MT105 Laboratory Management Quality Assurance PDF

MT105: Laboratory Management QUALITY ASSURANCE conducted by the institution that are Quality Control...

MT105: Laboratory Management QUALITY ASSURANCE conducted by the institution that are Quality Control directed toward assuring the quality of the Quality control relies heavily on quantitative services provided statistical methods that focus on the final QA focused on the recipient. product as defined by standard set by the Risk management, in-service and producer continuing education, safety programs, Historically, the application of statistical quality control, and peer review are all part methods to the evaluation of the quality of of the quality assurance program products and services. Quality Assurance Model In the QA model, QC refers specifically to the activities directed toward monitoring the individual elements of care (e.g instrument and test procedures Example: In the laboratory, controls are processed periodically to make sure that the procedure is within control limits. If the controls are within range under the QC model, the techs are secure in the knowledge that they are turning out a high quality result The strength of the QC approach to quality QUALITY CONTROL management is that precise performance Applied to all other activities that can be standards can be established and directed towards monitoring of the measured with objective analytic tools individual elements of care The weakness of your QC system lies in its Example: like instrument and other test emphasis on the evaluation of the final procedures product. This often makes troubleshooting QUALITY ASSURANCE also difficult More focused on the monitoring of Quality control relies on standards and outcomes or the output or the indicators of techniques that measure the quality of the care product in isolation from the needs of the One of the major criticisms of the quality customer or the patient assurance program is the absence of any Quality Assurance specific guidelines or reference materials material for meeting the JCAHO QA Developed out of the limitations of the QC accreditation standards approach and defined quality in the In 1985, JCAHO published its 10-step QA healthcare institutions with the success of monitoring process the total organization not just individual components of the system in achieving the 10-STEP QA MONITORING PROCESS goals of patient care 1. Assign responsibility for QA plan The Joint Commission on Accreditation of 2. Define scope of patient care Healthcare Organizations or JCAHO, defined 3. ID important aspects of care quality assurance as the overall activities MAAMO-GONATO-MERCADO  our patients. Although an improvement over quality 4. Construct indicators control, quality assurance over emphasize 5. Define thresholds for evaluation outcomes like the quality control model but it failed 6. Collect and organize data to improve the trouble shooting capabilities of the 7. Evaluate data system or to fully include the patient’s viewpoint in 8. Develop a corrective action plan the definition or measurement of quality. 9. Assess action; document improvement 10. Communicate relevant info QUALITY CONTROL AND QUALITY ASSURANCE COMPARISON CHART JCAHO attempted to provide a new QA QC terminology to nail down a program that both promotes and measures quality in A managing tool A corrective tool healthcare institutions. They were able to develop a plan to assess and ensure the Process - oriented Product- oriented quality of the services delivered by the Proactive strategy Reactive strategy laboratory. The manager must have a full understanding of both the history and Prevention of defects Detection of defects philosophy of quality up to this point as well Everyone’s Testing team’s as knowledge of specific statistical responsibility responsibility techniques and their application to the laboratory Performed in parallel Performed after the with a project final product is ready THE FOLLOWING COLLECTION OF ACRONYMS ILLUSTRATES THIS JOURNEY QUALITY ASSURANCE Managing tool because it is a process- oriented - This means that quality assurance creates a QC/MBO – QA – TQM/CQI – QA&I/CPI –?QC/MBO way of preventing mistakes and defects and manufactured products and also avoiding problems when delivering products and These illustrate the history of the terminology of services to our patients. It is part of quality quality and the programs that were in vogue in the management which focuses on providing healthcare community from the 1970s up until this confidence that quality requirements will be time. With the 1995 JCAHO standards, the concepts fulfilled and principles of quality management have returned to their roots of quality control and QUALITY CONTROL management by objectives that is to set A corrective tool because it is designed to detect, performance objectives and measure their reduce, and correct deficiencies especially in a achievement. This is not to say that we have not laboratory set up. learned a lot from a pursuit of a definition of quality - So the laboratory’s internal analytical and for ways to measure its existence and intensity. process prior to the release of our patient’s results. Also, in order to improve the quality We have actually learned a great deal. Following is a of the results reported by the laboratory brief review of the ideas and contributions found at itself. each stage of this voyage and the remaining Quality Control is a measure of precision. questions that have driven the search for new - How precise or how well the measurement methods. Lets go back to quality assurance. system reproduces the same result over time and under varying operating What do you think is the major contribution of conditions quality assurance? Laboratory quality control material - Is usually run at the beginning of each of the To point out that the true indicator of a quality shift per medtech after an instrument is also service is always patient care. Especially if we talk serviced or there are new reagents. So, about hospital setting or even in the laboratory set there’s a need for reagent lot changes or up. It is always patient care. It is not just an ability of after equipment calibration and whenever an individual medtech which is part of the entire patient results seem inappropriate. system of the hospital to do its job well but it is to - Quality control material should approximate make sure that we deliver the best quality service to the same matrix as patient specimens MAAMO-GONATO-MERCADO  taking into account properties such as service. viscosity, turbidity, composition, color. It should be simple to use with minimal vial to RESPONSIBIL Everyone on the Quality control is vial variability because variability could be ITY team involved in usually the misinterpreted as systematic error in the method or instrument developing the responsibility of a - It should be stable for long periods of time product is specific team that and available in large enough quantities for responsible for tests the products single batch to last at least one year. quality assurance for defects. - Liquid controls are more convenient than lyophilized or freeze dried controls because EXAMPLE Verification is an validation/ they do not have to be reconstituted example of QA Software Testing is minimizing pipetting errors. an example of QC QUALITY QUALITY CONTROL TECHNIQUES Statistical tools & When statistical ASSURANCE techniques can be tools and applied in both QA techniques are DEFINITION QA is a set of QC is a set of & QC. When they applied to finished activities for activities for are applied to products (process ensuring quality in ensuring quality in processes (process outputs), they are the processes by products, focused inputs & called as which products are on identifying operational Statistical Quality developed. defects in the parameters) they Control (SQC) & products are called comes under QC produced Statistical process control (SPC) & it FOCUS QA is a proactive QC is a reactive becomes the part quality process process to identify of QA. which aims to (and correct) prevent defects in defects in the AS A TOOL QA is a managerial QC is a corrective the process used to finished product/ tool tool make the product. ORIENTATION QA is a process QC is a product GOAL To improve To identify defects oriented oriented development and in a developed test processes to product before it’s reduce defects released. Management by Objectives when the product is MBO being developed. A program that embodies all of the HOW QA established QC find & concepts in the management process good quality eliminate sources Incorporates the principles of planning, management of quality operating, directing, and controlling and systems and the problems through even providing a mechanism to bring all of assessment of its tools & equipment these concepts into everyday practice adequacy and so that costumer’s especially when it comes to working inside conformance requirements are audits of the continually met. the laboratory. system. The core of MBO is through communication The success of failure depends on how well WHAT Prevention of The activities or the employees inside the laboratory quality problems techniques used understands the hospital or the laboratory’s through planned to achieve and mission and objectives and systematic maintain the activities including product quality, documentation. process and MAAMO-GONATO-MERCADO  Also laboratory managers must understand ➔ Total Quality Management’s Principles of where the staff are headed and how Continuous Quality Improvement is focused individual employees perceive their jobs on the complete process from supplier to To effectively design and implement an MBO our patient or customers and its analytical program the manager or the administrator and troubleshooting methodology are or even the chief medtech must understand contributions that remain an important part and be skilled at writing and monitoring all of all quality management programs of these objectives ➔ The very core of the adaptation of total quality management makes use of the TQM/CQI following factors TCM = Total Quality Management CQI = Continuous Quality Improvement Both of these ideas quickly replaced the quality assurance model because it has expanded emphasis on satisfying the needs of the customer or our patients especially in it’s ultimate definition of quality: “A delighted customer”. To accomplish the delighted customers goal TCM/CQI hed that the total enterprise as well as each unit within the organization 1. Patient Focus 2. Employee involvement and especially each employee had to (so we can provide best quality of service to successfully perform and meet the patients) obligations of three simultaneous roles: 3. Process centered Customer, Producer, and Supplier. (Certain processes are followed in order to give patients their definitive diagnosis) The inclusion of each component in the 4. Integrated System creation process from the acquisition of 5. Strategic and Systematic approach supplies to active follow-up after the (in dealing with patients) 6. Decision-making based on facts product or service has been received by a 7. Communication delighted customer broadens the focus of (Without it, there will be no understanding quality control and quality assurance on the and comprehension) end product 8. Continuous Improvement (once we succeed in the first trial of the This emphasis on total production process entire process, then that means we can use helps to correct a major deficiency of QC it again and again) and QA by providing tools with which to THE 6 C’S OF TQM identify and troubleshoot problems that 1. Commitment might occur at each stage of production 2. Culture LAYMAN’S WORDS DEFINITION OF THE TERMS 3. Continuous Improvement Total Quality Management 4. Cooperation ➔ The management philosophy and system 5. Customer Focus that promotes positive organizational 6. Control change as well as an effective cultural environment for continuous improvement of Act Plan all aspects of the organization Once we attain the plateau of Total Quality Continuous Quality Improvement Management and Continuous Quality ➔ A systematic approach to the measurement evaluation and improvement of the quality Improvement, we will have to make use of of all products and services through the use the Act Plan Do Study or Check Diagram of disciplined inquiry and teamwork MAAMO-GONATO-MERCADO  QA&I = Quality Assessment and Improvement CPI = Continuous Performance Improvement For several reasons including the reluctance of many 1. Determine what changes are to be made hospitals to support the requirement to adopt (Determine what changes are needed or is TQM/CQI, and acknowledge difficulty in defining there a need to change because of the quality, during the 1992, JCAHO introduced this new continuous quality improvement) monitoring standard: QA and I 2. Plan QA and I incorporates the concepts of QA and (if there should be a change or we do a test TQM/CQI. QA Especially the idea that quality is a subject or a test process before we change continuous process of improving the system, not just it) an endpoint measurement and that it requires the 3. Do (Execute the plan) direct support and active participation of the 4. Checking or studying leadership of the organizationa. (if you learned something new or if it is Focuses on the success of the organization in good/bad, summarize the learnings) designing and meeting set goals and objective. With the implementation of QA and I/CPI in 1994, JCAHO (and check the new process that was was also able to monitor certain indicators through a created so that there will be a continuous computerized reporting and evaluation system as part improvement of the quality in your of their accreditation process. management They made use of the term performance and not Continuous Cycle quality because it is a much easier concept to define and measure Another diagram for Continuous Quality JCAHO has defined the steps for improving Improvement organizational performance through standards that monitor each stage of the CPI process. 1. Plan the CPI process 2. Design the assessment and monitoring system 3. Measure the performance 4. Assess performance 5. Improve performance JCAHO 9 DIMENSIONS OF PERFORMANCE JCAHO has also established 9 dimensions of performance. The what and how of continuous performance improvement and patient care. That must be included and measured in the design of the organization’s quality assessment and performance improvement plan. These are the 9 dimensions of performance: 1. Efficacy Develop: we develop a certain process in order to 2. Appropriateness 3. Availability improve quality 4. Timeliness Implement: we implement that process into our 5. Effectiveness system or the management or the organization 6. Continuity 7. Safety Evaluate: Check if it is a good or bad technique or 8. Efficiency process and if ever it is a bad technique, then we 9. Care and respect need to improve it. Hence a continuous cycle Even before it has been fully implemented, QA and I is generating harsh criticism from those who point out QA&I/CPI that the measurement of pre-determined goals appears to be just as rehash of management programs such as MBO and standard QC practices. MAAMO-GONATO-MERCADO  Designed the cause and effect diagram Philip Crosby # Quality Defintion Evangelist of quality management Dimension He preached the need for quality practices in the book Quality is Free and through the 1 Performance Primary operating worldwide consulting network of quality characteristics of a colleges product Crosby propounded that “Quality is free, poor quality is expensive”, “Do things right 2 Features Characteristics that the first time”, and “Zero defects is the only supplement basic legitimate goal of a quality program”. product performance W. Edwards Deming features Often credited with providing the japanese with the information and training that 3 Reliability Probability of a brought them to their position as the world’s leader in the production of quality products products success A statistician who worked with Shewhart within a specific period introducing the use of statistical tools in of time decision making, problem solving, and troubleshooting the production process 4 Conformance Degree to which a Frequently cited as the source of most of the product’s design and concepts and methods contained in the operating total quality management model characteristics meet Total Quality Management Model pre-established standards 1 Create purpose for improvement 5 Durability Measure of product life: 2 Adopt new philosophy amount of time of use one obtains from a 3 Cease dependence on inspection to achieve product before it quality physically deteriorates 4 Work with one supplier to reduce cost 6 Serviceability Speed, courtesy ease of use, maintenance and 5 Continuous improvement service 6 On-the-job training 7 Aesthetics The look, fuel, sound, taste or smell of a 7 Leadership product 8 Drive out fear 8 Perceived quality Relates to the 9 Break down silos customer’s subjective opinion of the product’s 10 No slogans or company’s reputation 11 No quotas or numerical goals 12 Remove annual ratings or merit system Major Figures in Quality Management 13 Institute education and self-improvement Armand Feigenbaum programs Coined the term Total Quality Management Walter Shewhart 14 Involve all workers in the transformation His work served as a basis for the multi-role base, westgard rules Father of Statistical Quality Control Kaori Ishikawa MAAMO-GONATO-MERCADO  Deming’s 7 Deadly Diseases of Management 1. Lack of constancy of purpose 2. Emphasis on short-term profits 3. Evaluation by performance, merit rating, or annual review of performance 4. Mobility of management 5. Running a company on visible figures alone 6. Excessive medical costs 7. Excessive costs of warranty, fueled by lawyers who work for contingency fees Joseph Juran Established the concept that quality is a continuous improvement process that requires managers’ active pursuit in reaching and setting goals for improvement The Pareto Principle or 80/20 rule which states that 80% of serious problems arise from only 20% of the causes or trouble points was also introduced by Juran According to the Pareto Principle, managers should focus their time and efforts on identifying and solving the 20% Juran was a leader in promoting participatory management styles. He pointed out that it was necessary for all employees to be included in and committed to the continual process of designing and producing a quality product Quality circles and project teams, which use a wide variety of employee inputs, are 2 methods that trace their origins to the teaching of Juran. James O. Westgard A professor at a University of Wisconsin Medical School and asset director of clinical laboratories quality assurance with the University of Wisconsin Hospital and Clinics and Medicine He applied Shewhart's multi-role system to the evaluation of the quality control data in the medical laboratory, particularly the multi-range controls used in the clinical chemistry The six rules for accepting or rejecting control run are now commonly referred to as the Westgard Rules MAAMO-GONATO-MERCADO MT105: Laboratory Management QUALITY MONITORING AND ASSESSMENT TOOLS Quality Monitoring and Assessment Tools The precise techniques and mechanisms of quality control are familiar to every technical professional in the laboratory. The objective of this section is to present a short survey of the concepts and terminologies frequently found in professional examinations at the supervisory level. These concepts provide a baseline for the discussion of quality management in the medical laboratory. Tools for Measurement of Quality and Performance in the Lab can be reviewed in 5 groups: 1. Statistical techniques that establish performance limits for the analytical accuracy and precision of testing protocols. 2. Graphic and monitoring methods that aid in review, Not all accurate values are precise, not all precise values are troubleshooting, and decision making systems. accurate 3. Interpretative strategy for evaluating statistical and SAMPLE PROBLEM: monitoring methods. Analyze a triglyceride standard with a known value of 200 4. External programs that provide resources for the mg/dL five times. independent assessment of the technical performance of the lab. Precise but not accurate: If we analyze a 5. Methods that are intended to monitor the delivery triglyceride standard with a known value of 200 of the overall services of the laboratory as part of mg/dL five times and obtain values of 169, 167, 170, the health care team. 168, and 169. Basic Quality Control Statistics Accurate and precise: Analyzing a triglyceride standard with obtaining values of 200, 199, 198, 197 From the multitudes of statistical calculations available to the analyst, four measurements constitute the base and 196 for quality assessment efforts. These statistical tools are Accurate but not precise: Obtaining values at 201, quite familiar to laboratorians and are particularly 202, 170, 189. (There are outliers: very far values) But applicable to situations in which performance can be two values are closer to the true value. quantified. These four measurements are the Not accurate and not precise: No values reach the 1. mean (arithmetic average) correct or true values and none of the values are 2. standard deviation from the mean (SD) close to one another: obtaining values of 123, 99, 3. Coefficient of variance/variation 4. Percentage - The most widely used statistical 201, 300, and 400 calculation of all Standard in the laboratory Accuracy and Precision are two crucial terms in any When you are using a standard in the laboratory it has a analytical process predetermined value, meaning if your machine is about to The very core characteristic of a medical be calibrated by a certain standard it has to arrive at a technologist inside the laboratory certain value closest to the predetermined value. Accuracy High accuracy, High Results of the quality ▪ Closeness of a result to the actual value of an precision control is within the true or analyte when performing a test target value and all data ▪ That means "hitting the bull's eye” are close to one another Precision ▪ Determined by how well the procedure reproduces Low accuracy, low None of the values reach the same values. precision the target value and none ▪ That means the repetition of a certain number or the of the values are close to number closest to each other. one another ▪ Arrived at a calculator or a measurement that are close to one another Low accuracy, high The data are packed at  The individual values of a population fall within this precision one part or are close to following boundaries: one another but none of - 68.2% within ±1 SD of the mean the data reach the true - 95.4% are within ±2 SD of the mean- value accept/reject decision - 99.7% are within ±3 SD of the mean High accuracy, low Data are closer to the precision target value but are not PERCENTAGE AND PROBABILITY (P) close to one another P is usually expressed in statistical notation as a decimal (0.0 to 1.0) accdg to the likelihood of an event occuring. Data Population The nearer to zero, the less likely it is to occur The pool of individuals from which a statistical sample is The nearer to one, the more likely the event is about to drawn for a study, thus any selection of individuals happen grouped together by a common feature so they have a Probability may also be expressed in the negative, for common feature can be called a population. (Same sex, example: location, age, depending on the subject of interest) - The likelihood of an acceptable control value falling Used to describe and define the items that are being outside the ±3 SD range is only 0.003 studied at a particular time. How is it calculated? ❖ The population maybe all the values obtained on a Remember that ±3 SD has a percent of 99.79% so you normal creatinine control for one month or the subtract 1 (1-0.997= 0.003) patients who had glucose tolerance test during the - In a more common language, probability is past year expressed as a percentage like: Defined by the interest of the person doing the – there is a 50% chance of rain today statistical study. – or sometimes, you say it as there is a 0.5 probability of rain for today. Population Sample A sample for statistical purposes is a part of a population that is used to analyze the characteristics of that population. It is a particularly useful technique when evaluating a population with a large number of entities which makes it impractical to include every member in the study. In general, the larger the sample selected, the more representative of the population; however, as a general rule most statisticians hold that a sample size of at least MEAN 30 is satisfactory for most studies. To be truly representative and to avoid bias, samples should be Arithmetic average for all the data contained in a selected at random. sample population. Random (e.g Probability Sample) – in a manner that - Such as the value obtained by running a glucose ensures that each unit of the population has an equal control for 1 month chance of being included in the study. - Or your scores so that you can calculate for your N - number of observations (individuals, measurements midterm grade or values) that make up the sample used for calculating - Or other sets of data in order for you to get the statistical indexes. average or the mean. ❖ Example: The laboratory and the pharmacy maybe Computing the sum of the values contained in the interested in reviewing the causes for assumingly population and dividing it by the number of values high frequency of gentamicin trough levels that included in the calculator. exceed acceptable limits. The laboratory may example: have done several hundred gentamicin trough levels during the period of interest of which 100 exceeded acceptable dose levels. Instead of an in depth review of every assay, the study may need to investigate only 30 cases to find the cause of the deviation. (N=30) GAUSSIAN DISTRIBUTION “Bell- shaped curve”, “normal distribution”, “frequency polygon” and “Levey-Jennings chart” EAT GURLS  STANDARD DEVIATION REMINDER: The mean and the median are not always the same so don't Measurement of precision, to the tendency of the be confused. BOTH of this describes the midpoint of a values in each population to cluster, center, or population however, the mean is a calculated value whereas scatter around the mean the median is obtained by aligning the population from the smallest to the largest unit and selecting the midpoint. So the point at which exactly 50% of the population falls on both sides - If there are 2 midpoints, you add the two numbers, divide it by 2 and that would be your median number. - A range of two standard deviations: (+/- 2SD) – is generally considered as the minimal limit for individual control value to be acceptable because 95% of all legitimate values should be within this range. The mean and the standard deviation form the guidelines delineated in the Westgard Rules and the points plotted in the Levey-Jennings chart. MEAN - In calculating the SD for a particular control, the The average value difference or variants for each values for the mean How to find the Mean: is used to established the acceptable range for 1. Add up all the numbers. each control level. 2. Divide the sum by the number of values. E.g. the mean of 3,2,10,5 is 3+2+10+5 = 20 = 5 COEFFICIENT OF VARIANCE (CV) 4 4 This procedure allows the comparison and check on the precision and variability of each method. MODE The smaller the CV- the more precise the The most frequent number procedure. Special cases: The CV is usually expressed as a percent and is - No mode if all the numbers occur the same calculated by dividing the standard deviation by amount of times, the mean and multiplying the result by 100. - More than one mode if more than one number is The interpretation of CV numbers must be placed in the most frequent. the context of the methodology of each procedure. Tests that closely follow Beer’s law for endpoint MEDIAN reactions are expected to have very tight CV The middle number percentages whereas the rate reactions used to How to find the Median: measure enzyme activity usually experience a 1. Put the numbers from smallest to largest. much larger range. 2. The number in the middle is the median. If there are two middle numbers, add them and divide by two. RANGE Difference between the highest and lowest numbers How to find the Range: GRAPHIC AND SYSTEMATIC PRESENTATIONS OF 1. Put the numbers from smallest to largest. INFORMATION 2. Subtract the lowest value from the largest. One of the more difficult yet important task of any quality management program is turning the data collected from the monitoring process into information that can be used to troubleshoot and improve the production process. Data alone have no particular interpretative value. If placed within the context of other data points or material however, they can become extremely useful in the EAT GURLS  decision-making process. This topic outlines the These maybe helpful in presenting comparative, most popular techniques in quality management interpopulation and intrapopulation factors. This for organizing, grouping and sorting data into may range from showing the makeup of a formats that can assist the manager in evaluating population to comparing different populations with the situation and in taking the necessary action to a key indicator or measurement. bring out improvements. With the advent of The bars in the graph may extend vertically or computer technology and desktop publishing, the horizontally. The point is to present the information boundaries for the graphical display of information in a manner that best demonstrates and clarifies have exploded. Bar and circle graphs are now the information being detailed and that assists the being drawn in 3D, multicolored topographical users and their evaluation. schematic figures that can incorporate and demonstrate the relationships between numerous factors on a single graph. Standard Data Plotting Techniques First task: arrange and present the data in a manner that facilitates further analysis. This procedure is referred to as "Orderly array of data” from lowest to highest value, chronologically by run LINE GRAPHS or date, in groups of sex and age, etc. These are particularly useful for plotting and This step is usually part of the data collection plan tracking data over a period of time. If you connect with continuous monitoring systems such as a the dots on a Levey-Jennings chart, it will form a laboratory instrument. It is accomplished by line graph. Line graphs are very adaptable for plotting the QC data on a chart or graph as the test display of historical data, control values, instrument is performed. parameters, workload volume and blood bank Once the data have been arranged in an orderly refrigerator temperature monitoring are only a few manner, the results can be presented in an of the many uses of line graphs in the laboratory. informative format as a chart, graph or other When these values are plotted over a period of time pictorial display intended to demonstrate the (shifts, days, weeks, etc.) the patterns maybe quite problems and potential solutions. Most of the revealing about areas that need attention and methods are familiar to the reader both in the require improvement especially trends or laboratory and from everyday life because they deterioration in reagent or instrument performance. frequently appear in news broadcasts, advertisements, classroom training material and anywhere people may desire to make a certain point or pitch of product. Examples: bar and pie charts, as well as the control charts used to plot the QC data. Among the list of standard data plotting techniques are the seven old methods by Deming. BASIC STATISTICAL GRAPHS Three Most Basic Methods in Presenting Information CIRCLE/PIE CHARTS Circular figures with areas marked off, shaded or GAUSSIAN DISTRIBUTION DISPLAYS sketched according to the percentage of each Popular method of displaying the frequency component compared to the whole distribution characteristics of a population. A relative frequency scale represents the vertical axis of the graph; the values of the variable being studied are located on the horizontal axis. Histogram A bar graph format to show the relative size or frequency of each class interval Class interval-is a statistical term for each part of the population. Example: one bar may represent the age group 20-30 in a patient population. BAR GRAPHS EAT GURLS  The difference between a bar graph and a histogram is: a histogram has no spaces in between the bars compared to bar graphs Control Chart Familiar to the laboratorians Used to plot control measurements against standards (i.e upper and lower limits) usually equal Frequency Polygon to the numerical value of ± 2SD (plus minus 2sd) Line graphs that give the frequency distribution its REMEMBER: ± 2SD - acceptable range in equality descriptive name, “bell curve”. control process In both a histogram and a frequency polygon, a used to identify whether a process is in or out of relative frequency scale represents the vertical axis control. of the graph. The values of the variable being studied are located on the horizontal axis and the E.g. Levey- Jennings Chart values for each class interval are then plotted in the graph using the heights of the bars of the histogram to show the relative size and dots connected by a line for a frequency polygon. If the distribution of the population follows a normal pattern, the classic bell-shape appears. SEVEN OLD METHODS Many other methods maybe used to organize and summarize information in quality management studies. Each has its own distinct advantage and analytical purpose. Deming has suggested seven techniques which the quality manager should be familiar. Flow Charts Quality management borrows the techniques and symbols of logic flowcharts used by management information system specialist to chart and analyze the specific process of information flow. Serve the same purpose in quality management programs by identifying describing the exact sequence of work tasks and checking out ways for improvement by modeling work routes. Pareto Charts EAT GURLS  Term used to a bar chart that is designed to illustrate the classical pareto principle, which states that 80% of all problems can be attributed to 20% of the possible causes. According to this concept, if the problems are matched with their causes and plotted on a bar graph the area in which managers should devote the majority of their attention and energy become readily apparent. Cause and Effect Diagrams Other names: Ishikawa Diagrams (Kaoru Ishikawa), Fishbone Diagrams another standard data plotting technique under the seven old methods Used to identify the possible causes or contributing factors of problems or quality defects HEAD - problem is placed BACKBONE - possible causes Run Charts Other names: Trend Charts - as it is designed to show patterns of performance. Line graph used to display data over a period of time. EAT GURLS  Used: tracking missed phlebotomies or redraws, pattern analyzed to check dosage and collection data entry error or the number of tests that have to timing procedures. be rerun. Usually seen from a flow cytometry instrument in Charts can be as general (shift, section, the laboratory, usually a hematology analyzer. department) or as specific (individual, instrument, AM/ PM collection) Scatter Diagrams This method belongs from the seven old methods used to show the relationship between one variable and another. Advantages: all data points, not just the summary statistical indexes, are plotted on the graph. For example: a study may review the level of an antibiotic maintained in a patient compared to the time a sample was collected. So, it’s either the peak and trough studies a graph is prepared with the concentration of the drug on the vertical axis and the time of collection after administration as the horizontal base. The results of each sample are plotted at the appropriate site on the graph and the EAT GURLS  amount of computer paper it takes to print out a Story Boards plot for each analyte and the expense associated Technique of using a pictorial sequence on a flip with mailing this bulky material. INSTRUMENT PERFORMANCE MATRIX - used by chart or other visual aid to “tell the story” of a Coulter Hematology Reports for its interlaboratory quality management project. The presentation may quality assurance (QA) program is an example of a be very elaborate, containing many of the previously technique that has replaced by Youden Plot discussed methods to illustrate how the investigators conducted the study, or may be a simple outline of each stage of the project EXAMPLE: hand washing technique announcement in the restrooms SPECIALIZED LABORATORY DATA EVALUATION METHODS Three other techniques that have proved to be especially Multirule Analysis useful in our laboratory Commonly referred to as “WESTGARD RULES” that Levey-Jennings Chart or LJ Charts has formalized the application of multi-role techniques to the medical laboratory Control charts used to plot quality control values The 6 rules proposed by WESTGARD & BARRY for against previously set limits to determine if a accepting or rejecting a control run are based on the procedure is in or out of control. expected gaussian involves management choices about the degree of error that the laboratory finds Youden Plot acceptable when making decisions about the possibility of correctly accepting or rejecting a Used to demonstrate and compare the performance control run. of a laboratory on paired samples with other Each rule is designed to detect or warn off an laboratories using common control lots or a survey impending error or malfunction that may either halt material. the reporting of results until the problem is Use the mean and standard deviations from all corrected or signal the need for preventive participants to prepare a chart on which each maintenance. laboratory's result can be marked o show its performance in relationship to the whole group. Divided into 4 areas with a 45 degree line drawn from the x-y intercept separating the graph into two halves Depending on the location of a laboratory's results on the youden plot, the degree of accuracy position and type of error may be inferred. Discontinued or replaced with other graphical or numerical displays because of the voluminous EAT GURLS  8x rule violation Means that you have to reject when eight consecutive control measurements fall on the one side of the mean either the plus side or the positive side or the negative side of the mean It should be consecutive on either side of the mean 41s rule violation States that the run should be rejected if four consecutive control measurements have exceeded the same mean either plus one standard deviation or the same mean minus one standard deviation The Different WestGard Rules 12S rule Violation Usually a warning rule violated when a single control observation is outside the ± 2SD Some laboratories consider any quality control value outside its ± 2SD as the limit to be out of control and therefore incorrectly decide the patient's specimens and qc values to be invalid 13s rule violation An analytical run usually should not be rejected if a States that if a control is greater than plus single quality control value is outside the ± 2SD limit but it must be within the ± 3SDQC limit minus three standard deviations from the ○ This means that the 12S rule Violation is mean it should be rejected and rerun, this originally designed as a warning rule for is either because of a random error or a manual application of the westgard rule. very large systematic error has occurred 22s rule violation 10x rule violation It states that if two consecutive control Happens when 10 consecutive control measurements across runs exceed the same mean measurements fall on one side of the mean minus two standard deviations or either exceed the In addition you will sometimes see some same mean plus two sd or within a run, that means modifications of this 10x rule if two consecutive control values are outside the same two sd the run must be rejected EAT GURLS R4s rule violation WESTGARD RULES Applies to controls within a run, this means that it is on the same run If two controls exceed four sd, that is if one control 13s Refers to a control rule that is exceeds plus two sd on the other control or another commonly used with a Levey-Jennings control if more than two controls are tested chart when the control limits are set as exceeds -2 sd, the run should be rejected the mean plus 3s and the mean minus There are two consecutive control values that 3s. A run is rejected when a single exceed either plus minus 2sd control measurement exceeds the +2s is 1sd, +1s is another sd; mean plus 3s or the mean minus 3s below the mean, 1s and -2s, and that is 4sd control limit. Just count the yellow and the green lines 12S Refers to the control rule that is commonly used with a Levey-Jennings chart when the control limits are set as the mean plus/minus 2s. In the original Westgard multirule QC procedure, this rule is used as a warning rule to trigger careful inspection of the control data by the following rejection rules. 22S Reject when 2 consecutive control measurements exceed the same mean plus 2s or the same mean minus 2s control limit. R4S Reject 1 control measurement in a group exceeds the mean plus 2s and another exceeds the mean minus 2s. 41S Reject when 4 consecutive control measurements exceed the same mean plus 1s or the same mean minus 1s control limit. 8X Reject when 8 consecutive control measurements fall on one side of the mean. 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. INTERPRETATIVE STRATEGY The detection and correction of errors, both technical and administrative, are a major mission of quality management programs. EAT GURLS  All of the preceding methods are useless if the truly 100 million of the Filipinos agree with the technologist or the laboratory manager is not president when they only test a certain few of the aware of the types of problems, errors, normal people right, so this manipulation of data in functions that can occur in a process and of the statistical figures is really a controversy. clues that may trigger their recognition and resolution ➔ STATISTICAL BIAS ○ Old microbiology adage ◆ Set of numbers that do not truly reflect the - States that we tend to find what characteristics of the whole population, we are looking for, applies here as which may be either circumstantial or well intentional. ➔ OUTLIER Following is a list of some statistical terms and clues that ◆ The exclusion of a number that does not may tip the medical technologist or even the analysts to appear to belong in a group of data. possible problems: Not an uncommon occurrence in the lab. Eg. If a control were run 30 times and all the values ERROR - ACCEPT/ REJECT AND PROBLEM/ NO PROBLEM were between 19 and 31 except DECISIONS for one, which was 54. Error can be made in either direction It is a discretion of the medical technologist to Decision can be made to accept a control run (so exclude that number you may accept a control run incorrectly with the The exclusion of the outlier from statistical laboratory reporting out incorrect values, give the calculations is an example of an intentional bias. patient's results incorrectly or you may have a This may also be called cleaning up the data, a legitimate test result that can be rejected, resulting term particularly attractive to the person doing in a loss of time and reagent expense control limits their refinement. must be set with both potentials in mind). EXAMINATION OF CONTROL CHARTS May be classified into two types: ➔ RANDOM ERRORS Clues about data problems are often revealed in ◆ May occur at any time and place within the shape of the Gaussian distribution curve the testing or service process ◆ Indicative of imprecision in analytical ➔ SKEWED CURVES problems. ◆ Deviations from the symmetrical ➔ SYSTEMATIC ERRORS bell-shaped appearance of a frequency ◆ Occur in a consistent direction or pattern polygon serve as a signal that the data do ◆ Problems of inaccuracy not accurately reflect the parameters of Identifying the type of error is crucial to determining the population. the extent, nature and timing of action necessary. ◆ Distribution curves can be skewed in either E.g: a random error may need not only to be closely direction (left or right from the mean) this monitored for possible recurrence; a systematic is because of a non representative small error may need immediate remedial action sample size or by the inclusion of data that Control charts and the multi-role analysis may are flawed because of sampling or both give clues to the type of error because it process (technical, administrative) errors. shows the violations of west guard rules (1 3s and ◆ Problems that are not rectified may r4s are types of random errors; while 2 2s 4 1 s or 10 translate into misleading inferences or x or 8x rules that are being violated may indicate incorrect range limits on the Levey that the error is systematic) Jennings chart. This as every medical technology knows or those people who MANIPULATION OF DATA control runs may trigger unnecessary out Decisions about what to include in a population or of control flags causing much frustration sample are often criticised by those who question and wasted troubleshooting time. the validity of statistical figures ◆ There are three problem related patterns For example, out of the 104 million Filipinos, 100 that can be detected by studying how million agree with the president. How sure are we if data appear when plotted on a control EAT GURLS  chart : trends, dispersion and shifts. All system, such as a new lot of reagents, these patterns have been also matched repair or installation of an instrument part, with probable causes for their occurrence. or recalibration of the method. The medical technologist or the analyst Shifts are not necessarily bad and may must also be aware that these patterns reflect only some action taken to correct may all occur at the same time and be problems previously noted. constantly alert to the clues provided by each type of change in data configuration. PROBLEM -RELATED PATTERNS ➔ TRENDS Marked by a system drift in one direction away from the established mean. May be detected by 4s or 10× Westgard rule failures. It signals the gradual deterioration of procedure components such as Shifts and Trends reagents, standards, or instrumentation (e.gg light bulbs, electrical elements, filters and so on) ➔ Shift QC data results are distributed on one side of the mean for 6-7 consecutive days. ➔ Trend Consistent increase or decrease of QC data points over a 6-7 days. ➔ DISPERSION Control values are widely scattered in an unusual and unexpected pattern around the control chart; with increasing out-of-control (±2SD and ±3SD) results and Westgard rule violation 2-2s and R-4s. It is a sign of loss of precision and may be caused by inconsistency in such areas as a malfunctioning automatic dispenser or variations in technique by testing personnel. ➔ SHIFTS Sudden switch of data points to another area of the control chart away from the previous mean. They are usually associated with a change or replacement of some component of the analytical EAT GURLS MT105: Laboratory Management MANAGEMENT OF QUALITY Many entities offer advice and programs for different people you deal from the highest to the management of quality in an the lowest class and you can really see the organization. These include the promise all dedication of the healthcare professionals pre-packaged programs designed by working in the hospital wherein they have to expensive consultants and the theory based deal with them equally. concepts of management by objectives, quality assessment, total quality *Phlebotomy and blood bank section management and continuous quality - Interact and communicate with improvement and continuous performance different donors patients and improvement significant others of the patients - Usually it is your patients that are No matter what approach the manager takes being tested, you can deal with irate 3 areas or ingredients must be properly patients or sometimes you can keep aligned if the institution is to achieve its on explaining to some of the patients quality performance goals: who are illiterate or didn't have any The philosophy or attitude of the education so you really have to people explain it to them in layman's terms The operational system of the respectfully. enterprise Actual quality assessment and *The philosophy of caring and commitment monitoring program in place to the delivery of a high quality service starts at the very top and permeates every crevice of the institution. It is directly tied to the THE PHILOSOPHY OF QUALITY priorities placed on quality by the The attitude of the people toward their work, organization's leadership and is themselves, the organisation, and their demonstrated on how managers spend their customers is reflected in how they treat each time and what attracts and consumes their other, view their shared interest in achieving attention and to whom they issue rewards. If common goals, and view their the proper philosophy is not present, efforts professionalism in the delivery of their expended on the remaining two ingredients, product or service. the operational and quality management system, will be wasted. *There are other workmates that we have that just really don't care at all with their work and Tokenism and symbolism are not character just go to work and work on what they do and traits of quality. then just go home and right after that's it. But we also see some of our workmates that are TOKENISM very dedicated to their work wherein you can - Especially in the workplace, defined really feel the sincerity and the dedication to as the practice of doing something their job when they deal with customers and such as hiring a person who belongs clients or even our patients, especially in the to a minority group only to prevent hospital setting where we deal a lot of people LAPLANA - SABANDAL MT105: Laboratory Management MANAGEMENT OF QUALITY criticism and give the appearance OPERATIONAL SYSTEM that people are being treated fairly. QM begins with how well managers incorporate quality practices into CONSUELA KNOX their management fxn. - Pointed out that intent is important in OS represents the actual practices deciding whether or not a company is taking place in an organization. engaging in tokenism. Lundburg (1976) and Bozzo (1991) - It says there that if there's only one point out that the laboratory’s testing candidate from an underrepresented cycle begins with the doctor’s request minority within a group that could be for lab services and continues when an instance of tokenism or maybe the information is received by the company is only just beginning its physician and new requests are diversity efforts or perhaps the issued. company genuinely wants to improve From patient needs to patient needs: diversity among staff, but past ○ Service assessment → initiatives has been lacking there is a physician utilization → service great controversy regarding the requisition → spx collection → difference between diversity and spc processing → analytical tokenism. process → results assessment → information report → service assessment FROM PATIENTS TO PATIENT NEEDS SERVICE ASSESSMENT This happens when the patient is still identifying his or her problems For example if the patient has a headache, so that's their primary problem they either go to their general practitioner in their clinics or Tokenism - you hire someone that could be they might go directly to the good for your image so you hire them emergency room to be assessed temporarily PHYSICIAN UTILIZATION Diversity - you hire a minority group to be a The evaluation of the medical part of your organization and be heard so necessity, appropriateness and they will be a part of this institution efficiency of the use of healthcare permanently services procedures and facilities under the provisions of the applicable LAPLANA - SABANDAL MT105: Laboratory Management MANAGEMENT OF QUALITY health benefits plan sometimes distributed to the requested called utilization review. laboratory. Specimen processing staff also ship Service requisition patient samples to outside reference is the type of request that the laboratories if the procedure is not physician asks. performed in one of one of our Ex: there are laboratory tests that laboratories. For sent out specimens should be done or radiologic tests the laboratory personnel in charge for that can also be done or other tests transportation must follow the that must be performed for the transportation protocols diligently. patient in order to assess the patient and give a diagnosis properly. Once Analytical process the patient gets their service when the patient’s specimen is requisition or test request from theri prepared for testing and ends when doctors they can now proceed to the the test result is interpreted and laboratory for specimen collection. verified. The analytic phase involves the actual running of the test. Specimen collection this is the part where the patient's Results assessment blood sample or urine or other fluids laboratory tests check a sample of sample are obtain and drawn your blood, urine or body tissues a medical technologist or your doctor Specimen processing analyses the test samples to see if A service unit within the laboratory your results fall within the normal specimen processing receives range. The tests are used as a range incoming laboratory test specimens because what is normal differs from from patient floor and clinics either on person to person. Many factors affect and off site and staff in the laboratory the test results. This includes your sex, complete the entry of orders into the age, race, what you eat and drink, laboratory information system which medicines you take and how well you is maintained by the hospitals data followed pre-test instructions. The systems. doctor may compare your results When the specimen arrives a physical from previous tests. Laboratory tests inspection of the specimen is are often part of a routine checkup to performed to ensure that it is in the look for changes in your health; they correct tube, not damaged, and has also help doctors diagnose medical been transported to specimen conditions, plan or evaluate processing appropriately. The treatments and monitor diseases. specimen is then prepared in either centrifuge, divided into ali quotes and LAPLANA - SABANDAL MT105: Laboratory Management MANAGEMENT OF QUALITY Information report quality control slash management by is a report or a document that has a objectives list of the tests that you have undergone and at the same time the QC/MBO → QA → TQM/CQI → QA and I/CPI →