Research foundations

and maintaining occupational worker reports; and performing daily, monthly, annual and after servicing tests on equipment, including mechanical, hardware and software checks. A strong quality assurance programme is necessary for the prevention of medical errors.

An example of an accident that could have been prevented concerned the replacement of a cobalt-60 source in an existing unit. After several months, nursing staff reported increased skin reactions after treatment. A physicist reviewed output tables and original calibration and reported that the data were correct. During an intercomparison by a national medical physics board, it was noted that the calibration of the machine was wrong and that patients were receiving 25% more radiation than prescribed. Two hundred seven patients were treated incorrectly. The error in output values would have been discovered prior to patient treatment if there had been an independent verification of the machine’s output prior to its use for treatment [7.11].

There have been numerous reported errors in the calibration of radiotherapy equipment. In order to reduce these types of errors, the BSS require independent regular audits to review quality assurance programmes. In addition, the IAEA has developed a web based learning system for sharing information on radiotherapy incidents and near misses. The Safety in Radiation Oncology (SAFRON) event reporting system allows registrants and licensees to review and contribute information on incidents and near misses [7.13].

TABLE 7.1. OCCUPATIONAL EXPOSURE: LIST OF REQUIRED REGULATORY AND REGISTRANT OR LICENSEE ACTIVITIES (cont.) BSS referenceRegulatory requirementTypes of activities Requirement 19Establish and enforce dose limits for workers.Provide personnel monitoring to workers. Requirement 20Establish and enforce dose limits for workers.Maintain worker dose records and monitor the dose to ensure compliance. Requirement 21 Establish responsibilities for employers, registrants and licensees.

Provide monitoring and safety equipment (aprons and shields) to workers. Provide health surveillance and services to workers.

Requirement 22

Evaluate through inspections compliance of workers.

Establish policies and procedures requiring workers to wear monitoring and safety equipment. Establish a safety culture within the or

ganization. Requirement 23

Evaluate through inspection that workers are compliant and that a safety culture exists.

Maintain personnel exposure records including records from previous employees. Establish internal investigation levels and actions to be taken by workers and managers when investigation levels are exceeded.

Requirement 24

Require registrant and licensees to maintain a radiation protection programme by establishing organizational, procedural and technical arrangements.

Establish controlled areas; restrict access; provide signage to identify the controlled areas; monitor for radiation levels and contamination; conduct surveys; establish procedures; provide personal protective, radiation detection and decontamination equipment and supplies [7.15].

Requirement 25

Require registrant or licensees to monitor occupational exposure and worker health surveillance.

Provide personnel monitoring equipment such as film badges, dosimeters or thermoluminescent dosimeters. Maintain workers occupational exposure including past history records.

Allow workers access to their occupational exposure records.

7.1. OCCUPATIONAL EXPOSURE: LIST OF REQUIRED REGULATORY AND REGISTRANT OR LICENSEE Regulatory requirementTypes of activities

Require registrants and licensees to provide instruction information and training to workers.

Establish a training plan for workers, including initial training and refresher training. Records should include course material, a methodology to assess worker comprehension of the information (test) and documentation of worker completion of the training.

Require registrants and licensees to prohibit workers from receiving benefits as a substitute for radiation protect and safety

.

Establish ALARA (as low as reasonably achievable) procedures for workers

demonstrating that the registrant or licensee prohibits radiation exposure in exchange for benefits. Establish a safety culture within the facility

.

Regulatory bodies should have regulations in place for minors and for workers who are pregnant or breast-feeding. Prohibit through regulations persons under the age of 16 from being radiation workers.

Provide education and information to workers who perform tasks in areas where exposure can occur

. Provide monitoring equipment to pregnant

workers to monitor dose to embryo/foetus. Monitor for the duration of the pregnancy and maintain these records.

TABLE 7.2. PUBLIC EXPOSURE: LIST OF REQUIRED REGULATORY AND REGISTRANT OR LICENSEE ACTIVITIES (cont.) BSS referenceRegulatory requirementTypes of activities Requirement 29 Adopt international dose limits for the public and the environment and establish responsibilities for registrants or licensees.

Perform initial surveys, verification surveys. Develop procedures to prevent exposure to the public or environment and maintain compliance with international dose limits.

Requirement 30

Provide protection and safety to members of the public.

Prepare shielding diagrams and calculations for all areas where radiation sources will be used and stored. Survey areas after installation to ensure that public spaces are below regulatory thresholds. Provide appropriate signage and notification to the public of restricted areas and prohibit access. Perform follow-up surveys as required by regulations and after major structural changes and equipment modifications to demonstrate that public dose thresholds are not exceeded. Develop a plan to ensure that disused sources are safely and securely stored from unauthorized access. If using unsealed radioactive sources, have procedures in place to protect the public and the environment from exceeding exposure limits. Maintain a certificate or record authenticating that the device has been approved by the regulatory body . Maintain records of upgrades and equipment modifications.

7.2. PUBLIC EXPOSURE: LIST OF REQUIRED REGULATORY AND REGISTRANT OR LICENSEE Regulatory requirementTypes of activities Establish standards for the discharge of radioactive waste.

Minimize amount of waste generated, provide secured storage location for waste, maintain inventory and disposal pathways information for all radioactive waste.

Establish regulations for environmental monitoring and reporting.

Have equipment, personnel and procedures to conduct surveys of the environment and documents for reporting survey results to regulatory body

.

TABLE 7.3. MEDICAL EXPOSURE: LIST OF REQUIRED REGULATORY AND REGISTRANT OR LICENSEE ACTIVITIES (cont.) BSS referenceRegulatory requirementTypes of activities Requirement 34 Develop regulations requiring responsibilities, diagnostic reference levels, dose constraints and criteria and guidelines for release of patients.

Ensure that qualified personnel are performing medical procedures. Develop procedures to comply with diagnostic reference levels, dose constraints and release of patients after radiotherapy

. Develop procedures for exposure to caregivers and research subjects (if applicable). Requirement 35

Develop regulations on minimum education and training for health professionals using radiation in medicine.

Maintain records of health professionals’ education and training for

inspection. Develop training procedure based on regulatory requirements and needs of the facility

. Requirement 36

Develop regulations requiring referral for medical exposure, patient protection and notification to patient of radiation exposure.

Develop procedures that require authorization from a medical practitioner for medical exposure. Maintain records of all orders, written directives or prescriptions for radiation procedures.

Requirement 37

Develop regulations requiring registrants and licensees to have procedures in place justifying medical radiation exposure.

Develop procedures for authorizing consultation between the radiological medical practitioner and the referring medical practitioner on the appropriateness of the test, ur

gency of the test and risk to the patient from the test.

7.3. MEDICAL EXPOSURE: LIST OF REQUIRED REGULATORY AND REGISTRANT OR LICENSEE Regulatory requirementTypes of activities

Develop regulations requiring radiological medical practitioners to optimize medical exposure. Develop regulations concerning calibration and dosimetry of patients, diagnostic reference levels, dose constraints and quality assurance for medical exposure.

Perform acceptance and commissioning activities on new equipment, including software. Perform daily

, monthly and annual quality assurance

checks of equipment as required by regulatory body or recommended by manufacturer or professional or ganizations. Repeat activities after service or repair, if appropriate. Provide independent audit of quality assurance for

medical exposure. Support radiotherapy exposure using treatment planning systems to develop plans that tar

get treatment to the prescribed volume and minimize exposure outside the target [7.16, 7.17]. For radiopharmaceutical therapy, ensure that the correct radiopharmaceutical, activity and tagging agent are used.

Establish through regulations requirements for medical exposure for pregnant and breast-feeding women.

Provide signage instructing patients to inform staff if they are pregnant,

suspect pregnancy or are breast-feeding. Develop procedures requiring negative pregnancy test prior to radiotherapy for women of childbearing age and education for women of childbearing age to abstain from exposure that could cause pregnancy during treatment. Procedures should also include educating breast-feeding patients to discuss alternatives if breast milk may be contaminated from the radiotherapy

.

Establish regulations to ensure public protection from exposure from patients who are released after radionuclide therapy or implantation of sealed sources.

Develop procedures that prevent unauthorized release of patients after therapy as required by regulations. Provide oral and written instructions to patients on radiation risk and risk to the public and family members.

TABLE 7.3. MEDICAL EXPOSURE: LIST OF REQUIRED REGULATORY AND REGISTRANT OR LICENSEE ACTIVITIES (cont.) BSS referenceRegulatory requirementTypes of activities Requirement 41

Establish regulations that minimize unintended and accidental medical exposures. Require registrants and licensees to investigate and report such an event and to implement corrective actions.

Develop procedures to address unintended and accidental medical exposures,

including notification of an event, investigation and determination of the estimated dose to the patient(s) and corrective actions. Procedure should include instructions on establishing reporting requirements to the patient, management, referring physician and the regulatory body [7.18]. If the event is caused by equipment failure, the equipment should be evaluated, repaired and calibrated prior to continued use.

Requirement 42

Establish regulations for reviews and record retention.

Registrants or licensees should maintain and review records as required by the regulations and as described in relation to the requirements listed above. The regulations should specify the retention time for each required record. In situations where the retention time is not specified, the registrant or licensee should establish a conservative time, based on the need for long term access to the record.