Laboratory Management - 03 Quality Management System

LABORATORY MANAGEMENT • QUALITY MANAGEMENT SYSTEM OUTLINE o Manipulation of Data • Quality Management System o Examination of Control Charts o Introduction o External Quality Assessment o Quality Control Programs o Quality Assurance o Indicators of Quality o TQM & CQI Performance: Institutional o QA&I and CPI Programs o Major Figures in Quality o Management of Quality Management o Quality Monitoring and • Quality Control Assessment Tools o Quality Assurance o Basic Quality Control o Statistics Statistics o Quality Control o Graphic and Systematic o Westgard Rules & LeveyPresentations of Information Jennings Chart o Specialized Laboratory Data o QC Monitoring Evaluation Methods o Lean Sigma Six Methodology o Interpretative Strategy QUALITY ASSURANCE • • • QUALITY MANAGEMENT SYSTEM • The quality management system coordinates and controls the most comprehensive tool, linking and integrating all quality-related processes and procedures throughout the organization, with the aim to improve them permanently and thus, strengthen the company's position in the market and ultimately to secure the jobs. INTRODUCTION • • • • • Quality Management System o defined as “coordinated activities to direct and control an organization with regard to quality” Quality Control (QC) o refers specifically to the activities directed toward monitoring the individual elements of care Quality Assurance (QA) o a program in which the overall activities conducted by the institution are directed toward assuring the quality of the products and services provided Total Quality Management (TQM) o A quality management program that includes each component (customer, producer and supplier) in the creation process o Systems approach that focuses on teams, processes, statistics, and delivery of services/products that meet or exceed customer expectations Quality Assessment and Improvement (QA&I) o A quality management program that focuses on the success of the organization in designing and achieving its set goals and objectives • • Relies heavily on quantitative statistical methods that focus on the final product as defined by the standards set by the producer Is a system of ensuring accuracy and precision in the laboratory by including quality control reagents in every series of measurements Is a process of ensuring that analytical results are correct by testing known samples that resembles patient sample A program in which the overall activities conducted by the institution are directed toward assuring the quality of the products and services provided Focused on recipient (patient) and monitoring of outcomes or indicators of care 10 step QA monitoring process (JCAHO) o Assign responsibility for QA plan o Define scope of patient care o Identify important aspects of care o Construct indicators o Define thresholds for evaluation o Collect and organize data o Evaluate data o Develop corrective action plan o Assess action; document improvement o Communicate relevant information TOTAL QUALITY MANAGEMENT (TQM) AND CONTINUOUS QUALITY IMPROVEMENT (CQI) • • Replaced the QA model expanded emphasis on satisfying the needs of the customer Focus on the complete process (supplier to customer) and its analytical and troubleshooting methodology QUALITY ASSESSMENT AND IMPROVEMENT (QA&I) AND CONTINUOUS PERFORMANCE IMPROVEMENT (CPI) • • • • • QUALITY CONTROL • It involves the process of monitoring the characteristics of analytical processes that detects analytical errors during testing, and ultimately prevent the reporting of inaccurate patient test results QA&I incorporates the concepts of quality assurance and TQM/CQI QA&I focuses on the success of the organization in designing and meeting set goals and objectives “Continuous Performance Improvement” Steps in improving organizational steps (JCAHO): 1. Plan the CPI process 2. Design the assessment and monitoring system 3. Measure the performance 4. Assess performance 5. Improve performance 9 dimensions of performance 1. Efficacy 2. Appropriateness 3. Availability 4. Timeliness 5. Effectiveness 6. Continuity 7. Safety 8. Efficiency 9. Care and Respect MAJOR FIGURES IN QUALITY MANAGEMENT • • • • Philip Crosby W. Edwards Deming Joseph Juran James O. Westgard 1 QUALITY MONITORING AND ASSESSMENT TOOLS • • Standard Deviation o A measurement of precision or tendency of the values in each population to cluster, center or scatter around the mean o A measure of the dispersion of values from the mean. It helps describe the normal curve. A measure of the distribution range. It is the most frequently used measure of variation o Formula: • Coefficient of Variance o Allows a comparison and check on the precision and variability of each method o Formula: Tools for measurement of quality and performance in the laboratory: o Statistical techniques o Graphic and monitoring methods o Interpretive strategy o External programs o Methods that are intended to monitor the delivery of overall services BASIC QUALITY CONTROL STATISTICS • Accuracy vs Precision o • GRAPHIC AND SYSTEMATIC PRESENTATIONS OF INFORMATION Data Population vs Population Sample • Data alone have no particular interpretive value STANDARD DATA PLOTTING TECHNIQUES • • • Gaussian Distribution First task: arrange and present data in a manner that facilities further analysis-”orderly array of data” Once results are arrayed in an orderly manner, results can be presented in an informative format (graph, chart or pictorial display) o Basic Statistical Graphs o Gaussian Distribution Displays BASIC STATISTICAL GRAPHS • • • Circle or Pie Charts • Bar Graphs Percentage and Probability Mean ( x̅) • Arithmetic average for all the data contained in a sample population. • is a measure of central tendency, it is associated with symmetrical or normal distribution • Formula: Mean = ∑x N 2 • Line graphs • Pareto Charts • Cause-and-Effect Diagrams • • Run Charts Scatter Diagram • Story Boards GAUSSIAN DISTRIBUTION DISPLAYS • • Histogram Frequency polygon SEVEN OLD METHODS • Flow Charts SPECIALIZED LABORATORY DATA EVALUATION METHODS • • Levey-Jennings Chart o Control charts used to plot quality control against previously set limits to determine • Youden Plots o Used to demonstrate and compare performance of a laboratory on paired samples with other laboratories using common control lots or survey material Control Charts 3 o • Use means and SDs from all participants to prepare a chart on which each laboratory’s results can be marked to show its performance in relationship to the whole group • 2₂s -the last 2 control results ( or 2 results from the same run ) exceed either mean ± 2SD; respond most often to systematic errors/continuous error o Must be rejected, if occurs • 41s - the last four (or any four) consecutive control results exceed either mean ±1SD; respond to systematic errors • R4s - the range or difference between the highest and lowest control result within a analytical run exceeds 4SD; respond to random errors or increased imprecision • 6x – reject when 6 consecutive control measurements fall on one side of the mean, indicate shifts, systematic/calibration error • 7T – reject when seven control measurements trend in the same direction, i.e., get progressively higher or progressively lower., indicates trend o Reagent deterioration error Multirule Analysis o Commonly referred as “Westgard rules” o Each rule is designed to detect or warn of an impending error or malfunction that may be either halt the reporting of the results until the problem is corrected or signal the need for preventive maintenance WESTGARD RULES • • 1₂s -it is used as a rejection or warning rule when one control result exceeds the mean ±2SD; for screening purposes o no rejection, warning only 1₃s - one control result exceeds the mean ± 3SD; it is effective in determining random error; automatic reject o Random error - unexpected error due to fluctuations, variation in technique that disappear with repeating procedures 4 • 8x - reject when 8 consecutive control measurements fall on one side of the mean, indicate shifts, systematic/calibration error • 9x - reject when 9 consecutive control measurements fall on one side of the mean, indicate shifts, systematic/calibration error • • 31s - reject when 3 consecutive control measurements exceed same mean plus 1s or mean minus 1s control limit. INTERPRETATIVE STRATEGY • 10x – ten consecutive results are on the same side of the target mean; systematic error Error o Related to accept/ reject and problem/no problem decisions o An error can be made in either direction o 2 types: ▪ Random error- may occur at any time and place within the testing or service process; indicative of imprecision in an analytical process ▪ Systematic error- occurs in a consistent direction or pattern; problems of inaccuracy show up MANIPULATION OF DATA • Statistical Bias o Having a set of numbers that do not truly reflect the characteristics of the whole population which may be either circumstantial or intentional EXAMINATION OF CONTROL CHARTS • 12x – reject when 12 consecutive control measurements fall on one side of the mean. • 2of32s – reject when 2 out of 3 control measurements exceed the same mean plus 2s or mean minus 2s control limit • Skewed Curves o Deviations from the symmetrical bell-shaped appearance of a frequency polygon • Trend o Marked by a systematic drift in one direction away from the established mean o Signal the gradual deterioration of procedure components (reagent, standard or instrumentation) 5 • Dispersion o Occurs when control values are widely scattered in an unusual and unexplained pattern around the control chart o Sign of loss of precision INDICATORS OF QUALITY PERFORMANCE: INSTITUTIONAL PROGRAMS • • • Utilization Review Peer Review Organization Critical-Care Pathways o A hospital-wide quality care management program that places emphasis on the outcomes of treatment received by the patient as the definition of quality o Emphasis on the outcomes of treatment received by the patient as the definition of quality o Incorporates all the resources of the health care system into delivery of an exact series of interventions or treatments that are to be received by the patient in a designated time period in response to specific symptoms MANAGEMENT OF QUALITY • Shift o Sudden switch of data points to another area of the control chart away from the previous mean EXTERNAL QUALITY ASSESSMENT PROGRAMS • Areas o The Philosophy or Attitude of its People o The Operational Systems o The Actual Quality Assessment and Monitoring Program in Place QUALITY MANAGEMENT PROGRAMS • • 2 types for review purposes o Proficiency surveys o Licensure and accreditation programs/Laboratory Inspection Laboratory QA Process o Series of unknown samples are sent to the laboratory to from the reference laboratory or authorized program provider o Unknown samples must be tested by the laboratorians who regularly perform analysis of patient specimens using the same reagents and equipment for actual patient specimen o The results are submitted to the program provider, preferably as soon as every analysis is done • Ongoing activities that can be defined directly as part of quality management programs include: o Preventive Maintenance (PM) o Policy and Procedure Manual Writing and Review o Quality Control Functions o Staff Orientation, Continuing Education and Development o Participation in Proficiency Testing o Problem solving and troubleshooting o Laboratory Inspection, Accreditation and Licensure Process 6 QUALITY CONTROL • IMPORTANT FORMULAS Quality Management & Assurance - procedures used to monitor performance of laboratory subsumes all pahses QUALITY ASSURANCE • • • • • Monitor performance Covers all the phases of laboratory analysis: preanalytical, analytical, and post-analytical Quality control o Focus on the analytical phase o Method evaluation o Performed before testing o Done every day/every morning o Check if QC is acceptable for testing for the day ▪ Check if machines are working properly, instruments are well calibrated, and reagents are well intact to ensure accuracy and precision o Ensures accuracy and precision of testing Precision vs. Accuracy o Achieved for quality control o Precision - consistency and reproducibility of results ▪ Doesn’t always mean accurate o Accuracy - target, expected/true result; all results should be near the expected value; always considered as precise ▪ All runs will lead to specific target/expectation o Should go hand in hand Analytical Sensitivity vs. Analytical Specificity o Analytical Sensitivity - ability of method to detect lowest possible concentration ▪ Higher sensitivity increases chance of false pos o Analytical Specificity - ability of method to detect target/analyte of interest and able to discriminate all interferences ▪ Higher specificity lowers chance of false positive o Diagnostic sensitivity - ability to detect abnormality if result is positive/pathologic o Diagnostic specificity - ability to determine absence of disease if result are negative/within range • • QC - do not use minus 1 (degree of freedom) o Degree of freedom - take consideration other values when only a portion is used o Since all values are used, there is no need for degree of freedom CV - coefficient of variation QUALITY CONTROL • • • • • Systematic approach of monitoring the analytical phase of the laboratory analysis o Specifically, QC for machines Use of control, run as samples, and plot the results in a chart (Levey Jennings and Westgard Charts) o Controls - either prepared in-house or purchased commercially o Low, normal, high controls are used o Westgard rules - standardly used Each charts has a specific range of acceptable values known as “control limits” Specific set of rules (Westgard rules) is followed to determine if the run is acceptable or not Minimum runs per QC: 20 samples (1/day) WESTGARD RULES AND LEVEY-JENNINGS CHART • • Three control limits Use the Westgard rules to determine violations STATISTICS • • • Presenting/organizing data Descriptive Statistics o Central tendency (mean, median, mode) ▪ Mean - arithmetic average; important in lab ▪ Median - centermost value ▪ Mode - most occurring value o Dispersion/Spread (standard deviation and variance)’ ▪ SD - average distance of all values from mean ▪ Variance - ave. distance of values from each other o Used in lab management Inferential Statistics o Used to apply conclusions and/or generalizations o Compare significant differences (between two or more data sets/means) ▪ T-test - compare means ▪ F-test - compare variances o Determine relationships (between two or more data sets) ▪ Inverse relationship ▪ Direct relationship ▪ Pearson correlations • HOW TO CREATE LJ/WESTGARD CHART • • • • Step 1: Using the given values, solve the following: o Mean o Standard Deviation Step 2: Multiply your standard deviation to 1 (1SD), 2 (2SD), and 3 (3SD) Step 3: Determine your control limits by adding or subtracting your SD values (1, 2, and 3) to you mean (mean is the center of the graph) Step 4: Plot the values in the LJ Chart and check for violations in accordance with Westgard multirules 7 SAMPLE PROBLEMS • Values o Mean = 100.3 o SD = 22.89 ▪ Used =stdev.p(range) o +1SD = 123.19 -1SD = 77.41 o +2SD = 146.08 -2SD = 54.52 o +3SD = 168.97 -3SD = 31.63 • MEASURES OF DIAGNOSTIC PROCEDURE EFFICIENCY • • • • • • <10 values have minimal violations; minimum of 20 days to observe violation Always answer with the first violation that occur in the earliest date (for assessment) • QC CHARTS CAN BE USED TO DETECT ERRORS • • Random Error o May appear at any time, not continuous o May be due to ▪ Variations in technique ▪ Fluctuations ▪ Temperature ▪ Instrument instability Systematic Error o Continuous errors o May be due to ▪ Deteriorating reagents (replace) ▪ Improper technique ▪ Calibration and instrument/equipment error ▪ Poorly written SOP (Standard Operating Procedures) and laboratory procedure manual o Ruling out errors ▪ Check reagents → check instrument calibration → check equipment calibration → check technque QC MONITORING • Interlab QC (Internal) o Daily monitoring o Control materials may be prepared in-house or commercially purchased ▪ In-house - uses pooled serum or plasma ▪ Commercially purchase - cleaned out for possible infections Intralab QC (External) o Proficiency testing - CAP (College of American Pathologists); Private accrediting bodies ▪ Every 6 months, CAP sends samples o EQAS (External Quality Assurance Systems) ▪ Government-based (DOH) thru reference labs ▪ Lung Center - CC ▪ San Lazaro - venereal diseases ▪ East Avenue - Drug Testing ▪ RITM - transfusion-related diseases o Accreditations: ▪ Laboratory inspection (equipment, disposal) ▪ Chemical utilization (inventory) ▪ Internal QC (charts) o Has accrediting body o Lab is compared with other labs Diagnostic sensitivity - detect the presence of disease in unhealthy/ill patients o D Sens. % = [true positive / TP+FN] x 100 Diagnostic specificity - detect the absence of disease in healthy patients o D spec. %= [all negative results / TN + FP] x 100 Positive Predictive value - chance of an individual having a given disease or condition if the test is abnormal o PPV % = [all positive / TP + FP] x100 Negative Predictive value - chance an individual does not have a given disease or condition if the test is within the reference interval o NPV % = [all negative / TN + FN] x 100 Cut-off values /medical decision limits - values that separates normal from abnormal o Too high - increased false negative o Too low - increased false positive LEAN SIGMA SIX METHODOLOGY • • • • • Combination of Six Sigma quality management Developed by Motorola, with Lean manufacturing Pioneered by Toyota Tangible metrics for quality improvement DMAIC Methodology o Define phase - explicitly describes the quality improvement issues o Measure phase - the team collects data to measure the process and determine the difference between the current process and the desired one o Analyze phase - searches for the root causes of inefficiencies in the process o Improve phase - the team pilots process changes that seek to remove the identified root problems o Control phase - continues to measure the process and ensures changes are maintained 8