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PubMed2003

A survey of laboratory 'critical (alert) limits' in the UK.

INTRODUCTION: Critical or alert limits are the values of laboratory measurements that are regarded as requiring urgent clinical action and should be communicated to a clinician urgently. Despite this, there has been little evaluation of these values in the UK. METHODS: We have conducted a survey of hospital biochemistry laboratories in the UK. RESULTS: Ninety-four laboratories responded to the questionnaire; the response rate was not recorded. Twenty-three laboratories had derived their action limits locally from a consensus with their clinicians, experience over many years, and the literature. Only two laboratories quoted literature to support their values. Seven laboratories did not submit actual critical values. There was considerable variance in the values defined as critical by the responding laboratories. DISCUSSION: Each laboratory needs to evaluate its own list of acutely important critical values and aim for a small number of analytes that are always communicated to the doctor, so that clinical needs are met without raising the risk of information overload.

Chemistry, Clinical↗
PubMed2002

Evaluation of HER-2/neu immunohistochemical assay sensitivity and scoring on formalin-fixed and paraffin-processed cell lines and breast tumors: a comparative study involving results from laboratories in 21 countries.

Variation in assay sensitivity was studied in more than 90 laboratories that assayed 4formalin-fixed, paraffin-processed breast and ovarian carcinoma cell lines with graded levels of HER-2/neu protein overexpression and known levels of HER-2/neu gene amplification, in addition to breast carcinomas fixed and processed in the laboratories. Main methods were the HercepTest (DAKO, Ely, England) and individualized protocols using a polyclonal antibody and the CB11 clone. While the proportion of laboratories achieving appropriate results with the HercepTest was significantly higher than for participants using other assays, laboratories using other assays showed significant improvement in the second assessment run. The level of agreement in evaluations by 26 laboratories using the HercepTest was excellent on cell lines and tumors and was significantly greater than that achieved by the remaining 41 laboratories using other immunohistochemical methods. While laboratories using the DAKO HercepTest had the highest level of reproducibility in assay sensitivity and evaluation, the significant improvement in results by laboratories using other antibodies in the second assessment run suggests that stringent quality control and an ongoing quality assurance program using a standard reference material have the potential to improve the reliability of immunohistochemical assays for HER-2/neu, regardless of the antibody used.

Breast Neoplasms↗
PubMed2006

Analysis of search in an online clinical laboratory manual.

Online laboratory manuals have developed into an important gateway to the laboratory. Clinicians increasingly expect up-to-date laboratory test information to be readily available online. During the past decade, sophisticated Internet search technology has developed, permitting rapid and accurate retrieval of a wide variety of content. We studied the role of search in an online laboratory manual. We surveyed the utilization of search technology in publicly available online manuals and examined how users interact with the search feature of a laboratory handbook. We show how a laboratory can improve its online handbook through insights gained by collecting information about each user's activity. We also discuss future applications for search-related technologies and the potential role of the online laboratory manual as the primary laboratory information portal.

Clinical Laboratory Information Systems↗
PubMed2003

Effect of a controlled feedback intervention on laboratory test ordering by community physicians.

BACKGROUND: Most studies of interventions to reduce laboratory test utilization have occurred in academic hospital settings, used historical controls, or have had short post intervention follow-up. Interventions with the greatest impact use multiple approaches, are repeated regularly, include comparisons with physician peers, and have a personal approach. We determined whether laboratory test utilization by community physicians could be reduced by a multifaceted program of education and feedback. METHODS: We identified 200 physicians who ordered the largest number of common laboratory tests during 1 year in a nonhospital, commercial community (reference) laboratory. They were assigned to intervention and control groups (100 each). Intervention physicians were visited individually up to three times by laboratory representatives over a 2-year period. At each visit, educational material and the physician's personal laboratory test utilization data were presented and discussed briefly in general terms, with the latter compared with utilization data for the physician's peers. Overall test utilization rates 1 year before, during, and 2 years after the intervention were measured using population-based databases. Time-series analysis was used to determine the effect of the intervention on laboratory test utilization. RESULTS: The two groups began with similar test utilization: control group, 4.06 x 10(6) tests in 1.48 x 10(6) visits (2.73 tests/visit); intervention group, 3.90 x 10(6) tests in 1.41 x 10(6) visits (2.77 tests/visit). During the 2-year intervention, intention-to-treat analysis showed that utilization decreased significantly in the intervention group compared with the controls [relative reduction of 7.9% (P <0.0001); absolute reduction of 0.22 tests/visit (95% confidence interval, 0.20-0.24)]. This difference persisted until the end of study observation, or more than 2 years after the intervention ended. CONCLUSION: A multifaceted education and feedback strategy can significantly and persistently decrease laboratory utilization by practicing community physicians.

Clinical Laboratory Techniques↗
PubMed1998

Improved laboratory test selection and enhanced perception of test results as tools for cost-effective medicine.

Inconsistencies in the way physicians perceive and handle identical laboratory results have untoward effects on morbidity, mortality and cost of medical care. In this context, the selection of suitable tests to answer definite clinical questions, and the manner in which laboratory results are presented have great impact on the action taken by the clinician. This review addresses preferred methods to improve laboratory test selection, and examines methods that more effectively convey laboratory results to clinicians. It is anticipated that refined selection of tests, and presentation of the test results in a configuration that is easily perceived by the clinician, will facilitate interpretation of laboratory reports. Furthermore, any measures that promote the application of laboratory information in medical practice improve economics at the laboratory-clinical interface. The presently described methods to optimize test selection and interpretation are: likelihood ratios to provide estimates of the ability of a test to identify a clinical condition; consensus- and discriminant function-analysis to estimate the performance of tests in diagnosing a particular disease or condition; receiver operating characteristic (ROC) curves to assess discrimination capabilities. The methods which improve test result perception are expression of results as multiples of the upper normal limit, utilizing signal strength to provide prognostic probabilities, and presentation of results in graphic forms that display mutually interrelated functions, with a specific cluster of results being highly suggestive of a given condition. In addition, we discuss application of expert systems to provide rules based on knowledge and experience to analyze results of tests and suggest diagnosis and action, including additional tests when required. It is anticipated that judicious utilization of laboratory services by application of the reviewed methodologies will help to achieve medically justified responses at a lower cost and help to achieve a proper balance between cost of tests and their clinical usefulness.

Clinical Laboratory Techniques↗
PubMed1999

The changing face of clinical laboratories.

Laboratory medicine has undergone a sea change, and medical laboratories must now adapt to, and meet new, customer-supplier needs springing from shifts in the patterns of disease prevalence, medical practice, and demographics. Managed care and other cost-containment processes have forced those involved in health care to cooperate to develop a full picture of patient care, and this has affected clinical laboratory objectives, the main focus now being on improvement in medical outcomes. More recently, the resource shortages in health care and results of cost/effectiveness analysis have demonstrated that the value of a laboratory test must be ascertained not only on the basis of its chemical or clinical performance characteristics, but also by its impact on patient management, the only true assessment of the quality of testing being quality of patient outcomes. The time is ripe for changing the vision of laboratory medicine, and some of the reasons for this are the availability of results in real-time, the introduction of more specific tests, and the trend to prevent diseases rather than cure them. The information from laboratory tests designed to evaluate biochemical or genetic risk and/or prognostic factors cannot be replaced either by physical examination and/or the assessment of symptoms. Today, the importance of laboratory scientists must be proven in three broad areas: a) guaranteeing the quality of tests, irrespective of where they are performed; b) improving the quality of the service; c) maximizing the impact of laboratory information on patient management.

Chemistry, Clinical↗
PubMed1998

The activities of veterinary vaccine control laboratories.

The activities of veterinary vaccine control laboratories are reviewed. The National Veterinary Assay Laboratory (NVAL) in Japan is used as an example to describe a quality control system for veterinary vaccines. Veterinary vaccine control laboratories conduct tests on veterinary vaccines and perform studies to improve test methods to ensure quality, efficacy and safety. The primary responsibility of the veterinary vaccine control laboratory is the assay of animal vaccines for national use. In addition, vaccine control laboratories perform activities for the distribution of reference products, examinations, inspection of other laboratories to ensure implementation of 'good laboratory practices', technical training and other duties prescribed by the Ministry of Agriculture. The NVAL and veterinary control laboratories from other countries have participated in the work of the International Co-operation on Harmonisation of Veterinary Medicinal Products (VICH) group initiated by the Office International des Epizooties to harmonise technical requirements for registration of veterinary vaccines.

Animals↗
PubMed1988

A Danish inter-laboratory study of IgM rheumatoid factor (RF) determined by enzyme-linked immunosorbent assay (ELISA).

The present report concerns data on the applicability of a standardized IgM RF ELISA as undertaken in five laboratories in Denmark. The study was done upon the initiative of the Danish Association for Clinical Immunology who wished to get an impression of the inter-laboratory reproducibility of the assay, since several Counties in Denmark had de-centralized the IgM RF technique for economic reasons. All laboratories received a form describing the details of the recommended technique, a preparation of human IgG for coating of the microplates, a national standard preparation of IgM RF, 3 well-known control sera and 6 unknown patient sera from the Laboratory for Autoimmune Serology. The results were estimated in IU/ml, calculated in each laboratory. Coefficients of variation in positive sera were between 13 and 25%, and in negative sera 45-50%. Negative sera could always be clearly distinguished from low, middle and highly positive sera. Day-to-day variation was minimal in all laboratories (6%-13%). The IgM RF ELISA technique could thus be handled in all laboratories rendering reasonably reproducible results, and all laboratories could distinguish sera with low, intermediate and high levels of the antibodies from each other and from negative sera.

Enzyme-Linked Immunosorbent Assay↗
PubMed2005

Interlaboratory proficiency testing as a tool for improving performance in laboratories diagnosing bovine mastitis.

The National Veterinary and Food Research Institute (Finland) and the Veterinary Laboratories Agency of the Quality Assurance Unit, Department for Environment, Food and Rural Affairs, United Kingdom (previously the Ministry of Agriculture, Fisheries and Food) organized a proficiency testing program for laboratories analyzing veterinary mastitis samples. Three test samples with lyophilized strains of common aerobic bacteria were sent to the participating laboratories 7 times between 2000 and 2003. The participants returned 98% of the requested data. The overall performance of the laboratories varied from 63 to 93% in different testing rounds. All laboratories diagnosed Staphylococcus aureus and Escherichia coli correctly at every round. Improvement in diagnosing individual bacteria was observed for Staphylococcus epidermidis, Streptococcus dysgalactiae, Enterococcus spp. and Klebsiella spp. The overall performance of the laboratories improved with increased participation. The educational role of the program was important. Laboratories working in the veterinary field should implement a documented quality system covering all functions of the laboratory, as well as a planned quality assurance system.

Animals↗
PubMed2003

[Laboratory-performance study of the notified methods to detect genetically modified maize (CBH351) and potato (NewLeaf Plus and NewLeaf Y)].

To investigate the key factors affecting the reliability of the analytical results, a laboratory-performance study was attempted for the notified methods to detect genetically modified (GM) maize (CBH351) and GM potato (NewLeaf Plus and NewLeaf Y). The test samples were designed as three pairs of blind duplicates, which included 0%, 0.1% and 1.0% GM maize (CBH351) or GM potato (NewLeaf Plus or NewLeaf Y). Fourteen laboratories participated in the study. The test samples were sent to the participating laboratories along with the protocol. The data were collected from all laboratories and statistically analyzed. For the 0% sample of the CBH351 maize, one laboratory reported a false-positive result. It was considered that contamination could have occurred via the common use of equipment or tools for the test. For the 0.1% samples of the NewLeaf Plus potato or NewLeaf Y potato, on the other hand, three laboratories reported false-negative results. It was presumed that these results were due to changes of the conditions of the electrophoresis and agarose-gel staining. The other laboratories reported appropriate results. It was considered that the method employed in this study was suitable for the assessment of laboratory performance.

DNA, Plant↗
PubMed2006

Concordance between central and local laboratory HER2 testing from a community-based clinical study.

BACKGROUND: Women with HER2-overexpressing breast cancer have an unfavorable prognosis. Trastuzumab improves survival when combined with chemotherapy in the first-line treatment of patients with HER2-overexpressing metastatic breast cancer and decreases the rate of disease relapse by 52% and the rate of death by 33% in women with HER2-overexpressing early-stage breast cancer. HER2 testing can be performed using immunohistochemistry (IHC) or fluorescence in situ hybridization (FISH) and can be performed at local pathology laboratories or at central/reference laboratories. Because of the significant benefit seen with trastuzumab, it is critical to accurately identify women most likely to benefit. The method and the location of HER2 testing contribute to the accuracy of test results. PATIENTS AND METHODS: HER-First, a prospective, community-based, phase IV study of first-line trastuzumab/taxane therapy, enrolled patients with HER2-overexpressing metastatic breast cancer. Retesting of all tumor specimens by HER2 IHC and FISH at a high-volume, experienced laboratory was required. RESULTS: Concordance between local and central laboratory HER2 IHC testing was highest for local IHC 3+ samples (n = 377; 77%) and lowest for IHC 2+ samples (n = 184; 26%). Thirty-three percent of samples testing IHC 2+ at a local laboratory tested FISH-positive at the central laboratory. Concordance between HER2 IHC and FISH results was higher when both tests were performed at the central laboratory. CONCLUSION: Accurate HER2 test results are critical to identify patients who are appropriate candidates for trastuzumab, a therapy with significant clinical benefits in HER2-overexpressing breast cancer. These data show that HER2 testing is most accurate when performed at a high-volume reference laboratory.

Antibodies, Monoclonal↗
PubMed2004

Bronchodilator reversibility testing: laboratory practices in Australia and New Zealand.

OBJECTIVES: To determine the variation in the methods used to assess and interpret the reversibility of airflow limitation in lung-function laboratories throughout Australia and New Zealand. DESIGN: A postal survey performed in 2000, requesting details of methods used to assess and interpret bronchodilator reversibility. SETTING AND PARTICIPANTS: 60 lung-function laboratories identified from the Australian and New Zealand Society of Respiratory Science mailing list. MAIN OUTCOME MEASURES: Bronchodilator agent, dose, mode of administration, time to repeat spirometry and definition of a significant response. RESULTS: 37 laboratories responded (response rate, 64%). Thirty-three laboratories used salbutamol as their routine bronchodilator agent. Twenty-four laboratories used a metered-dose inhaler (MDI) with (21) or without (3) a spacer device as the preferred mode of bronchodilator administration. There was wide variation in the bronchodilator dose administered (median, 400 micro g; range, 200-800 micro g salbutamol for MDIs) and the time to repeat spirometry following bronchodilator administration (median, 10 min; range, 4-20 min). Ten laboratories used criteria consistent with either the National Asthma Council or Thoracic Society of Australia and New Zealand COPDX guidelines to define a significant bronchodilator response, and two used American Thoracic Society criteria. The remaining 25 respondents listed a variety of other criteria. CONCLUSION: The methods used to assess and interpret acute bronchodilator reversibility in lung-function laboratories in Australia and New Zealand vary considerably. This may have a significant effect on the diagnosis and management of patients. Laboratories should report the method used to assess bronchodilator response.

Asthma↗
PubMed1999

Gynecologic cytology turnaround time. A College of American Pathologists Q-Probes Study of 371 laboratories.

OBJECTIVES: To determine the turnaround time for gynecologic cytology in a large sample of laboratories and to identify laboratory and specimen characteristics associated with better and worse performance. DESIGN AND SETTING: Prospective evaluation of gynecologic cytology turnaround times in 371 laboratories. MAIN OUTCOME MEASURE: Gynecologic cytology case turnaround time. RESULTS: Three hundred seventy-one laboratories submitted information regarding laboratory characteristics and processes, and turnaround times of 66 042 gynecologic cytology cases. Half of the participating laboratories had mean turnaround times of 6 calendar days or less and were able to complete 90% of their cases within 8 calendar days. Ten percent of participants had mean turnaround times greater than 13 days and required 19 or more days to report 90% of their cases. Longer turnaround times were associated with the use of reference laboratories for all or part of the evaluation; contacting the physician's office for additional information; using cytotechnology students, residents, or fellows in the evaluation; and providing service on the weekend. CONCLUSION: Practice patterns contribute to the long turnaround times for gynecologic cytology found in some laboratories and may be improved by local site-specific process analysis.

Cytodiagnosis↗
PubMed2002

Routine outpatient laboratory test turnaround times and practice patterns: a College of American Pathologists Q-Probes study.

OBJECTIVES: To determine baseline parameters for routine outpatient test turnaround time (TAT), to identify influential factors, and to study the impact of managed care on this testing. METHOD: Using forms supplied by the College of American Pathologists Q-Probes program, laboratories conducted a self-directed study of routine outpatient TATs over a 4-week period. Data requested included various times of day associated with the collection, laboratory receipt, and result verification of specimens, as well as details on the drawing location and ordering and delivery methods for up to 3 tests, namely, a complete blood cell count (CBC), biochemical profile, or thyrotropin test. For the CBC, an indication was requested if a manual differential was performed. Additionally, practice-related questions were asked, including several about whether the laboratory was associated with a managed care organization (MCO). The main outcome measures included the components of the TAT process and related factors.Participants.-Six hundred nineteen laboratories from those enrolled in the 1997 College of American Pathologists Q-Probes program. RESULTS: Data were submitted by 614 participants, most US hospitals, and represented 30 240 CBCs, 25 683 biochemical profiles, and 14 801 thyrotropins. Collection to verification TATs increased for specimens received later in the day for all analytes, but the magnitude of the increase was greatest for thyrotropin. Collection to laboratory receipt TAT was similar for all analytes, but the time and distribution increased with time of day. Testing time (receipt to verification) was similar for the CBC and biochemical profile, but was greatly increased for thyrotropin. Most participants tested the CBC and the biochemical profile as they arrived, but many delayed testing for thyrotropin. Most (70%) outpatient specimens were collected within the institution; only about 10% came from local physicians' offices. A median 46.7% of hospital testing involved outpatients. Only 10% of laboratories operated under an MCO; these laboratories reported a median of 45% of specimens coming from their MCO. Being associated with an MCO increased TAT for the CBC and biochemical profile. CONCLUSIONS: Outpatient testing comprises about half of all hospital testing, yet systems are not optimized. Preanalytic TAT increases during the day, which indicates increasing delays in the collection and transport stages. Imposition of a test schedule on thyrotropin results in a delay pattern that is very different from the CBC and biochemical profile, which are tested on arrival. A laboratory's association with an MCO had a weak impact on TAT.

Ambulatory Care↗
PubMed2003

Specimen collection volumes for laboratory tests.

CONTEXT: Unnecessary tests, inefficient ordering practices, and collection of more blood than is required for testing contribute to iatrogenic anemia in hospitalized patients. Laboratories accredited by the College of American Pathologists are expected to review phlebotomy practices for specimen collection volumes periodically. OBJECTIVE: To report specimen collection, analytic, and discard volumes for routine laboratory tests and to identify practice variables associated with overcollection and blood wastage. DESIGN: Clinical laboratories participating in the College of American Pathologists Q-Probes laboratory improvement program recorded collection container size, laboratory-defined requested volume, manufacturer-defined analytic volume, and average discard volume for routine complete blood cell counts and electrolyte panels ordered for patients in intensive care units. Participants provided information about their specimen collection, processing, and analytic practices in a questionnaire. SETTING AND PARTICIPANTS: A total of 140 public and private institutions. MAIN OUTCOME MEASURES: Overcollections for routine collections and for situations in which a reduced volume of specimen is collected, and average discard volume per tube. RESULTS: Laboratories collected a median of 2.76 mL (or 8.5 times) more than their instrument's analytic volume for routine complete blood cell counts and 1.75 mL (or 12 times) more than their instrument's analytic volume for routine electrolyte panels. For clinical situations in which reduced collection volumes were necessary, overcollection for the same analytes was 0.5 mL (3 times) and 0.44 mL (4.2 times), respectively. The median discard volume was 2.8 mL/tube for complete blood cell counts and 2.0 mL/tube for electrolyte panels. Specimen collection container size was directly associated with overcollections and discard volumes. Instrument analytic volume was not a determinant of blood wastage. CONCLUSIONS: Most laboratories can decrease collection volumes without compromising the ability of the laboratory to report a reliable and timely result. Use of smaller collection tubes can help reduce blood wastage.

Blood Specimen Collection↗
PubMed2005

Detection and correction of systematic laboratory problems by analysis of clustered proficiency testing failures.

CONTEXT: The Laboratory Accreditation Program of the College of American Pathologists monitors the performance of its subscribers in proficiency testing (PT). Failure to perform as expected prompts the program to query the laboratory. OBJECTIVE: To determine whether laboratories are correcting apparent problems when contacted by the program about repeatedly unacceptable performance in a diagnostic test. DESIGN: Retrospective analysis of 1 year's records (2002-2003) from the College's Proficiency Testing Exception Summary correspondence, which identifies clusters of PT failures. The analysis focused on those laboratories in which the Proficiency Testing Exception Summary algorithm identified repeated failures over 3 or 4 testing events; PT performance is monitored as a condition of accreditation. During 1 survey year, approximately 6300 accredited laboratories collectively tested approximately 1,205,000 analytes and submitted results to their PT providers on more than 3,500,000 PT challenges. During the period of observation, 14,085 Proficiency Testing Exception Summary reports were mailed to participants. Educational materials were included to help laboratories identify and correct each PT failure. RESULTS: There were only 1304 cases of repeated PT failures after the initial correspondence from the accreditation program (9.3%). Of these, there were only 119 cases of unsatisfactory results on the subsequent PT event (9.1%). All systematic problems were resolved by the conclusion of the third round of correspondence. CONCLUSIONS: Accredited laboratories generally perform well in proficiency testing. Identification of clusters of PT failures by the accreditation provider can help those laboratories having analytic difficulties to investigate and correct the problems.

Accreditation↗
PubMed2006

Identification errors involving clinical laboratories: a College of American Pathologists Q-Probes study of patient and specimen identification errors at 120 institutions.

CONTEXT: Misidentified laboratory specimens may cause patient injury, but their frequency in general laboratory practice is unknown. OBJECTIVES: To determine (1) the frequency of identification errors detected before and after result verification, (2) the frequency of adverse patient events due to specimen misidentification, and (3) factors associated with lower error rates and better detection of errors. DESIGN: One hundred twenty clinical laboratories provided information about identification errors during 5 weeks. RESULTS: In aggregate, 85% of errors were detected before results were released; one quarter of laboratories identified more than 95% of errors before result verification. The overall rate of patient identification errors involving released results was 55 errors per 1,000,000 billable tests. A total of 345 adverse events were reported. Most of the adverse events caused material inconvenience to the patients but did not result in any permanent harm. On average, adverse events resulted from 1 of every 18 identification errors. Extrapolating the adverse event rate observed in this study to all United States hospital-based laboratories suggests that more than 160,000 adverse events per year result from misidentification of patients' laboratory specimens. CONCLUSIONS: Identification errors are common in laboratory medicine, but most are detected before results are released, and only a fraction are associated with adverse patient events. Even when taking into consideration the design of this study, which used imperfect case finding, institutions that did a better job of detecting errors within the laboratory released a smaller proportion of results that involved specimen misidentification.

Diagnostic Errors↗
PubMedDate not supplied

Developing an environmental assessment for effective clinical laboratory strategic planning: Part II. A five-step process.

The 1990s will pose a unique set of opportunities and challenges for clinical laboratories and the health-care field. Successful positioning of the clinical laboratory requires a well-thought-out strategic plan for the next 3 to 5 years and beyond. To develop an effective strategic plan, you must assess the environment in which your organization operates. This article, the second in a two-part series, focuses on the strategic planning process for the clinical laboratory and on environmental assessment. The first article (1) discussed CLMA's environmental assessment process and its findings. This article will present a step-by-step approach you can use to develop your own clinical laboratory environmental assessment. The future of the clinical laboratory and related industries provides the context within which clinical laboratories must position themselves to effectively meet their clients' needs. These two articles provide a starting point for developing a vision of the future for the clinical laboratory industry and for the individual clinical laboratory.

Laboratories, Hospital↗