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Following the suspension of the Immensa Covid testing laboratory in Wolverhampton, the Institute of Biomedical Science (IBMS) reiterates the necessity for registered staff and laboratory accreditation in ensuring that mass testing centres deliver the correct results.
As the professional body for scientists, support staff and students in the field of biomedical science, the IBMS expects any laboratory carrying out Covid testing to be accredited by the UK Accreditation Service (UKAS). Additionally, there must be appropriate numbers of Health and Care Professions Council (HCPC)-registered biomedical or clinical scientists available to supervise and deliver services during all hours that a laboratory is operating. In the case of a mass testing centre like Immensa’s, this means 24 hours a day, 7 days a week.
The errors that occurred in Wolverhampton were avoidable. They affect the public’s confidence in healthcare testing services and leave patients believing their test results lack importance, leading to the diagnostics workforce feeling undermined. The IBMS highlights that these professional biomedical science staff continuously put patient safety first and have risen to the occasion throughout the pandemic to uphold the highest standard of practice.
To avoid further risk to the lives of patients and to get the correct result the first time, it is vital that mass testing centres doing Covid testing meet the same minimum requirements as other diagnostic laboratory services in the UK; this position statement aims to offer advice towards this goal.
UKAS accreditation is a rigorous process of investigation which assesses medical laboratories to an internationally recognised standard (ISO15189) and outlines the minimum requirements for quality and competency. To gain accreditation, every process within a laboratory has to be carefully documented so that there is evidence that each procedure is being carried out in the correct way.
Having samples handled by a non-accredited laboratory can be a risk to patient safety and public health.
The IBMS expects any laboratory service providing Covid testing to gain UKAS accreditation and actively maintain ISO15189 standards.
Highly skilled and HCPC-registered
Biomedical Scientists are highly qualified, trained professionals who are held to rigorous standards of practice. Individual practitioners must be registered with the Health and Care Professions Council (HCPC), whose main remit is to protect patients.
Anyone who wants to practice as a Biomedical Scientist in the UK must hold an IBMS accredited degree in Biomedical Science (or equivalent) and then complete an IBMS registration training portfolio in an approved training laboratory before they can apply for entry onto the HCPC register.
All laboratory samples (blood, urine, faeces, tissue, etc.) are processed and handled with care because each represents a patient. Patient care and patient safety are at the forefront of everything that biomedical scientists and all other laboratory staff do; this is why HCPC registration is so important.
In addition to HCPC registration, many biomedical scientists have IBMS specialist/higher professional qualifications or postgraduate degrees to meet the complex requirements of their roles. A highly skilled and regulated workforce is necessary to ensure quality of testing and laboratory practice.
Assessment of quality assurance, training and staff competency are key components of the UKAS accreditation process. Accredited hospital diagnostic laboratories take quality very seriously, employing quality officers in each laboratory section; some pathology departments also have a designated quality manager who are usually HCPC registered biomedical scientists.
Senior laboratory management would take it extremely seriously if even one false negative was sent out to a patient, let alone 43,000. It is disheartening for qualified registered biomedical scientists in accredited laboratories to hear of such a lapse in quality assurance; as it reflects poorly on the high standards of their profession.
Biomedical scientists are working to make sure that Covid testing is done to the highest standards and at the required numbers to meet government targets, all while ensuring results are sent out in good time. For any laboratory to process at a consistently high standard, there must be an emphasis on quality assurance.
The previous points on UKAS accreditation, having HCPC registered staff and maintaining quality assurance parallel the current operating standards of diagnostics laboratories across the UK. If the application of these standards are not feasible for Covid mass testing centres, the IBMS advises that these testing centres should be absorbed into a local NHS laboratory diagnostic service network for management and quality assurance.
Now that we are nearly two years into the pandemic, the IBMS believes that the NHS diagnostic services can begin increasing testing capacity to absorb the work of some Covid mass testing centres in the long term. It is also important that Covid mass testing sites remain ‘single’ test laboratories and should not be allowed to increase their test repertoire.
To ensure that quality and consistency in testing is met, mass testing laboratories should remain under regular review.
Lastly, the IBMS offers the Government our expertise in quality assurance, sample handling and training to professional standards, in any future planning and consultation around mass testing centres.
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