Pre Analytical Phase : The Seismic Zone of Clinical Laboratory Testing (original) (raw)

Pre-analytical errors in the clinical laboratory and how to minimize them

Since evidence based medicine (EBM) is now become the main principle guiding clinical practice and is being followed universally the role of laboratory medicine in EBM needs not to be over-emphasized. So it is the need of the hour to ensure that the best evidence on testing is made available through the help of the laboratory to the clinician. This would result in making the best decision based on test results which would lead to increased probability of improved health outcomes. So it is necessary for the laboratory to maintain the strictest quality possible. Here we would see the steps of pre-analytical phase and the various points at which error can arise and how to mitigate them. The present study was carried out in our hospital central laboratory and data were collected and analyzed. Pre-analytical phase is most important in testing process and involves variables that are not under the control of the laboratory. So much care needs to be taken to deeply scrutinize this step of analysis and keep a tab on errors arising in it.

A study of pre-analytical variables and quality improvement in testing process of clinical laboratory

Introduction: Laboratory tests are important to diagnose the diseases, to monitor the progress and to see the response to the treatment of patients. Pre-analytical variables include specimen collection, timing, transportation & handling of the sample processing. Methodology: The data were obtained from Biochemistry Central Laboratory, Descriptive Cross Sectional study design was used and data were entered in excel and analysed by using Epi-info Software version 3.4.3. Descriptive statistics like frequencies and percentages were calculated. Results: The total number of samples received by the laboratory for a period of two months was 7333 and analyzed for pre-analytical errors in those samples. The most common pre-analytical error was wrong ordering which is 16.73% & followed by hemolysed sample, insufficient quantity, mixed with saline, empty tubes and the least one was mismatched samples. Conclusion: Quality improvement in the pre-analytical phase helps laboratories to deliver more timely and accurate test results for clinicians.

Pre-analytical phase in clinical chemistry laboratory

Journal of Clinical and Scientific Research, 2016

The laboratory testing process is divided into the pre-analytical, analytical and post-analytical phases. For obtaining reliable test results, the prevention and detection of errors at all steps is required. While analytical standards have been developed by recognized quality control criteria, there is a scarcity in the development of standards for the preanalytical phase. This phase is most prone to errors as the steps involved are directly dependent on humans and are out of direct control of the laboratory. Such errors in preanalytical stage often only become apparent in the analytical or post-analytical phase. The development of a pre-analytical quality manual is essential in achieving total quality control. Correct practices and strategies of error prevention can reduce preanalytical errors. This review focuses on prevention of pre-analytical errors that occur while collecting a specimen of blood, urine and cerebrospinal fluid. Most of these can be easily prevented with understanding and education of the personnel involved in and responsible for executing this crucial pre-analytical phase.

Effect of Pre-Analytical Errors in Laboratory Testing Facilities: the Way Forward

Texila International Journal of Public Health, 2023

Pre-analytical errors contribute a significant proportion of errors of all major sources of mistakes made in laboratory testing processes and are responsible for several patient safety risks. It contributes to wrong therapeutic interventions, irrelevant follow up laboratory investigations and diagnostic delays, which impact negatively on the economy and laboratory effectiveness of health services. Pre-analytical phase is directly related to the procedure of specimen collection and is mostly out of the direct control of the laboratory; further, most pre-analytical errors are related to human factors. The aim of the study is to determine the nature and the occurrence of pre-analytical errors and recommendations on possible measures to reduce these errors. A total of 300 specimens were randomly sampled from a study population of 600 patients and analyzed for pre-analytical errors. One hundred and eighty-four (184) samples were found unsuitable for further processing accounting for 1.9% of all samples analyzed for pre-analytical errors and sample rejection. Rejections were due to following reasons: hemolysis 21.7 % (40) wrong tubes 19 % (35); clotted blood 17% (32); inappropriate timing of collection 15.7% (29); mislabeled specimens 15.2% (28); insufficient specimen quantity 6.5 % (12) and lipemic specimens 4.3% (8). The overall percentage of rejection was 1.9% and the substantial numbers of the rejected specimens were re-tested. Efforts aimed to reduce the rates of rejected samples can improve the quality of laboratory-based health care response.

Evaluation of preanalytical and postanalytical phases in clinical biochemistry laboratory according to IFCC laboratory errors and patient safety specifications

Biochemia Medica, 2022

Introduction: The aim of the study was to determine the current state of laboratory's extra-analytical phase performance by calculating preanalytical and postanalytical phase quality indicators (QIs) and sigma values and to compare obtained data according to desired quality specifications and sigma values reported by The International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) Working Group-Laboratory errors and Patient Safety. Materials and methods: Preanalytical and postanalytical phase data were obtained through laboratory information system. Rejected samples in preanalytical phase were grouped according to reasons for rejection and frequencies were calculated both monthly and for 2019. Sigma values were calculated according to "short term sigma" table. Results: The number of rejected samples in laboratory was 643 out of 191,831 in 2019. Total preanalytical phase rejection frequency was 0.22%. According to the reasons for rejection, QIs and sigma values were: "Samples with excessive transportation time": 0.0036 and 5.47; "Samples collected in wrong container" 0.02 and 5.11. In December, QIs and sigma values were: "Samples with excessive transportation time": 0.01 and 5.34; "Samples collected in wrong container": 0.03 and 4.98. The postanalytical QIs and sigma values were: "Reports delivered outside the specified time": 0.34 and 4.21; "Turn around time of potassium": 56 minute and 3.84, respectively. There were no errors in "Critical values of inpatients and outpatients notified after a consensually agreed time". Conclusions: Extra-analytical phase was evaluated by comparing it with the latest quality specifications and sigma values which will contribute to improving the quality of laboratory medicine.

An audit of Preanalytical errors as a quality measure in central clinical laboratory of Rural Tertiary Care Hospital in Eastern Uttar Pradesh

IP innovative publication pvt. ltd, 2019

Introduction: Quality lab reports require high degree of precision and accuracy. This study was undertaken to study pre-analytical errors as a quality measure in Central Clinical Laboratories of rural Tertiary Care Hospital. Materials and Methods: This study was a non-participatory observational study for a period of two months from 6/7/2019 to 6/9/2019 conducted at HIMS, UP, India. After obtaining clearance from Institutional Human Ethical committee, study was undertaken in Central Clinical Laboratory(CCL). The blood samples of OPD and IPD were included. Checklist for pre-analytical errors was followed. Results: Total 13604 blood samples were received in CCL in study periodand pre-analytical error was found to be 398 (2.93%). The commonest error was inadequate (underfilled/Overfilled) samples(1.15%), second commonest was Clotted sample (0.99%), Hemolyzed samples were 0.26%, Lipemic samples were 0.15%, and remaining were diluted sample, incorrect vaccutainer and sample spillage each accounted for 0.08%, followed by test ID form missing (0.06%) and specimen ID and order form mismatch (0.02%). There was a statistical difference between pre-analytical errors in IPD(3.68%) and OPD(0.87%) samples with p value less than <0.05. Conclusion: Pre-analytical errors are avoidable and could be manage by preventive and corrective measures and proper education and skill enhancing training to paramedical staff and efficient monitoring by Lab managers.

A study of preanalytical errors in a hospital based clinical biochemistry laboratory and recommendation of required corrective measures

2016

Background & Objective: The errors associated with the total testing process in laboratory, affecting clinical decision making, may occur at the pre-analytical, analytical and post-analytical phase. This study is aimed at finding out the types and frequencies of errors recorded and recommending the corrective measures in pre analytical phase, which accounts for preventable errors significantly. Materials & Methods: This was a retrospective analysis of errors observed and recorded over 3 months period in clinical biochemistry laboratory at SMIMER hospital, Surat. Data analysis was done on an average of 12680 samples collected and tested. Samples included blood, urine and other fluids. Pre-analytical errors were identified and recorded subsequent to visual inspection of the samples and corresponding request forms by laboratory staff. Results: Pre-analytical errors were classified as A) inappropriate form (28.24%), B) inappropriate sample (3.52%), C) inappropriate transport (22.16%) and D) inappropriate centrifugation (7.29%). For category A, high error rate for date and time of sample collection (99.97%), provisional diagnosis (99.92%) and physician's detail (100%) were observed. For category B, error rate for insufficient sample volume was 26.38%. For category C, error rate for date and time of sample receipt was 100%. Pre-analytical error rate was highest for samples received from outpatient department (18.37%) and for urine sample (18.61%) comparatively. Conclusion: Pre-examination errors were high at this study location. Measures aimed at reducing the same and exposure to accreditation are recommended for improved laboratory quality output.

Study of pre analytical variables in clinical biochemsitry laboratory

IP innovative publication pvt. ltd, 2019

Introduction: Advances in science and Technology have led to transformation of laboratory diagnostics from manual, clumsy testing methods to fully automated science, ensuring accuracy and speed. Pre analytical errors have a major impact on diagnostic accuracy of laboratory results. There have been tremendous work and established quality control criteria for analytical phase of testing however there is paucity of standards for pre analytical phase. Quality indicators (QIs) should therefore cover all the steps involved in the pre-analytical phase, from test requesting, transport to sample storage. Objectives: The following were the objectives for the study: 1. To discern the percent age of pre-analytical errors in our central clinical biochemistry Laboratory (CCL); 2. To stratify the pre-analytical errors documented at CCL; 3. To formulate the possible corrective measures to be taken to minimise such errors. Materials and Methods: In patients (IPD) 18,982 blood specimens requested and received at CCL for various biochemical investigations during November 2018 to May 2019 (6 months) were first sorted out for pre analytical errors. And n= 1907 blood specimens were identified with pre analytical errors were further stratified and categorised according to the error contributing and expressed in percentage. Result: Total 1907 blood specimens were documented and grouped under pre analytical phase errors out of 18,982 total samples received at CCL. When sorted for individual pre-analytical error, out of total n= 1907; Improper request form (n= 107), incorrect timing of sample (n=37), improper labelling (n=65); improper tube collection (n=67) ; insufficient sample (n=228) and in-vitro haemolysis (n=251), sample not received (SNR) (n=1142) of samples amounted to be the major proportion of errors. Conclusion: Pre-analytical errors are not inevitable and can be avoided with a diligent application of proper quality control, proper education of phlebotomist about the errors and effective collection systems to improve the total quality management of laboratory so as to ensure total quality patient care.

Identifying Errors Involving Clinical Laboratory: A 1 Year Study

International Journal of Health Sciences and Research, 2014

OBJECTIVE: It is a known fact that in modern day, laboratory diagnosis is the cornerstone of health care system. It is seen that pre and post analytical phases in a testing cycle contribute majority of the laboratory errors. This study was conducted to recognize the errors that occurs in the three phases of the testing cycle and for improvement in the areas where required. METHODS: The present study was conducted during the period 2012-13 in the central laboratory in M.G.M. Hospital and Medical College. During a 12 month period 97,618 samples were monitored for major pre analytical, analytical and post analytical errors RESULTS: From the study it was documented that total errors were 14,149 of which pre-analytical were 9,867 (69.7%), analytical were 751 (5.3%) and post-analytical were 3,531 (25%). CONCLUSION: Our study showed that most of the errors pre-analytical either during sampling or preparation for analysis. The continuous improvement of the phases of testing cycle seems to b...