Independent review proposes an upgrade of pathology safety checks to improve patient outcomes

A need for transparency, better safety checks on testing, consistency and standardisation of processes and procedures are some of the recommendations made to NHS England in a review into pathology services.

Professor Sir Bruce Keogh, Medical Director of NHS England commissioned Dr Ian Barnes, chair of NHS England’s Pathology Quality Assurance Review Board, to strengthen and refine the quality assurance process for pathology services in England and to make the process more transparent.  His request for a detailed and thorough review was prompted by reports of inadequate assurance processes at Sherwood Forest Hospitals NHS Foundation Trust, which subsequently resulted in inappropriate care for a number of women with breast cancer.

NHS Pathology services respond to roughly 200 million requests a year, representing involvement in around 80% of patient interactions with the NHS.  Testing is at the heart of patient pathways and fundamentally informs diagnosis and treatment, with the potential to contribute significantly to better patient outcomes. The demand for tests is rising as the NHS continues to understand the contribution that pathology can make to better patient outcomes and longer lives.

Patients and clinicians have high levels of confidence in the current services.  This confidence isn’t without foundation: the UK has been at the forefront of quality assurance for the past 50 years, leading the way on external quality assurance.  For example, along with Holland, the UK was the first European country to introduce a laboratory accreditation scheme for pathology.

However the review has highlighted a need for quality assurance systems to be updated, as gaps exist.  The current system was fit for the purpose for which it was designed, but less so for the future, and it doesn’t meet the emerging need for transparency and well-evidenced quality assurance. The Barnes report recognises that NHS pathology services operate to a good standard; however, it acknowledges that the current system is focused on minimal acceptable standards, providing little in the way of sanctions when laboratory performance falls below these.  It accepts that elements of the service have become outdated and quality needs to be scrutinised, enhanced and made transparent.  Dr Barnes recommends:-

  •  NHS England facilitate a new Oversight Group to keep a high-level view of quality in pathology in the NHS, help open up quality data to support transparency, and to oversee the implementation of the recommendations.
  • Skills in quality management and improvement are updated through continual training, as well as training in new developments.
  • Roles and responsibilities for maintaining and improving quality should be formalised, and testing and reporting methods be standardised.
  • A culture developed where any errors made, are done so in an environment primed to detect and correct them, seeking constantly to improve clinical and working practices through continuous learning, sharing and innovation.
  • Transparency within the quality assurance framework should be introduced allowing doctors and patients to clearly see how well the laboratory processing their test is performing.
  • A sharper focus on strengthening existing structures should be developed, rather than introducing new layers of management, and that these practices should be embedded in provider governance and assurance framework.
  • Commissioners take a more active approach to managing contracts with their pathology providers, to ensure that they are of high enough quality to serve and protect patients and offer value for money consistently across the country
  • Laboratory processes should be harmonised so that patients can be confident about the consistency of their test results, especially as they start to gain access to their personal health records that may contain reports from different pathology services

The review has gone further than making recommendations.  It’s secured the support of the United Kingdom Accreditation Service as well as an agreement from the Royal College of Pathologists to refresh membership of a special working group which oversees external quality assurance programmes.  It’s obtained an agreement from Health Education England, the National Clinical Director for pathology and the Chief Scientific officer at NHS England for the development of changes to training plans. As well as this, NHS England will facilitate an oversight group to ensure that key players can maintain a high level view of quality assurance in pathology, ensuring that the recommendations Dr Barnes has made are put into practice.

Dr Ian Barnes, NHS England’s Chair of the Pathology Quality Assurance Review Board said; “Patient safety is paramount and is an essential part of everything the NHS does. It’s important that when mistakes are made like those in the testing of cancer patients at Sherwood Forest Foundation Trust that systems are reviewed and scrutinised for the benefit of patients and the public.  Stringent assurance processes need to be in place to ensure testing is robust and of the highest standard to maintain the confidence of patients and medical staff alike.  What I’ve offered through my recommendations is a way to improve structures, process and governance, with the aim of improving patient outcomes.  In this report, I’ve not only made recommendations but have gone further by securing the cooperation of bodies such as the RCPath and others that lead the pathology community to roll out some of the recommendations as soon as possible.

“Taken together, this is an action plan to make improvements to quality assurance from the level of the individual patient, all the way up through the system to the highest national structures.  Patients and medical staff will benefit from a reduction in errors and the system can be confident that test results mean the same thing irrespective of where they were performed. ”

Prof Sir Bruce Keogh, Medical Director of NHS England said, “Our NHS has a good pathology service but occasionally things go wrong and when they do we must learn and respond. This report describes the ambition, determination and consensus of the scientists, doctors and technicians providing these services to reduce the risk of error and set the international benchmark for reliability and excellence.”


  1. Julie Ryan says:

    As a quality manager I find the report interesting and it raises some points we ourselves have been raising for a number of years so this is the positive, and although I believe Pathology Departments will welcome this, I am not certain the recommendations will be supported by hospital Trusts particularly in relation to resourcing the recommendations within their own departments. I was also dissapointed that the Chartered Quality Institute does not seem to have been consulted or included in any of this. The recommendation regarding Quality Assurance training and devising appropriate programmes and education would have been good to have linked in with the CQI and the IBMS Quality Management course.

  2. Phil Bullock says:

    The concept that Commissioners should engage more with the pathology quality agenda is an interesting one given that they do not have expertise in this area and that they are continually subjected to reorganisation which inevitably diverts focus.

    It is also my perception that accreditation is likely to become less transparent to them under ISO 15189 as unlike CPA under which the whole laboratory service repertoire is assessed and accredited in one go under UKAS ISO15189 the laboratory can either chose not to submit all of its repertoire or – if it does submit it all but UKAS does not offer accreditation for the total service – have accreditation for some services but not others.

  3. Rashmi Rook says:

    Excellent report- thank you

    It is promising to see the focus on developing a culture of transparency with error management as it always should be- a means to detect, correct, prevent harm and improve, not blame.

    Would have been good to include the specific use of Lean Six Sigma / Kaizen methodology to help with rapid and continuous improvements, as I think these systems are not widely understood in many labs, and even some resistance to learn these techniques to help with improvements.

    Maybe this report will help standardise practices especially if the regulators/ accreditation agencies inspect to the same depth (MHRA / GMP standards would be best- tough but meaningful!).

  4. warwick davis says:

    A good start would be o standardise the accreditation process with one overseeign body instead of the CPA, MHRA, HTA, CQC, QARC etc all with slightly different standards, different inspection routines and different interpretations. The financial savings would also be significant.