Laboratory QA. Quality-Improvement Measures as Effective Ways of Preventing Laboratory Errors. Rachna, Agarwal, MD 1 * ABSTRACT

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1 Quality-Improvement Measures as Effective Ways of Preventing Laboratory Errors Rachna, Agarwal, MD 1 * Lab Med Spring 2014;45:e80-e88 DOI: /LMD0YIFPTOWZONAD ABSTRACT Laboratory error is defined as any defect from ordering tests to reporting and interpretation of results. Laboratory errors have a reported frequency of % of all test results which in turn has huge impact on diagnosis and patient management as 60-70% of all diagnosis are made on the basis of laboratory tests. Total testing process in the laboratory is a cyclical process divided into three phases: preanalytical, analytical and postanalytical. First, preanalytical phase in which requirement for a test is determined, the test is ordered and the patient is identified. It is followed by specimen collection and transport to the laboratory. The specimen is prepared and tested in the analytical phase. During the postanalytical phase, the results are reported to the individual who ordered the test and any action or intervention is undertaken. Initially, the policies and procedures developed by the laboratory were more concerned on analytical phase to reduce errors during laboratory testing and emphasis was in ensuring proper calibration and testing. The last few decades have seen a significant decrease in the rates of analytical errors in clinical laboratories. Currently, available evidences demonstrate that the pre- and postanalytical steps are more error prone. Keywords: laboratory errors, total testing process, preanalytical phase, analytical phase, postanalytical phase, quality assurance. In 1999, the Institute of Medicine (IOM) published a seminal report on medical errors, To Err is Human, which started a movement focusing on patient safety. 1 In that report, the IOM estimated that as many as 98,000 deaths per year in the United States were attributed to medical errors. Medical errors can be traditionally clustered into 4 categories, namely, errors of diagnosis, errors of treatment, errors of prevention, and miscellaneous. Because approximately 60% to 70% of medical decisions Abbreviations IOM, Institute of Medicine; NABL, National Accreditation Board for Testing and Calibration Laboratories; CAP, College of American Pathologists; JCI, The Joint Commission International; QC, quality control; COES, computerized order entry system; CLSI, Clinical and Laboratory Standards Institute; RFID, radio frequency identification; OCR, optical character recognition; TTP, thrombotic thrombocytopenic purpura; EQAS, External Quality Assurance Program; CLIA, Clinical Laboratory Improvement Amendments; IQC, interlaboratory QC; WHO, World Health Organization; ATE, allowable total error; POCT, point-ofcare testing 1 Department of Neurochemistry, Institute of Human Behavior and Allied Sciences, New Delhi, India *To whom correspondence should be addressed. rachna1000@hotmail.com related to diagnosis and treatment involve the laboratory, the discipline of laboratory science is ideally positioned to initiate patient-safety solutions. 2 However, one cannot view laboratory errors as single, isolated, and unpredictable incidents committed by medical professionals but rather as resulting from the characteristics of the overall health care system, including the ways that work is conducted and the completeness and efficiency of the system. Laboratories can achieve improvement in patient-treatment outcomes by implementing a quality-management system; this is the most effective path to improvement because it encompasses a multifaceted strategy, the ultimate target of which is to decrease the uncertainty inherent to the process. 3-5 Thus, quality assurance is a vital way of enhancing patient safety; quality-management systems include benchmarking, a process by which one compares the performance of one organization with that of others. Various national bodies such as the National Accreditation Board for Testing and Calibration Laboratories (NABL) in India and international bodies such as the College of American Pathologists (CAP) and The Joint Commission International (JCI) are involved in assessing the quality of laboratory services using different measurements and parameters to define, assess, and measure quality. e80 Lab Medicine Spring 2014 Volume 45, Number 2

2 Figure 1 Comprehensive plan to prevent total testing errors. 1. Developing clear written procedures 2. Regular training by and assessing of the skills of health care professionals 3. Automating functions for support and executive operations 4. Monitoring quality indicators 5. Improving communication among health care and laboratory professionals These agencies have been involved in quality control (QC) and proficiency programs. They are also in the process of developing programs to define laboratory errors. For example, CAP provides the Q-Probes comprehensive assessment of procedures within a laboratory, as well as Q Tracks, which monitors critical performance of assays in the laboratory in its total testing procedures. First and foremost, management strategies to prevent laboratory errors involve the identification of activities that pose the greatest risk of such errors. It is important to monitor the system and to identify the critical areas so that human and economic resources are not wasted in dealing with mistakes that are unlikely to occur. The identification of vulnerable areas is achieved by implementation of error detecting systems that have been specifically developed to target all 3 phases of the overall testing process (ie, the preanalytical, analytical, and postanalytical phases). 6 Critical areas typically identified for prevention of laboratory errors include appropriate test ordering by physicians, patient and specimen identification, specimen collection, transport and processing, analytical process quality, transmission of critical test results, interpretation of laboratory data, and communication of laboratory data to physicians (Figure 1). 6 Appropriate Test Ordering by Physicians The most important preanalytical procedure performed outside the laboratory (also called the pre preanalytical phase) is formulating a clinical question and selecting appropriate examination techniques. Although the inappropriate test ordering does not directly affect the patient s care, it results in patient inconveniences and an unjustifiable increase in cost. With the introduction of a number of tests, the specialized correlation of those tests with a particular disease and the complexities of the tests can result in excessive or inappropriate test ordering by physicians for defensive reasons, such as fear of uncertainty and poor or limited knowledge of new tests (diagnostic tests for coagulation disorder, genetic disorder, etc). Also, paper-based test requests, as are commonly made at present, pose risk because they may be completed only partially, may be placed in the wrong inbox, or may get lost. The introduction of information technology in health care has brought about changes in the laboratory by simplifying the processing portion of the testing process; this has resulted in substantial improvement in patient safety. One such change that has been made in the first step of the total testing process, namely, test ordering, is to implement a computerized order entry system (COES) to replace paper-based requesting. 7 This system allows treating physicians to enter orders directly into a computer, thus reducing transcription errors, number of lost requests, and improving ordering decisions and efficiency in test processing. The presence in the new system of decisionsupport mechanisms such as order sets can further improve the appropriate ordering of tests and can limit the rate of redundant and/or unnecessary orders. Laboratories often combine use of the COES system with electronic delivery of test results. Such procedures eliminate errors that had previously occurred due to lost results. Also, access to longitudinal clinical and laboratory data on patients can help to reduce request errors and to improve the capacity of the laboratory to provide accurate results for diagnosis and treatment. Patient-Specimen Identification The most fatal type of preanalytical error, which occurs relatively commonly, is improper patient identification, or mislabeling of test tubes. Misidentification of patients can lead to their being diagnosed and treated and their conditions managed based on the laboratory results from other patients. For this reason, patient identification and correct labeling are the most important tasks not only in the testing process but in all areas of health care. Downloaded from Spring 2014 Volume 45, Number 2 Lab Medicine e81

3 Guidelines are available from various international agencies for improving patient identification in various sectors of health care. According to JCI, identify patients correctly is the first goal in improving patient safety. 8 The organization recommends that at least 2 patient identifiers be used when taking blood specimens. A label should be fixed to a specimen vial only after phlebotomists have asked the patient to state his or her full name, age, or date of birth. The Clinical and Laboratory Standard Institute (CLSI) gives recommendations for improving the accuracy of identification of inpatients and outpatients. Per CLSI recommendations, inpatients should be asked to state their full name, address, birth date or age, and/or unique identification number. The laboratory technician, nurse, or treating physician must compare this information with that listed on the identification wristband that must be worn by the patient (when applicable) and the test requisition form or computer-generated labels for that patient. 9 Health care professionals should approach the problem of patient misidentification via the following methods: 1. Technical: The introduction of automated systems for positive patient identification and specimen labeling strongly helps to prevent diagnostic and medication errors. This can be achieved by using traditional bar codes or by using the more innovative methods of radio frequency identification (RFID), biometrics, magnetic stripes, optical character recognition (OCR), smart cards, and voice recognition devices. Using these systems reduces the burden of patient misidentification during biological specimen collection. 10 The most frequently used specimen identification system is made up of multiple linear bar code readers and radiofrequency identification of specimen carriers combined with 1 or more bar code readers. 2. Nontechnical: The problem of patient misidentification cannot be reduced without implementing nontechnical methods along with introduction of automated technology for patient identification. This includes implementation by the organization of policies and procedures in the laboratory for patient identification per CLSI guidelines, training of medical professionals on guidelines and procedures for patient identification, specimen labeling, and patient safety measures; health care organizations must follow the procedures which best help to reduce risk and to improve patient safety. Correct patient identification and test tube labelling before phlebotomy procedures, which are crucial factors in patient safety in conditions such as thrombotic thrombocytopenic purpura (TTP), can be maximized by use of automatic integrated technologies instead of repetitive manual operations. Specimen Collection, Transport, and Processing Specimen Integrity The second most essential requirement to reduce laboratory error during the preanalytical phase is specimen integrity. Specimen integrity depends on the number of processes performed, such as specimen collection, maintenance of specimen physiology, transportation, and processing. The following steps will ensure specimen integrity: 1. The laboratory should formulate easily understood policies for collecting, handling, and transporting specimens. The laboratory must enforce standard operating procedures (SOPs) for phlebotomy, which include proper procedures for specimen collection; universal precautions to be taken during specimen collection; and disposal of syringes, needles, and other materials used during the specimen collection process. This can only be achieved by undergoing training that begins in the new employee orientation period and involves a continuing 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. 2. Laboratories should have evidence-based criteria for specimen acceptance that must be implemented for handling the specimens before testing to assure the reliability of analytical results. 11 Laboratories should develop a standardized flowchart to detect and to appropriately treat hemolyzed, clotted, and insufficient specimen material. Modern technology has made it possible to introduce automated equipment and processes to tackle most of the preanalytical procedures performed within laboratories for specimen preparation before their introduction into automated analysis procedures. e82 Lab Medicine Spring 2014 Volume 45, Number 2

4 Preanalytical Automated Work Stations The aim of introducing automation in the preanalytical phase is to prevent human error, which is exacerbated by the fact that currently, laboratory workers are handling ever-increasing workloads alongside a reduction in personnel, which leads to physical and mental exhaustion. Automated robotic workstations effectively reduce the number of laboratory errors that occur in sorting, labeling, and aliquoting specimens, thereby improving the integrity of those specimens throughout the steps of specimen processing. 12 There are many advantages to introducing automation during the preanalytical phase. These advantages include decrease in repeat specimen collection; reduced specimen volume; secure patient and specimen identification; achievement of effective specimen integrity and preservation; decreased specimen handling, which helps laboratory personnel to avoid blood-based infection; containment of biohazardous materials; avoiding of risk of human error; and reduction of number of test tubes used. Analytical Process Quality During the past few decades, the number of laboratory errors in the analytical phase has decreased dramatically. Such a drop is not only due to the increasing automation of laboratory processes but also has resulted from the introduction of the External Quality Assurance Program (EQAS; Bio-Rad Laboratories, Inc., Hercules, CA) to assess the quality of testing results. Still, analytical quality is a major issue. A number of issues must be tackled by laboratory directors to ensure the low error rates that are possible in this phase. Some of these issues are as follows: 1. The participation of the laboratory in an internal QC program and in external quality assessment procedures does not directly ensure that the results reported by the laboratory are accurate and precise. Available data do not demonstrate that clinical laboratories comply consistently with evidence-based quality specifications. 2. Laboratories usually do not calculate the allowable total errors for all tests performed on all analytes, although this would improve the diagnostic process. 3. Different laboratory report reference values are nonspecific for age, sex, and physiological conditions (such as pregnancy). Quality Improvement in the Analytical Phase To improve the quality of the analytical phase of testing, the following processes must be streamlined: Automated Analysis Initially, when laboratory directors introduced automated instruments into laboratories, these instruments were used mostly to perform the tests that were requested most frequently. However, development of new procedures and techniques and the modification of existing techniques have made it possible to use automated instruments for most of the analyte testing performed in fields such as chemical chemistry, hematology, immunology, and genetic testing. The introduction of automation into testing processes has reduced the number of steps requiring human manipulation; also, the integration of computer hardware and software into analyzers has provided automatic process control and data processing capabilities. It may also be possible to store previous testing results in the memory of automated devices. In addition, different analyzers can be linked so that specimen- or patient-oriented reports may be produced instead of analyte-oriented reports. Depending on the requirements of the laboratory, different types of automated analyzers (such as bench top and random access discrete) are available for purchase and implementation. Validation of Analytical Procedures 13 The laboratory must carry out validation of all analytical procedures to establish that the performance characteristics of the method(s) in question meet the requirements for the intended analytical application. Also, method validation is the standard laboratory process that should be developed independently by the laboratory; this process may not necessarily be the same for every laboratory. However, in method validation, one performs a series of experiments designed to estimate analytical errors, such as linearity experiments, to determine reportable range, to estimate imprecision or random error, to estimate inaccuracy or systematic error, and to perform interference and recovery experiments. For modified methods, verification of analytical sensitivity and specificity is also desirable. Verification of Reportable Range: A minimum of 5 specimens with known values that cover the reportable range given in the kit insert should be analyzed in triplicate to assess the reportable range. Downloaded from Spring 2014 Volume 45, Number 2 Lab Medicine e83

5 Verification of Precision: The precision of the process indicates the reproducibility of its results. Per CLSI protocol (EP15-A2), laboratory personnel run 2 levels of controls, 3 times per run, for 5 days (ie, 15 replicates total) to calculate the precision value. The SD is calculated from values obtained and should then be compared with the value claimed by the manufacturer of the assay(s). If the actual value is higher than that claimed by the manufacturer, laboratory personnel must perform an evaluation to determine the cause. Personnel will also calculate precision to a clinically acceptable level of variation to assure that the method meets clinical needs. Important: To verify precision, use controls or calibrators, which have been stabilized, instead of patient specimen material. Verification of Analytical Accuracy: Analytical accuracy indicates the veracity of the result. A minimum of 20 patient specimens that span the entire testing range but do not exceed measurement range are required to determine this variable. Specimens should be tested via new and comparative methods (ie, the current method used by the laboratory and the reference method). The average bias is calculated by removing the difference between the method used by the laboratory and the comparison method, which should be within allowable limits. The clinically allowable bias accepted by the laboratory should be decided per Clinical Laboratory Improvement Amendments (CLIA) guidelines. Verification of Analytical Sensitivity: In this procedure, one calculates the lower detection limit. Per CLSI guidelines, the procedure includes running of blanks 20 times; if the results from less than 3 specimens exceed the stated blank value, the lower detection limit is acceptable. This step is followed by running low patient specimens, or those for which the results are near the detection limit; if the results from at least 17 specimens are above the blank value, the detection limit is accepted. Verification of Analytical Interferences: There is no approved protocol for performing this task, to our knowledge. Most commonly, laboratory professionals test for lipemia, hemolysis, and elevated bilirubin levels, usually by adding interfering materials to determine whether doing so changes the results; also, these professionals determine potential interferences that are specific to the test and methodology used. Verification of Reference Limits: Laboratory professionals adopt reference limits based on manufacturer recommendations, reference laboratory recommendations, and the reference limits mentioned in published articles. Each laboratory must verify its own reference limits by testing specific analytes in healthy populations. Each laboratory should standardize its procedures for validation of the methods used for all the analytes; the laboratory staff should be trained in these procedures. A hard copy of these SOPs should be made available at work stations. Quality of Examination Procedures The laboratory must establish a well-defined and welldocumented program for assessing and evaluating its examination procedures. The quality assurance program that should be followed in the laboratory has 2 components: 1. Internal QC Program: The QC program that is enacted by the laboratory at its own level to assess its daily performance is called the internal QC program. This program uses continual checks to ensure that the established reliability of the work of the laboratory does not fluctuate and that reports have been validated before they are released. It demonstrates not only the precision of results but is also a checkpoint at which reagents, instruments, and the proficiency of laboratory personnel are assessed. 2. External Quality Assurance Program: All the errors arising in the laboratory related to the accuracy and precision of the process of analysis cannot be detected merely by use of the IQC program. Dependence on only intralaboratory statistics (as in IQC) can lead to lack of awareness of gradual or sudden changes in the test system, changes that are not under the control of the laboratory. When changes occur in the testing system, as often occurs with software updates and reagent reformations, an interlaboratory quality control (IQC) program can yield early awareness of changes and can prevent costly test repeats and troubleshooting, thereby complimenting the internal QC program. IQC is defined by the World Health Organization (WHO) as the objective evaluation by a number of laboratories of material that is supplied especially for this purpose. The basic principle of EQAS is that the same material is sent from a national or regional center to a large number of laboratories. It is important that EQAS be performed at regular intervals. In this retrospective analysis, the performance of an individual laboratory is e84 Lab Medicine Spring 2014 Volume 45, Number 2

6 compared with that of other laboratories and with its own previous performance by calculating the standard deviation index and accuracy score. Laboratories should also participate in interlaboratory programs to complement their EQAS programs. In interlaboratory programs, specimens are exchanged between accredited laboratories that use similar methods to assess analytes. Such exchanges should be performed every 6 months to assess the veracity of results reported by each laboratory. Calculation of the Allowable Total Error (ATE) 14 The ATE is an analytical quality requirement that sets a limit for the imprecision (random error) and bias (systematic error) that are tolerable in a single measurement or single test result. Calculated ATE, as performed by the laboratory, is the quality goal. When ATE is low, the laboratory needs less stringent QC rules; when ATE is high, the laboratory needs more stringent QC rules. Peer Review Peer review 15 is the most widely used method to determine diagnostic accuracy and to prevent diagnostic errors in testing involving microbiology and pathology specimens. To our knowledge, no single method has been proven superior to and more acceptable than peer review in detecting errors. Most laboratories use multiple strategies to detect errors, such as review of cases for conferences, review of cases by peer group before sending out results, and a review of a selected percentage of cases or specific types of cases. The most common type of peer review method is second review by another pathologist before the first laboratory professional signs off on cases. Studies 15,16 have shown that the number of amended reports is decreased with review of specimens by a second pathologist. Transmission of Critical Test Results A quality reporting system is defined as a system that ensures the delivery of correct results to the appropriate health care professionals within a time frame that ensures patient safety without overburdening the health care professionals or the laboratory team. 17 Per the definition of this system, 2 important issues, if not addressed, may lead to risk to patient safety. The first is delivering the report in a time frame and the second is delivery to the appropriate [health care professional]. Regarding the first issue, a particularly important risk to patient safety may occur in the reporting of the critical values, defined as values that represent situations that could become life threatening unless some intervention is made by a physician and for which such interventions are possible. Without any well-defined norms, selection of the criticalvalue cut-off point is different, although core group of tests are similar in different institutions. However, in the absence of consensus among the laboratory community regarding the selection of a critical value cut-off point and formulation of a standard list or target time frames for reporting critical results, the selection of critical thresholds should depend strictly on the life threatening criteria. The critical values, the list of critical tests, and the time frame for reporting should be reviewed and approved independently by laboratories. The second issue, delivery to the appropriate [health care professional] is also significant and relates to who should notify and who should receive test results. Any attempt to establish interpretative critical values for reporting, by itself, will not be able to reduce the rate of latent errors because until the results are communicated to the applicable physician within the required time frame, management of patients in critical condition cannot be undertaken. The second goal instituted by JCI states that laboratories need to improve the timeliness of reporting, as well as the timeliness of receipt by the responsible caregiver, of critical values. 18 Other accreditation bodies have technical requirements for reporting critical values, as in clause 5.9 of 15189:2012 by the NABL, which is the most widely accepted standard by the medical laboratory community worldwide. 19 CAP and other international accreditation bodies support improvements in the communication of critical values. 13 Since 2001, the Q-Probes program put forth by CAP has been used as an effective tool for comparison of data among laboratories, a tool that allows revisions of critical results and values. 20 Hence, laboratories must develop strategies to improve their systems for rapid notification, to decrease the rate of unsuccessful notifications (ie, results that are not reported) and phone calls that are terminated or notifications made outside the useful time frame, and to improve the notification to treating physicians. These aims can be achieved by using information technology in the laboratory for communication with the treating health care professionals. This may include using computer-based alert systems that automatically detect critical values and notify the treating physicians and/or Downloaded from Spring 2014 Volume 45, Number 2 Lab Medicine e85

7 health care provider(s). 21,22 Such systems can improve not only notification of critical values but can also reduce the time frame of notification of the treating health care professional(s), leading to delivery of appropriate care and treatment to patients, which reduces their hospital stay and results in more favorable outcomes. Such technology can yield optimal results when clinical laboratories identify the health care professional responsible for receiving communication of critical values. Presently, some clinical laboratories also provide, to health care professionals, cell phones that are linked to the information system of the hospital to provide real-time critical value notification to the physician on call. Introduction of such an automated communication system helps to avoid potential errors in communication, improves the rate of successful notification, and shortens notification times. Unsafe procedures and processes may accumulate over time until hazards translate into adverse events. 3. To reduce turnaround time, some institutions have developed facilities to provide near-patient testing and point-of-care-testing (POCT), particularly to monitoring tests that determine, for instance, levels of blood gases and serum electrolytes. Such alternative sites of testing may compromise preanalytical factors such as specimen collection, collection in appropriate vials, and maintenance of the integrity of specimens. Comparisons between different laboratories have focused on reduction of the cost per test to the cost of total quality and may increase the risk of errors in the pre- and postanalytical steps. Limitations and Challenges to Quality-Improvement Measures To a certain extent, the advances made by practitioners of laboratory science in improving the quality of test results due to improved testing processes, the introduction of laboratory information technology, the automation of analytical process, and the implementation of measures to improve patient safety are offset by certain major challenges inherent to the delivery of safe laboratory services. Some of these challenges and limitations are as follows: 1. Consolidation of laboratory services into ever larger organizational units and outsourcing of laboratory services make the total testing process more difficult. The megalaboratories that are created by such consolidation often compromise on certain pre- and postanalytical points of procedure, such as prolonging the time for specimen transportation, maintaining specimen integrity, and addressing difficulties in communication with health care professionals. Such laboratories simply spew out analytical results; this undermines the testing process by increasing the number of, and risk of, errors in laboratory medicine. 2. Downsizing of laboratory staff, as a result of the economic pressure experienced by many health care organizations in recent years, has dramatically increased workloads and affected personal productivity. Errors and patient safety problems arising from downsizing and shortage of staff may not be immediately evident but will become evident in the long term. Changes Required for Quality Improvement Despite the limitations and challenges that laboratories might encounter in pursuing it, quality improvement in laboratory medicine is the key to bringing about patient safety. Changes in the following areas are desirable to achieve improvement in laboratory services. Change the Culture in Which Health Care is Provided It is required for real change to be brought about in the laboratory by convincing each laboratory staff member to buy into the culture of safety as an integral part of his or her work culture. The goal in the laboratory is to perform the correct steps, as a means of doing the right thing. For example, every staff member working in the laboratory should wash his or her hands in the prescribed manner and should properly identify each patient before specimen collection. To internalize the culture of safety, each new health care professional who joins the laboratory should be initially and consistently taught the safest ways to provide care. Establish System-Wide Transparency The accuracy of the total testing process depends on the transparency of the laboratory system; a high level of transparency can be achieved by following a systembased approach that asserts that errors arise due to e86 Lab Medicine Spring 2014 Volume 45, Number 2

8 flawed systems rather than weakness on part of laboratory personnel. This approach encourages staff to interact more constructively to identify weaknesses in procedures and processes. Staff members must be rewarded for acknowledging errors, identifying hazards, and initializing examination of ways to prevent future adverse events. Develop Multidisciplinary Teams With ongoing improvement in medical facilities and the introduction of new and complex tests, maintaining the high quality of laboratory results depends on collaborative input from health care professionals and laboratory professionals. All members of the health care team must recognize the importance of acknowledging the experience and contributions of other team members. It is important to develop a team that consists of pathologists, medical technologists, cytotechnologists, histotechnologists, health care professionals such as physicians and nurses, and other types of laboratory professionals, all of whom work together to provide optimal patient care. Introduce Information Technology to Advance Patient Safety Current information systems have an untapped capacity for real-time care delivery and retrospective care analysis to provide the data that will bring about changes in all aspects of health care. Laboratory information systems must be integrated with other clinical systems to harness the capacity of health care and laboratory professionals to recognize and to mitigate risks before these risks become confirmed safety issues. Support National and International Agencies for Patient Safety Laboratory medicine cannot be practiced in a vacuum. All laboratories should engage in national and international safety programs by providing copies of guidelines to laboratory professionals, health care professionals, and patients. Also, all laboratories should voluntarily obtain accreditation by national or international regulatory agencies. Take a Patients First Approach Laboratory personnel, in their quest to provide high quality services, should approach every issue through the perspective of patients. Laboratory and health care professionals should engage with the patients in their care, making them partners in safety. To achieve this, laboratory personnel should encourage patients to give feedback on their awareness of and their satisfaction level with the laboratory services provided to them, as well as with hospital infection control and patient safety. The patients first approach yields safer care and higher levels of patient satisfaction. LM References 1. O Kane M. 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9 18. 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: ISO 15189:2007: Medical laboratories: particular requirements for quality and competence. International Organization for Standardization, Geneva, Switzerland. 20. Howantiz 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: Dighe AS, Rao A, Coakley AB, Lewandrowski KB. Analysis of laboratory critical value reporting at a large academic medical center. Am J Pathol. 2006;125: Wager EA, Friedberg RC, Souers R, Stakovic AK. Critical values comparison: a College of American Pathologists Q-Probes survey of 163 clinical laboratories. Arch Pathol Lab Med. 2007;131: e88 Lab Medicine Spring 2014 Volume 45, Number 2