Managing Deviating EQA Results: A Survey to Assess the Corrective and Preventive Actions of Medical Laboratories Testing for Oncological Biomarkers

Laboratories testing predictive biomarkers in lung and colorectal cancer are advised to participate in external quality assessment (EQA) schemes. This study aimed to investigate which corrective actions were taken by laboratories if predetermined performance criteria were not met, to ultimately improve current test practices. EQA participants from the European Society of Pathology between 2014 and 2018 for lung and colorectal cancer were contacted, if they had at least one analysis error or test failure in the provided cases, to complete a survey. For 72.4% of 514 deviating EQA results, an appropriate action was performed, most often including staff training (15.2%) and protocol revisions (14.6%). Main assigned persons were the molecular biologist (40.0%) and pathologist (46.5%). A change in test method or the use of complex techniques, such as next-generation sequencing, required more training and the involvement of dedicated personnel to reduce future test failures. The majority of participants adhered to ISO 15189 and implemented suitable actions by designated staff, not limited to accredited laboratories. However, for 27.6% of cases (by 20 laboratories) no corrective action was taken, especially for pre-analytic problems and complex techniques. The surveys were feasible to request information on results follow-up and further recommendations were provided.

Laboratory management shall ensure that laboratory services, including appropriate advisory and interpretative services, meet the needs of patients and those using the laboratory services.

4.1.2.5
Laboratory management shall ensure that responsibilities, authorities and interrelationships are defined, documented and communicated within the laboratory organization. This shall include the appointment of person(s) responsible for each laboratory function and appointment of deputies for key managerial and technical personnel. NOTE: in smaller laboratories individuals can have more than one function and that it could be impractical to appoint deputies for every function.

4.1.2.6
Laboratory management shall have an effective means for communicating with staff, records shall be kept of items discussed in communications and meetings.

4.2.2
The quality management system shall include, but not be limited to, internal quality control and participation in organized interlaboratory comparisons such as external quality assessment schemes.

4.7
The laboratory shall establish arrangements for communicating with users on consulting on scientific and logistic matters such as instances of failure of sample(s) to meet acceptance criteria.

4.9
The laboratory shall have a documented procedure to identify and manage nonconformities. The procedure shall ensure that the responsibilities and authorities for handling nonconformities are designated, and that the immediate actions to be taken are defined. 4.14.7 The laboratory should establish quality indicators for systematically monitoring and evaluating the laboratory's contribution to patient care.

5.1.6
Following appropriate training, the laboratory shall assess the competence of each person to perform assigned managerial or technical tasks according to established criteria. Reassessment shall take place at regular intervals. Retraining shall occur when necessary.

5.1.8
A continuing education programme shall be available to personnel who participate in managerial and technical processes. Personnel shall take part in continuing education. The effectiveness of the continuing education programme shall be periodically reviewed.
Personnel shall take part in regular professional development or other professional liaison activities.

5.1.9
Records of the relevant educational and professional qualifications, training and experience, and assessments of competence of all personnel shall be maintained.

5.6.2.3
The laboratory shall have a procedure to prevent the release of patient results in the event of quality control failure.

5.6.3.1
The laboratory shall monitor the results of the interlaboratory comparison programme(s) and participate in the implementation of corrective actions when predetermined performance criteria are not fulfilled.

5.6.3.3
The laboratory shall integrate interlaboratory comparison samples into the routine workflow in a manner that follows, as much as possible, the handling of patient samples.
Interlaboratory comparison samples shall be examined by personnel who routinely examine patient samples using the same procedures as those used for patient samples.

5.6.3.4
When predetermined performance criteria during interlaboratory comparisons are not fulfilled (i.e., nonconformities are present), staff shall participate in the implementation and recording of corrective action. The effectiveness of corrective action shall be monitored. The returned results shall be evaluated for trends that indicate potential nonconformities and preventive action shall be taken. The performance in interlaboratory comparisons shall be reviewed and discussed with relevant staff.

5.6.4
The laboratory shall participate in interlaboratory comparisons such as those organized by external quality assessment schemes.

5.7.1
The laboratory shall have procedures to ensure that authorized personnel review the results of examinations before release and evaluate them against internal quality control and, as appropriate, available clinical information and previous examination results.

5.8.1
The results of each examination shall be reported accurately, clearly, unambiguously and in accordance with any specific instructions in the examination procedures.

5.9.1
The laboratory shall establish documented procedures for the release of examination results, including details of who may release results and to whom.