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Quality Assurance

East Suffolk and North Essex Foundation Trust (ESNEFT) Pathology Services are dedicated to providing high quality clinical and diagnostic services to doctors and clinicians who use its services.

This is demonstrated by the laboratories having already attained or working towards the U.K. Accreditation Service (UKAS) internationally recognised ISO 15189 Medical Laboratories: Requirements for Quality and Competence standard. This standard is underpinned by the ISO 17025 and ISO 9001 standards but is particular to medical laboratories. ESNEFT Pathology Services use the ISO15189 standard as a basis on how it functions across managerial and technical areas. Attainment of this accreditation demonstrates that a laboratory can consistently deliver valid test results.

Additionally, ESNEFT Blood Transfusion services also operate according to the Medicines and Healthcare Products Regulatory Agency (MHRA) Regulations to ensure that blood transfusion services meet applicable standards of safety, quality and efficacy. The MHRA consults with the Blood Consultative Committee which provides national advice on regulation of blood establishments through the Blood Safety and Quality Regulations (BSQR).

Additionally, ESNEFT Cellular Pathology services also operate according to the Human Tissue Authority (HTA) Codes or Practice and Standards, in particular Code A which guides the principles of consent to removal and storage of human tissue. This code of practice is enabled by close co-operation with the hospital mortuary & bereavement services.

ESNEFT Pathology Services also adhere to strict clinical laboratory safety standards issued by the Health and Safety Executive (HSE).

ESNEFT Pathology Services also provide educational and scientific professional development for its staff to ensure the highest ethical standards are maintained. ESNEFT Biomedical scientists performing patient sample analysis are regulated by the Health Care Professions Council (HCPC) which governs their conduct, performance, ethics and proficiency standards.

Many of our staff are supported by and are members of the Institute of Biomedical Science (IBMS) which is dedicated to the promotion, development and delivery of excellence in biomedical science and/or the Royal College of Pathologists (RcPath) concerned with all matters relating to the science and practice of pathology and oversees the training of pathologists and scientists working in 17 different specialties, which include cellular pathology, haematology, clinical biochemistry and medical microbiology.

Pathologists working in ESNEFT laboratories may work directly with patients in hospitals and the community. They are involved in the majority of all diagnoses, as well as playing an important role in disease prevention, treatment and monitoring.

Commitment to all of these overarching standards, guidance and regulation is evidenced in the ESNEFT Quality Policy 2019

ESNEFT Pathology Services laboratories are essential to the care of patients and are required to be available to meet both the patient’s needs as well as the needs of the clinical professionals responsible for patient care. All ESNEFT laboratory services are inclusive of:

  • Test Requesting
  • Preparing Patient’s for Tests (where applicable)
  • Identification of Patient Samples
  • Sample Collection Methods
  • Sample transportation
  • Sample Storage
  • Sample Processing
  • Sample analysis / examination
  • Interpretation of test results
  • Reporting of test results
  • Providing Advice for Test Results

Sample results generated through the above processes within ESNEFT laboratories are subjected to strict internal and external quality control procedures and inspection programmes as laid out in overarching standards and regulation.

Internal Quality Assurance (IQA):

IQA is guaranteed by strict adherence to standard operating procedures for all processes before sample analysis, during sample analysis and after sample analysis.

ESNEFT Pathology Services continually audit & inspect their own systems and processes following a programmed schedule of audits in order to provide confidence in the results that are generated. This also ensures that systems and processes are subject to continual improvement.

ESNEFT Pathology Services continually report, investigate and monitor incidents & complaints in order to identify trends helping to target improvements in particular areas of the services.

Internal Quality Control (IQC):

ESNEFT Pathology Services laboratories adhere to a comprehensive IQC programme which provides a continuous evaluation of the reliability of daily sample testing by the laboratories. IQC is specific to the sample types being analysed and is measured in order to reduce variance or deviation from the stated acceptance criteria for a test. IQC monitoring frequency is in line with the volumes of particular tests being analysed and can be as frequent as every 4 hours in our largest Biochemistry Laboratory.

External Quality Assurance (EQA):

ESNEFT Pathology Services participates in recognised National External Quality Assessment Schemes; these schemes are subscribed to by NHS and private laboratories and provide a means to assess ESNEFT Pathology Services against peers. External scheme organisers provide samples sourced outside of the laboratory that all laboratories that subscribe to the scheme receive and test under their own laboratory protocols and conditions. These are assessed and scored by external assessors and the laboratory score is able to be assessed against the national averages. ESNEFT Pathology Services continually monitor EQA performance and implement improvements to tests if and when any poor performance is identified.

Accreditation Status of Each Laboratory:

ACCREDITED / COMPLIANT

Biochemistry Ipswich Accredited

Cellular Pathology Ipswich Accredited

Haematology Ipswich Accreditation reinstated 20.5.2020 – no certificate issued yet

Blood Transfusion Ipswich Compliant with BSQR

 

WORKING TOWARDS ACCREDITATION

Cellular Pathology West Suffolk: Accreditation withdrawn following UKAS assessment 2019. Findings to be completed before reapplication.

Blood Transfusion Colchester Annual compliance report submitted April 2020. Action plan in progress

Blood Transfusion West Suffolk Annual compliance report submitted April 2020. Action plan in progress

Biochemistry Colchester: Anticipate submission of ISO 15189 application Summer 2020

Cellular Pathology Colchester: Anticipate submission of ISO 15189 application Autumn 2020

Biochemistry West Suffolk: Anticipate submission of ISO 15189 application Spring 2021

Haematology West Suffolk: Anticipate submission of ISO 15189 application Spring 2021

Haematology Colchester: Anticipate submission of ISO 15189 application Winter 2021

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