Benchmarking Laboratory Quality

Transcription

1 Benchmarking Laboratory Quality Paul Valenstein, MD, 1 Frank Schneider, MD 2 ( 1 Department of Pathology, St. Joseph Mercy Hospital, Ann Arbor, MI, 2 Department of Pathology, Duke University Medical Center, Durham, NC) DOI: /MPNFHFWBRTYUYBEP Abstract Proficiency testing is the oldest form of laboratory benchmarking. Today, laboratory managers can compare local laboratory quality to industry averages in many domains. This review discusses practical aspects of benchmarking laboratory quality when benchmarking is a good idea, common misunderstandings about what benchmarking can tell us, and examples of quality benchmarks that are widely used in the clinical laboratory industry. When we benchmark a product or service, we compare its performance to an external standard. When we benchmark clinical laboratory quality, we compare local laboratory quality to an external quality standard drawn from studying many laboratories or a few best performers. Clinical laboratories began benchmarking quality more than 6 decades ago, when a group of a dozen laboratories in Philadelphia decided to compare their results for hemoglobin testing. 1 Results were so widely discrepant that the Committee on Laboratories of the Pennsylvania Medical Society initiated a program to compare the accuracy of a number of chemistry tests throughout the state. This initiative gave birth to proficiency testing as we know it today. During the ensuing decades, interest in measuring the quality of laboratory services extended beyond the analytic domain to involve preanalytic and post-analytic processes, such as the accuracy of patient identification or the faithfulness with which critical results are called to caregivers. 2-4 Congress passed the Clinical Laboratory Improvement Amendments of 1988 (CLIA 88) in response to public concerns about erroneous cytopathology reports resulting in patient deaths. Instead of focusing on cytopathology, legislators and regulators scrutinized the entire laboratory medicine sector and developed standards for general laboratory performance. A decade later, the National Academy of Sciences Institute of Medicine claimed that as many as 1 million patients per year suffer injuries due to medical errors. 5 The Joint Commission (JC) shortly thereafter issued its Patient Safety and Quality Improvement Goals, a set of declarations designed to address common problems in clinical medicine. Today, laboratory managers can compare local laboratory performance to industry benchmarks in any of a number of quality and safety domains that include preanalytic, analytic, and post-analytic processes involving all sections of the clinical laboratory. This review discusses practical aspects of benchmarking laboratory quality when benchmarking quality is a good idea, common misunderstandings about what benchmarking can tell us, and examples of quality benchmarks that are widely used in clinical laboratories. We will draw heavily on the College of American Pathologists (CAP) Q-Probes 6 and Q-Tracks 4 program, because these services have generated the most widely used benchmark data about laboratory quality. We will not discuss benchmarking individuals who work in the laboratory or benchmarking laboratory finances, but interested readers can turn to several recent reviews When is Quality Benchmarking Useful? There are 4 main reasons to benchmark quality in the laboratory setting. Quality Improvement Some methods for improving quality do not require external benchmarking. Shewhart s plan-do-check-act (PDCA) is one such method. Yet laboratories that integrate benchmarking into their quality management programs enjoy several distinct benefits. First, benchmarking allows management to identify problem areas that require increased attention. Leadership at a typical laboratory struggles to decide which aspects of service are most in need of attention, since every part of an operation can benefit from increased focus and resources. Benchmarking helps managers identify areas where local performance lags behind industry averages. Second, many multi-institutional benchmarking studies identify practice variables that are associated with better performance. Managers who participate in benchmarking programs can learn about and adopt these practices to improve performance locally. Third, benchmarking results can motivate laboratory staff to take quality improvement efforts seriously. It is often easier to rally support for local quality improvement initiatives when benchmarking suggests that a large number of other facilities already demonstrate superior performance. Finally, when benchmarking of a single quality metric is performed longitudinally (over time), managers can use benchmarking data to determine whether the pace of quality improvement in the local laboratory is typical of other facilities that have committed themselves to improving performance in the same area. Satisfying Accreditation Requirements All United States laboratory accrediting organizations require that accredited laboratories maintain quality management programs. CLIA serves as the underlying legal framework and federal mandate for these requirements. 11 The CAP accreditation program has the most developed set of requirements, including a requirement that accredited laboratories monitor key indicators of quality and compare performance against a benchmark. 12 Joint Commission requirements are more abstract but also require accredited organizations to collect data to monitor their performance. 13 The International Standardization Organization (ISO) addresses the quality management plan in the management Downloaded 108 from

2 requirements section of its ISO standard for medical laboratories. 14 While it is possible to satisfy the requirements of CAP, JC, and ISO by using internal benchmarks (such as past performance) or setting standards through customer feedback, many laboratories satisfy regulatory requirements by benchmarking some aspects of their service against external norms. This can be accomplished by subscribing to benchmarking services or engaging consultants to provide comparative industry data. Satisfying Payer Requirements The Centers for Medicare and Medicaid Services (CMS) is the largest single payer of pathology services and has the authority to deny payment to laboratories that do not satisfy CLIA requirements. 15 Payers other than the CMS (particularly health maintenance organizations) periodically establish performance expectations for clinical laboratories that are permitted to serve plan beneficiaries. Laboratories can use data from benchmarking services to help demonstrate compliance with managed care plan quality requirements, and also to help managed care organizations set realistic goals. One of us (PV) negotiates contracts regularly with managed care organizations on behalf of a consortium of 60 hospital-based laboratories and has used benchmarking data to help plans set achievable targets as well as to motivate individual laboratories to improve performance. Positioning the Laboratory in a Competitive Marketplace In all industries, delivery of a high-value product helps to distinguish one provider from others who compete in the same market space. The value of laboratory services is generally measured in terms of cost and quality, and benchmarking can help laboratories make the case that their quality is comparable or superior to competitors. Benchmarking data can be used in promotional materials or newsletters to educate laboratory customers about the quality of a local laboratory in comparison to industry averages. Benchmarking data can also be used to educate customers who have unrealistic expectations about levels of quality that can be achieved, particularly in contentious areas such as turnaround time. Finally, laboratory involvement in a benchmarking service can signal to customers in a general way that management is engaged in continuous quality improvement and is not fearful of comparing local performance with others within the industry. Important Considerations and Common Misunderstandings Despite the many uses of benchmarking laboratory quality, we have found that confusion about the benchmarking process is widespread. In this section, we address some of the more common misunderstandings. Quality is not One-Dimensional There is no Composite Quality Score Perhaps the most common misunderstanding about the benchmarking process is the belief that benchmarking can be used to identify laboratories of overall high and low quality. Individuals who systematically study laboratory quality have come to appreciate that quality is not one-dimensional. A laboratory that excels in one aspect of service (say, turnaround time) does not necessarily excel in other aspects of service (say, the proportion of reported results that must be corrected). Excellent performance on microbiology proficiency testing does not make up for a troponin assay that is out of control. Busy executives who lead hospitals with many departments understandably desire a bottom line assessment of laboratory quality, and some laboratories do perform well on many quality measures. Yet trying to compress laboratory quality into a single dimension is like trying to describe an individual s intelligence using a single number. Too much information is lost. We believe it is best for laboratory management to report separately on laboratory performance for each aspect of quality that has been benchmarked. A balanced, multi-variable score card provides more useful information than a single composite score. Measuring Quality Does not Necessarily Improve Quality Several benchmarking studies have shown that laboratories that regularly report on a particular aspect of quality tend to perform better on that quality measure than facilities in which regular monitoring is not taking place. 16 Benchmarking quality over time is also associated with improved performance. 4 Laboratories measuring analytical quality through proficiency testing, for example, seem to show improved performance over time, even though proficiency testing was undertaken primarily for CLIA compliance. 17 The association between monitoring and performance has led many to incorrectly conclude that the simple act of monitoring improves laboratory quality. For most aspects of quality, the evidence for a cause-and-effect relationship is weak. Oftentimes, management and staff at laboratories that monitor quality are more committed than average to quality improvement, and it is their commitment to process improvement that is responsible for good laboratory performance, rather than monitoring per se. Research on the effects of monitoring shows that improvement due to monitoring itself tends to be slight and not long-lasting. After 6 to 12 months, the novelty of monitoring wears off, and performance reverts to baseline levels. For this reason, it is unfortunate that the quality assurance programs of many laboratories consist entirely of a series of monitors without any concrete programmatic steps to improve or maintain performance. Laboratory professionals like to measure things measurement is, in a sense, our business but the act of measuring quality produces only modest and short-lived quality improvement. More is required. Aspects of Quality that are Easiest to Benchmark are not Necessarily the Most Important Albert Einstein had a sign on his door at the Institute for Advanced Studies at Princeton that read, not everything that can be counted counts, and not everything that counts can be counted. Some aspects of laboratory quality that are difficult to measure such as the ethics of laboratory staff may be more important than qualities that are easily measured. Even when performance can be counted (quantified), the easiest way to measure quality is not always the best. For example, measurement of within-laboratory turnaround usually begins with the time specimens are accessioned into a laboratory information system, because this time is easier to acquire than the time specimens physically arrive in the laboratory. Yet specimens may sit for many minutes in the laboratory before they are accessioned into the computer. 18 Similarly, measurement of outpatient waiting time usually begins with the time a patient is registered, rather than the time a patient walks in the door of a phlebotomy service center. It is difficult to measure the actual time a specimen arrives in the laboratory or the time a patient walks into a Downloaded labmedicine.com from February 2008 Volume 39 Number 2 LABMEDICINE 109

3 phlebotomy area, but these starting points offer a more meaningful measure of turnaround and patient wait time than the time of accessioning or patient registration. Good Quality Does not Always Mean High Cost The College of American Pathologists has performed a number of internal studies comparing performance on various quality measures with laboratory staffing levels and costs. Correlations have been weak and are often statistically insignificant. While it is true that many quality issues can be addressed with additional staff or more modern equipment, some laboratories appear to meet the challenge without adding expense. While it is true that laboratories that are part of private hospitals, on average, perform better on many quality measures than government-run hospitals where budgets are presumably tighter, associations are not strong, and there are many government-run hospitals that perform better than their private counterparts. As a general rule, staffing levels and capital expenditures have not been strong predictors of laboratory quality in benchmarking studies. Improperly-Performed Benchmarking May Produce Misleading Results Many efforts to benchmark operations suffer from methodological shortcomings that limit the usefulness of results. One of the most common shortcomings is the use of an inadequate sample size that does not allow local laboratory performance to be estimated accurately. Reliance on dated benchmark data can also present problems, because industry performance is improving for many quality measures. For this reason, the use of published performance norms that are more than 5 years old may be misleading. Finally, laboratories without access to detailed data collection instructions may perform internal measurements that are incompatible with benchmark data, because sampling procedures or definitions are different, or because certain activities are inappropriately included in or excluded from local benchmarks. Table 1_Selected Quality Metrics Suitable for Interlaboratory Benchmarking Quality Metric Domains Addressed by Metric Pre- Post- Analytic General Lab Anatomic Clinical Chemistry/ Micro- Trans- Patient Customer Turnaround analytic analytic Systems Pathology Pathology Hematology biology fusion Safety Satisfaction Time Medicine Blood culture contamination Blood product wastage Completeness of cancer diagnoses adequacy of cancer reporting Corrected results Critical result reporting Gynecologic cytology- biopsy correlation Inpatient test result availability Order entry accuracy Patient satisfaction, specimen collection Patient wristband accuracy Physician satisfaction with lab services Proficiency testing performance Red blood cell utilization Specimen acceptability Specimen ID errors Stat test turnaround time Downloaded 110 from

4 When benchmarking laboratory quality, it is best to be guided by a benchmarking service or reputable consulting firm that has field-tested its data collection procedures and published its methods and performance data. Not Every Laboratory can be a Best Performer In the fictional town of Lake Wobegon, all children are reported to be above average. Sadly, the laws of statistics hold more firmly in the rest of the United States. Only 50% of laboratories can perform above the median in any quality benchmarking study, and fully 25% of laboratories are destined to fall into the bottom quartile. Since there is rarely any direct evidence that patients in below-the-median institutions are being harmed, there is no need for laboratory managers to declare a crisis when benchmarking shows a laboratory to be below average or even in the bottom quartile. What management should recognize, however, is that local performance in the bottom quartile signals an opportunity to improve operations. When staff at most other facilities have figured out how to perform at a higher level, local demands from caregivers for better service should be taken seriously. Industry Performance In a review of quality monitors used in 572 United States laboratories, Gayken and colleagues found that the most common monitors used by laboratories were proficiency testing (98%), quality control (96%), personnel competency testing (95%), turnaround time (94%), and patient identification accuracy (90%). 19 The 3 most common monitors are all required by U.S. regulations. Preanalytic monitors were less commonly employed, even though most laboratory problems relate to preanalytic issues. 20 No external benchmark data was available for many of the monitors in use, which meant that laboratory managers reviewing monitoring results were unlikely to have had a strong sense of how local performance compared with the laboratory industry as a whole. Although monitoring without benchmarks can be useful for tracking quality, we believe it is a good idea to benchmark a variety of laboratory processes, including different analytic testing disciplines and aspects of the pre- and post-analytic domains of laboratory service. Benchmarking data can be obtained from proprietary databases held by consultants and several published surveys conducted by state health departments and the Centers for Disease Control and Prevention. However, most multi-institutional benchmark data has been developed from the CAP Q-Probes and Q-Tracks benchmarking services. Q-Probes provides a onetime snapshot of laboratory performance in a particular area of service, whereas Q-Tracks additionally provides laboratories with the opportunity to trend performance over time. More than 100 manuscripts have been published in the peer-reviewed literature that describe industry performance as measured by the Q-Probes and Q-Tracks programs, and old manuscripts and data collection tools are available to the public without charge from the CAP Web site ( Some of the quality measures that we have found well suited for benchmarking are shown in Table 1, along with the domains addressed by each measure. Table 2 shows relative industry performance data for 3 additional metrics, and illustrates the format in which the authors of benchmark studies typically present results. Managers who wish to use external benchmarking as part of their quality management program should select measures for which published benchmark data are no more than 5 years old, and should use the same data collection methods used at facilities that contributed to the benchmark database. Not all laboratory monitoring must have external benchmarks, of course. External benchmarks are most useful when management is concerned that performance in a particular area may not be up to par, or when management believes that external benchmarking will help motivate individuals to take a known problem seriously and do something about it. Other than proficiency testing for so-called regulated analytes, laboratories are not currently required to benchmark specific aspects of their operations. At some point in the future, however, the federal government or major accreditors may explicitly require laboratories to measure their performance using other specific quality metrics, and to compare their performance with industry norms. LM 1. Belk WP, Sunderman FW. A survey of the accuracy of chemical analyses in clinical laboratories. Am J Clin Pathol. 1947;17: Hollensead SC, Lockwood WB, Elin RJ. Errors in pathology and laboratory medicine: Consequences and prevention. J Surg Oncol. 2004;88: Table 2_Examples of Industry Performance Relative Performance of Laboratories 1 Benchmark No. of Labs Year Published Reference 25th 50th (Median) 75th Automated complete blood counts with a manual review, scan, % 26.7% 39.1% or differential (%) Specimen identification errors detected before release of test % 86.1% 95.0% result (%) Receipt-to-report turnaround time for stat troponin ordered in the Emergency Department (minutes) 1 Higher percentiles do not necessarily indicate better performance. For example, in the case of manual review of automated differentials (reference 21), staff in the 75th percentile laboratory performed some sort of manual procedure in 39.1% of automated differentials while staff in the 25th percentile reviewed 18.5%. The authors of this study did not indicate that any particular frequency of review was more desirable. For specimen identification errors and turnaround time, higher percentiles and fewer minutes, respectively, indicate better performance. Downloaded labmedicine.com from February 2008 Volume 39 Number 2 LABMEDICINE 111

5 3. Berte LM. Patient safety: Getting there from here Quality management is the best patient safety program. Clin Leadersh Manag Rev. 2004;18: Zarbo RJ, Jones BA, Friedberg RC, et al. Q-Tracks. A College of American Pathologists program of continuous laboratory monitoring and longitudinal performance tracking. Arch Pathol Lab Med. 2002;126: Kohn L, Corrigan J, Donaldson M, eds. To Err is Human: Building a Safer Health System. Washington, DC: National Academies Press; Bachner P, Howanitz PJ. Using Q-Probes to improve the quality of laboratory medicine: A quality improvement program of the College of American Pathologists. Qual Assur Health Care. 1991;3: Wilkinson DS, Reynolds D. Using benchmarking to manage your laboratory. Clin Lead Manage Rev. 2003;16: Valenstein P, Sours R, Wilkinson DF. Staffing benchmarks for clinical laboratories. A College of American Pathologists Q-Probes Study of staffing at 151 institutions. Arch Pathol Lab Med. 2005;129: Valenstein P, Praestgaard A, Lepoff R. Six year trends in expense, productivity, and utilization of seventy three clinical laboratories. Arch Pathol Lab Med. 2001;125: Howanitz PJ, Valenstein P, Fine G. Employee competence and performancebased assessment. Arch Pathol Lab Med. 2000;124: Clinical Laboratory Improvement Amendments, 42 CFR College of American Pathologists, Laboratory Accreditation Program, Laboratory General Checklist GEN The Joint Commission, CAMLAB, Standard PI.1.10 EP ISO 15189: CFR Howanitz PJ. Quality assurance measurements in departments of pathology and laboratory medicine. Arch Pathol Lab Med. 1990;114: Ehrmeyer SS, Laessig RH. Has compliance with CLIA requirements really improved quality in US clinical laboratories? Clin Chem Acta. 2004;346: Valenstein P. Preanalytic delays as a component of laboratory turnaround time. Lab Med. 1990;21: Gayken J, Noble M, Taylor J, et al. IQLM and CLMA take a snapshot of America s hospital laboratory quality management. Clin Leadersh Manag Rev. 2005;19(5):E Bonini P, Plebani M, Ceriotti F. Errors in laboratory medicine. Clin Chem. 2002;48: Novis DA, Walsh M, Wilkinson D, et al. Laboratory productivity and the rate of manual peripheral blood smear review. A College of American Pathologists Q-Probes Study of 95,141 complete blood count determinations performed in 263 institutions. Arch Pathol Lab Med. 2006;130: Valenstein P, Raab SS, Walsh MK. Identification errors involving clinical laboratories. A College of American Pathologists Study of patient and specimen identification errors at 120 institutions. Arch Pathol Lab Med. 2006;130: Novis D, Jones B, Dale J, Walsh M. Biochemical markers of myocardial injury test turnaround time. A College of American Pathologists Q-Probes Study of 7020 troponin and 4368 creatine kinase MB determinations in 159 institutions. Arch Pathol Lab Med. 2004;128: Downloaded 112 from