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Section 2: Review of Endoscope Decontamination Practice in Scotland: November 2004 to May 2005
2.1 Aim
The aim was to undertake a structured review to provide assurance to the CMO that the response to HAZ(SC)04/05 had resulted in the necessary actions being taken and to inform him of any concerns about practice.
2.2 Objectives
The objectives of this study were:
- to highlight any overall deficiencies in line with the earlier reviews undertaken locally in response to HAZ(SC)04/05;
- to identify to the CMO potential areas of liability for healthcare providers through failure to implement best practice guidance;
- to provide an evidence base for the development of any control measures required to eliminate inadequate decontamination practice between endoscopic procedures;
- to make recommendations for any further action required.
2.3 Methodology
2.3.1 Study population
The study population comprised all units using and/or decontaminating endoscopes in NHS Boards and independent sector hospitals in Scotland.
A letter from the Chief Medical Officer [CMO(2004)16] (see Appendix 2) instructed all NHS Board Chief Executives to ensure that the review of endoscope decontamination was carried out in all healthcare facilities in which endoscopy is undertaken. The Scottish Commission for the Regulation of Care advised independent hospitals that they should also complete the review.
The inclusion of relevant units in the review was the responsibility of NHS Boards and independent sector hospitals in Scotland who, therefore, defined the units comprising the study population. In the absence of any national database recording all units in which endoscopy activity occurs, it is not possible to determine the sample portion of the target population.
2.3.2 Funding
Funding for the development of the Endoscope Decontamination Assessment Tool ( EDAT) was provided by NHS Quality Improvement Scotland. Any costs incurred in on-site data collection were met locally by the organisation providing the review data. HPS absorbed the additional costs for data analysis and reporting.
2.3.3 Development of the question set
The question set was developed by SAG based on the questions used in the Northern Ireland review of endoscope decontamination practice but extended to include more detailed assessment of decontamination equipment and processes. The questions were designed to provide data to meet the study objectives, they included questions on the range of the endoscopes in use, the extent of user recognition of channels present, the decontamination procedures being used and, the nature and status of any automated reprocessing equipment (see Appendix 3). The questions did not address to any great extent the environment in which decontamination was carried out, the management structures, operational and quality control procedures, traceability and staff training.
2.3.4 Development of the assessment tool
To facilitate the review it was agreed to develop a computer-based tool for on-site assessment of endoscope decontamination ( EDAT). EDAT was designed to collect data on endoscope decontamination practice within healthcare organisations ( NHS and independent) in Scotland. The assessment tool was constructed using the Advanced Data Acquisition Tool ( ADAT), an application programme developed by HPS to allow construction of automated assessment tools for a variety of applications. The development of the program itself utilised the most up to date Microsoft technologies. The .Net platform was identified as delivering the required functionality to allow for interoperability of software. Once completed EDAT consisted of a fully independent program, that interacts with one access database, and one .dat file, which contains the sites, secure information and is encrypted by the program before inserting into the .dat file.
The program was subject to a pilot at Ninewells Hospital. Following the pilot review, the set of seven forms were deemed to be ready for release. This release consisted of a co-ordinated download from a new live website and distribution of an auto-run CDROM.
2.3.5 Data collection
HPS developed EDAT for NHS Boards to capture the dataset from all relevant operational units. A SEHD letter to HDL (2001) 10 Manager on 8 th November 2004 advised them to nominate a professional to be responsible for EDAT completion and data return. Instructions for the completion of EDAT were included in the software 'instructions for use' (Appendix 5 describes this as 'help files') and incorporated guidance on staff who would be suitable to carry out the review and who should provide the information. It also drew attention to the facility to print out the data collected so that this could be checked for accuracy before closing the software and submitting the data to HPS. (Appendix 5). The collection of data was undertaken by local staff in each unit that was using or using and decontaminating endoscopes. A helpline was available during weekday working hours to provide assistance with any problems, which the users encountered. Initial data collection was undertaken between November 2004 and May 2005. Resubmission of the data was required in June 2005, due to data corruption during upload to the HPS database.
2.3.6 Data quality
SEHD assigned (see Appendix 4) to NHS Boards' nominees the responsibility for ensuring the accuracy and completeness of the endoscopy decontamination dataset. HPS reiterated this in the EDAT user instructions (see Appendix 5). The dataset included record fields for the name and contact details of the person responsible for the review and the name of the reviewer who collected the data. These data fields were completed for almost all the returned datasets.
Appendix 6 summarises the types of professional responsible for returning the datasets. It is apparent that, in almost all instances, the staff responsible for collecting the dataset (and ensuring its accuracy and completeness) were directly involved in endoscope decontamination or were other responsible professional staff in close and direct consultation with those directly involved in decontamination of endoscopes.
The data were entered directly into the EDAT system and this negated the need for secondary handling by another person, thus avoiding the introduction of transcription errors. Also, the ability of the program to print to hard copy, the answers entered electronically, facilitated data integrity as input could be checked and if incorrect, amended locally prior to submission. The fact that the program is standalone, further contributed to data integrity as this meant that the user could load the program onto a laptop and be onsite when filling in the forms. The only aspect identified where data may be skewed, is where the user created a new instance of a 'clinical unit review' for each endoscope or each washer disinfector, rather than using multiple (cloned) equipment forms within one review. This replication of data could be attributed to a lack of understanding of the programme and the reviewing process. Repetition of data could be checked locally and, if incorrect, amended locally prior to submission. Any evidence of replication in the submitted data was corrected after submission before analysis. Overall however, the absence of data transcription provides fewer chances of introducing errors and gives an anticipated concomitant increase in data quality.
2.3.7 Data processing
Upload of completed datasets was undertaken automatically through a web-based application. The data were held on the SHOW (Scottish Health On the Web) server. Once the cut-off date was reached the data were downloaded from the web server to HPS for analysis, and were inserted into SQL server 2000 for better data handling .
Uploaded datasets were checked and evidence of loss of integrity in some uploaded datasets was detected. An investigation was undertaken which revealed that packets of data were being dropped from the system and as a result, a request was made for resubmission of the data. To prevent a recurrence of the problem sites were asked to submit the data on a CDROM, or by e-mail. At this point, where necessary, submission of hard copy was also accepted (2 sites). These data were entered into the database manually. All data entered manually were verified by an independent manual check. The data were then reinserted into a new SQL server database. After the relevant information was extracted, it was exported to Reporting Services where a reporting program was built to enable the data to be viewed with appropriate security, via the intranet at HPS. When tabulated, data required further characterisation and it was exported to Excel where it could be filtered and analysed. Data were anonymised prior to analysis to avoid identification of the unit and site.
In order to verify the accuracy of data submitted on specific endoscopes an Endoscope Manufacturers Identification Database ( EMID) was created. EMID provided a searchable database of manufacturers' information on endoscope model numbers and the number and type of channels.
2.3.8 Data analysis
Anonymous data was provided for blind analysis. The analysis was undertaken by an accredited professional with appropriate experience, and cross- checked by one or both of two other appropriately qualified professionals. These data were tabulated to identify current practice in endoscopy decontamination, related in particular to the scope of HAZ(SC)04/05.
The analysis included review of submitted data against key elements of good practice, (See Section 1.5) and the elements of HAZ(SC)04/05:
- endoscope details (recognition of model number and channels etc),
- manual cleaning procedures,
- endoscope reprocessing equipment,
- process chemicals (detergents and chemical disinfectants),
- maintenance and testing including validation of reprocessing equipment
Further details on the key parameters utilised in the analyses of responses to the EDAT questions are summarised in Section 3 of this report. Where appropriate, the findings are presented with 'Key indicators of Good Practice' extracted from published guidance (See section 1.4). These key indicators relate to the main issues covered by EDAT but are not intended to cover all aspects of endoscope decontamination.
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