CTPA Performance Work Statement DRAFT.docx

PERFORMANCE WORK STATEMENT

Cardiothoracic PA Assistant Services

1. GENERAL:

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

1.2. Critical services include: endoscopic radial and saphenous vein harvesting (must have documented experience of >100 endoscopic procedures in each location); ultrasound guided arterial and venous access for central line placement; chest tube and pigtail insertion and removal; insertion and removal of Swan-Ganz catheter, removal of pacing wires, cardioversion, performance of first and second assistant responsibilities in cardiothoracic surgery in the operating room, as well as bedside assistant for robotic procedures.

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

1.3.

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

1.5. Policy/Handbooks - The contractor shall be subject to the following policies, including any subsequent updates during the period of performance: (include Handbook 5005 PA Qualifications and Directive 1063 PA Utilization )

1.5.1. VA Directive 1663: Health Care Resources Contracting - Buying https://www1.va.gov/vapubs/viewPublication.asp?Pub_ID=969&FType=2

1.5.2. VHA Directive 2010-018 “Facility Infrastructure” https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=2227

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

1.5.4. VHA Handbook 1100.17: National Practitioner Data Bank Reports - https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=2135

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

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

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

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

1.5.9. Joint Commission – http://www.jointcommission.org/standards/

1.5.10. HHS OIG Website –

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

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

1.6. Definitions/Acronyms: Terms used in this contract shall be interpreted as follows unless the context expressly requires a different construction and/or interpretation. In case of a conflict in language between the Definitions and other sections of this contract, the language in this section shall govern.

1.6.1. NCCA National Commission on Certification of Physician Assistants

1.6.2. ACGME: Accreditation Council for Graduate Medical Education

ACLS: Advanced Cardiac Life Support

1.6.3. BLS: Basic Life Support

1.6.4. CDC: Centers for Disease Control and Prevention

1.6.5. CDR: Contract Discrepancy Report

1.6.6. CEU: Certified Education Unit

1.6.7. CME: Continuing Medical Education-

1.6.8. CMP: Civil Monetary Penalty

1.6.9. CMS: Centers for Medicare and Medicaid Services

1.6.10. 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.

1.6.11. 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.

1.6.12. COS: Chief of Staff

1.6.13. CPARS: Contractor Performance Assessment Reporting System

1.6.14. DEA: Drug Enforcement Agency

1.6.15. ED: Emergency Department

1.6.16. ECMO: Extracorporeal Membrane Oxygenation

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

1.6.18. EMR: Electronic Medical Record

1.6.19. FSMB: Federation of State Medical Boards

1.6.20. FTEE: Full Time Equivalency Employee is defined by VA as a minimum of 80 hours every two weeks and does not include holidays

1.6.21. HHS: Department of Health and Human Services

1.6.22. HIPAA: Health Insurance Portability and Accountability Act

1.6.23. HR: Human Resources

1.6.24. ISO: Information Security Officer

1.6.25. 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).

1.6.26. NLNAC: National League for Nursing Accrediting Commission. www.nlnac.org

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

1.6.28. NP: Nurse Practitioner

1.6.29. NPPES: National Plan and Provider Enumeration System

1.6.30. OSHA: Occupational Safety and Health Administration

1.6.31. OIT: Office of Information and Technology

1.6.32. OPM: Office of CTPA Management

1.6.33. OPPE: Ongoing Provider Practice Evaluation

1.6.34. OR: Operating Room

1.6.35. PA: Physician Assistant/Associate

1.6.36. PIV: Personal Identity Verification

1.6.37. POP: Period of Performance

1.6.38. PPD: Purified Protein Derivative

1.6.39. PWS: Performance Work Statement

1.6.40. QASP: Quality Assurance Surveillance Plan

1.6.41. RFP: Request for Proposal

1.6.42. VAMC: Veterans Affairs Medical Center

1.6.43. Veterans Health Administration (VHA): The central office for administration of the VA medical centers throughout the United States. The VHA is located in Washington, D.C.

1.6.44. Veterans Integrated Services Network (VISN): The regional oversight for the VA medical centers.

1.6.45. VISTA (Veterans Integrated Systems Technology Architecture): A PC based system that will capture and store clinical imagery, scanned documents and other non-textual data files and integrates them into patient’s medical record and with the hospital information system.

1.6.46. VetPro: a federal web-based credentialing program for healthcare providers.

1.1.1. 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 Francisco Veterans Affairs Health Care System.

2. QUALIFICATIONS:

2.1. Staff/Facility – The contractor shall provide a CTPA who can work in the operating room two days per week, 6 hours per day located at the SFVAHCS.

2.1.1. License - All licenses held by the CTPA 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 CTPA shall submit evidence of current, full and unrestricted licenses, registration, certification, and/or other relevant credentials for verification prior to appointment and throughout the employment process, as requested by the COR. Contractor is responsible for keeping the COR informed of anything that would adversely affect or otherwise limit their clinical privileges. Failure to meet this requirement may result in termination of the contract.

2.1.2. Board Certification – The contractor’s employees and any subcontractors shall have all licenses, permits, and certifications as required by law and this contract.

2.1.3. Credentialing and Privileging - Contract CTPA fulfilling the conditions of the contract shall be subject to all bylaws, rules and regulations of the VAHCS. Each CTPA must be found acceptable by the Medical Executive committee and Governing Body. Credentialing and privileging through the Medical Staff Office is required. (PAs must be credentialed under a PA SOP). The ability for an individual CTPA 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 CTPA’s and to the reported as provider specific practice information at the time or an accreditation body with equal or better standards Joint Commission. .

2.2. Technical Proficiency - The Section Chief of Cardiothoracic Surgery at the SFVA is the program manager of this contract and has the right to replace any CTPA that is not performing to standards set forth by the contract terms. All CTPAs shall be vetted by the program manager prior to working under the contract. 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 CTPA(s) and contract CTPA (s) shall be responsible for abiding by the Facility's Medical Staff By-Laws, rules, and regulations (referenced herein) that govern medical staff behavior. Necessary proficiencies include: endoscopic radial and saphenous vein harvesting (must have documented experience of >100 endoscopic procedures in each location); ultrasound guided arterial and venous access for central line placement; chest tube and pigtail insertion and removal; insertion and removal of Swan-Ganz catheter, removal of pacing wires, cardioversion, performance of first and second assistant responsibilities in cardiothoracic surgery in the operating room, as well as bedside assistant for robotic procedures.

2.2.1.

2.2.2. 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 CTPA (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 CTPA (s). Tracking is kept and can be checked by employer at the NCCPA website .PAs are certified every 2 years under NCCPA

2.2.3. 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 PA(s) as required by the VA.

Other training may become required. VA will communicate any changes to the training requirement to the contractor.

VA Privacy and Information Security Awareness and Rules of Behavior

2.2.4. Standard CTPA Testing (PPD, etc.): Contractor shall provide proof of the following tests 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.

2.2.4.6. 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 PA

(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.

2.2.4.7. 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 CTPA ( 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.

2.2.5. 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.

2.2.6. Conflict of Interest: The Contractor and all contract CTPA (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.

2.2.7. Citizenship related Requirements:

2.2.7.1. 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;

2.2.7.2. 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.

2.2.7.3. 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.

2.2.7.4. 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.

2.2.7.5. 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.

2.2.8. 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.

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

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

2.8.1. 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 CTPA (s). When a Contractor or contract CTPA (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 CTPA:

2.10.1. The contractor shall provide the names of the contracted employee(s) assigned to the performance:

(i.e.; 1.

National Provider Identifier Nu

Substitutes

2.11. Emergency Substitutions: During the first ninety (90) calendar days of performance, the Contractor shall make NO substitutions of key CTPA 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. No substitutions shall be made without Chief of Cardiothoracic Surgery vetting. The substitution must be proctored by the senior CTPA and cleared by the Chief of CT surgery prior to working the case.

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 CTPA.

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 CTPA 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 CTPA regulations. Should the VA COS or designee show documented clinical problems or continual unprofessional behavior/actions with any contract CTPA (s), s/he may request, without cause, immediate replacement of said contract CTPA (s).

2.11.4. The CO and COR shall deal with issues raised concerning Contract CTPA (s) conduct. The final arbiter on questions of acceptability is the program manager or Chief of Cardiothoracic Surgery who can best attest to the clinical competence of the staff in question..

2.11.5. Contingency Plan: Because continuity of care is an essential part of VAMC’s medical services, The Contractor shall have a contingency plan in place to be utilized if the contract CTPA (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 CTPA referred to perform services under this contract prior to providing direct patient care. Contractor shall not have any CTPA report to duty until written notification is received from the Contracting Officer advising that the candidate (s) presented has met all requirements for contract performance.

3. HOURS OF OPERATION:

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

3.1.2. Work Schedule: Services shall be available from the Contractor 2 days per week, 6 hours per day.

3.1.3. Off-hours Coverage: There is no off-hours coverage required

3.2. Federal Holidays:

· New Year’s Day

· Martin Luther King’s Birthday

· President’s Day

· Memorial Day

· Independence Day

· Labor Day

· Columbus Day

· Veterans Day

· Thanksgiving Day

· Christmas Day

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

3.3. Cancellations: Cancellations must be made to the Chief of Surgical Service and COR at least 30 days in advance of the first business day that the cancellation begins.

3.4. Unless a state of emergency has been declared or clinics are otherwise cancelled by the VAMC, the Contractor shall be responsible for providing services.

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 hours/day and services provided against the contractor’s invoices.

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

4.2.1. American Board of Physician Assistants: https://www.aapa.org/

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

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

4.2.4. The requirements contained in this PWS

4.3. MEDICAL RECORDS

4.3.1. Authorities: Contract personnel (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’ (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.

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 Directive 1605.01, Privacy and Release of Information. The penalties and liabilities for the unauthorized disclosure of VA patient information mandated by the statutes and regulations mentioned above, apply to the Contractor.

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

4.3.6. Confidentiality - VA will provide the contract CTPA (s) access to pertinent patient medical information, within the existing privacy rules and regulations, for the purpose of providing coordinated comprehensive primary care. Contract CTPA (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 CTPA practicing within the VA Medical Center. Contract CTPA (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) in the course of treating VA patients under this agreement are the property of the VA and shall not be accessed, released, transferred or destroyed except in accordance with applicable federal law and regulations. Contract personnel (s) shall maintain computer access and prepare for cases the following day by obtaining the patient information and record within the current electronic health record system for review.

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

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 the EHR and writing a Perfusion note after each case.

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

4.4. Direct Patient Care: 99.8% of the time involved in direct patient care. Contractor shall be responsible for

4.5. Scope of Care: Contractor’s CTPA(s) shall be responsible for providing PA services for cardiothoracic surgeries as stated in the PA SOP. including but not limited to endoscopic graft harvesting for cardiac bypass surgery. Necessary skills include: endoscopic radial and saphenous vein harvesting (must have documented experience of >100 endoscopic procedures in each location); ultrasound guided arterial and venous access for central line placement; chest tube and pigtail insertion and removal; insertion and removal of Swan-Ganz catheter, removal of pacing wires, cardioversion, performance of first and second assistant responsibilities in cardiothoracic surgery in the operating room, as well as bedside assistant for robotic procedures.

4.4.1

4.4.2 Patient Care Responsibilities: Contractor’s personnel (s) shall be present on time at scheduled OR start times as documented by physical presence in the OR at the scheduled start time.

4.5 ADMINISTRATIVE: estimated_0.2% of time not involved in direct patient care

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

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

4.6 PERFORMANCE STANDARDS, QUALITY ASSURANCE (QA) SURVEILLANCE PLAN AND QUALITY IMPROVEMENT(QI) Quality Management/Quality Assurance Surveillance: Contract CTPA shall be subject to Quality Management measures. 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 on the Surgical Service to reconcile payments. The attendance log indicates the dates and times worked and procedures undertaken. The COR/designee reviews this attendance log as well as the CTPA Note to ensure proper documentation. 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.4.6.1

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

4.6.3 The Government reserves the right to refuse acceptance of any Contractor CTPA 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 PA regulations. The CO and COR shall deal with issues raised concerning Contractor’s conduct. The final arbiter on questions of acceptability is the CO.

4.6.4 Performance Standards:

4.6.4.1 Measure: Provider Quality Performance

Performance Requirement: Ongoing Provider Performance Evaluation (OPPE) shall perform in accordance with clinical standards Standard: OPPE documentation for all (100%) staff providing services under the contract Acceptable Quality Level: 100% 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: Quarterly

4.6.4.2 Measure: Qualifications of Key Personnel

Performance Requirement: All contract CTPAs must receive a passing score on the Physician Assistant National Certifying Examination (PANCE) for initial board certification by the National Commission on Certification of Physician Assistants and maintain a California Physician Assistant Board license. (Directive 1063)

Standard: All CTPAs shall be certified and compliant with all certifications Acceptable Quality Level: 100% Surveillance Method: Random Inspection of qualification documents Frequency: Annually

4.6.4.3 Measure: Scope of Practice/Privileging

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

4.6.4.4 Measure: Patient Access (A)

Performance Requirement: The Contractor shall provide Contractor’s CTPA(s) in accordance with the operating hours and VA schedule outlined in this PWS. Contractor’s CTPA(s) shall be available in location as needed to perform tasks as specified.

Standard: All (100%) Contractor’s CTPA(s) are on time and available to perform services.

Acceptable Quality Level: Contractor’s CTPA(s) are on-time and available to perform services 97% of the time.

Surveillance Method: Periodic Inspection of Time and Attendance Sheets.

Frequency: Annually at the renewal of option years and as requested by the COR or CO.

Incentive: Favorable contactor performance evaluation.

Disincentive: Unfavorable contractor performance evaluation, Deduction: Contractor will not be paid for days in which contract personnel do not provide services.

4.6.4.5 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%of patient safety incidents are reported using Patient Safety Report within 24 hours of incident.

Observation Frequency: As reported Incentive: Favorable contactor performance evaluation.

Disincentive: Unfavorable contractor performance evaluation, Deduction: Subject to removal of contract personnel depending on severity of incident as determined by the Chief of Staff, Chief of Surgical Service, or designee.

4.6.4.6 Measure: Maintains licensing, registration, and certification Performance Requirement: Updated Licensing, registration and certification shall be provided as they are renewed. All (100%) licensing, registration(s) and certification(s) for Contractor’s CTPA(s) shall be provided as they are renewed.

Licensing and registration information shall be kept current Standard: All (100%) licensing, registration(s) and certification(s) for contract CTPA (s) shall be provided as they are renewed Licensing and registration information shall be kept current Acceptable Quality Level: 100% licensing, registration(s) and certification(s) for Contractor’s CTPA(s) shall be provided as they are renewed. Licensing and registration information kept current.

Surveillance Method: Periodic Sampling and Random Sampling Frequency: As license, registration, and certification are renewed and as requested by the COR or CO.

Incentive: Favorable contactor performance evaluation.

Disincentive: Unfavorable contractor performance evaluation, Deduction: Removal from the contract until such time the contract CTPA(s) meet(s) qualification standard

4.6.4.7 Measure: Mandatory Training

Performance Requirement: Contractor shall complete all required training on time per VASFHCS policy.

Standard: All (100%) of required training is complete on time by Contractor’s CTPA(s).

Acceptable Quality Level: 100% completions.

Surveillance Method: Periodic Inspection and Random Sampling.

Frequency: Annually.

Incentive: Favorable contactor performance evaluation.

Disincentive: Unfavorable contractor performance evaluation, Deduction: Suspension or termination of all PA and/or electronic access privileges and removal from contract until training is completed.

4.6.4.8 Mandatory Privacy, Confidentiality and HIPAA

Performance Requirement: Contractor CTPA (s) shall complete all required training on time per VASFHCS policy. Contractor CTPA (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 (100%) contractor CTPA (s) shall comply with all laws, regulations, policies and procedures relating to Privacy, Confidentiality, and HIPAA.

Acceptable Quality Level: 100% completions Surveillance Method: Periodic sampling and Periodic Inspection; Contractor shall provide evidence of annual training required by SFVAHCS, reports violations per VA Directive 6500.6.

Frequency: Annually Incentive: Favorable contactor performance evaluation.

Disincentive: Unfavorable contractor performance evaluation, Deduction: Suspension or termination of all PA and/or electronic access privileges and removal from contract until training is completed.

4.6.5 Registration with Contractor Performance Assessment Reporting System

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

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

4.6.5.3 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.

4.6.5.4 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.

RECORDS MANAGEMENT OBLIGATIONS

A. Applicability This clause applies to all Contractors whose employees create, work with, or otherwise handle Federal records, as defined in Section B, regardless of the medium in which the record exists.

B. Definitions “Federal record” as defined in 44 U.S.C. § 3301, includes all recorded information, regardless of form or characteristics, made or received by a Federal agency under Federal law or in connection with the transaction of public business and preserved or appropriate for preservation by that agency or its legitimate successor as evidence of the organization, functions, policies, decisions, procedures, operations, or other activities of the United States Government or because of the informational value of data in them.

The term Federal record:

1. includes VHA records.

1. does not include personal materials.

1. applies to records created, received, or maintained by Contractors pursuant to their VHA contract.

1. may include deliverables and documentation associated with deliverables.

C. Requirements

1. Contractor shall comply with all applicable records management laws and regulations, as well as National Archives and Records Administration (NARA) records policies, including but not limited to the Federal Records Act (44 U.S.C. chs. 21, 29, 31, 33), NARA regulations at 36 CFR Chapter XII Subchapter B, and those policies associated with the safeguarding of records covered by the Privacy Act of 1974 (5 U.S.C.