P01 PWS QASP Medical Physicist Dosimetrist Draft.docx

VHA MEDICAL SHARING/AFFILIATE NATIONAL PROGRAM OFFICE (MSO)

ONSITE PHYSICIAN, THERAPEUTIC MEDICAL PHYSICISTS, MEDICAL DOSIMETRISTS AND/OR THERAPEUTIC RADIOLOGIC TECHNOLOGISTS SUPPORT SERVICES MASTER PACKAGE

INCLUDES:

(1) SCHEDULE OF SERVICES (Page 2)

(2) PERFORMANCE WORK STATEMENT (PWS) (Page 9)

(3) QUALITY ASSURANCE SURVEILLENCE PLAN (QASP) (Page 51)

NOTES:

This template may be revised upon provision of future guidance from Office of Primary Care, Specialty Care Services, Office of General Counsel or VA Office of Inspector General. Customers are required to check for updates to the template upon the start of any new procurement for subject services.

All templates are to be tailored to the local requirement in areas indicated in yellow AND any other area per the need of the requiring office.

The contract type for on-site Health Care Resources (HCR), if sole source with an affiliate, is Fixed Price-Economic Price Adjustment (FP-EPA) reimbursed hourly/Full-Time Equivalent (FTE). Sample Price Schedule instructional language for FP-EPA can be found at the MSO Customer Resource Center. If your requirement is a Sole Source Affiliate Contract (SSAC) the appropriate North American industry Classification System (NAICS) code is 611310.

SCHEDULE OF SERVICES

The Contractor shall furnish all key personnel to provide services necessary to perform onsite Radiation Oncology Physician, Therapeutic Medical Physics and Dosimetry Support Services to eligible beneficiaries of the Department of Veterans Affairs, VA Pittsburgh Healthcare System.

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 in Radiation Oncology Service, University Drive, Pittsburgh PA 15240 Pricing Instructions:

The offeror is instructed to edit the number of Sub-Line Items (SLIN) to correspond with the number of key personnel submitted for the line item number (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 The Contractor shall propose key personnel to be credentialed and be available for scheduling to meet the requirements of the contract.

Period of Performance: BASE: _________2024______________ to ______2025____________

Annual Cost

KEY PERSONNEL

TITLE/LEVEL OF EXPERIENCE: ____________

LIN 0001 TOTAL FOR BASE TERM

Annual Cost

KEY PERSONNEL

NAME: ____________

TITLE/LEVEL OF EXPERIENCE: ____________

Hours

LIN 0002 TOTAL FOR BASE TERM

ALL LINS TOTAL for BASE TERM: $_______

OPTION YEAR 1: _________2025______________ to ________2026_______________

Annual Cost

KEY PERSONNEL

NAME: ____________

TITLE/LEVEL OF EXPERIENCE: ____________

Hours

LIN 1001 TOTAL FOR OPTION YEAR ONE

Annual Cost

NAME: ____________

TITLE/LEVEL OF EXPERIENCE: ____________

KEY PERSONNEL

NAME: ____________

TITLE/LEVEL OF EXPERIENCE: ____________

Hours

LIN 1002 TOTAL FOR OPTION YEAR ONE

ALL LINS TOTAL for OPTION YEAR ONE: $_1,405,601.60______

OPTION YEAR 2: _________2026______________ to ________2027_______________

Annual Cost

KEY PERSONNEL

NAME: ____________

TITLE/LEVEL OF EXPERIENCE: ____________

Hours

LIN 2001 TOTAL FOR OPTION YEAR ONE

Annual Cost

NAME: ____________

TITLE/LEVEL OF EXPERIENCE: ____________

KEY PERSONNEL

NAME: ____________

TITLE/LEVEL OF EXPERIENCE: ____________

Hours

LIN 2002 TOTAL FOR OPTION YEAR TWO

ALL LINS TOTAL for OPTION YEAR TWO: $1,433,244.80

OPTION YEAR 3: _________2026______________ to ________2027_______________

Annual Cost

KEY PERSONNEL

NAME: ____________

TITLE/LEVEL OF EXPERIENCE: ____________

Hours

LIN 1001 TOTAL FOR OPTION YEAR THREE

Annual Cost

NAME: ____________

TITLE/LEVEL OF EXPERIENCE: ____________

NAME: ____________

TITLE/LEVEL OF EXPERIENCE: ____________

Hours

LIN 3002 TOTAL FOR OPTION THREE ONE

ALL LINS TOTAL for OPTION YEAR THREE: $1,461,886.40

OPTION YEAR 4: _________2027______________ to ________2028_______________

Annual Cost

KEY PERSONNEL

NAME: ____________

TITLE/LEVEL OF EXPERIENCE: ____________

Hours

LIN 4001 TOTAL FOR OPTION YEAR FOUR

Annual Cost

NAME: ____________

TITLE/LEVEL OF EXPERIENCE: ____________

NAME: ____________

TITLE/LEVEL OF EXPERIENCE: ____________

Hours

LIN 4002 TOTAL FOR OPTION YEAR FOUR

ALL LINS TOTAL FOR OPTION YEAR ONE $1,405,601.60

ALL LINS TOTAL FOR OPTION YEAR TWO $1,433,244.80

ALL LINS TOTAL FOR OPTION YEAR THREE $1,461,886.40

ALL LINS TOTAL FOR OPTION YEAR FOUR $1,491,120.80

TOTAL FOR BASE AND ALL OPTION PERIODS: $5,929,633.60

ONSITE PHYSICIAN, THERAPEUTIC MEDICAL PHYSICISTS, MEDICAL DOSIMETRISTS AND/OR THERAPEUTIC RADIOLOGIC TECHNOLOGISTS SUPPORT SERVICES

PERFORMANCE WORK STATEMENT (PWS)

Legend:

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 VA Pittsburgh Health Care System, University Drive C, Pittsburgh PA, 15240

1.4. Authority: Title 38 USC 8153, Health Care Resources (HCR) sharing Authority, FAR 13.5, VAAR 873

1.5. 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

1.5.1. 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

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. ABR: American Board of Radiology

1.5.3. ACGME: Accreditation Council for Graduate Medical Education

1.5.4. ACO: Administrative Contracting Officer

1.5.5. ACR: American College of Radiology

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: Certified 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: Certified 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

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 qualifications of a health care provider to provide care or services in or for the VA health care system. Credentials are documented evidence of licensure, education, training, experience, or other qualifications.

1.5.24. 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)

1.5.38. NPI: National Provider Identifier. NPI is a standard, unique 10-digit numeric identifier 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: Contract 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.

All licenses held by the key personnel working on this contract shall be full and unrestricted licenses. Contract 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.

2.2 Board Certification: All contract physician(s) shall be board certified. All continuing education courses required for maintaining certification must be kept up to date at all times. Documentation verifying current certification shall be provided by the Contractor to the VA COR on an annual basis for each year of contract performance.

2.2.1 Radiation Oncology Physician: The Contractor shall provide American Board of Radiology (ABR) certified physicians in the area of Radiation Oncology and contract physicians shall maintain certification throughout the period of performance. In the event that Contractor’s Radiation Oncology Physician(s) is/are not directly employed by the treating facility, documentation must be provided to ensure adequate certification.

2.2.2 Chief Therapeutic Medical Physicists must be Board Certified in Medical Physics or Therapeutic Medical Physics by the ABR and maintain licensure with the Board of Licensure for Professional Medical Physicists, if applicable. Certification must be maintained throughout the contract POP. In the event that Contractor’s medical physicist(s) is/are not directly employed by the treating facility, documentation must be provided to ensure adequate certification.

2.2.3 Medical Dosimetrists must be Certified Medical Dosimetrists (CMD) certified by the Medical Dosimetrist Certification Board. In the event that the Contractor’s Dosimetrist(s) is/are not directly employed by the treating facility, documentation must be provided to ensure adequate certification.

2.3.1 Credentialing of Health Care Professionals other than physicians: In accordance with VHA Directive 1100.20, all health care professionals who claim licensure, certification, 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.

2.3.2 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.

2.4 Qualifications:

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

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

2.4.1.2 Three (3) years of experience – Documentation detailing Therapeutic Medical Physics in a healthcare system that is ACR certified.

2.4.1.3 Three (3) years of experience - Varian Linear Accelerators: IX and Trilogy with Brain Lab Accessories following standards of TG-142

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

2.4.1.5 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)

2.4.1.6 Three (3) years of experience - IMRT QA: MapCheck I/II (or equivalent.

2.4.1.7 Three (3) years of experience - Toshiba CT Simulator (or equivalent) and following standards of TG-66

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

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

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

2.5.1. Board Certified Medical Physicist – MS Level: Candidate can either be Master’s Level or PhD. Must be Board Certified 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:

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

2.5.1.2. One (1) year of experience – Documentation detailing Therapeutic Medical Physics in a healthcare system that is ACR certified.

2.5.1.3. One (1) year of experience - Varian Linear Accelerators: IX and Trilogy with Brain Lab Accessories following standards of TG-142

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

2.5.1.5. One (1) 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)

2.5.1.6. One (1) years of experience - IMRT QA: MapCheck I/II (or equivalent)

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

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

2.5.2. CMD: Must be certified in medical dosimetry by the Medical Dosimetrist Certification 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:

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

2.5.2.2. One (1) year of experience - Documentation detailing CMD experience in a healthcare system that is ACR certified.

2.5.2.3. One (1) year of experience - Varian Linear Accelerators: Novalis TX with Brain Lab and ExacTrac, TrueBeam with Rapid Arc (or equivalent).

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

2.5.2.5. 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)

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

2.5.2.7. One (1) year of experience - Toshiba CT Simulator (or equivalent)

2.5.3. RTT: Must be graduate of an approved program in Therapeutic Radiologic Technology, evidence by a certificate or an Associate degree from an accredited institution by the JRCERT and certification by the ARRT in (T) radiation therapy. The qualifications 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.

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

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

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

2.5.3.4. 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.

2.5.4. Technical Proficiency: Contract physician(s) and other contract 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, certification and/or licensure related to the provision of care, treatment and/or services performed. Contractor’s physicians and other contract provider (s) shall have knowledge of professional care theories, principles, practices, and procedures to serve radiation oncology patient population. Contractor’s physician and other contract 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.

2.6. Continuing CME /CEU 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.

2.7. Training (BLS (Physicians & radiation therapy technologists only), 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.

List other Training per local facility

2.8. STANDARD INFECTION CONTROL MEASURES (PPD, IMMUNIZATIONS, ETC.): Contractor shall provide proof of the following 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.

2.8.1. 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.

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

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

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

2.8.5. 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}.

2.8.6. COVID-19:

2.8.7. 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.

2.8.8. 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.

2.9. Conflict of Interest: The Contractor and all contract physician(s) and other contract 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 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.

2.10. Citizenship related Requirements:

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

2.10.2. While performing services for the Department of Veterans Affairs, the Contractor shall not knowingly employ, contract, or subcontract with an illegal alien; foreign national non-immigrant who is in violation their status, 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.

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

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

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

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

2.11.1. 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 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 into contracts with excluded individuals to provide items or services to Federal program beneficiaries.

2.11.2. 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.

2.12. Clinical/Professional Direction: 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 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.

2.13. 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.

2.14. Inherent Government Functions: Contractor and Contract physician(s) and other contract 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.

2.15. No Employee Status: The Contractor shall be responsible for protecting Contract physician(s) and other contract 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:

2.15.1. Workers’ compensation

2.15.2. Professional liability insurance

2.15.3. Health examinations

2.15.4. Income tax withholding, and

2.15.5. Social security payments.

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

2.17. Key Personnel:

Contractor shall provide the number of qualified 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 national radiation oncology practice staffing guidelines.

2.17.1. The VA Full Time Equivalency (FTE): FTE for the services required is _2 Therapeutic Medical Physicist and .5 Certified Dosimetrist_.

2.17.2. The minimum number of Board-Certified Radiation Oncology physicians required to be on site on a daily basis is (0) as defined in paragraph Hours of Operation in this section.

2.17.3. The Board Certified Chief Therapeutic Medical Physicist is required to be on site at least 3 days during each week as defined in Hours of Operation in this section.

2.17.4. The number of Therapeutic Medical Physicists required to be on site on a daily basis is (2) as defined in paragraph Hours of Operation in this section.

2.17.5. The number of Certified Medical Dosimetrists required to be on site on a daily basis is (.5) as defined in paragraph Hours of Operation in this section.

2.22.6. 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 physician is unable to complete an assigned shift, the contractor shall provide replacement physician coverage within 2 hours and notify the Contracting Office Representative (COR) immediately of the schedule change.

2.18. 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.

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

2.18.2. For temporary substitutions where the key person shall not be reporting to work for _3_ consecutive workdays or more, the Contractor shall provide a qualified replacement for the key person. The substitute shall have comparable qualifications to the key person. Any period exceeding two weeks will require the procedure as stated above.

2.18.3. 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).

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

2.19. 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: The Medical Physicist(s) and Certified Dosimetrist shall assist the VAPHS full-time employee at least eight (8) hours daily to complete annual quality assurance radiation therapy equipment, patient treatment planning, and patient treatment administration. The Medical Physicist(s) and Certified Dosimetrist shall provide full and complete on-site physics coverage on a daily basis Monday–Friday, 7:00 a.m.-4:30 p.m. and as needed off tour coverage for the Radiation Therapy Service, VAPHS, University Drive, Pittsburgh, PA 15240.

3.2 Work Schedule:

3.2.1 Patients must be seen by a contract physician(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.

3.2.2 Contract Physicians, physicists and dosimetrists shall be available and present in clinic during normal Facility clinic hours, Facility 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, 8:00 a.m. to 4:30 p.m.

3.2.3 The CTMP/TMP may perform work after normal business hours as their calibrations and measurements have to be done after patient treatments. However, the CTMP must be on-site during clinical operational hours at least 50% of the time.

3.2.4 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.

3.2.5 Cancellation/Rescheduling: Unless a state of emergency has been declared or clinic cancelled the Contractor shall be responsible for providing services.

4 CONTRACTOR RESPONSIBILITIES

4.1 SERVICES REQUIRED: 2080 of Chief Medical Physicist, 2080 Medical Physicist, and 1040 hours of Medical Dosimetrist.

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

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

4.2.2 The professional standards of the TJC or equivalent accreditation: http://www.jointcommission.org/standards_information/hap_requirements.aspx

4.2.3 The requirements contained in this PWS.

4.3 MEDICAL RECORDS

4.3.1 Authorities: Contract 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).

4.3.2 HIPAA: This contract and its requirements meet exception in 45 CFR 164.502(e), and do not require a BAA in order for Covered Entity to disclose Protected Health Information to: a health care provider for treatment. Based on this exception, a BAA is not required for this contract. 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.

4.3.3 Disclosure: Contract 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; 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.

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

4.3.5 Release of Information: The VA shall maintain control of releasing any patient medical information and will follow policies and standards as defined, but not limited to Privacy Act requirements. 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.

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

4.4 Direct Patient Care: estimated _80__% of the time involved in direct patient care (pertaining to QA/QC (annual testing or equipment, commissioning, calibration, review treatment planning systems). This is applicable to the Medical Physicist and Certified Dosimetrist Requirements.

4.4.1 Board Certified Radiation Oncology Physician Services: Contractor shall provide, at a minimum, the following Radiation Oncology Physician services for Veteran patients in accordance with the terms and standards specified herein 2 Chief Medical Physicist and .5 Certified Medical Dosimetrist

4.4.1.1 Services…