Quality manual

4.14 Evaluation and Audits

4.14.1 General
The Department of Pathology implements QP-GEN-0002 Evaluation and Audits:

1. 
   To verify that the pre-examination, examination and post-examination and supporting processes are being conducted in a manner that meets the needs and requirements of the users.
   

2. 
   To ensure conformity to the quality management system
   

3. 
   To continually improve the effectiveness of the quality management system
   

In order to emphasise areas critically important to patient care, vertical audits of Haemovigilance activities and Traceability are carried out on an on-going basis by tracking blood and/or blood products from receipt to transfusion as per HP-GEN-0007 Operation and Function of Haemovigilance Role.

The Internal Audit Schedule is prepared by the Quality Co-ordinator and indicates the area to be audited, the month the audit is to take place, the auditor assigned.
All elements of the Quality Management System are subject to internal audit once every twelve months.
4.14.2 Periodic Review of Requests and Suitability of Procedures and Sample Requirements
Audits are performed by designated personnel who have undergone auditor training. Where possible, personnel do not audit their own activities. Auditors review the examinations provided by the laboratory to ensure that they are clinically appropriate for the requests received.
The laboratory reviews periodically sample volume, collection device and preservative requirements for blood, urine, other body fluids, tissue and other sample types, as appropriate, to ensure that neither insufficient nor excessive amounts of sample are collected and the sample is properly collected to preserve the measurand. This is described in QP-GEN-0004 Continual Improvement. The review is completed in each laboratory using the audit QF-GEN-0064 Review of Examinations Provided by the Laboratory
4.14.3 Assessment of User Feedback
There is a procedure in place to describe how assessment of user feedback is managed QP-GEN-0001 User Satisfaction. The laboratory performs user satisfaction surveys annually to determine whether the service meets the needs and requirements of the users. The surveys include co-operation with the users or their representatives in monitoring the laboratory’s performance, provided that the laboratory ensures confidentiality to other users. Records are kept of information collected and actions taken. Feedback is given when appropriate, to participants in surveys.
4.14.4 Staff Suggestions
The laboratory management encourages staff to make suggestions for the improvement of the laboratory service. Suggestions are evaluated, implemented as appropriate and feedback provided to the staff. Records of suggestions and action taken by the management are maintained using QF-GEN-0061 Log of Staff Suggestions/Preventive Action/Continual Improvement and entered on Q-Pulse if valid, following discussion at the general laboratory meeting.

5. 
   Internal Audit
   

The laboratory conducts internal audits at planned intervals to determine whether all activities in the quality management system including pre-examination, examination and post-examination:

1. 
   Conform to the requirements of ISO 15189 and to requirements established by the laboratory and
   

2. 
   Are implemented, effective and maintained
   

Audits are conducted by personnel trained to assess the performance of managerial and technical processes of the quality management system. The audit programme takes into account the status and importance of the processes and technical and management areas to be audited, as well as the results of previous audits. The audit criteria, scope, frequency and methods are defined and documented.

Selection of auditors and conduct of audits ensure objectivity and impartiality of the audit process. Auditors are, wherever resources permit, independent of the activity to be audited.
All elements of ISO 15189 as they relate to the services are audited at least once annually. The internal audit programme progressively addresses all aspects of the services. A horizontal audit is a detailed check of the efficacy of implementation of a particular aspect of the ISO15189 and AML-BB standards.
In addition, vertical audits are carried out periodically during the year. A vertical audit of a request is a detailed check that all the elements associated with a chosen examination are implemented (e.g. select a particular request form and audit its trail as follows: reprint the request form, locate the specimen, check IQC & EQA details, instrument maintenance, the report, interpretation etc).
Vertical audits of Haemovigilance/Traceability involve following a blood product from receipt at the Blood Bank to its final fate, ensuring that all defined Haemovigilance and traceability procedures were adhered to.
The Laboratory has a documented procedure which defines the responsibilities and requirements for planning and conducting audits and for reporting and maintaining records QP-GEN-0002 Evaluation and Audits. All Audit documentation is retained by the Quality Co-ordinator and they are responsible for the area being audited to ensure that appropriate action is promptly undertaken when non-conformances are identified. Corrective action is taken without undue delay to eliminate the causes of the detected non-conformances.
The results of internal audit are regularly evaluated by the Quality Co-ordinator and the decisions taken are documented, monitored, reviewed and acted upon. Any non-conformance detected through auditing is investigated as described in QP-GEN-0005 Control of Non-Conformances. The results of internal audits are discussed at monthly Quality Meetings and Management Reviews as described in MP-GEN-0021 Quality Meetings and MP-GEN-0020 Management Review Procedure, respectively.

5. 
   Risk Management
   

There is a procedure in place to describe the risk management process QP-GEN-0009 Risk Management Procedure.

The laboratory evaluates the impact of work processes and potential failures on examination results as they affect patient safety and modifies processes to reduce or eliminate the identified risks and document decisions and actions taken. Risk assessments are carried out on key areas of the pre-examination, examination and post examination processes to identify possible risks and to put controls in place to support potential vulnerable areas. All risk assessments are recorded on Q-Pulse.

5. 
   Quality Indicators
   

The laboratory establishes quality indicators to monitor and evaluate performance throughout critical aspects of pre-examination, examination and post-examination processes. This is described in QP-GEN-0004 Continual Improvement.

The process of monitoring quality indicators is planned and includes establishing the objectives, methodology, interpretation, limits, action plan and duration of measurement.
The laboratory establishes quality indicators for systematically monitoring and evaluating the laboratory’s contribution to patient care. All quality indicators have set target values.
Quality indicators are established through discussion at Laboratory meetings including Quality meetings and the Annual Management review meeting. The indicators are reviewed bi-annually to ensure their continued appropriateness on QF-GEN-0071 Quality Indicators Bi-Annual Audit

The laboratory, in consultation with the users, establishes turnaround times for each of its examinations that reflect clinical needs. Turnaround times for all tests are included in LP-GEN-0007 User Manual. The laboratory periodically evaluates whether or not it is meeting the established turnaround times.

5. 
   Reviews by External Organizations
   

When reviews by external organizations indicate the laboratory has non-conformances or potential non-conformances, the laboratory takes appropriate immediate actions and, as appropriate, corrective or preventive action to ensure compliance with the requirements of ISO 15189. Records are kept of the reviews and of the corrective actions and preventive actions taken. Hard copy reports are produced through audit by the Irish National Accreditation Board. Copies of the non-conformances from these audits are stored on Q-Pulse.