Doesn’t it seem like the HTM 01-05 has been around forever? It is almost difficult to remember a life before HTM 01-05, and even more difficult to remember how a dental practice managed to clean instruments without the help of a washer-disinfector and illuminated magnifier.
Nevertheless, the HTM 01-05 has put in place a process of decontamination of re-usable dental instruments which can be tested and validated, thus providing evidence to support the process of decontamination from start to finish.
In theory, it is a good thing the health department has issued this guidance. With the forthcoming mandatory registration with the Care Quality Commission in April 2011, the HTM 01-05 should give all dental practices a common, standardised message on what has to be done to comply with ‘essential requirements’ and what needs to be done to achieve ‘best practice’.
The not so good thing is rather than giving clear and standardised messages, the HTM 01-05 is being perceived as confusing, ambiguous, expensive to implement, and its evidence-base is subject to hot debate.
At the Dental Buying Group we are finding at this point of HTM 01-05 implementation, the nature of enquiries and requests for help have changed. Prior to all practices receiving the hard copy of the document, we found the initial influx of enquiries focussed on the actual decontamination process. Enquiries ranged from what detergents to use, pouching of instruments, right through to the design of local decontamination units and workflow from dirty to clean zones.
Now practices have received their hard copies of the HTM 01-05, the realisation for the need to test and validate the decontamination process has taken over, with enquiries now focussing on what validation tests need to be done and how often, who needs to do them and what evidence will be asked for during inspection.
Documentation provides the only evidence of completed and successful decontamination. A failure to produce documentation for any work item will indicate omission of that item. As a practice you may have spent a lot of money and hours on training staff on how to use new equipment. You may have gone to great lengths to check your detergents are the right ones to use, commenced new daily and weekly checks on decontamination equipment and even faced a revolt by your nursing staff when you implemented the new ‘scrub nurse’ rota.
But if no-one is recording what is being done, no-one is logging the results of validation testing and, subsequently, there is inconsistent and inadequate documentation to support all the flurry of decontamination activity, there is a substantial risk that during inspection your cross-infection procedures will be put into question.
So, what documentation is needed as evidence of validation of the decontamination process?
Log book
Each piece of decontamination equipment should have a dedicated log book for all results to be recorded. There are standardised log books available that contain generic information for all required tests. The practice can devise its own log book for each equipment item, but with the caveat the suitability of any in-house or standardised documentation should be consulted and approved by the decontamination equipment manufacturer and competent person or decontamination/service engineer. It may also be useful to consult with the PCT infection control team and, where available, an authorising engineer (decontamination). Examples of log book pages can be seen in Appendix 3 of the HTM 01-05.
All log books should provide a complete history of the decontamination item and should include:
- Records of commissioning and validation tests and checks
- Routine monitoring of every cleaning or sterilisation cycle
- Recording of failed cycles and what was done with the contaminated instruments
- Results of every item of maintenance, repair or modification;
- Records of training of the operator/user.
Log books for sterilisers should also include:
- Written scheme of examination under the Pressure Systems Regulation 2000
- Records of the inspection under the scheme of examination
- Certificate of insurance for the pressure system.
Log books should be sited by the decontamination equipment and completed according to the test being carried out: daily, weekly, quarterly or annual. It is important for the user/operator carrying out the daily and weekly checks to sign and date the log book as the signature acts as a ‘certification of fitness for use’ based on the information and advice supplied by the manufacturer or competent person of decontamination or service engineer. Any periodic testing, maintenance work or repair carried out by the competent person or service engineer will require recording in the log book followed by their signature. A validation check or test not followed by a signature may indicate a non-compliance issue.
Printouts
Printouts from ultrasonic baths, washer-disinfectors and sterilisers should be kept and attached to a process log sheet. However, it is recommended for the printouts to be photocopied as thermal paper fades over time. The printouts from decontamination equipment will need to be checked, the results recorded in the process log sheet followed by a signature by the user/operator to complete the validation process. Users/operators should avoid putting printouts in large box files without signature or accompanying process log sheet. The system has to be logical, neat and auditable. Remember, you may be required to find data relating to a specific date for specific equipment item at any time.
Documentation
Each decontamination equipment item will require evidence of quarterly and annual validation testing. These tests are usually performed by a service engineer or competent person (decontamination). The service engineer will need access to the log book and record the purpose of the visit, what was done, tests and checks carried out and validation results. In addition to recording all the information in the log book the service engineer/CPD may also supply separate documentation which should be included with the log book. This will also apply should the service engineer/CPD be required to carry out a maintenance, repair or modification to any equipment.
Training records
All dental staff must be aware of how micro-organisms can be transmitted and what procedures are in place to minimise cross-infection transmission.
All new staff must undergo infection control procedure training during their induction. Training new staff will enable them to understand:
- the practice’s policy and procedures in decontamination;
- personal hygiene expectations and handwashing policy;
- how to use decontamination equipment and how to record validation testing;
- what personal protection equipment is required;
- reporting of failures in decontamination equipment or witness to poor compliance to infection control procedure.
All staff must ensure they are kept updated with decontamination procedures with the General Dental Council identifying disinfection and decontamination as a mandatory continuing professional development area requiring at least five hours verifiable CPD in every cycle.
Training must be given to all staff to ensure ongoing competence in practice decontamination procedures. Any introduction of new equipment or validation test must be followed with training to ensure manufacturers’ guidelines are implemented and understood by all staff.
Immunisation policy and record
Immunisation is one of the most effective defenses for protecting individuals and the community from serious diseases. It is advisable to ensure all members of the dental team who have contact with contaminated materials and instruments immunised against the following infectious diseases:
- Diptheria
- Hepatitis B
- Polio
- Rubella, measles and mumps
- Tetanus
- TB
- Varicella-optional
It is an important safeguard to obtain proof of vaccination date and immunisation. A record should be kept to ensure that all immunisation requirements are monitored. This record should be kept up-to-date and boosters arranged if necessary.
Summary
It is acknowledged the list given is not exhaustive and each practice may vary according to the different types of testing and decontamination equipment you have. However, whatever systems you have in place, it is the need for consistency and strict compliance to the testing and logging process that will be the most important and can bring about success or failure of any system.
Documentation must include:
- Separate log books for ultrasonic baths, washer-disinfector and sterilisers
- Steriliser validation certificate
- Steriliser inspection certificate
- Washer-disinfector validation
- Waster-disinfector inspection certificate
- Ultrasonic bath inspection and maintenance certificate
- Water quality testing
- Hot and cold water supply temperature checks
- Hot and cold water supply annual visual inspection and maintenance
- Printouts from ultrasonic baths, washer-disinfectors and sterilisers (if applicable)
- Documentation from service engineers/CPDs
- Immunisation record including⇐ ⇔booster dates if applicable
- Evidence of immunisation
- Induction training record
- Individual staff training records
- Verifiable CPD in disinfection and decontamination record
- Proof of contractor competency
- Organisational chart describing roles and responsibilities
- Decontamination rota if applicable
- Cross infection policy and procedures
- Legionella risk assessment and written scheme
- Hand hygiene policy
- Manual cleaning policy
- Personal protective equipment policy
- Decontamination procedure
- Handpiece decontamination procedures
- Single-use and disposable items list.
Information retention
There is a minimum requirement for all validation and testing documentation to be kept at the practice for at least two years. Thereafter, it is good practice to keep the records for up to 11 years to follow the legal retention of patient dental records should a complaint arise. Local PCT requirements may differ so expectations should be confirmed and followed accordingly.
Spot checks and audits
The nominated lead for decontamination and/or practice manager and registered manager may well have the main responsibility for the day-to-day management of decontamination and cross infection control. However, the decontamination process does rely heavily upon the compliance of all staff to carry out each task within the decontamination process properly and to record validation testing consistently and accurately.
From time to time, each member of staff should be asked to demonstrate how they validate equipment and record the results; how they carry out the decontamination process; to retrieve the validation documentation for a specific date for a specific item of decontamination equipment
If these spot-checks and self-auditing techniques identify problems or gaps in information retrieved, then an opportunity has been identified to rectify matters. At least the shortcoming has been identified to you and not during inspection.
External organisations such as the Dental Buying Group can also help by carrying out a totally independent audit of your HTM 01-05 compliance and decontamination procedures. A non-judgemental, honest report with specific recommendations will be produced and aftercare services with ongoing support to offer peace of mind.
For more information about the Dental Buying Group call 0845 00 66 112 or visit www.thedbg.co.uk