|Year : 2019 | Volume
| Issue : 1 | Page : 2-6
Laboratory quality improvement: Act or perish
Rateesh Sareen, Menka Kapil, Gajendra Nath Gupta
Department of Pathology and Transfusion Medicine, Santokba Durlabhji Hospital, Jaipur, Rajasthan, India
|Date of Web Publication||26-Jul-2019|
Dr. Rateesh Sareen
Department of Pathology and Transfusion Medicine, Santokba Durlabhji Hospital, Jaipur, Rajasthan
Source of Support: None, Conflict of Interest: None
The increasingly dominant role of laboratory medicine in clinical decision-making and the simultaneous pressure on cost containment have led to careful evaluation and identification of preventable causes of errors in total testing process of laboratory analyte. The patient-centric health-care delivery system mandates the need to formulate policies and procedures based on international guidelines to minimize errors of laboratory professionals or nonlaboratory operators. The paper summarizes various areas of laboratory that are prone to errors so that the laboratory can redesign the system and make it resistant to errors unknowingly committed by health-care professionals.
Keywords: Analytical, laboratory errors, postanalytical, preanalytical, total testing process
|How to cite this article:|
Sareen R, Kapil M, Gupta GN. Laboratory quality improvement: Act or perish. QAI J Healthc Qual Patient Saf 2019;1:2-6
|How to cite this URL:|
Sareen R, Kapil M, Gupta GN. Laboratory quality improvement: Act or perish. QAI J Healthc Qual Patient Saf [serial online] 2019 [cited 2019 Dec 8];1:2-6. Available from: http://www.QAIJ.org/text.asp?2019/1/1/2/263594
| Introduction|| |
In recent years, health-care providers, patients, and personnel have placed a growing emphasis on improving the quality of health-care services. The Institute of Medicine (IOM) defines quality in health care as “the degree to which health-care services for individuals and populations increase the likelihood of desired health outcome and are consistent with current professional knowledge.”
Health-care decisions should be taken after due considerations to costs associated with quality improvement efforts requiring investments. The cost of quality (COQ) concept originated in 1950 that was aimed at assessing hidden costs in quality improvement tools. The quality costs can be broadly categorized under three heads – (1) prevention, (2) appraisal, and (3) failure. This paper addresses to the potential preventable errors that can arise in the laboratory leading to addition of costs and loss of quality. In May 2014, the Clinical and Laboratory Standards Institute (CLSI) published a report titled “understanding the cost of quality in laboratory (QMS20-R).” This report provides an overview of the different types of quality costs and helps laboratories to identify quality costs and eliminate unnecessary expenses.
The total testing process in laboratory comprises preanalytical, analytical, and postanalytical phases. “To err is human,” the IOM published seminal report on medical errors in 1999 that focused on patient safety. Medical errors can be traditionally clustered into four categories – errors of diagnosis, errors of treatment, and errors of prevention and miscellaneous. About 60%–70% of medical decisions depend on diagnosis and treatment where the laboratory plays a pivotal role. There is no doubt that laboratory science in the present is ideally positioned to initiate patient safety solutions. The quality of laboratory results directly impacts patient treatment outcome, and therefore, a quality management system is the most efficient path to improvement as it involves a multifaceted strategy whose ultimate target is to decrease the uncertainty inherent to process., Various national bodies such as the National Accreditation Board for testing and calibration laboratories in India and international bodies such as College of American Pathologists (CAP) and the Joint Commission International (JCI) and Quality and Accreditation Institute are involved in assessing the quality of laboratory services using various measurements to define quality.
The most important step in improving laboratory quality and prevent error is identification of activities that pose greatest risk to the occurrence of laboratory errors. The identification of vulnerable areas is done by implementing an error detecting system targeting all three phases of total laboratory testing cycle.
| Preanalytical Phase|| |
The ISO 15189:2007 standard for laboratory accreditation defines the preanalytical phase as “steps starting in chronological order from clinician's request and includes examination of request form, collection of sample, and the transport to the laboratory or within the laboratory culminating in analytical phase of testing.”
The preanalytical phase accounts for nearly 70% of the errors in laboratory testing. The preanalytical phase beyond doubt is the most error-prone phase, but recent data from the literature suggest that the errors occurring in the preanalytical phase are mostly related to procedures performed outside the laboratory by health-care personnel who are not under direct control of laboratory. For example, we are all aware of effect of hemolysis on serum potassium concentration. The sample collection by nursing staff in inpatients inward, intensive care unit, and clinical areas is more prone to errors than by sample collection done by laboratory personnel or phlebotomist. Again, the nursing staff is not directly under the control of laboratory. The laboratory personnel can train and evaluate competency of nursing staff for sample collection but cannot directly supervise them as both have different domains of working. However, the laboratory relies on the sample collection technique by nursing staff, and analysis of samples is done with reporting of tests. Plebani and Carraro in their papers have emphasized on the importance of preanalytical phase as a major determinant for curtailing errors in laboratory medicine. The lack of External Quality Assessment (EQA) for preanalytical phase further complicates the issue, as benchmarking is not possible for this phase of testing.
Incomplete and inappropriate laboratory test request forum
An important preanalytical procedure performed outside the laboratory is the selection of appropriate tests. Inappropriate tests cause inconvenience to the patients and result in unjustifiable increase in cost. In the era of evidence-based medicine and increased reliance on insurance reimbursement with ever increasing issues on claim settlements, has resulted in defensive approach by physicians. Nonetheless, the inappropriate tests as such do not affect quality of patient care.
Conventionally, the request forms are the most commonly and favored method for requesting tests. The paper-based test requests pose a greater risk as they may be incompletely filled or may get lost. The incomplete request forms are rarely rejected by the laboratory reception as many times the staff at reception are unaware of the importance of missing information on test requisition form. As per studies in the literature, the inappropriate tests may vary from 11% to 70% for general biochemistry and hematology, 5%–95% for urine screening and microbiology, and 17.4%–55% for thyroid and cardiac enzymes.,
With the use of information technology, test ordering should implement a computerized order entry system to replace paper-based requesting. This system allows doctors to enter orders directly into a computer; thus, a great deal of transcription errors can be reduced in this way. It could potentially eliminate lost test requests and bring improvement in ordering decisions. In later stages, a decision support mechanism can be put in place to limit redundant and or unnecessary orders; in addition to the above-mentioned advantages, it will provide access to longitudinal data on patients, thereby improving laboratory capacity to generate quality test results.
Inappropriate patient identification
It is suicide for laboratory to report on a wrong sample. This error is the most serious one as it can seriously jeopardize patient outcome and at times give rise to medicolegal complications. Guidelines are available from various international agencies for improving patient identification. JCI recommends that at least two identifiers be used when taking blood samples from patients. The label should be fixed to vial only after phlebotomist has asked the patient information as per the CLSI recommendation that for conscious patients to state their full name, address, date of birth or age, and unique identification number. The laboratory technician, nurse, or treating physician must compare this information with that listed on the identification wrist band that must be worn by the patient (when applicable) and the test requisition form or computer-generated labels for patients.
Patient misidentification problem can be minimized by two approaches – technical and nontechnical. The technical approach encompasses the use of automated system for positive patient identification and specimen labeling. This can be achieved by bar codes, radiofrequency identification, biometrics, magnetic strips, optical character recognition, smart cards, and voice recognition devices. The nontechnical approach is cornerstone to the elimination of misidentification problem. It includes implementation by the organization of policies and procedures in the laboratory for patient identification as per the CLSI guidelines.
Labeling of containers should always be done prior to sample collection in the container, as postsample collection labeling leads to increased errors.
The laboratory should formulate easily understood policies for collecting, handling, and transportation of specimens. Standard operating procedure (SOP) for phlebotomy includes proper procedures for specimen collection, universal precautions to be taken during specimen collection, and disposal of syringes, needles, and others during specimen collection process. The objectives can be achieved by undergoing training that begins in the new employee orientation period and involves a continuous education program undertaken annually or as required followed by annual proficiency and competency assessment. This training program should be targeted for all nonlaboratory and laboratory personnel involved in specimen collection. Laboratories should have evidence-based criteria for specimen acceptance that must be implemented for handling the specimen before testing to assure the reliability of analytical results.
| Analytical Phase|| |
The number of laboratory errors in the analytical phase has decreased not only due to automation but also by the introduction of External Quality Assurance Program to assess the quality of testing results.
EQA  has a pivotal role in the quality assurance of medical laboratories. EQA serves as a guiding tool for the participating laboratories which can compare its results for each analyzed with those of other participants. It is extremely important for participating laboratories to understand the EQA report, assigned values, and performance evaluation so that appropriate steps can be taken in case of outlier results. It is important for laboratory to actively participate in EQA. Mere participation in EQA scheme is no guarantee that the results provided by the laboratory are accurate. There may be deviation between particular instrument and method for assigned values. There are several factors that need to be addressed by laboratory pertaining to quality in analytical phase such as selection of laboratory reference values chosen by the laboratory, calculation pertaining to total allowable error, and data to demonstrate compliance of clinical laboratories with evidence-based quality specifications.
To improve quality in analytical phase, each laboratory should streamline the following phases, namely automation, validation, verification, quality of examination procedures – internal as well as external, calculation of total allowable errors, and reporting of critical values.
The following steps can significantly improve the quality of analytical procedures:
- The clinical laboratory automation has greatly reduced the number of steps requiring human handling. Process control and data processing are achieved by interfacing between the analyzer and computer. The delta check and storage of previous testing results in the computer are other helpful features of automation
- Validation of all analytical procedures should be developed by the laboratory in an independent manner. To establish that performance characteristics of the method meet the requirements for the intended analytical application, method validation is required by laboratory which comprises series of tests to estimate analytical error such as determination of reportable range, random error, linearity, and performance
- For verification of reportable range, a minimum of five specimens with known values covering the entire reportable range in kit insert should be analyzed to assess the reportable range 
- Precision verification refers to reproducibility of results. To calculate precision as per the CLSI protocol (EP-15-A2), the laboratory personnel should run two-level controls three times per run for 5 days (i.e., 15 replicates). The standard deviation calculated is then compared with value claimed by the manufacturer. If the value obtained is higher than the claimed value, laboratory personnel must evaluate the cause. Personnel will also calculate precision to a clinical acceptable level of variation to ensure that the method meets the desired clinical requirement
- Verification of analytical accuracy indicates the veracity of results. It means that the specimens should be tested with new and comparative methods and average bias should be calculated by removing the difference which should be within the allowable limits. The clinical allowable bias accepted by the laboratory must be according to the CLSI guidelines
- Analytical sensitivity calculates the lower detection limit. To calculate it, first 20 blanks are run; if the results from <3 specimens exceed the stated blank value, the lower detection limit is acceptable. As a second step, the low patient specimens are run; if 17 of the results are above the blank value, the detection limit is acceptable
- Verification of analytical interference is commonly done for lipemic, hemolyzed samples, or for those with high bilirubin values. It is not an approved protocol, but a laboratory should evaluate the effect of the above-mentioned pathological states on analyte results
- Verification of reference limit should be established by each laboratory by testing specific analytes in healthy population. The laboratory should standardize its procedure of validation it is pertinent to note that the staff should be well versed with their department SOP and the same should be readily available to them as when required.
Quality of examination process must be established by each laboratory as internal quality control (IOC) and External Quality Scheme. IQC is enacted by the laboratory on its own to assess the daily performance which demonstrates the quality of interference and recovery methods.
Allowable total error (ATE) sets the limit for imprecision (random error) and bias (systemic error) that are tolerable for single measurement. If ATE is low, laboratory requires less-stringent QC and if ATE is high, then stringent QC rules need to be employed. The peer review of reports in histopathology and microbiology is widely used method to determine the diagnostic accuracy of test results. There are studies in literature that have shown reduction in incidence of amended reports upon adoption of peer review policy by qualified second pathologist.,
Report delivery system should ensure that reports are delivered to the right person within the accepted time frame. The critical values, list of critical tests, and the time frame for reporting should be well defined and approved independently by each laboratory. There has been a lot of stress on the timeliness of reporting and recipient by responsible caregiver of critical values. CAP in 2001 devised Q program for improving critical result communications by laboratories. A computer-based-automated critical value detection system can notify the health-care providers and reduce the time frame of notification and thereby improve patient care and reduce hospital stay.
Post analytical phase
The postanalytical phase entails activities that are induced by certain laboratory result and taken before the result is communicated to the clinician such as reflex testing, validation of results by technologist, interpretation by laboratory specialist, and finally, the interpretation by clinician leading to clinical decision-making. These postanalytical activities call for sound understanding of analytical processes involved in generating results, the awareness of potential errors, and correlation of laboratory results with patient's status. The communication and collaboration between pathologist and clinician are of paramount importance for effective “added value” in laboratory medicine ultimately affecting patient management.
The timeliness with which the test results are delivered is prominent parameter of laboratory medicine and common indicator of performance which is routinely measured by monitoring turnaround time (TAT). The most widely used TAT measurement includes the activities under laboratory control, from sample receipt to result sending. Some laboratories expand the scope of measurement of TAT by evaluating “therapeutic TAT” the time from test order initiation to clinical decision implementation.
There are two risk-based categories of test results. Critical risk result (CRR) defined as result requiring immediate medical attention and action as they indicate high risk of patient harm or death. Significant risk result (SRR) which pertains to those test results that are less urgent but need to be reported within shorter time frame than for routine results, the results are no doubt significant but are not immediately life-threatening. For example, very abnormal potassium or glucose in serum/plasma is CRR while example of SRR might be an elevated leukocyte count or early adenocarcinomas in routine appendectomy specimen.
Laboratories need to have systems and mechanisms for rapid identification and timely reporting of high-risk results requiring urgent clinical review. The critical values and alert tests should be designed to serve patient safety and should be organized in agreement with clinical users considering the local institutional needs and resources. The CLSI guidelines on the management of CRRs and SRRs have recently been published to provide guidance to laboratories.
Laboratory reports and interpretation
The content, format, and physical presentation of information provided affect interpretation of laboratories reports by clinicians. Incorrect data of reference intervals, inaccurate personal details of patient, incorrect reporting of measurand, confusing information, lack of units of measurement, inappropriate units of measurement, and release of reports by unauthorized person lead to misunderstanding by the treating physician and compromise the efficacy of patient treatment.
Interpretation comments in line with clinical guidelines are generally welcomed by physicians, as they prevent an inordinate focus on certain values from leading to a disregard of other potentially important values., Professionals are responsible for facilitating the assimilation and comprehension of laboratory information by clinicians, and efforts should be made to identify the areas in which the harmonized use of quality indicators (QIs) defined consensually. Efforts should be made to encourage laboratories to collect QI data and take actions for improvement.
| Conclusion|| |
In the past decade, the implementation of IOC and EQA programs has led to a significant improvement in accuracy in terms of both precision and trueness. The vulnerability of pre- and postanalytical phases of total testing cycle due to variety of health-care professionals involved can only be guarded by implementation of quality control system in laboratories. The international accreditation bodies have devised principles, processes, and techniques for a good laboratory workflow, but all these are needed in inner insight, thoughtfulness, and eagerness on the part of laboratory personnel for the success of quality improvement initiatives, which are a part of dynamic continual learning process. It is extremely important for a country like India which is an emerging destination for medical tourism having great diversity in health care settings (government hospitals, private charitable hospitals, corporate hospitals), that the medical laboratories deliver quality diagnostic services. The saying is relevant in this context, “You don't have to be great to start, but you have to start to be great.”
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
| References|| |
Institute of Medicine. Crossing the Quality Chasm: A New Health 21st
Century. Washington, DC: National Academies Press; 2001.
Juran JM. Juran's Quality Handbook. 1st
ed. New York, NY: McGraw-Hill; 1951.
Westgard JO. Six Sigma Quality Design and Control. Madison, WI: Westgard QC; 2001. p. 225.
Clinical and Laboratory Standards Institute. CLSI Understanding the Cost of Quality in the Laboratory; A Report. CLSI document QMS20-R. Wayne PA: Clinical and Laboratory Standards Institute; 2014.
O'Kane M. The reporting, classification and grading of quality failures in the medical laboratory. Clin Chim Acta 2009;404:28-31.
Lippi G, Guidi GC. Risk management in the preanalytical phase of laboratory testing. Clin Chem Lab Med 2007;45:720-7.
Sciacovelli L, Secchiero S, Zardo L, D'Osualdo A, Plebani M. Risk management in laboratory medicine: Quality assurance programs and professional competence. Clin Chem Lab Med 2007;45:756-65.
Plebani M. Errors in clinical laboratories or errors in laboratory medicine? Clin Chem Lab Med 2006;44:750-9.
Lippi G, Chance JJ, Church S, Dazzi P, Fontana R, Giavarina D, et al.
Preanalytical quality improvement: From dream to reality. Clin Chem Lab Med 2011;49:1113-26.
Plebani M. Exploring the iceberg of errors in laboratory medicine. Clin Chim Acta 2009;404:16-23.
Bonini P, Plebani M, Ceriotti F, Rubboli F. Errors in laboratory medicine. Clin Chem 2002;48:691-8.
Silverstein MD. An approach to medical errors and patient safety in laboratory services. In: A White Paper. Atlanta: The Quality Institute Meeting; 2003.
Kirchner MJ, Funes VA, Adzet CB, Clar MV, Escuer MI, Girona JM, et al.
Quality indicators and specifications for key processes in clinical laboratories: A preliminary experience. Clin Chem Lab Med 2007;45:672-7.
Howanitz PJ. Errors in laboratory medicine: Practical lessons to improve patient safety. Arch Pathol Lab Med 2005;129:1252-61.
Clinical and Laboratory Standards Institute. Procedures for the Collection of Diagnostic Blood Specimens by Venipuncture. Approved Standard, GP41-A6. Wayne, PA: Clinical and Laboratory Standards Institute; 2013.
Nichols JH, Bartholomew C, Brunton M, Cintron C, Elliott S, McGirr J, et al.
Reducing medical errors through barcoding at the point of care. Clin Leadersh Manag Rev 2004;18:328-34.
Lau FY, Wong R, Chui CH, Ng E, Cheng G. Improvement in transfusion safety using a specially designed transfusion wristband. Transfus Med 2000;10:121-4.
Lippi G, Fostini R, Guidi GC. Quality improvement in laboratory medicine: Extra-analytical issues. Clin Lab Med 2008;28:285-94, vii.
ISO/IEC 17043: 2010 General Requirements for Proficiency Testing, ISO/IEC Committee on Conformity Assessment, ISO Head Quarters, Geneva; 2010.
Agarwal R. Quality-improvement measures as effective ways of preventing laboratory errors. Lab Med 2014;45:80-8.
Burtis CA, Ashwood ER, Bruns DE. Tietz Textbook of Clinical Chemistry. 4th
ed. New Delhi, India. Harcourt Brace and Company Asia PTE Ltd.; 2006.
Nakhleh RE. Patient safety and error reduction in surgical pathology. Arch Pathol Lab Med 2008;132:181-5.
Renshaw AA, Gould EW. Measuring the value of review of pathology material by a second pathologist. Am J Clin Pathol 2006;125:737-9.
Piva E, Plebani M. Interpretative reports and critical values. Clin Chim Acta 2009;404:52-8.
Valenstein PN, Wagar EA, Stankovic AK, Walsh MK, Schneider F. Notification of critical results: A College of American Pathologists Q-Probes study of 121 institutions. Arch Pathol Lab Med 2008;132:1862-7.
Howanitz PJ, Steindel SJ, Heard NV. Laboratory critical values policies and procedures: A college of American Pathologists Q-Probes study in 623 institutions. Arch Pathol Lab Med 2002;126:663-9.
Wagar EA, Friedberg RC, Souers R, Stankovic AK. Critical values comparison: A College of American Pathologists Q-Probes survey of 163 clinical laboratories. Arch Pathol Lab Med 2007;131:1769-75.
Kilgore ML, Steindel SJ, Smith JA. Evaluating stat testing options in an academic health center: Therapeutic turnaround time and staff satisfaction. Clin Chem 1998;44:1597-603.
White GH, Campbell CA, Horvath AR. Is this a critical, panic, alarm, urgent, or markedly abnormal result? Clin Chem 2014;60:1569-70.
Clinical and Laboratory Standards Institute. Management of Critical- and Significant-Risk Results. CLSI Guideline GP47. 1st
ed. Wayne, PA: Clinical and Laboratory Standards Institute; 2015.
Laposata ME, Laposata M, Van Cott EM, Buchner DS, Kashalo MS, Dighe AS, et al.
Physician survey of a laboratory medicine interpretive service and evaluation of the influence of interpretations on laboratory test ordering. Arch Pathol Lab Med 2004;128:1424-7.
Zarbo RJ, Nakhleh RE, Walsh M; Quality Practices Committee, College of American Pathologists. Customer satisfaction in anatomic pathology. A College of American Pathologists Q-Probes study of 3065 physician surveys from 94 laboratories. Arch Pathol Lab Med 2003;127:23-9.