Scottish Government

4(1)

The employer shall ensure that written procedures for medical exposures including the procedures set out in Schedule 1 are in place and shall take steps to ensure that they are complied with by the practitioner and operator.

Many of the employer's written procedures that were inspected during the incident investigation, for example Work Instruction WI.14.01.01 for Medulla Planning, were out of date. No evidence was presented of any steps taken to ensure that written procedures were complied with by the operator.

Schedule 1 (b)

Written procedures for medical exposures shall include procedures to identify individuals entitled to act as referrer or practitioner or operator;

At the time of this incident employer's written procedures to identify individuals entitled to act as referrer or practitioner or operator had been drafted but had not been adopted formally as an authorized procedure.

Schedule 1 (e)

Written procedures for medical exposures shall include procedures to ensure that quality assurance programmes are followed;

At the time of this incident there were no employer's written procedures to ensure that quality assurance programmes are followed. Written procedures were in place within the BOC's ISO 9000 quality system requiring annual reviews of written procedures but this requirement was not being followed.

Schedule 1 (k)

Written procedures for medical exposures shall include ) procedures to ensure that the probability and magnitude of accidental or unintended doses to patients from radiological practices are reduced so far as reasonably practicable.

Had such procedures been in place, it might be expected that they would have contained instructions on the measure to be taken at the BOC to ensure that the potential for changes to the treatment planning system (such as the change to Varis 7) to result in unintended doses to radiotherapy patients was properly evaluated. No such procedures were in place and no evidence has been presented by the BOC of such an evaluation having taken place. (Principal Planner A produced documents describing the required 'Changes in Eclipse with Varis Version 7' but these did not include an evaluation of the possible effect on patient safety.).

4(2)

The employer shall ensure that written protocols are in place for every type of standard radiological practice for each equipment.

Work instruction WI.14.01.01 for Medulla Planning was last updated in 1998 and did not contain the amendments made necessary by the introduction of Varis 7 in May 2005.

4(3)

The employer shall establish quality assurance programmes for standard operating procedures.

Written procedures were in place within the BOC's ISO 9000 quality system requiring annual reviews of written procedures but this requirement was not being followed.

5(4)

The operator shall be responsible for each and every practical aspect which he carries out….

See comments on 11(1) and 11(3) below.

11(1) and 11(3)

Regulation 11(1) requires that: ...no practitioner or operator shall carry out a medical exposure or any practical aspect without having been adequately trained. However, Regulations 11(3) qualifies this in that: Nothing in paragraph (1) above shall prevent a person from participating in practical aspects of the procedure as part of practical training if this is done under the supervision of a person who himself is adequately trained.

The regulations require that when Planner B undertook treatment planning for Miss Norris, he did so either as a trained 'operator', recorded as such by his employer, or as a trainee under the supervision of a properly qualified and identified operator. There is nothing in his employers written procedures to identify him as being an operator and his training records give no indication of having been adequately trained to act in this capacity. Therefore, the only person who participated in creating the treatment plans for Miss Norris who would qualify as an operator under the Regulations was Principal Planner A.
Regulation 11(3) would therefore require that the level of his involvement as a supervisor should have been sufficient that he could properly assume the responsibilities of an operator. However, the evidence suggests that his supervisory involvement was not to this level. Therefore, Regulation 11(1) was not complied with because practical aspects of the plan were completed by Planner B who was not a trained operator and was not under adequate supervision. Also, Regulation 5(4) was not complied with because the involvement of the operator (Principal Planner A) was not in keeping with his being responsible for each and every practical aspect of the plan.

11(4)

The employer shall keep and have available for inspection by the appropriate authority an up-to-date record of all practitioners and operators engaged by him to carry out medical exposures or any practical aspect of such exposures …showing the date or dates on which training qualifying as adequate training was completed and the nature of the training.

The training records for those involved in the incident were not up to date and had not been properly signed-off as required by BOC written procedures.