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PubMed2003

Personnel standards and quality assurance practices of biochemical genetic testing laboratories in the United States.

CONTEXT: It has been suggested that specific regulation of laboratories performing genetic testing may be needed to ensure standards and quality assurance, and to safeguard the rights of patients with regard to confidentiality and providing informed consent. Previously, a comprehensive analysis of current practices of molecular genetic testing laboratories was conducted, the results of which have assisted in the assessment of the need for regulation and its impact on access to testing. However, a study designed to determine clinical laboratory practices with regard to biochemical genetic testing has not been carried out. OBJECTIVE: To collect and analyze data regarding availability of clinical biochemical genetic testing, personnel standards, and laboratory quality assurance practices. DESIGN: A mail survey of biochemical genetic testing laboratory directors and assignment of a quality assurance score based on responses to genetic testing process items. SETTING: Hospital-based, independent, and research-based biochemical genetic testing laboratories in the United States. PARTICIPANTS: Directors of biochemical genetic testing laboratories (n = 133; response rate 68.5%). MAIN OUTCOME MEASURE: Laboratory process quality assurance score based on the standards defined by the American College of Medical Genetics Laboratory Practice Committee. RESULTS: Personnel qualifications varied, although all directors had doctoral degrees. The mean quality assurance score was 77% (range 28%-100%). Higher scores were associated with the following variables: test director having an MD degree versus PhD degree (P = .002), director board certification in biochemical genetics (P = .002), research and hospital laboratory versus independent laboratory setting (P < .001), and participation in a proficiency testing program (P = .03). Twelve percent of participants had a confidentiality policy, and 19% required informed consent before testing. CONCLUSION: The finding that a number of laboratories had quality assurance scores that may reflect suboptimal laboratory practices, particularly with regard to reporting practices, suggests that personnel qualification and laboratory practice standards may be in need of improvement to ensure quality in clinical biochemical genetic testing laboratories, as well as the appropriate clinical use of the test results.

Genetic Diseases, Inborn↗

PubMed1999

Exposure assessment of laboratory students.

The Massachusetts Institute of Technology (MIT) has two kinds of laboratories, teaching for undergraduate students and research laboratories for graduate students and research staff. The objective of this study is to determine chemical exposures during teaching and research activities. There are three hypotheses in this study: (1) Exposures in academic laboratories are well below health standards; (2) Students in undergraduate teaching laboratories have less chemical exposure compared to students in graduate research laboratories; and (3) Students in different disciplines are expected to have different exposures. From September 1996 to December 1996, 132 air samples were collected from both teaching and research laboratories in the departments of Material Sciences and Engineering, Chemical Engineering, and Biology. The most frequently sampled chemicals in these three departments were cobalt, styrene, and formaldehyde, respectively. A total of 23 different agents were measured. In this study, the American Conference of Governmental Industrial Hygienists (ACGIH) threshold limit value (TLV)-short-term exposure limit (STEL) is used as the health-effect standard for exposure time less than four hours. The ACGIH TLV-TWA (time-weighted average) is used as the standard for exposure times equal to or greater than four hours. The ratio of measured concentrations to the appropriate ACGIH standard was then calculated. The geometric mean of the ratio for the total samples was 0.34 percent of the standards. There were 70 samples from teaching laboratories (geometric mean = 0.38% of the standards), and 62 samples from research laboratories (geometric mean = 0.08% of the standards). The chemical exposures relative to the standards in teaching laboratories were statistically higher than in research laboratories (p-value < 0.001). Information about personal protective equipment and the use of laboratory chemical hoods was also collected. The differences in use of personal protective equipment (PPE) among these departments was not statistically significant. From the air sampling results, we concluded that (1) Chemical exposures in the academic laboratories in this study were all well below the health standards; (2) Undergraduate students in teaching laboratories had higher chemical exposures than graduate students in research laboratories; (3) Chemical exposures among departments were not significantly different; and (4) Hazard communication, safety training, and laboratory rules enforcement are important for protection and may be the reason that the results from this study indicate that chemical exposures in this academic institution are well below the health standards under normal operations.

Adolescent↗

PubMedDate not supplied

Required steps for the validation of a Laboratory Information Management System.

The task of managing laboratory data is not a new one. Over the past two decades, the use of Laboratory Information Management Systems (LIMS) has revolutionized how laboratories manage their data. A LIMS is more than software; it has become the workhorse of the laboratory, encompassing laboratory work-flow combined with user input, data collection, instrument integration, data analysis, user notification, and delivery of information and reporting. Types of organizations that utilize LIMS vary greatly from research laboratories to manufacturing laboratories to environmental testing laboratories. Commercially-available LIMS have been around since the 1980s. In addition, many laboratories have designed, implemented, and maintained in-house LIMS. The heart of any LIMS is the software. Like other laboratory systems, the LIMS software is subject to quality control and quality assurance checks. In regulatory environments this associated QA/QC is referred to as "system validation." The primary purpose of system validation is to ensure that the software is performing in a manner for which it was designed. For example, the system acceptance criteria should be established and tested against quantifiable tasks to determine if the desired outcome has been achieved. LIMS features, such as autoreporting, reproducibility, throughput, and accuracy must be quantifiable and verifiable. System validation ensures that the entire system has been properly tested, incorporates required controls, and maintains and will continue to maintain data integrity. Laboratories must establish protocols and standards for the validation process and associated documentation. Although vendors of commercial LIMS perform initial internal system validations, the system must be revalidated whenever the end user, vendor or third party adds modifications or customizations to the LIMS. Currently, detailed guidance regarding system validation of LIMS is not available to the user. The issue is addressed in Good Automated Laboratory Practices (GALP) and National Environmental Laboratory Accreditation Conference (NELAC) documents which indicate specific requirements or recommendations for operational checks and periodic testing; however, it is up to the laboratory to determine suitable methods to accomplish these tasks. Proper validation of a LIMS will allow a laboratory to comply with regulations and also provide comprehensive documentation on the system that is necessary to troubleshoot future problems.

Clinical Laboratory Information Systems↗

PubMed2000

Improvement in physician's office laboratory practices, 1989-1994.

BACKGROUND: In 1986 and 1989, the Centers for Disease Control and Prevention sponsored institutes on Critical Issues in Health Laboratory Practice. It was noted during the institutes that physician's office laboratories were a rapidly emerging site for clinical laboratory testing, yet no comprehensive data were available regarding the practice of clinical laboratory medicine in physician's office laboratories. As a mechanism to begin addressing this void, the Centers for Disease Control and Prevention added questions on clinical laboratory practice to the National Ambulatory Medical Care Survey, a national probability sample of ambulatory care provided by office-based physicians. Data were collected for survey years 1989, 1991, 1993, and 1994. METHODS: Each survey was conducted among a nationally representative, random sample of office-based physicians who provide ambulatory patient care. Sample physicians were enlisted using both mail and telephone contacts. Clinical laboratory data were obtained via telephone by trained field representatives. Weighted univariate and multivariate analyses were performed on responses from each of the 4 survey years. Analyses were repeated after combining survey responses from years 1989 and 1991 and 1993 and 1994 as representative of physician's office laboratory practices before and after implementation of the Clinical Laboratory Improvement Amendments of 1988 (CLIA '88) final rule in 1992. RESULTS: Quality laboratory practice indicators showed significant increases during the study interval, with implementation of the CLIA '88 final rule in 1992 playing a pivotal role. Relative to 1992, enrollment in proficiency testing programs increased from 32.4% to 52.7% (P<.001), use of daily quality control samples increased from 79.2% to 89.0% (P<.001), and use of daily quality control with written instructions for action following a questionable quality control result (quality control with action step documentation) increased from 62.6% to 77.2% (P<.001). The presence of a medical technologist or technician in the office laboratory was also significantly and independently associated with each of the quality indicators. Although the percentage of physician's offices performing on-site testing decreased from 56% to 45% during the survey interval, overall testing volume appeared unchanged. CONCLUSIONS: The quality of clinical laboratory practice in physician's office laboratories improved during the study interval (1989-1994) as measured by the quality indicators used in the study. The association of this improvement with implementation of the CLIA '88 final rule and the presence of a trained laboratory professional in the testing site indicate the importance of minimum practice standards and professional expertise in ensuring use of quality laboratory practices. Overall test volume appeared to be stable despite a decreased proportion of physician's offices at which on-site testing was performed.

Centers for Disease Control and Prevention, U.S.↗

PubMedDate not supplied

Development opportunities for hospital clinical laboratory joint ventures.

Regional health-care providers are being given the opportunity to collaborate in specialty health-care services. Collaboration to achieve superior economies of scale is very effective in the clinical laboratory industry. National laboratory chains are consolidating and enhancing their control of the industry to ensure their historic profitability. National companies have closed many laboratory facilities and have laid off substantial numbers of laboratory personnel. Health-care providers can regain control of their locally generated laboratory health-care dollars by joining forces with clinical laboratory joint ventures. Laboratorians can assist the healthcare providers in bringing laboratory services and employment back to the local community. New capital for operational development and laboratory information systems will help bring the laboratory to the point of care. The independent regional laboratory is focused on supporting the medical needs of the community. The profit generated from a laboratory joint venture is shared among local health-care providers, supporting their economic viability. The laboratories' ability to contribute to the development of profit-making ventures will provide capital for new laboratory development. All of the above will ensure the clinical laboratories' role in providing quality health care to our communities and employment opportunities for laboratory personnel.

Entrepreneurship↗

PubMed2000

Laboratory costs in the context of disease.

BACKGROUND: To determine the contribution of laboratory costs to the overall costs of managing hospital patients with different diseases, we studied the costs of laboratory testing overall and in relation to the other costs incurred during hospitalization. METHODS: We used a database developed by the University HealthSystems Consortium containing >1 million patients in 60 University Hospitals with diseases included in 486 diagnosis-related groups (DRGs). Laboratory costs included in the database comprised those associated with testing in the clinical laboratory together with those incurred in point-of-care testing and anatomic pathology but not those involving blood products and their transfusion. RESULTS: The mean laboratory costs to manage surgical patients were greater than those to manage medical patients in 19 of the 25 major diagnostic categories. The median laboratory costs for patients with liver transplants exceeded $8000, and the laboratory costs to support other organ transplants were among the highest. The highest proportion of total costs attributable to the laboratory was 18.3% for acute leukemia and kidney and urinary tract signs and symptoms, both in children. Laboratory costs were <1.0% of the total costs for only 15 DRGs. The highest median daily laboratory cost, $416, was attributable to liver transplant patients. Several conditions had median laboratory costs less than $30 per day, in spite of lengths of stay that exceeded 10 days in some cases. CONCLUSIONS: Although laboratory costs generally average 6% of the total costs for surgical conditions and 9% of the total costs for medical conditions, there is considerable variability. In general, laboratory costs were relatively poorly correlated with total costs. However, observation of high daily laboratory costs for many DRGs suggests that reducing length of stay would reduce both laboratory and total costs.

Costs and Cost Analysis↗

PubMed2002

Accreditation of clinical laboratories in the Philippines.

In order to assure the reliability of the results of laboratory services, clinical laboratories are regulated in the Philippines. This started with the passage of the Clinical Laboratory Law in 1965, which required the Licensing of clinical laboratories by the Bureau of Research and Laboratories, Department of Health (BRL, DOH) before they can operate. Standards were set for the various types of laboratory services. In 1988, the minimum standards of laboratory services were formulated for three categories, ie, primary, secondary and tertiary categories. Subsequently, to permit clinical laboratories to offer 'special service', accreditation of clinical laboratories was instituted. In 1968, the Philippine Society of Pathologists (PSP) decided to accredit clinical laboratories for Residency Training Program in Anatomic and Clinical Pathology. The following year after the passage of the Medical Technology Law, the BRL, DOH began accrediting clinical laboratories that trained Medical Technology Interns. A few years later, the BRL, DOH started to accredit clinical laboratories who did Water Analysis. In 1989, after realizing the serious implications of HIV Testing, the DOH mandated the BRL, DOH to set standards for clinical laboratories performing HIV testing. In 1997, upon request of the Philippine Health Insurance Corporation (PhilHealth), the PSP formulated and submitted standards for the accreditation of clinical laboratories, both hospital and free-standing, for reimbursement of fees for laboratory services rendered to patients enrolled in the PhilHealth social insurance program. In 2000, the Philippine Council for Accreditation of Healthcare Organizations (PCAHO) approved the Standards for the accreditation of Hospitals for the provision of quality medical services. Included were the standards for the Department of Pathology.

Accreditation↗

PubMed1992

Laboratory automation systems. An introduction to concepts and terminology.

The concept of laboratory automation has existed for years; such automation has been used primarily in nonclinical and industrial settings. The next step is to implement automation systems in the clinical laboratory. A laboratory automation system consists of robots, conveyor systems, machine vision, and computer hardware and software. Specimen movement and result reporting are based on the identification of specimens using bar coded specimens and bar coded specimen carriers. The implementation of a laboratory automation system is dependent on the presence of a laboratory information system. An interface between the laboratory information system and the laboratory automation system provides the information required to move the specimen through the laboratory. The reporting of results is dependent on the laboratory information system or manual input, depending on the type of work cell in which the results are produced. The greatest hurdle to overcome in developing and implementing a laboratory automation system is the integration of systems, including commercial laboratory instrumentation and user-defined work cells. The barriers to implementation primarily are proprietary in nature: instrument software and instrument hardware. When the instrument manufacturers realize the necessity for development of electronic and physical integration, the proliferation of laboratory automation systems will occur. Several opportunities exist for the reduction in laboratory expenses and the development of new positions, such as "robotechnologist," a staff member who would function in a manner similar to the current laboratory information systems manager. This article describes the author's concepts of laboratory automation.

Automation↗

PubMedDate not supplied

An analysis of reference laboratory (send out) testing: an 8-year experience in a large academic medical center.

BACKGROUND: Utilization of outside reference laboratories for selected laboratory testing is common in the United States. However, relatively little data exist in the literature describing the scope and impact of these services. In this study, we reviewed use of reference laboratory testing at the Massachusetts General Hospital, a large urban academic medical center in Boston, Massachusetts. METHODS: A retrospective review of hospital and laboratory administrative records over an 8-year period from fiscal years (FY) 1995-2002. RESULTS: Over the 8 years studied, reference laboratory expenses increased 4.2-fold and totaled 12.4% of the total laboratory budget in FY 2002. Total reference laboratory test volume increased 4-fold to 68,328 tests in FY 2002 but represented only 1.06% of the total test volume in the hospital. The menu of reference laboratory tests comprised 946 tests (65.7% of the hospital test menu) compared to 494 (34.3%) of tests performed in house. The average unit cost of reference laboratory tests was essentially unchanged but was approximately 13 times greater than the average unit cost in the hospital laboratory. Much of the growth in reference laboratory cost can be attributed to the addition of new molecular, genetic, and microbiological assays. Four of the top 10 tests with the highest total cost in 2002 were molecular diagnostic tests that were recently added to the test menu. CONCLUSION: Reference laboratory testing comprises a major component of hospital clinical laboratory services. Although send out tests represent a small percentage of the total test volume, these services account for the majority of the hospital laboratory test menu and a disproportionate percentage of laboratory costs.

Academic Medical Centers↗

PubMedDate not supplied

Tracing our roots: early clinical laboratory scientists and their work--myth and reality.

OBJECTIVE: To describe the 'real' and 'ideal' clinical laboratory scientist according to the perceptions of pathologists, clinical laboratory scientists, and the public during the early years of the profession (1918 to 1942). DESIGN: A survey of literature on the history of clinical laboratory science was conducted. References consulted include various books and professional journals. CONCLUSION: As early as 1920, young women learned, through career guides, that they were particularly well-suited for performing laboratory work because they possessed a unique set of attributes which were considered to be desirable qualities in a clinical laboratory scientist. In addition, magazine articles published in the popular press in the 1930s and 1940s romanticized laboratory technicians. Although later articles did present a more realistic description of the work of the laboratory technician, they continued to portray the occupation in idealistic terms. Pathologists and laboratory technicians also described the ideal laboratory technician in professional journals, citing those qualities that were essential or especially desirable in a competent laboratory technician. The relationship between the clinical pathologists and the laboratory technician was described as one of mutual interdependence and integration of responsibilities. In reality, pathologists maintained strict supervision and control over the work of laboratory technicians. The 'real' laboratory technician differed markedly from the 'ideal' prototype created by the public, pathologists, and by laboratory technicians, themselves.

Clinical Laboratory Techniques↗

PubMed2000

Laboratory automation: trajectory, technology, and tactics.

Laboratory automation is in its infancy, following a path parallel to the development of laboratory information systems in the late 1970s and early 1980s. Changes on the horizon in healthcare and clinical laboratory service that affect the delivery of laboratory results include the increasing age of the population in North America, the implementation of the Balanced Budget Act (1997), and the creation of disease management companies. Major technology drivers include outcomes optimization and phenotypically targeted drugs. Constant cost pressures in the clinical laboratory have forced diagnostic manufacturers into less than optimal profitability states. Laboratory automation can be a tool for the improvement of laboratory services and may decrease costs. The key to improvement of laboratory services is implementation of the correct automation technology. The design of this technology should be driven by required functionality. Automation design issues should be centered on the understanding of the laboratory and its relationship to healthcare delivery and the business and operational processes in the clinical laboratory. Automation design philosophy has evolved from a hardware-based approach to a software-based approach. Process control software to support repeat testing, reflex testing, and transportation management, and overall computer-integrated manufacturing approaches to laboratory automation implementation are rapidly expanding areas. It is clear that hardware and software are functionally interdependent and that the interface between the laboratory automation system and the laboratory information system is a key component. The cost-effectiveness of automation solutions suggested by vendors, however, has been difficult to evaluate because the number of automation installations are few and the precision with which operational data have been collected to determine payback is suboptimal. The trend in automation has moved from total laboratory automation to a modular approach, from a hardware-driven system to process control, from a one-of-a-kind novelty toward a standardized product, and from an in vitro diagnostics novelty to a marketing tool. Multiple vendors are present in the marketplace, many of whom are in vitro diagnostics manufacturers providing an automation solution coupled with their instruments, whereas others are focused automation companies. Automation technology continues to advance, acceptance continues to climb, and payback and cost justification methods are developing.

Automation↗

PubMed2006

[Validation of the ISO 15189 trial assessment results of clinical laboratories--effects of accreditation and interpretation of ISO 15189].

Japanese Committee for Clinical Laboratory Standards (JCCLS) and the Japan Accreditation Board for Conformity Assessment (JAB) have developed an accreditation program for clinical laboratories using ISO 15189 in Japan. On October 1, 2004, twelve clinical laboratories applied for trial accreditation assessment. Seven laboratories were selected, including a university hospital laboratory, two other hospital-based laboratories, three large private clinical laboratories and an other private clinical laboratory. JAB had given a one week-training course to the candidate technical assessors who were nominated from the Japanese Society of Laboratory Medicine (JSLM) and the Japanese Association of Medical Technologists (JAMT), and candidate system assessors who were nominated from JAB. Thirty-five members had successfully passed the examination. During the period from November 2004 to May 2005, five laboratories were visited for assessment by four to six assessors for two or three days. Final assessment reports were discussed by the program developing committee for the validation of the accreditation program. The conclusions were that the program did not have any critical problems, but the assessment visit would have been more efficient if JAB published an easily understandable guidance document on ISO 15189, and had some training courses for laboratories in Japan in order to understand ISO 15189 more deeply. In addition, JAB should develop a more simplified checklist, mainly describing the important requirements. JAB formally started the clinical laboratory accreditation scheme from August 1, 2005 and five laboratories were accredited by the newly started accreditation committee on August 31, 2005, and four laboratories were additionally accredited on November 28, 2005. The most difficult clauses in ISO 15189:2003 were 5.6.2 and 5.6.3 on uncertainty and traceability, and 5.7.1 on post-examination procedures. Some difficult clauses to understand in the International Standard were discussed.

Accreditation↗

PubMed1998

Accuracy and reproducibility of blood lead testing in commercial laboratories.

OBJECTIVE: To assess the proficiency of commercial laboratories in analyzing lead in clinical blood samples from subjects without overt lead exposure. DESIGN: We submitted masked duplicate blood lead specimens to 8 masked laboratories. Each laboratory received blood aliquots immediately following drawing (time 1) and 2 weeks later (time 2) from 7 human subjects and 3 bovine blood samples with known lead levels of 0.26, 0.57, and 0.79 micromol/L (5.4, 11.8, and 16.4 microg/dL). Of the 8 laboratories, 5 were commercial laboratories, 1 was a state laboratory, 1 was a research laboratory, and 1 was the Centers for Disease Control and Prevention reference laboratory. OUTCOME MEASURES: Correlation coefficients were calculated, and differences within and between laboratories were assessed by analysis of variance. RESULTS: Results were obtained for all specimens, with all the human subjects' overall mean lead levels being less than 0.48 micromol/L (<10 microg/dL). Each laboratory reported all human blood specimens appropriately, as having lead levels less than 0.48 micromol/L (<10 microg/dL) and within 0.14 micromol/L (3 microg/dL) of the overall mean for that subject. All internal reproducibilities were very high (range, 0.92-1.00) except for one (0.60), possibly lower because of 1 pair of specimens. Mean differences between blood samples analyzed at time 1 and time 2 ranged from -1.4 to 1.2, with only 2 laboratories having significant differences (P<.01). CONCLUSIONS: Overall, there was strong reproducibility within and among laboratories, with no overall time trend or interlaboratory or intralaboratory variance. The storage conditions did not seem to affect the aggregate results. The data suggest that through implementation of the Centers for Disease Control and Prevention/Wisconsin Blood Lead Proficiency Testing Program, the Centers for Disease Control and Prevention's Blood Lead Laboratory Reference System, and mandated federal and state proficiency programs, laboratories in this geographic region have improved their performance as compared with previous published studies and an unpublished study.

Humans↗

PubMed2000

Atypical epithelial cells and specimen adequacy: current laboratory practices of participants in the college of American pathologists interlaboratory comparison program in cervicovaginal cytology.

CONTEXT: The Bethesda System for reporting cervical/vaginal cytologic diagnoses introduced terminology for atypical squamous and glandular cells and categories for specimen adequacy. OBJECTIVES: To analyze current laboratory reporting practices and compare trends to previous surveys. DESIGN: Questionnaire surveys were mailed to 2000 laboratories in 1996 and 1997. PARTICIPANTS: Laboratories enrolled in the College of American Pathologists Interlaboratory Comparison Program in Cervicovaginal Cytology. MAIN OUTCOME MEASURES: Laboratory policies, criteria, and reporting rates for Bethesda System categories. RESULTS: The 1996 specimen adequacy survey had 1166 respondents, and 768 laboratories returned the 1997 questionnaire focusing on atypical squamous cells of undetermined significance (ASCUS) and glandular cells of undetermined significance (AGUS). Nearly all laboratories (92%) routinely reported specimen adequacy, an increase from the 66% rate in 1991. The median rate for unsatisfactory specimens was 0.5% (mean 0.95%), and the median rate for the satisfactory but limited category was 5.8% (mean 9.3%). The Bethesda criteria for designating a specimen unsatisfactory were used by more than 90% of laboratories. Nearly all laboratories (97%) used the term ASCUS in 1997, and more than 80% of laboratories used the Bethesda criteria for this category. Median reporting rates for epithelial abnormalities were as follows: ASCUS, 4.5%; AGUS, 0.3%; low-grade squamous intraepithelial lesion (SIL), 1.6%; and high-grade SIL, 0.5%. The median ASCUS/SIL ratio was 2.0, with 80% of laboratories reporting ratios between 0.64 and 4.23. The median ASCUS rate and ASCUS/SIL ratio were higher than 1993 survey results. Nearly all laboratories attempted follow-up studies on patients with abnormal cytology results, and midsized laboratories achieved the highest rates of follow-up. Median rates of abnormalities following an ASCUS or AGUS diagnosis were 20% and 15%, respectively. Laboratory respondents commonly used written recommendations in ASCUS/AGUS reports. CONCLUSIONS: Most laboratories that responded to the surveys had adopted Bethesda terminology and criteria for specimen adequacy and ASCUS/AGUS. Reporting rates for SIL and adequacy categories have remained stable, but median ASCUS rates and ASCUS/SIL ratios are higher than in 1993. The AGUS category is reported infrequently, but can be associated with significant pathology.

Clinical Laboratory Techniques↗

PubMed2002

Situation of laboratory service and instruments in Thailand: a descriptive study from questionnaires.

Laboratory instruments are one of the main items in laboratory investment. To establish data for the situation of laboratory service and instruments in Thailand, questionnaires were randomly sent to one hundred and twenty laboratories. Sixty-three filled questionnaires from eleven university and affiliated hospitals, thirty-four government hospitals, and eighteen private hospital laboratories were sent back to the authors to be analyzed. Only the number of samples and instruments used during office hours were analyzed in this study by descriptive method. From the data it was found that the average number of personnel and tests of the university and affiliated hospital laboratories was the highest. To analyze the efficiency of the instruments used in the laboratories, the authors compared the average service number of samples or tests to the average number of samples or tests that was calculated from the instruments. The ratio of the average number of samples or tests that were calculated from the instruments and the average service number of samples or tests for chemistry and CBC were 2.13, 3.41, 5.24 and 2.33, 2.76, 3.71 in university and affiliated hospital laboratories, government hospital laboratories, and the private hospital laboratories, respectively. From the data, it was concluded that the instrument situation in laboratories of the university and affiliated hospitals was more appropriate than government hospital and private hospital laboratories. To improve the efficiency of using laboratory instruments, more concern must be given to the management of laboratory instruments and cooperation between hospitals could increase the efficiency of the instrument investment.

Chemistry, Clinical↗

PubMed2005

Commercial laboratory IgM testing for Toxoplasma gondii in pregnancy: a 20-year experience.

OBJECTIVE: This study was performed to review the clinical utility of commercial laboratory Toxoplasmosis-specific IgM testing during pregnancy and outcomes of the gestation at our institution. METHODS: A retrospective review of all women referred for suspected acute Toxoplasma gondii infection during pregnancy from 1984 through 2004 was performed. Women were diagnosed with suspected acute toxoplasmosis based on commercial laboratory serologic antibody testing. All women had blood sent to a recognized reference laboratory for antibody testing within 2 weeks of the commercial laboratory results. The study protocol was approved by the Institutional Review Board. Chi-square analysis were used with a significance of P < .05. RESULTS: A total of 130 women were evaluated during the study period with 116 IgM positive results from the commercial laboratories. The commercial laboratory antibodies were as follows: IgM positive with IgG negative (n = 20), IgM positive with IgG positive (n = 96), and IgM negative with IgG positive (n = 14). There was a significant reduction in the IgM positive results when comparing commercial laboratory (n = 116) with the reference laboratory results (n = 28; p < .001). Acute toxoplasmosis infection was diagnosed in 7 (5%) of the women. All cases of acute toxoplasmosis infection had a positive commercial laboratory IgM result. The false positive rate for the commercial laboratory IgM was 88.6% and the diagnostic indices were sensitivity 100%, specificity 11.4%, positive predictive value 6% and negative predictive value 100%. CONCLUSION: Commercial laboratory Toxoplasmosis-specific IgM is associated with a high false positive rate. The commercial and reference laboratory IgM results identified all cases of acute toxoplasmosis infection. Commercial laboratories reflexively obtaining reference laboratory confirmation of positive results could reduce costs associated with testing, referrals, retesting, and invasive procedures.

Adolescent↗

PubMed2004

The professions of dentistry and dental laboratory technology: improving the interface.

BACKGROUND: Dentistry's mission to provide rehabilitation services to patients who experienced dental disease is being jeopardized through the continual reduction of critical to quality skills and knowledge in dental laboratory technology being offered in dental and dental laboratory technician education. These reductions are creating a shortage of knowledgeable dentists and dental laboratory technicians who will be needed to address the projected public demand for laboratory-fabricated tooth replacements and restorations. METHODS: Demographic trend analysis supports a hypothesis that without immediate action by dentistry, substantial patient needs will not be met owing to inadequate levels of dental laboratory support for general dentists. RESULTS: The sophistication of laboratory-based rehabilitative and elective therapies demand closer cooperation between dentists and dental laboratory technologists. CONCLUSIONS: Dentistry must not abdicate its responsibilities in dental technology as it pursues a path away from rehabilitation services toward a projected future of prevention services. With decreasing educational exposure and training in dental laboratory procedures, dentists will have difficulty participating with dental laboratory technologists to fabricate laboratory-based rehabilitative and elective therapies. Without significant guidance from dental professionals in establishing laboratory standards in both education and practice, proprietary interests and commercial biases may set the laboratory and clinical standards of the future. CLINICAL IMPLICATIONS: Dentists will have limited experience or background to evaluate the dental laboratory technology offered in the marketplace and will be subject to the marketing of the industry. A shortage of educationally trained dental laboratory technologists will create a clinical and an economic burden on both dentists and patients.

Dental Technicians↗

PubMed2000

The Hunterian Neurosurgical Laboratory: the first 100 years of neurosurgical research.

Modern neurosurgery has long had a strong laboratory foundation, and much of this tradition can be traced to the Hunterian Neurosurgical Laboratory of the Johns Hopkins Hospital. Founded with the basic goals of investigating the causes and symptoms of disease and establishing the crucial role that surgeons may play in the treatment of disease, the Hunterian laboratory has adhered to these tenets, despite the dramatic changes in neurosurgery that have occurred in the last 100 years. Named for the famous English surgeon John Hunter (1728-1793), the Hunterian laboratory was conceived by William Welch and William Halsted as a special laboratory for experimental work in surgery and pathology. In 1904, Harvey Cushing was appointed by Halsted to direct the laboratory. With the three primary goals of student education, veterinary surgery that stressed surgical techniques, and meticulous surgical and laboratory record-keeping, the laboratory was quite productive, introducing the use of physiological saline solutions, describing the anatomic features and function of the pituitary gland, and establishing the field of endocrinology. In addition, the original development of hanging drop tissue culture, fundamental investigations into cerebrospinal fluid, and countless contributions to otolaryngology by Samuel Crowe all occurred during this "crucible" period. In 1912, Cushing was succeeded by Walter Dandy, whose work on experimental hydrocephalus and cerebrospinal fluid circulation led to the development of pneumoencephalography. The early days of neurosurgery evolved with close ties to general surgery, and so did the Hunterian laboratory. After Dandy began devoting his time to clinical work, general surgeons (first Jay McLean and then, in 1922, Ferdinand Lee) became the directors of the laboratory. Between 1928 and 1942, more than 150 original articles were issued from the Hunterian laboratory; these articles described significant advances in surgery, including pioneering research on calcium metabolism by William MacCallum and Carl Voegtlin and seminal preclinical work by Alfred Blalock and Vivian Thomas that led to the famous "blue baby" operation in 1944. With the introduction of the operating microscope in the 1950s, much of the focus in neurosurgical science shifted from the laboratory to the operating room. The old Hunterian building was demolished in 1956. The Hunterian laboratory for surgical and pathological research was rebuilt on its original site in 1987, and the Hunterian Neurosurgical Laboratory was reestablished in 1991, with a focus on novel treatments for brain tumors. The strong tradition of performing basic research with clinical relevance has continued.

Baltimore↗