D.3 Attachment 3- QASP.pdf

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ONSITE/ON-CALL RADIATION/ONCOLOGY PHYSICIAN SERVICES

PERFORMANCE WORK STATEMENT (PWS)

1. GENERAL:

1.1. Services Required:

The Minneapolis VA Health Care System (MVAHCS) has a requirement for the provision of services of board-certified Radiation Oncologists to provide Radiation Oncology services to Veterans at the Minneapolis VAHCS. Services are required by the Surgical/Specialty Care Patient Service Line (SSC PSL) in support of the Radiation Oncology Department. Contractor shall provide personnel necessary to perform services under this performance work statement. The contractor is responsible to ensure that contract personnel providing work on this contract are fully trained and fully competent to perform the required services for the duration of the contract period. Contractor will be compensated only for actual hours worked.

The VA Radiation Oncology Services are accredited by the American College of Radiology (ACR) and follow the standards & guidelines set forth by (ACR). As such any contractor providing on-site radiation oncology services must adhere to all the American College of Radiology Guidelines & Technical Standards for Radiation Oncology: A contractor providing on-site radiation oncology services must provide evidence the radiation oncology practice meets or exceeds the American College of Radiology Guidelines for Radiation Oncology.

http://www.acr.org/Quality-Safety/Standards-Guidelines/Practice-Guidelines-by-Modality/Radiation- Oncology http://www.acr.org/Quality-Safety/Appropriateness-Criteria/New-and-Revised

1.1.1 Scope of Services: The contractor shall provide services up to 3,120 onsite hours onsite.

This requirement is for one full-time Radiation Oncologist to include back up Radiation Oncologist coverage.

1.2 Place of Performance: Contractor shall furnish services at the Minneapolis VA Health Care

System, One Veterans Drive, Minneapolis, MN 55417.

1.3 Period of Performance: Services are required for twelve-month base period with one (1) twelve-month option period.

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

1.5 Policy/Handbooks: Contractor personnel providing services in a VA Health Care facility shall provide services in accordance with the following U.S. Government statutes, and VHA/VA Regulations, Directives, Handbooks, and Policies implementing these statues. Electronic copies may be obtained at the websites listed below. This contract incorporates the below attachments by reference with the same force and effect as if they were given in full text.

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

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

1.5.3 VHA Handbook 1100.19: Credentialing and Privileging

https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=2910

1.5.4 Responding to State Licensing Boards

https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=1364

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

1.5.6 VHA Directive 1156 Accreditation of VHA Radiation Oncology Services/Sections:

https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=7450

1.5.7 VHA Directive 1414 Stereotactic Body Radiotherapy:

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

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

1.5.9 VHA Directive 1220: Facility Procedure Complexity Designation Requirements to Perform

Invasive Procedures In Any Clinical Setting https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=8365

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

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

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

http://www.justice.gov/oip/foia_updates/Vol_XVII_4/page2.htm

1.5.13 Primary American Association of Medical Physicists Reports http://www.aapm.org/pubs/reports/

1.5.14 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

1.5.15 Minneapolis VA Health Care System Policy: The Minneapolis VAHCS policies are only available on the Minneapolis VA Intranet site. This site is not available to the general public. Copies of these policies will be provided:

1.5.15.1. POL-05 PIV Card Policy (Personnel Identification Verification – ID Badge)

1.5.15.2. IM-01M Medical Records (Management of Information)

1.5.15.3. IM-06F Information Security Policy/Procedures

1.5.15.4. PE-01G Assessment of Patients

1.5.15.5. MS-03H House Staff Coverage/On-Call Procedures

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

1.6.1. AAPM: American Association of Physics in Medicine

1.6.2. ACGME: Accreditation Council for Graduate Medical Education

1.6.3. ABR: American Board of Radiology

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

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1.6.5. ACO: Administrative Contracting Officer

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

1.6.7. AOA: American Osteopathic Association

1.6.8. ARIA: MVAHS record and verify system Technologists(T) in Radiation Therapy

1.6.9. ARRT(T): American Registry of Radiologic

1.6.10. BAA: Business Associate Agreement

1.6.11. CAMPEP: Commission on Accreditation of Medical Physics Educational Programs

(http://www.campep.org/default.asp)

1.6.12. CDC: Centers for Disease Control and Prevention

1.6.13. CEU: Certified Education Unit

1.6.14. CME: Continuing Medical Education

1.6.15. CMS: Centers for Medicare and Medicaid Services

1.6.16. CO: Contracting Officer

1.6.17. COR: Contracting Officer’s Representative

1.6.18. COS: Chief of Staff

1.6.19. CPARS: Contractor Performance Assessment Reporting System

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

1.6.21. HER (Electronic Health Record): Electronic health record system used by the VA

1.6.22. FSMB: Federation of State Medical Boards

1.6.23. Full Time Equivalent (FTE): VA’s definition for full time- working the equivalent of 80 hours every two (2) weeks, 2080 hours per year. In calculating FTE, any hours not worked on national holidays shall not be included.

1.6.24. HHS: Department of Health and Human Services

1.6.25. 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.

1.6.26. HIPAA: Health Insurance Portability and Accountability Act

1.6.27. IGRT: Image Guided Radiation Therapy is the process of frequent two (2) and three (3) dimensional imaging, during a course of radiation treatment, used to direct radiation therapy utilizing the imaging coordinates of the actual radiation treatment plan.

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1.6.28. 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.

1.6.29. IROC: Imaging and Radiation Oncology Core

1.6.30. ISO: Information Security Officer

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

1.6.32. 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)

1.6.33. NROP: National Radiation Oncology Program

1.6.34. NRC: National Radiation Safety Committee

1.6.35. POP: Period of Performance

1.6.36. PPD: Purified Protein Derivative

1.6.37. PWS: Performance Work Statement

1.6.38. QA/QI: Quality Assurance/Quality Improvement

1.6.39. QM/PI: Quality Management/Performance Improvement

1.6.40. QASP: Quality Assurance Surveillance Plan

1.6.41. QMP: Quality Management Program

1.6.42. SPE: Senior Procurement Executive

1.6.43. 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.

1.6.44. SBRT: Stereotactic Radio Therapy

1.6.45. TJC: The Joint Commission

1.6.46. TLD (Thermoluminescent Dosimeter): A device that measures radiation dose

1.6.47. TMP: Therapeutic Medical Physicist

1.6.48. TRT: Therapeutic Radiologic Technologist (interchangeable Names: Radiologic Therapy

Technologist, Radiation Therapist)

1.6.49. VA: Department of Veterans Affairs

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1.6.50. VAMC: Veterans Affairs Medical Center

1.6.51. VetPro: A federal web-based credentialing program for healthcare providers.

1.6.52. VHA: Veterans Health Administration

2. QUALIFICATIONS:

2.1. Staff and Facility:

2.1.1. License: The contractor’s physician(s) assigned by the contractor to perform the services covered by this contract shall have a current license to practice medicine in any State, Territory, or Commonwealth of the United States or the District of Columbia) when services are performed onsite on VA property.

All licenses held by the personnel working on this contract shall be full and unrestricted licenses. Contractor’s physician(s) who have current, full and unrestricted licenses in one or more states, but who have, or ever had, a license restricted, suspended, revoked, voluntarily revoked, voluntarily surrendered pending action or denied upon application will not be considered for the purposes of this contract.

2.1.2. Board Certification: All contractor’s physician(s) shall be board certified Radiation Oncologists. All continuing education courses required for maintaining certification must always be kept up to date. Documentation verifying current certification shall be provided by the contractor to the VA COR on an annual basis for each year of contract performance.

2.1.2.1. Radiation Oncology Physician: The contractor shall provide American Board of

Radiology (ABR) board certified physicians in the area of Radiation Oncology and contractor’s physician(s) shall maintain certification throughout the period of performance. If contractor’s Radiation Oncology Physician(s) is/are not directly employed by the treating facility, documentation must be provided to ensure adequate certification.

2.1.3. 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 contractor’s physician(s) prior to obtaining approval by the Minneapolis VAHCS Professional Standards Board, Medical Executive Board and Medical Center Director.

2.1.3.1. If a contractor’s physician(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.

2.1.4. Technical Proficiency: Contractor’s physician(s) shall be technically proficient in the skills necessary to fulfill the government’s requirements, including the ability to speak, understand, read and write English fluently. Contractor shall provide documents upon request of the CO/COR to verify current and ongoing competency, skills, certification and/or licensure related to the provision of care, treatment and/or services performed.

Contractor’s physician(s) shall have knowledge of professional care theories, principles, practices, and procedures to serve radiation oncology patient population.

Contractor’s physician(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 contractor’s physician(s) shall be responsible for abiding by the Facility's Medical Staff By-Laws, rules, and regulations (referenced herein) that govern medical staff behavior.

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2.1.5. Continuing CME 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.

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

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

Training Frequency Annual Hours

VA Privacy and Information Security Awareness and Rules of Behavior – TMS course # 10176

Once a Year 1 hour

Mandatory Training for Transient Clinical Staff – TMS course # 20152

Once a Year 1.5 hours

CPRS Once 4 hours VISTA Imaging Once 1 hour

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

2.1.7.1. TUBERCULOSIS TESTING: Contractor shall provide proof of a negative

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

2.1.7.2. MEASLES, MUMPS, & RUBELLA TESTING: Contractors shall provide proof of immunity for all contractor physician(s) {This is applicable to all health care workers}.

2.1.7.3. VARICELLA: Contractors shall provide proof of immunity for all contractor physician(s) {This is applicable to all health care workers}.

2.1.7.4. ACELLULAR PERTUSSIS: Contractors shall provide proof of 1 dose of Tdap vaccination for all contractor physician(s) {This is applicable to all health care workers}.

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

2.1.7.6. 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

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Hepatitis B vaccination series and Hepatitis B surface antigen test results following the Hepatitis B vaccination series; maintain an exposure determination and control plan; maintain required records; and ensure that proper follow-up evaluation is provided following an exposure incident.

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

2.1.8. National Provider Identifier (NPI): Contractor’s physician(s) who provide billable healthcare services to VA; VHA, shall obtain an NPI as required by the Health Insurance Portability and Accountability Act (HIPAA) 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. Contractor’s physician(s) needs only one NPI, valid for all employers and health plans. Contractor’s 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.

2.1.9. DEA: Contractor shall provide copy of current DEA certificate. DEA has granted VA an exception to allow on-station contract physicians to use the Minneapolis VA’s institutional DEA registration number with suffix when prescribing or administering controlled substances, provided they are professionally licensed to prescribe controlled substances in any State, Territory or Commonwealth of the United States of America or the District of Columbia. The contract physician is limited to prescribing and handling the controlled substance schedules as authorized by his/her license.

Prescribing or administering controlled substances is exclusively limited to VA beneficiaries.

2.1.10. Conflict of Interest: The contractor and all contractor’s physician(s) are responsible for identifying and communicating to the CO and COR conflicts of interest at the time of proposal and during the entirety of contract performance. At the time of proposal, the contractor shall provide a statement which describes, in a concise manner, all relevant facts concerning any past, present, or currently planned interest (financial, contractual, organizational, or otherwise) or actual or potential organizational conflicts of interest relating to the services to be provided. The contractor shall also provide statements containing the same information for any identified consultants or subcontractors who shall provide services. The contractor must also provide relevant facts that show how it’s organizational and/or management system or other actions would avoid or mitigate any actual or potential organizational conflicts of interest. These statements shall be in response to the VAAR provision 852.209-70 Organizational Conflicts of Interest (Jan 2008) and fully outlined in response to the subject attachment in Section D of the solicitation document.

2.1.11. Citizenship related Requirements:

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

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

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

2.1.11.4. This certification concerns a matter within the jurisdiction of an agency of the

United States and the making of a false, fictitious, or fraudulent certification may render the maker subject to prosecution under 18 U.S.C. 1001.

2.1.11.5. The contractor agrees to obtain a similar certification from its subcontractors.

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

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

2.1.12.1. Therefore, contractor shall review the HHS OIG List of Excluded

Individuals/Entities on the HHS OIG web site at http://oig.hhs.gov/exclusions/index.asp to ensure that the proposed contractor’s physician(s) 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.

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

2.2. Clinical/Professional Performance: The qualifications of contractor personnel are subject to review by VA Medical Center COS or his/her clinical designee and approval by the Medical Center Director as provided in VHA Handbook 1100.19. Clinical/Professional performance monitoring and review of all clinical personnel covered by this contract for quality purposes will be provided by the VAMC COS and/or the Chief of the Service or his designee. A clinical COR

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

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

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

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

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

2.7.1. Workers’ compensation

2.7.2. Vacation time

2.7.3. Sick leave

2.7.4. Professional liability insurance

2.7.5. Health examinations

2.7.6. Income tax withholding, and

2.7.7. Social security payments.

2.8. Tort Liability: The Federal Tort Claims Act does not cover contractor or contractor’s physician(s).

When a contractor or contractor’s physician(s) have 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 contractor’s physician(s)) action or non-action shall be the responsibility of the contractor and/or insurance carrier.

2.8.1. Medical Liability Insurance: The contractor shall furnish their own medical liability insurance and will hold certificate of insurance for general liability and malpractice insurance. Prior to award of the contract, the contractor shall furnish to the VA a certificate of insurance evidencing that all required coverage has been obtained. The contractor shall be responsible for maintaining this certificate/coverage for the duration of the contract. Under no circumstances will contract physicians be considered a MVAHCS employee nor will contractor personnel be covered by VA liability insurance.

2.9. 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 Minneapolis VAHCS Chief of Staff and in accordance with American College of Radiology staffing guidelines.

Contractor will be responsible to ensure that the contractor personnel providing work on this contract are fully trained and fully competent to perform the required services for the duration of

Revision v0017 03/06/2020 Page 10 of 36 the contract period. Contractor’s personnel provided under this contract must meet the qualifications, training, and all requirements as stated in Section 2.

2.9.1. The minimum number of board certified and certified Radiation Oncology physicians required to be on site daily is one (1) as defined in paragraph Hours of Operation in this section.

2.9.2. 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 24 hours and notify the Contracting Office Representative (COR) at the Minneapolis VAHCS immediately of the schedule change.

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

2.9.3.1. 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 fifteen (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.

2.9.3.2. 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.

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

Standards for conduct shall mirror those prescribed by current federal personnel regulations. Should the VA COS or designee show documented clinical problems or continual unprofessional behavior/actions with any contractor’s physician(s), s/he may request, without cause, immediate replacement of said contractor’s physician(s). The CO and COR shall deal with issues raised concerning contractor’s physician(s) conduct. The final arbiter on questions of acceptability is the CO.

2.9.3.4. Contingency Plan: Because continuity of care is an essential part of VAMC’s medical services, the contractor shall have a contingency plan in place to be utilized if the contractor’s physician(s) leaves contractor’s employment or is

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3. VA HOURS OF OPERATION/SCHEDULING:

3.1. VA Business Hours: The Minneapolis VA Health Care System is open 24 hours per day 7 days a week, 365 days per year. The services covered by this contract shall be furnished by the contractor as defined in the work schedule below.

3.1.1. Patients must be seen by a contractor’s physician(s) on-site at the Minneapolis

VAHCS in a timely manner in accordance with VA Rules and Regulations on clinic wait times and consult completion. Contractor shall notify the COR at least monthly about any obstacles to meeting this performance measure.

3.1.2. Contractor shall provide one full-time Radiation Oncologist to be available and present in clinic during normal Radiation Oncology clinic hours, which will be established, and may be revised, as deemed appropriate for patient care by the Director of Radiation Oncology or his/her designee. Currently, normal clinic hours are:

Monday through Friday, from 7:45am to 4:15pm.

Note: All daily schedules will include a 30-minute non-paid lunch break

3.1.2.1 Contractor will provide additional key personnel (up to .5 FTE) who can provide back-up leave coverage (as needed) for MVAHCS employed Radiation Oncologists. Schedules will be provided at least 30 days in advance for scheduling purposes unless an urgent/emergent leave situation occurs.

3.1.3. Off-hours Coverage: Contractor must make the contractor’s physician(s) available on-call during all hours when the Radiation Oncology clinic is closed, including evenings, weekends and holidays. The contract radiation oncologist will rotate call coverage with Minneapolis staff.

3.1.3.1. On-Call emergency services may be required during off-duty hours. On-call requirements will not exceed 4,152 hours per twelve months. Off-duty hours are:

Weekdays: Monday through Thursday from 4:15pm – 7:45am.

Weekends: Staring Friday at 4:15pm – 7:45am on Monday.

Holidays: 7:45am – 7:45am (24 hours).

3.1.3.2. On-call contractor’s physician(s) must always be available for phone consultations with VA residents and physicians.

3.1.3.3. The contractor is not required to be onsite for call coverage. The contractor must respond to a call or page within 30 minutes of receipt and in person within 60 minutes of the call or page when medically indicated or negotiated with the referring provider.

3.1.3.4. Concurrent call is acceptable if there is a back-up in place.

3.1.3.5. If call results in on-site services, surgeon will be paid at the contract hourly rate.

It is estimated that on-call/call back services will not to exceed 24 hours per twelve months.

3.1.3.6. Call schedules will be provided by the Program Support Assistant 30 calendar days from beginning of the next month.

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

New Year’s Day Martin Luther King’s Birthday President’s Day Memorial Day Independence Day Labor Day Columbus Day Veterans Day Thanksgiving Christmas Any day specifically declared to be a national holiday.

3.3. Cancellation/Rescheduling: Requests for clinic cancellations will be made in writing to the clinic director and the COR with no less than six (6) weeks’ notice accompanied by an appropriate justification, with provisions made to ensure effective implementation of patient notification and a rescheduling plan to ensure that patient access and continuity of care issues is addressed.

Providers that cancel clinics are responsible for reviewing records of the scheduled patients and ensuring that urgent problems are addressed and that patients are seen on a clinically appropriate basis as agreed upon and approved by the Clinic Director. This six (6) week notice policy applies to continuing education, meetings or conferences, vacations days, or other than non-emergency reasons.

3.3.1. Unless a state of emergency has been declared, the contractor shall be responsible for providing services.

4. CONTRACTOR RESPONSIBILITIES:

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

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

The Minneapolis VHACS requires the services of up to 3,120 hours onsite, 24 hours call back and up to 4,152 hours on-call coverage of a board-certified Radiation Oncologist to provide Radiation Oncology services per twelve-months.

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 the Minneapolis VAHCS medical professionals, including, but not limited to, NHPP, AAPM and TJC standards and ACR 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 ACR national standards as established by:

4.2.1. The American College of Radiology (ACR) Guidelines for Radiation Oncology.

http://www.acr.org/Quality-Safety/Standards-Guidelines/Practice-Guidelines-by- Modality/Radiation-Oncology http://www.acr.org/Quality-Safety/Appropriateness-Criteria/New-and-Revised

Revision v0017 03/06/2020 Page 13 of 36

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 standards of the American Hospital Association

http://www.hpoe.org/resources?show=100&type=8 and;

4.2.4. The requirements contained in this PWS.

4.3. Resident Supervision and Teaching: Reserved

4.4. Medical Records:

4.4.1. Authorities: Contractor’s physician(s) providing healthcare services to VA patients shall be considered as part of the Department Healthcare Activity and shall comply with the 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: Contractor’s 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 1907.01, Health Information Management and Health Records and VHA Directive 1605.01, Privacy and Release of Information.

The penalties and liabilities for the unauthorized disclosure of VA patient information mandated by the statutes and regulations mentioned above, apply to the contractor.

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

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

Revision v0017 03/06/2020 Page 14 of 36

Act requirements. In the case of the VA authorizing the Contractor to release patient information, the Contractor in compliance with VA regulations, and at his/her own expense, shall use VA Form 3288, Request for and Consent to Release of Information from Individual’s Records, to process “Release of Information Requests.” In addition, the contractor shall be responsible for locating and forwarding records not kept at their facility. The VA’s Release of Information Section shall provide the contractor with assistance in completing forms. Additionally, the contractor shall use VA Form 10- 5345, Request for and Authorization to Release Medical Records or Health Information, when releasing records protected by 38 U.S.C. 7332. 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: Jon Power, Jon.Power@va.gov, 612-467-2365.

4.5. Direct Patient Care: 98% 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 on treatment visit.

4.5.1.2. Contract Radiation Oncologist shall provide evaluation and a treatment plans;

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 external beam radiotherapy modalities include: IMRT, IGRT, Stereotactic Radiotherapy, and 3D CRT shall be fully justified in accordance with the appropriateness criteria of the American College of Radiology (ACR). ACR Quality-Safety Appropriateness Criteria may be accessed at: http://www.acr.org/Quality-Safety/Appropriateness- Criteria/New-and-Revised

4.5.1.4. 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 the EHR, including at least:

4.5.1.4.4.1. Name of Attending Physician;

4.5.1.4.4.2. Radiation treatment type (e.g., conventional, IMRT);

4.5.1.4.4.3. Curative or palliative radiation treatment;

4.5.1.4.4.4. Dose amount and duration of radiation treatment, and

4.5.1.4.4.5. Discussion of evaluation with patient.

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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 contractor’s 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, and 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.

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. Contractor’s 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 the current electronic health record.

4.5.1.6.1. Prior to beginning radiation treatment, contractor’s 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. Contractor’s physician(s) shall evaluate each patient for treatment management at a minimum of once per five (5) treatments. These treatment management evaluations, addressing tumor response and side effects of therapy and medications prescribed, include pertinent laboratory and imaging studies. Patient’s progress shall be reported to the referring physician using the electronic medical record, Electronic Health Record (EHR), to include name of attending physician, treatment date, radiation treatment type, radiation dose amount and duration of treatment, radiation treatment dose to date and remaining dose to be provided, skin check of treated area, plan of care and number of treatments left to complete.

4.5.1.6.3. Contractor’s physician(s) shall provide the patient with written guidelines regarding their rights and responsibilities. This includes keeping the patient informed of all issues affecting care and inviting full participation in planning and implementing care. Patient expectations of contractor’s physician(s) should also be outlined. The patient must

Revision v0017 03/06/2020 Page 16 of 36 be advised of their right to submit complaints and procedures concerning such. This instruction must be documented in the medical record within 24 hours.

4.5.1.6.4. Contractor’s physician(s) shall maintain written policies and procedures that clearly define guidelines for protecting patients and employees from all unnecessary radiation exposure, provisions for the safe use, removal, handling and storage of radiation and other radioactive elements.

4.5.1.6.5. Contractor’s physician(s) shall monitor all therapy for side effects or complications; prescribe dose changes as needed; and review all cases at physician conference.

4.5.1.7. Treatment Discharge: Contractor’s physician(s) shall document treatment summary (End of Treatment Note) in the EHR to include total radiation treatment doses, patient’s condition at completion of treatment, discharge instructions to patient and a follow-up appointment within 5-10 business days post treatment.

4.5.1.8. Follow-up Evaluations: Unless alternative arrangements are arranged with the referring service, a Board-Certified Radiation Oncologist must see each patient at least one (1) time following the radiation therapy treatment courses as medically indicated within 30-120 calendar days of the end of a treatment series.

The follow-up examination shall consist of a physical examination of the patient and a review of the current medical record including x-rays and laboratory studies. The purpose of this examination is to evaluate the patient’s response to therapy, monitor for recovery from acute side effects of treatment and monitor for development if late side effects of treatments. A written evaluation shall be completed for the patient’s medical record within two (2) business days of the follow-up visit.

4.5.1.9. Peer Review Conferences: Contract staff shall attend and participate in weekly peer review conferences to discuss the appropriateness of treatment decisions, treatment goals and expected results related to the Minneapolis VAHCS Radiation Oncology patients. These conferences may be joint conferences at which contractor’s Radiation Oncology Service patients are also presented.

4.5.1.9.1. At a minimum, 100% of the following with respect to the Minneapolis

VAHCS Radiation Oncology patients shall be presented at these conferences:

4.5.1.9.1.1. Consultations;

4.5.1.9.1.2. Re-evaluations;

4.5.1.9.1.3. New start treatment fields, including boosts and off cord fields;

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

4.5.1.9.1.5. Patients seen in…