Quality assurance: Clinical Laboratory System
Poor vigilance allows lab facilities to put patients at risk Publish Date: Jun 29 2016 12:37AM greater kashmir
"Dr Fiaz Fazili
http://www.greaterkashmir.com/news/opinion/story/221687.html oubklished date-
Everyone assumes lab results are always correct. The first thing that everyone, patients and doctors, should remember is that lab test results can be wrong. Ms. Bn (name changed ) having on the advice of an endocrinologist for her subclinical symptoms went to a popular lab of city to test her thyroid function status; few days later she was handed over result of TSH 8.6. Not believing the result, her treating doctor advised her to repeat the test before he could think of prescribing thyroxin for her. This time she chose another lab for her TFT. Two days later this lab reported her TSH level as 4.5mcgm;(at 4.5 you may not start thyroxine while value of 8.6 warrants some sort of hormone replacement) . Another patient, a teacher, with type 2 diabetes while doing her regular self check of Diabetic control asked for Hb A1c level at one of the city lab. The result was 8.5 (poor glycaemic control). Unconvinced and depressed the teacher went to another lab, their result was 6.6 (good glycaemic control). With such erratic results (tip of ice berg ) from labs I can understand how difficult it is for patients along with their treating physicians especially when it pertains to Endocrinology, Nephrology, or Rheumatology, to manage the disease
Where things can go wrong?
As a clinical auditor and expert on quality control, I learnt that computers can be unreliable, but unaudited human handlers are even more unreliable. Any system which depends on machines or human without cross checks and balances is unreliable. I have yet to see any manufacturer’s life time guarantee for zero fault or error free equipment. This may sound rather sacrilegious for some non accredited labs who don’t ‘follow any national or international quality control standards when clients are made to believe that a computer generated piece of paper containing figures of our tests the result must be accurate regarded by lab owners with the sort of reverence .
Is there anything that we can learn and change to do things better way? Speaking in general, not blaming in particular, I do appreciate efforts of labs who run on no profit/loss, or carry out tests under constant vigil of highly qualified professionals and trained personnel operate maintain sensitive equipment with audit tools of reliability, precision and accuracy. I say ,”there is always room for further improvement”.
What are the indicators of test reliability?
Quality control in clinical laboratory system is very important. The goal of the service is to provide comprehensive and accurate analytical results, thereby forming a bridge between the patient and care providers. The primary aim of quality control is to see that the very purpose for which a test is performed is not defeated due to unreliability of the result. Accuracy and Precision in Lab testing are two most commonly used key performance indicators to determine the reliability of a clinical lab test. Statistical measurements of accuracy (Trueness) and precision (Repeatability) reveal a lab’s basic reliability, reflect how well the test method performs day to day in a laboratory. It is imperative on each lab that the accuracy and precision of each test method are established with strict follow up through frequent monitoring/auditing by the professional lab personnel.
Causes and frequency of clinical lab errors.
Many mistakes in the total testing process are called "laboratory errors", although these may be due to poor communication, action taken by others involved in the testing process (e.g., physicians, nurses and phlebotomists), or poorly designed processes, all of which are beyond the laboratory's control. Organization for Standardization (ISO) recommends a new, broader definition of the term "laboratory error" and a classification of errors according to different criteria pre-, intra- and post-analytical errors . In the delivery of laboratory testing, mistakes occur more frequently due to pre-analytical factors (46-68.2% of total errors), while a high error rate (18.5-47% of total errors) has also been found in the after (post-analytical) the test has been performed. Errors due to analytical problems have been significantly reduced over time, but there is evidence that, particularly for immunoassays, interference may have a serious impact on patients.
Currently, we have two types of labs. In majority ;sample collection and analysis is done under same roof, but many labs have collection centers at different places, inside /outside city /state and samples are transported from these centers to main lab situated inside or outside state .For such labs transport of blood samples or components to the appropriate locations /designated centers, the following requirements/ SOPs need to be in place-;who is responsible for transporting blood samples; validation of transport container for appropriateness of temp –ice-packing- cooling pack ;security of transport container ,was the sample received within recommended transport time? etc.
Errors in clinical laboratories or in laboratory medicine are well recognized and reputed lab managers carry our regular internal /external equipment audit butmajority of our labs remain unaccredited (sadly majority of our labs don’t have- National Accreditation Board for Testing and Calibration Laboratories (NABL certification). For all stake holders , patients, physicians ,lab owners and administrators the way one perceives errors and risks is important; it aims the investigation for causes, and thus possibilities for prevention, of errors. There are often combinations of several factors that give rise to an error. Thus, a “fix-all” solution is seldom sufficient to prevent an accident from happening again.Pending CAPA –corrective and preventive action from competent authorities , if you’ve had an incorrect lab test or suspicious results know of problems in a specific lab-or your lab results don’t match the clinical condition; the first thing you or your treating Physician should do is repeat the result in the same /other lab, I am sure certain lab owners whom I know personally will not hesitate to repeat the test free of cost. In case you have reservation you can chose another lab after few days' interval.
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