Errors in POCT (Point of Collection Testing) and alternative site testing
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Nilou Lab
Latest Update:
2020/05/22
Errors in POCT (Point of Collection Testing) and alternative site testing
In the literature, data on errors in POCT are scarce, the main focus being on analytic errors.
The claimed advantage of POCT, in addition to its reduced turnaround-time is that it calls for fewer steps in producing laboratory results.
In addition, ‘errors originating during transport are substantially reduced and post-analytical errors are practically totally eliminated, since results are presented directly to the care-giver’.45
This, in turn, should reduce associated errors.
However, despite the illusion of simplicity, POCT, devices are affected by several environmental and operatorrelated factors.
Managing the pre-, intra- and post-analytic processes is a major challenge in POCT, just as it is in centralized laboratories.
Recently we analysed errors and patient safety problems related to POCT adopting a modified Kost error classification framework that takes into account all steps of the testing process, thus demonstrating that POCT reduces errors and risks of error only in a few steps
of the entire testing process.46,47
Furthermore, from a risk management perspective, POCT has given rise to new and serious challenges, particularly in relation to operator competence and non-adherence to procedures.
A potentially more dangerous possibility is that the rapid availability of results and immediate therapeutic intervention might amplify the clinical impact of errors and translate into adverse events for patients.48,49
Recently, we have demonstrated a significant number of errors in data transcription and incomplete data reported using portable glucose
meters in the hospital setting, thus stressing the vulnerability of post-analytical phase when using POCT.50
While these errors do not arise in the laboratory, they pertain to the utilization of results by clinicians and care-givers and, as part of the overall testing and diagnostic process, should be taken into consideration and managed according to a patient-centred perspective.
TTP thus provides the unique framework for analyzing and reducing errors and the risk of errors, not only in ‘centralized’ laboratory
testing but also in POCT and all other alternative site testing options.• We always have a concern in our lab regarding the reliability in performing POCT due to many factors like variation in educational and experience levels of staff performing the tests and their turnover which influence reliability of result in spite of consistent staff training and monitoring with appropriate competency assessment because non-laboratory trained individuals often lack an understanding of the importance of QC and QA.
Additionally, implementation of POCT to a clinical unit might impact the workflow for busy staff who have to integrate processes related to POCT such as daily QC testing, instrument maintenance and troubleshooting issues with POCT devices.
Furthermore, the method employed in POCT differs from that employed in the central laboratory which makes the comparison of results impossible.
Furthermore, POCT instruments may not be interfaceable that challenges LIS and the electronic health records which may in turn create errors in reporting.
Note: CAN/CSA-Z22870-07 (R2013) Standard:
CAN/CSA-Z22870-07 (R2013) - Point-of-Care Testing (POCT) - Requirements for Quality and Competence (Adopted ISO 22870:2006, first edition, 2006-02-01, with Canadian deviations)
ISO 22870, Point-of-care testing — Requirements for quality and competence.Common elements of the full-text POCT standards include:
* Personnel
- - An interdisciplinary group is established (possibly by the head of the lab) to determine which POCTs are appropriate for the institution.
- - The interdisciplinary group periodically reassesses the POCT practices of the institution.
- - Roles and responsibilities regarding ordering, performing, and monitoring of tests are clearly defined.
- - Staff training, certification, and competency are documented.
* Collection
- - A procedure manual for specimen collection exists that defines those authorized to take and handle samples, and identifies appropriate methods for identification, preparation, and collection.
* Quality control
- - POCT should be subject to both internal and external quality control assessment.
- - There must be a periodic evaluation of POC tests and reagents against standard samples.
- - Follow-up actions to quality issues are documented.
* Equipment
- - Choice of equipment should be made based on precision, accuracy, detection limits, utilization limits, and robustness.
- - An inventory of equipment should be kept.
- - Validation, calibration, and maintenance activities should be recorded.
- - Standard procedures for maintenance and use should be in place.
- - Instructions for troubleshooting problems should be available.
- - Guidelines for cleaning and decontamination practices are in place.
* Results
- - Results are clearly entered into the patient’s permanent medical record with reference ranges and are identified as the result of a POCT.
- - The physician is notified of critical results.
- - Any clinical action resulting from a POCT is recorded in the patient’s medical record.
- - The full versions of these standards can be accessed through the links provided in Appendix 14B: Provincial Laboratory Accreditation.
In the literature, data on errors in POCT are scarce, the main focus being on analytic errors.
The claimed advantage of POCT, in addition to its reduced turnaround-time is that it calls for fewer steps in producing laboratory results.
In addition, ‘errors originating during transport are substantially reduced and post-analytical errors are practically totally eliminated, since results are presented directly to the care-giver’.45
This, in turn, should reduce associated errors.
However, despite the illusion of simplicity, POCT, devices are affected by several environmental and operatorrelated factors.
Managing the pre-, intra- and post-analytic processes is a major challenge in POCT, just as it is in centralized laboratories.
Recently we analysed errors and patient safety problems related to POCT adopting a modified Kost error classification framework that takes into account all steps of the testing process, thus demonstrating that POCT reduces errors and risks of error only in a few steps
of the entire testing process.46,47
Furthermore, from a risk management perspective, POCT has given rise to new and serious challenges, particularly in relation to operator competence and non-adherence to procedures.
A potentially more dangerous possibility is that the rapid availability of results and immediate therapeutic intervention might amplify the clinical impact of errors and translate into adverse events for patients.48,49
Recently, we have demonstrated a significant number of errors in data transcription and incomplete data reported using portable glucose
meters in the hospital setting, thus stressing the vulnerability of post-analytical phase when using POCT.50
While these errors do not arise in the laboratory, they pertain to the utilization of results by clinicians and care-givers and, as part of the overall testing and diagnostic process, should be taken into consideration and managed according to a patient-centred perspective.
TTP thus provides the unique framework for analyzing and reducing errors and the risk of errors, not only in ‘centralized’ laboratory
testing but also in POCT and all other alternative site testing options.• We always have a concern in our lab regarding the reliability in performing POCT due to many factors like variation in educational and experience levels of staff performing the tests and their turnover which influence reliability of result in spite of consistent staff training and monitoring with appropriate competency assessment because non-laboratory trained individuals often lack an understanding of the importance of QC and QA.
Additionally, implementation of POCT to a clinical unit might impact the workflow for busy staff who have to integrate processes related to POCT such as daily QC testing, instrument maintenance and troubleshooting issues with POCT devices.
Furthermore, the method employed in POCT differs from that employed in the central laboratory which makes the comparison of results impossible.
Furthermore, POCT instruments may not be interfaceable that challenges LIS and the electronic health records which may in turn create errors in reporting.
Note: CAN/CSA-Z22870-07 (R2013) Standard:
CAN/CSA-Z22870-07 (R2013) - Point-of-Care Testing (POCT) - Requirements for Quality and Competence (Adopted ISO 22870:2006, first edition, 2006-02-01, with Canadian deviations)
ISO 22870, Point-of-care testing — Requirements for quality and competence.Common elements of the full-text POCT standards include:
* Personnel
- - An interdisciplinary group is established (possibly by the head of the lab) to determine which POCTs are appropriate for the institution.
- - The interdisciplinary group periodically reassesses the POCT practices of the institution.
- - Roles and responsibilities regarding ordering, performing, and monitoring of tests are clearly defined.
- - Staff training, certification, and competency are documented.
* Collection
- - A procedure manual for specimen collection exists that defines those authorized to take and handle samples, and identifies appropriate methods for identification, preparation, and collection.
* Quality control
- - POCT should be subject to both internal and external quality control assessment.
- - There must be a periodic evaluation of POC tests and reagents against standard samples.
- - Follow-up actions to quality issues are documented.
* Equipment
- - Choice of equipment should be made based on precision, accuracy, detection limits, utilization limits, and robustness.
- - An inventory of equipment should be kept.
- - Validation, calibration, and maintenance activities should be recorded.
- - Standard procedures for maintenance and use should be in place.
- - Instructions for troubleshooting problems should be available.
- - Guidelines for cleaning and decontamination practices are in place.
* Results
- - Results are clearly entered into the patient’s permanent medical record with reference ranges and are identified as the result of a POCT.
- - The physician is notified of critical results.
- - Any clinical action resulting from a POCT is recorded in the patient’s medical record.
- - The full versions of these standards can be accessed through the links provided in Appendix 14B: Provincial Laboratory Accreditation.
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