Attachment 1 - PWS - Rad Onc.docx

PERFORMACNE WORK STATEMENT

ONSITE RADIATION ONCOLOGY PHYSICIAN SERVICES

SCHEDULE OF SERVICES

The Contractor shall furnish all personnel to provide services necessary to perform onsite Radiation Oncology Physician, Therapeutic Medical Physics and Dosimetry Support Services to eligible beneficiaries of the Robley Rex Department of Veterans Affairs Medical Center (hereinafter referred to as VAMC), located in Louisville, Kentucky. The Contractor’s physician(s)’ care shall cover the range of initial and follow-up Radiation Oncology evaluation 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 the American Society of Radiation Oncology; Home - American Society for Radiation Oncology (ASTRO).

All VHA Radiation Oncology Services are accredited by a nationally recognized accrediting body contracted through the National Radiation Oncology Program (NROP). As such any Contractor providing on-site radiation oncology services must adhere to all the policies and procedures; practice standards, guidelines, patient care operations; patient safety; quality assurance and quality management of radiotherapy planning, equipment, and delivery; and continuous quality improvement initiatives promulgated by the American College of Radiology, American Society for Radiation Oncology and American Association for Physicist in Medicine.

Place of Performance: Services shall be provided on-site at the Robley Rex Department of Veterans Affairs (VA) Medical Center (VAMC) (also known as the Louisville VAMC) located at 800 Zorn Avenue, Louisville, KY 40206.

Pricing Instructions:

The offeror is instructed to edit the number of Sub-Line Item Numbers (SLIN) to correspond with the number of key personnel submitted for the LIN. Affiliate Offerors shall include the “title” of the personnel submitted. Other commercial health care Offerors shall identify by title/position or level of experience the key personnel submitted. Also, renumber SLINs if adding or removing Key Personnel. The offeror is instructed to include all other than price and cost information supporting the proposed price as directed in Instructions to Offerors addendum to 52.212-1 and/or Section D- Contract Documents, Exhibits, or attachments, Other Than Cost and Pricing Information.

The Contractor shall propose a minimum of 2 key personnel to be credentialed and be available for scheduling to meet the requirements of the contract.

Period of Performance: One Year from Date of Award

ONSITE RADIATION ONCOLOGY PHYSICIAN SERVICES

1. GENERAL:

1.1. Services Provided: The Contractor shall provide Board Certified /Board Eligible Radiation Oncology Physician Services on-site in accordance with the specifications contained herein to beneficiaries of the Department of Veterans Affairs (VA) and the Robley Rex VA Medical Center in Louisville, Kentucky. The Contractor’s qualified Radiation Oncology physician(s) shall provide outpatient services, with a minimum of (1) 3-hour clinic session day per week and a maximum of (2) 3-hour clinic sessions per week as need is identified by VA; each clinic with a minimum of (6) patient slots and maximum of (8) patient slots. Clinic sessions, including days of the week, will be negotiated, and mutually agreed upon between Contractor and Medical Center Services will be rendered at the Robley Rex Veterans Affairs Medical Center (VAMC), 800 Zorn Avenue, Louisville, KY 40206. In addition, the Robley Rex VAMC will work with the contracting staff to implement virtual clinics off-site, for future needs in this contract. Contract physicians shall meet or exceed currently recognized national standards as established by The Joint Commission (TJC), and the standards of the American Hospital Association (AHA). In addition, physicians shall comply with all Veterans Health Administration’s (VHA) regulations and directives. The Contractor shall provide sufficient personnel who meet all requirements herein and who can be relied on to perform in strict accordance with the contract. The Contractor shall provide physicians who are competent, qualified, and adequately trained to perform assigned duties.

1.1.1. The Contractor will provide outpatient consultation services for the diagnosis and treatment of Radiation Oncology services. Outpatient services should be offered as needed to meet demand, with a minimum of (1) 3-hour clinic session day per week and a maximum of (2) 3-hour clinic sessions per week as need is identified by VA; each clinic with a minimum of (6) patient slots and maximum of (8) patient slots. It is expected that a provider will be designated for each clinic for the life of the contract to provide continuity of care, when possible, unless circumstances beyond their control necessitate a change. The goal is for all new appointments for outpatient services to be scheduled and seen within 28 days or sooner if clinically indicated. Follow-up clinic appointments are to be seen per established guidelines. In addition, the Robley Rex VAMC will work with the contracting staff to implement virtual clinics off-site, for future needs in this contract.

1.1.2. Patients will be presented to an appropriate multi-disciplinary tumor board, including those of the Contractor. Contractor staff will work with VA leadership in an advisory manner on VA tumor boards to improve care for our veterans.

1.2. Place of Performance: The Robley Rex Department of Veterans Affairs (VA) Medical Center (VAMC) (also known as the Louisville VAMC) located at 800 Zorn Avenue, Louisville, KY 40206. In addition, the Robley Rex VAMC may work with the contracting staff to implement virtual clinics off-site, for future needs in this contract.

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

1.4. Policy/Handbooks: The contractor shall be subject to the following policies, including any subsequent updates during the period of performance.

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

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

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

1.4.4. VHA Directive 1003.04: VHA Patient Advocacy: https://vaww.va.gov/vhapublications/ViewPublication.asp?pub_ID=5970

1.4.5. VHA Directive 1088: Communicating Test Results to Providers and Patients: https://vaww.va.gov/vhapublications/ViewPublication.asp?pub_ID=3148

1.4.6. VHA Directive 1192.01: Seasonal Influenza Prevention Program: https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=8948

1.4.7. VHA Directive 1220(1): Facility Procedure Complexity Designation Requirements to Perform Invasive Procedures In Any Clinical Setting: https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=8365

1.4.8. VHA Directive 1400.01: Supervision of Physician, Dental, Optometry, Chiropractic, and Podiatry Residents: https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=8579

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

1.4.10. VHA Directive 1907.01: VHA Health Information Management and Health Records: https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=9235

1.4.11. VHA Directive 1100.20 Credentialing of Health Care Providers: https://vaww.va.gov/vhapublications/ViewPublication.asp?pub_ID=9444

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

1.5.1. American Society of Radiation Oncology; Home - American Society for Radiation Oncology (ASTRO).

1.5.2. ACGME: Accreditation Council for Graduate Medical Education

1.5.3. ACLS: Advanced Cardiac Life Support

1.5.4. AOD: Admitting Officer of the Day

1.5.5. BLS: Basic Life Support

1.5.6. CDC: Centers for Disease Control and Prevention

1.5.7. CDR: Contract Discrepancy Report

1.5.8. CEU: Certified Education Unit

1.5.9. CME: Continuing Medical Education

1.5.10. CMS: Centers for Medicare and Medicaid Services

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

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

1.5.13. COS: Chief of Staff

1.5.14. COVID-19: Coronavirus Disease 2019

1.5.15. CPARS: Contractor Performance Assessment Reporting System

1.5.16. Credentialing: Credentialing is the systematic process of screening and evaluating qualification and other credentials, including licensure, required education, relevant training and experience and current competence and health status.

1.5.17. DEA: Drug Enforcement Agency

1.5.18. ED: Emergency Department

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

1.5.20. FSMB: Federation of State Medical Boards

1.5.21. Full Time Equivalent (FTE): VA’s definition for full time- working the equivalent of 80 hours every two weeks, 2080 hours per year. In calculating FTE, any hours not worked on national holidays shall not be included.

1.5.22. HHS: Department of Health and Human Services

1.5.23. HIPAA: Health Insurance Portability and Accountability Act

1.5.24. HR: Human Resources

1.5.25. ISO: Information Security Officer

1.5.26. Medical Emergency: a sudden onset of a medical condition manifesting itself by acute symptoms of sufficient severity that the absence of immediate medical attention could reasonably result in: Permanently placing a patient's health in jeopardy, causing other serious medical consequences, causing impairments to body functions, or causing serious or permanent dysfunction of any body-organ or part.

1.5.27. MOD: Medical Officer of the Day

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

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

1.5.30. NPPES: National Plan and Provider Enumeration System

1.5.31. POP: Period of Performance

1.5.32. PPD: Purified Protein Derivative

1.5.33. PWS: Performance Work Statement

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

1.5.35. QA/QI: Quality Assurance/Quality Improvement

1.5.36. QM/PI: Quality Management/Performance Improvement

1.5.37. QASP: Quality Assurance Surveillance Plan

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

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

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

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

1.5.42. Veterans Affairs Medical Center (VAMC): Unless identified with the name of a different VA medical Center, for purposes of this contract, this term shall mean the Robley Rex VA Medical Center.

2. QUALIFICATIONS:

2.1. Staff/Facility

2.1.1. License: The Contractor’s physician(s) assigned by the Contractor to perform the services covered by this contract shall have a current license to practice medicine in any State, Territory, or Commonwealth of the United States or the District of Columbia) when services are performed onsite on VA property. All licenses held by the personnel working on this contract shall be full and unrestricted licenses. Contractor’s physician(s) who have current, full, and unrestricted licenses in one or more states, but who have, or ever had, a license restricted, suspended, revoked, voluntarily revoked, voluntarily surrendered pending action or denied upon application will not be considered for the purposes of this contract.

2.1.2. Board Certification: All Contract Radiation Oncology provider(s) shall be Board Certified /Board Eligible by the American Board of Internal Medicine (ABIM) in Radiation Oncology Radiation Oncology Board Certification | ABPS (abpsus.org), and be currently certified in Basic Life Support (BLS) and Advanced Cardiac Life Support (ACLS) or equivalency. All continuing education courses required for maintaining certification must be always 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.

2.1.3. Credentialing and Privileging: Credentialing and privileging is to be done in accordance with the provisions of VHA Handbook 1100.19 and VHA Directive 2012-030 referenced above. The Contractor is responsible to ensure that proposed provider (s) possesses the requisite credentials enabling the granting of privileges. No services shall be provided by any contract provider (s)prior to obtaining approval by the Robley Rex VA Medical Center Professional Standards Board, Medical Executive Board and Medical Center Director.

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

2.1.4. Technical Proficiency: Contractor’s physician(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’s physicians shall have knowledge of professional care theories, principles, practices, and procedures to perform assignments of Radiation Oncology patient/critically ill patient population. Contractor’s physician shall demonstrate knowledge of growth and development, and pathophysiology of disease processes specific to the Radiation Oncology population. Contractor shall provide verifiable evidence of all educational and training experiences including any gaps in educational history for Contractor’s physician(s) shall be responsible for abiding by the Facility's Medical Staff By-Laws, rules, and regulations (referenced herein) that govern medical staff behavior.

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

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

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

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

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

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

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

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

2.1.7.6. COVID-19: Contractors shall comply with VHA Supplemental Contract Requirements for Combatting COVID-19 {This is applicable to all health care workers}. – See Section D attachment.

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

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

2.1.8. 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). The Contractor shall have or obtain appropriate NPI and if pertinent the Taxonomy Code confirmation notice issued by the Centers for Medicare and Medicaid Services (CMS) National Plan and Provider Enumeration System (NPPES) be provided to the Contracting Officer with the proposal.

2.1.9. DEA: Contractor shall provide copy of current DEA certificate.

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

2.1.11. Citizenship related Requirements:

2.1.11.1. 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;

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

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

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

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

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

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

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

2.2. Clinical/Professional Performance: The qualifications of Contractor personnel are subject to review by VA Medical Center COS or his/her clinical designee and approval by the Medical Center Director as provided in VHA Handbook 1100.19 and VHA Directive 1100.20. Clinical/Professional performance monitoring and review of all clinical personnel covered by this contract for quality purposes will be provided by the VAMC COS and/or the Chief of the Service or his designee. A clinical COR may be appointed, however, only the CO is authorized to consider any contract modification request and/or make changes to the contract during the administration of the resultant contract.

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

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

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

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

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

2.7.1. Workers’ compensation

2.7.2. Professional liability insurance

2.7.3. Health examinations

2.7.4. Income tax withholding, and

2.7.5. Social security payments.

2.8. Tort Liability: The Federal Tort Claims Act does not cover Contractor or contract provider(s). When a Contractor or contract provider (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 physician(s)) action or non-action shall be the responsibility of the Contractor and/or insurance carrier.

2.9. Key Personnel:

2.9.1. The VA Full Time Equivalency (FTE) for the services required is 2 FTE is defined by VA as a minimum of 80 hours every two weeks and does not include holidays.

2.9.2. Personnel Substitutions: During the first ninety (90) calendar days of performance, the Contractor shall make NO substitutions of key personnel unless the substitution is necessitated by illness, death, or termination of employment. The Contractor shall notify the CO, in writing, within 14 calendar day(s) 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 90 calendar days prior to making any permanent substitutions.

2.9.2.1. 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 90 calendar days after receipt of all required information of the decision on the proposed substitutes. The contract will be modified to reflect any approved changes of key personnel.

2.9.2.2. For temporary substitutions where the key person shall not be reporting to work for three 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.

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

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

3. VA HOURS OF OPERATION/SCHEDULING:

3.1. VA Business Hours: Monday-Friday, 8am-430pm.

Clinic Hours: A minimum of (1) 3-hour clinic sessions day per week and a maximum of (2) 3-hour clinic sessions per week, between the hours of Monday-Friday, 8am-430pm.

3.1.1. Patients must be seen by a contractor’s physician(s) on-site at Robley Rex VA Medical Center in a timely manner in accordance with VA Rules and Regulations on clinic wait times and consult completion. Contractor shall notify the COR at least monthly about any obstacles to meeting this performance measure.

3.1.2. Contractor’s physician(s) shall be available and present in clinic during normal Robley Rex VA Medical clinic hours, Robley Rex VA Medical which will be established, and may be revised, as deemed appropriate for patient care by the Chief of Staff. Currently, normal clinic hours are Monday-Friday, 8am-430pm.

3.1.3. Consults will be received and reviewed by the contractor staff on the same day as clinic. The reviewer is responsible for determining the clinically indicated date. The goal is for all new and follow-up appointments, to be scheduled and seen within 28 days or sooner (of Patient’s Preferred Date), if clinically indicated. Documentation will be in accordance with documentation guidelines published by the Centers for Medicare and Medicaid Services (CMS), and all applicable coding standards. Outpatient consults will be completed using a consult note in CPRS that directly links the response to the original consult and completing the associated encounter form within 24 hours of patient visit. Follow-up visits will be completed using a follow-up note and completing the associated encounter form within 24 hours of patient visit.

3.2. Committee/Conference Attendance Coverage: Committee/conference attendance is required in this contract, totaling 52 hours each year, to include the committees/conferences listed below. Committee assignments of the Radiation Oncology contractors shall be made in a collaborative manner. However, once assigned, attendance is mandatory as it helps provide expert consultation on policies and procedures that help our veterans.

3.2.1. When attending a meeting, the contractor provider will document their presence, entering start/end times of their clinic time, on the designated “attendance log.”

3.2.2. Meetings include:

* In absence of staff provider, contractor must attend committee as a back-up, when notified in advance. Contractor will receive a minimum of a 2-week notice.

3.3. Federal Holidays: The following holidays are observed by the Department of Veterans Affairs:

· New Year’s Day

· President’s Day

· Martin Luther King’s Birthday

· Memorial Day

· Juneteenth

· Independence Day

· Labor Day

· Columbus Day

· Veterans Day

· Thanksgiving

· Christmas

· Any day specifically declared to be a national holiday.

4. CONTRACTOR RESPONSIBILITIES

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

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

4.2. Standards of Care: The contract physician(s)’ care shall cover the range of Radiation Oncology 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 TJC, VA and national standards as established by:

4.2.1. American Society of Radiation Oncology Home - American Society for Radiation Oncology (ASTRO).

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. Resident Supervision and Teaching:

4.3.1. Resident Supervision/Teaching: According to the guidelines dictated by the Residency Review Committee of ACGME, the Contractor’s physician(s) performing the services shall be responsible for residents. Contractor’s physician(s) shall be responsible for:

4.3.2. Academic environment: Provide for an academic environment conducive to the training and professional development for residents rotating through the Internal Medicine/Radiation Oncology Service.

4.3.3. Resident patient care documentation: Contract provider (s)shall be responsible for complying with the Residency review documentation and ensuring that all notes and encounters are completed and shall appropriately document medical records in accordance with VA standards, equivalent to TJC compliance guidelines, standard commercial practice and guidelines established by Robley Rex VA Medical Center. The Contractor shall also perform any administrative duties relative to documentation of resident training, as required and directed by the VA COS or designated representative.

4.3.4. Clinical Direction and Oversight: Contractor’s physician(s) shall provide clinical direction to and oversight of residents/fellows consistent with current accreditation guidelines, clinical research, protocol development, data management of protocols, quality assurance conferences and meetings, and affiliate /VA staff meetings. Ensure on-site resident supervision in accordance with the national VHA Directive 1400.01: Supervision of Physician, Dental, Optometry, Chiropractic, and Podiatry Residents, dated November 07, 2019. https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=8579

4.3.4.1. Attending Physician: Clinics/Radiation Oncology procedures shall not be conducted by residents in the absence of an attending physician. All procedures, inpatient admissions and consults shall be the responsibility of an attending physician.

4.4. MEDICAL RECORDS

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

4.4.2. 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 of VA patients. Based on this exception, a BAA is not required for this contract. Health records generated by this contract or provided to the Contractors by the VA are covered by the VA Privacy Act system of records entitled ‘Patient Medical Records-VA’ (24VA10A7). Contractor generated VA Patient records are the property of the VA and shall not be accessed, released, transferred, or destroyed except in accordance with applicable laws and regulations. Contractor shall ensure that all records pertaining to medical care and services provided to VA patients are captured in the VA electronic health record system as required by VA policy as discussed in 4.4.4. 4.4.3.

4.4.3. Disclosure: Contractor’s physician(s) may have access to patient medical records for the purpose of providing medical care and services to VA patients and performing services under the contract. VA authorizes the Contractor to discuss patient health information for coordination of care with community health care providers in compliance with VA regulations, HIPAA and VHA Directive 1605.01, Privacy and Release of Information. The VA will provide the Contractor with a copy of VHA Handbook 1907.01, Health Information Management and Health Records and VHA Directive 1605.1, Privacy and Release of Information. The penalties and liabilities for the unauthorized disclosure of VA patient information mandated by the statutes and regulations mentioned above, apply to the Contractor.

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

4.4.5. Release of Information: The VA shall maintain control of releasing any copies of patient health information or health records and will follow policies and standards as defined, but not limited to Privacy Act requirements. Contractor will not release or disclose copies of records and will refer all such requests to the Release of Information Department at the VA facility were assigned.

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

4.5. Direct Patient Care: estimated 95% of the time involved in direct patient care.

4.5.1. Per the qualification section of this PWS, the Contractor shall provide the following staff:

4.5.1.1. Board Certified /Board Eligible Radiation Oncology Physicians.

4.5.1.2. The Contractor shall provide treatment for Radiation Oncology services in the outpatient services, with a minimum of (1) 3-hour clinic sessions day per week and a maximum of (2) 3-hour clinic sessions per week as need is identified by VA; each clinic with a minimum of (6) patient slots.

4.5.1.3. Participation in the following VA Committees/Conferences:

4.5.1.4. The Contract physician is fully responsible for all care rendered to the patient, as well as the clinical outcome. Contract physicians are required to utilize Computerized Patient Record System (CPRS) and Veterans Health Information Systems and Technology Architecture (VISTA) for retrieval of information and documentation of services. The Contractor shall provide physicians who shall:

4.5.1.4.1. Sign notes at the time of the clinic visit, no later than 24 hours of the visit. Perform all documentation requirements, per VHA Handbook 1400.01, dated December 19, 2012.

4.5.1.4.2. Assure that outpatient encounters are documented and completed in CPRS at the time of the visit.

4.5.1.4.3. Maintain compliance with all VA National and VISN directives concerning consult management and clinic scheduling practices as noted.

4.5.1.4.4. Adhere to documentation levels that are standard in the medical community (CMS).

4.5.1.4.5. Perform Tort, peer, and other reviews as assigned by the Chief, Medical Services, or his/her designated representative.

4.5.1.4.6. Participate in hospital performance improvement activities: attend scheduled and emergency committee meetings that relate to the specialty of Radiation Oncology.

4.5.1.4.7. Participates in the review and response to patient complaints and/or congressional inquiries.

4.5.2. Scope of Care: Contractor’s physician(s) (as appropriate and within scope of practice/privileging) shall be responsible for providing Radiation Oncology care, including, but not limited to:

1.1.2.1. Clinic and Surgical Care: Contractor’s physician(s) shall provide clinical Radiation Oncology services. Contractor’s physician(s) shall be present on time for any scheduled clinics as documented by physical presence in the clinic at the scheduled start time.

1.1.2.1.1. Approximate case load is as follows:

· Number of patients per outpatient clinic (as requested by the VA Medical Center): Approximately a minimum of 6 patient slots scheduled for every clinic, and a maximum of 8 patient slots per clinic.

· Meeting Attendance: Total of 52 hours each year of committee attendance.

1.1.2.1.2. All initial Radiation Oncology consult appointments will be made by the VA nursing staff. All treatment and follow-up appointments will be coordinated by contractor. This includes the post-care coordination, i.e., CT simulation/planning, treatment and any required follow-up care appointment with the VA, contractor agency or thru community care vendors.

1.1.2.2. Medications: Contractor’s physician(s) shall follow all established medication policies and procedures. No sample medications shall be provided to patients. All recommendations for FDA-approved agents and diagnostics that are recommended in NCCN guidelines will be presented appropriately by the chemotherapy review committee.

1.1.2.3. Clinic Discharge education: Contractor’s physician(s) shall provide discharge education and follow up instructions that are coordinated with the next care setting for all Radiation Oncology clinical patients.

4.5.3. ADMINISTRATIVE: estimated 5% of time not involved in direct patient care

4.5.3.1. Quality Improvement Meetings: The Contractor’s physician(s) shall participate in continuous quality improvement activities and meetings with committee participation as required by the VAMC Chief of Service, Chief of Staff, or designee. When attending one of these meetings, the contractor should log participation by signing designated attendance log.

* In absence of staff provider, contractor must attend committee as a back-up, when notified in advance. Contractor will receive a minimum of a 2-week notice.

4.5.3.2. Staff Meetings: N/A

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

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

4.6. PERFORMANCE STANDARDS, QUALITY ASSURANCE (QA) AND QUALITY IMPROVEMENT(QI)

4.6.1. Quality Management/Quality Assurance Surveillance: Contractor’s physician(s) 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.

4.6.2. Patient Complaints: The CO will resolve complaints concerning Contractor relations with the Government employees or patients. The CO is final authority on validating complaints. 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 personnel. This does not preclude refusal in the event of incidents involving physical or verbal abuse.

4.6.3. The Government reserves the right to refuse acceptance of any Contractor personnel at any time after performance begins, if personal or professional conduct jeopardizes patient care or interferes with the regular and ordinary operation of the facility. Breaches of conduct include intoxication or debilitation resulting from drug use, theft, patient abuse, dereliction, or negligence in performing directed tasks, or other conduct resulting in formal complaints by patient or other staff members to designated Government representatives. Standards for conduct shall mirror those prescribed by current federal personnel regulations. The CO and COR shall deal with issues raised concerning Contractor’s conduct. The final arbiter on questions of acceptability is the CO.

4.6.4. Performance Standards:

4.6.4.1. Measure: Medical Record Documentation

Performance Requirement: Outpatient consults, and follow-up visits will be completed using appropriate CPRS note and associated encounter within 24 hours of visit.

Stand…