NCI-130074-63_SOW.pdf

Statement of Work Radiation Support and Related Services NCI-130074-63 Page 1

STATEMENT OF WORK

SCOPE OF CONTRACT

The Radiation Oncology Branch (ROB), Center for Cancer Research (CCR), National Cancer Institute

(NCI), National Institute of Health (NIH), Bethesda, Maryland is responsible for providing radiation therapy treatments and related services to clinical protocol patients at the Clinical Center, NIH. These treatments will take place on-site, using linear accelerators, simulators, and dosimetry equipment.

The Contractor shall:

1) provide radiation therapy treatments, dosimetry treatment plans and verification, physics services, and related services as required by the Statement of Work; 2) operate associated equipment in the ROB such as high energy linear accelerators, radiation therapy simulators, CT scanners, radiation therapy treatment planning computers, associated dosimetry equipment, medical laboratory equipment, and MRI equipment; 3) provide on-call emergency radiation services, when required, in accordance with established radiation therapy practices, and 4) participate in on-site training. All staff shall have the appropriate board or registry certifications and appropriate state licensure for the field of practice as evidence by the curriculum vitae (CV).

Radiation Therapy Treatments

The Contractor shall provide radiation therapy treatments, dosimetric calculations, and measurements based on HIPAA Medical Code Sets identified by the Healthcare Common Procedure Coding System

(HCPCS) Current Procedural Terminology (CPT) procedure codes. Codes used at the National Cancer

Institute (NCI) include, but are not limited to, the following:

1. 77413 – Radiation treatment delivery, three or more separate treatment areas, blocking, transgential ports, wedges, rotational beam, compensators, special particle beam, 6-10 MeV.

2. 77414 – Radiation treatment delivery, three or more separate treatment areas, blocking, transgential ports, wedges, rotational beam, compensators, special particle beam, 11-19 MeV.

3. 77408 – Radiation treatment delivery, single treatment area, single port or parallel opposed ports, simple blocks or no blocks, 6-10 MeV.

4. 77409 – Radiation treatment delivery, single treatment area, single port or parallel opposed ports, simple blocks or no blocks, 11-19 MeV.

5. 77403 – Radiation treatment delivery, single treatment area, single port or parallel opposed ports, simple blocks or no blocks, 6-10 MeV.

6. 77404 – Radiation treatment delivery, single treatment area, single port or parallel opposed ports, simple blocks or no blocks, 11-19 MeV.

7. 77372 – Radiation treatment delivery, stereotactic radiosurgery (SRS), complete course of treatment of cranial lesion(s) consisting of 1 session, linear accelerator based.

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8. 77373 – Stereotactic body radiation therapy, treatment delivery, per fraction to 1 or more lesions, including image guidance, entire course not to exceed 5 fractions.

9. 77418 – Intensity modulated treatment delivery, single or multiple fields/arcs, via narrow spatially and temporally modulated beams, binary, dynamic MLC, per treatment session.

10. 77290 – Therapeutic radiology simulation-aided field setting; complex.

11. 77295 – Therapeutic radiology simulation-aided field setting; 3-dimensional.

12. 77334 – Treatment devices, design and construction; complex (irregular blocks, special shields, compensators, wedges, molds or casts).

Dosimetry Treatment Plans and Verification

The Contractor shall provide dosimetry treatment plans, and plan verifications, as requested by attending physicians, based upon the American Medical Billing Codes. Codes used at the National Cancer Institute

(NCI) include, but are not limited to, the following:

1. 77310 – Teletherapy, isodose plan (whether hand or computer calculated), intermediate (three or more treatment ports directed to a single area of interest).

2. 77315 – Same as above, complex (mantle or inverted Y, tangential ports, the use of wedge, compensators, complex blocking, rotational beam, or special beam considerations).

3. 77301 – Intensity modulated radiotherapy plan, including dose-volume histograms for target and critical structure partial tolerance specifications.

4. 77321 – Special teletherapy port plan, particles, hemibody, total body.

5. 77328 – Complex (multiplane isodose plan, volume implant calculations, over 10 sources/ribbons used, special spatial reconstruction, remote after loading brachytherapy, over 12 sources).

Physics Services

The Contractor shall provide physics services, including commissioning of radiotherapy equipment;

periodic quality assurance measurements of equipment; quality assurance and verification of treatment plans; quality assurance of patient records, including paper and electronic charts; based upon the

American Medical Billing Codes. Codes used at the National Cancer Institute (NCI) include, but are not limited to, the following:

1. 77336 – Continuing medical physics consultation, including assessment of treatment parameters, quality assurance of dose delivery, and review of patient treatment documentation in support of the radiation oncologist, reported per week of therapy.

2. 77330 – Special medical radiation physics consultation.

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3. 77399 – Unlisted procedure, medical radiation physics, dosimetry and treatment devices, and special services.

4. 77331 – Special dosimetry (e.g. TLD, microdosimetry) only when prescribed by the treating physician.

Personnel Requirements

The Contractor shall:

1. Ensure that the proposed Chief Radiation Therapist is certified by the American Association of

Radiation Technologists (ASRT) in Radiation Technology, possesses an Associate of Science degree in Radiation Science, and has at least two years of supervisory experience as Chief or Assistant Chief

Therapist.

2. Ensure that the proposed Radiation Therapists are certified by the ASRT in Radiation Technology, possess an Associate of Science degree, and have at least one year of experience as a Radiation

Therapist.

3. Provide documentation that verifies that the Radiation Therapists have experience in operating all of the following equipment, including: Varian RapidArc accelerator, Tomotherapy Hi-ART helical tomotherapy unit, Nucletron MicroSelectron High-Dose-Rate Remote Afterloader, Varian ARIA patient management system, and Philips Brilliance CT Simulator. Copies of certifications shall be supplied.

4. Ensure the Supervisory Physicist is certified by the American Board of Radiology or an equivalent organization in Therapeutic Radiological Physics, Radiation Therapy Physics or Radiological

Physics, possess a Master of Science degree in Physics, Biology, Nuclear Engineering or Medical

Physics, and has at least five years of experience.

5. Ensure the Supervisory Physicist has at least one year of experience in the treatment planning of proton radiotherapy.

6. Ensure the Supervisory Physicist has been a Nuclear Regulatory Commission-recognized Authorized

Medical Physicist for at least three years and has supervisory experience for at least three years.

7. Ensure the Supervisory Physicist has experience in assisting with all physics and dosimetry aspects of clinical research as demonstrated by authorship in oral and poster presentations at scientific meetings and authorship of articles published in peer-reviewed journals.

8. Ensure the Supervisory Physicist has factory-based training in Tomotherapy Hi-ART planning, quality assurance, operation, and first-line maintenance; Radionics XKnife planning, operation, and maintenance; Varian RapidArc planning, On-Board Imaging, and basic accelerator maintenance; and

Nucletron Oncentra-BPS brachytherapy planning, and quality assurance and MicroSelectron operation.

9. Ensure the Staff Physicists have a minimum of a Master’s Degree in Physics, Medical Physics, or a related discipline and five years of experience; or a Doctoral degree with three years of experience.

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10. Ensure the Staff Physicists are certified by the American Board of Radiology in Therapeutic

Radiologic Physics, Radiation Therapy Physics or Radiologic Physics.

11. Ensure the Staff Physicists have factory-based specialty physics training on at least one of the following systems: Varian RapidArc, Nucletron MicroSelectron, and Oncentra BPS, Tomotherapy or

XKnife radiosurgery, and have had on-site training on the remainder of the systems.

12. Ensure Junior Physicists have a minimum of a Master’s Degree in Physics, Medical Physics, or a related discipline and two years of experience.

13. Ensure Junior Physicists are graduates of a CAMPEP-approved medical physics residency program and shall be eligible for the ABR accreditation process. They shall complete all requirements for board certification within five years from the date of hire. Junior Physicists shall matriculate to Staff

Physicists upon successful completion of the ABR certification process, and upon approval of the

Government.

14. Ensure Dosimetrists are certified by the Medical Dosimetry Certification Board of the American

Association of Medical Dosimetrists (AAMD), possess an Associate of Science degree in Radiation

Science, and have at least five years of experience.

15. Ensure Dosimetrists have factory-based training on the Tomotherapy Hi-ART treatment planning system and the Radionics XKnife radiosurgery planning system.

16. Ensure Imaging Scientists have a Ph.D. in imaging science or computer science specializing in image processing, and have a minimum of 2 years of experience, plus a demonstrated competency through publications in recognized scientific journals or patents.

17. Ensure Biomedical Engineers have a Bachelor of Science and minimum of 2 years of experience specializing in radiation oncology.

General Technical Requirements

The Contractor shall:

1. Ensure that physics and dosimetry personnel consist of a Supervisory Physicist, Staff Physicists, a possible Junior Physicist, and 1-2 Dosimetrists. There may or may not be a Junior Physicist, but there shall be no more than one. There shall be at least one Dosimetrist.

2. Ensure that only the contractor Supervisory Physicist reports to and takes direction from the

Contracting Officer’s Representative (Chief of Radiation Physics).

3. All Radiation Therapists shall have experience treating patients according to specifications set forth in clinical research protocols and shall be familiar with the treatment and delivery aspects of those protocols.

4. Provide approximately 1,875 treatments for base period (1 month) and 1,875 treatments for option period 1(1month) over the duration of this contract.

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5. Perform treatment procedures at the National Institutes of Health Clinical Center located in Bethesda, Maryland, or at any additional location as specified by the Government. The NCI shall furnish the

Government equipment and supplies to perform the Statement of Work.

6. Perform treatment procedures as required five (5) days per week, except Federal holidays. Core business hours at the NCI are 8:00 AM to 4:30 PM, Monday through Friday. Occasionally, the

Contractor may be required to adjust its work schedule to perform treatment procedures to accomplish project needs. Additional hours may be required on an as needed basis due to emergency or scheduling requirements.

7. Perform all work in accordance with applicable laws and regulations pertaining to the work.

8. Devote a minimum of 10% time educating radiation oncology residents, medical physics residents, postdoctoral associates, summer students or other personnel as deemed appropriate by the Contracting

Officer’s Representative.

9. Keep all medical certifications current.

10. Ensure that no Contractor personnel be exposed to occupational radiation greater than the standard allowed by Local, State, or Federal Laws or Regulations. The Contractor shall certify that all work performed meets or exceeds the safety requirements of Federal radiation standards for occupational exposure.

11. Participate in on-site training as required by the COR and NIH community, including, but not limited to annual radiation safety training and annual security awareness training.

12. Inform the NCI Contracting Officer Representative (COR) of any unforeseen circumstances that may delay timely completion or progress of study activities. All study-related activities, documents, and procedures must be approved by the COR prior to implementation. Types of support to be provided by the Contractor in the support of studies may vary.