PCS LIMS Quality Control Features
REQUEST LINE AUDIT
"PCS LIMS", allows to audit these links - both top-down and bottom-up - for example when making a follow-up of a complaint as described in the scenario above. "PCS LIMS" permit's a detailed audit of this kind in both directions.
Sample-line Audit
The result should be produced by an investigation performed on a given sample that has been collected from a certain individual. Implicit in this statement is "PCS LIMS" provides systems for sample labelling and identification that acts together with the sample cycle so as to prevent sample exchange by mistake.
Medical validation
A technologist responsible for patient results validation is using a "PCS LIMS" workstation. In the investigation of an unexpected result value of the measurement of parameter, alerted by a delta-check alarm, the technologist performs the following:
Sample view
Sample view of results the technologist wants to see the results of the other measurements performed in the same sample, as this might give a clue, Logically the technologist then follows the relations from the result, through the investigation up to the sample and from the sample down through all investigations requested for that sample to their results.
Historical view
As no explanation for the unexpected value was found, technologist then displays all previous results of the same kind. In this case the route is from the results through the investigation and sample up to the patient, and from the patient down through all samples and investigations of the same type to their results. He now may inspect the historical view of that investigation. (The two last results of this view could be the basis for the delta-check alarm.)
Cumulative view
Finally, it was necessary to display a complete cumulative view of results for this patient. The traces now combine those of the sample and historical views (see above): When moving down from the patient, a set of sample views is generated
Audit View
To make the audit view possible, it is important that there is workflow information available of all major events along the sample audit trail. All deletions and changes anywhere along this audit trail is traceable in "PCS LIMS".
ANALYTICAL TRACE ABILITY:
As defined by accredited bodies, is very important for quality management: The result of an investigation should be traceable back to appropriate analytical standards "through an unbroken chain of comparisons". "PCS LIMS" support's analytical trace ability.
"PCS LIMS" always permit tracing of a measurement result back to a certain analytical run on a given instrument (or in some cases, runs on several types of analytical equipment used in the measurement procedure).
"PCS LIMS" also provides possibilities to record information on the analytical quality of this/these analytical run(s), where this is possible and desirable. Examples of this kind of information include:
Quality status of an analytical result.
"PCS LIMS" makes it possible to review easily every aspect of quality that may determine the validity and reliability of measurement results. Not forcing the technologist to look up for information in various sources, possibly located at different sites in the laboratory, to review the quality context of the unexpected result
A technologist responsible for patient results validation is using a "PCS LIMS" workstation as a consequence of the situation described in the scenario above, "PCS LIMS" support analytical audit by providing the following pieces of information:
The overall task of validation can be divided into
Technical validation phase:
"PCS LIMS" have tools for computer-assisted validation of results and alerting functions, which may free the staff from the burden of evaluating a mass of non- suspicious data. Relevant traces of the validation activity is stored in the database both for auditing and documentation
As results are transmitted from the analyser a number of checks are applied to them to ensure that they are technically correct. Results that fail technical validation are put onto a technical validation fail list for investigation before a report is issued. Technologist monitors the technical validation fail list and results may be held while the samples are sent to a list for reanalysis as neat samples, diluted samples, or using increased volumes. Results on the technical validation fail list may be edited with the result from a manual or non-interfaced analysis replacing the original. The report may be passed for clinical validation with some results suppressed if the sample quality is suspect or interference is suspected. Comments may be added to the results explaining problems detected during technical validation.
a) Instrument specific checks
The Fundamental process in assessing the validity of patients' results is establishing the RTQC status. This process may be a simple target value and allowable range for each control material used, or the use of multi-rule and multi-stage processes. The RTQC status must be acceptable for patient results to pass this stage of production. Acceptable RTQC status ensures that the patients' result fall within the defined Allowable Analytical Error (AAE) for each analysis.
Clinical Validation Phase :
The purpose of this process is to run a "clinical believability" or plausibility check on the results and to identify results requiring discussion with and /or urgent communication to the medical team, i.e. to ensure that results in the final patient report are consistent with each other, previous results, clinical diagnosis and treatment, and do not fit a result pattern that indicates sample contamination or mix-up. Clinically implausible results might indicate a laboratory error; hence it is useful to check further before results are released. The ultimate purpose is to ensure that the report can be used in the diagnosis and treatment of the patient. The results in the final patient report may have been generated by a number of different analysers and/or manual methods. Clinical validation is normally performed once patient results have passed Technical validation. Failure during the Clinical Validation phase will result in further investigation of the report and may include re-analysis of the sample, checking the labelling and identification of the sample, confirming the all pre- analytical variables are known, and that the performance of the analysers is acceptable.
Clinical validation may be used to identify results that are clinically critical and should be communicated to the medical team treating the patient. Results that fail clinical validation are put onto a clinical validation queue for investigation before a report is issued. Senior laboratory staff process this queue by investigating each failed report and confirming the validity of the results. The report is thus validated and can be released to the medical team. The staff processing the validation queue may add comments and explanations to the report, and transfer the report to the ward or for discussion with the medical team. If the results are outside defined limits (e.g. Sodium < 120 mmol/l) the validated report may also be added to a review queue for the laboratory physician.
To assist Clinical Validation, ""PCS LIMS " provides appropriate checking algorithms. Here follow short descriptions of commonly used checks:
"PCS LIMS", allows to audit these links - both top-down and bottom-up - for example when making a follow-up of a complaint as described in the scenario above. "PCS LIMS" permit's a detailed audit of this kind in both directions.
Sample-line Audit
The result should be produced by an investigation performed on a given sample that has been collected from a certain individual. Implicit in this statement is "PCS LIMS" provides systems for sample labelling and identification that acts together with the sample cycle so as to prevent sample exchange by mistake.
Medical validation
A technologist responsible for patient results validation is using a "PCS LIMS" workstation. In the investigation of an unexpected result value of the measurement of parameter, alerted by a delta-check alarm, the technologist performs the following:
Sample view
Sample view of results the technologist wants to see the results of the other measurements performed in the same sample, as this might give a clue, Logically the technologist then follows the relations from the result, through the investigation up to the sample and from the sample down through all investigations requested for that sample to their results.
Historical view
As no explanation for the unexpected value was found, technologist then displays all previous results of the same kind. In this case the route is from the results through the investigation and sample up to the patient, and from the patient down through all samples and investigations of the same type to their results. He now may inspect the historical view of that investigation. (The two last results of this view could be the basis for the delta-check alarm.)
Cumulative view
Finally, it was necessary to display a complete cumulative view of results for this patient. The traces now combine those of the sample and historical views (see above): When moving down from the patient, a set of sample views is generated
Audit View
To make the audit view possible, it is important that there is workflow information available of all major events along the sample audit trail. All deletions and changes anywhere along this audit trail is traceable in "PCS LIMS".
ANALYTICAL TRACE ABILITY:
As defined by accredited bodies, is very important for quality management: The result of an investigation should be traceable back to appropriate analytical standards "through an unbroken chain of comparisons". "PCS LIMS" support's analytical trace ability.
"PCS LIMS" always permit tracing of a measurement result back to a certain analytical run on a given instrument (or in some cases, runs on several types of analytical equipment used in the measurement procedure).
"PCS LIMS" also provides possibilities to record information on the analytical quality of this/these analytical run(s), where this is possible and desirable. Examples of this kind of information include:
- Calibration data
- Results of internal quality controls
- Warning and error messages/codes issued by the analytic equipment employed
Quality status of an analytical result.
"PCS LIMS" makes it possible to review easily every aspect of quality that may determine the validity and reliability of measurement results. Not forcing the technologist to look up for information in various sources, possibly located at different sites in the laboratory, to review the quality context of the unexpected result
A technologist responsible for patient results validation is using a "PCS LIMS" workstation as a consequence of the situation described in the scenario above, "PCS LIMS" support analytical audit by providing the following pieces of information:
- The instrument and method used for the actual measurement,
- Assessment of the previous calibration
- Status of short-term and long-term internal quality controls,
- Traces of patient result validation (automatic or performed by laboratory staff).
- "PCS LIMS" acquires calibration data on-line, and to store, process and display it graphically. Data of previous calibration data is also maintained. Automatic monitoring of the raw data produced during calibration is used to alert the operator when the calibration data falls outside specified parameters. When raw data for calibration falls outside the specified parameters, the computer system trigger a fault diagnosis process and suggest corrective action.
- "PCS LIMS" acquire on-line, store and process data obtained during real time quality control, necessary for the technical validation of patient results, and long time quality control, used to assess the performance of each method of measurement over a period of time.
The overall task of validation can be divided into
Technical validation phase:
"PCS LIMS" have tools for computer-assisted validation of results and alerting functions, which may free the staff from the burden of evaluating a mass of non- suspicious data. Relevant traces of the validation activity is stored in the database both for auditing and documentation
As results are transmitted from the analyser a number of checks are applied to them to ensure that they are technically correct. Results that fail technical validation are put onto a technical validation fail list for investigation before a report is issued. Technologist monitors the technical validation fail list and results may be held while the samples are sent to a list for reanalysis as neat samples, diluted samples, or using increased volumes. Results on the technical validation fail list may be edited with the result from a manual or non-interfaced analysis replacing the original. The report may be passed for clinical validation with some results suppressed if the sample quality is suspect or interference is suspected. Comments may be added to the results explaining problems detected during technical validation.
a) Instrument specific checks
- Technical Limit check. The results are checked to ensure that they are within the measurable limits for the analyser. Results outside the technical limits may be reanalysed, as dilutions or larger sample volumes. In some cases they may be reported as less than or greater than the limit exceeded. Clinically critical results that exceed the technical limits of the analyser, and have no other errors, may be added to an action queue to be given as interim report. E.g. if a glucose result exceeds the technicallimits of an analyser, an interim report is given to the medical team indicating that the glucose is greater than the technical limit and the actual value will follow.
- Analyser Error checks. Modern analysers perform a number of self-monitoring functions and may append a flag to patient results indicating the analyser status. Patient results that have a flag indicating an analyser error that may affect the quality of results (e.g. sampling mechanism operating erratically) must be held for review and/or re-analysis.
The Fundamental process in assessing the validity of patients' results is establishing the RTQC status. This process may be a simple target value and allowable range for each control material used, or the use of multi-rule and multi-stage processes. The RTQC status must be acceptable for patient results to pass this stage of production. Acceptable RTQC status ensures that the patients' result fall within the defined Allowable Analytical Error (AAE) for each analysis.
Clinical Validation Phase :
The purpose of this process is to run a "clinical believability" or plausibility check on the results and to identify results requiring discussion with and /or urgent communication to the medical team, i.e. to ensure that results in the final patient report are consistent with each other, previous results, clinical diagnosis and treatment, and do not fit a result pattern that indicates sample contamination or mix-up. Clinically implausible results might indicate a laboratory error; hence it is useful to check further before results are released. The ultimate purpose is to ensure that the report can be used in the diagnosis and treatment of the patient. The results in the final patient report may have been generated by a number of different analysers and/or manual methods. Clinical validation is normally performed once patient results have passed Technical validation. Failure during the Clinical Validation phase will result in further investigation of the report and may include re-analysis of the sample, checking the labelling and identification of the sample, confirming the all pre- analytical variables are known, and that the performance of the analysers is acceptable.
Clinical validation may be used to identify results that are clinically critical and should be communicated to the medical team treating the patient. Results that fail clinical validation are put onto a clinical validation queue for investigation before a report is issued. Senior laboratory staff process this queue by investigating each failed report and confirming the validity of the results. The report is thus validated and can be released to the medical team. The staff processing the validation queue may add comments and explanations to the report, and transfer the report to the ward or for discussion with the medical team. If the results are outside defined limits (e.g. Sodium < 120 mmol/l) the validated report may also be added to a review queue for the laboratory physician.
To assist Clinical Validation, ""PCS LIMS " provides appropriate checking algorithms. Here follow short descriptions of commonly used checks:
- Limits-based checks. Results that fall outside predefined warning and panic limits, and pass delta- checks and clinical detail checks, are held for further investigation or communication to the medical team. As for results that fail the technical limits, clinically critical results that exceed the warning or panic limits can be released as interim report if the laboratory physician has not authenticated the results.
- Delta-checks. This process involves the comparison of present results with past results and checking that there is not an unreasonable change between the two results. This is the most common form of clinical validation and is useful in detecting sample mix-ups, pre-analytical errors or laboratory error not detected by technical validation.
- Result Pattern checks. (Co-relational Checks) This is also referred to as Internal Consistency checks. It involves checking abnormal results with other results on the same sample to confirm that they conform to a pattern consistent with a known condition, e.g. a report with a raised creatinine should also have a raised urea. Results that do not fit an acceptable pattern must be held for further investigation. Results can also be checked for patterns that indicate incorrect anti-coagulant use (e.g. ETDA) or incorrect storage of samples (e.g. sample left un separated overnight).
- Clinical Details checks. This process evaluates the results with the available details of the medical context. The results are evaluated against the known clinical details of diagnosis, treatment and progression of disease states. The clinical details may be available from the request form or be available from an integrated Hospital Information System and LIS. Results that are not consistent with the clinical details must be held for further investigation.
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