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Quality Control

in the
Pathology Laboratory

John Santangelo

Quality Assurance and Quality Control

Quality assurance in pathology and laboratory medicine is the practice of assessing performance in all steps of the laboratory testing cycle. including pre-analytic, analytic, and post-analytic phases.

Quality control is an integral component of quality assurance and is the sum of processes and techniques to --

detect, reduce, and correct deficiencies in an analytical process. e.g. designing new and better methods for analysing blood or serum.

Quality improvement is the practice of continuously assessing and adjusting performance using statistically and scientifically accepted procedures.
Preventive Maintenance of Equipment Continual monitoring of the temperature of water baths and refrigerators is important to the maintenance of reagent quality and test performance. Equipment such as microscopes, centrifuges, and spectrophotometers should be cleaned and checked for accuracy on a regular schedule. Failure to monitor equipment regularly can produce inaccurate test results and lead to expensive repairs.

Factors in Quality Assurance

To guarantee the highest quality patient care through laboratory testing, a variety of pre-analytical, analytical and post-analytical factors in addition to analytical data must be considered. Pre-analytical, analytical and post-analytical factors are all part of Quality Control Non-analytical factors that support quality testing include the following:

Qualified Personnel Established laboratory policies The laboratory procedure manual

Proper procedures for specimen collection and storage

Preventive maintenance of equipment Appropriate methodology Established quality assurance techniques Accuracy in reporting results

Pre Analytical
Proper Procedures for Specimen Collection and Storage

Strict adherence to correct procedures for specimen collection and storage is critical to the accuracy of any test.

Pre-analytical errors are the most common source of laboratory error.

The correct patient identification is critical.

Date of Birth. (careful with overseas people as Month & day might be reversed)
Ask patient to spell their name.

Pre Analytical (cont)

Each blood specimen obtained should be labeled with the patients first and last name, hospital identification number, patient location, time, date and the phlebotomists initials. Correct storage of specimens is critical to obtaining accurate results.
Some specimens are stored at room temperature and some in the refrigerator. Specimen integrity is an important issue when blood is collected at a site away from the testing facility.

Blood must be centrifuged within 30 minutes of collection.

Delayed centrifugation will result in wrong results.

Pre Analytical (cont)

Specimens are to be transported to the laboratory in the appropriate containers, e.g. coolers.

Physiologic Factors Affecting Test Results

Posture- Changing from a supine to a sitting or standing position results in a shift of body water from inside the blood vessels to the interstitial spaces. Larger molecules cannot filter into the tissues and concentrate in the blood. There will be significant increases in test values for lipids, enzymes and proteins.

Pre Analytical (cont)

Diurnal Rhythm- Diurnal pertains to daylight, and diurnal rhythm refers to the daily body fluctuations that occur.
Certain hormone levels such as cortisol and adenocorticotropic hormones, decrease in the afternoon. Other test values, such as iron and eosinophils, increase in the afternoon.

Pre Analytical (cont)

Exercise- muscle activity elevates creatinine, protein, creatine kinase, aspartate transaminase, and lactate dehydrogenase values. Research also suggests that exercise activates coagulation and fibrinolysis and increase platelet counts.

Stress- Anxiety can cause temporary increase in white blood cells, catecholamines as well as an acid-base imbalance.

Pre Analytical (cont) Dieting- Fasting means no food or beverages except water for 8-12 hours prior to blood collection. If a patient has recently eaten, there will be a temporary increase in glucose and lipid content in the blood. As a result, the serum or plasma may appear cloudy or turbid, which interferes with testing, especially with tests such as glucose, sodium, and complete blood counts.

Pre Analytical (cont)

Smoking- Patients who smoke prior to blood collection may have increased WBC counts and cortisol levels. Long-term smoking can lead to decreased pulmonary function and result in increased hemoglobin levels. (secondary polycythaemia)

Analytical Appropriate Methodology

When new methods are introduced, it is important to check the procedure for accuracy and variability.
Replicate analyses using control specimens are recommended to check for accuracy and to eliminate factors such as day-to-day variability, reagent variability and differences between technologists.

Analytical (cont)
Established Quality Assurance Techniques Each procedure should have an established protocol to assure the quality of the results. Usually, the normal and abnormal control samples are analyzed at the same time patient specimens are analyzed. Established limits of acceptable performance must be determined for each type of test. If control results are not within acceptable limits, patient results cannot be guaranteed to be accurate. In these cases, the source of error must be identified and the entire test repeated before a patients result can be reported.

Analytical (cont) Accuracy in Reporting Results When extremely abnormal results or differences from previous test values are found, the laboratory protocol should establish the method of rechecking and reporting such results.

Things that go wrong during analysis

1. Equipment faults

2. Reagents expired
3. Reagents contaminated 4. Reagents not stored under the right conditions 5. Temperatures not checked 6. Automatic pipettes not maintained 7. Dirty glassware 8. Bad operator technique

Qualified Personnel The entry-level examination competencies of all certified persons in hematology must be validated. Validation takes in form of both external certification and new employee orientation to the work environment. Continuing competency is equally important.

Established Laboratory Policies Laboratory policies should be included in the laboratory reference manual that is available to all hospital personnel.
The Laboratory Procedure Manual Laboratory procedures should be included in the manual.

A batch or lot is a collection of products all identical in size, type, conditions and time of production. All controls have a Batch Number and expiry date so that a fault can be traced easily. The number of tests between controls.

Drift: The control results are steadily increasing or decreasing away from the true published mean value found in the package insert.

Interference: Something outside or inside the autoanalyser causing unreliable control and test results. e.g. electrical interference, a light source losing brilliance, dirt or dust etc. Insects. Interpolation: Someone changing a test or control result because it doesnt look or feel right. Random error: An unexpected and unacceptable test or control result which disappears when repeated. Fibrin blocking the autoanalyser.

Standard Deviation: (SD)

Any control results greater than 2 standard deviation are flagged and the analyser usually stops.

Calibrator: (standard):
A know value supplied in the package insert to calculate the unknown value.

There are Internal and External controls. Internal controls are reconstituted and assayed.

The values are given in the insert package.

External controls are sent from an outside national or international laboratory.

The results are not supplied until after they receive your results. This way cheating is eliminated.
Controls above and below normal reference ranges should be performed. Important when monitoring therapeutic Drugs.

Bias is a problem and is widespread when doing internal controls. This is why external controls are done in parallel. Examples of bias: 1. All controls should be done with the normal run, not separately and not in duplicate. Often the laboratory staff will do controls separately and several times until they get the answer they want. This is incorrect and cheating. Controls are run to detect problems with equipment and technique. 2. Large batches should have a control about every 10 to 15 samples not at the beginning and end of a sample run.

3. The external and internal controls should not be tested separately or in triplicate.
4. Cheating.

Organizations and programs that monitor Laboratories

NATA National Association of Testing Authority RCPA Royal College of Pathologists of Australia QAP Quality Assurance Programs

Book are kept to monitor refrigerator temperatures, water baths, autoclaves etc, and faults that occur and how they were rectified. This is required by NATA. NATA inspections are done about every three years. Any problems have to be fixed before NATA gives approval to continue to operate as a laboratory. Many laboratories have been closed down for not complying with the standards required by NATA.

Conclusion (Quality Assurance QA) QA is the sum of all those activities in which the laboratory is engaged to ensure that information generated by laboratory is correct. QA includes all aspects of laboratory activities that affects the results produced, from the choice of methods, to the education of personnel, to the handling of specimens and reporting results. The real purpose of QA activities is to determine how correct or incorrect the results coming from the lab are, and to allow those managing the lab to determine whether or not the lab is fulfilling its functions satisfactorily.

3 major activities of QA : 1) Preventive those activities that are done prior to the examination of the specimen or sample and that are intended to establish systems conducive to accuracy testing ( eg : preventive maintenance and calibration of instruments, testing of media, orientation and training of personnel ) 2) Assessment those activities that are done during testing to determine whether the test systems are performing correctly ( eg : the use of standard and controls, maintenance of control charts ) 3) Corrective those activities that are done, when error is detected, to correct the system ( eg : equipment troubleshooting, recalibration of instruments )

QA in Haematology Laboratory QA in haematology lab is intended to ensure the reliability of the lab tests. The objective is to achieve precision and accuracy

4 components of QA programme :

1) Internal Quality Control ( IQC )

2) External Quality Control ( EQC )

- the closeness of the estimated value to the true value. - can be checked by the use of reference materials which have been assayed by independent methods of known precision Precision - reproducibility of a results, whether accurate or inaccurate within a define frame time ( eg: within the same day, from week to week etc ) - can be controlled by replicate tests, check tests on previously measured specimens and statistical evaluation of results

Internal Quality Control ( IQC )

Based on monitoring the Haematology tests procedures that are performed in the lab. includes measurements on CONTROLS & is intended to ensure that there is continual evaluation of the reliability of the work of the lab and that control is exercised over the release of the results.

External Quality Control ( EQC )

The objective evaluation by an outside agency of the performance by a number of laboratories on material which is supplied specially for the purpose. is usually organized on a national or regional basis. analysis of performance is retrospective. the objective is to achieve comparability with results of other labs.

Control materials
Specially prepared It may be anticoagulated whole blood, preserved pooled red cells, plasma or serum. It can be used to check for accuracy if the value has been reliably determined ( eg : reference centre ) Should have controls of high, normal and low values At least 1 control specimen should be used for every batch. If large specimens, use 1 control for every 20 specimens.

Analysis of data
Standard deviation of control specimens Dispersion of results around the mean will indicate the error of reproducibility. 95% of results on the same specimen should be within 2 SD and 99.7% within 3 SD. by chance, 1 in 20 of measurement might expected to fall outside 2 SD and only 1 in 333 outside 3 SD. If measurement more widely dispersed, this indicates an error in the test.

Control Charts
Originally described by Shewhart, 1st applied in clinical chemistry by Levey and Jennings. Samples of the control specimen are included in every batch of patients specimens and the results checked on a control chart. To check precision, it is not necessary to know the exact value of the control specimen. Value has been determined reliably by a reference method, the same material can be used to check accuracy or to calibrate an instrument. If possible, controls with high, low and normal values should be used. Advisable to use at least one control sample per batch even if the batch is very small. The results obtained with the control samples can be plotted on a chart.

A minimum of 100 patients are selected to establish a Normal Reference Range

Total = 95.4%
Within 2 Standard Deviations