Quality is never an accident. It is afways the result of high intention, sincere effort, intelligent direction and skilful execution. It represents the wise choice of many alternatives — William A. FosterThe International Organization for Standardization (ISO) 9000(2000) defines quality as the degree to which a set of inherent characteristics fulfill require- ments. Quality assurance (QA) is the tool that helps the laboratory to provide relevant reliable, timely and correctly interpreted laboratory results. Quality assurance provides confidence that quality requirements will be fulfilled. In general, quality assurance is a process to aid companies in improv- ing the reliability, quality and the overall performance of the organization and help to develop a systematic approach to processes and procedures. Quality assurance is part of quality management and is an ongoing process that is implemented to monitor and evaluate every step of the laboratory’s testing operation, including pre-analytical, analytical and post-analytical processes. This concept of continuous quality improvement is important, as defects in quality are often built into the system and are not necessarily caused by deficiencies of people. Identification of problems is basic to their correction.Quality assurance depends not only on good quality control program, but also on good management practices and the commitment of the people in the orga- nization. Thus, it involves all the steps taken by the laboratory, right from the time the client (patient) walks into the laboratory ending with correct interpre- tation of the results along with advice, if any. The most common quality assurance systems in clinical laboratory are the ISO 9000, CLIA’88 (Clinical Laboratories Improvement Amendments) and ISO 25. Closer home, the National Accreditation Board for Testing and Calibration Laboratories (NABL) uses the ISO 25 quality system for accred- itation of testing and calibration laboratories. However, since 2005 NABL accredits medical laboratories based on the ISO 15189:2003 standard, which was developed for implementation of quality systems in medical (clinical) laboratories.Consistent procedures ‘Continuous quality improvement Accreditation Components of quality assuranceQuality Management and Planning Quality management is a set of coordinated activities to direct and control an organization. Quality planning should be the responsibility of the labora- tory management. The management may decide to delegate function to the pathologist or a quality specialist. The implementation may be delegated to technicians. This has to be, however, supervised regularly by the pathologist or the quality manager. At the end of the day, quality and its implementation should be a collective process.Quality Control (QC) and Its Purpose QC (quality control) is an important part of the quality assurance system. It is a scientific and technical procedure that is implemented on a daily basis by the staff of the laboratory and is supervised by the pathologist, QC is a process where known samples are tested routinely to confirm the reliability and preci- sion of the analytical (testing) process. It includes procedures for monitor- ing and detecting problems and making the necessary corrections before the delivery of the product (in the case of a clinical laboratory — test report) to the client (patient).It helps people in a laboratory gain confidence in their output and gives them a way to check whether their work and the functions involved in the process are correct. An objective way of doing this is to use statistical QC. Results of the testing are expected to fall within certain statistical limits. The mean and standard deviation are calculated from the laboratory measurements and control charts are drawn to identify results that are unexpected and need to be investigated and rechecked. This will be discussed in detail in the chap- ters that follow. QC should not be regarded as a tool for biochemistry (clinical chemistry) testing only. It must be clearly understood that each aspect and department of laboratory medicine should follow QA and QC techniques. Phases of Quality Control Quality control program in any department of laboratory medicine can be divided into the following phases. © Pre-analytical phase @ Analytical phase © Post-analytical phaseMany experts believe that 40% of the errors in a laboratory are pre-analytical, 40% of the errors are post-analytical and only 20% of errors are analytical. Ross and Boon reviewed 363 incidents that occurred in a tertiary care hospital in 1987.5 Pre-analytical mistakes accounted for 46% of total incidents* This phase includes patient preparation, sample collection, labeling, transport of the samples to the testing area and preparation of the samples. Proper care should be taken at every level. The following important points should be kept in mind. © Test request should be scrutinized with care. The patient’s name, age, sex, and physician’s name should be recorded. It is a good practice to enter the patient’s contact numbers and address in the database. This simple step can save a lot of heartaches, especially if the patient is needed to be contacted later. e Check for patient’s preparation. For example, find out if the patient is indeed fasting for a lipid profile or a fasting blood sugar. An erroneous result can be obtained if the patient is not fasting for these tests. e Call in one patient at a time for collection of sample. Overcrowding is bad for the patients as well as the phlebotomist. Confirm the patient’s full name at this time. e Assemble all the needed vials/ materials according to tests prescribed. Use a good syringe and needle to draw the blood. e@ The tourniquet should be removed well before the blood is allowed to flow into the syringe. Remember, stasis can lead to wrong results. Avoid hemo- lysis for the same reason.e EDTA as an anticoagulart is preferable to citrates or oxalates. Generally, heparinized plasma is suitable for most of the parameters, including elec- trolytes. e When transferring the blood from the syringe into the assembled anticoag- ulant bottles, see that the needle is first removed. This prevents hemolysis. © Mix the anticoagulants thoroughly with the blood to prevent clotting. e Add the correct amount of blood to the anticoagulant vials. Adding less amount of blood leads to anticoagulant excess with erroneous results. Adding more amount of blood may lead to clotting of blood. ® The samples should be transported to the laboratory as soon as possible. e Routine order of draw (when the laboratory collects more than 1 tube of blood at a time on a patient) is as follows > Blood culture bottle Non-additive serum tube Citrate tube Serum separator tube, plastic serum tube Heparin tube EDTA tube >» Glycolytic inhibitor tube (fluoride) The above basic steps remain the same for most disciplines of laboratory medicine. Special needs, if any, are dealt with in the appropriate chapters on hematology, urine analysis, histo- and cyto-pathology, microbiology and blood banking. v vvyvyPre-analytical and post-analytical errors fall into the category of “obvious” errors, as these can be easily spotted by the patient or his physician. A small mistake like a misspelt name or wrong age could very well make the patient or his physician lose faith in the report. Thus, it is vital that the laboratory not only take care of the analytical errors but also of errors occurring during the phase of pre- and post-analysis of the sample. Pre-analytical variables Pre-analytical variables at times lead to problems in interpreting laboratory tests. These are discussed here, because knowing that it is possible for certain factors to affect tests may help the pathologist in breathing easier when they arise in the course of the day. There are many variables that may affect the results,'*" .These may pose a problem when serial tests are performed on a patient. Some of these may be associated with preparation of the patient for the tests; others may be due to conditions that exist during the testing, and finally some may be observed due to biologic variation'*"'* in the patient himself.Pre-analytic variation associated with the preparation of the patient The duration of overnight fast, time of collection of the specimen, whether the patient has exercised prior to sample collection, type of sample (whether capillary or venous) and positioning of the patient (whether lying down or sitting) may all affect the test values. Patients should be clearly told to fast for 12-15 hours before a lipid profile. Likewise, the patient should be fasting when he comes in for a fasting sugar. However, prolonged fasting is also known to affect a few laboratory tests like serum bilirubin. After fasting for 48 hours, it is known that the hepatic clear- ance of bilirubin is greatly increased. (In fact this forms the basis of diagnosis of Gilbert’s syndrome!) The quality of the blood report depends directly on the way the sample is collected. Phlebotomy, hence, is one of the most important steps in a good QA program. Leaving the tourniquet on for a longer time has been known to drastically affect the values of blood components. Prolonged use of tourniquet increases the cholesterol levels by 1.5% after 2 minutes and 10-15% after 15 minutes. There is a 5-8% increase in the concentration of proteins after 1 minute of application of the tourniquet.Hemolysis makes the estimation of potassium, magnesium and lactic dehydrogenase impossible. Likewise, colorimetric tests could also be affected because of the inherent color caused by the hemolysis. Vigorous exercise shortly before blood collection has been shown to increase blood cholesterol level up-to 6%. A change in position between sitting and lying can produce a 15% variation in total and HDL choles- terol, Likewise, healthy adults have shown up to 32% decrease in platelet count, in capillary sampling as compared to venous. There can be a 10% increase in hemoglobin and up to 23% increase in total leukocyte count for the capillary specimens.Biologic variation Biologic variation refers to variation of an individual patient’s results over a period of time relative to a group mean (inter-individual variation) or relative to the patient’s own mean (intra-individual variation). Inter-individual varia- tion may be due to such physiological factors as age, sex, pregnancy, history of smoking, etc. Intra-individual variation may occur within the same day or from one day to another. Take the following examples: Hemoglobin, hematocrit, and RBC have highest values in the morning, These parameters are known to fluctuate on a regular diurnal basis. The leukocyte counts are highest in the aftemoon. Triglycerides, phosphate, urea, and creatinine levels, on the other hand, are lowest in the morning and highest in the early evening.Post-analytical Phase The main components of the post-analytical phase are the calculations, tran- scription of the patient’s data onto the final report, typing and proper distribu- tion of the report. The importance of calculations and rechecking of the calculations cannot be stressed enough. Tallying of the differential count and lipid fractions before signing out of the report is a must. A small error in the report may cost the laboratory the confidence of the patient. The laboratory might have used the best reagents and state-of-the-art technology, but the slightest mistake here has the potential to make all the hard work redundant! Most of the laboratories now have customized software to register the patients. Laboratories doing a manual entry of the results need to be extremely careful. Missing a single value, typing the value against the wrong param- eter, wrong entry of decimal points are the errors that can occur during this phase. Many laboratories now have sophisticated instruments with a direct interphase between the instrument performing the test and the main server housing the patients’ data. Data is transferred directly from the instrument to the file of the particular patient. Thus, human errors in transcription of the data are completely avoided. Another error that can occur in this phase is handing over the report to the wrong patient. It is very important to confirm the name and the labo- ratory accession number prior to handing over the report to the patient (especially if you happen to have two patients with the same name on that particular day!)Concept of Total Quality Management (TQM) Total Quality Management is being implemented over the last decade in many healthcare organizations. It involves setting quality goals, quality plan- ning, establishing laboratory processes, quality control and quality improve- ment © Components of TQM Quality goals Quality lab. processes Quality Quality planning control Quality improvement@ Quality goals: These should be formulated by each laboratory to satisfy the needs of the clients, The requirements are to provide accurate results within stated limits and within the time frame promised. For example, the laboratory may decide that its quality goal is “To provide reliable reports to the patients in the minimum turn around time at a reasonable cost”. The laboratory will then have to device processes and practices to put this goal into practice. ® Quality laboratory processes: These consist of the policies, procedures, staff standards and use of resources to get work done in the laboratory. The standard operating procedures are an important part of laboratory processes, as these describe how work should be done to produce good Tesults.@ Quality control: As stated previously, statistical quality control is used to monitor the analytical performance. This detects problems and helps to make corrections before the report is given to the client. ® Quality improvement: It is done based on the QA and QC. Prob- lems may be identified on day-to-day basis and need to be promptly addressed to meet the quality goals. Some of the problems identified may require a team of people for solution, while others may be rec- tified by any one member of the team. To quote an example, there may be too many errors occurring when samples are labeled by hand. These may range from illegible handwriting to mistakes in writing numbers. One way to get around this problem may be to introduce bar-code labels to attach to the sample tubes. This is a definite quality improvement measure. The performance goals have to be defined by the management team and are specific to the laboratory. Analyte-specific performance goals may be decided based on long term imprecision as reported by the manufacturer of the control and given as standard deviation of the parameters or as determined and mea- sured by the laboratory. The performance goal may also be defined using total allowable error (TEa) as defined by CLIA 88 or other professional organiza- tions or Government bodiesEnsure proper conditions Patient preparation © Posture © Tourniquet © Anticoagulant Collect specimen Pre-analytic phase Record test request ; Proper transport of Select suitable method specimen to the laboratory Quality controt Care of instruments ‘Analytic process |}<——— e Internal QC ¢ Instrument calibration a 1 © External QA instrument maintencnce © Equipment check Record values. Record results Post-analytic phase Reference values ————_» Generate report Convey report to clinicianExternal Quality Control While the internal quality control takes care of the precision of the values obtained during running the laboratory tests, external quality control pro- vides an assessment of the accuracy of the testing procedure with respect to other testing sites, This is done periodically and retrospectively and, hence, sometimes the term ‘assessment’ is used for this procedure. External quality assessment or proficiency testing involves the organization, performance and evaluation of tests on identical or similar test materials by two or more labo- ratories,EQA (External Quality Assurance) schemes were introduced in clini- cal chemistry (biochemistry) in the late 1940s. The idea was subsequently extended to other fields of laboratory medicine like hematology, immunology, microbiology and even to cyto- and histo-pathology. Accreditation standards like the ISOAEC 17025 and ISO 15189 recommend EQAS. The process of EQAS works as follows: The laboratory subscribes to a quality control program run by a nodal or recognized agency — usually professional associations, official bodies or manufacturers of control material run such programs. A sample is sent by the agency for analysis to the participating laboratory; the laboratory has to run the sample and send back the results to the nodal agency. The results are then scrutinized by the nodal agency and the performance of the laboratory is thus. evaluated. Laboratories wishing to obtain accreditation must comply with this requirement. It is important to subscribe to a program which is approved by the agency from which accreditation is sought (in India, the agency is NABL). The duration of the scheme and the number of control materials are usually dependent on the scheme. Most of the schemes last for 1 year. The testing is done monthly, bimonthly or quarterly. ‘Once the laboratory enrolls in the scheme, a code number is assigned to the laboratory to protect the confidentiality.Functions of External Quality Assessment Schemes EQA serves the following functions: © Measures inter-laboratory variability ¢ Allows comparison and evaluation of methods, instruments, reagents, ete. Shows laboratory performance e Allows determination of consensus values © Investigates factors affecting quality © Serves as a source for uncertainty calculation © Provides third party evaluation for accreditation