Endoscopy Inquiry at Canterbury Health Released
23 July 1999
Ministry Investigation - Endoscopy Inquiry at Canterbury Health Released
The Ministry of Health Inquiry into the malfunction of endoscopy cleaning equipment at Canterbury Health found that patients treated with an endoscope were protected by numerous safeguards in place to prevent cross infection.
The safeguards included manual cleaning of endoscopes - considered by international experts as the most important part of the cleaning process, a diligent nursing taskforce and training for new staff members.
The Inquiry found insufficient evidence to support prosecution for contravention of the Hospitals Regulations.
However, the Ministry found there were administrative inadequacies relating to documentation and control procedures and makes 19 recommendations to the Canterbury Health Ltd, its endoscopy unit, the local agent of the machine's manufacturer and the Health Funding Authority.
The Ministry has been in discussion with Canterbury Health and been advised by the Chief Executive that the recommendations are accepted and will be put in place.
Ministry of Health Chief Advisor of Safety and Regulation Dr Bob Boyd said the Inquiry found that the basic error arose from staff not following one specific instruction from the manual for the endoscope washer.
"This instruction was not followed since the washer was installed. There are conflicting views about whether staff were given appropriate information by the company which installed the machine. The fault is compounded by the instruction manual for the machine being of poor quality and difficult to read."
Not all safeguards
for disinfecting endoscopes were in use through a chain of
separate circumstances which include:
o staff, having previously trialled a similar model, could be assumed to know its correct operation
o the instruction manual arrived sometime after the machine was installed
o there was no formalised training and poor supporting information and records of training
o quality control and infection control manual policies were not followed completely
o staffing changes resulted in some procedures lapsing.
Dr Boyd said the Ministry of Health has made a number of recommendations to the Endoscopy Unit at Canterbury Health, to Canterbury Health itself, the company supplying the endoscopy washing machine and to the HFA.
The recommendations from the inquiry are summarised below
the Endoscopy Unit
Updating the staff manual for endoscopy disinfection, better documentation of training, a review of existing manuals and manufacturers instructions, a review of some disinfection procedures, investigating improvements to the endoscopy washing machine and upgrading the plumbing for the machine.
for Canterbury Health
Ensuring recommendations for the Unit are put in place. Also ensuring quality assurance procedures are followed such as involving technical staff in equipment purchases, operations manuals are supplied with new equipment and followed, training is provided and recorded and a endoscopy user group be re-formed to pass on lessons learned to other users.
for the endoscopy washing machine supplier
Sending a copy of the Ministry's inquiry to the manufacturer, better documentation of modifications and a review of manuals and operating procedures. Where existing manuals are replaced, this should be accompanied by a full explanation to the responsible person.
for the Health Funding Authority
The Ministry's inquiry be provided to the quality team auditing Canterbury Health.
A check by the Ministry of Health of hospitals using endoscopes since the incident at Canterbury Health has revealed that another 17 hospitals use similar endoscopy washing machines. All are following the manufacturers instructions.
The Ministry of Health has asked Canterbury Health to pass on to all screened patients the results and recommendations of the inquiry and to provide access to patients of the full inquiry where required.
A separate inquiry by the Health and Disability Commissioner is investigating compliance with the Code of Health and Disability Services Consumers' Rights. That inquiry is continuing. The Commissioner is expected to visit Canterbury Health as part of her inquiry next week.
The Director General of Health's Inquiry into Canterbury Health looked at compliance with Regulation 19 of the Hospital Regulations.
This regulation states that hospitals will not permit any equipment that may have become infected during the treatment of any patient to be used in the treatment of any other patient until it has been disinfected.
The results of the Inquiry and recommendations are attached below:
RESULTS OF INQUIRY
There is insufficient evidence to support prosecution for contravention of the requirement that 'the Manager of a hospital must not permit any equipment which may have become infected during the treatment of one patient with a communicable disease from being used in the treatment of any other patient until it has been disinfected in a proper manner.'
There were numerous safeguards in place in the endoscopy unit at Christchurch Hospital to prevent cross infection through reuse of the endoscope, including a diligent nursing taskforce, who were prepared to train new staff members to follow the same routine they had been taught.
The basic error of not following one specific instruction in the manual appears to have been present since the unit installed a Labcaire Autoscope endoscope washing and disinfecting machine in July 1996 and has been passed on from one staff member to another.
Not all the safeguards
were in use, through a chain of separate circumstances
o the staff has already trialled a smaller model of the same machine and could have been assumed to know the correct operation ;
o the manual did not arrive in the unit until sometime after the machine was installed ;
o there was no formalised training in the unit and there was inadequate recording of training and orientation, and there was a deficient procedures manual ;
o the requirements of both the Corporate Quality manual and the Infection Control manual were not followed to the letter ;
o when one staff member left, her assigned duties were not allocated to another staff member.
There is no evidence that there was a conscious decision to stop following the instruction in the manual to "lift the tips" of the endoscopes.
There is no evidence of a conscious decision to stop bacteriological monitoring of the processed endoscopes in December 1998, which would have provided reassurance about the disinfecting process.
Although the machine has required repairing and maintaining, there is no record of previous unnoticed irrigation pump failure which might have put other patients at risk.
The Endoscopy Unit
The inquiry team recommends that:
o the Gastrointestinal Investigation Unit Procedures Manual, first drafted on 8 July 1999 be peer-reviewed by a multidisciplinary group, confirmed and re-issued with full document control, ensuring that it makes reference to any other manuals staff may refer to and is complete (e.g. states the strength of solutions to be used).
o Training requirement in the unit be documented and individuals have their training recorded, as already required in the Corporate Human Resource manuals.
o all manuals and written instructions from the equipment manufacturers be reviewed so as to achieve consistency between process and manufacturer's recommendations.
o 'Infection Control' should check the rationale for having 5, 10 and 15 minute glutaraldehyde irrigation cycles for disinfection, in order to minimise the number of times operators have to re-set the automated machine. This could reduce the potential for having an incorrect setting used on the next pair of endoscopes.
o 'Infection Control' should review the recommendation that certain endoscopes should be considered "more likely to be contaminated" than others and receive longer disinfection, when current thinking is that all equipment should be considered as potentially contaminated.
o the Autoscope manufacturer be consulted about decommissioning the single/double rocker switches to reduce risk of unwittingly interrupting the disinfection irrigation
o Canterbury Health Limited investigate whether having the print-out option fitted to the machine would be cost-effective as an extra safeguard
o Canterbury Health Limited urgently complete the plumbing work required to control and monitor the water supply to the Autoscope machine.
Canterbury Health Limited
The inquiry team recommends that Canterbury Health Limited:
o monitor progress on recommendations made to the endoscopy unit
o review compliance with the following Quality Assurance procedures, most of which are covered generically in the Corporate Quality Document,
o involvement of Technical Services in equipment purchase decisions and installation
o operators manuals are supplied with new equipment at the time of installation and are immediately document-controlled
o initial training on new equipment is recorded and the training material retained
o staff training/orientation is formalised, and recorded and signed off for each individual
o The endoscopy-users group be reconstituted to consider whether lessons can be learned by other endoscopy providers within the hospital.
Technical (NZ) Limited
The inquiry team recommends that:
o a copy of this report be provided to Labcaire Systems Limited for their consideration
o that SciTech reviews its service documentation to ensure that all modifications (such as the affixing of warning stickers) are recorded and dated
o that SciTech urgently arranges for review of the manuals and operating instructions for the Autoscope and progressively for other equipment it sells and services, but only replaces documents held by its customers as a controlled procedure, with full explanation to the responsible person in the customers organisation
Health Funding Authority
The inquiry team recommends that:
a copy of this report be provided to the HFA's Quality Team, to be referenced during their on-site quality systems audit of Canterbury Health Limited and in preparing their report.