Quality and Governance

Most tests offered by our services are accredited by UK Accreditation Service (UKAS) against ISO15189. Work conducted under accreditation shall be reported in a clear and unambiguous way. It is a mandatory requirement for an accredited laboratory to clearly reference UKAS accreditation on all reports that include accredited results, either by use of the appropriate symbol or statement.

When reports incorporating reference to UKAS accreditation contain results from non-accredited tests, the non-accredited work shall be clearly identified as ‘Not UKAS accredited’.

• Chemical Pathology - 8692
• Immunology - 8634
• Haematology Department, (Haematology and Blood Transfusion, SIHMDS) - 8623
• Histopathology - 8661
• Microbiology & Virology - 8675

Our services conform to all the legal and statutory regulatory requirements of the Human Tissue Act (HTA), JACIE and MHRA.

The laboratories subscribe to national and international quality assurance schemes for all assays where available. The laboratory validates and verifies all tests prior to implementation and incorporates internal quality control measures within its procedures.

To fulfil the requirements of ISO15189 in relation to referral laboratories we have made the relevant information available within on this webpage. We have a contract with you, if we are sent the appropriate sample and accompanying request form. We will follow all our internal processes to report results in a timely manner.

Laboratory Medicine follows both the Great Ormond Street Hospital for Children NHS Foundation Trust Consent policy (Shared Decision Making in Healthcare and Research) and the local Laboratory Medicine Consent Policy.

The laboratory is not in direct contact with most patients. It is therefore accepted practice that the referring clinician is responsible for obtaining consent for testing and possible storage of patient material. The patient presenting to the point of sample collection or providing a sample themselves to the laboratory implies consent.

Where informed consent is required before testing, the laboratory will provide a form to be completed by patients.

Medical laboratories are responsible for ensuring that test results are fit for clinical application by defining analytical performance goals and selecting appropriate measurement procedures. All types of measurement have some inaccuracy due to bias and imprecision; therefore, measurement results can only be estimates of the values of the quantities being measured.

To properly use such results, medical laboratories and their clinical users need some knowledge of the accuracy of such estimates. The complete result of a measurement is a value, a unit, and an estimate of uncertainty. This estimate of uncertainty is conventionally referred to as Measurement Uncertainty (MU) and incorporates the cumulative range of factors involved in the testing procedure itself in addition to consideration of the inter-individual and intra-individual biological variation which will potentially influence the overall test result.

Evaluating measurement uncertainty is an ISO 15189 accreditation requirement. Measurement Uncertainty, which has been estimated for each assay during the verification/validation procedure, is reviewed at regular intervals to ensure that Measurement Uncertainty values do not exceed the pre-defined maximum allowable uncertainty for each assay. Overall assay performance is also regularly monitored through internal quality control (IQC) and external quality assessment (EQA) schemes and incorporated in test result interpretation. Measurement Uncertainty for individual assays is available upon request.

Laboratory Medicine follows both the Great Ormond Street Hospital for Children NHS Foundation Trust Consent policy (Shared Decision Making in Healthcare and Research) and the local Laboratory Medicine Consent Policy.

The laboratory is not in direct contact with most patients. It is therefore accepted practice that the referring clinician is responsible for obtaining consent for testing and possible storage of patient material. The patient presenting to the point of sample collection or providing a sample themselves to the laboratory implies consent.

Where informed consent is required before testing, the laboratory will provide a form to be completed by patients.

We are committed to providing an excellent service, and to improving our services by listening and responding to the views of our users. Whether clinician or patient, if our service levels do not meet your expectations and you would like to complain, please find out how to make a complaint at GOSH.

Details of the complaint will be treated as confidential, and the information you provide will link into our management procedures for incident investigation. Corrective and preventative actions will be introduced where needed. Any complaints received will be shared and discussed at all levels within the service where appropriate.

For information about how your data personal data is collected, used and stored please including your rights, please read the GOSH privacy policy.