post analytical processes - society for quality in...
TRANSCRIPT
![Page 1: POST ANALYTICAL PROCESSES - Society for Quality in ...sqhn.org/.../uploads/2013/10/Medical-lab-post-analytical-processes.pdf · BY Dr. Adebola Olu-Taiwo. MBBS, MPH, MWACP, FMCPath](https://reader031.vdocuments.us/reader031/viewer/2022021513/5b1a5e417f8b9a19258d9b6e/html5/thumbnails/1.jpg)
BY
Dr. Adebola Olu-Taiwo. MBBS, MPH, MWACP, FMCPath. Consultant Haematologist and Laboratory Physician. PATHCARE NIGERIA.
POST ANALYTICAL PROCESSES
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Introduction • Post-analytical quality. ¾This is the ultimate check on the consistency of
pre- and intra-analytical quality, and can be considered as the overall quality.
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Introduction
• It ties together: ¾the quality of the question to be answered, ¾the analytical quality achieved and ¾the usefulness of the answer obtained, and
also ¾the context of the patient and ¾the perceived abilities of the physician to
interpret and utilize laboratory information.
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Introduction
• Similar to the pre-analytical step, the post-analytical phase can be subdivided into: ¾one phase performed within the laboratory
and ¾another (post-post-analytical phase) in
which the clinicians receive, interpret and react to laboratory results.
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Factors influencing quality Pre analytical Analytical Post analytical Right Specimen Laboratory
professionals Recording
Right collection Reagents Interpretation
Right labeling Equipment Turnaround time
Right quantity Selection of test - SOP
Report to right user
Right transport Records
Right storage Bio-Safety
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Post analytical procedures
• The post-analytical procedures performed within the laboratory include: ¾verifying laboratory results, ¾feeding them into the laboratory information
system, and ¾communicating them to the clinicians in a
number of ways (in particular, by producing a report and making any necessary oral communications regarding ‘‘alert’’ or panic results).
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Post analytical QC
• Involves: ¾ Report generation without any transcription
errors ¾ Double checking of printed report and
counter signed by a pathologist or senior laboratory scientist ¾ Report dispatch to right person ¾ Storage of reported material ¾ Disposal of specimen ¾ Monitor TAT
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Post analytical errors
• Post-analytical causes of errors accounting for 18.4–47% of total laboratory errors
¾Transcription errors
¾Wrong validation
¾Excessive delay in reporting values
¾Incorrect reference values
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¾Physician not notified of a panic or critical value ¾Incorrect interpretation of lab results by
physician ¾Incorrect data entry of lab result
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• Manual test validation ¾This is a big problem in our environment. ¾This is a time-consuming process with large
inter-individual variation; ¾moreover, it slows down the response of the
laboratory to the clinic, thus causing delay in the diagnostic and therapeutic process.
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• This validation process can be automated; some automated validation systems with satisfactory sensitivity and specificity have been developed and introduced into clinical laboratories.
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• For example, if the same person does a manual blood group test on a large number of samples and also run some other tests at the same time, this could lead to errors due to fatigue if the same person has to validate these results.
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CASE SCENARIO 1
• O.J. is a 32 year old male who came in for ABO blood grouping test, test was done manually and read as O positive but while transcription was being done it was recorded as A positive. A visual verification was done by the pathologist prior to release of result revealed the error and correct result was documented as O positive.
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• In order to avoid transcriptional errors in the results of the test, the reporting/signatory pathologist has to verify the results entered manually or through on-line instrument interfaces before the results are reported or despatched.
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• Reference intervals for healthy subjects and diseased populations are important benchmarks for the clinical interpretation of laboratory test values.
• The use of different, sometimes erroneous, reference intervals may markedly affect the clinical interpretation of laboratory data, leading to errors in clinical decision-making
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• For example, the reference value for platelets that is used in Nigeria are Caucasian and European values of 150-450 x10^9/L, but some studies in Western Nigeria have revealed that normal Platelet reference value is lower in Africans, as low as 90 x10^9/L.
• This could affect clinical interpretation and patient management.
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• The production and release of the laboratory report is the crucial step in post-analytical procedures, ¾as its format, ¾content, and ¾communication significantly affect the
interpretation and utilization of laboratory data by clinicians.
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CASE SCENARIO 2 • Another patient came to a laboratory for a Lipid
profile test. A manual transcription of the result was done and instead of transcribing 3.1mg/dl, the scientist typed in 13.1mg/dl. The physician on getting the result doubled the dose of simvastatin from 40mg nocte to 160mg nocte. A few weeks later the patient begins to complain of pain in the right upper quadrant, LFTs done were deranged and markedly elevated. Simvastatin was stopped and a careful review of patients results by doctor and the pathologists revealed a transcription error.
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• The importance of information technology in improving reliability and security of result reporting is widely recognized.
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• Requirements for information technology in laboratory medicine now go well beyond the provision of purely analytical data and include fundamental aspects of data communication, namely the notification of results that fall within established critical or alert intervals
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• In particular, the role of interpretative comments in improving patient outcomes has been of interest.
• Guidelines for the provision of interpretative comments have been released and schemes for assessing the quality of comments have been initiated.
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• The results obtained indicate that interpretation provided by laboratory professionals with inadequate expertise can be dangerous, and highlight the need for improvement in the standard of interpretation currently provided.
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• In the post-analytical phase performed outside laboratory control (post-post-analytical phase): ¾the clinician receives, ¾reads and interprets the results, and ¾makes a decision on the basis of information
from the laboratory and other sources.
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Post analytical activities
• Review and evaluate the following: ¾Effectiveness of the corrective actions ¾Procedures and policies to prevent
recurrences ¾Accuracy and completeness of results and
reports ¾Disposition of unacceptable specimens ¾Turnaround times
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Post analytical activities
¾Referral specimens and their reports ¾Corrected reports ¾Procedures for notification of test results
with statistics ¾Assurance of confidentiality of patient
information
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Reporting of results
• Release of reports only to authorized person • Timely release of provisional and final report • Any value which exceeds the normal limit
must be clearly published, understood and conveyed verbally, electronically or printed form- when, where, what and to whom was reported- document it
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Result format
• Name and address of lab • Name of patient with gender • Lab ID number • Date and time of receipt of sample • Type of sample • Name of test requested with a brief clinical
background • Results with the units • The normal or reference range of the test
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• Expected turnaround time- if delay, notify the doctor
• Types of reports- standard paper, electronic and web based
• Quality assessment and corrected report monitor and evaluate its results
• If sample was unacceptable- prompt communication
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• Interpretation and explanation of the value of result
• Any disclaimers, Eg. SOP on sample rejection criteria
• Value added textual interpretative comments • Name of the person authorizing the release
of the report • Signature of the person releasing the report
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• Treat the patient, not the result. • If you are in doubt, call the pathologist
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Laboratory management – good team work
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Resource Materials • ISO documents: • 15189
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