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PubMed1991

Quality control does improve the performance of laboratory practice in primary health care.

Quality control surveys combined with teaching courses and expert consultations were offered to laboratories serving general practitioners in the county of Sør-Trøndelag, Norway. Fifty-one laboratories participated in the programme and the surveys during 1988-89. During the study period the number of laboratories having acceptable accuracy of their haemoglobin determination increased from approximately 80% to more than 90%. A similar increase was found also in precision where CV declined from 6.7% to approximately 2%. Additional positive effects were more close co-operation and more fruitful dialogues between the specialist laboratory and that of the general practitioners. The results offer promising perspectives to the control of laboratory performance in primary health care and the optimal use of laboratory tests.

Blood Specimen Collection↗

PubMedDate not supplied

Computerized management of a medical bacteriology laboratory using real-time processing.

The computer system of the Bacteriology Laboratory at the Hôpital Cardiologique in Lyon is one of the elements in the computer management of patient data. It dovetails in with the various units for admission, patient location, ward surveillance, outpatient appointments. The main objectives are as follows: to improve quality of sample information, to reduce clerical work and accelerate information circulation, to widen the scope of epidemiological research. Computers can register samples, edit laboratory work sheets, entry lists, record results, generate reports, give a visual listing of all analyses performed before a patient leaves hospital, list pending analytical results, make available in the total system all laboratory-validated information, produce automatic billing of analyses and statistical editing. The Bacteriology Laboratory has three visual display units and two printers at its disposal. Computer laboratory management has been operational since May 1977. First results are satisfactory and suggest extension of the system to other laboratories and handling of quality control.

Bacteriology↗

PubMed2000

Problems in interpreting laboratory tests. What do unexpected results mean?

It is always important that physicians not overreact to apparently abnormal laboratory values by undertaking inappropriate further investigations or clinical treatments. When confronted with unexpected differing test results from repeat testing in the same individual, physicians should be aware of explanations other than laboratory error and change in the patient's clinical status. While test-related variables may be factors, intraindividual biologic variation is much more common and may be the explanation for discrepant results. For this reason, physicians need to know which laboratory tests are associated with significant intraindividual biologic variation as well as the magnitude of possible changes. Age-associated physiologic changes may significantly alter certain laboratory values in the elderly without constituting a pathologic process. Laboratory values that may appear abnormal in 10% or more of the healthy elderly without necessarily representing a pathologic process include serum alkaline phosphatase, fasting blood glucose, 2-hour postprandial glucose, erythrocyte sedimentation rate, hemoglobin, and a normal serum creatinine level in the face of a markedly decreased creatinine clearance. To ensure proper assessment of the geriatic patient, the clinician needs to be aware of these age-related changes and possible effects on laboratory values. More clinical research is needed to establish appropriate reference ranges, especially for those over the age of 75 years.

Adolescent↗

PubMed1994

Laboratory diagnosis of infectious diarrhea.

The microbiology laboratory, in conjunction with the medical staff, must determine a reasonable approach to the evaluation of diarrheal stools since the cost to rule out all potential pathogens is prohibitive and control of the use of laboratory services is now a major focus in all institutions. All stool cultures should be examined for Campylobacter, Salmonella, and Shigella, the most common causes of inflammatory bacterial diarrhea in the United States. Special media for other pathogens should be added only if there is high regional endemicity or significant clinical suspicion. If a child has bloody diarrhea, a search for E coli O157:H7 is indicated. For patients with a history of raw seafood ingestion or foreign travel, the laboratory should be asked to screen specimens for Vibrio and Plesiomonas species. The report from the laboratory should specifically state what enteropathogens have been excluded, for example, "No Salmonella, Shigella, or Campylobacter isolated." A report of "negative" or "no enteric pathogens" is not very useful. Diagnosis of viral and parasitic enteritis and antibiotic-associated diarrhea require a variety of additional tests. Clinicians are encouraged to discuss these issues with the pathologist or microbiologist at their local laboratory and be familiar with community microbiology practice, particularly which organisms require a special request for the laboratory to attempt identification.

Bacterial Infections↗

PubMed2002

Proficiency testing for laboratories performing fluorescence in situ hybridization with chromosome-specific DNA probes.

OBJECTIVE: To assess laboratory performance, use, and limitations in the joint College of American Pathologists and American College of Medical Genetics proficiency testing program for laboratories performing cytogenetic tests based on fluorescence in situ hybridization (FISH). DATA SOURCES: Eight proficiency surveys dealing with FISH detection of microdeletions or microduplications, aneuploidy in interphase cells, gene amplification, and neoplasm-specific translocations. Participating laboratories used their own DNA probes (commercial or home-brew), hybridization methods, and analytic criteria to answer clinical questions about cases represented by slides included in the survey materials. They also described their test results according to the International System for Human Cytogenetic Nomenclature (ISCN) and answered supplementary questions relating to their experience with the subject test systems. DATA EXTRACTION: In addition to evaluating diagnostic accuracy, we evaluated survey use, laboratory experience, variation in methodologic approach, and the practicality of using ISCN nomenclature for describing test results. SYNTHESIS AND CONCLUSIONS: With the exception of one challenge, at least 80% of the participants reached the correct diagnostic conclusion. In the sole exception, there was still a consensus of 91.7% of participants with the same (albeit erroneous) diagnostic conclusion. The overall outstanding performance of participating laboratories clearly shows the reliability of current FISH methods. Despite the fact that a large number of laboratories reported little or no experience with the specific test systems, the overwhelming majority performed very well. This result shows that the program's strategy of targeting classes of abnormalities (vs a single abnormality associated with a specific disease) did not put at a disadvantage participants who did not routinely perform all of the potential tests in the class. The extraordinary variation in ISCN descriptions submitted by participants showed that the existing system for human cytogenetic nomenclature is not suitable for facile communication of FISH test results.

Chromosome Aberrations↗

PubMed2004

Comparative analytical costs of central laboratory glucose and bedside glucose testing: a College of American Pathologists Q-Probes study.

CONTEXT: One of the major attributes of laboratory testing is cost. Although fully automated central laboratory glucose testing and semiautomated bedside glucose testing (BGT) are performed at most institutions, rigorous determinations of interinstitutional comparative costs have not been performed. OBJECTIVES: To compare interinstitutional analytical costs of central laboratory glucose testing and BGT and to provide suggestions for improvement. DESIGN: Participants completed a demographic form about their institutional glucose monitoring practices. They also collected information about the costs of central laboratory glucose testing, BGT at a high-volume testing site, and BGT at a low-volume testing site, including specified cost variables for labor, reagents, and instruments. PARTICIPANTS: A total of 445 institutions enrolled in the College of American Pathologists Q-Probes program. MAIN OUTCOME MEASURE: Median cost per glucose test at 3 testing sites. RESULTS: The median (10th-90th percentile range) costs per glucose test were 1.18 dollars (5.59 dollars-0.36 dollars), 1.96 dollars (9.51 dollars-0.77 dollars), and 4.66 dollars (27.54 dollars-1.02 dollars) for central laboratory, high-volume BGT sites, and low-volume BGT sites, respectively. The largest percentages of the cost per test were for labor (59.3%, 72.7%, and 85.8%), followed by supplies (27.2%, 27.3%, and 13.4%) and equipment (2.1%, 0.0%, and 0.0%) for the 3 sites, respectively. The median number of patient specimens per month at the high-volume BGT sites was 625 compared to 30 at the low-volume BGT sites. Most participants did not include labor, instrument maintenance, competency assessment, or oversight in their BGT estimated costs until required to do so for the study. CONCLUSIONS: Analytical costs per glucose test were lower for central laboratory glucose testing than for BGT, which, in turn, was highly variable and dependent on volume. Data that would be used for financial justification for BGT were widely aberrant and in need of improvement.

Blood Glucose↗

PubMedDate not supplied

The integration of molecular diagnostic methods into the clinical laboratory.

Since the advent of the polymerase chain reaction in the mid-1980s, molecular diagnosis has become an important component of the services offered by many clinical laboratories. This presentation reviews selected applications of molecular methods in various sections and specialties of the clinical laboratory, and assesses the intellectual and technical qualifications and resources that traditional clinical laboratories can bring, and are bringing, to performance of molecular diagnostic tests. Special requirements for performance of molecular assays, in terms of both technical matters and clinical approaches, are also considered. Finally, attention is given to several contemporary factors that are tending to slow growth of molecular diagnosis in the clinical laboratory, and to other factors that are having a contrary effect, tending to promote growth in this area. A decision by an individual laboratory concerning the extent of its participation in molecular diagnosis should be based on recognition of the essential requirements for satisfactory performance of molecular testing, and a realistic appraisal of the laboratory's ability to meet these requirements.

Clinical Laboratory Techniques↗

PubMedDate not supplied

The reemergence of the hospital-based laboratory.

The Reference Laboratory Alliance (RLA) in Pittsburgh is an example of multiple hospital laboratories integrated for the purpose of delivering competitive outpatient laboratory services in a managed-care environment. Developed in 1994, the RLA model includes a "virtual" core laboratory (comprising four tertiary care centers of excellence) and a distributed network of more than 30 community hospitals. Linked through information systems, logistics, and an extensive committee structure, the RLA is capable of delivering a "seamless" service to the region's managed-care organizations. In its first full year of operation, the RLA is expected to shift between $12 and $15 million worth of laboratory activity back into the community's hospitals. Through its pathology component, the RLA is now actively engaged in redefining the role of the clinical laboratory in the managed-care environment.

Community Networks↗

PubMedDate not supplied

Career choices and professional attitudes of graduating clinical laboratory science students: a nationwide survey.

OBJECTIVE: To conduct a nationwide survey of graduating clinical laboratory science students in order to gather descriptive data and to determine how graduates felt about their profession and what their career goals were for the next 5 years. DESIGN: Survey PARTICIPANTS: A total of 866 clinical laboratory science seniors from hospital-based and university-based clinical laboratory science programs in the United States. OUTCOME MEASURES: Results of questions designed to gather descriptive data and professional goals as well as scales measuring professional attitudes about various aspects of the clinical laboratory science profession. RESULTS: Respondents indicated a high level of satisfaction with their chosen profession as indicated by the positive ratings of their clinical laboratory science program and immediate and long-term employment goals. CONCLUSION: Graduating clinical laboratory science students displayed satisfaction with their profession as evidenced by their career choices immediately following graduation, their professional goals 5 years after graduation, and their responses assessing professional attitudes.

Attitude of Health Personnel↗

PubMedDate not supplied

A method for capitation rate calculation using financial data readily available to the laboratory manager.

The advent of managed care has expanded the universe of information needed by laboratory administration to properly manage a clinical laboratory. This article presents a method for calculating proposed capitation rates for laboratory services using financial information that is readily available to the laboratory manager. Having this information is essential before entering into negotiations with a managed care organization and also gives the manager information regarding the laboratory's competitive position in relation to market capitation rates. Once a cost-based capitation rate is determined, laboratory administration must assess whether or not to pursue the contract and how it can be consummated. This article briefly outlines questions to consider in determining whether and how to proceed in contracting with a managed care organization and the ongoing analysis that is required after the contract is won.

Capitation Fee↗

PubMedDate not supplied

Tracing our roots: origins of clinical laboratory science.

OBJECTIVE: To trace the roots of clinical laboratory science by explaining how women initially gained access to scientific work and to describe the emergence of clinical laboratories. DESIGN: A survey of literature on the history of clinical laboratory science was conducted. References consulted include various books and professional journals. CONCLUSION: The origin of the field of clinical laboratory science can be traced to the early 1900s. Between 1890 and 1910, women were able, for the first time, to pursue careers in scientific professions, clinical laboratories became established in hospitals, and the clinical utility of laboratory tests became more widely recognized by physicians.

Clinical Laboratory Techniques↗

PubMedDate not supplied

From student laboratory to clinical environment.

OBJECTIVE: To describe a clinical laboratory practice simulation experience for clinical laboratory science (CLS) students which was intended to improve the transition from the student laboratory to the clinical environment. SETTING: University of Kentucky Center for Rural Health, a rural health professions education center for a state-assisted institution. PRACTICE DESCRIPTION: Baccalaureate-level CLS program. PRACTICE INNOVATION: Clinical laboratory practice simulation experience allows students to become familiar with the clinical environment. It also allows faculty to assess student performance and to provide students with feedback in a controlled setting. MAIN OUTCOME MEASUREMENT: Perception of benefit from the simulation experience by CLS graduates. RESULTS: CLS graduates report the simulation experience helped to prepare them for practice in the clinical environment. CONCLUSION: Clinical laboratory simulation can improve the transition to actual clinical laboratory practice and is a valuable tool to evaluate pre-clinical deficiencies.

Chemistry, Clinical↗

PubMed1999

[The future of clinical laboratory database management system].

To assess the present status of the clinical laboratory database management system, the difference between the Clinical Laboratory Information System and Clinical Laboratory System was explained in this study. Although three kinds of database management systems (DBMS) were shown including the relational model, tree model and network model, the relational model was found to be the best DBMS for the clinical laboratory database based on our experience and developments of some clinical laboratory expert systems. As a future clinical laboratory database management system, the IC card system connected to an automatic chemical analyzer was proposed for personal health data management and a microscope/video system was proposed for dynamic data management of leukocytes or bacteria.

Clinical Laboratory Information Systems↗

PubMed1999

Computerized material management, inventory control, and purchase orders in the clinical laboratory.

The management of supplies, purchase orders, and equipment is of critical importance to the operation of the clinical laboratory. The InvMan software program has reduced hands-on time for performing the counting of inventory and the time required to generate purchase orders. These changes save the laboratory about $11,170 per year in personnel costs. While the use of a structured system does impose some constraints on the user, the program has helped the laboratory organize all of its supply, vendor, location, PO, and equipment data. It has allowed the laboratory to respond more rapidly and accurately to inquiries related to inventory. The varied functions of InvMan provide flexibility to the laboratory and permit it to define the inventory as best fits a particular situation. The application is well suited to its target audience. The program has performed well, allowing the laboratory to make significant improvements to its material management system.

Computers↗

PubMedDate not supplied

Access to laboratory testing: the impact of managed care in the Pacific Northwest.

Patient access to health-care services has become an important issue owing to the growth of managed care organizations and the number of patients enrolled. To better understand the current issues related to access to laboratory testing, with a particular focus on the impact of managed care, we gathered information from a network of clinical laboratories in the Pacific Northwest. Two questionnaires were sent to the 257 Laboratory Medicine Sentinel Monitoring Network participants in November 1995 and March 1996 to investigate trends in the availability and utilization of laboratory testing services and changes in onsite testing menus. Although laboratories reported that managed care was a factor in their decisions about laboratory practices, testing decisions were more likely made for business reasons, based on medical practice changes and marketplace influences not associated with managed care.

Clinical Laboratory Techniques↗

PubMed2000

Developing an automation concept that is right for your laboratory.

BACKGROUND: Trends in laboratory automation and critical project principles and design concepts are presented. APPROACH: MDS AutoLab technology development and automation projects were reviewed. Successful methods and approaches were extracted. ISSUES: Continued pressure on the laboratory to reduce costs and increase productivity has catalyzed dramatic development in laboratory automation. Today, laboratories can choose from a wide range of options. The most effective choices are not always the most obvious and will not be the same for all laboratories. Laboratory automation projects are highly complex and must be planned and managed across clinical, technical, operational, financial, and human dimensions. CONCLUSIONS: Success requires excellent communications, an understanding of the risks and barriers, and a dedicated team supported by strong champions throughout the organization. The automation project team will need to use a variety of skills and techniques to evaluate and reengineer processes to identify the highest value targets for automation.

Automation↗

PubMed2000

Bioterrorism and the importance of the public health laboratory.

Biological terrorism is a threat to the United States that public health laboratories cannot afford to ignore. With the ability to recognize unusual strains of organisms, or an increase in test requests or isolation of specific organisms, the public health laboratory can detect the beginning of an outbreak. The laboratory can also facilitate appropriate response measures with rapid diagnostic testing and by determining antibiotic resistance patterns. Public health laboratory personnel need to assess their capabilities, improve them where indicated, and know where to turn for assistance. As improvements in bioterrorism detection occur in the civilian sector, military laboratories must integrate with local, state, and federal health department systems. Laboratories are essential components in surveillance, recognition, and response for both bioterrorism and naturally occurring disease outbreaks.

Biological Warfare↗

PubMed2000

Determining clinical laboratory science curriculum for the 21st century.

OBJECTIVE: To conduct a study to show possible differences in clinical laboratory science (CLS) education in relation to knowledge and skill levels deemed most important to job performance success of entry bench level CLS practitioners as determined by laboratory supervisors. Information gained from the study may indicate areas of program curriculum needing revision, or the incorporation of subject areas not presently offered. DESIGN: Survey. PARTICIPANTS: CLS educators from 100 different hospital-based and university-based CLS programs, and medical laboratory departmental supervisors from 209 different hospital laboratories. OUTCOME MEASURES: An analysis of the data from the survey consisted of individual item percentages generated by both surveys and a comparison of tasks deemed highly important by supervisors with class time estimates devoted to those tasks. RESULTS: The study indicated differences between what supervisors viewed as important knowledge and skills of entry bench level CLSs and the amount of class time devoted to those subjects by CLS educators. CONCLUSIONS: To ensure continuing professional credibility, additional study will be needed regarding the education and practice of CLSs as automation, emerging technologies, and laboratory restructuring will continue to change the laboratory environment.

Curriculum↗