PWS_-_Regulatory_Compliance_and_Radiation_Safety_Support.pdf

Section C

Regulatory Compliance and Radiation Safety Support Contract

PERFORMANCE WORK STATEMENT

ARTICLE C.1 BACKGROUND

The National Institutes of Health (NIH) is a large biomedical research facility with approximately

1,360 radioactive materials laboratories and a 350-bed research hospital. The NIH possesses a

Broad Scope license issued by the U.S. Nuclear Regulatory Commission (NRC) to use a wide variety and appreciable quantities of radioactive materials in biomedical research, medical diagnosis and treatment. Additionally, the NIH possesses a Cyclotron Production license enabling the NIH to create a number of radionuclides for clinical and research applications.

These licenses require NIH to establish and implement a comprehensive radiation safety program under the Division of Radiation Safety (DRS), Office of Research Services.

The majority of the radioactive material laboratories and use areas are located in Bethesda, MD;

however, some laboratories are located at other licensed locations in Gaithersburg, MD, Rockville, MD, Kensington, MD, Poolesville, MD, Frederick, MD, and Baltimore, MD. In addition to routine radioactive materials laboratories, NIH has a number of special-use laboratories in the Nuclear Medicine Department, the Building 21 hot lab facility, the cyclotron facility, a cGMP facility, BSL-3 and BSL-4 labs. NIH has approximately 1,180 radiation safety instruments in service in the various laboratories and facilities used for work with radioactive materials.

The purpose of this procurement is to contract for qualified technical assistance to be provided to support the DRS in carrying out selected elements of the radiation safety program.

The scope of the work is as follows:

Comprehensive Radiation Safety Surveys of Radionuclide Use Areas

Monthly Surveys of Designated Areas (optional service researchers can order)*

Checks on Security of Radioactive Materials (during and after normal work hours)

Inspection of radiation-producing equipment and associated lead shields

Preparation and Decontamination of I-131 Therapy Rooms

Field Calibration of Survey Meters Used for Contamination Monitoring

Calibration of Instruments Used to Measure Exposure or Dose Equivalent Rates

Radioactive material package receipt processing

Delivery of received radioactive material from central location to laboratories

Transfers of radioactive material between buildings owned or leased by the NIH

Inventory of radioactive material

Delivery and retrieval of radiation safety documents

*This requirement also seeks novel solutions, which are both technically and financially feasible, for meeting monthly survey requirements for all labs in which radioactive materials are used and/or stored instead of just those ordered by and paid for by individual researchers.

ARTICLE C.2 GENERAL REQUIREMENTS

The purpose of this Contract is for the Contractor, independently and not as an agent of the

Government, to perform:

1. Comprehensive radiation safety surveys of selected NIH laboratories, storage areas, and corridors

2. Monthly surveys in designated areas

3. Checks on security of radioactive materials

4. Inspections of radiation-producing equipment and associated lead shields

5. Preparation and decontamination of I-131 therapy rooms

6. Field calibrations and inspections of survey meters used for monitoring of radiological contamination

7. Calibration of instruments used to measure exposure or dose equivalent rates

8. Radioactive material package receipt processing functions

9. Delivery of received radioactive material from a central receipt location to the laboratories that have ordered the material

10. Annual inventory of radioactive material

11. Transfers of radioactive material between buildings owned or leased by the NIH

12. Delivery and retrieval of radiation safety documents.

These services shall be performed in compliance with:

a. 10 CFR 19

b. 10 CFR 20

c. 10 CFR 30

d. 10 CFR 35

e. 10 CFR 37

f. 21 CFR 1010

g. 29 CFR 1900-1910

h. 49 CFR 171-174

i. Conditions of NIH's NRC licenses

j. NIH Radiation Safety Web Site http://drs.ors.od.nih.gov/Pages/default.aspx

k. NIH policy on security of radioactive materials

l. DRS Policy on Personnel Monitoring

m. NIH Waste Calendar

n. NUREG-1556, Volumes 9, 11, and 21

o. COMAR for radiation-producing machines

p. ANSI/HPS N43.2-2001 “Radiation Safety for X-ray Diffraction and Fluorescence

Analysis Equipment,”

q. The following National Council on Radiation Protection and Measurements

(NCRP) reports:

49- Structural Shielding Design and Evaluation for Medical Use of X-rays and Gamma Rays of Energies up to 10 MeV (1976)

57- Instrumentation and Monitoring Methods for Radiation Protection (1978)

02-Medical X-ray Electron Beam and Gamma-ray Protection for Energies up to 50 MeV (1989)

144-Radiation Protection for Particle Accelerator Facilities (2003)

145-Radiation Protection in Dentistry (2003)

147-Structural Shielding Design for Medical X-ray Imaging Facilities (2004)

148- Radiation Protection in Veterinary Medicine (2004)

ARTICLE C.3 LOCATION/HOURS OF WORK/SPECIFIC REQUIREMENTS

1. The Contractor shall perform comprehensive radiation safety surveys on approximately

1,360 laboratories, storage areas, and corridors in facilities that operate under the auspices of NIH's NRC licenses. Most of these facilities are located in Bethesda, MD.

There are, however, satellite locations in Gaithersburg, MD, Rockville, MD, Kensington, MD, Poolesville, MD, Frederick, MD, and Baltimore, MD. The surveys will be spread relatively evenly throughout the month in which they are due.

2. The Contractor shall conduct approximately 300 monthly surveys each month, spread evenly throughout the month. Having the Contractor perform monthly surveys is an optional service that researchers can order under this contract. The Contractor is responsible for arranging for performance of and payment for this service directly with the researchers requesting the service. Some such transactions can be paid for with a credit card; others require a Common Accounting Number (CAN) or Purchase

Order. Some researchers have to pay on a month to month basis; others can pay for longer periods of time, up to 1 year. Payments are based on Fiscal Years, which run from October 1 through September 30, so monthly survey commitments need to be re-negotiated at the beginning of each Fiscal Year. The Contractor shall be responsible for tracking start and stop dates for this service and for maintaining records on which labs are due for monthly surveys each month. If no radioactive materials have been used in a lab since the last monthly survey, instead of conducting a survey the Contractor shall submit a “no use” survey via the DRS portal. For labs in which the Contractor conducts monthly surveys, no monthly survey is needed during months when the Contractor has conducted a comprehensive survey.

3. On average, 10 radioactive material packages are received, inspected, processed and delivered at Radiation Safety daily (about 2,500 packages per year). These packages typically contain radionuclides in microcurie or millicurie quantities. Most shipments involve only 8 radionuclides, H-3, C-14, F-18, P-32, S-35, Cr-51, I-125, and

I-131. However, the NIH may receive a wide range of radionuclides as specified in its

Nuclear Regulatory Commission (NRC) license.

4. Daily QA of the Liquid Scintillation Counting (LSC) device used in package receipt and daily surveys shall be performed and documented per DRS SOP. If the QA fails the established criteria, the Contractor shall notify the Contracting Officer’s Representative

(COR), alternate COR, Radiation Safety Operations Branch (RSOB) or Materials Control and Analysis Branch (MCAB) chief, or a Health Physicist, in that order, immediately.

DRS will provide initial training to the Contractor on how to perform the QA.

5. Package opening and processing functions shall be performed in Building 21 on the NIH

Bethesda Campus. These functions involve (1) certification that the package contents comply with the order, (2) examination for gross damage or leakage, (3) verification of radioactivity contamination and measurement of dose rates from the package, (4) recording of results, and (5) repackaging for delivery. ARTICLE C.10, PACKAGE

PROCESSING FUNCTIONS, describes the current package opening requirements.

6. Radioactive material packages shall be delivered to the research laboratories at the NIH

Bethesda Campus and Satellite Facilities. Delivery to each satellite facility is required at least once per day, except there are no deliveries to Poolesville on Thursdays; no delivery to Frederick on Fridays; no delivery to Baltimore on Wednesdays. Delivery locations, a typical delivery schedule, a list of satellite facilities and delivery specifications are provided in ARTICLE C.11, DELIVERY OF PACKAGES.

7. At the NIH Bethesda Campus, all processing and delivery shall be performed from 6:30 a.m. until 4:00 p.m. Eastern Time zone, Monday through Friday, excluding federal holidays.

8. All packages containing radioactive material with a half-life of less than 2 hours must be processed and delivered within one hour of receipt. If the delivery location is outside of the main campus, the contractor must depart to deliver the packages within an hour of receipt or notification of a package needing to be processed. All packages designated for human use will receive priority processing and delivery over non-human use material. All other packages must be delivered the same day unless they arrive after 3:00 p.m.

Determination as to the number of staff needed to accomplish this requirement is the responsibility of the Contractor.

9. Package processing and storage areas must be secured at all times. The Contractor shall lock all entrances when packages cannot be secured via line of sight supervision.

10. The package processing and storage area will be surveyed by the contractor at the end of each work day for contamination and radiation levels. Daily surveys should take no longer than 15 minutes and need to be recorded. The record shall include, at a minimum, the initials of the surveyor, the serial number of the meter(s) used, the date, and the count rate of any contamination found. The survey shall include at least 10 smear swipes of each for each equivalent laboratory module. Each smear swipe shall cover at least 100 square centimeters. After award of the contract, DRS staff shall provide instructions to the Contractor's employees in the correct smear swipe technique. Work areas contaminated above levels specified in NIH NRC license shall be decontaminated by the

Contractor. Meter surveys will be performed using an instrument calibrated for dose rate.

Dose rate measurements are to be made at varying locations 30 centimeters from the surface of freezers, refrigerators, shielding, hoods, and any package or area suspected to contain radioactive materials. Any area with dose rates exceeding 5 mrem/hr at 30 cm should be brought to the attention of the COR after the surveys are completed. Any area with dose rates exceeding 100 mrem/hr should be brought to the attention of the COR immediately or, in their absence, an Area Health Physicist.

11. Verification of package processing and delivery is entered into the DRS database computer system by the Contractor. Instruction concerning data entry and computer report generation shall be provided by the DRS staff after award of the contract. This instruction shall be provided over a one (1) month time frame and shall consist of on-the-job training which shall be closely monitored. In the event that, after receiving the NIH provided instruction, any of the Contractor's employees is replaced, the Contractor shall provide training for the replacement employees.

12. Temporary or long-term storage of packages will require holding areas consisting of either:

a. Proper shielding for packages whose dose rate at 30 centimeters exceeds 5 mrem/hr;

b. Low temperature freezers; Packages in dry ice as specified by the manufacturer; Proper storage for packages containing potentially volatile compounds; or secured storage space.

The NIH shall provide any shielding, ventilation apparatus, refrigerators or freezers as needed. Specific requirements for storage will be provided at award of contract.

13. The Contractor shall designate one essential employee for package receipt, inspection and delivery aspects of this contract. In the event that the Government installation is closed due to adverse weather conditions or other emergencies, the Contractor's essential employee shall report for duty at the NIH Bethesda Campus by 8:00 a.m. and shall be responsible for the receipt and delivery of RAM packages. All human use radionuclides shall receive priority over non-human use. The Contractor's essential employee shall contact all users on a list provided by DRS staff to verify if any more shipments of RAM for human use are to arrive. Typically, once all human use material has been received and delivered, no normal deliveries are provided as none of the staff are present in the labs. However, the essential employee shall receive and deliver all other material if staff is available. The Contractor’s essential employee may leave once the processing and delivery of the RAM packages is completed. No packages are delivered to Satellite facilities when the Federal Government is closed because of these events. No contract staff, including the essential employee will report to duty during a government shutdown that is caused by funding issues.

14. All incidents involving radioactive material packages must be reported to the COR within one hour. Incidents include, but are not limited to breakage, or spillage of radioactive materials, loss or theft of packages, delivery of packages to the wrong

Authorized User, packages left unsecured or unattended in an unrestricted area, or violations of Department of Transportation (DOT) or Nuclear Regulatory Commission

(NRC) regulations.

15. The inventory of radioactive materials is performed annually and shall be performed between 7:30 a.m. and 4:00 p.m.; however, it must be completed by December 1 st each year as specified in ARTICLE C.12, ANNUAL INVENTORY.

16. Transfers of material between NIH labs are performed when requested as researchers move to new labs or labs are renovated. The requirements are located in ARTICLE

C.13, TRANSFERS OF RADIOACTIVE MATERIALS.

17. In accordance with DRS standard operating procedures, the Contractor shall prepare all contractor-generated swipes and load them into the appropriate counter in the DRS analytical laboratory or package receipt room. All swipes generated in relation to package receipt, including the daily surveys in the receipt room, shall be analyzed by the

Contractor using the LSC in the receipt room. If the LSC in the receipt room is not in operable condition (e.g. fails daily QA, activity on swipe is too high to be quantified), the

Contractor shall prepare and load them in the DRS analytical lab. If possible, these swipes will receive priority processing by the analytical lab and results will be returned to the contactor as soon as possible. Swipes from the I-131 therapy room shall be analyzed in the analytical lab. They can be prepared and loaded any time during the day they were collected. All other contractor-generated swipes shall be prepared and loaded between 12:00 p.m. and 4:00 p.m. on the day they were collected. DRS will analyze these swipes and report the results to the Contractor by noon of the day the surveys are due.

18. The Contractor shall perform checks on security of radioactive materials based on a computer-generated list that specifies areas to be checked weekdays, some to be checked weekday evenings (between 6:00 p.m. and 6:00 a.m.), and some to be checked on weekends. The frequency of security checks in a particular area is based on the history of that area's compliance with the DRS security policy, and in some cases, the presence of perimeter security systems. Frequencies are determined by DRS staff.

19. The Contractor shall arrange with the appropriate Custodian a mutually-convenient time for the inspection of radiation-producing equipment and associated lead shielding. Most of this equipment is on the main campus in Bethesda, but some units are in satellite locations in Gaithersburg, MD, Rockville, MD, Kensington, MD, Poolesville, MD, Frederick, MD, and Baltimore, MD.

20. Routine surveys of radiation-producing equipment shall be scheduled by the Contractor from an NIH supplied list of units, locations and Custodians, so that each unit shall be surveyed within 12 months of the previous survey. All routine surveys shall be completed by the end of the calendar year.

21. By December 1 st 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.

22. In the event that the COR designates a radiation-producing unit that requires an expedited survey, the Contractor shall survey the unit within three workdays.

23. Complete re-surveys shall be performed on existing x-ray units following modifications and adjustments that might increase the radiation hazard (e.g., relocation of a unit, replacement of an x-ray tube, changes in filtration of beam, changes in image intensification, etc.). The COR will notify the Contractor of any such units and the time frame for completing the surveys, e.g., whether or not expedited surveys as defined above are needed.

24. Complete decontamination of the I-131 therapy room for release as an unrestricted area is required approximately 6 times per year. Ordinarily, the decontamination can be completed over 2 or 3 days. However, it shall be completed within 1 work day if directed by the COR or designee.

25. Decontamination and preparation of the I-131 therapy room between I-131 therapy patients is required approximately 6 times per year and shall be completed within 1 work day of notification.

26. The Contractor shall inspect and calibrate (on-site) survey meters used only for contamination monitoring. The method of calibration must be submitted and approved by DRS. Any changes to the method must be approved by DRS before they are implemented. There are approximately 1,180 such survey meters located at the facilities specified on NIH's NRC broad scope license.

27. The Contractor shall calibrate approximately 60 instruments which are used for measurement of exposure or dose equivalent rates at the facilities specified on NIH's

NRC license. Most of these instruments can be taken off-site for calibration. However, a few are non-portable instruments, e.g., wall-mounted alarms that must be calibrated on-site.

28. The Contractor shall provide to the COR telephone numbers by which Contractor staff can be reached during the workday.

29. All contract personnel are required to wear appropriate personnel dosimeters. These dosimeters will be supplied by DRS unless other arrangements are made with the COR.

The dosimetry service must be NVLAP certified and the dose data must be provided to

DRS to assure compliance with NRC license conditions.

30. At least once per week, documents relating to radiation safety shall be delivered or retrieved (if required) from off-site locations.

31. At least once per day, documents relating to radiation safety shall be delivered or retrieved (if required) from on-campus locations.

32. Every six months, two labs in Building 21 require stripping and waxing of the floor. The

Contractor shall provide such services and maintain security of these labs during the task.

33. Each contract staff member is required to carry a mobile device capable of receiving and delivering phone calls and email while performing duties required under this contract.

34. The contractor shall provide a software and hardware system capable of tracking package delivery vehicles.

35. Contract staff will receive initial on the job training in some aspects of the contractual requirements (e.g. data entry mechanisms, use of internal Oracle database, report generation, report filing, etc.). In the event that, after receiving the NIH provided instruction, any of the Contractor's employees is replaced, the Contractor shall provide training for the replacement employees.

ARTICLE C.4 COMPREHENSIVE SURVEY PROCEDURES

A. Background

1. Most labs are currently on a semi-annual frequency for comprehensive surveys. About

1% requires more frequent comprehensive surveys. The percentage of labs on a particular survey frequency may change at any time.

2. An estimated 3,500 comprehensive radiation safety surveys shall be performed per 12-month period.

3. Each month, the Contractor shall download data on the laboratories and corridors due for comprehensive surveys to devices such as tablet PCs. The Contractor shall use these devices in the field to collect survey data electronically. In the event that a device is not functioning properly or is unavailable, the Contractor shall document survey results on paper forms and enter the data into the DRS database.

4. Routine comprehensive surveys at NIH are unannounced. Surveyors shall conduct thorough surveys without unduly disrupting work being performed in the area. If the

Surveyor is unable to gain access to an area which needs to be surveyed, the Surveyor shall contact the Authorized User or other researcher familiar with radioactive material usage in the lab and schedule a survey during the month in which it is due.

5. DRS Form 603, "Radiation Survey Report" (Attachment 1) shall be the basis and guide for comprehensive surveys of laboratories and other areas. This form may be revised by the DRS at any time; the COR shall inform the Contractor of any revision and instruct the Contractor in its proper use. In general, a comprehensive survey shall include an inspection covering all areas on the form. However, the survey procedure may be modified by the COR for corridors, weekly surveys and other special cases.

6. Security of radioactive material is extremely important at NIH. Contract personnel shall provide the necessary surveillance and security for check sources and/or calibration sources in their possession. Also, Contract personnel shall adhere to the current NIH policy on security of radioactive materials.

7. The Contractor shall typically submit completed comprehensive survey reports electronically, using hardware and software provided by the Government. However, in the event that a device is not functioning properly or is unavailable, the Contractor shall submit survey results on paper forms. The surveys shall be submitted to the COR by 4 p.m. of the second workday following the survey, unless there was no appropriate person to interview. In such a case, the Contractor shall notify DRS if any contamination was found, but not submit the survey until the interview has been completed. The survey still needs to be completed and submitted within the month in which it is due (see

Attachment 1, section A, item 3).

8. If survey results were documented on paper instead of electronically, the Contractor shall enter the data from surveys that have been approved by the COR or designee into the database within 1 work day.

9. In the event that the Electronic Survey System is offline or not operating properly, the

Contractor shall give the appropriate Health Physicist and Authorized User a copy of the survey within 2 days of completion of the survey. The Health Physicist (HP) will then give the reviewed and completed survey back to the Contractor.

10. On a daily basis the Contractor shall maintain the master listing of areas requiring comprehensive surveys on the DRS database, including corrections, additions, and deletions. Information for corrections may come from observations by the Contractor when performing surveys, or from DRS. Note, however, that all changes, including those proposed by the Contractor, shall be approved by DRS through a “green sheet” before the Contractor enters them into the database. The Contractor shall process “green sheets” within one work day.

11. The Contractor shall send one copy of each acceptable survey to the Authorized User. If a comprehensive survey showed a violation of Item 20 (contamination levels), the

Contractor shall send the AU the appropriate "fact sheet" created by DRS to inform the

AU how to correct the violation.

12. The Contractor shall enter or transmit data from comprehensive surveys into the database within one work day.

B. Detailed Technical Requirements (Attachment 1)

1. Specific Requirements

2. "Radiation Survey Report" (DRS Form 603) explained

3. Procedures for Corridor Radiation Safety Surveys

ARTICLE C.5 MONTHLY SURVEYS

1. Each month, the Contractor shall download a list of labs due for a Contractor-conducted monthly survey.

2. The Contractor shall determine whether or not radioactive materials have been used in each lab since the last survey.

3. If radioactive materials have been used, the Contractor shall perform a contamination survey unless the lab is scheduled for a comprehensive survey that month. The Contractor shall document the results of each monthly survey on an NIH Form 88-12, "Monthly Laboratory

Contamination Survey", or electronic equivalent, ensuring that the designation of the modules matches those in DRS's database.

4. The Contractor shall monitor the lab with an appropriate survey meter and take 10 swipes per module in various areas, such as but not limited to, the floor, benches on which radioactive materials are used, and refrigerators in which radioactive materials are stored.

5. The Contractor shall submit each monthly survey to the COR or designee by 4:00 p.m. the second workday following the survey.

6. If the survey is deemed acceptable by the COR or designee, the Contractor shall electronically transmit a copy to the Authorized User of the laboratory module that was surveyed.

7. If no radioactive materials have been used in a lab since the last monthly survey, instead of conducting a survey, the Contractor shall submit a “no use” survey via the portal.

8. The Contractor shall enter or transmit data to the DRS database within one workday.

ARTICLE C.6 SECURITY CHECKS

1. Using a computer-generated list, the Contractor shall do a walkthrough of each facility scheduled for security checks to ensure compliance with the current DRS policy for securing radioactive materials.

2. Regardless of whether or not a particular lab is posted for the use and/or storage of radioactive materials, the Contractor shall determine if the lab is locked or occupied. If it is neither locked nor occupied, the Contractor shall determine whether or not any unsecured radioactive materials are present.

3. In addition to looking for unsecured radioactive waste and other radioactive materials in plain view, the Contractor shall carefully open labeled refrigerators and freezers to check for unsecured radioactive materials. However, the Contractor shall not rummage through refrigerator/freezers.

4. The Contractor shall also check for unsecured radioactive materials in corridors and other unrestricted areas in each facility scheduled for security checks. In unrestricted areas, the Contractor shall check refrigerators and freezers for unsecured radioactive materials and shall be alert for unattended packages of radioactive material.

5. The Contractor shall document the results of security checks on DRS Form 003

"Laboratory Surveillance Program" or electronic equivalent. If the Contractor was able to access an irradiator room, he/she shall immediately notify DRS by calling the main number, 301-496-5774, (workdays) or, if after hours, via the emergency call list provided to the Contractor by the COR.

6. If unsecured radioactive materials are present, the Contractor shall describe them in detail (i.e., radionuclide, physical form, activity, number of containers, labeled or unlabeled, how full if unsecured waste containers) in the section labeled "Violations

Noted." In addition, the Contractor shall describe any interactions he/she had with lab personnel regarding the violation and how access was gained to the lab. The Contractor shall also note the name and DRS number of the Authorized User associated with the laboratory, if applicable.

7. The Contractor shall not cite as a violation, unsecured, unattended radioactive waste containers or other labeled items, which appear to be empty.

8. Whenever possible the Contractor shall correct the apparent violation by securing the area or the materials. If the Contractor is unable to correct the violation and it involves source vials, he/she shall immediately notify the DRS by calling the main number, 301-496-5774 (workdays), or if after hours, via the emergency call list provided to the Contractor by the COR. The Contractor may be directed to confiscate the source vial(s) and place them in secure storage in Building 21. The Contractor shall be given specific instructions for each satellite building for the event of finding unsecured source vials that cannot be secured at the satellite facility.

9. The Contractor shall submit "Lab Surveillance Program" forms to the NIH COR by 4:00 p.m. of the first workday following the security checks.

10. With a minimum of 8 hours of advance notice, the Contractor shall conduct emergency security checks of specified areas within a time frame established by the COR or designee. The time frame may include daytime, evenings, or weekends.

11. The Contractor shall enter or transmit data to the DRS database within one workday.

ARTICLE C.7 SURVEY OF RADIATION-PRODUCING EQUIPMENT AND

ASSOCIATED SHIELDING

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, Kensington, Frederick, Poolesville, and Baltimore. The type and approximate number of these devices are as follows:

Type of Unit Number of Units

Radiographic unit 10

Fluoroscopic unit 12

Bone densitometer 7

Dental radiographic unit 8

Cabinet x-ray 38

X-ray diffraction 4

CT scanner 10

Linear Accelerator 3

3. There are approximately 30 additional units that are surveyed by NIH Clinical Center staff. The Contractor shall be responsible only for routing these reports to the Area

HP for review, and if approved, entering or transmitting the data from these reports into the DRS database.

4. The Contractor shall perform and document surveys 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, DRS ID number, problems noted with the unit, and what is required to bring the unit into compliance with the regulations.

5. 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 or not expedited surveys are needed. The Contractor shall assign a DRS ID number to each new unit and affix a sticker showing that number.

6. With prior approval of the Custodian, 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.

7. 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.

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

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

10. Emergency notification per Attachment 1, Section A, item 17 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.

11. 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.

12. The Contractor shall document the results of the inspection of personal protective shields on a simple form indicating the kind of shield, its ID number, and method of survey. The Contractor shall provide documentation of any defects. Additionally, the Contractor shall enter or transmit results of inventory and inspections performed by NIH Clinical Center Staff on their own personal protective shields.

13. By December 1 st 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.

14. The Contractor shall enter or transmit data from all surveys of radiation producing equipment and shielding devices into the DRS database. A copy of the results shall be sent to the custodian of the equipment or devices.

15. 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.

16. The Contractor shall submit survey reports to the COR within 5 work days from the date of survey.

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

18. The Contractor shall enter or transmit data to the DRS database within one workday.

ARTICLE C.8 PREPARATION AND DECONTAMINATION OF IODINE-131

THERAPY ROOMS

The NIH Clinical Research Center maintains an inpatient I-131 therapy program in which greater than 33 millicuries of I-131 is administered to patients orally or intravenously. Since this is a systemic therapy, all body fluids are contaminated, and the patient is kept in isolation until eligible for release in accordance with NRC regulations. There are 2 specially-designed rooms which can be used to house the patients while they are in isolation. These rooms are not currently dedicated for therapies. Therefore, unless another therapy is imminent, following release of the patient, the room needs to be decontaminated for unrestricted use. The

Contractor shall properly prepare the room prior to therapies to prevent surface contamination throughout the room and then monitor and decontaminate rooms after the therapy patients have been released in accordance with Attachment 2.

ARTICLE C.9 SURVEY METER CALIBRATIONS

1. All survey instruments used for contamination monitoring only, or for measuring exposure or dose equivalent rates, shall be calibrated annually in accordance with ANSI standard N323A-1997 (and any subsequent updates) and Appendix K of NUREG-1556, Volume 9. Results shall be documented in accordance with Appendix K of NUREG-

1556, Volume 9.

2. Each calibration shall be performed between 11 and 12 months from the previous calibration date. New survey instruments must be inspected and calibrated by the

Contractor prior to initial use.

3. The Contractor shall locate, inspect, and calibrate for contamination (on-site) meters that are called in for calibration or are due based on the DRS computerized database.

4. Contractor personnel shall contact someone in each of the laboratories to verify the information (Custodian name, DRS number, telephone number, location of meter) from the database and update the database as needed.

5. If the Contractor is unable to locate a meter following two thorough searches performed in two consecutive months, the Contractor shall inactivate that meter on the database after entering the dates of the searches. A thorough search is one in which the Contractor searches the last reported location of the meter, searches surrounding labs, requests assistance in finding the meter from the Custodian to whom the meter is assigned, and requests assistance from other researchers in the surrounding areas.

6. An adequate calibration, including inspection, replacement of batteries and cables as necessary, labeling, and completion of the calibration form is estimated to require about

30 minutes of time, exclusive of data entry.

7. For calibration of instruments for exposure or dose equivalent rate, if performed off-site, the Contractor shall collect each instrument with the permission of the Custodian or designee, calibrate it, and return the instrument to the Custodian or designee within five work days. Calibration forms shall be submitted to the COR or designee for review/approval within 1 work day after calibration.

8. If there is no check source on the meter, the Contractor shall fasten an appropriate (Tl-

204 for GM probe, I-129 for NaI probe, Cs-137 for either probe) check source to the meter case with adhesive. For ZnS probes, the Contractor shall place a gas lantern mantle in a plastic bag and tie the bag to the meter.

9. The Contractor shall check the batteries and replace them if necessary.

10. If the cable is damaged, badly worn, or appears to be malfunctioning, the Contractor shall replace it.

11. The Contractor shall tag inoperable meters, describe the problem on the Form 2, and notify the Custodian. The Contractor shall NOT affix a calibration sticker to the survey meter if an INOPERABLE tag is required.

12. The strengths of the sources for this calibration shall be commensurate with the calibration task. Any source system used in the field shall be constructed to be portable, yet totally self-contained and sufficiently shielded so that a member of the public could not receive 100 mrem in a year. The Contractor shall keep such sources under constant surveillance or secure them from unauthorized access.

13. The method of calibration must be approved by DRS prior to its implementation. Any change in the method must be approved by DRS before being used.

14. The Contractor shall enter or transmit all associated data into the DRS database within one work day.

15. On a daily basis the Contractor shall maintain the master listing survey meters requiring calibrations on the DRS computer, including corrections, additions, and deletions.

ARTICLE C.10 PACKAGE PROCESSING FUNCTIONS

NOTE: The following package processing functions have been developed according to the

NIH's NRC license. Changes in that license or NRC regulations may require changes in the following functions.

NOTE: If contract staff is not present when material is delivered to building 21for package processing, a DRS staff member will contact contract staff via phone call to notify them of a package needing processing functions. If the call isn’t answered, a voicemail and email will be sent. This notification shall be the reference time from which the contractor must take action on all time sensitive package processing functions.

NOTE: If any radioisotope of plutonium arrives, THE COR MUST BE NOTIFIED

IMMEDIATELY.

A. PACKAGES CONTAINING RADIOACTIVE MATERIALS EXCEEDING TYPE A

QUANTITY LIMITS or PACKAGES OF RADIOACTIVE MATERIALS THAT ARE

CRUSHED, WET, OR DAMAGED

See table in this Article for Type A Quantity Limit for typical NIH radionuclides. Consult

10 CFR Part 71, Appendix A, Table A-1 for those not listed. If any packages arrive at NIH and fall into this category, THE COR MUST BE NOTIFIED IMMEDIATELY.

1. Make arrangements to receive a package when the carrier offers it for delivery, or make arrangements to receive notification of arrival of package at the carrier's terminal and take possession of the package expeditiously. Transport the package immediately to

NIH Building 21 or to another location as instructed by the COR.

2. If a package receipt or notification occurs during normal working hours, the contract staff must perform the following tasks as soon as practical, but no later than three (3) hours after package notification or receipt. If the package contains an isotope with a half-life less than two hours, the contractor must perform the tasks within one hour.

If a package receipt or notification occurs after normal working hours, the contract staff must perform the following tasks the following business day as soon as practical but no later than three (3) hours from the beginning of the business day.

a. Measure the radiation levels from the package at a distance of one meter from the package surface and at the package surface using an appropriately calibrated radiation survey meter.

The "Transportation Index" (T. I.) shown on "Yellow II" and "Yellow III" labels indicates the expected approximate radiation level in millirem per hour at one meter from the surface of the package.

i. The surface radiation level from packages with Yellow II labels should not exceed 50 millirem per hour or Yellow III labels should not exceed 200 millirems per hour.

ii. The surface radiation level from packages having a White I label should be less than 0.5 millirem per/hour.

iii. If radiation levels are measured on the external surface of the package in excess of 200 millirem per hour, or in excess of 10 millirem per hour at one meter from the external surface of the package, STOP AND NOTIFY THE

COR, or, in his/her absence, the Chief MCAB, Chief RSOB or the NIH

Radiation Safety Officer (RSO). The RSO shall notify the appropriate NRC

Regional Office and the final delivering carrier, as required by Title 10 CFR

20.1906 (d).

3. Follow the requirements for "PACKAGES CONTAINING RADIOACTIVE

MATERIAL IN TYPE A QUANTITY OR LESS" below.

B. PACKAGES CONTAINING RADIOACTIVE MATERIAL IN TYPE A QUANTITY

OR LESS

See table in this Article for Type A Quantity Limits for typical NIH radionuclides. Consult

10 CFR Part 71, Appendix A, Table A-1 for those radionuclides not listed.

If a package receipt or notification occurs during normal working hours, the contract staff must perform the following tasks as soon as practical, but no later than three (3) hours after package notification or receipt. If the package contains an isotope with a half-life less than two hours, the contractor must perform the tasks within one hour.

If a package receipt or notification occurs after normal working hours, the contract staff must perform the following tasks the following business day as soon as practical but no later than three (3) hours from the beginning of the business day.

1. Wear appropriate clothing and gloves when opening and inspecting packages of radioactive materials. Monitor hands and clothing for radioactive contamination when inspection/opening functions are completed and before leaving the Log Room.

2. Visually inspect the exterior package for any sign of damage, e.g., wet or crushed. If damage is noted, STOP AND NOTIFY THE COR.

3. For packages that are labeled with a White-I, Yellow-II or Yellow-III label, monitor the external surfaces of the package for removable contamination using an appropriate contamination smear technique unless the package contains only radioactive material in the form of a gas or in special form as defined in 10 CFR

71.4. This shall be performed by smearing the external surfaces of the package.

4. Screen the contamination smears for removable contamination using the appropriate instrument, as follows:

a. For H-3, C-14, S-35, and other low-energy beta emitters, count the smear in a calibrated liquid scintillation counter or other appropriately calibrated instrument.

b. For other beta or beta-gamma emitters, count the smear with a properly calibrated, shielded, thin-window G.M. counter or other appropriately calibrated instrument.

c. For I-125, count the smear with a properly calibrated, shielded, thin window Nal

(TI) detector or other appropriately calibrated instrument.

5. For smears not countable in the liquid scintillation counter, the smears shall be submitted to the DRS analytical lab. Take precautions to prevent the potential spread of contamination.

6. Record the results of external contamination found in units of disintegrations per minute (dpm) per 100 square centimeters (dpm/100 cm ) in the DRS database.

Guidelines on removable contamination limits are specified in 10 CFR 71.87. If removable contamination in excess of regulatory limits is found, STOP AND

NOTIFY THE COR, or, in his/her absence, the Chief MCAB, Chief RSOB or the

NIH Radiation Safety Officer (RSO).

7. Open the outer package, following any special instructions from the supplier. Then open the inner package and verify that the stated contents agree with the order placed by the Authorized User, as specified on the Form NIH 88-1, "Request for

Purchase and Use of Radioactive Material" or its electronic facsimile in the database.

a. If there is a discrepancy, compare the stated contents to the packing slip, if the packing slip is available. Discrepancies in the amount of activity received that are greater than one millicuries in activity listed on the Form 88-1 and/or the packing slip, and discrepancies in the radionuclide, compound, etc., shall be brought to the attention of the COR or his/her designee.

b. Advise the DRS staff of such discrepancies and determine if the shipment is still acceptable.

c. Do not release material to a user that is not authorized to receive that material.

Acceptable users of radionuclide shipments must be listed on the NIH 88-1, be active, and have adequate training. Authorized Users must have general authorizations, be active and not be under suspension. This type of information is easily accessible from the database screens.

8. Inspect the integrity of the final source container. Look for broken seals on vials, loss of liquid, condensation, or discoloration of packing materials. If a potential problem is noted, take precautions to prevent the spread of contamination and notify the COR or the designee.

9. Using the procedure listed above in stages 3 through 6 monitor the exterior surface of the final source container for removal contamination.

a. Guidelines on removable contamination limits for the final source container are as follows:

i. Beta or Gamma Emitters: 220 dpm/100 cm

ii. Alpha Emitters: 22 dpm/100 cm

b. Shipments having externally contaminated source vials not exceeding the above guidelines may be released to the Authorized User.

c. For shipments having contaminated source vials with contamination that exceeds these limits, but not exceeding ten times these limits, the contractor shall insert a warning notice in the package, and notify the receiving lab by directly talking to a user listed on the 88-1 form before delivery to the Authorized User. When contact is made with a user on the 88-1, the Contractor shall document whom the information was provided to in the DRS database.

d. Shipments having contaminated source vials with contamination that exceeds one hundred times the limits in a. shall be held and not delivered. Notify the COR or the designee, or in their absence the appropriate Area Health Physicist so that further action may be taken.

C. PACKAGES OF RADIOACTIVE MATERIAL NOT HAVING WHITE-I, YELLOW-

II OR YELLOW-III LABELS (ALSO KNOWN A RADIOACTIVE MATERIAL

EXCEPTED PACKAGE-LIMITED QUANTITY OF MATERIAL, UN2910)

Certain in-vitro test kits that could normally be received under a General License pursuant to

Title 10 CFR 31.11 are subject to a special set of requirements for "safely opening packages containing radioactive material," as follows:

1. Visually inspect the exterior package for any sign of damage, e.g., wet or crushed.

If damage is noted, STOP AND NOTIFY THE COR.

2. Verify that the material received agrees with the order placed by the Authorized

User, as specified on the Form NIH 88-1, "Request for Purchase and Use of

Radioactive Materials". If there is a discrepancy, notify the COR or the designee.

D. PREPARATION OF PACKAGES FOR DELIVERY

1. All radioactive materials shipments must be repackaged in original packaging.

Substitute packaging must be approved by the COR. Appropriately record the receipt of each shipment. Carefully repack and label the shipment that may be released. Utilization and Disposal (UD) sheets that are printed using the DRS database are placed on the package using clear adhesive backed envelopes. Add labels that include the "Caution Radioactive Materials" wording. Apply other labels as required by NIH and/or NRC and DOT requirements. Some packages require special repacking such as dry ice, absorbent materials or special inserts. Follow the manufacturer’s instructions for repackaging all shipments. All NIH requirements for repacking shipments must be followed:

a. All RAM must be repacked in strong, tight packages that will not leak any of the radioactive materials during conditions normally incident to transportation.

b. All RAM that arrived with dry ice or wet ice must be repacked with enough dry or wet ice to assure the contents will not be damaged or spoil during the delivery to the

Authorized User’s laboratory.

c. The contractor must maintain a supply of dry ice such that there must be at least 150 lbs. of dry ice available at the end of each work day.

2. Monitor packing materials and empty shipping containers to ensure that they are free radioactive contamination, and remove or deface all warning labels before discarding the materials and containers in the ordinary trash.