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At least 1,369 records · Page 76Linked to original sources
PubMed1999

Laboratory surveillance of Shigella dysenteriae type 1 in KwaZulu-Natal.

OBJECTIVE: To collect data on the antimicrobial susceptibility of Shigella dysenteriae type 1 in KwaZulu-Natal, including the testing of newer therapeutic agents, and to evaluate the ability of laboratories to participate in a provincial surveillance programme. DESIGN: Prospective descriptive study. SETTING: Hospital laboratories in KwaZulu-Natal, including peripheral laboratories and the medical microbiology laboratory of the University of Natal. MAIN OUTCOME MEASURES: Antimicrobial susceptibility pattern of surveillance strains and evaluation of the ability of provincial laboratories to isolate Shigella. RESULTS: All 354 strains tested were resistant to ampicillin, chloramphenicol and tetracycline. Co-trimoxazole resistance was found in 92.2% of strains, and 0.8% of strains were resistant to nalidixic acid. All strains were susceptible to ceftriaxone, ciprofloxacin, ofloxacin, pivmecillinam, azithromycin, loracarbef and fosfomycin. Of the 29 laboratories surveyed, 18 (62.1%) were able to isolate and identify S. dysenteriae correctly, and 9 (32%) were able to serotype it further to S. dysenteriae type 1. Twenty-seven (93.1%) had appropriate culture media and 26 (89.7%) had antisera for Shigella identification. CONCLUSIONS: There is little variation among strains of S. dysenteriae type 1 in KwaZulu-Natal with regard to their antimicrobial susceptibility pattern. Nalidixic acid should remain the antimicrobial of choice for treatment of dysentery in our region as resistance to it is low. The majority of KwaZulu-Natal laboratories have the expertise and equipment to perform the isolation and identification of Shigella species.

Anti-Bacterial Agents↗
PubMedDate not supplied

Hazardous waste disposal and the clinical laboratory.

Negligent, unregulated hazardous waste management has resulted in real and potential threats to public health and safety. The federal government has responded with laws and regulations aimed at the producers of hazardous waste, including clinical laboratories. Clinical laboratory managers must understand how the requirements apply to their facilities and how to comply with them, or risk violating the law. The Resources Conservation and Recovery Act (RCRA) imposes controls on hazardous waste management through the Code of Federal Regulations (CFR). The Environmental Protection Agency (EPA) and the Department of Transportation (DOT) regulate these activities through 40 CFR and 49 CFR, respectively. 49 CFR specifies the characteristics of hazardous waste and lists more than 400 toxic chemicals, including several commonly used in clinical laboratories. Laboratories must conduct chemical inventories to determine if they should obtain an EPA identification number as a hazardous waste generator. Most clinical laboratories can operate satellite accumulation points and accumulate, store, transport, and dispose of waste in accordance with EPA and DOT regulations. Regulations pertaining to infectious waste, sure to affect many clinical laboratories, are being developed now by the EPA. The tracking system mandated by the federal government can be supplemented by state and local authorities and poses a significant regulatory challenge to clinical laboratory managers.

Facility Regulation and Control↗
PubMed1990

On-line, on time. A centralized laboratory information system speeds the results.

Catholic Medical Center of Brooklyn and Queens (CMC), Jamaica, NY, is a multihospital system that is concerned with providing a more cost-effective method of delivering healthcare in an urban environment. To reach this goal CMC centralized its laboratory services to save time, cut costs, and ultimately improve patient care. The centralized laboratory's manual delivery and tracking system put in place at first appeared to hinder the success of the centralized laboratory concept. Through a detailed planning and review process, CMC then implemented a multihospital laboratory information system to allow the centralized laboratory (1) to electronically access patient information from any on-line hospital and (2) to transmit test results back to the originating hospital. CMC believed the automated system would improve the quality of care, reduce the number of duplicated tests, eliminate late charges, and reduce the length of a patient's hospital stay. Since the implementation of the laboratory management system, its member hospitals agree that CMC has finally begun to realize the full benefits of its centralized laboratory services.

Centralized Hospital Services↗
PubMed1997

Protecting the integrity of clinical laboratory test results.

The authors' inspection reports demonstrate that the improper alteration of patient data is not a rare aberration in private commercial clinical laboratories. Although laboratory surveyors could be trained to recognize this problem, the availability of unprotected test systems makes even trained inspectors ineffectual. Both regulatory agencies and professional accrediting agencies should be concerned that their surveyors may be placing a seal of approval on what are, in reality, compromised or even fabricated data. In proposing the regulations discussed in this paper, the FDA sought to "preserve the integrity of the agency's enforcement process." This goal will remain unattainable, however, until a mechanism has been devised to secure the original raw data produced by all of the analytical systems being used not only in clinical laboratories but also in environmental laboratories, pharmaceutical laboratories, etc. Laboratories, as well as regulatory agencies and accrediting bodies, need to be concerned on behalf of the patient, but laboratories may also need to be concerned on their own behalf. In the coming era of unprecedented cost constraints and competitive bidding, unscrupulous testing facilities or groups of such facilities could have a significant edge over their conscientious competitors if the issues raised here continue to be ignored. Although the analytical data management systems provide tremendous benefits, some have serious problems in ensuring the security of their data. However, if regulatory agencies, accrediting bodies, professional organizations, and the analyzer vendors make a united commitment, the problem of securing the integrity of analytical data could eventually be resolved. It is hoped that such a commitment will be made in the near future.

Autoanalysis↗
PubMed1997

Approval of the Commission on Office Laboratory Accreditation for Immunohematology--HCFA. Notice.

This notice announces the approval of the Commission on Office Laboratory Accreditation (COLA), which is an accrediting organization for clinical laboratories under the Clinical Laboratory Improvement Amendments (CLIA) program, for the addition of the full specialty of immunohematology. This approval adds immunohematology to the specialties and subspecialties approved by HCFA in a notice published in the Federal Register on December 23, 1993 (58 FR 68148). We have found that the accreditation process of this organization provides reasonable assurance that the laboratories accredited by it for immunohematology meet the conditions required by Federal law and regulations. Consequently, laboratories that voluntarily become accredited by COLA for the specialty of immunohematology in lieu of receiving direct Federal oversight and continue to meet COLA requirements would meet the CLIA immunohematology condition level requirements for laboratories. These laboratories performing immunohematology testing are not subject to routine inspection by State survey agencies to determine their compliance with applicable Federal requirements. They are, however, subject to validation and complaint investigation surveys.

Accreditation↗
PubMed1992

Specific list for categorization of laboratory test systems, assays and examinations by complexity--PHS. Notice with comment period.

The Clinical Laboratory Improvement Amendments of 1988, Public Law 100-578, requires that the Secretary provide for the categorization of specific laboratory test systems, assays and examinations by level of complexity. 42 CFR 493.17, published in the Federal Register on February 28, 1992 established criteria for such categorization. It is the Department's intention to complete the categorization of all currently available clinical laboratory test systems, assays and examinations prior to the effective date of 42 CFR 493 (September 1, 1992). This notice announces the third of a series of lists containing specific clinical laboratory test systems, assays and examinations, categorized by complexity. Additional lists of test systems, assays and examinations by complexity will be published periodically. A complete list of all laboratory test systems, assays and examinations, categorized by complexity, will be published in the form of a compilation of these Notices. Any clinical laboratory test system, assay or examination that is not on the compilation list will be considered high complexity, until categorized otherwise as provided under 42 CFR 493.17. After publication of the compilation list, categorization or recategorization of laboratory test systems, assays and examinations will follow the procedures delineated in 42 CFR 493.17(c). After the effective date of 42 CFR 493, notices will be published periodically in the Federal Register to announce any additional test system, assay or examination that has been categorized (or re-categorized) during the preceding interval.

Clinical Laboratory Techniques↗
PubMed1992

Specific list for categorization of laboratory test systems, assays and examinations by complexity--PHS. Notice with comment period.

The Clinical Laboratory Improvement Amendments of 1988, Public Law 100-578, requires that the Secretary provide for the categorization of specific laboratory test systems, assays and examinations by level of complexity. 42 CFR 493.17, published in the Federal Register on February 28, 1992, established criteria for such categorization. It is the Department's intention to complete the categorization of all currently available clinical laboratory test systems, assays and examinations prior to the effective date of 42 CFR part 493. This notice announces the fourth of a series of lists containing specific clinical laboratory test systems, assays and examinations, categorized by complexity. This notice also includes deletions and corrections to the list of test systems, assays and examinations published on February 28, 1992. After publication and close of comment period on the published partial lists, a complete list of all laboratory test systems, assays and examinations, categorized by complexity, and responses to public comments received on the partial lists will be published in the form of a compilation of these Notices. Any clinical laboratory test system, assay or examination that is not on the compilation will be considered high complexity, until categorized otherwise as provided under 42 CFR 493.17. After publication of the compilation, applications will be taken to categorize (or re-categorize) other laboratory test systems, assays and examinations following the procedures delineated in 42 CFR 493.17(d). After the effective date of 42 CFR part 493, notices will be published periodically in the Federal Register to announce any additional test system, assay or examination that has been categorized (or re-categorized) during the preceding interval.

Clinical Laboratory Techniques↗
PubMedDate not supplied

Development of a computer simulation for laboratory planning.

OBJECTIVE: This study presents a description of a laboratory simulation model and how it can be used to aid in making management decisions for meeting laboratory personnel and instrumentation needs to provide the quality of health care desired. DESIGN: Observations were made and data recorded about resources from the appropriate areas in the laboratory. The computer model was developed using a simulation application program. The simulation was then run in three different configurations to obtain data on how changes in the laboratory may affect resource usage. SETTING: A 600-bed hospital laboratory was used as the model to collect initial data. MAIN OUTCOME MEASURES: Measurements were obtained for the effects of three different employee/instrument mixes to determine the effects of instrument utilization, employee workload, and specimen turn around time. RESULTS: The outcomes measured showed varying degrees of resource utilization versus processing times of specimens. CONCLUSION: Simulation can be an effective means of providing information to aid the laboratory manager in making decisions about resource needs in the clinical laboratory.

Chemistry, Clinical↗
PubMed1986

Interpretive reporting to improve the effectiveness of clinical laboratory test results. An ECRI technology assessment.

Interpretive reporting encompasses a range of efforts by the clinical laboratory community to develop improved methods of transferring information from laboratories to physicians in a form that they can understand and use. The purpose of laboratory tests is to provide clinically useful information that can be used to answer a specific question for the clinician. However, growing physician reliance on laboratory and other diagnostic tests and the increased testing volumes made possible by laboratory automation have yielded some unintended negative effects. Laboratories can now provide more information than can be effectively assimilated. The resulting "information overload" can cause clinicians to misinterpret tests, ignore significant results, or fail to act appropriately when results indicate a treatable condition. Research indicates, however, that interpretive reporting improves information transfer and thus increases clinicians' understanding of the significance of laboratory test results.

Artificial Intelligence↗
PubMed1999

[A consideration for the situation of the commercial laboratories and their connection with the medical administration in Japan].

The commercial laboratories in Japan have been serving all physicians to be able to use all laboratory tests even if they are newly developed. Though the commercial laboratories have functioned very well for clinically, for economically they have made a great margin between the official price which is decided by medical insurance and the business price which is dealt with hospitals. The margin and the margin from drugs have caused excess clinical testing and drug prescription, subsequent increase of total medical cost in Japan. We are going to revise our medical insurance system to improve various inconvenience in the present and future status. For the Japan Registered Clinical Laboratories Association which is the representative of the commercial laboratories, it's a time to cooperate with the other clinical laboratory tests-related organizations (ex. Japan Association of Medical Technologists, Japan Association of Clinical Laboratory Physicians, etc.) and to built new acceptable circumstances of the clinical testing corresponding to medical administration.

Japan↗
PubMed1999

Sputum examination for acid-fast bacilli in private laboratories, Kathmandu Valley, Nepal.

OBJECTIVE: To investigate the characteristics of private laboratories and the process of sputum examination for acid-fast bacilli (AFB). DESIGN: A door-to-door survey of private laboratories in an urban municipality of Kathmandu valley was conducted during the first quarter of 1998. Semi-structured interviews were conducted with staff of 14/20 (70%) identified laboratories. RESULTS: All 14 private laboratories conducted sputum examination for AFB. The majority (71%) of staff lacked special training for AFB examinations. Monocular microscopes were commonly used (36%). Reagents were prepared irregularly, without quality control, and kept for as long as they lasted, often up to 4-6 months (43%). Laboratory registers were usually present (86%), but lacked information on patient's address and the purpose of the test. A median of 12.5 slides per laboratory had been examined during the previous month (range 0-70). A total of 235 AFB slides were examined, of which 18 (7.7%) were reported as positive. CONCLUSION: AFB examinations were widely available. Lack of training and quality control suggest a variable standard of AFB test results. It is recommended that the National Tuberculosis Programme (NTP) provide support and quality control to two to three (i.e., one for every 10) private laboratories in the area to secure private doctors' confidence in sputum testing.

Humans↗
PubMedDate not supplied

The use of the Delphi panel for consensus development on indicators of laboratory performance.

The objective of this research study is to identify laboratory performance areas and indicators of performance from the perspective of key laboratory constituencies. A specific technique, the Delphi panel, is used to achieve consensus on a system of indicators that can be used by laboratory service managers to build information pathways, increase efficiency, and improve outcomes. Individual panels represented the five highest ranked stakeholder groups: hospital executives, managed care executives, referring physicians, laboratory regulators, and laboratory managers. The instruments used for the Delphi panels were developed and validated in a pilot study. After three rounds, each panel had identified a set of priority performance areas and indicators for each area. Although concurring that the Delphi was valuable and effective in identifying performance areas, participants indicated that it was less useful in developing specific indicators enabling monitoring of laboratory performance over time or cross-laboratory comparisons.

Consensus Statements as Topic↗
PubMed1999

[Reliability of results evaluation for the passive hemagglutination test in pertussis obtained from WSSE laboratories].

This study was undertaken for assessing of the reliability of the passive haemagglutination test with B. pertussis endotoxin in 18 laboratories of the Sanitary Epidemiological Stations. Each laboratory determined the level of pertussis antibodies in three serum samples twice, at interval of two weeks. The correct results were obtained in 7 laboratories (38.9%). The results of pertussis antibodies determination in only one or two samples were differed more than twice from correct in 5 additional laboratories; in this way the test was carried out satisfactorily in 12 laboratories (66.7%). Reproducibility of the results was good in 12 laboratories (66.7%). The study showed the necessity of repeated interlaboratory controls and periodic training of laboratory workers for raising of the quality and reliability of serological investigations for pertussis.

Hemagglutination Tests↗
PubMed2000

The state of public health laboratories.

Public health laboratories in the United States exist at the federal, state, and local level. The earliest laboratories were created in the late 1800s in the wake of the work of Robert Koch and Louis Pasteur. Currently, these laboratories make up a loosely formed network. The combined state portion of this network employs more than 6,000 staff members, tests more than 20 million specimens each year, and has a combined annual budget of more than $300 million. Public health laboratories are found in a variety of organizational settings. Several efforts have been made to define the roles of public health laboratories. Recently, the Association of Public Health Laboratories adopted a consensus position that has formally set forth the core functions, which include activities such as environmental testing, emergency response, surveillance, and reference services. Public health laboratories are being challenged with funding, new technology, and current issues such as bioterrorism, food safety, and antimicrobial resistance.

Communicable Diseases↗
PubMed2000

Laboratories and disease surveillance.

The U.S. communicable disease surveillance system depends on high-quality testing and reporting by clinical and public health laboratories (PHLs). Clinical laboratories offer a wide range of microbiological services, provide a large portion of all disease reports, and refer isolates and samples to PHLs for confirmation and typing. The PHLs support disease surveillance by providing special reference testing, serological or molecular typing to identify disease clusters and sources, primary laboratory services for high-risk clients, quality assurance and training for clinical laboratories, and testing for unique agents unavailable elsewhere. However, profound changes in the health care industry are threatening the ability of public- and private-sector laboratories to carry out disease surveillance activities. Isolates for typing and confirmation are less available, PHL surveillance testing volumes are lower, and relationships between clinical laboratories and PHLs have changed. The integrity of the U.S. disease control infrastructure depends on maintaining a complementary network of clinical and public health laboratories, and a national system for public health testing is needed.

Communicable Disease Control↗
PubMed1999

Hematology laboratory standardization: a plan for harmonization in Asia.

Hematology laboratory is generally required in the hospital. At the macroscale, hematology laboratories have served a large number of population. In Asia, more than 3,000 million people are potentially to use the hematology laboratory service, particularly the complete blood count. Since 1970s, automated technology has been introduced to Asia and as years passed by, technology diversity is increasing. However, there are considerable number of hematology laboratories that have no automated machine. They are still relied on manual technology which is still variable in spectrophotometer for hemoglobin determination, centrifuge for hematocrit and diluting pipet for cell counting. In particular, blood smear preparation and interpretation are very difficult to control for standardization from person to person and laboratory to laboratory. Different methodology and a large population in the huge geographical area in Asia, the agreement of standard criteria is greatly important. This report has shown strategy and action plan to reach the goal of hematology laboratory standardization in Asia.

Asia↗
PubMed2000

Updating the immunology curriculum in clinical laboratory science.

OBJECTIVE: To determine essential content areas of immunology/serology courses at the clinical laboratory technician (CLT) and clinical laboratory scientist (CLS) levels. DESIGN: A questionnaire was designed which listed all major topics in immunology and serology. Participants were asked to place a check beside each topic covered. For an additional list of serological and immunological laboratory testing, participants were asked to indicate if each test was performed in either the didactic or clinical setting, or not performed at all. SETTING: A national survey of 593 NAACLS approved CLT and CLS programs was conducted by mail under the auspices of ASCLS. PARTICIPANTS: Responses were obtained from 158 programs. Respondents from all across the United States included 60 CLT programs, 48 hospital-based CLS programs, 45 university-based CLS programs, and 5 university-based combined CLT and CLS programs. MAIN OUTCOME MEASURES: The survey was designed to enumerate major topics included in immunology and serology courses by a majority of participants at two distinct educational levels, CLT and CLS. Laboratory testing routinely performed in student laboratories as well as in the clinical setting was also determined for these two levels of practitioners. RESULTS: Certain key topics were common to most immunology and serology courses. There were some notable differences in the depth of courses at the CLT and CLS levels. Laboratory testing associated with these courses also differed at the two levels. Testing requiring more detailed interpretation, such as antinuclear antibody patterns (ANAs), was mainly performed by CLS students only. CONCLUSION: There are certain key topics as well as specific laboratory tests that should be included in immunology/serology courses at each of the two different educational levels to best prepare students for the workplace. Educators can use this information as a guide to plan a curriculum for such courses.

Allergy and Immunology↗
PubMed2000

The role of the clinical laboratory in managing chemical or biological terrorism.

BACKGROUND: Domestic and international acts of terrorism using chemicals and pathogens as weapons have recently attracted much attention because of several hoaxes and real incidents. Clinical laboratories, especially those affiliated with major trauma centers, should be prepared to respond rapidly by providing diagnostic tests for the detection and identification of specific agents, so that specific therapy and victim management can be initiated in a timely manner. As first-line responders, clinical laboratory personnel should become familiar with the various chemical or biological agents and be active participants in their local defense programs. APPROACH: We review the selected agents previously considered or used in chemical and biological warfare, outline their poisonous and pathogenic effects, describe techniques used in their identification, address some of the logistical and technical difficulties in maintaining such tests in clinical laboratories, and comment on some of the analytical issues, such as specimen handling and personal protective equipment. CONTENT: The chemical agents discussed include nerve, blistering, and pulmonary agents and cyanides. Biological agents, including anthrax and smallpox, are also discussed as examples for organisms with potential use in bioterrorism. Available therapies for each agent are outlined to assist clinical laboratory personnel in making intelligent decisions regarding implementation of diagnostic tests as a part of a comprehensive defense program. SUMMARY: As the civilian medical community prepares for biological and chemical terrorist attacks, improvement in the capabilities of clinical laboratories is essential in supporting counterterrorism programs designed to respond to such attacks. Accurate assessment of resources in clinical laboratories is important because it will provide local authorities with an alternative resource for immediate diagnostic analysis. It is, therefore, recommended that clinical laboratories identify their current resources and the extent of support they can provide, and inform the authorities of their state of readiness.

Animals↗