RPPM 8.0 Records Management

8.1 Radiological Records Management

 

  • An unpopular topic for most radiation users that is associated with the most non-compliance findings
  • Failure to maintain radiological records has consequences for many activities in a radiation use area:
  • Safety – Did “Last User”  do an after-use survey and leave the RAM work area “clean”?
  • Security – Where did the Cs-137 source “disappear to” this time ?
  • Compliance – I’m sure a contamination survey was completed last month, but I can’t find the record form and “no one” made an entry the survey log !
  • It is not unusual for a single inaccurate record (i.e. – contents of a radioactive waste container) to create an unneeded safety risk; a corrective actions response from the RSO and RSC; and a non-compliance citation +/- fine for the University when the waste is shipped off-site to a commercial waste broker.
  • While it is likely that most radiation workers are detailed and diligent maintaining records, an occasional “it’s waste of time” and not my problem” can lead to a “world of hurt”;
  • It is the Authorized User and radiation worker’s responsibility to assure that all regulatory records are completed and properly maintained throughout the required retention period.

It is important that all AUs demonstrate for their workers that records maintenance:

  • Is important and required;
  • Must be standardized and required for everyone working under their Authorization;
  • Will be audited by the lab supervisor, AU and RSO.

 

  • Records for Compliance to Regulations and License Conditions
  • A WA DOH inspectors will find the University in non-compliance to the University’s license conditions and/or WAC regulations whenever a required radiological record:
  • Cannot be made available in a legible condition during an inspection that is completed any time within the record’s required retention period;
  • Has not been completed correctly (is incomplete; inadequate; unsigned; etc.)
  • Contains data that is legally indefensible (i.e. – no documented survey meter pre-use performance check);
  • Has been fabricated or created after the fact.
  • The WA DOH inspectors expect to find non-compliant records, and have a very good idea of what they should be looking for…….

Health Phys. 2004 Mar; 86(3):308-15.

A comparison of the results of regulatory compliance inspections in 1999 by the states of Texas, Maine, and Washington.  Brown BJ1, Emery RJ, Stock TH, Lee ES.

……”Of particular note were the violations that were identified to be consistently issued in all three states. These included physical inventories and utilization logs not performed, not available, or incomplete; leak testing not performed or not performed on schedule; inadequate or unapproved operating and safety procedures; radiation survey and disposal records not available or incomplete; detection or measurement instrument calibration not performed or records not available; and radiation surveys or sampling not performed or performed with a noncalibrated instrument.”…….

 

  • RSO and WA DOH audits of radiologic records are completed on a routine and on-going basis;
  • The audit process is completed in a timely manner, if the records are readily available at the radiation use location and are organized appropriately.
  • Any of the following produce a findings of non-compliance –

No record (survey done, but no record created); an incomplete record; or inaccurate record.

 

  • When there is a finding of non-compliance associated with a record, the RSO staff will:

 

  • During the audit:
  • Notify the radiation workers that there is a “problem” with the radiological records and ask for their assisitance in investigating and resolving the “problem”;
  • If needed, provide workers with a short, in-lab re-training session on records management to avoid repetitive or on-going problems.
  • After the audit:
  • Notify the Authorized User of the non-compliance finding(s) and recommend appropriate corrective actions;
  • Make a timely follow-up visit to the Authorization’s facilities to confirm that appropriate actions have been implemented and the “problem” has been resolved;
  • Report chronic and unresolved problems in records management to the URSO and/or RSC for the implementation of a corrective actions directive.

 

8.2  Record Categories and Records Management Responsibility Assignment

 

  • The table below lists the common record categories and whether the RSO, AU, or both have responsibilities in the management of that record category:
Record category Responsibility
Licenses + Permits from Federal + State Agencies RSO
  License applications and supporting documents RSO
  Correspondence to and from licensing offices RSO
  Radioactive Waste Site Use Permits RSO
  Radiation Machine Registrations RSO
  Regulatory Agency Inspections + follow-up actions RSO
Radiation Protection Program Records
Radiation Safety Committee RSO
      University Radiation Safety Officer RSO
      Radiation Safety Office RSO
      Radiation Use Authorization file RSO + AU
      Worker Training + Oversight RSO + AU
      Radiation Worker Exposure Tracking RSO
RAM Inventory Tracking and Control Records RSO + AU
     RAM Inventory Tracking Database  
      RAEL reports RSO
      Broadscope Annual RAM Inventory Unity Report RSO
Radiation Facilities and Equipment RSO + AU
  Assessment of facility suitability for use RSO
  Restricted area oversight + ALARA assurance RSO + AU
  Record of required surveys through to decommissioning RSO + AU
  Radiation protection instrument QA RSO + AU
Shipment and Transport of RAM RSO + AU
Sealed Source Records  
  NRC Sources of Concern Inventory Reports RSO
  Leak Test Records RSO
   
(continued)  
   
Record category Responsibility
Radiation Generating Machines RSO + AU
  State radiation machine registrations RSO
  Facility Shielding + Safety Assessments RSO + AU
  ALARA Oversight Records RSO + AU
  Transfer and Disposal RSO + AU
Radioactive Waste Management and Disposals RSO + AU
Spill, Incident and Emergency Response RSO + AU

 

8.3  Authorized User and Radiation Worker Radiological Records Management

 

  • Authorization’s radiological records management system

A radiological records management system should satisfy the following requirements –

  • Records must be legible and available for inspection throughout the retention period;
  • Records must be accurate, complete and legally defensible, and include:
  • Identification of the facility, specific location, function and process
  • Signature or initials or other identifier of the preparer and date the record was created
  • Legible entries in permanent ink or other marker
  • Corrections identified by a single line-out, initialed and dated
  • Supervisory signature of reviewer indicating acceptance of properly completed of forms.
  • Unless otherwise specified, the quantities used in radiological records at the University should in units of:
  • Curie, rad, roentgen, or rem, including multiples and subdivisions of these units;
  • Oher conventional units, such as dpm, dpm/100 cm2, or mass units.

NOTE:  The SI units of becquerel (Bq), gray (Gy), and sievert (Sv) may be provided parenthetically for reference with scientific standards.

  • Radiological control records should not include:
  • Opaque substances for corrections. It is best to “crossout” mistakes and initial nearby.
  • Shorthand or other non-standardized terms. [The record must be legally-defensible so ask yourself, will a “qualified expert” be able to interpret the record, as completed, with no confusion or doubts as to what “you” meant when you completed it.).
  • The records management system needs to work for the user so In a laboratory setting, the following recommendations can be made for radiological records held by an Authorization:
  • Records can be organized into one or more notebooks (3-ring binder) or a similar filing system that allows for:
  • Within a notebook, the records should be separated by category ( i.e. – training; inventory; survey, etc.) and type (i.e. – hazardous awareness training = guest + ancillary staff; radiation workers);
  • Records within each notebook section are best filed in chronological order to allow easy updating and search-ability by record type = surveys by room + date or stock inventory by radionuclide, receipt date;
  • Efficient auditing of the records notebook by the laboratory supervisor will assure the records are completed and filed correctly and are readily available and auditable by the AU; RSO auditor; and WA DOH inspectors.
  • The records maintained by a RAM Authorization would contain:
  • Authorization administrative records;
  • Worker training records that provide documentation of AU-provided, on-site training, including:
  • Training of ancillary support personnel and any unescorted visitors allowed entry to a posted facility;
  • Training of radiation workers specific to the hazards associated with the sources of radiation, uses and responsibilities they are assigned under the Authorization (i.e. – all workers handling RAM must know how to perform a contamination survey of self and their work area).
  • Radioactive materials and sealed source inventory records and use logs;
  • Restricted area compliance required survey records;
  • Radioactive waste disposal records.
  • Physical Protection and Security of Records
  • Methods for protecting documents throughout the retention period should be consistent with the University records retention requirements (BPPM 90.01);
  • Records storage methods and locations should minimize the risks for physical damage caused by moisture, excessive handling or manipulation, stacking, fire, etc.;
  • Radiological records must be within or nearby the restricted area(s) and accessible for inspection by WA DOH and RSO auditors.

 

  • Record retention schedules for Authorization Radiological Records
  • Compliance required survey records and radiation protection instrument quality control records for instruments must be available for inspection by WA DOH inspectors for five years to meet the conditions of a Radioactive Air Emissions License (RAEL);
  • To simplify the in-lab record retention schedule, it is recommended that most required records be held for 5 years from the date of their creation, including:
  • Survey records and instrument QC records,
  • Authorization-provided hazard awareness and radiation worker in-lab training,
  • RAM package delivery, inventory and use logs;
  • Radioactive waste records.
  • If an Authorization is terminated, existing records are to be transferred to the RSO for custodial care until the end of the retention period;
  • An Authorization is not to hold or retain radiation worker exposure records or any other worker record that would be considered personal medical information (i.e. – Declaration of Pregnancy, Incident Report detailing personnel radiation exposures, etc.).

 

  • Radiation worker training and adherence to record management protocols
  • To be effective a records management program requires rigorous, on-going training and re-enforcement for all staff.
  • All staff should be provided with regular and on-going training in the use of the protocols used by the Authorization to complete and maintain good records.
  • Radiation workers must understand that there are consequences to the Authorization and to the Radiation Protection Program for not maintaining appropriate radiological records.
    • A routine and on-going records quality assurance protocol (audits) can prevent compliance problems and will verify that all staff are adhering to the records management protocol.