Original Article Objective The study was carried out to assess the frequency of pain and Identificationwithdrawal movements of afterthe Types of Pre-analytical Errors in the injection of rocuronium and Clinicaleffects of preChemistry-treatment with Laboratory from Jan-2012 to Dec-2012 atlignocaine. Jinnah Hospital, Department JahangirDesign Sultan , Tariq Afzal, Kokab Jabeen It was a double blind study.

Place and Duration of Study ABSTRACTThis study was of six months Objective:duration To and evaluate was carried the leading out causes of pre- the laboratory. Results: Of the 1,54,554 tubes analyticalfrom March errors 2004 in a toclinical September chemistry laboratory. received during the data collection period, 2505 Methods:2004 at A Combined retrospective Military analysis of the results samples were found unsuitable for further processing. obtainedHospital from Kharian. the clinical chemistry laboratory for This accounted for 1.52% of all samples collected in errorsPatients in the and pre Methods-analytical phase has been carried the laboratory. Rejections arose as a result of the outOne to hundred summarize and datatwenty regarding the frequency of following reasons: 0.48 % were rejected due to theunpremedicated main factors affect patientsing withthe pre -analytical quality hemolysis; 0.92 % were specimens without proper of ASA results. grade Laboratory I and II, aged personnel were asked to requisition slips; and 0.14 % had insufficient sample registerbetween rejections, 18-60 years and andcauses of both for rejection of ward quantity. Conclusion: Of all the samples received in as sexeswell aswere out -enrolledpatient samples in the study. collected in the lab, the overall percentage of rejection is 1.62%. Patients were randomly divided into two groups of 60 patients INTRODUCTIONeach. After induction of Modern day diagnosis is heavily dependent upon occurring before the sample is processed in the auto anaesthesia with thiopentone, 2 reliablepatients laboratory in group A, data. received It is 3 therefore pertinent to analyzer. These include inappropriate tests that have ensureml of credibility lignocaine ofplain the while results emanating from the been ordered, improper sample collection, transport clinical laboratories. Remarkable advances in delays, and illegible handwriting on requisition slips.3,4 automation,those inArticle sample collection, transport, and dispatch Although these areas are beyond the jurisdiction of the of reports have led to a drastic improvement in the clinical laboratory per se, the credibility of performance of these laboratories. But there is long the labs is at stake due to these errors.5,6,7 The labs path to tread before we achieve 100% accuracy and have to bear the burden of the inconsistencies or precision. Errors arising during sample processing are incorrect reporting that can ensue because of these pre- classified into pre-analytical, analytical, and post- analytical errors.8,9 analytical, depending upon their source and time of The goal of the present paper is to enumerate and presentation respectively. The pre-and post-analytical analyze the prevalence of different pre-analytical phases of the process account for 93% of errors.1 The errors that surfaced during sample processing in the pre-analytical phase comprises all of the processes clinical department during a 1-year period. Corresponding Author Jinnah Hospital is a tertiary care super specialty center Dr. Jahangir Sultan in Lahore specializing in , cardiothoracic Assistant Professor Pathology surgery, , , gastroenterology, Chemical Section gastro surgery, and . Jinnah Hospital is a teaching hospital as well. With 1416 students studying Continental Medical College, Lahore, to be doctors at Allama Iqbal Medical College and Pakistan learning practical procedures at Jinnah Hospital, over E-mail: [email protected] 7,000 doctors have graduated from here over the last ten years. A.P.M.C Vol: 7 No. 1 January-June 2013 96

It is a 1250-bed hospital offering specialized Na/K/Cl,ABG Nova biochemical Analyser, and medical and surgical treatment to about an other ancillaries for sample processing. Inpatient average of patients 700,000 visit the Out-Patient phlebotomies are performed by clinical and Emergency Department every year, where department staff, whereas blood specimens from 70% of the treatment is given completely free. outpatients are collected on site at a centralized Every year more than 1,500,000 tests are carried collection center by laboratory personnel. The out in Pathology Laboratory samples are delivered to the lab by the The clinical biochemistry department is equipped paramedical staff from the wards and laboratory with a state-of-the-art autoanalyzer with ISE– support staff from the OPD respectively. Beckman Coulter CX9PRO Clinical System (Hamburg, Germany), electrolyte Plus analyzer–

REVIEW OF THE LITERATURE ON LABORATORY ERRORS

Sector of the Lapworth Goldschmidt M.Pleban.15 Plebani Stahl M et Jahangir Ranjan Romero laboratory and Teal.12 and Lent. 11 and al.14 Kokab and and Carro.16 and Binita.17 Cobos.18 Tariq Sector of the Clinical Whole Primary Stat Whole Clinical Clinical Primary laboratory chemistry laboratory care. laboratory laboratory chemistry chemistry care. Data collection 1 year 6 year 6 month 6 month 3 year 1 year 1 year 3 month period No of Patients 997000 ND 160714 ND ND 154554 96328 52,669 No of errors 120 123 180 189 4135 2505 736 3885 Frequency 0.47 % of 0.61% of 1. 6% of 1.5 %.of 7.4% of patients patients patients patients patientss Pre-analytical 31.6% 53% 55% 55.65 68.2% 0.05% 0.11%of phase patients

MATERIALS AND METHODS A total of 1,54554 samples from the outpatient according to the following accepted criteria: department and in-house patients were received by our inappropriate volume, wrong or missing patient clinical chemistry laboratory during the period from identification, inappropriate container, visible January 2012 to December 2012. Out of these, 97,185 hemolysis after centrifugation, and lipemic samples. samples were collected from the patients admitted in The pre-analytical variables evaluated included all the the wards and 57,369 samples were collected in the criteria mentioned above for sample rejection as well outpatient department. The samples are collected using as incomplete/incorrect patient details and illegible evacuated tubes (vacutainers evacuated tubes from BD handwriting. (Franklin Lakes, NJ). The lab provides routine and reference testing in biochemistry. Upon receiving the RESULTS samples, the lab supervisor visually detects any We will first discuss the findings of the routine problems. When an error occurs, entries are made in samples obtained from the inpatients in our hospital. the problem notification log book. The data generated Out of the 97,185 blood collection tubes screened over is reviewed on a weekly basis. The data collection a period of 1 year, pre-analytical errors were observed procedure involved review of blood samples received in 1626 samples, which is approximately 1.6 % of the from the inpatient as well as outpatient departments. total number of samples received. The distribution of Venous blood samples are considered unsuitable the different types of errors was then calculated (Table

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1). The majority of the rejected samples were Table-2 hemolyzed. Hemolysis was responsible for rejection of Preanalytical Errors Observed in a Total of 57,369 692 samples, which accounts for 0.71% of the total Outpatient Samples number of samples received during this period. The Sr. No. Preanalytical Variable Frequency amount of blood was insufficient for complete analysis 01 Insufficient volume 75(0.13 %) in 0.15 % (i.e., 144out of the 97,185samples). 02 Hemolysis 55(0.09 %) A total of 687 samples were accompanied by 03 Sample with insufficient inappropriate slips (i.e., wrong requisition slip, without information (wrong 738(1.28 %) requisition slip, central registration number ward not vial/wrong slip) mentioned). This comprised approximately 0.70 % of 04 Lipemic samples 11(0.019%) all the samples received by the laboratory. Out of these 203 samples, laboratory personnel managed to DISCUSSION ascertain correct patient data in 153 cases, and hence Advances in science and technology have led to many reporting was completed successfully for these patients. path-breaking innovations that have transformed Fifty samples could not be processed even after laboratory diagnostics from manual, cumbersome elaborate and painstaking efforts by the laboratory testing methods to fully automated science, ensuring 1, 2 staff. Gross lipemia led to rejection of 103samples accuracy and speed. However, the laboratory cannot (0.10 %). function in isolation. It is dependent upon other Similarly, we evaluated the slips obtained from the departments; mainly the clinical division for properly 1, outpatient department. A total of 57,369 samples were filled requisition slips and samples for analysis. 2 received for processing from our OPD. Out of these, Mounting evidence indicates that reliability cannot be achieved in a clinical laboratory through the mere the number of pre-analytical errors documented was promotion of accuracy in the analytical phase of the 879. This constitutes an error rate of 1.5 %. The 3 testing process. distribution of the various pre-analytical variables is It is evident that the majority of all errors in the total depicted in (Table 2). The most frequent error testing processing are of pre-analytical origin, i.e. they encountered during processing was sample with occur before the sample arrives in the laboratory and insufficient information (wrong vial/wrong slip). This the phase after the sample is analyzed (post-analytical) constitutes an error rate of 1.28% this led to rejection are equally important.4 The pre-analytical phase is of 738 samples out 57369 samples. The insufficient riddled with many shortcomings ranging from lax volume with an incidence of 0.13 %. Hemolysis, attitude about filling the requisition slips to the staff's which constituted the most frequent pre-analytical lack of education about ideal phlebotomy procedures. The health care system must be more diligent in error observed during sample processing of admitted applying scientific knowledge to reduce the errors in patients, contributed to the rejection of 0.09 % of the this phase. This is imperative to curtail the dent on samples in OPD as compared to 0.71% in the previous laboratory services that arise due to human errors. case. There has been varied information on the error rate within the whole lab testing procedure (0.1% to 9.3%). Table-1 Plebani and Carraro observed in their paper that the Frequency of the Different Preanalytical Errors great majority of errors result from problems in the Observed in a Total of 97,185 Routine Inpatient pre-analytical or post-analytical phases.5 Samples Pre-analytical errors are largely attributable to human Sr. No. Preanalytical Variable Frequency mistakes and the majority of these errors are 01 Insufficient volume 144(0.15%) preventable.15This is understandable, since the pre- 02 Hemolysis 692 (0.71%) analytical phase involves much more human handling, 03 Sample with insufficient compared to the analytical and post-analytical phases. 6 information (wrong 687 (0.70%) Hemolysis accounted for the majority of rejections in vial/wrong slip) our study. The introduction of vacuum tubes along 04 Lipemic samples 103(0.10 %) A.P.M.C Vol: 7 No. 1 January-June 2013 98

with the closed system of blood collection has made serum/plasma for analysis. The main reasons behind blood collection efficient and easy. But lack of staff this anomaly are ignorance of the phlebotomists, training engaged in phlebotomy is an impediment for difficult sampling as in pediatric patients, patients with expediting sample collection and transport. Hemolysis chronic, debilitating diseases, and patients on of samples occurs when blood is forced through a fine chemotherapy whose thin veins are difficult to localize. needle, shaking the tubes vigorously, and centrifuging Insufficient sample volume constituted the most the sample specimens before clotting is complete.7 frequent cause of test rejection in the samples collected Red top vacutainers without any anticoagulant should in the OPD (1.28%). 12 not be shaken after the sample has been collected, and Inpatient sampling with a frequency of 0.15 % for vacutainers for plasma should be gently inverted a few inadequate volume only. The difference is striking. times so the anticoagulant mixes with the blood. This may be attributed to a number of factors. We have Freezing and thawing of blood specimens may cause a centralized collection center where samples for massive hemolysis. In a study by Jay and colleagues, clinical biochemistry, hematology, microbiology, and the majority of hemolyzed samples (>95%) could be gastroenterology are collected simultaneously.13 Due attributed to in vitro processes resulting from incorrect to the paucity of man power; the ratio of patients to sampling procedure or transportation.8 Hemolysis phlebotomists is disproportionate, making sample leads to the extravasation of intracellular contents into collection difficult. This may hamper proper sample the plasma, leading to false high values of potassium collection, leading to inadequate collection. The and intracellular enzymes such as SGOT and LDH. It collection is carried out during fixed hours. Hence, this also leads to a prolongated turn around time (TAT) due patient load combined with shortage of time may to the need for fresh samples for processing the adversely affect proper sample collection in the OPD request.9 The frequency of hemolysis was more in the setting. Difficult sampling and patient non-compliance samples that were collected from the admitted patients further aggravates this problem. Nevertheless, it is as compared to the patients attending the OPDs (0.71% mandatory for the laboratory staff to practice a certain as compared to 0.09 %). One plausible explanation for basic level of workmanship and skillful phlebotomy this phenomenon could be the systematic blood techniques to reduce such errors to a minimum.14 collection technique followed by the laboratory staff in A total of 0.70 % samples in the wards were the OPD.10 As a part of our endeavor to achieve accompanied by inappropriate requisition slips. The accreditation for our laboratory services; we carry out same figure for OPD samples was1.28 %. It has been regular in-house training sessions for our technicians observed that the clinicians often send incomplete slips to familiarize them with the standard protocols for with the samples. This could be due to excessive sample processing. For this purpose, we have patient load or lack of awareness regarding patient developed standard operating procedures (SOPs) for information. Modern day diagnostics is not merely the different steps involved in ideal laboratory sample processing and preparation of reports. The operations and ethics. Such training has facilitated in laboratories are actively involved in disseminating the adoption of ideal phlebotomy practices by our information about critical results to clinicians so laboratory personnel. The samples are thereby corrective measures can be initiated at the earliest. transported to our laboratory from the collection center Incomplete/wrong patient information makes the by our staff following the basic precautions that must practice redundant. Our laboratory staff could arrange be adhered to during transportation. There is an urgent the correct information about some of the patients need to instill awareness about the intricacies of a admitted in the wards through their painstaking efforts. seemingly “easy and basic” activity that forms the This leads to loss of precious time and is a labor- mainstay of laboratory services - phlebotomy among intensive activity. The same protocol could not be the staff engaged in sample collection in our hospitals followed for the OPD patients as it was virtually to reduce inadvertent hemolysis.11 impossible to ascertain the patient/test information Another factor leading to rejection of blood samples in from either the clinicians or the patients. We followed Our study was insufficient blood volume. Every a different protocol for these patients. The requisition analytical process requires a fixed volume of slips, with an appropriate note citing reasons for

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sample rejection, were dispatched to the OPD for the initiate steps for the inculcation of ideal phlebotomy clinicians’ knowledge. Those tests were repeated with practices among health care workers.17, 18 fresh samples and new requisition slips as and when the patients revisited the hospital for checkup. This is CONCLUSIONS definitely inconvenient for patients, who have to The concept of total quality management encompasses undergo the same process of registration and all the steps involved in sample processing, beginning consequent sampling. Such errors can be completely from test ordering to the final interpretation of results wiped out by persistence by the laboratories for by the clinicians to reduce or eliminate the errors that complete information and sincere efforts by the may arise during the various steps. The promotion of clinicians to provide the same. This will facilitate ideal phlebotomy practices and sample transport speedy sample processing and report dispatch to the procedures is a pre-requisite for the efficacy of patients to initiate therapeutic interventions at the Laboratory functioning. The dependence on accurate earliest.15, 16 laboratory results for diagnostics makes it mandatory Lipemia accounted for rejection of 0.10 % and for labs to ensure accountability and accuracy of 0.019 % of the samples in the inpatient and outpatient results to negate incorrect diagnosis as a consequence departments respectively. Lipemic samples can arise of faulty reporting. A practice of keeping a record of due to collection after heavy meals or the presence of the errors at all stages of analysis and then devising some metabolic disorder (hyperlipoproteinemias). This corrective strategies for their prevention can gradually can be avoided by sample collection, preferably after free a laboratory from such errors. an overnight fast. If the patient has a metabolic Errors in the laboratory can lead to inaccurate reports disorder, the same must be mentioned in the dispatched to clinicians, affecting health care services requisition slip. Lipemia interferes with optical reading greatly. Ensuring the credibility of results is of utmost by the instrument and can affect interpretation of importance. While many clinicians probably believe electrolyte values. A higher incidence of lipemia in that most errors in the laboratory are analytical, there OPD patients may be due to non-dissemination of are data showing that the pre-analytical and post- information regarding prior preparation to the patients analytical phases are the greatest contributors to by the clinicians as well as non-compliance and/or laboratory mistakes. miscomprehension of preparation rules by the patients. Though it is impossible to completely eliminate errors, Hence, many patients give samples in non-fasting it is possible to reduce them. We conclude that training states leading to erroneous reporting. It is the of phlebotomists and technicians, bar coding of responsibility of the clinicians and the phlebotomists to samples, implementation of a LIS, adoption of ensure that proper patient preparation is instituted standardized procedures along with participation in before sample collection.17 external quality assessment programs and accreditation These data are comparable to those provided by other schemes can help to reduce laboratory errors to a investigators, which confirm that problems directly minimum. related to specimen collection are the main cause of To attain this goal, we first implemented a continued pre-analytic errors, especially hemolyzed, clotted, education program, financed by our Regional Health insufficient, and incorrect samples.16, 17 Service and focused in Primary Care Nurses. With the exclusive use of vacutainers, the frequency of errors found in our study is 1.62 %. It is clear from the REFERENCES above discussion that incorrect phlebotomy practices 1. Ranjna Chawla, PhD, Binita Goswami, MD, are the main reason behind pre-analytical errors. The DNB, Devika Tayal, MD, V Mallika, reason for incorrect phlebotomy practice includes lack MD.Identification of the Types of Preanalytical of awareness or possibly a heavy workload. This is the Errors in the Clinical Chemistry Laboratory: 1- reason phlebotomy has been considered a separate area of improvement for medical technicians in developed Year Study at G.B. Pant Hospital. LAB MED. Countries. Those of us in developing nations must 2010; 41: 89-92. adopt a similar approach toward phlebotomy and

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