PWS 07262022.pdf

B.3 PERFORMANCE WORK STATEMENT

For onsite Diagnostic Physicist Services for Equipment Testing and Inspections for

Bronx VAMC

1. General:

1.1. Introduction: As part of a federal agency, multiple VAMCs located throughout VISN 2 Southern Region, are subject to NRC regulation.

Regulations issued by the NRC are found in Title 10 Code of Federal Regulations (CFR), Chapter 1, Parts 0 through 199. VAMCs are required to abide by the terms and conditions of the Veterans Health Administration (VHA) Master Materials License (MML) agreement with the Nuclear Regulatory Commission (NRC). The MML sets forth the required administrative and operational procedures for safe management of all radioactive materials, regardless of source or method of production, and required application of the standards for acquisition, receipt, storage, distribution, use, transfer, and disposal of radioactive materials. The purpose of this contract is to procure, by way of contract, Diagnostic Medical Physicist services that can perform all services necessary to ensure that the respective VAMCs, are in compliance with requirements of the MML and NRC and other regulatory bodies, e.g., OSHA, DOT, and EPA.

The Contractor shall provide Board certified Diagnostic Physicists to provide equipment testing services and provide back-up assistance with Radiation Safety duties on an as needed basis. The contractor shall furnish all labor, material, supplies, equipment, and qualified personnel to provide on-site diagnostic medical physics support services for medical physicist services for Diagnostic imaging specified in the scope of work section below. All services will be provided under the direct supervision of a Board-Certified Medical Physicist.

The FDA, New York State Department of Health, and New York City Department of Health require testing of diagnostic x-ray equipment to ensure diagnostic imaging quality, and a safe environment of radiation safety for patients, staff, and visitors. The VA requires that these requirements be satisfied.

Contractor shall offer a diverse, multi-modality experienced team of qualified Board Certified Diagnostic Medical Physicist professionals.

1.2. Place of Performance: Services for the Board Certified Diagnostic Medical Physicist will be at the: Department of Veterans Affairs, James J. Peters VA Medical Center, Biomedical Engineering, Room 6A05, 130 West Kingsbridge Road, Bronx, NY 10468.

1.3. Terms of Service: The contract will be written for a one (1) base period with four (4) one (1)-year ordering periods.

1.3.1. This contract is issued subject to the availability of appropriations for FY 2023 and ensuing fiscal years.

1.3.2. Option years, if deemed necessary, will be exercised via a unilateral modification by serving appropriate notice and approved by the Contracting

Officer.

1.4. Authority: Title 38 USC 7301(b), FAR 12 and

1.5. Policy/Handbooks:

1.5.1. VHA Directive 1129 Radiation Protection for Machine Sources of Ionizing Radiation: VHA Directive 1129

1.5.2. VHA Directive 1105 Management of Radioactive Materials: VHA Directive 1105

1.5.3. VHA Directive 1129.01 Transmittal Sheet March 21, 2019; Mandatory Reporting for Misadministration of Therapy Machine Sources of Ionizing Radiation:

1.5.4. VHA Directive 1105.04 Fluoroscopy Safety: VHA Directive 1105.04 (Fluoroscopy Safety)

1.5.5. VHA Directive 1105.02 Nuclear Medicine and Radiation Safety Administrative Service: VHA Directive 1105.02 Nuclear Medicine and Radiation Safety Administrative Service

1.5.6. 10 CFR Part 20, Standards for Protection Against Radiation and 10 CFR Part 35, Medical Use of Byproduct Material

1.6. Definitions: Terms used in this contract shall be interpreted as follows unless the context expressly requires a different construction and/or interpretation.

1.6.1. Contracting Officer: The person with the authority to enter into, administer, and/or terminate contracts and make related determinations & findings.

1.6.2. Contracting Officer Representative: Any person or persons authorized to act for the contracting officer within specific limits of the contract, normally to provide technical assistance and advice, coordination of workload, and certification of invoices.

1.6.3. Contractor: An individual, partnership, corporation, or organization having a contractual relationship with the Government for provision of services.

1.7. Acronyms/Abbreviations:

1.7.1. ABHP: American Board of Health Physics

1.7.2. ABRB: American Board of Radiology

1.7.3. ACR: American College of Radiology

1.7.4. ALARA: As Low as Reasonable Achievement

1.7.5. ADP: Automated Data Processing

1.7.6. AMA: American Medical Association

1.7.7. CO: Contracting Officer

1.7.8. COR: Contracting Officer Representative

1.7.9. CQI: Continuous Quality Improvement

1.7.10. D&T: Diagnostics & Therapeutic Care Line

1.7.11. DHCP: Decentralized Hospital Computer Program

1.7.12. FAR: Federal Acquisition Regulation

1.7.13. ISO: Information Security Officer

http://www.google.com/url?sa=t&rct=j&q&esrc=s&source=web&cd=1&sqi=2&ved=0ahUKEwi_s7qYj-nLAhXCHh4KHTl3CosQFggcMAA&url=http%3A%2F%2Fwww.va.gov%2Fvhapublications%2FViewPublication.asp%3Fpub_ID%3D3081&usg=AFQjCNFQUUGA0SXpYqxCgPDwqz__UXOjYQ&bvm=bv.118353311%2Cd.dmo http://www.google.com/url?sa=t&rct=j&q&esrc=s&source=web&cd=1&sqi=2&ved=0ahUKEwi_s7qYj-nLAhXCHh4KHTl3CosQFggcMAA&url=http%3A%2F%2Fwww.va.gov%2Fvhapublications%2FViewPublication.asp%3Fpub_ID%3D3081&usg=AFQjCNFQUUGA0SXpYqxCgPDwqz__UXOjYQ&bvm=bv.118353311%2Cd.dmo http://www.google.com/url?sa=t&rct=j&q&esrc=s&source=web&cd=1&ved=0ahUKEwiKuavkiOnLAhVEkh4KHfMvDQ4QFggcMAA&url=http%3A%2F%2Fwww.va.gov%2Fvhapublications%2FViewPublication.asp%3Fpub_ID%3D3080&usg=AFQjCNGLPxfsrcd5szyaVz-TXTRfzUwi8A&bvm=bv.118353311%2Cd.dmo http://www.google.com/url?sa=t&rct=j&q&esrc=s&source=web&cd=1&ved=0ahUKEwiKuavkiOnLAhVEkh4KHfMvDQ4QFggcMAA&url=http%3A%2F%2Fwww.va.gov%2Fvhapublications%2FViewPublication.asp%3Fpub_ID%3D3080&usg=AFQjCNGLPxfsrcd5szyaVz-TXTRfzUwi8A&bvm=bv.118353311%2Cd.dmo http://www.google.com/url?sa=t&rct=j&q&esrc=s&source=web&cd=1&ved=0ahUKEwjip_SujenLAhXHHB4KHeX3B9MQFggcMAA&url=http%3A%2F%2Fwww1.va.gov%2Fvhapublications%2FViewPublication.asp%3Fpub_ID%3D2764&usg=AFQjCNFreWnZTzCWpZIquTj5qPhiAFShjA&bvm=bv.118353311%2Cd.dmo http://www.google.com/url?sa=t&rct=j&q&esrc=s&source=web&cd=1&ved=0ahUKEwjip_SujenLAhXHHB4KHeX3B9MQFggcMAA&url=http%3A%2F%2Fwww1.va.gov%2Fvhapublications%2FViewPublication.asp%3Fpub_ID%3D2764&usg=AFQjCNFreWnZTzCWpZIquTj5qPhiAFShjA&bvm=bv.118353311%2Cd.dmo http://www.google.com/url?sa=t&rct=j&q&esrc=s&source=web&cd=1&ved=0ahUKEwjip_SujenLAhXHHB4KHeX3B9MQFggcMAA&url=http%3A%2F%2Fwww1.va.gov%2Fvhapublications%2FViewPublication.asp%3Fpub_ID%3D2764&usg=AFQjCNFreWnZTzCWpZIquTj5qPhiAFShjA&bvm=bv.118353311%2Cd.dmo http://www.google.com/url?sa=t&rct=j&q&esrc=s&source=web&cd=1&ved=0ahUKEwjip_SujenLAhXHHB4KHeX3B9MQFggcMAA&url=http%3A%2F%2Fwww1.va.gov%2Fvhapublications%2FViewPublication.asp%3Fpub_ID%3D2764&usg=AFQjCNFreWnZTzCWpZIquTj5qPhiAFShjA&bvm=bv.118353311%2Cd.dmo

1.7.14. IRMS: Information Resources Management Service

1.7.15. JCAHO: Joint Commission on Accreditation of Healthcare Organizations

1.7.16. NCQA: National Committee for Quality Assurance

1.7.17. NRC: Nuclear Regulatory Commission

1.7.18. OSHA: Occupational Safety and Health Administration

1.7.19. PO: Privacy Officer

1.7.20. PO: Purchase Order

1.7.21. QA: Quality Assurance

1.7.22. QI: Quality Improvement

1.7.23. RSO: Radiation Safety Officer

1.7.24. SDB: Small Disadvantaged Business

1.7.25. USC: United States Code

1.7.26. VA: Department of Veterans Affairs

1.7.27. VAMC: VA Medical Center

1.7.28. VA NHPP: VA National Health Physics Program

1.7.29. VISN: Veterans Integrated Service Network

1.7.30. VISTA: Veterans Health Information Systems & Technology Architecture

2. Qualifications:

2.1. Staff/Facility

2.1.1. Certification: All contract personnel that will provide services on this contract shall be Board Certified Diagnostic Medical Physicists by the American Board of Radiology, ABR (theabr.org).

2.1.2. All certifications of contract personnel shall also be subject to review prior to execution of the contract for approval, by the Department of Veterans Affairs. All certifications of the contract personnel shall be full and unrestricted certifications.

2.1.3. The selected awardee will inquire with to the Contracting Officer Representative (COR) for a list of vaccinations that may be required. It is the responsibility of the COR to notify the Contractor if any new vaccinations have been identified through the life of the contract.

2.1.4. Technical Proficiency - Contractor’s physicist(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 shall provide verifiable evidence of all educational and training experiences including any gaps in educational history for all Contractor’s physicist(s) and Contractor’s physicist(s) shall be responsible for abiding by the Facility's Medical Staff By-Laws, rules, and regulations (referenced herein) that govern medical staff behavior.

2.1.4.1. 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.

https://www.theabr.org/about/abr-board-certification/our-certificates#diagnostic-rad http://www.cdc.gov/hicpac/pdf/InfectControl98.pdf

2.1.4.2. Conflict of Interest: The Contractor and all Contractor’s physicist(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.

2.1.5. Citizenship related Requirements:

2.1.5.1. The Contractor certifies that the Contractor shall comply with any and all legal provisions contained in the Immigration and Nationality Act of 1952, As Amended;

its related laws and regulations that are enforced by Homeland Security, Immigration and Customs Enforcement and the U.S Department of Labor as these may relate to non-immigrant foreign nationals working under contract or subcontract for the Contractor while providing services to Department of Veterans Affairs patient referrals.

2.1.5.2. 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.

2.1.5.3. 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.

2.1.5.4. 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.

2.1.5.5. 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.

2.1.6. 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.

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

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

2.3. Inherent Government Functions: Contractor and Contractor’s Certified Medical Diagnostic Physicist (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.

2.4. No Employee status: The Contractor shall be responsible for protecting Contractor’s Certified Medical Diagnostic Physicist (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:

2.4.1. Workers’ compensation

2.4.2. Professional liability insurance

2.4.3. Health examinations

2.4.4. Income tax withholding, and

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

2.4.5. Social security payments.

2.5. Tort Liability: The Federal Tort Claims Act does not cover Contractor or Contractor’s Certified Medical Diagnostic Physicist (s). When a Contractor or Contractor’s Certified Medical Diagnostic Physicist (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 Contractor’s Certified Medical Diagnostic Physicist (s)) action or non-action shall be the responsibility of the Contractor and/or insurance carrier.

2.6. Key Personnel:

2.6.1. The contractor is not filling in for the VA Radiation Safety Officer but is expected to provide monitoring, reporting, etc as per the scope of work when called during the contract period.

2.6.2. Key personnel, Education, Licensure and competency requirements:

2.6.2.1. All Diagnostic Medical Physicists must be board certified, licensed and must maintain continuing education as required by their certifying agency. They must be able to speak the English language proficiently. They are also required to meet the standards:

2.6.2.1.1. New York State Department of Health, Radiation Safety. Quality Assurance Program for large x-ray facilities

2.6.2.1.2. New York State Department of Health regulations for CT

2.6.2.1.3. FDA regulations

2.6.2.1.4. 10 NYS PART.16 https://regs.health.ny.gov/volume-title-10/content/part-16-ionizing-radiation)

2.6.2.1.5. Contractor shall have a minimum of three (3) Certified Diagnostic Medical Physicists to be fully vetted for the duration of the contract to provide services.

2.7. 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 15 calendar day (s) after the occurrence of any of these events and provide the information required below. After 90 days, the Contractor shall submit the information required below to the CO at least 90 calendar days prior to making any permanent substitutions.

2.7.1. 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 seven (7) 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.

2.7.2. For temporary substitutions where the key person shall not be reporting to work for services, the Contractor shall provide a qualified replacement for the key person. The substitute shall have comparable qualifications to the key person requested to perform services IAW the Schedule of Healthcare Resources.

https://regs.health.ny.gov/volume-title-10/content/part-16-ionizing-radiation https://regs.health.ny.gov/volume-title-10/content/part-16-ionizing-radiation

2.7.3. 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 Certified Medical Diagnostic Physicist (s), s/he may request, without cause, immediate replacement of said Contractor’s Certified Medical Diagnostic Physicist (s) .The CO and COR shall deal with issues raised concerning Contractor’s Certified Medical Diagnostic Physicist (s) conduct. The final arbiter on questions of acceptability is the CO.

2.7.4. 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 Certified Diagnostic Medical Physicist(s) leaves Contractor’s employment or is unable to continue performance in accordance with the terms and conditions of the resulting contract.

2.8. Hours of Operation

2.8.1. VA Business Hours: The medical center hours are from 8:00 a.m. to 4:30 p.m. Monday through Friday, except for Federal Holidays.

2.8.1.1. Federal Holidays are:

o New Year’s Day o Martin Luther King Jr. Day o Presidents Day o Memorial Day o Juneteenth o Independence Day o Labor Day o Veterans Day o Columbus Day o Thanksgiving Day o Christmas Day o And any other day that the President of the United States determines is a Federal Holiday.

2.9. Work Hours:

2.9.1. The contractor will be required to construct a schedule with the COR that is in accordance with the Nuclear Regulatory Commission (NRC) and will need it approved by the COR and Radiology staff prior to commencing work for the given contract. Any changes with approved schedule will be communicated with COR and new schedule to be submitted for approval. The contractor will perform support services during normal hours that are identified under section 2.8.1. Routine testing, such as Quality Assurance (QA) and Radiation Safety Surveys will generally be conducted during business hours; however, it must not interfere with the clinical service. Schedule of services shall be completed within the first fourteen (14) days of contract award.

2.9.2. Contractor shall leave all documentation with Biomedical Engineering during business hours.

2.9.3. Certified Medical Diagnostic Physicists shall be available for phone consultations.

2.9.4. Contractor’s will be required to sign in and out for all services provided when onsite.

Processes and procedures will be provided during post-award meeting.

Time and Attendance sheets shall be required upon contract award.

2.10. Contractor Responsibilities:

2.10.1. Services Required: Provision of a Certified Diagnostic Medical Physicist to support the respective VAMCs’ radiation safety program as specified in sections 2.10.3 to 2.10.7. It is at the discretion of the Bronx’s RSO to determine what assisted duties shall be performed off site by the Contractor. All duties performed on, and off site will be tracked and logged using time sheets for billing purposes.

2.10.2. Standards of Practice: The Contractor’s care shall cover the range of services for radiation safety management, including the provision of a contractor to act as a backup for the Radiation Safety Officer, as described above, if needed due to, per the requirements contained in this PWS.

2.10.3. Required Tasks of the contracted Certified Medical Diagnostic Physicists:

2.10.3.1. The contracted Certified Medical Diagnostic Physicists serves as the functional and operational arm of the facility’s RSO and Radiation Safety Committee for assistance in implementing policy, development of procedures and ongoing oversight of local uses of radioactive materials as described in a permit. New policies and procedures may be indicated when the Radiation Safety Committee reaches a consensus that existing ones do not achieve their intended results; when a new regulation affects, or is affected by, the routine operation of each VAMC; or when a deficiency in the radiation safety program has been identified by the committee. The committee will summarize the results of its deliberations in the quarterly meeting minutes or when emergency situations arise.

2.10.3.2. The contracted Certified Medical Diagnostic Physicists assists the RSO as he/she investigates overexposures, accidents, spills, losses, thefts, and unauthorized receipt, use, transfer or disposal of radioactive materials, medical mis-administrations and other deviations from approved radiation safety practices and implements corrective actions as necessary. The RSO will generate a report whenever an investigation occurs. Documentation specified in 10 CFR Part 20, Standards for Protection Against Radiation and 10 CFR Part 35, Medical Use of Byproduct Material, will be generated.

2.10.3.3. The contracted Certified Diagnostic Medical Physicists develops and recommends to the VAMCs’ Radiation Safety Committee local procedures in writing for acquisition, receipt, storage, inventory, safe use, emergency procedures, surveys, equipment performance checks, disposal, personnel training, and user and facility record keeping requirements. These procedures are established in the VAMCs’ radioactive materials license application and are documented in each VAMCs’

Radiation Safety Handbook. Modification of one of these procedures constitutes a modification of the organization’s radioactive materials license agreement and must be approved by the committee, which meets quarterly.

2.10.3.4. The contracted Certified Diagnostic Medical Physicists briefs healthcare system management at least once each year on the status of the facility Radiation Safety Program. The medical diagnostic physicist in conjunction with the RSO performs an annual review in collaboration with a designated member of the Radiation Safety Committee; the result is submitted in a written report for approval by the committee.

Refer to Scope of Work section. Due September 30, annually,

2.10.3.5. The contracted Certified Diagnostic Medical Physicists develops and recommends to the Radiation Safety Committee investigational action levels for personnel exposures, contamination, and surveys immediately, no later than 72 hours once contacted.

2.10.3.6. The contracted Certified Diagnostic Medical Physicists will provide technical assistance and oversight to the development of imaging protocols for Computed Tomography for dose optimization and will review all written protocols on an annual basis.

2.10.3.7. The contracted Certified Diagnostic Medical Physicists assists the Radiation Safety Committee in the performance of its functions, including its annual evaluation of the facility radiation safety program.

2.10.3.8. The contracted Certified Diagnostic Medical Physicists performs periodic on-site evaluations of all activities involving the use of radioactivity in the healthcare system including, but not limited to, visits to all areas of use, examination of required records, and evaluations of radiation safety procedures. Laboratories are inspected quarterly and documented in laboratory survey reports. X-ray equipment is inspected Semi-annually and documented in x-ray survey reports.

2.10.3.9. The contracted Certified Diagnostic Medical Physicists set trigger reporting thresholds for fluoroscopic dose exposure and reviews all events exceeding the thresholds for deterministic effects of radiation exposure.

2.10.3.10. The contracted Certified Diagnostic Medical Physicists provide instruction principles of radiation safety and techniques for safe handling of radiation generating equipment or radioactive isotopes and compounds.

2.10.3.11. The contracted Certified Diagnostic Medical Physicist (s) agrees to perform applicable testing required by The Joint Commission and reports will demonstrate The Joint Commission verbiage.

2.10.4. The contracted Certified Diagnostic Medical Physicists will provide assistance in management of radiation disasters and acts of radiation terrorism, including the following:

2.10.4.1. Participation in VA radiation disaster planning and inclusion in VA radiation disaster training exercises.

2.10.4.2. Responding to VA radiation disaster incidents including acts of terrorism involving radiation within one hour during regular business hours and within three hours outside of regular business hours.

2.10.4.3. Assisting VA staff in identifying personnel contaminated with radioactive material during radiation disaster incidents or terrorist actions and supervising decontamination of contaminated personnel.

2.10.4.4. Analyzing radioactive contaminants to identify the radioactive material involved.

2.10.5. The contracted Certified Diagnostic Medical Physicists will not recommend or administer policies, procedures and methods of oversight that differ substantially from those already developed by the Contractor, except where specifically required to meet regulatory requirements applicable only to the VA and NRC or where required to comply with recommendations made by the Radiation Safety Committee.

2.10.6. The contracted Certified Diagnostic Medical Physicists must agree, in writing, to be responsible for implementing the radiation protection program in accordance with 10 CFR Part 35, Medical Use of Byproduct Material, Subpart B, paragraph 35.24.

2.10.7. Reporting and Documentation Requirements: The contracted Certified Diagnostic Medical Physicists performs or supports in the performance of the following tasks in connection with reporting and documentation:

2.10.7.1. Assists in the preparation of the annual radiation safety report for the Environmental Protection Agency (EPA).

2.10.7.2. Prepares the annual report on the Radiation Materials Safety Program for management.

2.10.7.3. Assists in the preparation of quarterly reports on the Radiation Materials Safety Program for the VAMCs’ Environment of Care Committee.

2.10.7.4. Provides the following reports to the Radiation Safety Committee for quarterly review:

2.10.7.4.1. Refer to Scope of work section for this data

2.10.7.5. Assistance in reviewing each of the VAMCs’ Radiation Safety Management Program, including:

2.10.7.5.1. Incidents of misadministration.

2.10.7.5.2. Report on fluoroscopy users training

2.10.7.5.3. Summary exposure reports for personnel working with radioactive materials.

2.10.7.5.4. Results of surveys for the ALARA program conducted in restricted areas.

2.10.7.5.5. Quarterly inventory on nuclides in research areas and assessment of levels against allowable license limits.

2.10.7.5.6. Reports of radioactive spills and other incidents, including remedial action recommended or taken.

2.10.7.5.7. Results of unannounced inspections conducted by the RSO.

2.10.7.5.8. Report on radioactive waste; The contracted Certified Diagnostic Medical Physicists are required to provide a report of low-level radioactive waste, including red bag waste, liquid waste, decay in storage, and long-life radioactive waste. Such reports will include quantities of waste identified as contaminated with radioactive material, disposition plans, monitoring activity and disposal actions taken.

2.10.7.5.9. Approval of new users and requests by authorized users of radioactive materials; the RSO is required to report on the training and experience of proposed new users and authorized users to allow for a determination by the Radiation Safety Committee that their qualifications are sufficient to enable them to perform their duties safely and in accord with VA regulations and the Master Material License (MML).

2.10.7.5.10. Status of radiation safety surveys of x-ray units and recommendations for remedial action as necessary.

2.10.7.5.11. Other subjects pertaining to Radiation Safety that may arise.

2.10.7.6. Prepares compliance reports on radioactive waste for regulatory bodies.

2.10.7.7. Maintains records and documentation of all training provided to staff.

2.10.7.8. Ensures that any incidents regarding noncompliance with VA or NRC regulations, whether found by the NRC or by the respective VAMCs’ personnel, are corrected as soon as possible and that corrective actions are fully documented and kept on record.

2.10.8. Radiation Safety Training for the Bronx VAMC Radiation Staff will be provided by the Certified Diagnostic Medical Physicists during the times from 8:00 am to 4:00 pm annually to go over radiation safety. Coordination’s shall be made with radiation safety supervisors and COR. All training shall be conducted onsite and in person by the Contractor. The training will be for all affected services as needed.

2.10.8.1. The contractor shall have oversight on an as needed basis of the Nuclear Medicine Technicians and assist in the training for the Bronx’s fulltime Radiation Safety Staff to perform the following duties:

2.10.8.1.1. Dose calibrator of the Nuclear Medicine Program

2.10.8.1.2. Quarterly Linear Checks

2.10.8.1.3. Radioactive waste handling

2.10.8.1.4. Weekly surveys of storage sheds

2.10.8.1.5. waste transfer from research labs to the storage shed

2.10.8.1.6. weekly spot checks of trash monitor

2.10.8.1.7. Survey meters

2.10.8.1.8. Distribution and collection of meters of all users (for calibration)

2.10.8.1.9. Shipping/ handling of meters to vendor for calibration

2.10.8.1.10. Employee badges

2.10.8.1.11. Monthly collection and distribution of badges

2.10.8.1.12. Return badges to vendor monthly

2.10.8.1.13. Distribution of badge reports

2.10.8.1.14. Addition and deletion of badges

2.10.8.2. I-131 Therapy

2.10.8.2.1. On-site training of staff

2.10.8.2.2. Room preparation

2.10.8.2.3. Thyroid uptake measurements

2.10.8.2.4. Room surveys and radioactive waste handling

2.10.8.2.5. QMP of Nuclear Medicine Therapy

2.10.8.2.6. Inventory and wipe tests of all sealed sources

2.10.8.2.7. Provide RSO with data for Quarterly and Annual Reports, to include:

- QMP records of Nuclear Medicine

- Record and track radioactive shipments

- Badge information

- Inventory of sealed sources

2.10.8.2.8. In-service staff as needed

2.10.9. According to JJP VAMC Continuity of Operation Plan for RSO coverage, PM 11-184, a temporary RSO coverage for 60 working days may be required in the event the RSO becomes unavailable to be consulted either in person or by other means concerning radiation safety matters . Reference is in accordance with VHA Permit Number 31- 00636-07. In the event that this occurs, the Contractor shall become available to fulfill RSO coverage.

2.11. Standards: The services to be performed by the contractor will be performed in accordance with VA policies and procedures and the regulations of the medical staff by laws of the VA facility.

2.12. Scope Of Work: The contractor shall provide all resources (labor, equipment, travel, parts and services) necessary to accomplish the following:

2.12.1. Quarterly collimation tests as specified in Part 16 NY State Sanitary Code for all radiographic and fluoroscopic systems.

2.12.2. Semi-annually the Contractor will perform Part 16 NY State tests including:

2.12.2.1. Radiographic: reproducibility, HVL, kV calibration, exposure time accuracy, mA linearity, photo timer evaluation, interlocks and tomography evaluation.

2.12.2.2. Fluoroscopic: reproducibility, HVL, kV calibration, timer accuracy, mA linearity, photo timer evaluation, high and low contrast resolution, and maximum and typical fluoroscopic entrance exposure rates.

2.12.2.3. Audit of Diagnostic Radiology QC program to include X-ray, CT, and MRI.

2.12.2.4. CT Quality Assurance tests, including dose profiles, spatial resolution and low-contrast detectability testing as required by the ACR, and the NY City and State Departments of Health.

2.12.3. Annually:

2.12.3.1. Review Medical Imaging’s technical quality assurance program.

2.12.3.2. Review CT protocols to optimize patient dose.

2.12.3.3. Estimated skin exposures for commonly used exams in all rooms.

2.12.3.4. Fluoroscopic tabletop exposure rates.

2.12.3.5. CT Quality Assurance tests and dose estimates as specified by the NY State Department of Health.

2.12.3.6. Review of Diagnostic Radiology’s departmental policies and procedures by the Department of Health.

2.12.4. Perform emergency acceptance tests of CT tubes within 30 days of replacement.

2.12.5. MRI physics services for one (1) MRI unit:

2.12.5.1. Perform gauss line measurements and establish safety zones consistent with American College of Radiology (ACR) guidelines.

2.12.5.2. Support an ongoing quality control program and audit the program periodically, consistent with ACR standards.

2.12.5.3. Perform all tests to comply with ACR and manufacturer recommendations.

2.12.6. CR physics services for one (1) CR unit:

2.12.6.1. Perform all tests to comply with NY State Department of Health requirements.

2.12.7. DR physics services:

2.12.7.1. Perform all tests to comply with NY State Department of Health requirements.

2.12.8. Ultrasound transducer quality control testing.

2.12.9. Provide medical physics consultations as needed.

2.12.10. As needed perform in-service training for staff.

2.12.10.1. Other Required Services:

2.12.10.1.1. Perform any dose calculations required on radiated patients

2.12.10.1.2. Provide in-service to staff as requested

2.12.10.1.3. Attend Radiation Safety Meetings as needed

2.12.11. All testing will be scheduled through Radiology Service or Imaging Program Manager Monday through Friday, 8:00am to 4:30pm

2.12.12. The contractor will provide all the calibrated equipment necessary to complete the evaluations and document the data.

2.12.13. Any testing equipment that involves the use of a contractor owned laptop will be used only for the purpose of gathering test equipment data. At no time will the Contractor have access to any aspect of the VA information technology network including CPRS, Vista, Outlook or the LAN.

2.13. Requirements –Nuclear Medicine:

2.13.1. Quarterly Responsibilities:

2.13.1.1. Review of personnel dosimetry reports, including vacancy analysis.

2.13.1.2. Review of radiation area surveys and wipe tests.

2.13.1.3. Review of ALARA practices and an annual management audit of the department.

2.13.1.4. Perform dose calibrator quality control analysis (including accuracy, constancy, geometry and linearity).

2.13.1.5. Review isotope inventory control.

2.13.1.6. Perform semi-annual sealed source leak testing.

2.13.1.7. Review of all mandated records to ensure compliance with regulatory agencies.

2.13.2. All testing will be performed on a scheduled monthly basis and performed within the month scheduled. Call back service will require a 15-minute phone response and an onsite physicist within sixty (60) to one hundred (100) minutes of phone contact.

2.13.3. Monthly reports of current work will be provided, in writing or electronically to the Radiation Safety Officer and/or Imaging Program Manager of the specific VA Medical Center. Annual reports on the Radiation Safety Program will be provided to the Radiation Safety Committee.

2.14. Workload Projections: Monthly and based on historical data an estimate of ten (10) unscheduled call back visits per year to include:

2.14.1. Shielding evaluations.

2.14.2. Exposure evaluations to patient or staff

2.14.3. New equipment specifications and acceptance testing

2.14.4. Review of corrective actions.

2.14.5. In service technologists/technicians in QC test procedures

2.14.6. In service groups regarding radiation safety

2.14.7. Meet with Diagnostic Radiology Quality Assurance Committee

2.14.8. Whenever changes are implemented that would impact on patient doses, contractor will provide estimated skin exposures for commonly used exams.

2.15. Diagnostic X-ray Equipment:

2.15.1. Contractor will perform the following tests at their indicated frequencies and submit reports:

2.15.1.1. Quarterly:

a) Collimation, Radiographic:

• Light field/x-ray field alignment

• PBL sizing

• X-ray field/image receptor alignment

b) Collimation Fluoroscopic:

• X-ray field/image receptor alignment

• X-ray field/spot film sizing

2.15.1.2. Semi-Annually

a) Radiographic timers

b) AEC

c) KVp for all tubes

d) mA linearity and reproducibility for all tubes

e) Fluoroscopic image resolution

• Spatial resolution

• Low contrast resolution

f) Tomographic equipment

g) Exposure switches

h) Interlocks

2.15.1.3. Annually:

a) HVL for all tubes

b) Fluoroscopic timers

c) Fluoroscopic tabletop rates

d) Dose measurements, including pulse rate used for each output measurement

2.15.1.4. All testing will be scheduled by the Radiology or Nuclear Medicine Service during regular work-day hours, Monday through Friday, 7:00am to 5:30pm.

2.16. Contractor Deliverables: The contractor shall provide documentation of services provided. The documentation will include legible detailed descriptions of the services and parts delivered. All records and logs shall be turned over to the COR or Biomedical Engineering Designee at the completion of the work performed. Failure to provide all required documentation and equipment service reports, payment will be withheld until all documents are received.

2.16.1. The contractor shall provide a checklist with worksheet originals indicating work to be performed and actual values obtained. Contractor must maintain an Inspection Record Log.

Each service report shall include:

2.16.1.1. Reports must be submitted for all tests and reviews/audits. Reports shall be submitted upon completion either electronically and/or hardcopy.

2.16.2. Valid licensing and maintenance of continuing education as required by their certifying agency; also, by the approval of the VA Radiation Safety Officer.

2.16.3. References: No patient care or research activities are required. Administrative and educational activities are limited to written documentation, equipment evaluations and technical training of staff on radiation safety as it pertains to the equipment covered under the contract:

2.16.3.1. Review/complete the on-line VAMC Contract Worker Orientation Handbook/Post-test and abide by all facility rules and regulations.

2.16.3.2. Comply with all OSHA requirements as related to Performance of Work.

2.16.3.3. Obtain contractor photo identification badges from VAMC Police Department.

2.16.3.4. Furnish, wear, and maintain personal dosimeters.

2.17. Delivery:

2.17.1. General Services:

2.17.1.1. Upgrade the Quality Assurance program to ensure compliance with recent local government requirements.

2.17.1.2. Provide an Annual Radiation Safety Program Report.

2.17.1.3. Assist in selection of equipment to be purchased.

2.17.1.4. Supply complete Quality Control manuals where necessary.

2.17.1.5. Training the appropriate staff in proper techniques for implementing the Quality

Control Program.

2.17.1.6. Establish Radiation Safety procedures that are compatible with latest governmental guidelines.

2.17.1.7. Monitor the Quality Control programs periodically and submit reports

2.17.1.8. Attend quality control meeting annually.

2.17.1.9. Provide technical and/or radiation safety in-services to your staff as required.

2.18. Progress and Compliance: The VA COR, Radiation Safety Officer, Radiology Service, Imaging

Service, and/or Nuclear Medicine Service will monitor the performance of the Contractor. The Specific monitor procedure to be used:

2.18.1. Log in and review for completion all required reports by Contractor.

2.18.2. Notify Biomedical Engineering of any unacceptable test results denoted by the Contractor.

2.18.3. All reports shall be sent to the attention of the COR to the following address for any hard copy reports as necessary, at no additional expense to the Government:

James J. Peters VA Medical Center Biomedical Engineering, Room 6A05 130 West Kingsbridge Road Bronx, NY 10468

2.18.4. Electronic files may be sent to the COR, Biomed Field Representative and the Bronx VA

Radiation Safety Supervisor.

2.19. Contractor Identification: The contractor personnel must have in their possession for inspection by

VA Police Department a valid state or government issued identification such as drivers’ license or passport. Personnel may be required to surrender their ID to the VA Police to obtain a temporary day pass at the discretion of VA Police. ID will be returned upon leaving US Government property.

2.19.1. Day pass must be worn at all times above the waist, in front, with the face of the card visible.

2.19.2. Once issued a temporary identification badge, the contractor’s Physicist are to report to the

Biomedical Engineering Department to log in and sign the VA vendor sign-in sheet located on the outside door of the Biomedical Engineering Department. This check-in is mandatory.

2.19.3. The contractor will then be escorted by Biomedical Engineering personnel to the respective work site. When the service is completed, the Physicist shall submit a report within 7 business days of the visit accompanied by a cover sheet with findings and failures noted for action by Biomed.

2.19.4. Upon completion, the Contractor shall be required to check-out with Biomedical Engineering.

2.19.5. Contractor shall contact COR/POC Biomedical Engineering Service office for all reporting and coordination: COR: Luis-Enrique Davila at office GB-02, (718) 584-9000 Ext 5516 and alternate POC: William Schimmer at 2A-30 (718) 584-9000 Ext: 6852.

2.20. Equipment List:

2.20.1. See Section D, D.1 Active Equipment List. New lists will be provided to the contractor by the COR electronically when the equipment list changes.

2.21. Scheduling and Response Times:

2.21.1. All quarterly, semi-annual, and annual tests shall be scheduled in advance by the service supervisor. To ensure regulatory compliance, the Contractor shall provide required testing reporting within (7) seven days from the effective date of award.

2.21.2. Testing is required within 30 days of repair or modification to equipment and shall be requested by: Biomed POC.

2.21.3. Equipment that becomes inoperable due to unforeseen emergency circumstances will require retesting by the contractor (s) prior to using for patient care. This will prevent any disruption. Contractor shall provide physical onsite testing within twenty-four (24) hours of receipt of request. This is non-negotiable and time frame will not change unless approved by the Bronx VAMC.

2.21.4. The contractor is required to perform all new testing of equipment within seven (7) days from the time of request in order to maintain functionality and minimize the effect on patient care.

2.22. Equipment Performance Evaluation and Quality Assurance Tests:

2.22.1. The contractor will perform the following equipment performance and quality assurance testing on:

2.22.1.1. Radiographic and Fluoroscopic Equipment: Quarterly QA Tests:

2.22.1.1.1. Radiographic

2.22.1.1.2. Light Field/X-Ray Field Coincidence

2.22.1.1.3. Positive Beam Limitation Evaluation

2.22.1.1.4. X-Ray Field/Image Receptor Alignment

2.22.1.1.5. Fluoroscopic and Spot Film

2.22.1.1.6. X-Ray Field to Image Receptor Alignment

2.22.1.2. Semi-Annual Radiographic & Fluoroscopic QA Tests:

2.22.1.2.1. Radiographic & Fluoroscopic kVp Accuracy

2.22.1.2.2. Radiographic mAs Linearity

2.22.1.2.3. Radiographic Timer Accuracy and

2.22.1.2.4. Radiographic Exposure Reproducibility

2.22.1.2.5. Fluoroscopic High Contrast (Spatial) Resolution

2.22.1.2.6. Fluoroscopic Low Contrast Resolution

2.22.1.2.7. Automatic Exposure Control (AEC) System Reproducibility (for each image receptor)

2.22.1.2.8. Exposure Switch Function

2.23. Annual Radiographic & Fluoroscopic QA Tests/Evaluations:

2.23.1. Radiographic and Fluoroscopic Beam Quality Assessment (HVL determination)

2.23.2. Fluoroscopic Timer Function

2.23.3. Fluoroscopic entrance exposure rate (or air kerma rate). Maximum output and typical output using a phantom representing a standard size patient for all clinically used settings, including all image receptor sizes. [The mode of operation [e.g., magnification mode, frame rate, and any other mode selected) must be documented for each measurement.]

2.23.4. Fluoroscopic Acquisition (image recording) entrance exposure rate (or air kerma rate) for cine imaging, if performed and entrance exposure (or air kerma) for spot images (if performed). Maximum output and output using a phantom representing a standard size patient for all clinically used settings. [The mode of operation (e.g., magnification mode, frame rate, etc.) must be documented for each measurement.]

2.23.5. Source Image Distance (SID) Indicator Accuracy

2.23.6. Fluoroscopic Timer Performance

2.23.7. Fluoroscopic Interventional Reference Point Calibration Verification (f present).

2.23.8. Evaluation of Integrity of Unit Assembly

2.23.9. Evaluation of Equipment Radiation Safety Functions

2.23.10. Grids used with portable x-ray units shall be imaged for uniformity.

2.23.11. Video and Digital Monitor Performance

2.23.12. Digital Image Receptor Performance

2.24. CT Quality Assurance Tests:

2.24.1. Annual Tests:

2.24.1.1. Slice Positioning Accuracy

2.24.1.2. Table Travel Accuracy

2.24.1.3. Slice Thickness Accuracy

2.24.1.4. CT Number Calibration

2.24.1.5. Low Contrast Resolution

2.24.1.6. CT Number dependency on kVp

2.24.1.7. Contrast-to-Noise Ratio

2.24.1.8. Image Uniformity

2.24.1.9. Artifact Evaluation

2.24.1.10. In-Plane Distance Measurement

2.24.1.11. CT Dose Index (CTDIvol) Measurement and Evaluation (2 protocols)

2.24.1.12. CT Dose Profile Analysis

2.24.2. VHA requires the inspection of CT scanners following repairs or modifications that may affect patient dose or image quality, further, a medical physicist must perform and document testing after these repairs or modifications before the CT scanner is returned to clinical service. This testing is necessary to ensure that repaired or modified CT scanners do not expose patients to radiation doses that exceed national standards.

2.25. Semi-Annual Test:

2.25.1. CT Dose Profile Analysis

2.26. Joint Commission Testing:

2.26.1. Diagnostic CT Scanners*

2.26.2. Measures the radiation dose (in the form of volume computed tomography dose index

[CTDIvol]) produced by each diagnostic CT imaging system for the following CT protocols:

adult brain and adult abdomen. If one or more of these protocols is not used by the hospital, other commonly used CT…