One of the questions we are continually asked about HTM 01-05 relates to the authority of the document, specifically regarding the fact that advice in HTM 01-05 is advisory, not mandatory.
It is clearly important that dental practices are aware of what is expected of them, but different interpretations of the requirements are being made and this could lead to difficulties when inspected by the CQC.
The important document is The Health and Social Care Act. This document is a law, and lays down mandatory compliance criteria. Particularly relevant here are Compliance Criterion 2 and 8, stating respectively:
- 'Provide and maintain a clean and appropriate environment which facilitates the prevention and control of HCAI' (Health Care Acquired Infections)
- 'Have and adhere to appropriate policies and protocols for the prevention and control of HCAI'
The question then is how best to meet these mandatory requirements?
HTM 01-05 is indeed advisory, the Health and Social Care Act makes this clear when it states: 'This guidance is not mandatory but is considered to represent the basic steps to ensure that the criteria can be met. There may be additional or alternative strategies that a service provider is able to justify as equivalent or more effective in achieving compliance in their circumstances. Providers are free to decide to use alternative approaches but should be prepared to justify to an inspecting body how the chosen approach is equally effective or better in ensuring that the criteria are met.'
The options are therefore to either implement HTM 01-05 or be clear how you will show to the CQC that your chosen alternative is equally as effective. The problem is right there. It's not enough to just decide not to implement the advice given, non-adherence requires a practice to show an effective alternative.
Let's look at the perennial debate regarding washer disinfectors as a good example.
HTM01-05 states that manual cleaning is acceptable under 'essential requirements', but not if surgeries are operating to 'best practice' standards. The statement is made that a washer disinfector should be used 'wherever possible'. Putting aside exactly what constitutes 'wherever possible', what are the alternatives if surgeries choose not to use an automated and validated washer disinfector?
The alternative suggested is manual cleaning in combination with an ultrasonic cleaner. However, manual cleaning is not an easily validated process and methodology differs from one person to the next. HTM 01-05 lays down a protocol for manual cleaning that appears to be fairly arduous, and in practice it is rare to find a surgery adhering to all aspects of the procedure. For example:
- How are you monitoring the volume of water and detergent to ensure the correct concentration?
- Are you constantly monitoring the temperature of the water using a non-mercury thermometer?
- Are you using a single use long handled brush, or if not what procedures have you implemented regarding the cleaning of a reusable brush?
- Do you ensure that all instruments are always scrubbed beneath the water to prevent aerosol spray of contaminated water?
- Do you rinse instruments with RO or distilled water?
- Do you fully inspect each instrument separately using an illuminated magnifying source?
- Do you wear personal protective clothing?
- How are you manually cleaning instruments and also ensuring you exercise duty of care to staff by minimising the chance of sharps injuries?
You are not required to follow these procedures as the document is advisory, but if you are not following them, then what evidence are you able to present to show that whatever methodology you do use is equally or more effective?
This is the sting in the tail, because most surgeries differ from the suggested advice, not because they have a technique that is demonstrably equally or more effective, but simply because of historical convention within their practice.
Some surgeries and dentists suggest that the advice given is unnecessary and/or not evidence based. Regardless of the reality of this suggestion however, expressing scepticism over the advice given is not the same as showing a proven alternative. According to the Health and Social Care Act, the CQC, or any inspecting body, will expect either adherence to the advice in HTM 01-05 (use of a washer disinfector or compliance to the full manual cleaning procedure in Section 16), or another method that you can demonstrate is equally or more effective.
In summary, it appears that whilst there will always be methods and alternatives to the advice given in HTM 01-05, implementing such methods and demonstrating their equal or greater effectiveness will generally prove difficult and arduous at best. Although there is no statutory requirement to follow HTM 01-05 advice, the de facto position might be that it may be simpler, safer, quicker (and even cheaper) to simply 'bite the bullet'!