Professional Documents
Culture Documents
in the
Pathology Laboratory
John Santangelo
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.
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.
Date of Birth. (careful with overseas people as Month & day might be reversed)
Ask patient to spell their name.
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.
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.
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.
Batch:
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.
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.
Controls:
There are Internal and External controls. Internal controls are reconstituted and assayed.
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:
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.
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 :
Accuracy
- 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
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.
Total = 95.4%
Within 2 Standard Deviations