub_ID=969&FType=2 VHA Handbook 1907.01: Health Information Management and Health Records https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=3088 Privacy Act of 1974 (5 U.S.C. 552a) as amended http://www.justice.gov/oip/foia_updates/Vol_XVII_4/page2.htm Joint Commission http://www.jointcommission.org/standards/ HHS OIG Website http://oig.hhs.gov/exclusions/index.asp American Journal for Infection Control - AJIC 1998; 26:289-354 http://www.cdc.gov/hicpac/pdf/InfectControl98.pdf Definitions/Acronyms: Terms used in this contract shall be interpreted as follows unless the context expressly requires a different construction and/or interpretation. In case of a conflict in language between the Definitions and other sections of this contract, the language in this section shall govern. ABCP American Board of Cardiovascular Perfusion ACGME: Accreditation Council for Graduate Medical Education ACLS: Advanced Cardiac Life Support BLS: Basic Life Support CDC: Centers for Disease Control and Prevention CDR: Contract Discrepancy Report CEU: Certified Education Unit CME: Continuing Medical Education CMP: Civil Monetary Penalty CMS: Centers for Medicare and Medicaid Services 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. 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. COS: Chief of Staff CPARS: Contractor Performance Assessment Reporting System DEA: Drug Enforcement Agency ED: Emergency Department ECMO: Extracorporeal Membrane Oxygenation EHR: Electronic Health Record - electronic health record system used by the VA EMR: Electronic Medical Record FSMB: Federation of State Medical Boards FTEE: Full Time Equivalency Employee is defined by VA as a minimum of 80 hours every two weeks and does not include holidays HHS: Department of Health and Human Services HIPAA: Health Insurance Portability and Accountability Act HR: Human Resources ISO: Information Security Officer 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). NLNAC: National League for Nursing Accrediting Commission. www.nlnac.org Non-Contract Provider - any person, organization, agency, or entity that is not directly or indirectly employed by the Contractor or any of its subcontractors. NP: Nurse Practitioner NPPES: National Plan and Provider Enumeration System OSHA: Occupational Safety and Health Administration OIT: Office of Information and Technology OPM: Office of Personnel Management OPPE: Ongoing Provider Practice Evaluation OR: Operating Room PA: Physician Assistant PIV: Personal Identity Verification POP: Period of Performance PPD: Purified Protein Derivative PWS: Performance Work Statement QASP: Quality Assurance Surveillance Plan RFP: Request for Proposal VAMC: Veterans Affairs Medical Center Veterans Health Administration (VHA): The central office for administration of the VA medical centers throughout the United States. The VHA is in Washington, D.C. Veterans Integrated Services Network (VISN): The regional oversight for the VA medical centers. VISTA (Veterans Integrated Systems Technology Architecture): A PC based system that will capture and store clinical imagery, scanned documents and other non-textual data files and integrates them into patient s medical record and with the hospital information system. VetPro: a federal web-based credentialing program for healthcare providers. Veterans Affairs Medical Center (VAMC): Unless identified with the name of a different VA Medical Center, for the purpose of this contract, this term shall mean the San Diego VA Medical Center. QUALIFICATIONS: Staff/Facility The contractor shall provide 1.0 Full Time Equivalency Employees (FTEEs), consisting of 2 Board Certified Perfusionists located at the San Diego VA Medical Center. License - All licenses held by the personnel working on this contract shall be full and unrestricted license to the services covered by this contract issued in any State, Territory, or Commonwealth of the United States or the District of Columbia. Contract personnel shall submit evidence of current, full and unrestricted licenses, registration, certification, and/or other relevant credentials for verification prior to appointment and throughout the employment process, as requested by the COR. Contractor is responsible for keeping the COR informed of anything that would adversely affect or otherwise limit their clinical privileges. Failure to meet this requirement may result in termination of the contract. Board Certification The contractor s employees and any subcontractors shall have all licenses, permits, and certifications as required by law and this contract. All Perfusionists shall be certified with at least a minimum of ten (10) years of experience. All Perfusionists shall be a graduate of an accredited Allied Health Education Program School of Perfusion Technology and shall be certified by the American Board of Cardiovascular Perfusion, demonstrate evidence of meeting continuing education requirements and shall have performed a minimum of 1000 clinical cases. Experience shall be demonstrated in the following areas: Open heart surgery, autotransfusion, heart lung machine, membrane oxygenation, left/right heart bypass, intra-aortic balloon pumping and centrifugal ventricular assist device. 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. Credentialing and Privileging - Contract Perfusionist fulfilling the conditions of the contract shall be subject to all bylaws, rules and regulations of the VAMC. Each Perfusionist shall be credentialed and privileged prior to providing services and must be found acceptable by the Medical Executive committee and Governing Body. Credentialing and privileging is to be completed in accordance with VHA Handbook 1100.19 referenced above. The ability for an individual Perfusionist to continue to render services under the contract shall be dependent upon demonstration of clinical competence. Clinical competency shall be assessed on an ongoing basis, is true for all Perfusionist and to the reported as provider specific practice information at the time or an accreditation body with equal or better standards Joint Commission. 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. Technical Proficiency - Contract personnel (s) shall be technically proficient in the skills necessary to fulfill the government s requirements, including the ability to speak, understand, read and write English fluently. Contractor shall provide documents upon request of the CO/COR to verify current and ongoing competency, skills, certification and/or licensure related to the provision of care, treatment and/or services performed. Contractor shall provide verifiable evidence of all educational and training experiences including any gaps in educational history for all contract personnel(s) and contract personnel (s) shall be responsible for abiding by the Facility's Medical Staff By-Laws, rules, and regulations (referenced herein) that govern medical staff behavior. Continuing Medical Education (CME)/ Certified Education Unit (CEU) Requirements: Contractor shall provide the COR copies of current CMEs as required or requested by the VAMC. Contract personnel (s) registered or certified by national/medical associations shall continue to meet the minimum standards for CME to remain current. Contractor shall report CME hours to the credentials office for tracking. These documents are required for both privileging and re-privileging. Failure to provide shall result in loss of privileges for contract personnel (s). 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 (The following training is mandatory per VHACO for Contracted Physicians) Frequency (once a year, etc) Annual Hours Contactor Rules of Behavior Annual Training Government Ethics Annual Training VHA San Diego Safety & Environment of Care Annual Training Prevention of Workplace Harassment/No Fear Act Annual Training VA Core Values Training (ICARE Recommitment) Annual Training VA Privacy and Information Security Awareness and Rules of Behavior Annual Training VHA Privacy and HIPAA Focused Training Annual Training ACLS/BLS Every 2 years 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. 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. MEASLES, MUMPS, & RUBELLA TESTING: Contractors shall provide proof of immunity for all Contractor physicians {This is applicable to all health care workers}. VARICELLA: Contractors shall provide proof of immunity for all Contractor physicians {This is applicable to all health care workers}. ACELLULAR PERTUSSIS: Contractors shall provide proof of 1 dose of Tdap vaccination for all Contractor physicians {This is applicable to all health care workers}. 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}. 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. 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. 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. 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. Citizenship related Requirements: The Contractor certifies that the Contractor shall comply with any and all legal provisions contained in the Immigration and Nationality Act of 1952, As Amended; its related laws and regulations that are enforced by Homeland Security, Immigration and Customs Enforcement and the U.S Department of Labor as these may relate to non-immigrant foreign nationals working under contract or subcontract for the Contractor while providing services to Department of Veterans Affairs patient referrals; 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. 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. 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. 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. 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. 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. 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. 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. Non- Personal Healthcare Services: The parties agree that the Contractor and all contract personnel (s) shall not be considered VA employees for any purpose. 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. Prohibition Against Self-Referral: Contractor s physicians are prohibited from referring VA patients to contractor s or their own practice(s). 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. 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: Workers compensation Professional liability insurance Health examinations to include: Annual TB Skin Test and recent chest X-ray if there is a history of positive TB skin test 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 Evidence of a Hepatitis C titer Varicella titer if contracted employee has not had chicken pox Income tax withholding, and Social security payments Tort Liability: The Federal Tort Claims Act does not cover Contractor or contract personnel (s). When a Contractor or contract personnel (s) has been identified as a provider in a tort claim, the Contractor shall be responsible for notifying their legal counsel and/or insurance carrier. Any settlement or judgment arising from a Contractor s (or contract provider (s)) action or non-action shall be the responsibility of the Contractor and/or insurance carrier. Key Personnel: The VA Full Time Equivalency (FTE): FTE is defined by VA as a minimum of 80 hours every two weeks and does not include holidays. The number of Board Certified Perfusionists required to be on site daily as needed as defined in paragraph Hours of Operation of this section. The Contractor shall be responsible for providing coverage to the VA during periods of vacancies of the Contractor s personnel due to sick leave, personal leave, vacations and additional coverage as required. In the event a scheduled provider is unable to complete an assigned shift, the contractor shall provide replacement provider coverage within 2 hours and notify the Contracting Office Representative (COR) at the (San Diego VA Medical Center) immediately of the schedule change. Contractor shall provide the names of the contracted employee(s) assigned to the performance: Key Personnel/Substitute Name (s) Official Title FTEE (i.e.; 1.0, .5,) National Provider Identifier Number 1. Perfusionist 1.0 2. Perfusionist 1.0 Substitutes 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. 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. 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. 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). The CO and COR shall deal with issues raised concerning Contract personnel (s) conduct. The final arbiter on questions of acceptability is the CO. Contingency Plan: Because continuity of care is an essential part of VAMC s medical services, The Contractor shall have a contingency plan in place to be utilized if the contract personnel (s) leaves Contractor s employment or is unable to continue performance in accordance with the terms and conditions of the resulting contract. 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. HOURS OF OPERATION: Work Schedule: Scheduling of services shall be on-call basis as needed. There are no minimum number of hours guaranteed. Contractor shall be available to provide Board Certified Cardiovascular Perfusionist coverage 365/366 days a year. The perfusionist shall be available twenty-four (24) hours a day, seven (7) days a week, including all national holidays The perfusionist shall be on site to set up heart lung machine within one (1) hours of notification of need for services. 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 CONTRACTOR RESPONSIBILITIES: 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. 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. 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: American Board of Cardiovascular Perfusion: http://www.abcp.org The professional standards of The Joint Commission (TJC) http://www.jointcommission.org/standards_information/standards.aspx The standards of the American Hospital Association (AHA) http://www.hpoe.org/resources?show=100&type=8 and; The requirements contained in this PWS MEDICAL RECORDS 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). HIPAA: This contract and its requirements meet exception in 45 CFR 164.502(e), and do not require a BAA in order for Covered Entity to disclose Protected Health Information to: a health care provider for treatment. Based on this exception, a BAA is not required for this contract. Treatment and administrative patient records generated by this contract or provided to the Contractors by the VA are covered by the VA system of records entitled Patient Medical Records-VA (24VA10P2). Contractor generated VA Patient records are the property of the VA and shall not be accessed, released, transferred, or destroyed 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. 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 1907.01, Health Information Management and Health Records and VHA Directive 1605.01, Privacy and Release of Information. The penalties and liabilities for the unauthorized disclosure of VA patient information mandated by the statutes and regulations mentioned above, apply to the Contractor. Professional Standards for Documenting Care: Care shall be appropriately documented in medical records in accordance with standard commercial practice and guidelines established by VHA Handbook 1907.01 Health Information Management and Health Records: https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=3088 and all guidelines provided by the VAMC. Release of Information: The VA shall maintain control of releasing any patient medical information and will follow policies and standards as defined, but not limited to Privacy Act requirements. The Contractor may respond to requests for records contained in their non-VA record system, but all requests for VA records will be forwarded to Portland VA Health Care System Release of Information Office (ROI) for response. The ROI office may be contacted via phone at 503-220-8262 extension 55196, and fax at 503-721-1054. 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. 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. 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. 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. Contract personnel (s) shall participate in quality improvement projects, initiatives, and reporting as requested. 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 the EHR and will not be utilizing the VISTA system. 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. 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. 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. Direct Patient Care: 95% of the time involved in direct patient care. The Perfusionist role will be 95% to patient care related. 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 Contractor shall provide perfusion services during open heart surgery, service for take back and angioplasties, intra-aortic balloon pump and left ventricular assist device set up and monitoring and cell save set up and operation. The Perfusionist is required to operate machinery that continues to pump oxygenated blood through the patient during open-heart surgical procedures. The clinical perfusionist shall as required, administer medications, such as blood products during surgery. The Perfusionist shall be well versed by virtue of training and experience in all aspects of clinical perfusion. This includes experience utilizing standard cardiopulmonary bypass equipment preference shall be given for experience in the utilization of SORIN© equipment which is currently utilized at this facility), with the ability to use Computerized Patient Record System (CPRS) (preference shall be given for experience in the utilization of CPRS) and integrate with the SORIN© Data Management System, standard membrane and non-membrane oxygenerator systems, blood and red cell salvaging equipment ( preference shall be given for experience in the use of the SORIN© Cell Saver Systems), pulsatile preservation routines, intra-aortic balloon pumps and a research or clinical experience in other forms of assisted circulation. The perfusionist shall be capable of and have successful experience in operating both standard cardiopulmonary bypass and intra-aortic balloon pumps simultaneously, without the need for another cardiopulmonary bypass perfusionist or assisted circulation technician The Perfusionist shall have experience in fabricating new cardiopulmonary circuits and assisting in the specification of custom made tubing packs. He/she shall be completely versed in the operation of all cardiopulmonary bypass equipment so that repair can be improved on an emergent basis in the event of equipment failure 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 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. ADMINISTRATIVE: estimated 5% of time not involved in direct patient care ( QA/QI documentation: The Contractor s physician(s) shall complete the appropriate documentation pertaining to all procedures, complications and outcome of examinations. Patient Safety Compliance and Reporting: Contractor s physician(s) shall follow all established patient safety and infection control standards of care. Contractor s physician(s) shall make every effort to prevent medication errors, falls, and patient injury caused by acts of commission or omission in the delivery of care. All events related to patient injury, medication errors, and other breeches of patient safety shall be reported to the COR VA Safety Policy. As soon as practicable (but within 24 hours) Contractors shall notify COR of incident and submit to the COR the Patient Safety Report, following up with COR as required or requested. PERFORMANCE STANDARDS, QUALITY ASSURANCE (QA) SURVEILLANCE PLAN AND QUALITY IMPROVEMENT(QI) Quality Management/Quality Assurance Surveillance: Contract personnel shall be subject to Quality Management measures, such as patient satisfaction surveys, timely completion of medical records, and Peer Reviews. Methods of Surveillance: Focused Provider Practice Evaluation (FPPE) and Ongoing Provider Practice Evaluation (OPPE). Contractor performance will be monitored by the government using the standards as outlined in this Performance Work Statement (PWS) and methods of surveillance detailed in the Quality Assurance Surveillance Plan (QASP). The QASP shall be attached to the resultant contract and shall define the methods and frequency of surveillance conducted. Contract monitoring will be accomplished through a record keeping system (attendance log) maintained by the Chief, Surgical Service in order to reconcile payments. Contractor s employees shall sign in and sign out of the attendance log indicating the dates and times worked. Procedure documentation shall be maintained by the contractor and shall be signed by the contractor s employee(s). The Chief, Cardio-Thoracic Section shall certify the actual number of procedures completed. Copies of the procedure documentation sheets shall be forwarded to the Chief, Surgical Service for review and concurrence. The Chief, Surgical Service is responsible for monitoring the professional components of the contract. All adverse actions shall be reported to the Contracting Officer immediately. The Contracting Officer and COR shall examine methodologies and quality control procedures during the contract term. All activities shall comply with Joint Commission standards and the policies and procedures of the VAMC. 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. 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. Performance Standards: 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% Surveillance Method: OPPE a. Patience Care Performance b. Medical/Clinical knowledge c. Practiced Based Learning & Improvement d. Interpersonal & Communication Skills e. Professionalism f. System Based Practice Frequency: Biennial 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. Standard: All Perfusionists shall be certified and compliant with all certifications Acceptable Quality Level:100% Surveillance Method: Random Inspection of qualification documents Frequency: Annually 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 All perfusionists must be credentialed in accordance with VetPro requirements. Acceptable Quality Level:100% Surveillance Method: Random Inspection of records Frequency: Every 2 years 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 60 minutes of the facility Acceptable Quality Level:100% Surveillance Method: Direct observation and random inspection Frequency: Quarterly Incentive: Favorable contractor performance evaluation Disincentive: Unfavorable contractor performance evaluation Removal from contract until such time the contract personnel (s) meet qualification standard Measure: Patient Access (B) Performance Requirement: Pre-Operative Briefing Standard: Perfusionists shall be onsite and attends Pre-Operative Briefing Huddle Acceptable Quality Level:100% Surveillance Method: Observation and random inspection Frequency: Quarterly Measure: Patient Safety Performance Requirement: Patient safety incidents shall be reported using Patient Safety Report All incidents shall be reported immediately (within 24 hours) Standard: All of patient safety incidents are reported using Patient Safety Report within 24 hours of incident Acceptable Quality Level: 100% Surveillance Method: Direct Observation and periodic inspection Frequency: Quarterly Measure: Clinical Information Performance Requirement: Cardiac Perfusionist report is entered and electronically signed. Standard: Report to be entered and signed within 24 hours of the procedure being performed. Acceptable Quality Level: 100% Surveillance Method: Observation, Periodic Sampling and Random Sampling Frequency: Annually Measure: Mandatory Training, Privacy, Confidentiality and HIPAA Performance Requirement: Contractor personnel (s) shall complete all required training on time per VAMC policy. Contractor personnel (s) is aware of all laws, regulations, policies and procedures relating to Privacy, Confidentiality, and HIPAA and complies with all standards Zero breaches of privacy or confidentiality. Standard: All contractor personnel (s) shall comply with all laws, regulations, policies and procedures relating to Privacy, Confidentiality, and HIPAA. Acceptable Quality Level:100% Surveillance Method: Periodic sampling. Contractor personnel (s) shall provide evidence of annual training required by VAMC, reports violations per VA Directive 6500.6. Frequency: Annually 4.5.4.10. Measure: Documentation/Timesheet Performance Requirement: Time Sheet Documentation to be completed monthly and turned in to Section Chief for concurrence Standard: Monthly Acceptable Quality Level: 100% Surveillance Method: Periodic inspection and random sampling Frequency: Weekly Incentive: Favorable contractor performance evaluation Disincentive: Unfavorable contractor performance evaluation Registration with Contractor Performance Assessment Reporting System As prescribed in Federal Acquisition Regulation (FAR) Part 42.15, the Department of Veterans Affairs (VA) evaluates contractor past performance on all contracts that exceed the Simplified Acquisition Threshold and shares those evaluations with other Federal Government contract specialists and procurement officials. The FAR requires that the contractor be provided an opportunity to comment on past performance evaluations prior to each report closing. To fulfill this requirement VA uses an online database, CPARS, which is maintained by the Naval Sea Logistics Center in Portsmouth, Virginia. CPARS has connectivity with the Past Performance Information Retrieval System (PPIRS) database, which is available to all Federal agencies. PPIRS is the system used to collect and retrieve performance assessment reports used in source selection determinations and completed CPARS report cards transferred to PPIRS. CPARS also includes access to the federal awardee performance and integrity information system (FAPIIS). FAPIIS is a web-enabled application accessed via CPARS for contractor responsibility determination information. Each contractor whose contract award is estimated to exceed the Simplified Acquisition Threshold is required to register with CPARS database at the following web address: http://www.cpars.csd.disa.mil. Help in registering can be obtained by contacting Customer Support Desk @ DSN: 684-1690 or COMM: 207-438-1690. Registration should occur no later than thirty days after contract award and must be kept current should there be any change to the contractor s registered representative. For contracts with a period of one year or less, the contracting officer will perform a single evaluation when the contract is complete. For contracts exceeding one year, the contracting officer will evaluate the contractor s performance annually. Interim reports will be filed each year until the last year of the contract, when the final report will be completed. The report shall be assigned in CPARS to the contractor s designated representative for comment. The contractor representative will have thirty days to submit any comments and re-assign the report to the VA contracting officer. Failure to have a current registration in the CPARS database, or to re-assign the report to the VA contracting officer within those thirty days, will result in the Government s evaluation being placed on file in the database with a statement that the contractor failed to respond. GOVERNMENT RESPONSIBILITIES: VA Support Personnel, Services or Equipment: VA owned equipment list: Sorin Heart lung machine Intra-aortic balloon pump Centrifugal ventricular assist device The Perfusionists are responsible for preparation, operation and maintenance of the heart and lung machines/pump, intra-aortic balloon pump and centrifugal ventricular assist device. Contract Administration/Performance Monitoring: After award of contract, all inquiries and correspondence relative to the administration of the contract shall be addressed to: CO: COR: The Contracting Officer is the only person authorized to approve changes or modify any of the requirements of this contract. The Contractor shall communicate with the Contracting Officer on all matters pertaining to contract administration. Only the Contracting Officer is authorized to make commitments or issue any modification to include (but not limited to) terms affecting price, quantity or quality of performance of this contract. The Contracting Officer shall resolve complaints concerning Contractor relations with the Government employees or patients. The Contracting Officer is final authority on validating complaints. In the event the Contractor effects any such change at the direction of any person other than the Contracting Officer without authority, no adjustment shall be made in the contract price to cover an increase in costs incurred as a result thereof. In the event that contracted services do not meet quality and/or safety expectations, the best remedy will be implemented, to include but not limited to a targeted and time limited performance improvement plan; increased monitoring of the contracted services; consultation or training for Contractor personnel to be provided by the VA; replacement of the contract personnel and/or renegotiation of the contract terms or termination of the contract. COR RESPONSIBILITIES: The COR shall be the VA official responsible for verifying contract compliance. After contract award, any incidents of Contractor noncompliance as evidenced by the monitoring procedures shall be forwarded immediately to the Contracting Officer. The COR will be responsible for monitoring the Contractor s performance to ensure all specifications and requirements are fulfilled. Quality Improvement data that will be collected for ongoing monitoring includes but is not limited to: Entering data that may be collected. The COR will maintain a record-keeping system of services by the use of the EHR computer system (Electronic health record system used by the VA). The COR will review this data monthly when invoices are received and certify all invoices for payment by comparing the hours documented on the VA record-keeping system and those on the invoices. Any evidence of the Contractor's non-compliance as evidenced by the monitoring procedures shall be forwarded immediately to the Contracting Officer. The COR will review and certify monthly invoices for payment. If in the event the Contractor fails to provide the services in this contract, payments will be adjusted to compensate the Government for the difference. All contract administration functions will be retained by the VA. Monitoring/Reporting Procedures - The service to be performed by the contractor will be under the direction of the Chief, Surgical Services of the VA Medical Center. Contract monitoring of authorized procedures shall be accomplished through records reviewed by the Chief, Surgical Services who will be responsible for monitoring the professional components of the contract. The contractor shall submit monthly reports to the Contracting Officer s Representative (COR) summarizing services rendered to include a time sheet for all contract employees as well as a report of the completed procedures. The COR shall determine the report format and contents with concurrence from the provider and the Chief of Surgical Service. The report shall be submitted no later than the 10th calendar day of each month. Reports shall verify: Dates and times the contractor was performing work within the facility Date of procedure Name of procedure Contract Employee s Name Patient s Name Patient s identification Number The contractor shall provide a written statement quarterly to the Chief, Surgical Service regarding a summary of performance. The report shall be submitted directly to the Contracting Officer s Representative who shall distribute to the appropriate parties. The report shall be submitted no later than the 10th calendar day of each month. Contractor s employees shall also be monitored utilizing signed procedure notes. The Government will evaluate the quality of professional and administrative services provided but retains no control over the medical, professional aspects of services rendered (e.g. professional judgments, diagnosis for specific medical treatment).
