Draft PWS - Radiation Oncology Physicist Dosimetrist and Technologist Services - VALBHS.pdf

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ONSITE PHYSICIAN, THERAPEUTIC MEDICAL PHYSICISTS, MEDICAL DOSIMETRISTS

AND/OR THERAPEUTIC RADIOLOGIC TECHNOLOGISTS SUPPORT SERVICES

DRAFT PERFORMANCE WORK STATEMENT (PWS)

1. GENERAL

1.1 SERVICES REQUIRED: The VA Radiation Oncology Services are accredited by a nationally recognized accrediting body contracted through NROP. As such any Contractor providing on-site radiation oncology services must adhere to Guidelines & Technical Standards for Radiation Oncology promulgated by the American College of Radiology, American Society for Radiation Oncology and American Association for Physicist in Medicine: A contractor providing on-site radiation oncology services must provide evidence the radiation oncology practice meets or exceeds the established clinical practice guidelines and standards.

1.2. PLACE OF PERFORMANCE: Contractor shall furnish services at the Tibor Rubin VA Medical Center, 5901 E. 7th St. Long Beach, CA 90822

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

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

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

1.4.2. VHA Directive 1003.04: VHA Patient Advocacy

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

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

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

1.4.6. VHA Directive 1100.20: Credentialing of Health Care Providers

1.4.7. VHA Directive 1100.21: Privileging

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

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

1.4.10. VHA Directive 1605.01: Privacy and Release of Information

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

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

1.4.13. VHA Directive 1156 Accreditation of VHA Radiation Oncology Services/Sections

1.4.14. VHA Directive 1414 Stereotactic Body Radiotherapy

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

http://www.justice.gov/oip/foia_updates/Vol_XVII_4/page2.htm https://www.va.gov/vapubs/ https://www.va.gov/vhapublications/index.cfm https://www.va.gov/vhapublications/index.cfm http://www.justice.gov/oip/foia_updates/Vol_XVII_4/page2.htm

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1.4.16. US Nuclear Regulatory Commission for management and use of radioactive materials for medical use and radiation safety requirements, to include (but not limited to) 10 CFR Parts 19, 20, 30, 33, 35, and 71:

http://www.nrc.gov/reading-rm.html

1.5. ACRONYMS/DEFINITIONS:

1.5.1. AAPM: American Association of Physics in Medicine

1.5.2. ACGME: Accreditation Council for Graduate Medical Education

1.5.3. ABR: American Board of Radiology

1.5.4. ACR: American College of Radiology (www.acr.org/)

1.5.5. ACO: Administrative Contracting Officer

1.5.6. ALARA: As Low as Reasonably Achievable (least & lowest radiation exposure possible)

1.5.7. AOA: American Osteopathic Association

1.5.8. ARRT(T): American Registry of Radiologic Technologists (T) in Radiation Therapy

1.5.9. ASTRO/APEx: American Society for Radiation Oncology/Accreditation Program for Excellence ® (https://www.astro.org/Daily-Practice/Accreditation)

1.5.10. BAA: Business Associate Agreement

1.5.11. CAMPEP: Commission on Accreditation of Medical Physics Educational Programs (http://www.campep.org/default.asp)

1.5.12. CDC: Centers for Disease Control and Prevention

1.5.13. CEU: Certif ied Education Unit

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

1.5.15. CMD: Certif ied Medical Dosimetrist

1.5.16. CME: Continuing Medical Education

1.5.17. CMS: Centers for Medicare and Medicaid Services

1.5.18. CO: Contracting Officer

1.5.19. COR: Contracting Officer’s Representative

1.5.20. COS: Chief of Staff

1.5.21. CPARS: Contractor Performance Assessment Reporting System http://www.nrc.gov/reading-rm.html http://www.acr.org/ http://www.campep.org/default.asp

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1.5.22. CPRS: Computerized Patient Recordkeeping System- electronic health record system used by the VA.

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

1.5.24. DEA: Drug Enforcement Agency

1.5.25. EHR: Electronic Health Record – electronic health record system used by the

VA

1.5.26. FSMB: Federation of State Medical Boards

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

1.5.28. HHS: Department of Health and Human Services

1.5.29. HICPAC: Healthcare Infection Control Practices Advisory Committee- a federal advisory committee made up of 14 external infection control experts who provide advice and guidance to the CDC and the Secretary of HHS regarding the practice of health care infection control, strategies for surveillance and prevention and control of health care associated infections in United States health care facilities.

1.5.30. HIPAA: Health Insurance Portability and Accountability Act

1.5.31. IGRT: Image Guided Radiation Therapy is the process of frequent two and three-dimensional imaging, during a course of radiation treatment, used to direct radiation therapy utilizing the imaging coordinates of the actual radiation treatment plan.

1.5.32. IMRT: Intensity Modulated Radiation Therapy is the process of delivering highly conformal radiotherapy to the tumor while sparing the surrounding normal tissues by varying radiation intensity across treatment portals.

1.5.33. IROC: Imaging and Radiation Oncology Core

1.5.34. ISO: Information Security Officer

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

1.5.36. MU: Monitor Unit is a measure of machine output of a linear accelerator in radiation therapy.

1.5.37. NHPP: National Health Physics Program- NHPP provides regulatory oversight for the Nuclear Regulatory Commission master materials license issued to VHA to include permitting for use of materials, on-site inspections, and investigations of allegations, medical events, and incidents. In addition, we provide oversight for machine sources of ionizing radiation used for radiation therapy. Finally, we provide assistance and technical information for uses of ionizing radiation for healthcare diagnosis and treatment and non-human biomedical research.

(http://www.patientcare.va.gov/NHPP.asp) http://www.patientcare.va.gov/NHPP.asp

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

1.5.39. NROP: National Radiation Oncology Program

1.5.40. NRSC: National Radiation Safety Committee

1.5.41. POP: Period of Performance

1.5.42. PPD: Purified Protein Derivative

1.5.43. PWS: Performance Work Statement

1.5.44. QASP: Quality Assurance Surveillance Plan

1.5.45. QMP: Quality Management Program

1.5.46. SPE: Senior Procurement Executive

1.5.47. SRS: Stereotactic Radio Surgery: a minimally invasive form of surgical intervention which makes use of a three-dimensional coordinated system to locate small targets inside the body and to perform on them some action such as ablation, biopsy, lesion, injection, stimulation, implantation, radiosurgery (SRS) etc.

1.5.48. SBRT: Stereotactic Body Radiotherapy

1.5.49. TJC: The Joint Commission

1.5.50. TLD: Thermoluminescent Dosimeter- a device that measures radiation dose.

1.5.51. TMP: Therapeutic Medical Physicist

1.5.52. TRT: Therapeutic Radiologic Technologist (Interchangeable Names: Radiologic Therapy Technologist, Radiation Therapist)

1.5.53. VA: Department of Veterans Affairs

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

1.5.55. VHA: Veterans Health Administration

1.5.56. VISN: Veterans Integrated Services Network

1.5.57. VistA: Veterans Information Systems Technology Architecture

2. QUALIFICATIONS:

2.1. License: The contractors clinical physics/dosimetry support services assigned by the Contractor to perform the services covered by this contract shall have a current license to practice medicine in the State of California and/or Commonwealth of the United States.

All licenses held by the key personnel working on this contract shall be full and unrestricted licenses. Contractors’ clinical physics/dosimetry support staff 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

Revision 01/16/2024 Page 5 of 36 surrendered pending action, or denied upon application will not be considered for the purposes of this contract.

Board Certif ication: Medical physicist and dosimetrist shall be board certif ied. All continuing education courses required for maintaining certif ication must be kept up to date at all times. Documentation verifying current certif ication shall be provided by the Contractor to the VA COR on an annual basis for each year of contract performance.

2.1.1. Chief Therapeutic Medical Physicists must be Board Certif ied in Medical Physics or Therapeutic Medical Physics by the ABR and maintain licensure with the Board of Licensure for Professional Medical Physicists, if applicable.

Certif ication must be maintained throughout the contract POP. If contractor’s medical physicist(s) is/are not directly employed by the treating facility, documentation must be provided to ensure adequate certif ication.

2.1.2. Medical Dosimetrists must be Certif ied Medical Dosimetrists (CMD) certified by the Medical Dosimetrist Certif ication Board. If the contractor’s dosimetrist(s) is/are not directly employed by the treating facility, documentation must be provided to ensure adequate certif ication.

2.1.3. Certif ied Radiation Therapy Technologists shall be a graduate of an approved program in Therapeutic Radiologic Technology, evidence by a certif icate or an associate degree from an accredited by the Joint Review Committee on Education in Radiologic Technology (JRCERT) and certif ication by the American Registry of Radiologic Technologists (ARRT)

2.2. Credentialing and Privileging: Credentialing and privileging is to be done in accordance with the provisions of VHA Directive 1100.20 and VHA Directive

1100.21 referenced above. The Contractor is responsible to ensure that proposed clinical physics/dosimetry support possesses the requisite credentials enabling the granting of privileges. No services shall be provided by any contract physician(s) prior to obtaining approval by the Facility Medical Executive Board and Medical Center Director.

2.2.1. Credentialing of Health Care Professionals other than physicians. In accordance with VHA Directive 1100.20, all health care professionals who claim licensure, certif ication, or registration, as applicable to the position (this applies to all who are appointed or utilized on a full-time, part-time, intermittent, consultant, without compensation, on-station fee-basis, on-station contract, or on-station sharing agreement basis) and who are not currently privileged in accordance with VHA Directive 1100.21, must be credentialed in accordance with this directive. NOTE: The credentialing requirements are found in Attachment A of this Directive.

2.2.2. If a contract physician(s) and/or other contract provider(s) are not credentialed and privileged or have credentials/privileges suspended or revoked, the Contractor shall furnish an acceptable substitute without any additional cost to the government.

2.3. Qualif ications:

2.3.1. Board Certif ied Chief Therapeutic Medical Physicist–Ph. D Level: Must have at least five (5) years of documented post-board experience after board certif ication and at least three (3) years of continuous work experience within

Commented [RT1]: Board Certified/Board Eligible?

Commented [jp2R1]: Board Certified.

Revision 01/16/2024 Page 6 of 36 the last five (5) years to ensure the TMP’s experience is current and relevant.

Senior TMP must also have the following minimum years of experience, expertise, and knowledge on the following procedures, equipment, and software:

2.3.1.1. Five (5) years of experience – Documentation detailing experience in performing QA procedures.

2.3.1.2. Three (3) years of experience – Documentation detailing Therapeutic Medical Physics in a healthcare system that is ACR or APEx certif ied.

2.3.1.3. Three (3) years of experience - Varian Linear Accelerators:

TrueBeamwith Brain Lab Accessories following standards of TG-142

2.3.1.4. Three (3) years of experience -Image Guided Radiation Therapy (IGRT) including Cone Beam CT (following standards of TG-142).

2.3.1.5. Three (3) year of experience - Eclipse treatment planning system; and ARIA record & verify system, including the following treatment modalities: 2D/3D Conformal, SRS, SRT, SBRT, and IMRT/VMAT (following standards of TG-53)

2.3.1.6. Three (3) years of experience - IMRT QA: MapCheck (or equivalent).

2.3.1.7. Three (3) years of experience –GE Discovery CT Simulator (or equivalent) and following standards of TG-66

2.3.1.8. Three (3) year of experience - Using Superficial X-ray Machine.

2.3.1.9. Successfully perform one (1) acceptance testing (i.e., work with vendor to ensure proper working condition during installation) on a linear accelerator.

2.3.1.10. Successfully perform one (1) commission of (i.e., gathered necessary measurements or data) a linear accelerator for a treatment planning system.

2.3.2. Board Certif ied Medical Physicist – MS Level: Candidate can either be master’s Level or PhD. Must be Board Certif ied with at least two years of continuous working experience within the last three years to ensure TMP’s experience is current and relevant. Junior TMP must also have the following minimum years of experience, expertise, and knowledge on the following procedures, equipment and software:

2.3.2.1. Two (2) years of experience – Documentation detailing experience in performing QA procedures.

2.3.2.2. One (1) year of experience – Documentation detailing Therapeutic Medical Physics in a healthcare system that is ACR/APEx certif ied.

2.3.2.3. One (1) year of experience - Varian Linear Accelerators: True Beam with Brain Lab Accessories following standards of TG-142

2.3.2.4. One (1) year of experience - Image Guided Radiation Therapy (IGRT) including Cone Beam CT (following standards of TG-142).

2.3.2.5. One (1) year of experience - eclipse treatment planning system; and ARIA record & verify system, including the following treatment

Revision 01/16/2024 Page 7 of 36 modalities: 2D/3D Conformal, SRS, SRT, SBRT, and IMRT/VMAT (following standards of TG-53)

2.3.2.6. One (1) years of experience - IMRT QA: MapCheck (or equivalent)

2.3.2.7. One (1) year of experience - Toshiba CT Simulator (or equivalent) and following standards of TG-66

2.3.2.8. One (1) year of experience - Using Superficial X-ray Machine

2.3.3. CMD: Must be certif ied in medical dosimetry by the Medical Dosimetrist Certif ication Board (MDCB) with at least two years of continuous work experience within the last three years to ensure the CMD’s experience is current and relevant. CMD must also have the following minimum years of experience, expertise and knowledge on the following procedures, equipment, and software:

2.3.3.1. Two (2) years of experience - Documentation detailing experience in performing QA procedures.

2.3.3.2. One (1) year of experience - Documentation detailing CMD experience in a healthcare system that is ACR/APEx certif ied.

2.3.3.3. One (1) year of experience - Varian Linear Accelerators: TrueBeam with Brain Lab and Rapid Arc (or equivalent).

2.3.3.4. One (1) years of experience - Image Guided Radiation Therapy (IGRT) including Cone Beam CT (following standards of TG-142).

2.3.3.5. One (1) year of experience - Eclipse treatment planning system; and ARIA record & verify system, including the following treatment modalities: SRS, SRT, SBRT, and IMRT (following standards of TG-53)

2.3.3.6. One (1) year of experience - MapCheck and ArcCheck (or equivalent)

2.3.3.7. One (1) year of experience – GE Discovery CT Simulator (or equivalent)

2.3.4. RTT: Must be graduate of an approved program in Therapeutic Radiologic Technology, evidence by a certif icate or an associate degree from an accredited institution by the JRCERT and certif ication by the ARRT in (T) radiation therapy. The qualif ications of such personnel shall be subject to review by the VA Chief of Staff and approval by the VA Facility Director.

Competency requirements shall be defined by the VA Long Beach Healthcare System.

2.3.4.1. One (1) year of experience - Knowledge of overall characteristics and clinical relevance of radiation oncology treatment machines and equipment.

2.3.4.2. One (1) year of experience - Delivery of prescribed therapeutic radiation for the purposes of cancer and abnormal cell growth treatments.

2.3.4.3. One (1) year of experience – in 3-dimensional conformal radiation therapy (3D-CRT), Intensity-Modulated radiation therapy (IMRT), Image-guided radiation therapy (IGRT).

2.3.4.4. One (1) year of experience - Education and expertise necessary to generate radiation dose distribution and dose calculations in collaboration with the medial physicist and radiation oncologist.

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2.3.5. Technical Proficiency: Contract support staff and provider(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, certif ication and/or licensure related to the provision of care, treatment and/or services performed.

Contractor’s support staff and provider(s) shall have knowledge of professional care theories, principles, practices, and procedures to serve radiation oncology patient population. Contractor’s support staff and provider(s) shall demonstrate knowledge of growth and development, and pathophysiology of disease processes specific radiation oncology patient population. Contractor shall provide verifiable evidence of all educational and training experiences including any gaps in educational history for all contract physician(s) and other contract provider (s) shall be responsible for abiding by the Facility's Medical Staff By- Laws, rules, and regulations (referenced herein) that govern medical staff behavior.

2.4. Continuing CME support staff and provider(s) requirements: Contractor shall provide the COR copies of current CMEs as required or requested by the VAMC.

Contractors registered or certified by national/medical associations shall continue to meet the minimum standards for CME to remain current. CME hours shall be reported to the credential’s office for tracking. These documents are required for initial and renewal privileging. Failure to provide shall result in loss of privileges.

2.5. Training BLS (Radiation therapy technologists only), and VA MANDATORY:

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

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

Frequency (once a year, etc.)

Annual Hours

BLS

Contractor Rules of Behavior

VA Core Values Training

(ICARE Recommitment)

VA Privacy and Inf ormation Security Awareness and Rules of Behavior

Code Blue Training

Fire and Saf ety Training

Inf ection Control Procedures

VHA Privacy and HIPAA Focused Training

Cyber Security Training

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2.6. STANDARD INFECTION CONTROL MEASURES (PPD, IMMUNIZATIONS, ETC.):

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

2.6.1. TUBERCULOSIS TESTING: Contractor shall provide proof of a negative Tuberculosis Skin Test (TST) or interferon-gamma release assays (IGRA) for all Contractor’s physician(s) upon hire in accordance with CDC guidance. (This is applicable to all health care workers). A negative chest radiographic report for active tuberculosis shall be provided in cases of positive TST or IGRA results.

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

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

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

2.6.5. 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}.

2.6.6. COVID-19: Contractors shall provide proof having received the vaccine unless it is contraindicated.

2.6.7. 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.

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

2.7. Conflict of Interest: Contract support staff and provider(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 http://www.cdc.gov/hicpac/pdf/InfectControl98.pdf

Revision 01/16/2024 Page 10 of 36 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.

2.8. Citizenship related Requirements:

2.8.1. 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;

2.8.2. 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.

2.8.3. 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.

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

2.8.5. The Contractor agrees to obtain a similar certif ication from its subcontractors.

The certif ication shall be made as part of the offerors response to the RFP using the subject attachment in Section D of the solicitation document.

2.9. 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.

2.9.1. Therefore, Contractor shall review the HHS OIG List of Excluded Individuals/Entities on the HHS OIG web site at

Revision 01/16/2024 Page 11 of 36 http://oig.hhs.gov/exclusions/index.asp to ensure that the proposed contract physician(s) is 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.

2.9.2. By submitting their proposal, the Contractor certif ies 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.

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

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

2.12.Inherent Government Functions: Contract support staff and provider(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.

2.13.No Employee Status: The Contractor shall be responsible for protecting Contract support staff and provider(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:

2.13.1. Workers’ compensation

2.13.2. Professional liability insurance

2.13.3. Health examinations

2.13.4. Income tax withholding, and

2.13.5. Social security payments.

2.14.Tort Liability: The Federal Tort Claims Act does not cover Contract support staff and provider(s). When a Contract support staff and provider(s) has been identif ied 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 http://oig.hhs.gov/exclusions/index.asp

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Contractor’s (or contract physician(s) or other contract provider (s)) action or non-action shall be the responsibility of the Contractor and/or insurance carrier.

2.15.Key Personnel:

Contractor shall provide the number of qualif ied staff as is necessary to perform the services required under this contract, at the staffing level determined to be professionally acceptable by the Facility Chief of Staff and in accordance with American College of Radiology staffing guidelines.

2.15.1. The VA Full Time Equivalency (FTE): FTE for the services required is 5.

2.15.2. The minimum number of Board-Certif ied Chief Therapeutic Medical Physicist (PhD) required to be on site daily is 1 as defined in paragraph Hours of Operation in this section.

2.15.3. Board-Certif ied Chief Therapeutic Medical Physicist (PhD) is required to be on site at least 3 days during each week as defined in Hours of Operation in this section.

2.15.4. The number of Board-Certif ied Medical Physicist (MS) required to be on site daily is 1 as defined in paragraph Hours of Operation in this section.

2.15.5. The number of Board-Certified Medical Dosimetrist required to be on site daily is 2 as defined in paragraph Hours of Operation in this section.

2.15.6. The number of Radiation Therapy Technologists required to be on site daily is 1 as defined in paragraph Hours of Operation in this section.

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

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

2.16.1. 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 qualif ications to those of the persons being replaced. The CO will notify the Contractor within 15 calendar days after receipt of all required information of the decision on the proposed substitutes.

The contract will be modified to reflect any approved changes of key personnel.

2.16.2. For temporary substitutions where the key person shall not be reporting to work for 5 consecutive workdays or more, the Contractor shall provide a qualif ied replacement for the key person. The substitute shall have

Revision 01/16/2024 Page 13 of 36 comparable qualif ications to the key person. Any period exceeding two weeks will require the procedure as stated above.

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

Standards for conduct shall mirror those prescribed by current federal personnel regulations. Should the VA COS or designee show documented clinical problems or continual unprofessional behavior/actions with any contract physician(s), s/he may request, without cause, immediate replacement of said contract physician(s).

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

2.17. Contingency Plan: Continuity of care and uninterrupted operations of a Radiation Oncology Program are essential components of this contract and will be primary factors in Contractor’s assignment of staff and frequency of substitutions. The Contractor shall have a contingency plan in place to be utilized if the contract physician(s) and other contract provider (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: 0800- 1630 daily Monday to Friday, with an option of compressed schedule of 10-hour shifts/4 days a week, 0700-1730.

3.1.1. Patients must be seen by a contract support staff and provider(s) on-site at Facility 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. Contract support staff and provider(s) shall be available and present in clinic during normal facility clinic hours, 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 through Friday, 0730 to 1600

3.1.3. The CTMP/TMP may perform work after normal business hours as their calibrations and measurements must be done after patient treatments. A flexible schedule may be established based on patient workload and the ability to access the treatment machines. It will include but is not limited to machine testing after hours; work on Federal holidays; and work on weekends. A schedule of work being performed after normal business hours must be presented to the COR ahead of work being performed.

3.1.4. Off-hours Coverage: Contractor may be available for on-call duty hours when the Facility clinic is closed, including evenings, weekends, and holidays.

Revision 01/16/2024 Page 14 of 36

3.1.5. Extenuating Circumstances: In the event of where the macroenvironment is projected to affect the well-being of our patients as well as our staff, the contractor may be asked to perform their given duties remotely. These duties will be completed during VA Business hours, outlines in section 3.1.

3.1.6. 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.

3.1.7. Cancellation/Rescheduling: Contract support staff and provider(s) shall be responsible for providing services in accordance with the contract and local policies and procedures.

4. CONTRACTOR RESPONSIBILITIES

4.1. SERVICES REQUIRED:

4.1.1 2080 hours Board Certif ied Chief Therapeutic Medical Physicist PhD

4.1.2 2080 hours Board Certif ied Medical Physicist MS

4.1.3 4160 hours Board Certif ied Medical Dosimetrist

4.1.4 2080 hours Radiation Therapy Technologist

4.2 Contractor’s personnel shall be responsible for signing in and out when in attendance.

These sign-in/sign-out sheets will be used by the COR to confirm hour(s)/day(s) provided against the contractor’s invoices. Contractor personnel shall only be paid for actual hours worked.

4.3 Standards of Practice: The medical practice and patient care provided by Contractor shall be evidence based best practices that meet or exceed all standards of professional practice and performance measures applicable to (Facility) medical professionals, including, but not limited to, NHPP, AAPM and TJC standards and national recognized accrediting body current practice guidelines in radiation oncology.

Contractor’s care shall cover the range of services as would be provided in a state-of-the-art civilian medical treatment facility. Contractor shall provide evidence the

Revision 01/16/2024 Page 15 of 36

Contractor’s radiation oncology standard of care is of a quality that meets or exceeds currently recognized VA and ACR national standards as established by:

4.3.1 Applicable Radiation Oncology practice guidelines and standards promulgated by ACR, ASTRO, and AAPM.

4.3.2 The professional standards of the TJC or equivalent accreditation:

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

4.3.3 The requirements contained in this PWS.

4.4 MEDICAL RECORDS

4.4.1 Authorities: Contract support staff and provider(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. Based on this exception, a BAA is not required for this contract. Health records generated by this contract or provided to the Contractors by the VA are covered by the VA system of records entitled ‘Patient Medical Records-VA’ (24VA10A7).

Contractor generated VA Patient records are the property of the VA and shall not be accessed, released, transferred, or destroyed except in accordance with applicable laws and regulations. Contractor shall ensure that all records pertaining to medical care and services provided to VA patients are captured in the VA electronic health record system as required by VA policy as discussed in 4.4.4.

4.4.3 Disclosure: Contract support staff and provider(s) may have access to patient medical records for the purpose of providing medical care and services to VA patients and performing services under the contract; however, Contractor shall obtain permission from the VA before disclosing any patient information outside VA. VA authorizes the Contractor to discuss patient health information for coordination of care within community health care providers in compliance with VA regulations, HIPAA, 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 Directive 1907.01 Health Information Management and Health Records:

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

4.4.5 Release of Information: The VA shall maintain control of releasing any patient medical information and will follow policies and standards as defined, but not http://www.jointcommission.org/standards_information/hap_requirements.aspx http://www.rms.oit.va.gov/SOR_Records/24VA19.asp http://www1.va.gov/vhapublications/viewpublication.asp?pub_id=1423 http://www1.va.gov/vhapublications/viewpublication.asp?pub_id=1423 https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=9235

Revision 01/16/2024 Page 16 of 36 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 minimal involvement in direct patient care is required for board certif ied chief medical physicist, board certif ied medical physicist and medical dosimetrist. Estimated 100% direct patient care involvement is required for radiation therapy technologist.

4.5.1 Board Certif ied Chief Medical Physicist Services: Contractor shall provide, at a minimum, the following services for Veteran patients in accordance with the terms and standards specified herein.

4.5.1.1 Conventional Radiation Treatment: Use of the following advanced modalities, IGRT, Stereotactic Radiosurgery, Stereotactic Radiotherapy, and/or HDR or LDR brachytherapy shall be fully justif ied in accordance with the appropriateness criteria of the American College of Radiology (ACR). ACR Quality-Safety Appropriateness Criteria may be accessed at: http://www.acr.org/Quality-Safety/Appropriateness-Criteria/New-and- Revised

4.5.1.1.1 All treatment plans shall undergo peer review prior to initiation of treatment.

4.5.1.2 Peer Review Conferences: Contract Staff shall attend and participate in peer review conferences to discuss the appropriateness of treatment decisions, treatment goals and expected results related to Facility Radiation Oncology patients.

4.5.1.2.1 At a minimum, 100% of the following with respect to Facility Radiation Oncology patients shall be presented at these conferences:

• Consultations.

• re-evaluations.

• new start treatment fields, including boosts and off cord fields.

• staging evaluations, to assure that adequate staging and disease localizations have been performed; and

• patients seen in consultation for whom no treatment is recommended to assure the appropriateness of the decision not to offer radiotherapy.

4.5.1.2.2 Each conference shall be attended by:

• at least one medical physicist and one dosimetrist.

• Contractor peer reviewers must maintain familiarity with VA tumor site specific treatment guidelines.

4.5.1.3 Documentation Requirements: All patient care documentation including, but not limited to continuing physics consultation which covers weekly http://www.acr.org/Quality-Safety/Appropriateness-Criteria/New-and-Revised http://www.acr.org/Quality-Safety/Appropriateness-Criteria/New-and-Revised

Revision 01/16/2024 Page 17 of 36 chart review checks, special physics consultation notes, and other required documentation, shall be recorded in CPRS in accordance with VA Rules and Regulations (see Section D, page 83 for CPRS User Guide and By-Laws and Rules of the Medical Staff of the VA RADIATION ONCOLOGY), including, but not limited to:

• Inclusion of correct Current Procedural Terminology (CPT) and diagnoses codes, and service connection of condition being treated on encounters.

• electronic signature on all entries; timeframes for electronic signing, completion and closing of entries and encounters.

4.5.2 Chief Therapeutic Medical Physicist: Each VHA facility with radiation oncology services must have a registration certif icate that lists, by name, its Chief Therapeutic Medical Physicist (CTMP). These certif icates, issued by NHPP, must be requested as follows. The request must describe the training, experience, and certif ications of the contracted candidate. Such a request is usually sent by the Facility Director or, with permission of the Director, by the Radiation Safety Officer with concurrence from the Radiation Oncology Service or Section Chief. Qualif ications required to meet this mandate include education in medical physics, at least 5 years of experience, experience with treatment modalities, and experience with specific equipment and software as detailed below, and board certif ication in medical physics.

The Contractor shall submit its potential candidate’s resume/curriculum vita (CV), and with at least two (2) references letters from prior employers with firsthand knowledge of the candidate’s performance, to the Contracting Office for submission to the National Radiation Oncology Program for approval as Chief Therapeutic Medical Physicist.

In addition, the potential candidates shall submit a personal statement stating he/she will be available to perform these services at least 50% of the time per week during clinical hours while patients are being treated and when needed to start.

The Contractor must provide a Board-Certif ied Chief Medical Physicist to serve as the CTMP to VA radiation oncology service. The CTMP will oversee all physics and dosimetry operations. To ensure the quality of the Radiation Oncology Physics Program, the Contractor’s designated CTMP, identif ied in the Schedule as Key Personnel, assigned to the VA facility, reporting on-site at least 5 days/week.

4.5.2.1 Contractor’s CTMP shall provide quarterly Quality

Assurance reports for the Quality Assurance Committee and Radiation Safety Committee, as well as attend quarterly Radiation Safety meetings.

4.5.2.2 Contractor’s CTMP shall track, evaluate, and document all equipment-related quality assurance data including TLD and credentialing measurements for independent 3rd party analysis.

4.5.2.3 Contractor’s CTMP shall also provide shielding surveys and reports as required by the National VA Health Physics Program of

(NHPP).

Revision 01/16/2024 Page 18 of 36

4.5.2.4 Contractor’s CTMP shall also be responsible to ensure licenses are current for the linear accelerator equipment.

Contractor’s CTMP shall ensure Radiation Oncology Service has appropriate licenses for users of all our software applications.

4.5.2.5 Contractor’s CTMP shall also be responsible for ensuring continuity of medical physics operations including communication among key personnel.

4.5.2.6 Contractor’s CTMP shall develop, implement, supervise, and periodically review all QMP policies and procedures that pertain to radiation therapy equipment. Contractor’s CTMP is responsible for the design, implementation, and periodic review of all aspects of the QMP that involve the use of radiotherapy equipment.

4.5.2.7 Contractor’s CTMP will oversee the technical activities of all other physicists, dosimetrists, and other staff members assigned to the unit; directs the technical aspects of treatment procedures; and performs duties qualifying them as a supervisor. Contractor’s CTMP will not perform administrative oversight of federal employees.

4.5.2.8 When newly published techniques or procedures are being implemented for the first time within…