WVUH Purchasing Instructions

WVU Hospitals Purchasing Instructions

The immediate approval of a purchase order for radioactive material is delegated by the Nuclear Medicine Physician to the Nuclear Medicine Technologist. The Nuclear Medicine Physician must be authorized by the University Radiation Safety Committee to use radiopharmaceuticals for human use and such uses must be reviewed by the Radiation Safety Officer (RSO). The Nuclear Medicine Technologist is responsible for the inventory of all radioactive material used routinely. Radioactive materials will be procured from NRC or State licensed suppliers.

Ordering Radioactive Materials

• A written directive will be obtained from the physician who will perform or oversee the procedure. The written directive will contain the isotope, total prescribed dose and signature and date of the authorized user.
• Persons ordering the material will reference the physician's written request when placing the order. The physician’s request will indicate isotope, compound, activity level, patient’s name, etc.
• The physician's written request will be referenced when receiving, opening, or storing the radioactive material.
• It is essential that written records be maintained for all ordering and receipt procedures.
• Use the above information to serve as a model for ordering radioactive material.
• For deliveries during normal working hours, inform carriers to deliver radioactive packages directly to a specified area.
• For deliveries during off-duty hours, inform security personnel or other designated persons if they should accept the delivery in accordance with Radiation Safety Precautions and provide designated persons with RSD contact information.
  
  

Receiving

Only Authorized Users or specifically identified designees are permitted to open shipping packages (shipping/transport containers) containing radioactive material. If an Authorized User, designee, or RSD representative is not available when the package is delivered, the package will be placed in a secure, pre-designated remote location of the facility awaiting such person(s). The package will not be opened. Packages containing radioactive material shall be inspected and surveyed as soon as practical after receipt of the package, but not later than three (3) hours after the package is received at the facility if it is received during normal working hours. Packages containing radioactive material that are received after normal working hours at the facility shall be inspected and surveyed not later than three (3) hours from the beginning of the next working day.

Opening

• Put on gloves to prevent contamination. Always assume that the package and material inside are contaminated until proven otherwise.
• Visually inspect the package for evidence of potential contamination (crushed, wet, damaged). If damage is noted, stop the procedure and notify the RSD or other knowledgeable person.
• Measure the dose rate from the package at 1 meter and at the package surface. If it is higher than expected, stop and notify the RSD. The expected dose rate in mrem/hr at one meter should be close to the transportation index (T.I.) value as noted on the package [49 CFR 173.403]. The expected maximum dose rates at the surface of the package and Transportation Indices are listed below [49 CFR 172.403(c)]:

* - The final delivery carrier and the NRC Operations Center (301-816-5100) or appropriate Agreement State Agency must be immediately notified by telephone [10 CFR 20.1906(d)] if external radiation levels exceed limits specified in 10 CFR 71.47.

• Wipe at least 300 cm2 of the exterior of the package and analyze the wipe. The final delivery carrier and the NRC Operations Center (301-816-5100) or appropriate Agreement State Agency must be immediately notified by telephone [10 CFR 20.1906(d)] if removable surface contamination levels exceed the limits specified in 49 CFR 173.443.
• Record the results of the external radiation (if applicable) and removable contamination surveys (if applicable).
• Remove packing slip.
• Open the outer package following the supplier’s instructions, if provided.
• Open the inner package and verify that the contents agree with the packing slip.
• Check the integrity of the final source container if not a gas or special form material. Look for broken seals or vials, loss of liquid, condensation, or discoloration of packing material. If anything unusual is found, stop and notify the RSD. Take appropriate precautions to prevent the spread of contamination. Notify the user of the material of any contamination found.
• Check the user request to ensure that the material received is the material that was ordered.
• Monitor the packing material and empty packages for contamination with a radiation detection survey instrument prior to discarding. If it is contaminated, treat it as radioactive waste.
  
  

Records

Each clinical area is responsible for maintaining the master record file or log of all radioactive material ordered, received, transferred, used and disposed. The Nuclear Medicine Technologist, Medical physicist or Dosimetrist will maintain these records under the supervision of the Radiation Safety Officer. Records of radiation surveys, incident reports, personnel dosimetry results, leak tests, and survey instrument calibration shall also be maintained in each clinical area.

The following records must be kept and are to be available for inspection at any time by the Radiation Safety Department and authorized regulatory agency representatives:

• Type and amount of radionuclides on hand.
• Results of radiation surveys.
• Sealed source leak tests and inventories, dose calibrator quality control testing, and survey meter calibrations control testing, and survey meter calibrations.
• Method and amount of disposal, including radiation survey results for material held for decay.
• Patient dose records, including patient's name dose prescribed, dose assayed, type of procedure, and date. Records will be retained for review by the licensing body for the periods specified below.
  
  

The following records must be kept indefinitely:

• Personnel Monitoring and Bioassay Records
• Radiation Accident Investigation Results
• Radiation Safety Committee Minutes
  
  

The following records must be kept for ten (10) years:

• Medical Event Reports
  
  

The following records must be kept for five (5) years:

• Sealed Source Leak Test and Inventory Results
  
  

The following records must be kept for three (3) years:

• Patient Dose Records
• Survey Results, Including Area Surveys and Hold For Decay Surveys
• Mo-99 Breakthrough Results
• Survey Meter Calibration and Dose Calibrator QC Test Results