Quality Assurance Regs to Tighten for UK Labs

NHS pathology review recommends several important changes to lab quality requirements

CEO SUMMARY: In the United Kingdom, a window of opportunity has opened for improving the quality assurance activities of pathology and histopathology laboratories. Last week, at the Frontiers in Laboratory Medicine conference, the newly-published “Pathology Quality Assurance Review” was the focus of several keynote sessions. One recommendation is to develop key assurance indicators (KAIs) that each lab would report to the National Health Service and the public.

THERE WILL BE A MORE RIGOROUS SYSTEM OF QUALITY ASSURANCE for medical laboratories and histopathology laboratories in the United Kingdom (UK), based on the findings and recommendations of an independent pathology review that was made public last week.

In the United Kingdom, there is a different type of nationwide scheme for medical laboratory regulation, compared to what exists in the United States. Expectations are that this pathology review will initiate the development and promulgation of tighter national quality assurance standards for pathology laboratories in the UK.

The United Kingdom thus has the opportunity to create a state-of-the-art scheme for quality assurance and laboratory accreditation and become a global leader in this regard. That is, if the system it eventually adopts is properly designed and incorporates the latest methods in continuous improvement, Six Sigma, and quality management systems.

In its press release about the review, the National Health Service (NHS) stated that the report, titled “Pathology Quality Assurance Review,” was recommending the “need for transparency, better safety checks on testing, consistency and standardization of processes and procedures” in how laboratories in the United Kingdom perform clinical lab testing.

It was Sir Bruce Keogh, Medical Director of NHS England, who commissioned the review in December 2012. Earlier that year, it was disclosed that, at the Sherwood Forest Hospitals NHS Foundation Trust, between 2004 and 2010, as many as 120 breast cancer patients may have had inaccurate results from post-surgical testing of their tissues for estrogen receptors.

The review was led by Dr. Ian Barnes, who was the National Clinical Director for Pathology in 2012. Last Tuesday, at the 11th Annual Frontiers in Laboratory Medicine (FiLM) conference in Birmingham, England, Barnes and Peter Huntley, Workstream Lead for the pathology review, discussed the conclusions in the report, along with its recommendations.

FiLM is co-produced annually by the Association for Clinical Biochemistry and THE DARK REPORT. Its Editor, Robert L. Michel, was in attendance. This intelligence briefing is based on the notes taken by Michel during the presentation made by Barnes and Huntley.

The pathology review team determined that the current system for quality assurance in the UK “relies almost entirely on professionalism and goodwill.” It is “focused on minimum acceptable standards,” and is not “designed to provide public assurance to patients, nor to assist Boards and commissioners in fulfilling their statutory duties.”

No Serious System Issues

One bit of good news from the pathology quality assurance review was that serious systemic problems in pathology testing were not found, with the caveat that the ability to accurately and precisely determine the quality of lab testing activities is falling behind the pace of new technology advances in diagnostic medicine.

In fact, the two speakers noted that the United Kingdom has been “at the forefront of quality assurance in pathology for the past 50 years, leading the way on external quality assurance. The UK was— along with Holland—the first European country to introduce a laboratory accreditation scheme for pathology.”

Barnes and Huntley next identified why changes and improvements in quality assurance are necessary. They noted that:

  • The current system of quality assurance in medical laboratories is fit for what it was originally designed to do, but, importantly, the current state is not fit for the future.
  • The current system does not meet emerging requirements for transparency and well-evidenced quality assurance.
  • The current quality assurance framework lacks key assurance indicators (KAI) to evidence quality and safety of pathology services.

‘Too Much Variation’

Just as in the United States, experts in the United Kingdom have called attention to the weaknesses in the existing system of quality assurance and quality control when viewed across the entire profession of laboratory medicine. In the words of Barnes and Huntley, in the UK, there is “too much variation in the pathology testing service, a lack of harmonization and standards [across different laboratories], which is unacceptable to patients and users.”

In the sidebar on page 5, the key recommendations of the Pathology Quality Assurance Review are listed. A number of the recommendations represent significant change to the existing system of quality assurance found in pathology and histopathology laboratories across the United Kingdom.

For example, it is recommended that key assurance indicators be developed and be published regularly. The goal is to allow the trusts, the commissioners (who “buy” lab testing services for their trusts), and patients to see the performance of individual pathology laboratories throughout the nation.

Quality Assurance Training

Another major change will be to upgrade the training of individuals responsible for quality assurance in their laboratories. At the same time, these individuals will need to undergo regular testing of their competency in this field.

Another recommendation with the potential to effect significant change involves better compliance by labs in reporting errors and incidents that might have caused—or did cause—patient harm. In this regard, the United Kingdom and the United States have one thing in common, which is that the true number of errors or incidents in labs with the potential to cause patient harm are unknown to government regulators. Further, many of those incidents which do reach the attention of regulators are not published, denying consumers access to that information.

As part of the review, Barnes and Huntley noted that pathology services in the United Kingdom employ about 33,000 people who work in 150 lab organizations. These labs perform approximately 200 million requests annually.

Within the UK, an organization called the United Kingdom Accreditation Service (UKAS) is responsible for two main accreditation processes in laboratory medicine. Laboratory organizations must accredit to the standards of ISO 15189. External Quality Assessment sources must accredit to ISO 17043–Conformity Assessment—General Requirements for Proficiency Testing.

Review Has Broad Support

Following Barnes’ presentation, representatives from several important lab organizations each spoke of their support for the findings and recommendations of the Pathology Quality Assurance Review.

Included were individuals representing the Royal College of Pathologists, the Association for Clinical Biochemistry, the Institute of Biomedical Science, and the British In Vitro Diagnostics Association.

At this moment in time, the pathology review has the full attention of the NHS leadership and there is forward momentum. However, a change in government or unforeseen budget issues could cause this pathology reform effort to be sidelined before it is fully implemented.

Recommendations from UK Pathology Quality Review

BELOW ARE LISTED THE MAJOR RECOMMENDATIONS of the “Pathology Quality Assessment Review” done for the National Health Service in the United Kingdom and published last week. (For entire report: http://goo.gl/GGsN6i)

  • Systematically train pathology staff in skills of quality management systems and quality improvement methodology.
  • Expand membership role and function of Joint Working Group for Quality Assessment in Pathology (JWGQA) of the Royal College of Pathology, and work with the United Kingdom Accreditation Service (UKAS) to implement changes in the accreditation process and publication of performance data [of participating laboratories].
  • Assessment of individual’s performance in external quality assurance (EQA) schemes.
  • Integrate quality and governance systems of pathology providers with that of the trusts. To include regular publication of quality performance and key assurance indicators (KAIs). Lab providers to refer samples for testing to third-party services.
  • Improved adherence to existing guidance on the standardization and transparent reporting of errors from pathology services, including reporting of all incidents that could have, or did lead to patient harm.
  • Improved pathology informatics to remain a priority. Professional bodies, IVD manufacturers, and others should work to minimize the differences between analytical processes, requesting, and reporting.
  • Update accreditation of pathology services to clearly show which laboratories meet minimum requirements, and which are excelling to provide first-rate service quality.

 

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