Jenny Nixon, Business Development Director at Dentisan.
Aims & Objectives
- To teach readers about the importance of compliance and record keeping in the dental environment.
- To relate infection control practice to the latest UK legal requirements and guidance.
- To teach readers how to develop systems and processes for good record keeping.
This article meets the criteria of the GDC’s development outcomes for enhanced CPD in category C
Accurate record keeping is an essential part of running a modern dental practice and is necessary in the provision of high-quality, safe and effective patient care. It creates a physical audit that enables the practice to demonstrate compliance with legal and regulatory requirements and provides a permanent record of levels of care that might prove useful in the event of patient complaints or litigation.
Dental professionals are required to make and keep accurate clinical records of care provided to all patients, whether NHS or private and although in this respect responsibility ultimately lies with the treating clinician, there are other areas of the practice that demand the same level of detailed audit and accurate record keeping.
There are several pieces of UK legislation that require both NHS and private practitioners to keep records[i]. These include:
- The Consumer Protection Act 1987 under which an action could arise for a defective product
- The Medical Devices Directive (Directive 93/42/EEC) which relates to custom-made devices
- The Medicines Act 1968
- The Misuse of Drugs Regulations 2001
The General Dental Council (GDC), the Care Quality Commission (CQC), NHS England, SDCEP, Healthcare Inspectorate Wales (HIW) and the RQIA in Northern Ireland are all concerned with standards of patient record keeping. The GDC’s ‘Standards for the Dental Team’[ii] expects patient records to be contemporaneous, complete and accurate.
At Section 4.1, the guidance states: “You must ensure that all documentation that records your work, including patient records, is clear, legible, accurate and can be readily understood by others.”
Records are how healthcare providers demonstrate to the CQC that the service they are providing complies with regulations and CQC standards and is safe, effective and responsive to patients’ needs.
Periodically the GDC shares insights from fitness to practice investigations and in its published 2020 report it advised that in the first three quarters of 2019, 7.5% of all cases referred to the assessment stage included a concern about record keeping[iii].
In addition to patient records, there are many other record keeping and administrative tasks that are central to the day-to-day running of an organised and compliant practice.
Maintaining a sterile and safe environment is a top priority and there should be a clear understanding of the hierarchy of responsibility within each individual practice as to who is responsible for implementing and adhering to infection control protocols.
HTM 01-05 and UK guidance states that all dental practices must have a nominated lead member of staff responsible for infection control and decontamination, a role often fulfilled by the practice manager or lead dental nurse. This role of Decontamination Lead includes ensuring all systems, procedures and records for infection control and decontamination are in place, that staff members are correctly trained and competent, and that all essential processes and policies are evidenced and up to date.
The Decontamination Lead can also nominate or adopt the role of a designated person. It is the designated person’s responsibility to ‘act as the interface between the practice and support services supplied externally, including service, maintenance and testing’[iv]. This includes maintaining all testing and validation records for decontamination equipment and ensuring this equipment is serviced/validated, and in the case of steam sterilisers, undergo a pressure vessel inspection (PVI check) in accordance with manufacturers’ guidance.
Staff with decontamination duties should be appropriately trained during their induction and this training should be documented. This enables staff to understand the practice’s policy and procedures and to learn how to correctly use decontamination equipment, record validation testing and report any equipment failures.
The introduction of new equipment or validation tests must be accompanied with training to ensure manufacturers’ guidelines are followed and understood by all relevant staff members.
Documentation provides the only evidence of completed and successful decontamination processes. A clear and concise record keeping process ensures there are no shortfalls in infection control routines and streamlines other aspects of infection control to provide a full audit trail of compliance to keep patients and the practice protected at all times.
Each piece of decontamination equipment requires a specific document which should detail a complete history of each item which can be completed according to the test being carried out on a daily, weekly, quarterly or annual basis.
Practices have various options for record keeping:
- Devise their own system.
- Use the templates provided in guidance documents such as HTM 01-05 or the SDCEP Practice Support Manual.
- Use a manufacturer’s log book specific to each machine.
- Use a supplier’s universal log book.
Whichever method is chosen the document should be clearly laid out and provide an easy prompt for decon leads and those responsible to complete the necessary details. It’s also important to have a filing system for the quarterly and annual audits carried out by 3rd party engineers and a faults and repair record.
The need for compliance
HTM 01-05 emphasises the need for validation, testing, maintenance and servicing as recommended by the manufacturer/supplier and that all records of these procedures should be up-to-date and be retained for audit/inspection purposes at any time. Section 11.3 states: “Failure to perform these tasks or retain evidence of their performance may indicate non-compliance of the decontamination process”.
The CQC in England states that in order to meet Essential Quality Requirements, periodic tests should be carried out in accordance with manufacturers’ instructions or as set out in HTM 01-05 for sterilisers, ultrasonic baths and washer-disinfectors. Documentation relating to this should be “available for inspection” and it is advised to “keep hard copy records with the steriliser log book, either within the log book or in a separate folder”[v].
In Scotland, Scottish Health Technical Memoranda (SHTM) provide technical guidance on how to choose, use and validate equipment for decontamination processes.
The CQC states that all testing and validation documentation should be retained by a practice for a minimum of two years. However, it is considered good practice to keep these records for the same minimum retention period as patient records advised by regional health authorities in case a complaint or litigation should arise. In England and Wales, for adult patients the NHS currently recommends a minimum of 15 years while the Scottish government advises a minimum of 10 years from when the patient last attended[vi].
Record keeping is not just confined to patient records and decontamination equipment. Other examples include:
- A record of CPD hours as an important part of maintaining GDC registration.
- Immunisation records to ensure all members of the dental team are protected against diseases such as diphtheria, hepatitis B, polio, measles, mumps and rubella (MMR).
- Water quality testing.
- Hand hygiene policy.
- Handpiece decontamination procedures.
- Individual staff training records.
- Hot and cold water supply temperature checks.
Record keeping is a key part of daily life for dental professionals and the standard of record keeping ultimately reflects on the standard of professional practice. Guidance around record keeping changes frequently, so it is important to keep up to date with the latest legislation and relevant local guidelines.
In this way dental teams can guarantee high standards, traceability and compliance to ensure peace of mind that patients, staff and the business itself are always well protected.
[i] Dental Protection Ltd.
[ii] Standards for the Dental Team (2013) General Dental Council. Standard 4.1
[iv] HTM 01-05 (2013 edition) Section 9.3
[vi] Howden, E. Retaining and destroying patient records. BDJ Team 10, 23 (2023). https://doi.org/10.1038/s41407-023-1712-x