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PubMed2001

Integrated patient data for optimal patient management: the value of laboratory data in quality improvement.

Managed care organizations are shifting from traditional utilization management programs to focus on initiatives that improve the health of an insured population. This strategy requires sophisticated data integration to identify at-risk individuals and track outcomes. Laboratory data are becoming increasingly valuable tools for managed care organizations and healthcare providers. The HEDIS Effectiveness of Care measures have incorporated laboratory data into several key performance indicators. By building a comprehensive repository of laboratory data that includes both procedure codes and laboratory values, managed care organizations can realize substantial savings by avoiding the costly medical record reviews required when administrative data are incomplete. In addition to tracking clinical outcomes, laboratory data provide the ability to risk-stratify a population to target high-risk individuals for case management and disease management interventions. Healthcare organizations face several challenges in the integration of laboratory data into medical databases and practice management software. Confidentiality is a key consideration in view of recent healthcare regulations. Providers of laboratory services should work collaboratively with organizations setting standards for healthcare informatics to facilitate the pooling of data for quality improvement and outcomes research. Health Level Seven, Inc. (HL7), Logical Observation Identifier Names and Codes (LOINC), and Systematized Nomenclature of Medicine (SNOMED) will likely play a key role in this process.

Clinical Laboratory Techniques↗
PubMed2001

Overview of evidence-based medicine: challenges for evidence-based laboratory medicine.

Evidence-based medicine (EBM) has been driven by the need to cope with information overload, by cost-control, and by a public impatient for the best in diagnostics and treatment. Clinical guidelines, care maps, and outcome measures are quality improvement tools for the appropriateness, efficiency, and effectiveness of health services. Although they are imperfect, their value increases with the quality of the evidence they incorporate. Laboratory professionals must direct more effort to demonstrating the impact of laboratory tests on a greater variety of clinical outcomes. Laboratory and clinical practitioners must be familiar with many of the accessible electronic and paper tools for searching for evidence. Detailed statistical and epidemiologic knowledge is not essential, but critical appraisal skills and a competent understanding of the strengths and weaknesses of systematic review and metaanalysis are necessary. Overemphasis on complexity and failure to recognize time limitations are major barriers to translating EBM into everyday practice. Emphasizing and practicing the role of the laboratory professional as a skilled clinical consultant strongly grounded in evidence as well, in addition to better integration of laboratory and clinical information and improved laboratory reports will overcome most barriers. There is a poverty of good, primary studies of test evaluations. Institution of more consistent standards for the design and reporting of studies on diagnostic accuracy should improve the situation. If nothing else, systematic reviews have demonstrated the need for more good-quality primary research in laboratory medicine.

Chemistry, Clinical↗
PubMed2001

The clinical relevance of microbiologic testing: a comparative analysis of microbiologic samples secured from the same sites and cultured in two independent laboratories.

A field study using five different private periodontal practices was conducted; it compared two microbiologic culture samples simultaneously secured from the same sites within 23 individual patients and submitted for bacterial identification and antibiotic sensitivity testing to two separate laboratories. The results from the two laboratories were often different. In no instance did both laboratories agree on the presence of identical bacterial species. When only bacteria above threshold levels were compared, agreement was found in only nine of 23 cases. When examining antibiotic sensitivity, using 100% kill of all tested pathogens as the ideal, agreement between the two laboratories was poor. The laboratories agreed on the use of amoxicillin 17% of the time, tetracycline 26% of the time, and metronidazole 48% of the time. The use of amoxicillin and metronidazole in combination yielded a 78% agreement when the results of both laboratories were combined. It would appear from the data that the empirical use of amoxicillin-metronidazole combination therapy may be more clinically sound and cost effective than culturing and antibiotic selection based on the results of culture from any single microbiologic testing laboratory.

Adult↗
PubMedDate not supplied

Risks faced by laboratory workers in the AIDS era.

Laboratory workers are at occupational risk of exposure to microrganisms that cause a wide variety of diseases, from inapparent to life-threatening ones. Principal routes of transmission include percutaneous and permucosal inoculation (comprising clinical inapparent cutaneous or mucosal exposure to blood or blood products), inhalation, and ingestion. The appearance of the Acquired Immunodeficiency Syndrome (AIDS) epidemic and the first reports of occupational Human Immunodeficiency Virus (HIV) infections in health care workers resulted in high anxiety among laboratory workers. Indeed, 21% of worldwide documented cases of occupational HIV infection occurred among laboratory workers. Research laboratories pose the highest risk of infection. Safe methods for managing infectious agents ("containment") in the laboratory setting include laboratory practice and technique, safety equipment, and facility design. Infection control in the laboratory setting should take into account adherence to guidelines (biosafety levels), education and training, and the development of safety products designed to reduce the risk of exposure.

Acquired Immunodeficiency Syndrome↗
PubMed2001

Guidelines for laboratory test result reporting of human immunodeficiency virus type 1 ribonucleic acid determination. Recommendations from a CDC working group. Centers for Disease Control.

Monitoring human immunodeficiency virus type 1 (HIV-1) ribonucleic acid levels (also known as HIV viral load) has become the standard of care for monitoring response to therapy in HIV-infected patients. In 1999, CDC published updated surveillance case definitions for HIV infection and acquired immunodeficiency syndrome (AIDS) reporting, including positive results of HIV-1 viral detection tests (CDC. Guidelines for national human immunodeficiency virus case surveillance, including monitoring for human immunodeficiency virus infection and acquired immunodeficiency syndrome. MMWR 1999;48[No. RR-131:1-28). Since 1996, an increased number of public and private laboratories have begun performing viral load tests. Results obtained with available test methods are variable, and laboratories present these results in different ways, indicating that guidelines to promote standard practice in reporting of test results are warranted. This report provides guidelines for standardized reporting of viral load test results by licensed laboratories to health-care providers and facilities for public health case reporting of HIV infection and AIDS. Recommended standards were developed through data review, input involving a working group of physicians and laboratorians experienced in viral load testing, and an assessment of laboratory practices. These guidelines were discussed, refined, and endorsed at the annual Human Retrovirus and Hepatitis C Laboratory Testing Conference, held March 6-9, 2000, in Charlotte, North Carolina, with participation of representatives from public health, hospital, independent, and blood-collection-facility laboratories. Adoption of these guidelines by all public and private laboratories that perform HIV viral load testing will improve the quality and usefulness of viral load test results for the physician ordering the test and for reporting to public health departments.

Clinical Laboratory Techniques↗
PubMedDate not supplied

Laboratory sampling. Alternate site perspectives.

Laboratory test results are a major diagnostic tool in the determination of a patient's condition. Clinical decisions and treatment regimens are based on these results. Laboratory testing requires a complex combination of skill, knowledge, planning, and attention to details for the end result to be an accurate representation of the patient's condition at a specific point in time. Competency in techniques, knowledge of the purpose of the testing, effects of variables on laboratory results, and the importance of following quality standards are imperative. Alternate sites present many challenges to laboratory testing. Physicians' offices, clinics, and patient's homes are rapidly replacing the traditionally controlled laboratory setting. Point-of-care technology has addressed many of the logistical problems inherent in laboratory testing for the alternate site; however, competence and quality assurance remain important parts of laboratory testing and the analysis of results.

Clinical Laboratory Techniques↗
PubMed1996

Extraneous tissue in surgical pathology: a College of American Pathologists Q-Probes study of 275 laboratories.

OBJECTIVE: To develop a multi-institutional reference database of extraneous tissue (contaminants) in surgical pathology. DESIGN: In 1994, participants in the College of American Pathologists Q-Probes quality improvement program performed prospective and retrospective evaluations of extraneous tissue found in surgical pathology microscopic sections for a period of 4 weeks or until 1000 slides were reviewed in each participating laboratory. PARTICIPANTS: Two hundred seventy-five surgical pathology laboratories institutions, predominantly from North America. MAIN OUTCOME MEASURES: Extraneous tissue contamination rate for slides in prospective and retrospective reviews; staffing and practice procedures; location of extraneous tissue on slides; type of extraneous tissue (normal, abnormal, nonneoplastic, neoplasm, microorganisms, etc); class of extraneous tissue (slide or block contaminants); source of extraneous tissue (different or same case); origin of extraneous tissue (pathology laboratory, physician's office or operating room); and degree of diagnostic difficulty caused by extraneous tissue. RESULTS: Three hundred twenty-one thousand seven hundred fifty-seven slides were reviewed in the prospective study and 57083 slides in the retrospective study. There was an overall extraneous tissue rate of 0.6% of slides (2074/321757) in the prospective study and 2.9% of slides (1653/57083) in the retrospective study. Of those slides with extraneous tissue, the extraneous tissue was located near diagnostic tissue sections in 59.5% of the slides reviewed prospectively and in 25.3% of slides reviewed retrospectively; deeper sections were performed to evaluate extraneous tissue in 12.2% of prospective cases and in 3.1% of retrospective cases. Of the laboratories, 98% had written guidelines for changing solution in tissue processors, and 64.9% had guidelines for maintaining water baths free of extraneous tissue. A total of 98.9% used lens paper, filter bags, or sponges for processing fragmented and small specimens. Written protocols for documentation of extraneous tissue in surgical pathology reports were established in 6.1% of laboratories, for removal of extraneous tissue from blocks in 5.7%, and for removal of extraneous tissue from microscopic slides in 4.7%. In 24% of laboratories no comment or record was kept to document extraneous tissue. Extraneous tissue consisted of neoplasm in 12.7% of the prospectively reviewed slides and in 6.0% of the retrospectively reviewed slides. For the prospective study, 59.4% of extraneous tissue was classified as slide contaminants, and 28.4% was found to be contaminants within the paraffin block; for the retrospective study, 72.9% was classified as slide contaminants and 15.9% as block contaminants. For the prospective study, 63.2% of extraneous tissue was presumed to be from a different case, and in the retrospective study, 48.5% was presumed to be from a different case. Over 90% of extraneous tissue was thought to originate from the pathology laboratory. The degree of diagnostic difficulty caused by extraneous tissue was judged to be severe in 0.4% of slides in the prospective study and 0.1% of slides in the retrospective study. In the prospective study, it could not be determined whether the tissue in the diagnostic sections was extraneous in 0.6% of slides, and in the retrospective study, it could not be determined whether tissue in the diagnostic sections was extraneous in 0.1%. CONCLUSIONS: This study has documented the frequency, type, origin, source, and diagnostic difficulty of extraneous tissue and presents benchmarks of extraneous tissue experienced in the general practice of surgical pathology.

Databases, Factual↗
PubMed2002

[A go-between the laboratory medicine and clinical chemistry].

The Joint Annual Meeting of the Japanese Society of Laboratory Medicine and the Japanese Society of Clinical Chemistry is held in Yokohama at the first time in the history of both Societies. A chance of this time, we should consider the subjects to cooperate each Society. At first, standardization of the clinical tests at clinical laboratory field including clinical chemistry should be promoted by the both Societies. At second, EBLM(evidence based laboratory medicine) making the core of EBM (evidence based medicine) is very important tool practicing science based medicine by the reason of the getting out from experience-medicine. The hard effort which find out evidence on the clinical laboratory tests from enormous literature must be carried out on many clinical test items. In the Japanese Society of Laboratory Medicine, EBLM Committee was formed at last year and the work has been started. At third, if serum and other body fluids as well as tissues which are got from patients are used outside the purpose, ethics should be asked. Ethics Committee in both Society will make a guideline for the ethics for the handling the materials from patients including genetic subjects. At forth, clinical laboratory is said to be necessary the method of quality management(QM). The accreditation process is needed under unified national control survey, if we promote QM. At fifth, medical science rapidly advances at twenty-first century. Especially, there will be advanced at the fields of gene therapy, organ substitution, prevention and complete therapy of arteriosclerosis diseases and diabetes mellitus, terminal care, infectious diseases control and so on. The effective way of activating clinical laboratory is to related to those medical fields.

Chemistry, Clinical↗
PubMed2002

Papnet-assisted cytological diagnosis intensifies the already marked variability among cytological laboratories.

OBJECTIVE: The main objective was to assess the sensitivity, specificity and reliability of PAPNET-assisted diagnosis in comparison with conventional screening. SETTING: Seven Italian and one English University or Research Institutes, and a random sample of an other 20 Italian Laboratories of the Italian National Health Service (INHS) provided the cervical smears. METHODS: During the training phase every center examined in rotation four sets of slides for a total of 300 representative slides. Afterwards, 900 "positive" slides were added to the 3,100 slides which were collected consecutively without any selection or exclusion. The eight main centers were divided into four couples and each couple of centers examined 775 slides with the PAPNET system, "blindly" to the original diagnosis. An expert cytopathologist (M.A.) of the National Institute of Health (NIH) reassessed 40% of the slides with an original negative diagnosis to evaluate the false negative rate. Two expert NIH cytopathologists (M.A., G.M.) re-examined all slides where a disagreement had been observed between the original and one or both of the study diagnoses. The main analyses concerned the following three main categories: WNL and unsatisfactory for evaluation; ASCUS, AGUS and LSIL; HSIL and carcinoma. A special algorithm was devised to define the reference diagnosis for sensitivity and specificity assessment. RESULTS: Laboratories, even belonging to the same couple, classified as "no review" a very different proportion of slides ranging from 35% to 74%. The index of kappa agreement between the members of couples examining the same sets of slides was low or very low, ranging from 0.30 to 0.03. The sensitivity of the review classification was particularly low in some laboratories. Surprisingly, only a small correlation was observed between the sensitivity of the review classification and the proportion of slides classified as "review". The "tentative" diagnosis on PAPNET tiles of the "review" slides was almost as reliable as the microscopic diagnosis. In the overall performance, there were many significant differences among the eight laboratories. The best laboratory had a sensitivity of 95% and a specificity of 96%. At least three laboratories displayed unacceptably low sensitivity and one a very low specificity. CONCLUSION: Altogether these results seem to confirm that there are wide differences among cytological laboratories per se, and that these differences are intensified by the use of an instrument like PAPNET. The huge variation in performance may be explained by differences in basic skills and by different training, but it is difficult to understand exactly what could have been done to reduce it.

Autoanalysis↗
PubMed2002

[Rational utilization of laboratory diagnosis].

Standard way of laboratory utilisation does not meet professional and financial criteria. Rational laboratory use, which in essence means nothing else than seeking the answer to a specific clinical question, must be the basis for a changing approach towards laboratory diagnostics. In order to do that, clinicians need to have access to all the information necessary for right data interpretation, which is usually not the case. The following points are discussed: clinicians have to get acquainted with the preanalytical issues which affect the laboratory result, with analytical and biological variability of any given laboratory parameter, critical difference within longitudinal patient evaluation, as well as with diagnostic specificity and sensitivity which determine the value of a test within certain clinical context. Preanalytical phase comprises all the influences affecting the patient and the specimen and it can have a substantial impact on laboratory values. Biological variability is mainly dependent on homeostatic regulation, and it might thus be considerably high for certain parameters (end products of the metabolism, enzymes). As a consequence, the value of critical difference (absolute value in actual units which reflects a true change in clinical status) might be unexpectedly high. Finally, diagnostic sensitivity and specificity are main determinants of diagnostic performance of any given test and the lack of this information is a frequent cause of inappropriate laboratory use.

Clinical Laboratory Techniques↗
PubMed2002

Accreditation and credentialing in the vascular laboratory.

The vascular diagnostic laboratory remains an integral component of the vascular surgeon's practice and has replaced many invasive techniques for the diagnosis and treatment plan of vascular disease. Although financial challenges have been leveled at the vascular laboratory, the actual number of laboratories continues to increase, suggesting a greater demand for vascular laboratory studies. With this, also comes the challenge of maintaining quality within each laboratory as well as ensuring a standard of quality for all laboratories nationwide. Credentialing and accreditation have been used for this purpose in nearly all areas of medicine and have provided a mechanism for assuring a minimum standard of competency. Over the last decade, similar mechanisms have been applied toward the vascular diagnostic laboratory, which likely have resulted in improved vascular diagnostic studies and overall care.

Accreditation↗
PubMed2002

Automated transport and sorting system in a large reference laboratory: part 1. Evaluation of needs and alternatives and development of a plan.

BACKGROUND: Our laboratory, a large, commercial, esoteric reference laboratory, sought some form of total laboratory automation to keep pace with rapid growth of specimen volumes as well as to meet competitive demands for cost reduction and improved turnaround time. METHODS: We conducted a systematic evaluation of our needs, which led to the development of a plan to implement an automated transport and sorting system. We systematically analyzed and studied our specimen containers, test submission requirements and temperatures, and the workflow and movement of people, specimens, and information throughout the laboratory. We performed an intricate timing study that identified bottlenecks in our manual handling processes. We also evaluated various automation options. RESULTS: The automation alternative viewed to best meet our needs was a transport and sorting system from MDS AutoLab. Our comprehensive plan also included a new standardized transport tube; a centralized automated core laboratory for higher volume tests; a new "automation-friendly" software system for order entry, tracking, and process control; a complete reengineering of our order-entry, handling, and tracking processes; and remodeling of our laboratory facility and specimen processing area. CONCLUSIONS: The scope of this project and its potential impact on overall laboratory operations and performance justified the extensive time we invested (nearly 4 years) in a systematic approach to the evaluation, design, and planning of this project.

Automation↗
PubMed2002

The development of systematic quality control method using laboratory information system and unity program.

Quality control (QC) process is performed to detect and correct errors in the laboratory, of which systematic errors are repeated and affect all the laboratory process thereafter. This makes it necessary for all the laboratories to detect and correct errors effectively and efficiently. We developed an on-line quality assurance system for detection and correction of systematic error, and linked it to the Unity Plus/Pro (Bio-Rad Laboratories, Irvine, USA), a commercially available quality management system. The laboratory information system based on the client-server paradigm was developed using NCR3600 (NCR, West Columbia, USA) as the server and database for server was Oracle 7.2 (Oracle, Belmont, USA) and development tool was Powerbuilder (Powersoft Burlignton, UK). Each QC material is registered and gets its own identification number and tested the same way as patient sample. The resulting QC data is entered into the Unity Plus/Pro program by in-house data entering program or by manual input. With the implementation of in-house laboratory information system (LIS) and linking it to Unity Plus/Pro, we could apply Westgard's multi-rule for higher error detection rate, resulting in more systematic and precise quality assurance for laboratory product, as well as complementary to conventional external quality assessment.

Chemistry, Clinical↗
PubMed2003

Implementation of proficiency testing in conjunction with a rechecking system for external quality assurance in tuberculosis laboratories in Mexico.

SETTING: In developing countries, tuberculosis is diagnosed by identification of acid-fast bacilli (AFB) on sputum smears. OBJECTIVE: To evaluate the quality of AFB microscopy, the Mexican Secretary of Health National Reference Laboratory implemented proficiency testing for its network of 637 laboratories. DESIGN: A total of 586 (92%) laboratories were inspected and 430 technicians evaluated by proficiency testing consisting of 10 slides with known numbers of AFB. Results were compared with those of slide rechecking and with proficiency testing performed 2 years later. RESULTS: Of the 430 technicians evaluated by proficiency testing in 1998, 196 (46%) scored less than 80% and received intensive training in 1999. From a previous mean score of 65% their results increased to 90% (P < 0.0001). In 2001, they again underwent proficiency testing, and the mean score was 83%. The main factors affecting proficiency testing results were the type of laboratory in which the microscopists worked and the number of low-positive slides (1-9/100) in the test. Laboratories whose work was rechecked had better scores (P = 0.002). Proficiency testing scores and the estimated sensitivity of the microscopist's laboratory were associated (P = 0.01). CONCLUSION: External quality assessment and training improve diagnostic performance. Rechecking and proficiency testing are both viable measures of laboratory performance.

Clinical Competence↗
PubMedDate not supplied

Legal and regulatory issues in hospital laboratory outreach and partnering arrangements.

An independent laboratory's joint venture with a chain of five nonprofit hospitals unraveled in 1999. Despite substantial management control over the joint venture and 3 years spent investing in and managing a massive consolidation project, the laboratory operator was ousted by the hospital group in favor of a national laboratory competitor. In the process, it lost the $6 million commercial laboratory business it brought to the joint venture. The laboratory operator sued the hospital group for destroying its business. Were the hospital's actions legal? Could the laboratory operator have protected itself better? Although by no means the only causes of this disaster, regulatory restrictions and uncertain contract terms contributed to the problems experienced by the laboratory operator.

Antitrust Laws↗
PubMed2003

[Safety surveillance and management of specimen associated with SARS in clinical laboratory].

OBJECTIVE: To avoid the staff's infection and environmental contamination, we establish the rules suited for severe infectious disease in our laboratory. METHODS: (1) Enhance the staff's notion of safety, institute a rule for biological safety and make sure the responsibility of safety for everybody. (2) Set up a special laboratory or area for detection of specimens associated with SARS, appoint the staff specially assigned for the task. The approach to environmental cleaning and disinfection in the laboratory is according to the guidance. (3) Laboratory staff should take precaution when entering and leaving laboratory according to the guidance. (4) Collection, transportation, pre-disposal and storage of specimen from patients with SARS for testing should be done in leak-resistant environment. These specimen should be performed in biological safety cabinet. All Clinical waste must be placed in an appropriate leak-resistant biohazard bag or container, labeled and disposed of safely. RESULTS: Since the outbreak of SARS, no staff was infected with SARS in our clinical laboratory. CONCLUSION: Our precaution is feasible and effective. A series of rules ensure the safety for the laboratory staffs and environment.

Adult↗
PubMed2003

[Role of laboratory medicine in medical care--from the point of view of a manager].

The Japanese health insurance system has been praised because of the comprehensive coverage of medical costs. The long lifespan of Japanese, the longest in the world, however, because economic conditions are getting worse and medical costs are increasing with the increase of aged people in Japan, the health insurance system is under pressure. The Japanese government is going to start to reduce costs of medical care by applying a system like the DRG/PPS system in the USA, called Diagnosis Procedure Combination(DPC), next year in university hospitals. Under the DPC system, laboratory tests will be non-profit. We have to change the management style of clinical laboratories to cut costs for tests and labor as much as possible, choose tests selectively, respond rapidly to clinical needs, and utilize information technology efficiently for processing of laboratory data. Therefore, corresponding to changes in the medical care system, laboratory medicine has been changing. Commercial clinical laboratories are expanding their pressure in hospitals, and in-hospital laboratories are having a very hard time coping with the pressure. Since laboratory medicine is an essential part of clinical practice, we do not have to be antagonistic.

Clinical Laboratory Techniques↗
PubMed2003

[Postgraduate medical training in laboratory medicine and clinical genetics in Chiba University Hospital].

Compulsory postgraduate clinical training in laboratory medicine will start on a national basis in April 2004. It remains to be discussed how departments of laboratory medicine and/or divisions of clinical laboratory should contribute to the training program. I here summarize what we are planning to do in Chiba University Hospital together with my personal views on this topic. Two points are of note in our program. First, one-week training in the division of clinical laboratory is essential as a part of the 6-month training of internal medicine. The items in the program include Gram staining, white blood cell differential counting, urinary sediment study, and representative point-of-care testing. A program to follow the entire flow of laboratory tests(from withdrawal of blood to reporting of the test results) is also included to highlight a variety of pre-analytical errors. Furthermore, trainees are encouraged to learn how to work and co-operate with co-medical personnel. Second, our program aims at training postgraduate medical students to be clinical geneticists competent at genetic counseling. Genetic counseling is the process by which patients or relatives at risk of a disorder that may be hereditary are advised of the consequences of the disorder, the probability of developing or transmitting it and of the ways to test them. Thus, our final goal is to foster genetically oriented experts in laboratory medicine and clinical geneticists with a wide knowledge of laboratory medicine.

Clinical Laboratory Techniques↗