Quality manual
Ensuring Quality of Examination Results
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- Bu səhifədəki naviqasiya:
- Quality Control General
- Quality Control Materials
- Quality Control Data
- Inter Laboratory Comparisons Participation
- Alternative Approaches
- Analysis of Interlaboratory Comparison Samples
- Evaluation of Laboratory Performance
- Comparability of Examination Results
5.6 Ensuring Quality of Examination Results
The laboratory ensures the quality of examinations by performing them under defined conditions. Appropriate pre and post examination processes are implemented. The laboratory does not fabricate any results.
The Department of Pathology implements daily internal quality control (QC) systems. These QC systems verify the attainment of the intended quality of results. Results of QC testing are checked to ensure that expected results are achieved, prior to the release of test results, thus assuring the quality of test results. Results of all QC testing are logged as described in Internal Quality Assurance procedures. Internal QC results are reviewed regularly by the Chief Medical Scientist. Staff are required to sign off on the Internal Quality Assurance procedure having read and fully understood all aspects therein. This ensures that staff members understand the Internal QC system as a basis for technical and related medical decisions. The Department of Pathology complies with quality control processes as follows: a) Participate in suitable programmes of inter laboratory comparisons e.g. NEQAS, LabQuality programs. b) Use of suitable reference materials, certified to indicate the characterization of the material. c) Examine or calibrate by another procedure, where required. d) Document statements regarding reagents, procedures or the examination system when traceability is provided by the supplier or manufacturer e.g. certificates of analysis.
The Department of Pathology uses quality control material that reacts to the examining system in a manner as close as possible to patient samples. Quality control materials are periodically examined with a frequency that is based on the stability of the procedure and the risk of harm to the patient from an erroneous result. Use of independent third party control materials are considered, either instead of, or in addition to, any control materials supplied by the reagent or instrument manufacturer.
The Department of Pathology has procedures to prevent the release of patient results in the event of quality control failure. The work processes in the Department of Pathology are designed to eliminate mistakes in the process of handling samples, requests, examinations and reports. In relation to eliminating errors, processes in the Department of Pathology include:
Special attention is paid to the elimination of mistakes in the process of handling samples, requests, examinations, reports, etc. Best practice work practices are encouraged to ensure accuracy and to eliminate degree of manual error. When the quality control rules are violated and indicate that examination results are likely to contain clinically significant errors, the results are rejected and relevant patient samples are re-examined after the error condition has been corrected and within specification performance is verified. The laboratory also evaluates the results from patient samples that were examined after the last successful quality control event. Quality control data is reviewed at regular intervals to detect trends in examination performance that may indicate problems in the examination system. When such trends are noted, preventive actions are taken and recorded. Statistical and non-statistical techniques for process are used wherever possible to continuously monitor examination system performance.
The Department of Pathology participates in inter laboratory comparisons organized by external quality assessment schemes as per the procedures for QP-GEN-0003 External Quality Assessment, LP-HAEM-0015 External Quality Control in Haematology, LP-BIO-0020 External Quality Control in the Biochemistry Department and LP-MIC-0040 External Quality Assurance in Microbiology. The results of external quality assessments are monitored and any failures are documented, investigated and resolved as per the non-conformance system, QP-GEN-0005 Control of Non-Conformances. The results of the assessments are reviewed and signed-off by the Consultant, Chief Medical Scientist and Senior Medical Scientist. In addition they are discussed at the Quality Meetings with the Consultant. A review of these results is presented at the Annual Management Review Meeting. Inter laboratory comparison programmes are in substantial agreement with ISO/IEC 17043. External quality assessment programmes provide clinically relevant challenges that mimic patient samples and have the effect of checking the entire examination process, including pre- and post-examination procedures. The laboratory has a documented procedure for interlaboratory comparison participation QP-GEN-0003 External Quality Assessment that includes defined responsibilities and instructions for participation, and any performance criteria that differ from the criteria used in the interlaboratory comparison programme. Interlaboratory comparison programmes chosen by the laboratory do, as far as possible, provide clinically relevant challenges that mimic patient samples and have the effect of checking the entire examination process, including pre-examination procedures and post-examination procedures, where possible.
There are External Quality Assurance Programmes available for the tests listed on the scope of ISO 15189 accreditation in the Blood Bank and for the tests proposed for extension to scope of ISO 15189 accreditation by Haematology and Biochemistry Departments. There is no need for alternative approaches to be taken.
The laboratory integrates interlaboratory comparison samples into the routine workflow in a manner that follows, as much as possible, the handling of patient samples. Interlaboratory comparison samples are examined by personnel who routinely examine patient samples using the same procedures as those used for patient samples. The laboratory does not communicate with other participants in the interlaboratory comparison programme about sample data until after the date for submission of the data. The laboratory does not refer interlaboratory comparison samples for confirmatory examinations before submission of the data, although this would be routinely done with patient samples.
The performance in interlaboratory comparisons are reviewed and discussed with relevant staff. Final reports are discussed at the monthly quality meetings and QF-GEN-0042 Review of External Quality Control is signed off by the appropriate Consultant, Chief Medical Scientist and Senior Medical Scientist. When predetermined performance criteria are not fulfilled (i.e. non-conformances are present), staff participate in the implementation and recording of corrective action. The effectiveness of corrective action is monitored. The returned results are evaluated for trends that indicate potential non-conformances and preventive action is taken.
There are defined means of comparing procedures, equipment and methods used and establishing the comparability of results for patient samples throughout the clinically appropriate intervals. This is applicable to the same or different procedures, equipment, different sites, or all of these. The laboratory notifies users of any differences on comparability of results and discusses any implications for clinical practice when measuring systems provide different measurement intervals for the same measurand and when examination methods are changed. This is in accordance with MP-GEN-0001 Management of the Laboratory. The laboratory documents, records, and, as appropriate, expeditiously acts upon results from the comparisons performed. Problems or deficiencies identified are acted upon and records of actions retained.
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