Levelling the playing field

The increasing legislation in the commercial laboratory sector is putting more and more pressure on government laboratories to be accredited. Rob Clinton tells us about this increasingly familiar trend and how organisations can lessen the financial impact of accreditation

Police forensics units are under guidance by the National Policing Improvement Agency and the Forensics Science Regulator to comply with ISO17025. With the cease of the government funded Forensic Science Service, police scientific investigations teams were forced to use commercial organisations for outsourced forensics work. In order to supply these, organisations are required to hold ISO17025 themselves, although government laboratories are not. The industry complained that this was a case of double standards, prompting a home office to review making ISO17025 mandatory for police scientific investigations departments.

The European Union Council Framework Decision 2009/905/JHA states that providers, who carry out DNA and fingerprint laboratory services, should be certified to ISO17025 for DNA by 2013 and fingerprint by 2015 respectively.

The increasing legislation around companies offering laboratory services to government organisations is forcing more and more public service laboratories to gain accreditation to standards like ISO17025. The private sector believes that if they are forced to comply, then it is only fair that internal services also comply with the same standards as they are effectively competitors.

The cost of gaining and then maintaining this standard can be substantial. There is an emerging trend for increasing numbers of laboratories opting to use electronic quality and records management systems to lessen the financial impact of accreditation. Over and above, these electronic solutions are seen as a way of decreasing the risk associated with losing accreditation due to human errors and loss of data. If a company was to lose its accreditation, it would effectively lose its licence to supply to agencies such as the home office.

In addition to standards such as ISO17025, diagnostic service providers are now seeing increasing pressure to comply with other regulatory standards. The ‘improving quality in physiological diagnostic services’ (IQIPS) programme is administered by the Royal College of Physicians (RCP) and delivered by the United Kingdom Accreditation Service (UKAS).

IQIPS aims to improve service quality, care and safety for patients undergoing physiological diagnostics and treatments. The programme is based on a self-assessment, which will define an internal improvement project and finally lead to accreditation by UKAS.

IQIPS is based on 4 core domains: Patient experience; facilities, resources and workforce; safety and clinical.

This system should be implemented and monitored, meaning that documentation, compliance, audit and incident management are required. UKAS will be looking for an effective monitoring system and a culture of continual improvement.

The Patient experience domain is about ensuring that service delivery is patient-focused. This is achieved by ensuring the patient has access to appropriate information, before, during and after a procedure.

Patients should give consent to a procedure once they have been fully informed of the details of the procedure in a patient-friendly format, such as e-forms. Moreover, the patient should also be able to feedback information on their experience, which can also be recorded via e-forms.

UKAS will require that roles and responsibilities are clearly defined around delivering each element of each domain. Under the facilities, resource and workforce domain the provider is required to develop and monitor systems that ensure facilities and resource is available, and that staff members are competent and motivated.

As in traditional quality management and good laboratory practice, this requirement includes calibration of measuring devices and assurance of procedural understanding and competence. Records management is the key to assuring the availability of competent staff and functioning equipment are in place. When records are managed electronically software can be used to prompt testing, maintenance and to highlight resource gaps. Competence can be continually assessed both at an employee level and across the organisation.

A good monitoring system will help management ensure that the service being offered is ready and available at all times and the quality of service is not affected by staff which is not adequately trained.

Safety is paramount in an environment that often encounters distressed members of the public and delivers diagnostic services that may require the use of hazardous materials and sharps, which is the focus of the third domain.

Safety management systems also require the implementation of risk assessment, education and mitigation. Once a safety management programme is implemented, monitoring and improvement are crucial to maintaining a working environment that is safe for both health workers and the public.

As in all of the above domains, this will create considerable documentation, records and tasks. Managing these electronically would significantly decrease the administrative burden.

The final domain, clinical, is to promote the service’s role in rapid and accurate diagnosis. Clinical services are likely to be well-documented and governed by existing standards. However, the IQIPS requirement will mean that these existing systems need to be mapped to the new standard in order to gain accreditation. There is an ever increasing requirement for standards to integrate, saving time and money on duplication of effort and work across standards.

Electronic systems increase awareness of existing methods of best practice and standards. If stakeholders are aware of these systems many hours of work can be saved and vital lessons learnt that may prevent patient harm. The need for electronic systems is only strengthened by the targets set by Jeremy Hunt, for a paperless NHS to be achieved by 2018.

 Author: Robert Clinton, Director of Compliance Solutions, Ideagen www.ideagenplc.com