PWS_P01 Q522 Onsite Radiation Oncology Physician.pdf

PERFORMANCE WORK STATEMENT

1. GENERAL

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.

1.1. PLACE OF PERFORMANCE: Contractor shall furnish services at the James

H. Quillen VA Medical Center, Corner of Lamont & Veterans Way, Mountain Home TN 37684.

1.2. AUTHORITY: Title 38 USC 8153, Health Care Resources (HCR) sharing

Authority.

1.3. Policy/Handbooks:

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

1.3.2. VHA Notice 2018-34 “Rescission of VHA Directive 2006-041 Veterans Health Care Service Standards” https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=7475

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

1.3.4. VHA Handbook 1100.18 Reporting and Responding to State Licensing Boards -https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=1364

1.3.5. VHA Handbook 1100.19 Credentialing and Privileging -

https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=1806

1.3.6. VHA Directive 2012-030 Credentialing of Health Care Professionals – https://vaww.va.gov/vhapublications/ViewPublication.asp?pub_ID=2815

1.3.7. VHA Handbook 1907.01 Health Information Management and Health

Records:

https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=3088

1.3.8. VHA Directive 1156 Accreditation of VHA Radiation Oncology

Services/Sections:

https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=7450 https://www.va.gov/vapubs/viewPublication.asp?Pub_ID=969&FType=2 https://www.va.gov/vapubs/viewPublication.asp?Pub_ID=969&FType=2 https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=7475 https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=2135 https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=1364 https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=1806 https://vaww.va.gov/vhapublications/ViewPublication.asp?pub_ID=2815 https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=3088 https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=7450

1.3.9. VHA Directive 1414 Stereotactic Body Radiotherapy:

https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=8197

1.3.10. 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

1.3.11. 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. DEFINITIONS/ACRONYMS:

1.4.1. AAPM: American Association of Physics in Medicine

1.4.2. ACGME: Accreditation Council for Graduate Medical Education

1.4.3. ABR: American Board of Radiology

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

1.4.5. ACO: Administrative Contracting Officer

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

1.4.7. AOA: American Osteopathic Association

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

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

1.4.10 BAA: Business Associate Agreement

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

1.4.10. CDC: Centers for Disease Control and Prevention

1.4.11. CEU: Certified Education Unit

1.4.12. CMD: Certified Medical Dosimetrist

1.4.13. CME: Continuing Medical Education

1.4.14. CMS: Centers for Medicare and Medicaid Services

1.4.15. CO: Contracting Officer

1.4.16. COR: Contracting Officer’s Representative

1.4.17. COS: Chief of Staff

1.4.18. CPARS: Contractor Performance Assessment Reporting System https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=8197 http://www.nrc.gov/reading-rm.html http://www.justice.gov/oip/foia_updates/Vol_XVII_4/page2.htm http://www.acr.org/ https://www.astro.org/Daily-Practice/Accreditation http://www.campep.org/default.asp

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

1.4.20. FSMB: Federation of State Medical Boards

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

1.4.22. HHS: Department of Health and Human Services

1.4.23. 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.

1.4.24. HIPAA: Health Insurance Portability and Accountability Act

1.4.25. 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.

1.4.26. 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.

1.4.27. IROC: Imaging and Radiation Oncology Core

1.4.28. ISO: Information Security Officer

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

1.4.30. 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)

1.4.31. NROP: National Radiation Oncology Program

1.4.32. NRSC: National Radiation Safety Committee

1.4.33. OSLD: Optically Stimulated Luminescence Dosimeter

1.4.34. POP: Period of Performance

1.4.35. PPD: Purified Protein Derivative

1.4.36. PWS: Performance Work Statement

1.4.37. QASP: Quality Assurance Surveillance Plan

1.4.38. QMP: Quality Management Program

1.4.39. SPE: Senior Procurement Executive

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

1.4.41. SBRT: Stereotactic Body Radiotherapy

1.4.42. TJC: The Joint Commission

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

1.4.44. TMP: Therapeutic Medical Physicist

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

1.4.46. VA: Department of Veterans Affairs

1.4.47. VAMC: Veterans Affairs Medical Center

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

1.4.49. VHA: Veterans Health Administration

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 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 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 N/A

2.2.3. Medical Dosimetrists N/A

2.3. Credentialing and Privileging–Credentialing and privileging is to be done in accordance with the provisions of VHA Handbook 1100.19 referenced above.

The Contractor is responsible to ensure that proposed physician(s) 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

James H. Quillen VA Medical Center Professional Standards Board, Medical Executive Board and Medical Center Director.

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

2.3.2. Credentialing of Health Care Professionals other than physicians. N/A

2.4. Qualifications: N/A

2.4.1. Board Certified Chief Therapeutic Medical Physicist– N/A

2.4.1.1. Five (5) years of experience – Documentation detailing experience in all aspects of clinical physics operations. N/A

2.4.1.2. Three (3) years of experience – Documentation detailing clinical experience as Therapeutic Medical Physics in an accredited radiation oncology service. N/A

2.4.1.3. Three (3) years of experience - Hands -on experience on a state-of-the-art radiation delivery system. N/A

2.4.1.4. Three (3) years of experience -Image Guided Radiation Therapy (IGRT) including Cone Beam CT and optical surface imaging systems. N/A

2.4.1.5. Three (3) year of experience - 3D treatment planning system; and radiotherapy record & verify system, including the following treatment planning and delivery techniques: 2D/3D Conformal, SRS, IGRT, SBRT, IMRT/VMAT, and Brachytherapy. N/A

2.4.1.6. Three (3) years of experience - State-of-the-art QA devices for all advanced procedures such as SRS, SBRT, and IMRT. N/A

2.4.1.7. Three (3) years of experience - CT Simulator including 4D imaging. N/A

2.4.1.8. Successfully perform one (1) acceptance testing (i.e., work with vendor to ensure proper working condition during installation) on a state-of-the-art linear accelerator. N/A

2.4.1.9. Successfully perform one (1) clinical commissioning of (i.e., gathered necessary measurements or data) a linear accelerator for a treatment planning system. N/A

2.4.1.10. Understanding of the risk-assessment techniques recommended in the AAPM Report TG-100. N/A

2.4.2. Board Certified Therapeutic Medical Physicist – N/A

2.4.2.1. Two (2) years of experience – Documentation detailing experience in all aspects of clinical physics operations. N/A

2.4.2.2. One (1) year of experience – Documentation detailing clinical physics experience as a Therapeutic Medical Physics in an accredited radiation oncology service. N/A

2.4.2.3. One (1) year of experience - N/A

2.4.2.4. Hands -on experience on a state-of-the-art radiation delivery system.

N/A

2.4.2.5. One (1) year of experience - Image Guided Radiation Therapy (IGRT) including Cone Beam CT and optical surface imaging systems. N/A

2.4.2.6. One (1) year of experience - 3D treatment planning system; and radiotherapy record & verify system, including the following treatment planning and delivery techniques: 2D/3D Conformal, SRS, IGRT, SBRT, IMRT/VMAT, and Brachytherapy One (1) years of experience - State-of-the-art QA devices for all advanced procedures such as SRS, SBRT, and IMRT. N/A

2.4.2.7. One (1) year of experience - CT Simulator including 4D imaging. N/A

2.4.3. Board Eligible Therapeutic Medical Physicist – Candidate can either have MS or PhD degree. Must meet the eligibility requirements for Board certification by ABR. Board Eligible TMP must also have the following minimum years of experience, expertise, and knowledge on the following procedures, equipment, and software: N/A

2.4.3.1. Two (2) years of experience as TMP resident – Documentation detailing experience in all aspects of clinical physics operations. N/A

2.4.3.2. One (1) year of experience as TMP resident – Documentation detailing clinical physics experience as a Therapeutic Medical Physics in an accredited radiation oncology service. N/A

2.4.3.3. One (1) year of experience as TMP resident - N/A

2.4.3.4. Hands -on experience on a state-of-the-art radiation delivery system.

N/A

2.4.3.5. One (1) year of experience - Image Guided Radiation Therapy (IGRT) including Cone Beam CT and optical surface imaging systems. N/A

2.4.3.6. One (1) year of experience - 3D treatment planning system; and radiotherapy record & verify system, including the following treatment planning and delivery techniques: 2D/3D Conformal, SRS, IGRT, SBRT, IMRT/VMAT, and Brachytherapy One (1) years of experience - State-of-the-art QA devices for all advanced procedures such as SRS, SBRT, and IMRT. N/A

2.4.3.7. One (1) year of experience - CT Simulator including 4D imaging. N/A

2.4.4. 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: N/A

2.4.4.1. Two (2) years of experience - Documentation detailing experience in performing QA procedures. N/A

2.4.4.2. One (1) year of experience - Documentation detailing CMD experience in an accredited radiation oncology service. N/A

2.4.4.3. One (1) year of experience - State-of-the-art radiation delivery system.

N/A

2.4.4.4. One (1) years of experience - Image Guided Radiation Therapy (IGRT) including Cone Beam CT and optical imaging system. N/A

2.4.4.5. One (1) year of experience - 3D treatment planning system; and Radiotherapy record & verify system, including the following treatment modalities: SRS, SRT, SBRT, and IMRT. N/A

2.4.4.6. One (1) year of experience - state-of-the-art image registration and image fusion techniques (Both rigid and deformable). N/A

2.4.4.7. One (1) year of experience - CT Simulator. N/A

2.4.5. 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. 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 XXX Healthcare System. N/A

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

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

2.4.5.3. One (1) year of experience – in 3-dimensional conformal radiation therapy (3D-CRT), Intensity-Modulated radiation therapy (IMRT), Image-guided radiation therapy (IGRT) and SRS. N/A

2.4.5.4. One (1) year of experience - Education and expertise necessary to perform manual monitor unit calculations for simple treatments in collaboration with the medial physicist and radiation oncologist. N/A

2.5. 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 credentialing 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, CPRS and VA MANDATORY): Contract physician (s) and other contract provider (s) shall meet all VA educational requirements and mandatory course requirements defined herein; all training must be completed by the contract physician (s) and other contract provider (s) as required by the VA.

2.8. Standard Personnel Testing/Infection Control: The Contractor must provide documentation that demonstrates that all Contractor employees have a satisfactory health status, including a current physical and the below tests, per the CDC immunization recommendations for healthcare workers:

https://www.cdc.gov/vaccines/adults/rec-vac/hcw.html. The required proof must be provided within 14 calendar days after contract award and prior to a TMPs’ performance of services under the contract.

2.8.1. Tuberculosis (TB) Testing: Contractor shall provide proof of a negative Blood Test (also called interferon-gamma release assays or IGRA) for all Contractor employees as a baseline. Two TB blood tests are approved by the FDA: the QuantiFERON – TB Gold In-Tube test (QFT-GIT) and the T-SPOT TB test (T- Spot). Subsequent testing is not required unless the Contractor employee has been exposed to someone with TB. CDC recommendations for TB testing for health care personnel:

https://www.cdc.gov/tb/topic/infectioncontrol/healthcarepersonnel-faq.htm

2.8.2. TDaP (TETNUS/DIPTHERIA/PERTUSSIS): Contractors shall provide proof of 1 dose of Tdap vaccination for all Contractor employees. Boosters are required every 10 years.

https://www.cdc.gov/vaccines/adults/rec-vac/hcw.html https://www.cdc.gov/tb/topic/infectioncontrol/healthcarepersonnel-faq.htm

2.8.3. Influenza: Contractors shall provide proof that all Contractor employees have received the annual Influenza vaccine unless it is contraindicated. If the Contractor employee has a medical contraindication to the vaccine, they are required to wear a mask during the Influenza season.

2.8.4. Hepatitis B: Contractor shall provide evidence of completing and passing generic self-study blood-borne pathogen training for all Contractor employees;

provide their own Hepatitis B vaccination series (3 doses required) plus a serologic titer (1-2 months after final dose) to document immunity 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.

2.8.5. Measles, Mumps, & Rubella: Contractors shall provide proof of immunity for all Contractor employees, i.e., at least 2 doses of vaccine or serologic evidence of immunity.

2.8.6. Varicella: Contractors shall provide proof of immunity for all Contractor employees, i.e., at least 2 doses of vaccine or serologic evidence of immunity.

2.8.7. The VAMC shall notify the Contractor of any significant communicable disease exposures as appropriate. Contractors 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.

Contractors shall provide follow up documentation of clearance to return to the workplace prior to their return.

2.8.8. The VAMC shall notify the Contractor of any significant communicable disease exposures as appropriate. Contractors 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.

Contractors shall provide follow up documentation of clearance to return to the workplace prior to their return.

2.9. National Provider Identifier (NPI): Contract physician (s) and other contract provider (s) who provide billable healthcare services to VA; VHA, shall obtain a NPI as required by the Health Insurance Portability and Accountability Act (HIPPA) National Provider Identifier Final Rule, administered by the CMS. This rule establishes assignment of a 10-digit numeric identifier for Contractor staff, intended to replace the many identifiers currently assigned by various health plans.

Contract physician (s) needs only one NPI, valid for all employers and health plans. Contract physician (s) must also designate their Specialties/Subspecialties by means of Taxonomy Codes on the NPI application. The NPI may be obtained via a secure website at: https://nppes.cms.hhs.gov/NPPES

2.10. DEA (as required) - Contractor shall provide copy of current DEA certificate.

2.11. 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 http://www.cdc.gov/hicpac/pdf/InfectControl98.pdf http://www.cdc.gov/hicpac/pdf/InfectControl98.pdf https://nppes.cms.hhs.gov/NPPES or potential organizational conflicts of interest relating to the services to be provided. The Contractor shall also provide statements containing the same information for any identified consultants or subcontractors who shall provide services. The Contractor must also provide relevant facts that show how it’s organizational and/or management system or other actions would avoid or mitigate any actual or potential organizational conflicts of interest. These statements shall be in response to the VAAR provision 852.209-70 Organizational Conflicts of Interest (Jan 2008) and fully outlined in response to the subject attachment in Section D of the solicitation document.

2.12. Citizenship related Requirements:

2.12.1. 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.

2.12.2. 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.

2.12.3. 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.

2.12.4. 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.

2.12.5. 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.

2.13. 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.

2.13.1. 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.

2.13.2. 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.

2.14. 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 Handbook 1100.19. Clinical/Professional direction of all clinical personnel covered by this contract will be provided by the VAMC COS and/or the Chief of the Service or his designee. A clinical COR may be appointed, however, only the CO is authorized to consider any contract modification request and/or make changes to the contract during the administration of the resultant contract.

2.15. 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.

2.16. 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.

2.17. 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:

2.17.1. Workers’ compensation

2.17.2. Professional liability insurance

2.17.3. Health examinations

2.17.4. Income tax withholding, and

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

2.17.5. Social security payments.

2.18. 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.

2.19. 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 James H. Quillen VA Medical Center Chief of Staff and in accordance with American College of Radiology staffing guidelines.

2.19.1. The number of Board-Certified Radiation Oncology physicians required to be on site daily is 1 as defined in paragraph Hours of Operation in this section.

2.19.2. 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. N/A

2.19.3. The number of Therapeutic Medical Physicists required to be on site daily is N/A

2.19.4. The number of Certified Medical Dosimetrists required to be on site daily is N/A

2.20. 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.

2.20.1. 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.

2.20.2. For temporary substitutions where the key person shall not be reporting to work for three (3) consecutive workdays or more, the Contractor shall provide a qualified replacement for the key person. The substitute shall have comparable qualifications to the key person. Any period exceeding two weeks will require the procedure as stated above.

2.20.3. 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).

2.20.4. The CO and COR shall deal with issues raised concerning Contract physician

(s) conduct. The final arbiter on questions of acceptability is the CO.

2.21. 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 normal duty hours are between 7:30 a.m. to 4:00 p.m., Monday through Friday.

3.2. Work Schedule: Monday-Friday 7:30am to 4:00pm

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

3.2.2. Contract Physicians, physicists and dosimetrists shall be available and present in clinic during normal James H. Quillen VA Medical Center Radiation Oncology 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, 7:30 a.m. to 4:00 p.m.

3.2.3. The CTMP/TMP may perform work after normal business hours as their calibrations and measurements must be done after patient treatments.

However, the CTMP must be on-site during clinical operational hours at least 50% of the time. N/A

3.2.4. Off-hours Coverage: (WHEN ALL CALL IS REQUIRED- TAILOR THIS SECTION FOR TERMS OF ON-CALL) Contractor must make a Radiation Oncologist and/or therapeutic medical physicist available on-call during all hours when the (Facility) clinic is closed, including evenings, weekends, and holidays. N/A

3.2.4.1. On-call contract physicians and therapeutic medical physicists must be available at all times for phone consultations with VA residents and physicians.

3.2.4.2. Patients must be seen within 2 hours of the page when immediate evaluation or radiotherapy is medically indicated.

3.2.4.3. Contract physician(s) or TMP(s) timesheets shall not include time for carrying the on-call pager but may include call back hours for time spent on-site and will be paid at the physician(s) hourly rate as identified in the Schedule.

3.2.5. 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 by the President of the United States to be a national holiday.

3.2.6 Cancellation/Rescheduling: Unless a state of emergency has been declared, the Contractor shall be responsible for providing services.

4. CONTRACTOR RESPONSIBILITIES

4.1. SERVICES REQUIRED: Radiation Oncologist will be responsible for all functions which fall under the scope of care of Radiation Oncology Service.

These include initial patient evaluation, patient simulation, radiation treatment plan and prescription, patient management during treatment, follow up care post treatment, consultation with other services and provide emergency care.

Contract physician must be on site 8 hours per day on scheduled days.

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 James H. Quillen VA Medical Center 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 nationally recognized accrediting body 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. Resident Supervision and Teaching: % of time included in Direct Patient Care or can be combined with Administrative Time. N/A

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

4.3.2. Academic environment: Provide for an academic environment conducive to the training and professional development for residents rotating through the Radiation Oncology Service. Contractor will provide board certified faculty for supervision and training of radiation oncology and therapeutic medical physics residents. N/A

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

4.3.4. Clinical Direction and Oversight: Contract physician (s) shall provide clinical direction to and oversight of residents/fellows consistent with current accreditation guidelines, clinical research, protocol development, data management of protocols, quality assurance conferences and meetings, and affiliate /VA staff meetings. Ensure on-site resident supervision in accordance with the national VHA Handbook 1400.01, Resident Supervision, dated December 19, 2012.

http://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=2847

4.4. MEDICAL RECORDS

4.4.1. Authorities: Contract physician (s) providing healthcare services to VA patients shall be considered as part of the Department Healthcare Activity and shall file:///C:/Users/jpalta/AppData/Local/Microsoft/Windows/INetCache/Content.Outlook/Y03GPXIM/Applicable%20Radiation http://www.jointcommission.org/standards_information/hap_requirements.aspx http://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=2847 comply with the U.S.C.551a (Privacy Act), 38 U.S.C. 5701 (Confidentiality of claimants records), 5 U.S.C. 552 (FOIA), 38 U.S.C. 5705 (Confidentiality of Medical Quality Assurance Records) 38 U.S.C. 7332 (Confidentiality of certain medical records), Title 5 U.S.C. § 522a (Records Maintained on Individuals) as well as 45 C.F.R. Parts 160, 162, and 164 (HIPAA).

4.4.2. 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. Treatment and administrative patient records generated by this contract or provided to the Contractors by the VA are covered by the VA system of records entitled ‘Patient Medical Records- VA’ (24VA19). Contractor generated VA Patient records are the property of the VA and shall not be accessed, released, transferred, or destroyed except in accordance with applicable laws and regulations. Contractor shall ensure that all records pertaining to medical care and services are available for immediate transmission when requested by the VA. Records identified for review, audit, or evaluation by VA representatives and authorized federal and state officials, shall be accessed on-site during normal business hours or mailed by the Contractor at his expense. Contractor shall deliver all final patient records, correspondence, and notes to the VA within twenty-one (21) calendar days after the contract expiration date.

4.4.3. Disclosure: Contract physician(s) may have access to patient medical records:

however, Contractor shall obtain permission from the VA before disclosing any patient information. Subject to applicable federal confidentiality or privacy laws, the Contractor, or their designated representatives, and designated representatives of federal regulatory agencies having jurisdiction over Contractor, may have access to VA ‘s records, at VA’s place of business on request during normal business hours, to inspect and review and make copies of such records. The VA will provide the Contractor with a copy of VHA Handbook 1907.1, Health Information management and Health Records and VHA Handbook 1605.1, Privacy and Release of Information. The penalties and liabilities for the unauthorized disclosure of VA patient information mandated by the statutes and regulations mentioned above, apply to the Contractor.

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

http://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=2791 and all guidelines provided by the VAMC.

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 limited to Privacy Act requirements. In the case of the VA authorizing the Contractor to release patient information, the Contractor in compliance with VA regulations, and at his/her own expense, shall use VA Form 3288, Request for and Consent to Release of Information from Individual’s Records, to process “Release of Information Requests.” In addition, the Contractor shall be responsible for locating and forwarding records not kept at their facility. The http://www.rms.oit.va.gov/SOR_Records/24VA19.asp http://www.rms.oit.va.gov/SOR_Records/24VA19.asp http://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=1469 http://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=1469 http://www1.va.gov/vhapublications/viewpublication.asp?pub_id=1423 http://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=2791 http://www4.va.gov/vaforms/va/pdf/VA3288.pdf http://www4.va.gov/vaforms/va/pdf/VA3288.pdf

VA’s Release of Information Section shall provide the Contractor with assistance in completing forms. Additionally, the Contractor shall use VA Form 10-5345, Request for and Authorization to Release Medical Records or Health Information, when releasing records protected by 38 U.S.C. 7332. Treatment and release records shall include the patient’s consent form. Completed Release of Information requests will be forwarded to the VA Privacy Officer at the following address: VHAMOUPrivacyOfficer@va.gov

4.5. DIRECT PATIENT CARE: 90% of the time involved in direct patient care

4.5.1. 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

4.5.1.1. Services shall include evaluation and treatment of transported inpatient and outpatient clinical services for both palliative and curative cancer patients; follow-up, re-evaluation, and treatment visit.

4.5.1.2. Contract Radiation Oncologist shall provide evaluation and a treatment plan; follow patients for treatment management, continuing monitoring, and follow-up evaluations. Contract Radiation Oncologist shall complete any documentation associated with the treatment provided to VA patients treated by them.

4.5.1.3. Conventional Radiation Treatment: Use of the following advanced modalities: IMRT, IGRT, Stereotactic Radiosurgery, and Stereotactic Radiotherapy shall be fully justified in accordance with the appropriateness criteria promulgated by the American College of Radiology, American Society for Radiation Oncology and American Association for Physicist in Medicine.

4.5.1.4. Patient Consultation/Pretreatment Evaluation: A radiation therapy consultation is defined as a comprehensive patient evaluation provided at the request of the referring physician. A consultation shall consist of a meeting of the patient and a radiation oncologist within the timeframes established by VA Rules and Regulations, a history and physical examination, and a review of pertinent x-rays and laboratory results as well as the patient’s medical record.

4.5.1.4.1. Review previous history, radiographic and lab studies.

4.5.1.4.2. Order any other test required for workup; and

4.5.1.4.3. Discuss with patient and perform examination.

4.5.1.4.4. Document the evaluation in EHR, including at least:

• Name of Attending Physician.

• Radiation treatment type (e.g., conventional, IMRT).

• Curative or palliative radiation treatment.

• Dose amount and duration of radiation treatment, and

• Discussion of evaluation with patient.

http://www4.va.gov/vaforms/medical/pdf/vha-10-5345-fill.pdf http://www4.va.gov/vaforms/medical/pdf/vha-10-5345-fill.pdf http://www4.va.gov/vaforms/medical/pdf/vha-10-5345-fill.pdf

4.5.1.5. Treatment Planning: When it is determined radiation therapy is appropriate, a goal-oriented treatment plan from supporting data shall be developed by the Contract physician (s) for each patient, discuss treatment plan with patient and obtain patient’s signed consent, and made a part of the VA medical record. The treatment plan shall include the type of radiation to be administered, prescribed dose, treatment site location, Dose Volume (DV) based planning to include DV Histograms (DVH), designation of Organs at Risk (OAR) for radiation injury, DV based radiation delivery goals for each OAR.

4.5.1.5.1. All treatment plans shall undergo peer review prior to initiation of treatment. N/A

4.5.1.5.2. Treatment plans shall be altered as necessary during the course of the patient’s treatment.

4.5.1.5.3. Contract physician (s) shall document initial consultation and full plan of care that includes name of attending physician on all clinical notes, indicate radiation treatment type (i.e., conventional, IMRT), date of simulation or procedure date, curative or palliative radiation treatment, dose amount and duration of radiation treatment and signed patient consent for treatment.

4.5.1.6. Treatment Management: Includes weekly examination of the patient under radiation therapy by attending physician. Weekly examination includes review of the daily and/or weekly port films by the attending physician, monitoring all therapy for side effects or complications, prescribed dose changes and other adjustment in treatment as needed, review of all cases at weekly case conferences or chart rounds and documented encounters and clinical progress notes in CPRS.

4.5.1.6.1. Prior to beginning radiation treatment, contract physician(s) shall instruct the patient and care givers on the risks involved including symptom management and symptoms requiring immediate intervention. This instruction must be documented in the medical record within 24 hours. The patient shall be given names and telephone numbers of persons to contact to report these symptoms. Informed consent shall be completed prior to implementation of initial treatments.

4.5.1.6.2. Contract physician (s) shall evaluate each patient for treatment management at a minimum of once per five treatments.