N.D.D.H. Pathology provides a complex, specialist diagnostic service and we pride ourselves on compliance with a number of organisations which we must achieve and maintain standards both in the way our services are run and the technical quality assurance of the results and reports we issue. Below is a description of some of the things we do to ensure we provide a quality diagnostic service to users.
(i) ISO 15189 Accreditation by the United Kingdom Accreditation Service (UKAS)
The Pathology Service at the North Devon District Hospital has been granted accreditation by UKAS to ISO 15189, ‘Medical Laboratories – Requirements for Quality and Competence.’ This award replaces the previous CPA accreditation which expired at the end of March 2018.
Our schedule of accredited tests can be found on the UKAS website. Enter our UKAS number (9100) into the search box to access the schedule. However, this schedule should be viewed in tandem with the list of non-accredited tests, below.
With UKAS accreditation, individual laboratory tests are accredited, rather than the overall laboratory service. As a result of this and due to continuing quality improvements in Pathology, where equipment and tests methods are changed for example, there are some tests that are waiting for assessment by UKAS. See below for a list of the tests that are currently not accredited (waiting for assessment).
Biochemistry – All automated biochemistry tests. E.g. general biochemistry such as U/E, LFT, CRP, TROP etc. and immuno assay tests such as TFT, B12, Feratin, folate, PSA, LH etc., (due to the implementation of new auto analysers on 15/03/18).
Haematology & Blood Transfusion – CD4 count and Fetal maternal-haemorrhage (Kleihauer test).
Microbiology – Trichomonas Vaginalis*+, Influenza A, Influenza B, RSV, Norovirus, confirmatory Gonorrhea (GC) test, MRSA, HSV.
Cellular Pathology – Myoglobin antibody stain*, Phloxine Tatrazine special stain*.
Unaccredited tests have not been independently assessed by our accreditation body (UKAS) for compliance to ISO 15189. However they are subject to internal quality control procedures and are registered with External Quality Assurance (EQA) schemes or equivalent to provide assurance of quality for all users.
UKAS are scheduled to assess the laboratory’s current scope of accredited tests as well as the majority of unaccredited tests on various dates in September, October and November 2018.
*These tests are not in our scope of accredited tests and there are no plans to include them in the future.
+ There is no internal quality control available for this test and it is not included in an EQA scheme, however it is part of the laboratory’s Internal Quality Assurance programme.
(ii) The Medicines and Healthcare products Regulatory Agency (MHRA)
The N.D.D.H. Blood Transfusion Laboratory was last assessed by the MHRA in July 2007 and holds a current letter of compliance from the MHRA.
The MHRA is responsible for regulating and assessing and hospital blood banks and the transfusion laboratories in which they are situated. Statutory Instrument 2005 No. 50 and its Amendment (SI 2005/2898) about blood safety and quality became effective from 8 November 2005.
The Regulations set the standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components. The Regulations do not require routine inspection of blood banks. However, inspections of blood banks “for cause” may be carried out by the MHRA. Blood banks or blood establishments that are operating as blood banks are required to submit an annual return to the department setting out how they comply with the requirements of the Regulations.
(iii) The Human Tissue Authority (HTA)
The HTA last inspected the N.D.D.H. Mortuary and associated Cellular Pathology services in February 2011, and these departments are currently licenced for the activities for which they undertake.
HTA inspections are conducted based on the findings from an annual, desk based assessment and any other relevant information. The focus during a site visit inspection is on reviewing operational policies and procedures, inspection of premises, scrutiny of practices which involves review of documentation, and in some cases interviews with a range of staff at the establishment.
|Quality Related Policies and Information|
|Pathology Quality Policy|
|Protection of Personal Information|
Internal Quality Control (IQC): All tests performed in our labs are regularly checked against IQC material of known values. This allows us to ensure that the accuracy, precision and quality of results is maintained 24/7, as we only report patient results if the IQC values are within acceptable ranges.
External Quality Control: Samples are regularly received from external quality assurance schemes, analysed in our labs and the results are returned for marking against known values and comparison with other laboratories. One such organisation which provides this service is UK NEQAS.
Since 1969 the United Kingdom National External Quality Assessment Service (UK NEQAS) has been providing a comprehensive world-wide service that enables laboratories to fulfil quality goals and facilitate optimal patient care. UK NEQAS comprises a network of 144 testing schemes operating from 24 centres based at major hospitals, research institutions and universities throughout the UK. The services cover qualitative and interpretative investigations in andrology, cellular pathology, clinical chemistry, genetics, haematology, immunology and microbiology. Each is directed by experts in their field, with support and advice from Steering Committees.
There is a system of regular reviews of quality through scheduled audits. All grades of pathology staff are encouraed to participate in the audit process, which usually involes examining all the stages of processing a patients specimen – from start to finish, as well Quality Management System specific audits such as document control compliance and equipment records for example.
Non-compliances found as a result of the audit process are investigated and the responsibility for remedial action determined. Remedial action is implemented against an agreed timescale and monitoring the effectiveness of the action taken. Non-compliances will we investigated for a root cause and where appropriate, action will be taken to remove the root cause, therefore preventing a recurrence.
Measurement Uncertainty (MU)
Despite all the safeguards and assurances described above, there will always be factors which could introduce an element of uncertainty to a pathology result.
Within the laboratory, once we receive a specimen, we aim to eliminate or reduce to a minimum the levels of uncertainty for the results that are issued. However, there are many stages in the patient pathway over which we do not have direct control, (click link to show diagram 1 below), all of which may introduce a level of uncertainty to a result.
In areas where uncertanty could be introduced, the Pathology Department offers advice on how to minimise or eliminate it. Please contact us if you wish to ask advice or discuss this in more depth.
For each test process where there is a measurement step, the laboratory has determined the MU values for those steps. These values are available upon request to the Pathology Quality Manager.
Inspection of Quality Improvement & Evaluation Records
Records of any of the following quality improvement & evaluation processes are available to view upon request by making an appointment to visit the laboratory.
- Assessment of user satisfaction and complaints
- Pathology Management Review
- Internal audit of quality management system
- Internal audit of examination processes
- External quality assessment
- Reports from external assessment bodies
- Quality improvement, including corrective and preventive action and the monitoring of quality indicators
- Identification and control of nonconformities
Should you wish to view any of these records, please contact the Pathology Quality Manager on 01271 335758 to make an appointment.
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