Quality

The Laboratories uphold the principles of continuous improvement to all of its services with the patient at the heart of all practices. There are comprehensive and robust Quality Management Systems in place to underpin this principle and to ensure the highest possible standards of performance excellence are achieved and they are tested by regular internal audit programmes, assessment by external accreditation organisations and quality peer proficiency review (External Quality Assurance) provided by accredited schemes where possible. There are written policies and standard operating procedures that guide practices and these are subject to regular review by competent and qualified practitioners to ensure consistency of approach and validity of process. Tests performed are subjected to regular validation and verification process to ensure that they continue to meet the expectations of our service users and customers are surveyed periodically to gauge satisfaction and allow corrective actions to be formulated where we fail to meet requirements.

The Laboratory Quality Management Systems are founded on:

• Robust organisational structure
• Strong and decisive leadership, management and review
• Vision and direction
• Recruitment of highly motivated and competent practitioners at all levels
• Strong investment in training and education
• Investment in high quality materials and equipment and supplier qualification
• Service level agreements and market recall
• Inventory management
• Service user engagement and responsiveness to their needs and concerns
• Proficiency testing
• Efficient and effective working practices and protocol
• A culture of continuous learning and quality improvement
• Process development, validation, verification and change control
• Annual review, document control and robust retention, storage and retrieval processes
• Information Technology investment and management
• Incident and nonconformity identification, investigation, analysis, categorisation and effective management

The laboratories, following the Royal College of Pathology guidelines, use Key Performance Indicators (KPI's) to gauge the effectiveness and quality of the services provided. The guidelines are used as the acceptable baseline and the laboratories aim to ensure that their standards are maintained at the highest possible levels above this. Although not exhaustive the key indicators broadly cover the following elements:

• Availability of documentation and accompanying clinical advice in the end to end service process.
• Quality of end to end service and clinical advice
• Timeliness of testing and reporting linked to the required level of patient care (turnaround times)  User engagement and satisfaction
• Teaching, training, education
• Proficiency testing
• Trending of Incidents and Non-Conformances (informtion available on request)

These general categories are broken down into measurable sub elements that are regularly reviewed by the laboratory management teams and corrective and remedial actions are implemented where nonconformities are identified, as an integral part of the overall quality improvement process.

The laboratories are committed to continual quality improvement programmes and promoting a free thinking environment amongst its workforce to ensure innovation and high performance are at the forefront of our services and the patients and service users benefit from the processes. User engagement and feedback sets the benchmark for quality maintenance and improvement and we welcome all approaches made.

The laboratories run control materials with known acceptability of control results is a prerequisite to subsequent patient sample testing and the validity of the results. Performance is carefully monitored and unacceptable trends are quickly identified and corrective actions implemented prior to patient testing. The laboratories are registered with external proficiency testing schemes (External Quality Assurance schemes) or utilise confidential exchange processes with other institutions for all tests performed. This independent assessment of quality provides peer assurances of ongoing accuracy and precision in the testing process.

All departments are now accredited to the ISO15189:2022 standards for Medical laboratories. On-site assessments occur annually to ensure ongoing compliance. Conformance to these standards and ongoing accreditation remains the prime quality objective and provides reassurance to service users of our ongoing commitment to attaining the highest levels of service quality. The scopes are available via the UKAS website:

• Cellular Pathology & Mortuary -UKAS accredited testing laboratory No.9717
• Clinical Biochemistry, Haematology & Transfusion -UKAS accredited testing laboratory No.8666
• Microbiology & Serology. -UKAS accredited testing laboratory No.9341

The laboratories comply with all legislative requirements for practice and are assessed appropriately by external bodies such as the Human Tissue Authority (HTA), Medicines and Health Regulatory Agency (MHRA) and the Home Office for evidence of conformity

Confidentiality of information is a core value and the laboratories have a number of local policies that supplement the Trust direction and embrace the stipulations of the GDPR, to ensure that this requirement is upheld at all times.

All data and information acquired while providing the services of the laboratory is handled in strict accordance with the Trust Confideniality Policy. This ensures data is managed in compliance with all relevant legal obligations, standards and guidelines and professional codes of conduct.

Pathology laboratories are bound by privacy laws regarding the use and release of personal information. This means pathology test results can only be released to health practitioners directly involved in the person's care. Other potentially interested parties, including family members, cannot access pathology test results without the consent of the person who had the pathology test.

There are circumstances where pathology laboratories are required to release pathology test results to a third party such as:

• when they are ordered by a court to do so
• when they are required by law to send results of newly diagnosed cancers to Cancer Registries in each State or Territory, or report notifiable diseases, such as measles, to the relevant health authority

Please note: The Pathology service does not offer results directly to patients. Patients are advised to contact the clinician responsible for their care to obtain their results.

Reference ranges and critical values are assessed regularly by qualified laboratory clinical and scientific practitioners to ensure that they remain current and appropriate to the test repertoire. The laboratory will update the details on the website as required and will notify service users of changes. There will be a regular review and update of service user contact details by the laboratory to facilitate the accurate and timely notification of value changes.

This is at the heart of laboratory practice and sample acceptance, rejection and correct labelling is of paramount importance to the analytical process. The majority of errors in testing occur at the pre-analytical stage at the point where the samples are taken and labelled. In order for the laboratory to uphold its commitment to producing high quality test results and returning them to service users in a timely manner, the latter must ensure that a valid and correctly labelled sample is provided. The laboratories have produced a number of policies (see below) to guide service users in the provision of a valid sample and these are available on the Trust website. Policies:

• Sample Acceptance and Rejection Policy (available on the handbook)
• Patient Identification- Policy for the correct identification of patients (available on Trust intranet)
• Specimen Transport Policy (available on handbook)

Maintaining and developing our test repertoire is another laboratory core value and ensuring that our tests and reporting are of the highest standard and continue to meet the needs of service users is fundamental to our practices. To this end our test portfolio is subjected to regular review by qualified and competent clinical and scientific practitioners in order to maintain, develop and implement improved practices in the analytical process. We seek to streamline processes where possible and ensure full validation and verification of methodology and technology occurs regularly. Although not exhaustive the tools used include:

• Accuracy
• Precision
• Sensitivity
• Specificity and interferences
• Linearity of measurement
• Stability of samples/specimens
• Comparative evaluation
• Reference intervals (Ranges)
• Reportable ranges
• Limitations of performance
• Clinical interpretation and advice
• Standardisation of testing between instruments and testing sites.

We are committed to providing high quality results in a timely manner to provide rapid diagnostic support for the clinical management of patients. Turnaround time monitoring is undertaken by regular audit and is integral to laboratory practice.

Patient record retention conforms to national requirements and in accordance with Caldicott principles and General Data Protection Regulation (GDPR). The duration of retention varies regarding the subject matter and full details the times involved can be obtained directly from the laboratories.

The laboratories have robust plans to ensure business continuity in the event local or wider scope failures that could impact on services provided. The contingency plans are designed to minimise impacts on laboratory services and practices and to ensure that patient care is not compromised.

County Durham and Darlington Pathology services Management, Staff and Sub-contractors fully understand the importance of impartiality in undertaking its Laboratory activities. Pathology services will therefore ensure that, in all its dealings with customers or potential customers all employees or other personnel are and will remain impartial.