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Length of time to laboratory diagnosis of Mycobacterium tuberculosis infection: comparison of in-house methods with reference laboratory results.

OBJECTIVES: To audit the time taken to obtain laboratory confirmation of infection with Mycobacterium tuberculosis using in-house methods of polymerase chain reaction (PCR) and culture and referral to a reference laboratory. METHODS: Retrospective collection of data from laboratory records covering a period of 1 year. RESULTS: Median time to microbiological diagnosis of a new infection using the in-house services in addition to the reference laboratory was 22.0 days. Using reference laboratory results alone, median time to diagnosis would have been 61.5 days. CONCLUSIONS: Development of on-site laboratory facilities to identify Mycobacterium tuberculosis can reduce the time to its identification by almost two-thirds.

Clinical Laboratory Techniques↗

Allergy to laboratory animals in laboratory technicians and animal keepers.

The prevalence of allergy to laboratory animals (LAA) was investigated in laboratory technicians and animal keepers. In a questionnaire 41 of 101 technicians reported symptoms provoked by work with laboratory animals. On clinical investigation 30 were found to have symptoms and signs related to contact with animals, and allergy was confirmed by radioallergosorbent tests (RAST) and skin tests in 19. All had rhinitis and 10 also had bronchial asthma. Forty seven other technicians who had stopped working with laboratory animals showed the same relative numbers of respiratory tract symptoms and of confirmed allergy to laboratory animals as did those currently handling animals. Seven of 23 animal keepers had work related symptoms. LAA symptoms were found in four and confirmed animal allergy in two. All four animal keepers with animal related symptoms had rhinitis, none had bronchial asthma. Positive animal RAST and skin tests were found only among people with animal related symptoms. A history of atopic disease was commoner among those with positive animal test results than among those with negative test results. No relation between smoking and the development of allergy to laboratory animals emerged. Simple prophylactic measures often sufficed to help technicians with animal related symptoms to remain at work.

Adult↗

Viability testing of material derived from Mycobacterium tuberculosis prior to removal from a containment level-III laboratory as part of a Laboratory Risk Assessment Program.

BACKGROUND: In the field of clinical mycobacteriology, Mycobacterium tuberculosis (MTB) can be a difficult organism to manipulate due to the restrictive environment of a containment level 3 (CL3) laboratory. Tests for rapid diagnostic work involving smears and molecular methods do not require CL3 practices after the organism has been rendered non-viable. While it has been assumed that after organism deactivation these techniques can be performed outside of a CL3, no conclusive study has consistently confirmed that the organisms are noninfectious after the theoretical 'deactivation' steps. Previous studies have shown that initial steps (such as heating/chemical fixation) may not consistently kill MTB organisms. METHODS: An inclusive viability study (n = 226) was undertaken to determine at which point handling of culture extraction materials does not necessitate a CL3 environment. Four different laboratory protocols tested for viability included: standard DNA extractions for IS6110 fingerprinting, crude DNA preparations for PCR by boiling and mechanical lysis, protein extractions, and smear preparations. For each protocol, laboratory staff planted a proportion of the resulting material to Bactec 12B medium that was observed for growth for 8 weeks. RESULTS: Of the 208 isolates initially tested, 21 samples grew within the 8-week period. Sixteen (7.7%) of these yielded positive results for MTB that included samples of: deactivated culture resuspensions exposed to 80 degrees C for 20 minutes, smear preparations and protein extractions. Test procedures were consequently modified and tested again (n = 18), resulting in 0% viability. CONCLUSIONS: This study demonstrates that it cannot be assumed that conventional practices (i.e. smear preparation) or extraction techniques render the organism non-viable. All methodologies, new and existing, should be examined by individual laboratories to validate the safe removal of material derived from MTB to the outside of a CL3 laboratory. This process is vital to establish in house biosafety-validated practices with the aim of protecting laboratory workers conducting these procedures.

Clinical Laboratory Techniques↗

Total laboratory automation can help eliminate the laboratory as a factor in emergency department length of stay.

We obtained data on laboratory turnaround time (TAT) and emergency department (ED) length of stay (LOS). We correlated potassium test TAT outlier percentage (TAT-OP) with ED LOS and found that for each outlier percentage (potassium result > 40 minutes), a projected impact on ED LOS was approximately 2.8 additional minutes (ED LOS = 2.79 TAT-OP + 78.77). To address this issue, we began implementation of a totally automated chemistry system to decrease TAT-OPs. Our TAT means did not change substantially with automation (potassium, 28 to 27 minutes); however, TAT-OPs decreased substantially (potassium, 18% to 5%). Preautomation average ED LOS correlated best with the TAT-OP (r(2) = 0.98; P = .01), but this relationship weakened substantially after automation (r(2) = 0.29; P > .05), suggesting the laboratory was no longer a factor in ED LOS. The postautomation ED LOS correlated best with ED patient volume (r(2) = 0.88; P = .06). Although laboratories have focused on TAT means for performance assessment, our study suggests TAT-OPs are more clinically relevant benchmarks. Furthermore, our findings suggest that total laboratory automation can effectively improve overall laboratory service reliability and help eliminate the laboratory as a factor in ED LOS.

Autoanalysis↗

Evolving delivery systems for clinical laboratories: the Albany Medical Center Regional Laboratory Network.

The Albany Medical Center is a not-for-profit institution consisting of the Albany Medical College and the Albany Medical Center Hospital. Before 1989, the college's pathology department was not affiliated with the clinical laboratories of the hospital and no regional laboratory program existed. Subsequent to 1989, with the recruitment of a new chairman of the department of pathology, the department and the clinical laboratories of the hospital merged to create the Department of Pathology and laboratory Medicine. The strategic plan for the redesign included goals to respond to new opportunities and seek new contracts in the community, to enhance the efficiency within the clinical laboratories, and to increase the volume of anatomic pathology specimens. The newly formed department decided to explore the opportunities to work with hospitals, physician groups, and insurers in the area to create a regional laboratory network. This article describes how changes were implemented, including some of the problems that were encountered. An assessment of the result evaluates the success of the network and discusses its future direction.

Academic Medical Centers↗

A survey measuring the degree of model compliance plan for clinical laboratories implementation in small/rural hospital laboratories.

The Office of the Inspector General published the Model Compliance Plan for Clinical Laboratories (MCPL) in February 1997. In March and April 1998, a survey of 200 Midwest hospital laboratory managers (hospital size < or = 200 beds) was performed to determine the degree to which their laboratories had implemented the various recommendations of the MCPL. Of the 200 surveys sent out, 76 were returned--a 38% response rate. Aspects of the survey were broken down into two categories: "Laboratory Manager Responsibility," those items that can be implemented independently by the laboratory manager; and "Administration Responsibility," those items requiring administration's direction. With the exception of rewriting job descriptions to include compliance issues, > or = 75% of the laboratory managers have implemented the items within their power.

Data Collection↗

[Standardization of laboratory data: verification of inter-laboratory data variations].

Standardization of clinical laboratory and compatible clinical data is needed for accurate diagnosis in routine medical practice or medical care. An external quality survey program in clinical laboratory testing and recommendation methods for laboratory test and/or standard materials are proposed. The Japan Society for Clinical Chemistry established guidelines to determine the activity of serum enzymes and other materials. JCCLS established a new project, the Committee for Investigation of Standardization of Laboratory Testing. It has three columns and column two is the verification of inter-laboratory variations. Sixteen institutions in 2004 and 40 in 2005 were enrolled in this program. The current inter-laboratory variations are discussed.

Clinical Laboratory Techniques↗

Current status and future options for the development of laboratory animal technology and the training of laboratory animal technicians.

Laboratory animal technology has evolved into a specialised field of expertise which is associated with the production, care and use of laboratory animals in biomedical teaching and research. A survey of laboratory animal facilities and supporting personnel was undertaken to assess the uses of laboratory animals in relation to the administrative and technical staffing of animal facilities. The results of this study indicate that there is a need for training in laboratory animal science at both the technical and professional levels. Options for the development of formal training in laboratory animal technology are reviewed.

Academies and Institutes↗

Medical laboratory audit: performance of twelve selected laboratories in metropolitan Enugu, Nigeria.

The abilities of 12 medical diagnostic laboratories situated in Enugu metropolis to estimate haemoglobin concentration accurately and precisely, by the cyanmethaemoglobin photometric method, were assessed. Nine (75%) of these laboratories showed good precision. Three (25%) were imprecise. As assessed by variance index (VI), only 5 (8.3%) of the entire haemoglobin results obtained from the participating laboratories showed good excellent accuracy (VI = 0 < or = 0.5). Conversely, 16 (26.7%), 9 (15%) and 30 (50%) of the entire haemoglobin results were satisfactory (VI > 0.5 - 1), acceptable (VI > 1 - 2) and rejectable (VI > 2) respectively. Furthermore, only 4 (33.3%) of the laboratories produced haemoglobin results that were both accurate and precise. Non-compliance with desirable practices that ensure quality of laboratory determinations were observed as possible contributing factor to this rather poor performance. The latter underscores the need for institution of external quality control laboratories in Nigeria.

Hemoglobins↗

[Current state and problems in the microbiology laboratory--organizing the laboratory].

The microbiological laboratory in the hospital has many roles including the rapid and precise identification of pathogenic bacteria in specimens, their antimicrobial susceptibility tests, microbial antigen detection using immunological methods and DNA hybridization methods, surveillance of bacterial milieu of the hospital environment, monitoring quality control of microbiological methods, to educate microbiological skills of staffs, the economical management of laboratory and so on. The last two issues are our major concerns. Improvement of the microbiological skills of the staff is most important in the laboratory, but is a time-consuming. From our experience, a technical expert, intermediately skilled technicians and beginners should always work in the laboratory, together. On the other hand, the economical management of the microbiological laboratory is also another concern. Although the mechanization of procedures comes to mind, it is hard to improve the economical conditions in the laboratory. Because of the control of the machines is not completely automatic and requires the knowledges and decisions of technical experts, the work force and running cost can not be reduced. As the technical expert can economize in the use of media or tests for identification of pathogens, good training of beginners into skillful successors, is important.

Humans↗

Laboratory managers' perceptions of the impact of teaching on the clinical laboratory.

OBJECTIVE: To determine managers' perceptions of the impact of teaching students on the clinical laboratory, including: productivity, costs, recruitment/new employee orientation, staff morale/attitude, and staff professionalism. Managers' views on responsibility for teaching and reasons for not having students were also determined. DESIGN: Written survey, randomized sampling. PARTICIPANTS: Five hundred laboratory managers certified by the National Credentialing Agency. MAIN OUTCOME MEASURES: Participants completed a forced-choice written survey consisting of demographic information and statements assessing the impact of teaching. RESULTS: Managers agreed with impact statements on professionalism, recruitment, and new employee orientation. They were also in agreement that clinical teaching is essential. Neutral responses were obtained for impact statements related to laboratory productivity, costs, and staff morale and attitude. Over 90% of respondents who presently had students or who had had students at one time indicated that they hired their graduates. CONCLUSIONS: Laboratory managers understand the importance of clinical education and the benefits to recruitment, new employee orientation, and staff professionalism. Managers are undecided about the effects of teaching on laboratory costs and staff productivity.

Administrative Personnel↗

The laboratory test justified. An effective means to reduce routine laboratory testing.

In an attempt to reduce clinical laboratory testing, a strategy was designed for a clinician-oriented restriction policy imposed on the laboratory test-ordering mechanism. The program examined the requirement of a written justification to accompany test requests. Directed justification, where specified conditions were required for test performance, was applied to the prothrombin and partial thromboplastin times and resulted in a mean reduction of 44% (P less than 0.001) in these tests; a nonspecific justification directive for leukocyte differentials, where any clinical condition listed generated the test, reduced differentials 35% (P less than 0.001). The justification policy then was extended more broadly and applied on a trial basis to general medical wards. Although no review was made on validity of listed test rationalizations, the justification process alone significantly reduced four common laboratory tests from 28% (BUN/creatinine) to 45% (electrolytes); significant reductions were not seen in less frequently ordered tests. The authors concluded that the most common clinical laboratory tests may be reduced by demanding that the clinician perform a clerical justification when requesting these tests. This mild restrictive policy in the ordering process allows the clinician to maintain responsibility over laboratory testing, while effectively reducing laboratory volume.

Attitude of Health Personnel↗

Health Care Financing Administration/American Society for Cytotechnology inspections: government assessment of cytology laboratory practice under the regulations of the Clinical Laboratory Improvement Amendments of 1988.

Since 1988, the American Society for Cytotechnology has performed inspections of 206 cytology laboratories in the United States under contract to the Health Care Financing Administration. These surveys are conducted by a team of supervisory-qualified cytotechnologists, including a specially trained survey team leader. A board-certified anatomic pathologist is assigned to each team and is on call for each survey. Laboratories are assessed for compliance with the regulations of the Clinical Laboratory Improvement Amendments of 1988 and, in particular, the area of quality control in cytology. These surveys are unique in that a sample of at least 0.1% of a laboratory's annual case volume is reevaluated by the survey team. Of the 206 laboratories surveyed, 116 were found to be in substantial compliance with the regulations while 90 were found to have Condition level deficiencies. Of those with Condition level deficiencies, 8 have had their Clinical Laboratory Improvement Amendments of 1988 certificates limited for cytology, and 16 have been terminated from Medicare participation.

Accreditation↗

College of American Pathologists Conference XXXI on laboratory monitoring of anticoagulant therapy: laboratory monitoring of oral anticoagulant therapy.

OBJECTIVE: To review the state of the art of laboratory monitoring of oral anticoagulant therapy, as reflected by the medical literature and the consensus opinion of recognized experts in the field, and to make recommendations for improvement in laboratory monitoring of oral anticoagulant therapy. DATA SOURCES: Review of the medical literature, primarily from the last 10 years, and current laboratory practices by a panel of 8 international experts in the field of oral anticoagulant monitoring. DATA EXTRACTION AND SYNTHESIS: After an initial assessment of the literature, key points were identified. Experts were assigned to do an in-depth review of the literature and current practices relevant to each of the key points and to prepare a summary of their findings and recommendations. A draft manuscript was prepared and circulated to every participant in the College of American Pathologists Conference XXXI on Laboratory Monitoring of Anticoagulant Therapy prior to the conference. Each of the key points and associated recommendations was then presented for discussion at the Conference. Recommendations were accepted if a consensus of the 26 experts attending the Conference was reached. The results of the discussion were used to revise the manuscript into its final form. CONCLUSIONS: Consensus was reached on 12 recommendations concerning the laboratory monitoring of oral anticoagulant therapy. Detailed discussion of the rationale for each of these recommendations is found in the text of this article. Discussion of points on which consensus was not reached is also included in the text. It is hoped that widespread adoption of these recommendations will further improve the laboratory monitoring of oral anticoagulant therapy.

Administration, Oral↗

The laboratory workstation: a data management model for a small laboratory section.

Many small sections of clinical chemistry laboratories fail to benefit fully from laboratory information system (LIS) installation because the volume does not justify cost of interfacing the instruments in these sections to the LIS. The opportunity for manual data entry errors remains a problem in these sections. This paper describes the design of a laboratory workstation that serves as a data hub that makes it feasible to use one instrument interface line from the LIS to acquire data from four instruments. This approach reduces the likelihood of data entry error and improves the efficiency of personnel in the laboratory section. Further, the tools necessary to create such a workstation are commercially available and do not depend on microcomputer programming and support personnel within the chemistry laboratory.

Chemical Phenomena↗

Cost and quality control of laboratory services: the New York City medicaid centralized laboratory proposal.

Faced with constantly increasing costs for the provision of laboratory services to Medicaid recipients, the New York City Department of Health last year attempted to implement a program to fundamentally restructure the organizational patterns and financing mechanisms of New York City's clinical laboratory industry. The program, based on competitive bidding, gave one laboratory in each of New York's five boroughs exclusive rights to process Medicaid lab samples and replaced presently existing fee-for-service reimbursement mechanisms with a unique system combining unit pricing and capitation. This paper outlines the principal provisions of the City's proposed contract, analyzes the underlying motivations of the City's decision, and describes the reactions of the existing laboratory service delivery system. In addition, the generic problems of implementing effective administrative techniques for cost and quality control of laboratory services are discussed.

Clinical Laboratory Techniques↗