Pathology UKAS accreditation

The United Kingdom Accreditation Service (UKAS) provides international assessment of pathology departments adherence to the quality standards described in ISO 15189.

This involves comprehensive assessment that the department adheres to the ISO 15189 standards. These standards assess the full range of the service provided by the Pathology pre/post-analytical, analytical, quality management system and advisory services provided by UHDB.

 

Services from Derby within UHDB of the UKAS accreditation service

  • Andrology
  • Phlebotomy
  • Biochemistry
  • Haematology
  • Immunology
  • Microbiology
  • Serology
  • Cellular Pathology
  • Cytology
  • Consultant lead clinical advisory services for all disciplines

 

Services not currently within the scope of UKAS accreditation service

  • Point-of-care testing
  • Microbiology based at QHB
  • Chemistry based at QHB
  • Haematology based at QHB

 

Assays not currently within the scope of UKAS accreditation service

Haematology

  • FBC performed on Sysmex XN550 analyser (located in satellite lab on ward CDU)
  • Ascitic Fluid cell counts
  • Aquios CD4, CD19, Lymphocyte subsets
  • CSF cytospins
  • APTT Mixing studies
  • PT Mixing studies
  • Platelet Function Analysis
  • FVIII Inhibitor assay using chromogenic FVIII (bovine) assay 

 

During on-going service/assay improvements there maybe occasions when methods used to measure  tests listed on the UKAS website have changed and are awaiting re-assessment by UKAS, before being included in the schedule. These exceptions will be listed below. If a test is not listed in the UKAS website or is displayed below it is not UKAS accredited.

For more information contact Mariska Faint-Uffen, the pathology quality manager. Email: mariska.faint-uffen1@nhs.net

 

Assays awaiting assessment, not UKAS accredited:

  • Vitality assessment
  • Retrograde Urine analysis


Biochemistry:

  • Vitamin A&E


Histology

Validated and awaiting UKAS assessment:

  • Adipophilin - new test;
  • BSAP - new test;
  • CAIX  - new test;
  • SATB2 - new test;
  • MSH2  - change of testing platform;
  • MSH6 - change of testing platform;
  • MLH1 - change of testing platform;
  • PMS2 - change of testing platform;
  • CD10 - change of supplier;
  • PLAP - change of supplier;
  • P16 - change of supplier

Commercially available as research use only, but validated internally and UKAS assessed:

  • Ca19.9;
  • Pan-Cytokeratin


Microbiology:

  • SARS-CoV-2 PCR 
  • EUCAST antimicrobial susceptibility 

 

Service not currently within the scope of UKAS accreditation service as awaiting re-assessment

Until recently we were accredited to UKAS 15189 for the following tests. Following an equipment upgrade, some of the analysis is now performed on new analysers from our existing supplier, which we have verified internally and are now awaiting accreditation approval by UKAS.


Biochemistry

  • Placental growth
  • Procalcitonin
  • Soluble fms-likw tyrosine kinase-1 (sFlt-1)
     

Patient consent and data protection

The Pathology department relies on the requesting clinician to meet the requirements for patient consent for any pathology investigations. Therefore, we will presume consent to have been given if patient attends for blood test (presents arm) or delivers a sample to the laboratory with a suitably completed request form. Under the human tissue act 2004 informed written patient consent is required for all solid tissue samples submitted to histopathology, genetic testing and for the storage of relevant material from deceased patients. If appropriate, the consent should always include reference to its retention for further diagnostic or therapeutic purposes.

Pathology samples from living patients may be stored, unless opted out, for the following purposes; Audit, education and training, performance assessment, quality assurance and anonymised research.

Patients should also be aware that their personal information (and family information where relevant, e.g. genetic testing) will be provided with all samples sent to the Pathology laboratory. All patient information and results are treated as confidential and will be stored securely with restricted access to Pathology staff to ensure compliance with the Data Protection Act 1998.