Washer-Disinfector and Medical Equipment Audit - Report Example

Washer-Disinfector and Medical Equipment Audit Report Introduction A compliance evaluation has been performed for Holby SSD Hospital, particularly practices of the Sterile Services Department to ensure quality in performance, and compliance with regulatory requirements. The washer-disinfector, surgical instruments, anaesthetic accessories, and hollowware were tested for performance requirements set in the HTM 2030, developed by the NHS. A report has been prepared for the management, where the results have been discussed and further action has been recommended. Audits Audits are characterised by at least one of the following; high risk; high volume; cause for concern; and high cost. The risk of cross-infection has made it imperative to sterilise instruments to a high standard in general practice or dental environment. Any surgical instrument used on one patient is a potential source of infection to another patient or the handler, and this risk could be minimised by cleaning and sterilising as soon as possible. NHS has prepared HTM 2030 as the governing standard for washing and disinfection of surgical and dental instruments. Along with HTM 2010, HTM 2030 establishes the benchmark for safe and effective surgical instrument decontamination. Guidelines for designing an audit include selection of sample; prospective or retrospective; data collection; data collector; resources for completion of audit; and analysis and presentation of data. While selecting the sample, there should be a check on the criteria. This should be done by the infection control nurse. The audit should observe the events of the day, and also retrospectively observe records maintained. The staff procedures while dealing with contaminated instruments should be observed. The records and analyses for risk from cross-infection should be examined. Data collection, analysis and preparation of report must be performed by the nurse responsible for cross infection or the designated manager (“Clinical Audit in Primary Care: Demonstrating Quality and Outcomes”). Performance Requirements HTM 2030 is a guidance document for the selection, specification, procurement, installation, validation, testing, operation and maintenance of washer disinfectors used by the National Health Service for processing of medical devices, sanitary products, and laboratory goods. The section on validation and verification addresses specific aspects related to testing of washer-disinfectors. Schedules and procedures for periodic tests have been laid out in the document (“Washer – disinfectors”). Stringent cleaning procedures have been specified, including the use of chemical agents specifically formulated for the removal of soil and disinfection. Testing of washer disinfectors for surgical instruments has been covered by HTM 2030 to ensure that they operate correctly. Periodic testing of equipment in use and final rinse water enables verification of the effectiveness of procedures used. A failure could mean renewed contamination of equipment. Validation and verification of washer-disinfector processes has been addressed by HTM 2030/HTM 01. Testing parameters include alkalinity/acidity; appearance; calcium and magnesium; chloride; electrical conductivity; cobalt, copper, zinc, lead, nickel, cadmium; iron; pH; phosphate; silicate; total dissolved solids; total hardness; bacterial endotoxins; total viable count; and environmental mycobacteria (“Washer Disinfector Testing to HTM 2030/HTM 01”). Audit Results A summary of tests performed on various equipment and results have been illustrated in table 1. Table 1. Test Summary Test Summary Sl No Equipment Information Test Information/Standard Result Remarks 1 Washer-Disinfector Yearly Validation and Re-performance Qualification Tests/HTM 2030 Compliant 2 Washer-Disinfector Annual Test/HTM 2030 Compliant Next test due on 14 March 2003 3 Surgical Instruments Yearly & Revalidation Test/HTM2030 Compliant Third party testing. Further investigation of water system. 4 Anaesthetic Accessories Yearly & Revalidation Test/HTM2030 Compliant Third party testing. Further investigation of water system. 5 Hollowware Yearly & Revalidation Test/HTM2030 Compliant Third party testing. Further investigation of water system. Yearly validation and re-performance qualification tests, based on HTM 2030 were performed on the washer disinfector on 26/03/02. All requirements were satisfied. Annual test, based HTM 2030 was performed on the washer disinfector on 14/03/02, and all requirements were satisfied. Observations on the yearly record included the following tasks: maintenance; weekly safety checks; housekeeping and weekly record check, and all were found to be satisfactory. Water quality tests included water hardness for soft water and RO water; water conductivity for soft water and RO water; and water system analysis. The maximum allowable limits were 210mg/l, 210 mg/l, 300 µscm-l, and 10 µscm-l respectively. Water conductivity for soft water was found to be 743 µscm-l, which was above the maximum allowable level. Other results indicated water quality to be satisfactory. The water system analysis failed the test. Yearly and revalidation tests, based on HTM 2030 were performed on the surgical instruments on 14/03/02, and all the requirements were met. Yearly and revalidation tests, based on HTM 2030 were performed on the anaesthetic accessories on 14/03/02, and all the requirements were satisfied. Yearly and revalidation tests, based on HTM 2030 were performed on the hollowware on 14/03/02, and all the requirements were satisfied. A performance qualification test was performed by the user on the anaesthetic accessories and hollowware. The requirements, based on HTM 2030 include yearly safety checks, automatic control tests, verification of calibration of washer disinfector instruments, water systems, drainage, doors and door interlocks, fault interlocks, water vapour discharge test, aerosol discharge test, chemical additive dosing tests, load carriers, test for air quality, cleaning efficacy test, over-temperature cut-out test, thermoelectric test for thermal disinfection, load dryness test, and process residues. The testing for surgical instruments, anaesthetic accessories and hollowware were performed by a third party. Details for each aspect tested and photographs taken have been included in the yearly test record, and have been found to meet the requirements. It was observed that the water system was not operating correctly, and further investigation was required. Procedures followed for testing have been as per guidelines in HTM 2030 and tests have been documented. Equipment used for testing has been recorded and certified for calibration before testing to ensure quality. Plots of temperature over time have been plotted by the temperature logger and data analysed. Conclusion A comprehensive audit has been performed based on guidelines set in HTM 2030. The tests were performed with assistance from a third party. It was found that the washer-disinfector satisfied requirements for yearly validation and re-performance qualification and annual tests. The surgical instruments, anaesthetic accessories, and hollowware satisfied requirements for yearly and revalidation tests. Water conductivity for soft water was found to be 743 µscm-l, which was above the maximum allowable level of 300 µscm-l. The cause must be examined and further tests would be necessary to ensure that the levels are within the allowable limits. The water system analysis failed the test, and further investigation has been recommended. Quality is essential in the delivery of healthcare services, and all efforts must be made to ensure performance quality and compliance with regulatory requirements. The management has a distinct role in the operation of the services and is responsible for any non compliance or non performance. In the best interests of the services, it is necessary that prompt remedial action be taken. References Cambridge City and Cambridgeshire Primary Care Trusts. (2006). Management and Control of Decontamination of Reusable Medical Devices. Available: http://www.cambridgeshirepct.nhs.uk/documents/Staff%20Information/Policies/CambsCityandSouth/clinical/Decontamination%20Policy%20Feb%202006.pdf?preventCache=03%2F04%2F2006+10%3A50. Last accessed 16 May 2009. Chambers, R. & Wakley, G (2005). Clinical Audit in Primary Care: Demonstrating Quality and Outcomes. UK: Radcliffe Publishing. 1-173. NHS Estates. (1997). Washer Disinfector. Available: http://195.92.246.148/knowledge_network/documents/2030Opman_Exec_summ_20071204113441.pdf. Last accessed 16 May 2009. SMS Environmental. (2008). Washer Disinfector Testing to HTM 2030/HTM 01. Available: http://www.sms-environmental.co.uk/washer_disinfector_testing.html. Last accessed 16 May 2009. TEST Ltd. (2009). HTM 2030. Available: http://www.testmedical.co.uk/htm2030.aspx. Last accessed 16 May 2009. UK NHS. (2009). Were Here Whenever You Need Health Advice & Information. Available: http://www.nhsdirect.nhs.uk/. Last accessed 16 May 2009. UK NHS. (2009). Your Health, Your Choices. Available: http://www.nhs.uk/Pages/HomePage.aspx. Last accessed 16 May 2009. UK NHS Estates/Department of Health. (2006). HTM 2030. Washer – disinfectors. Available: http://www.nric.org.uk/IntegratedCRD.nsf/ffb73bee6c8e4ead8025700600449763/8d17c8fc3d00176a8025726c00386b72?OpenDocument. Last accessed 16 May 2009. Read More