Evaluation of Quality Indicators in a Laboratory Supporting Tertiary Cancer Care Facilities in India Savitha Anil Kumar, MD, 1* Prashanth Jayanna, PhD, 2 Shilpa Prabhudesai, MD, 1 Ajai Kumar, MD 2 Lab Med Summer 2014;45:272-277 DOI: 10.1309/LMP0E6DVC0OSLYIS ABSTRACT Objective: To collect and tabulate errors and nonconformities in the preanalytical, analytical, and postanalytical process phases in a diagnostic clinical laboratory that supports a super-specialty cancer center in India, and identify areas of potential improvement in patient services. Methods: We collected data from our laboratory during a period of 24 months. Departments in the study included clinical biochemistry, hematology, clinical pathology, microbiology and serology, surgical pathology, and molecular pathology. We had initiated quality assessment based on international standards in our laboratory in 2010, with the aim of obtaining accreditation by national and international governing bodies. We followed the guidelines specified by International Organization for Standardization (ISO) 15189:2007 to identify noncompliant elements of our processes. Advances in our knowledge of the molecular basis of disease have increased the capability of laboratory professionals to investigate complex diseases such as cancer using a variety of tests that provide diagnostic, prognostic, and risk-stratification information. 1-3 The clinical use of these tests makes it essential that the results are highly accurate and reproducible with a minimal occurrence of errors. 4-6 Thus, objective measures must be identified that enable quantitative evaluation of the Abbreviations QC, quality control; QMSs, quality management systems; QIs, quality indicators; NABL, National Accreditation Board for Testing and Calibration Laboratories; CAP, College of American Pathologists; QA, quality assurance; ISO, International Organization for Standardization; SOPs, standard operative procedures; TAT, turnaround time; NCs, nonconformances; LIS, laboratory information system; ILQA, interlaboratory QA. 1 Triesta Reference Laboratory and 2 Triesta Research and Development Division, HealthCare Global Enterprises, Ltd, Bangalore, India *To whom correspondence should be addressed. E-mail: drsavithanilkumar@gmail.com Results: Among a total of 144,030 specimens that our referral laboratory received during the 2-year period of our study, we uncovered an overall error rate for all 3 process phases of 1.23%; all of our error rates closely approximated the results from our peer institutions. Errors were most common in the preanalytical phase in both years of study; preanalytical- and postanalytical-phase errors constituted more than 90% of all errors. Conclusion: Further improvements are warranted in laboratory services and are contingent on adequate training and interdepartmental communication and cooperation. Keywords: quality indicators, laboratory medicine, tertiary cancer center, errors, quality control, quality management performance of a laboratory in providing critical diagnostic data domains. 7,8 In a large clinical laboratory, mistakes are inevitable given the volume of specimens, the number of individuals handling these specimens, and the number of steps involved in the testing process. However, appropriate training, quality control (QC) checks, and periodic review of protocols have been shown 9,10 to minimize errors. Medical laboratories have developed rigorous quality management systems (QMSs) consisting of a number of quality indicators (QIs) that are used to monitor laboratory functions. Such systems include audits by internal and external evaluators, as well as accreditation by nationally and internationally recognized organizations such as the National Accreditation Board for Testing and Calibration Laboratories (NABL) and the College of American Pathologists (CAP), all of which have been demonstrated 11,12 to promote highly effective quality assurance (QA) procedures. Preparations for such audits include documentation, implementation, and adherence to International Organization for Standardization (ISO) 15189:2007 272 Lab Medicine Summer 2014 Volume 45, Number 3 www.labmedicine.com
standards. These preparations encompass creating and/ or adapting quality policies, the quality manual(s), qualitybased system procedures, standard operative procedures (SOPs), the safety manual(s), and the primary specimen collection manual(s). Also included are creation and/or adaptation of technical and quality records related to tests, equipment, supplies, internal QC measures, proficiency tests, and turnaround time (TAT). The laboratory maintains and periodically reviews all records related to concerns, feedback from doctors and clients, daily and audit-revealed nonconforming data (hereafter, nonconformances [NCs]), corrective and preventive actions undertaken, staff training, and competency evaluation. Based on these records, the laboratory can establish various technical and quality-based activities that its staff can analyze quarterly to generate review summaries to be published in quality reports. In this article, we summarize our experience operating and maintaining a QMS that serves the referral laboratory of an Indian tertiary cancer care center during a 2-year period from January 2010 through December 2011. As part of our QA program, we enumerated variables from the preanalytical (specimens rejected due to collection and labeling issues), analytical (elements that did not conform with QC procedures) and postanalytical (amended reports) phases that occurred in the various sections of the laboratory. Materials and Methods Our cancer care hospital caters to the needs of more than 30,000 new patients annually. Its headquarters, located in Bangalore, India, is a 250-bed hospital that offers a wide spectrum of services, including diagnostic support for a variety of cancer-associated morbidities. The diagnostic services of the laboratory involve the disciplines of biochemistry, hematology and clinical pathology, microbiology and serology, surgical pathology, and molecular pathology. The laboratory is accredited by the NABL and CAP; it is well equipped with biosafety level 2 (BSL 2) facilities for handling a variety of clinical specimens. The staff are well trained in virtually all common laboratory techniques and in ISO 15189:2007 quality system principles. Johnson & Johnson), the MINICAP electrophoresis platform (Sebia Electrophoresis, Norcross, GA), and other auxiliary equipment for specimen processing. The hematology and clinical pathology departments use the Sysmex XT-4000i and 1800i automated cell count analyzers (Sysmex Corporation, Kobe, Japan), the Stago STA Compact and Stago STart automated and semiautomated hemostasis workstations (Diagnostica Stago Inc, Parsippany Troy Hills, NJ), and the CLINITEK Status automated urine analyzer (Siemens AG, Munich, Germany). For blood cultures, the microbiology section uses the semiautomated mini API and the BacT/ALERT 3D automated systems (both by biomérieux SA, Marcy l Etoile, France) for identifying bacteria and typing their antimicrobial resistance levels. The surgical pathology section is supported by the Leica TP1020 automated tissue processor, the Leica EG1150 H automated embedding module, a Leica CM1850 cryostat (Leica Biosystems, Wetzlar, Germany), and several Xmatrx automated slide processors (BioGenex Laboratories, Inc, San Ramon, CA). Our molecular pathology section is equipped with a Dako CyAn ADP flow cytometer (Beckman Coulter, Inc, Brea, CA). All instruments are calibrated at regular intervals according to a defined schedule of maintenance; laboratory personnel document daily maintenance, instrument failures, and corrective actions for each instrument. We subject all instrumentation to required validation studies before clinical use. Specimens received from the outpatient and inpatient departments, are labeled with the patient identifying and order information and a unique barcode generated by our laboratory information system (LIS). Specimen data captured in the LIS include the name, age, and sex of the patient; full name of the referring consultant; specimen type; date and time of collection; time of receipt of specimen; and signature of the technical staff member(s) who handled the specimen. Laboratory personnel screen specimens for preanalytical errors before processing those specimens; specimen acceptance and rejection criteria are based on ISO 15189:2007 guidelines. Data from specimens not adhering to the criteria are rectified, sometimes by requesting a repeat specimen, and the reason for rejection is documented. Laboratory staff members periodically review and perform root cause analysis of specimenrejection trends to identify frequent preanalytical errors. The clinical biochemistry section is equipped with the Vitros 350 autoanalyzer (Ortho-Clinical Diagnostics, Johnson & Johnson, Raritan, NJ), the Vitros ECiQ immunoassay analyzer (Ortho-Clinical Diagnostics, Specimens marked urgent are processed by laboratory personnel immediately after receipt; consultants enter the reports for such specimens as soon as possible into the LIS. Consultants will convey predefined critical www.labmedicine.com Summer 2014 Volume 45, Number 3 Lab Medicine 273
Figure 1 Errors in the 3 phases of laboratory practice at a tertiary cancer care hospital in India. 2010 2011 9.9% 6.1% laboratory findings to the treating physicians immediately; a read-back policy is in place for the nursing staff and the consultants who receive the information. Laboratory personnel release regular reports to the physician and patient (depending on circumstance) after verification and authentication. This report includes the TAT, which is the time period from collection of the specimen through dispatching of reports. The TAT varies from test to test; the following TAT values constitute a representative range for different departments: biochemistry, 2 hours to 24 hours; hematology and clinical pathology, 2 hours to 48 hours; microbiology and serology, 24 hours to 7 days; surgical pathology, 20 minutes to 4 days; molecular pathology, 2 days to 14 days. Laboratory staff members also maintain a record of amended reports issued, to evaluate the occurrence of postanalytical errors. Laboratory managers analyze these records monthly and suggest or undertake corrective and/or preventive actions to reduce or eliminate the future occurrence of such errors. Our laboratory subscribes to proficiency evaluations at the national and international levels, such as the external QA programs offered by CAP and interlaboratory QA (ILQA) measures. We process QA specimens in the same manner as routine specimens. If proficiency testing programs are unavailable for a particular test, we perform split-specimen analyses to ensure the accuracy of results. We document all steps in the analytical process to minimize the occurrence of errors. Staff training, in the form of a continuing education program, is mandatory at regular intervals, to ensure that staff members possess current knowledge of the techniques and technologies used in the laboratory. We based our evaluation of laboratory performance on quality indicators in all 3 phases of specimen processing; 50.4% namely, the preanalytical, analytical, and postanalytical phases. The data presented herein were collected from specimens that arrived in our laboratory between January 2010 and December 2011. Results 39.8% 49.4% Preanalytical variables Analytical variables Postanalytical variables 44.5% Our referral laboratory received a total of 144,030 specimens during the 2-year period of our study. We observed a 30.49% increase in the specimen numbers from the first year to the second. We calculated the overall error rate for all 3 analytical phases by dividing the total number of errors by the total number of specimens; the result was 1.23%. Errors were most common in the preanalytical phase in both years of the study; preanalytical- and postanalytical-phase errors constituted more than 90% of the total errors (Figure 1). Preanalytical components included specimen collection, quality, labeling, and delivery. Table 1 identifies the various preanalytical indicators that we used as benchmarks in this study. Hemolysis was the most common cause of specimen rejection (4.74/1000), followed by clotted specimens (0.83/1000). The other indicators included incomplete request forms (0.01/1000), labeling errors (0.08/1000), and inappropriate or wrong container (0.07/1000). We combined indicators with an extremely low frequency of errors, such as lipemic specimens (0.006/1000), and observed a total prevalence of 0.39/1000 for the low frequency indicators. Table 2 shows the prevalence of certain quality indicators for the analytical processes we use in our laboratory. We decided to include noncompliance with quality assurance 274 Lab Medicine Summer 2014 Volume 45, Number 3 www.labmedicine.com
measures for the analytic process as an indicator of the performance of the laboratory (0.06/1000). Proficiency testing performance, which compares the analytical results in our laboratory to peer laboratories, appeared to be the major source analytical errors (0.9/1000). The postanalytical variables that we used to measure the quality of our laboratory services are listed in Table 3. Analysis exceeded the specified testing time for 666 specimens (4.62/1000), whereas we gave out a total of 82 amended reports (0.57/1000). We followed the guidelines specified by ISO 15189:2007 for laboratory quality and competence. Accordingly, we recorded incidents of NCs with the standard management and technical requisites outlined in the ISO quality manual. The number of such NCs that occurred during the 2-year duration of our study is shown in Figures 2A and 2B. Among the management requirements, the highest number of NCs was recorded for maintenance of quality and technical records in both years. Regarding the technical specifications, we most often recorded deviations from the required standards for the preexamination procedures. Discussion Quality, as a measure of excellence, is a critical feature of service-oriented professions such as healthcare from the medical and commercial standpoints. Modern medical interventions rely heavily on laboratory testing; 13 hence, the quality of these services can have crucial repercussions on patient safety and the effectiveness of treatments. Quality assurance becomes especially critical in tertiary cancer care centers that offer advanced therapies for intractable cancers. In such patients, healthcare professionals often order and/or perform a battery of tests to assess the status of the patient and his or her disease before formulating a plan of therapy. In this environment the precision, accuracy, and speed at which these tests are performed are highly important in determining the type and timing of the clinical interventions. Our hospital is supported by a multidisciplinary laboratory that performs routine tests and advanced diagnostic tests that encompass the disciplines of molecular pathology and molecular biology. We report herein the error rates in our laboratory and compare them to recently reported averages. 14 The overall error rate in our laboratory during a 2-year period was 1.23%; this figure is within the range of 0.1% Table 1. Prevalence of Preanalytical Quality Indicators a Year Total No. (No. per 1000) Variable 2010 2011 of Specimens Hemolyzed 295 (4.72) 388 (4.76) 683 (4.74) Clotted 63 (1.01) 56 (0.69) 119 (0.83) Incomplete 1 (0.02) 1 (0.01) 2 (0.01) Unlabeled/wrongly labeled 7 (0.11) 4 (0.05) 11 (0.08) Inappropriate or wrong container 7 (0.11) 3 (0.04) 10 (0.07) Other 30 (0.48) 26 (0.32) 56 (0.39) Total errors 403 (6.45) 478 (5.86) 881 (6.12) a n = 144,030. Table 2. Prevalence of Analytical Quality Indicators a Year Total No. (No. per 1000) Variable 2010 2011 of Specimens Noncompliance with QC measures 6 (0.10) 3 (0.04) 9 (0.06) Proficiency-testing performance 73 (1.17) 56 (0.69) 129 (0.9) Total errors 79 (1.26) 59 (0.72) 138 (0.96) QC, quality control. a n = 144,030. Table 3. Prevalence of Postanalytical Quality Indicators a Year Total No. (per 1000) Variable 2010 2011 of Specimens Amended reports 27 (0.43) 55 (0.67) 82 (0.57) Prolonged turnaround time 291(4.66) 375 (4.6) 666 (4.62) Total errors 318 (5.09) 430 (5.27) 748 (5.19) a n = 144,030. www.labmedicine.com Summer 2014 Volume 45, Number 3 Lab Medicine 275
A Reporting of Results B Postexamination Procedures Assuring the Quality of Examination Procedures Examination Procedures Preexamination Procedures Laboratory Equipment Accommodation and Environmental Conditions Figure 2 Personnel 0 10 20 30 40 50 60 No. of NCs 2010 2011 to 3.0% that had been published by Lippi et al 15 in a summary of data from a number of studies. The rate decreased across the study period from 1.28% to 1.19%, which may be due to the increased number of specimens handled by the laboratory and also the implementation of the QA training program in the laboratory. Our reports mirrored the results of several earlier studies 16-19 in that the preponderance of errors occurred in the preanalytical and postanalytical phases. The analytical phase of the laboratory process, which consists of steps directly related to specimen testing, has been shown 20-23 to be amenable to improvements; this is due to technological advances, as well as adoption of universal internal QC procedures. In keeping with this trend, our analytical error rate showed the largest improvement, falling from 1.26 per 1000 to 0.72 per 1000 during the 2-year period of our study. We believe that improved instrumentation, in tandem with enhanced training of personnel, will further decrease this error rate. The preanalytical phase, which encompasses processes that mostly occur outside the laboratory, includes test ordering, specimen transport, and specimen processing, is the phase where most errors in the total testing process occur; for instance, Hammerling 14 reported a range of 46% to 68.2% (of total laboratory-related errors). Some studies have focused solely on errors occurring in this phase. 24,25 All of our preanalytical variables dealt with specimen quality; we observed that hemolysis was the most frequent cause of specimen rejection. These results are consistent with those of other studies performed in India and elsewhere. 26-28 We observed a slight increase in the rate of hemolyzed specimen across the study period (4.72/1000 to 4.76/1000), which may have occurred Management Reviews Internal Audits Quality and Technical Reports Continual Improvement Preventive Action Corrective Action Identification and Control of NC Resolution pf Concerns Advisory Services External Services and Supplies Examination by Referral Laboratories Review of Contracts Document Control Quality Management System Organization and Management because of an increased patient load that produced greater demand on the infrastructure at the phlebotomy counter. Rates of mistakes in labeling (0.08/1000) were low in our study; we expect this low error rate is due to the barcoding system in place for specimen handling in our laboratory. Postanalytical errors can occur in processes involving the verification, transcription (electronic or manual), and communication of test results to the health care professionals. Our postanalytical error rates were within a range reported previously, 29 with increased TAT being the most commonly recorded NC issue (4.62/1000); this is within the specifications reported in another study by Kirchner et al. 30 Report reissue was the other criterion that we and other researchers enumerated; the rates for this item were comparable to those reported by Kirchner et al. Although merely reporting on the performance status of QIs does not improve the quality of services provided by the laboratory, it plays a highly important role in identifying potentially problematic areas within the total testing process. 28 Further, preparations for audits hinge on the systematic, transparent, and consistent reporting of deviations from the established procedures. This process, coupled with appropriate and conscientious corrective and preventive actions, will address failures within the system and help laboratory staff to achieve the goals of a patientcentered laboratory service. LM Acknowledgments 0 1 2 3 4 5 6 7 No. of NCs Nonconformities recorded in our hospital laboratory. A, Recorded in fulfilment of management requirements of the International Organization of Standardization (ISO) guideline 15189:2007. B, Recorded in the fulfillment of technical requirements of the ISO guideline 15189:2007. NCs indicates nonconformities. This work was financially and materially supported by HealthCare Global Enterprises Ltd, including its Triesta 2010 2011 276 Lab Medicine Summer 2014 Volume 45, Number 3 www.labmedicine.com
reference laboratory and division of research and development (R&D), Bangalore, India. References 1. Guidi GC, Lippi G. Will personalized medicine need personalized laboratory approach? Clin Chim Acta. 2009;400:25-29. 2. Guidi GC, Lippi G. Laboratory medicine in the 2000s: programmed death or rebirth? Clin Chem Lab Med. 2006;44:913-917. 3. Panteghini M. The future of laboratory medicine: understanding the new pressures. Clin Biochem Rev. 2004;25:207-215. 4. Lippi G, Fostini R, Guidi GC. Quality improvement in laboratory medicine: extra-analytical issues. Clin Lab Med. 2008;28:285-294. 5. Lippi G, Guidi GC. Risk management in the preanalytical phase of laboratory testing. Clin Chem Lab Med. 2007;45:720-727. 6. Plebani M. Exploring the iceberg of errors in laboratory medicine. Clin Chim Acta. 2009;404:16-23. 7. Committee on Quality of Health Care in America. Kohn LT, Corrigan J, Donaldson MS, eds. To Err is Human: Building a Safer Health System. Washington, DC: National Academy Press; 2000. 8. Panteghini M. Traceability, reference systems and result comparability. Clin Biochem Rev. 2007;28:97-104. 9. Comprehensive Accreditation Manual for Pathology and Laboratory Services. Northfield, IL: The Joint Commission; 2009. 10. Shahangian S, Snyder SR. Laboratory medicine quality indicators: a review of the literature. Am J Clin Pathol. 2009;131:418-431. 11. Erasmus RT, Zemlin AE. Clinical audit in the laboratory. J Clin Pathol. 2009;62:593-597. 12. Harper J, SenGupta S, Vesela K, et al. Accreditation of the PGD laboratory. Hum Reprod. 2010;25:1051-1065. 13. Boone DJ. Is it safe to have a laboratory test? Accred Qual Assur. 2004;10:5-9. 14. Hammerling JA. A review of medical errors in laboratory diagnostics and where we are today. Lab Med. 2012;43:41-44. 15. Lippi G, Plebani M, Simundic A-M. Quality in laboratory diagnostics: from theory to practice. Biochemia Medica. 2010;20:126-130. 16. Astion ML, Shojania KG, Hamill TR, Kim S, Ng VL. Classifying laboratory incident reports to identify problems that jeopardize patient safety. Am J Clin Pathol. 2003;120:18-26. 17. Bonini P, Plebani M, Ceriotti F, Rubboli F. Errors in laboratory medicine. Clin Chem. 2002;48:691-698. 18. Howanitz PJ. Errors in laboratory medicine: practical lessons to improve patient safety. Arch Pathol Lab Med. 2005;129:1252-1261. 19. Plebani M. Laboratory errors: How to improve pre-and post-analytical phases? Biochemia Medica. 2007;17:5-9. 20. Carraro P, Plebani M. Errors in a stat laboratory: types and frequencies 10 years later. Clin Chem. 2007;53:1338-1342. 21. Plebani M, Carraro P. Mistakes in a stat laboratory: types and frequency. Clin Chem. 1997;43:1348-1351. 22. Stull TM, Hearn TL, Hancock JS, Handsfield JH, Collins CL. Variation in proficiency testing performance by testing site. JAMA. 1998;279:463-467. 23. Witte DL, VanNess SA, Angstadt DS, Pennell BJ. Errors, mistakes, blunders, outliers, or unacceptable results: how many? Clin Chem. 1997;43:1352-1356. 24. Simundic A-M, Nikolac N, Vukasovic I, Vrkic N. The prevalence of preanalytical errors in a Croatian ISO 15189 accredited laboratory. Clin Chem Lab Med. 2010;48:1009-1014. 25. Wiwanitkit V. Types and frequency of preanalytical mistakes in the first Thai ISO 9002:1994 certified clinical laboratory, a 6-month monitoring. BMC Clin Pathol. 2001;1:5. 26. Chawla R, Goswami B, Singh B, Chawla A, Gupta VK, Mallika V. Evaluating laboratory performance with quality indicators. Lab Med. 2010;41:297-300. 27. Goswami B, Singh B, Chawla R, Mallika V. Evaluation of errors in a clinical laboratory: a one-year experience. Clin Chem Lab Med. 2010;48:63-66. 28. Sciacovelli L, Sonntag O, Padoan A, Zambon CF, Carraro P, Plebani M. Monitoring quality indicators in laboratory medicine does not automatically result in quality improvement. Clin Chem Lab Med. 2012;50:463-469. 29. Plebani M. Errors in clinical laboratories or errors in laboratory medicine? Clin Chem Lab Med. 2006;44:750-759. 30. Kirchner MJA, Funes VA, Adzet CB, et al. Quality indicators and specifications for key processes in clinical laboratories: a preliminary experience. Clin Chem Lab Med. 2007;45:672-677. To read this article online, scan the QR code, http://labmed. ascpjournals.org/content/45/3/272.full. pdf+html www.labmedicine.com Summer 2014 Volume 45, Number 3 Lab Medicine 277