Overview of Quality Control and its implementation in the laboratory.pptx
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The document provides an overview of quality control (QC) in clinical laboratories, emphasizing its importance for accurate diagnostic outcomes and patient care. It covers methodologies for implementing QC, including internal quality control (IQC) and external quality assessment (EQA), and discusses the significance of proper pre-analytical, analytical, and post-analytical processes to minimize errors. Additionally, the document highlights challenges in laboratory communication and the necessity for laboratory experts to be integrated into the healthcare decision-making process.
![Six sigma matrics
• Six Sigma metrics are being adopted as the universal
measure of quality to be applied to their processes and
the processes of their suppliers.
• Six Sigma provides a more quantitative framework for
evaluating process performance and more objective
evidence for process improvement.
• Two methods can be used to assess process
performance in terms of a sigma metric (+6S to -6S).
• outcomes by inspection & variation and predict process
performance.
• Sigma = (TEa − bias)/SD [TEa=allowable total error]
• Methods with Six Sigma performance are considered
“world class”; methods with sigma performance less than](https://image.slidesharecdn.com/overviewofqualitycontrol-220923045201-c5f34f47/85/Overview-of-Quality-Control-and-its-implementation-in-the-laboratory-pptx-49-320.jpg)
Overview of Quality Control and its implementation in the laboratory.pptx
- 1. Overview of Quality Control and its implementation in the laboratory Dipesh Tamrakar MSc. Clinical Biochemistry (IOM-TUTH) BSc. MLT, CMLT
- 2. • Why do we need to about TQM/QA/QC? • What are its practical approaches in the lab? • Can we do it regularly in the lab of our setup?
- 3. Overview • Brief on TQM, QA, QC • Quality Indicators • Lab errors • Quality Control • Implementation of QC in the lab
- 4. WHAT IS LABORATORY TEST ? • “A laboratory test is intervention of any kind (diagnostic or therapeutic) ; more likely to benefit than to harm the patient and can be done at a reasonable cost and with reasonable risk”. • Laboratory tests provide information (with strong impact) which help doctors to provide better and more effective care for their patients. • Laboratory results are component of 70% medical claims = 70% of medical decisions = 70% of medical records
- 5. ROLES OF LABORATORY MEDICINE 1. Perform laboratory investigations 2. Improve testing appropriateness 3. Improve patient outcomes 4. Improve decision making strategies 5. Improve cost effectiveness 6. Educate clinical users 7. Clinical optimization of operational efficiencies 8. Survey performance through appropriately designed quality control 9. Assist and improve on laboratory clinic interface 10. Improve information accessibility to the patient 11. Speed-up bringing in new diagnostic EVIDENCE BASED technologies 12. Redesign diagnostic paths towards an easier integrated service
- 6. STATUS and CHALLENGES • Status: Laboratory experts are often perceived as a service for doctors. • In order to have a successful healthcare ecosystem, they need to have the same status as other experts in their own medical disciplines. • Laboratory experts involve themselves more in structuring and ordering tests • Poor communication between medical departments and laboratories. • Initiatives to make laboratory experts act as medical consultants are being neglected that weakens the communication. • Modern healthcare systems are oriented towards developing better communication between doctors and laboratory experts. • This form of communication has an enormous influence on the treatment outcomes and medical expenses in general.
- 7. OFTEN KNOWN AS: • Total Quality Control • Total Quality Leadership • Continuous Quality Improvement • Quality Management Science
- 8. • Quality assurance relates to how a process is performed or how a product is made. • Quality control can be defined as "part of quality management focused on fulfilling quality requirements." • Quality control is more the inspection aspect of quality management.
- 9. • Quality Assurance - the overall program that ensures that the final results reported by the laboratory are correct. • It is much more concerned with :Right result from the Right test at the Right time on the Right specimen from the Right patient with the Right result interpretation based on correct reference data at the Right price
- 10. Quality Control • One of the most scientific and significant tool to correct errors in analytical phase in the clinical laboratories • Designed to monitor the routine performance of testing process • Detect possible errors, reduce and correct deficiencies before the test results are reported • From service user: Quality of a good service for the price of the product • Internal quality control (IQC) and external quality assessment (EQA) programs are used to assess and improve analytical performance.
- 11. IQC Vs EQA • IQC is self-assessing tool by using control samples for the continuous and immediate monitoring of the analytical part. • IQC : to observe precise and accurate results on daily analytical phase • EQA is intended for periodic and retrospective observing of laboratory results by an autonomous external agency to specify to the laboratory about the accuracy or bias in their systems methods and results. • EQA : to monitor long term accuracy and bias of their results and stability of methods over a longer period of time.
- 12. Aims of Quality assurance • Accuracy and precision • Satisfactory • Quality report • Economical • Aims at preventing defects rather than detecting the defects • Minimize errors • Timely report
- 13. Quality Assurance An overall management plan to guarantee the integrity of data (The “system”) PRECISION The degree of fluctuation in the measurements Quality Control A series of analytical measurements used to assess the quality of the analytical data (The “tools”) ACCURACY The closeness of measurements to the true value Quality Control is used to monitor both the precision and the accuracy of the assay in order to provide reliable results.
- 14. • Precise and inaccurate • Precise and accurate • Imprecise and inaccurate
- 15. LABORATORY ERRORS ??? • From the patient’s perspective, every error is perceived the same, whether it is made in pre-analytic, analytic or post-analytic phase. • Most of the errors occur outside the laboratory due to various pre-analytic factors. • A large number of errors occur in post-analytic phase as well. • In recent time, errors in analytic phase got significantly reduced.
- 17. How to implement a laboratory quality control program???
- 18. FLOW OF LAB PROCESS
- 19. •Data and Lab Management •Safety •Customer Service Patient/Client Prep Sample Collection Sample Receipt and Accessioning Sample Transport Quality Control Record Keeping Reporting Personnel Competency Test Evaluations Testing The Quality Assurance Cycle
- 21. Pre-analytical stage • Test requisition slip • Patient preparation • Sample tube labeling • Sample collection • Sample transportation • Reagent storage • Reagent preparation • Quality control sera storage • Callibrator storage • QC alliquet storage • Quality monitoring of refrigerator, waterbath • Maintenance and cleaning of instruments Machine maintenance: Daily, Weekly, Monthly and Annually
- 22. Preanalytical errors • The importance of correctly carrying out all pre-analytical activities performed by laboratory and non-laboratory staff in safeguarding the quality and reliability of the final laboratory information. • An error in any step of pre-analytical phase can adversely affect both the quality of analytical results and the interpretation of information provided.
- 23. Quality indicators of preanalytical phase Misidentification error • Misidentified requests • Misidentified samples • Samples with fewer than 2 identifiers • Unlabeled samples Inappropriate test request • Requests without clinical questions (OPD) • Inappropriate requests (OPD) • Inappropriate requests (IPD)
- 24. Test transcription errors • Erroneous data entry of • Test name • Missed test • Added test Unintelligible request • Inappropriate sample type • Samples collected in wrong container • Incorrect fill level • Inappropriate sample-anticoagulant volume
- 25. Unsuitable samples for transportation and storage problems • Samples not properly stored before analysis • Samples damaged during transportation • Samples transported at inappropriate temperature • Samples with excessive transportation time • Contaminated samples • Hemolyzed sample • Clotted samples • Inappropriate time in sample collection
- 26. Quality indicators for analytical phase • Test with inappropriate IQC performances (CV higher than expected) • Test uncovered by an EQA • Unacceptable performances in EQA schemes • Data transcription errors (manual or LIS failure)
- 27. Selection of Control & Calibrators • Has a known concentration of the substance (analyte) being measured • Used to adjust instrument, kit, test system in order to standardize the assay Sources of QC samples: • Appropriate diagnostic sample ( repeated samples for consecutive days) • Obtained from: • Another laboratory • EQA provider • Commercial product • IQC depends on the analyzers available in the lab. • EQA depends on availability of the resources
- 28. Characteristics of a Good Control • The composition of the control material should be as similar to the patient sample as possible, reacting in the same manner • The analyte concentration should be at medically significant levels • Stable under storage for longer period of time prior to preparation & even after prep • Low vial-to-vial variability • Requiring a minimum preparation or ready to use • Reasonable in price
- 29. Storage of QC Samples • Controls are aliquoted into smaller ‘user friendly’ volumes for storage • Establish a storage protocol: • store at -20oC • in use vials stored at 4oC • use 0.5 ml vial maximum of one week
- 30. Monitoring QC Data • Use Levey-Jennings chart • Plot control values each run • Acceptance of run • Monitor precision and accuracy of repeated measurements • Review charts at defined intervals, take necessary action, and document
- 31. Findings Over Time • Ideally should have control values clustered about the mean (+/-2 SD) with little variation in the upward or downward direction • Imprecision = large amount of scatter about the mean. Usually caused by errors in technique • Inaccuracy = may see as a trend or a shift, usually caused by change in the testing process • Random error = no pattern. Usually poor technique, malfunctioning equipment
- 33. Westgard Rules • “Multirule Quality Control” • Uses a combination of decision criteria or control rules • Allows determination of whether an analytical run is “in-control” or “out-of-control” • Atleast run 2 control samples 12S rule R4S rule 13S rule 41S rule 22S rule 10X rule
- 34. Westgard – 12S Rule • “warning rule” • One of two control results falls outside ±2SD • Alerts tech to possible problems • Not cause for rejecting a run • Must then evaluate the 13S rule 12S rule violation
- 35. Westgard – 13S Rule • If either of the two control results falls outside of ±3SD, rule is violated • Run must be rejected • If 13S not violated, check 22S 13S rule violation
- 36. Westgard – 22S Rule • 2 consecutive control values for the same level fall outside of ±2SD in the same direction, or • Both controls in the same run exceed ±2SD • Patient results cannot be reported • Requires corrective action 22S rule violation
- 37. Westgard – R4S Rule • One control exceeds the mean by – 2SD, and the other control exceeds the mean by +2SD • The range between the two results will therefore exceed 4 SD • Random error has occurred, test run must be rejected R4S rule violation
- 38. Westgard – 41S Rule • Requires control data from previous runs • Four consecutive QC results for one level of control are outside ±1SD, or • Both levels of control have consecutive results that are outside ±1SD 41S rule violation
- 39. Westgard – 10X Rule • Requires control data from previous runs • Ten consecutive QC results for one level of control are on one side of the mean, or • Both levels of control have five consecutive results that are on the same side of the mean 10x rule violation
- 41. When a rule is violated!!!!! • Warning rule = use other rules to inspect the control points • Rejection rule = “out of control” • Stop testing • Identify and correct problem • Repeat testing on patient samples and controls • Do not report patient results until problem is solved and controls indicate proper performance
- 42. Types of Errors Random=Fluctuations Temperature Personnel Systematic Reagent problem Device problem
- 45. Quality indicators for post analytical phase • Turn around time • Laboratory reports • Notifications of critical values • Interpretative comments
- 46. Post-Analytical Stage • Delta Check • Report entry • Report verification at 2 different levels • Report print out • Turn around time • Emergency parameters: 1 hour • Routine parameters: 2 hours • Special immuno parameters: 2:30 hours
- 47. Sample storage for last 2 days at 4 degree C
- 48. How to get it done in the lab? • Plan: define the course of action • Organized process • systematically monitored by using accurate measures • Staff: who does what • Lead the action • Control the system process
- 49. Six sigma matrics • Six Sigma metrics are being adopted as the universal measure of quality to be applied to their processes and the processes of their suppliers. • Six Sigma provides a more quantitative framework for evaluating process performance and more objective evidence for process improvement. • Two methods can be used to assess process performance in terms of a sigma metric (+6S to -6S). • outcomes by inspection & variation and predict process performance. • Sigma = (TEa − bias)/SD [TEa=allowable total error] • Methods with Six Sigma performance are considered “world class”; methods with sigma performance less than
- 50. THANK YOU
- 51. Points to take away ???