Medical Physics SOW (2019).docx

Medical Physics Statement of Work (DRAFT)

Period of Performance: From: 04/01/2020 to 03/31/2023

Section 1: Medical Physics Services Primary Duties and Responsibilities

1. Perform dosimetry calculations in support of NIH clinical research protocols to assure the safety and efficacy of procedures involving radiation. It estimated to be approximately 100 dosimetry calculations per year.

a. may require consultation with researcher

b. measurement of the fundamental exposures

c. calculation of relevant organ doses

2. Develop a library of radiation dosimetry tables for standard procedures in partnership with the NIH Radiation Safety Committee (RSC) to be referenced by Principal Investigators (PIs) in writing clinical research protocols.

3. Perform dosimetry for individual patients as requested.

4. Provide guidance for radiation dosimetry related concerns as requested by the NIH Radiation Safety Committee (RSC).

Section 2: Inspection of radiation-producing equipment and associated lead shields

Inspection of radiation-producing equipment:

1. As a federal facility, the NIH is not bound by the Code of Maryland Regulations (COMAR) and is not required to register radiation-producing equipment with the State of Maryland. NIH does, however, use COMAR as the basis for surveying radiation-producing equipment.

2. The Contractor is required to survey radiation-producing equipment operated by the NIH at Bethesda, Maryland and satellite facilities in Gaithersburg, Rockville, Frederick, Poolesville, and Baltimore. The type and approximate number of these devices are as follows:

Type of Unit Number of Units

3. There are approximately 30 additional units that are surveyed by NIH Clinical Center (CC) staff. The Contractor may be asked to survey these units only upon request.

4. The Contracting Officer’s Representative (COR) will supply the Contractor with a list of units due for survey each month at the 1st business day of the that month.

5. The Contractor shall perform and document surveys in a report in accordance with the COMAR, as well as with ANSI/HPS N43.2-2001 “Radiation Safety for X-Ray Diffraction and Fluorescence Analysis Equipment”. If any problems are identified, the Contractor shall attach a cover sheet to the survey report highlighting the type of unit, the unit’s assigned unique identification number, problems noted with the unit, and what is required to bring the unit into compliance with the regulations.

6. For newly-installed units the Contractor shall include the usual survey requirements, an evaluation of radiation exposure to adjacent areas based on the occupancy of those areas, and specific recommendations for additional shielding if required. The COR will notify the Contractor of any new units and whether expedited surveys (1-week turnaround) are needed. The Contractor shall assign a DRS ID number to each new unit and affix a sticker showing that number. New install surveys are expected to be completed within two weeks.

7. The Contractor shall perform inspection of radiation producing equipment as requested following modifications and adjustments that may have resulted in increase of radiation hazard (e.g., relocation of a unit, replacement of an x-ray tube, changes in filtrations of beams, changes in image intensifications).

8. With prior approval of the point of contact for the unit, the Contractor can independently operate radiation-producing units, except for bone densitometers, x-ray diffraction units, and CT scanners, which must be operated by NIH personnel. The Contractor shall be held liable for any damage to a machine by virtue of the Contractor's operation of it.

9. The Contractor shall be responsible for scheduling appointments and arranging to have an NIH operator familiar with the unit present during the survey when required. Advance notice is essential to assure that the particular equipment is available for the scheduled service.

10. Whenever possible, the Contractor shall correct violations identified, such as those pertaining to the posting of appropriate caution signs and charts.

11. Upon completion of each survey, the Contractor shall affix to the unit a label indicating the date of the survey and the initials of the Surveyor.

12. Emergency notification to the COR is required immediately if major violations are noted such as: warning lights are not “fail safe,” interlocks are not operating correctly, shielding is defective, or table top exposure on fluoroscopic unit is excessive.

13. The Contractor shall submit equipment survey reports to the COR within 5 work days from the date of survey. Survey reports will be reviewed and may be returned to the Contractor for correction.

14. Equipment survey reports deemed unacceptable to the COR or designee shall be amended and/or corrected and resubmitted to the COR within 5 working days.

Inspection of associated lead shields

15. The Contractor is required to survey personal shielding, primarily lead aprons, thyroid shields, lead gloves, and gonad shields. The approximate number of these shields is 270.

16. The Contractor shall place a non-removable sticker carrying a number and a location on each lead apron, thyroid shield, lead glove, and gonad shield. The sticker shall not penetrate shielding materials. Annually, the Contractor shall inventory the items. The Contractor shall inspect each item visually and by fluoroscopy when available, otherwise by physical palpation.

17. The Contractor shall document the results of the inspection of personal protective shields on a provided form indicating the kind of shield, its ID number, method of survey, survey date, and surveyor name. The Contractor shall provide documentation of any defects.

18. By December 1st of the calendar year, the Contractor shall inspect and submit the associated report for the inspection of shielding devices (e.g. lead aprons, lead gloves, thyroid shields, etc.) that are used with radiation-producing equipment for defects. NIH CC staff typically perform surveys of their own personal protective shields although the Contractor may be asked to perform these surveys ad hoc.

19. All data generated in the course of performing any of the surveys shall be maintained for at least 36 months and available, when requested, for NIH verification.

20. The Contractor shall submit personnel shielding survey reports to the COR within 5 work days from the date of survey. Survey reports will be reviewed and may be returned to the Contractor for correction.

21. Personnel shielding survey reports deemed unacceptable to the COR or designee shall be amended and/or corrected and resubmitted to the COR within 5 working days.

Section 3: Additional duties

1. Perform shielding design for renovation and new facility projects upon request, in accordance with NCRP 147 guidance or updated best practice guidance. A written report shall be submitted to the COR within three weeks.

2. Perform visual evaluation of shielding prior to finishing, in coordination with construction engineering and the COR.

3. Perform and complete an evaluation and report of radiation exposure from radiation producing equipment to adjacent areas based on the occupancy of these areas, using a radiation source equivalent to the equipment’s output. Include clear and specific recommendations for additional shielding if required.

Section 4: Qualifications

1. The Contractor shall provide qualified personnel for the performance of this contract to assure that services are delivered in a prompt and safe manner.

2. Individuals performing surveys are considered key personnel; any replacement of these people shall have prior approval by the Contracting Officer under HHS Clause 352.270-5 “Key Personnel.”

3. Key personnel must have the following minimum qualifications:

a. A four-year college degree in a physical science or related field or equivalent training and experience;

b. Specific training in radiation safety, medical physics, or health physics either through formal college or equivalent special training;

c. Three years of experience in radiation safety, medical physics, or health physics, including one year in work similar to that required herein;

d. The ability to work independently after proper training and direction;

e. The skill to record and report data on documents and forms;

f. The ability to communicate in a polite and professional manner exercising tact and diplomacy with researchers.

4. Contractor personnel providing dosimetry calculations shall be certified as (or directly supervised by) a Medical Physicist by the American Board of Radiology.

5. Contractor personnel surveying radiation-producing equipment and shields shall be licensed by the State of Maryland to inspect radiation-producing machines.

6. Contractor personnel performing shielding design and evaluation shall be certified as (or directly supervised by) a Medical Physicist by the American Board of Radiology or a Certified Health Physicist by the American Board of Health Physics.

7. The Contractor shall comply with all Occupational Safety and Health Administration regulations as well as the policies of the NIH Division of Occupational Health and Safety (DOHS), while performing work under this contract. This includes the Contractor satisfying the requirements of an animal surveillance program and the requirements for entering BSL-3 and BSL-4 facilities, if necessary. These requirements are in place to comply with DOHS policy. An example would be initial and periodic testing for tuberculosis or the enrollment in the NIH Biosurety program.

8. Contractor personnel must undergo a background investigation and be found suitable to receive an NIH-ID badge.

9. For entry into BSL-3 and BSL-4 laboratories, in addition to passing a higher-level background check, staff must be able to meet physical and mental health requirements determined by DOHS.

10. Contractor personnel shall present a neat appearance and provide services in a professional and courteous manner while complying with all applicable NIH rules, regulations, and requirements. For example, contractor personnel shall park in designated areas, not smoke on NIH property and wear NIH Contractor identification at all times.

Deliverables and Reporting Requirements:

· Monthly status reports to include information on current and completed activities; problems encountered; corrective actions taken; and recommendations for the next reporting period.

· Status reports to assess progress, as requested by the COR.

Place of Performance:

· Generally, the Contractor is expected to perform the majority of work on the main campus in Bethesda, MD.

· Work may also need to be performed at satellite facilities located in Gaithersburg, Rockville, Frederick, Poolesville, and Baltimore.