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PubMed1997

The virtual laboratory: regional clinical diagnostics for integrated delivery systems.

With the rise of integrated delivery systems (IDSs), hospital laboratories need to transform themselves to better serve these large regional systems. Four factors are driving this need for transformation: the decline in the customer base of hospital clinical laboratories, the expanding number of test options, the need to control costs, and the proliferation of new technologies. In the future, clinical diagnostic capabilities will be available via integrated regional laboratory systems, or "virtual laboratories". The virtual laboratories serving IDSs will consist of a control center to manage laboratory services across the system, a core laboratory to perform large-volume testing and all testing that does not require a rapid turnaround, satellite laboratories for quick-turnaround testing, and a range of point-of-care testing options. Developing these virtual laboratories will pose challenges, including a redeployment of resources and a reengineering of testing policies and procedures. Success in implementing a virtual laboratory also will depend on the development of effective information systems technology to link the laboratory's components.

Clinical Laboratory Information Systems↗
PubMed2004

[ISO 15189 medical laboratory accreditation].

This International Standard, based upon ISO/IEC 17025 and ISO 9001, provides requirements for competence and quality that are particular to medical laboratories. While this International Standard is intended for use throughout the currently recognized disciplines of medical laboratory services, those working in other services and disciplines will also find it useful and appropriate. In addition, bodies engaged in the recognition of the competence of medical laboratories will be able to use this International Standard as the basis for their activities. The Japan Accreditation Board for Conformity Assessment (AB) and the Japanese Committee for Clinical Laboratory Standards (CCLS) are jointly developing the program of accreditation of medical laboratories. ISO 15189 requirements consist of two parts, one is management requirements and the other is technical requirements. The former includes the requirements of all parts of ISO 9001, moreover it includes the requirement of conformity assessment body, for example, impartiality and independence from any other party. The latter includes the requirements of laboratory competence (e.g. personnel, facility, instrument, and examination methods), moreover it requires that laboratories shall participate proficiency testing(s) and laboratories' examination results shall have traceability of measurements and implement uncertainty of measurement. Implementation of ISO 15189 will result in a significant improvement in medical laboratories management system and their technical competence. The accreditation of medical laboratory will improve medical laboratory service and be useful for patients.

Accreditation↗
PubMed1991

[Unnecessary laboratory tests in diagnosis and treatment].

The beneficial contact between the practitioner and the clinical laboratory is jeopardized by poor use and overuse of laboratory services. Physicians who order tests excessively put an unjustified burden on the laboratory. This overuse does not contribute to the quality of medical care, does not shorten hospital stay, nor reduce mortality. In clinical departments of another large university hospital there were differences of up to 82% in the number of tests performed, despite similar size and function of the departments. Among the reasons for overuse of laboratory tests is lack of an incentive for patient, physician or clinical department to reduce costs. The fragmentation of laboratory services, the conflicting interests of hospitals, as well as the multitude of personal, institutional and professional interests, also contribute to the variety and excess of superfluous laboratory tests. Analysis leads to suggestions for simple methods to contain the number and cost of laboratory services. Introduction of a reimbursement structure and introduction of new test request forms without a "menu" of tests, and education of practitioners in appropriate test-ordering would promote more appropriate utilization of laboratory services. The educational initiatives would provide guidelines for the clinician as to optimal test selection, the availability of cost-efficient tests, and optimal utilization of the laboratory. Based on decision-analysis methodologies, available test profiles should be restructured to match clinical problems, treatment, and patterns of clinical thinking. Improved access to information and computer-based analysis of data should improve test selection. The suggested methods of reducing unnecessary test ordering, and strategies for more discerning use of laboratory services will undoubtedly improve the practice of medicine and improve the laboratory-physician relationship.

Clinical Laboratory Techniques↗
PubMed1998

A system to monitor a portion of the total testing process in medical clinics and laboratories: feasibility of a split-specimen design.

OBJECTIVE: The purpose of this study was to assess the feasibility of using a prototype split-specimen design to assess integrity of a portion of the total testing process in medical clinics and laboratories. DESIGN: Two or three tubes of venous blood were collected from 177 patients for analysis of one of three analytes (serum potassium, serum total cholesterol, and whole-blood hemoglobin). Patients were seen at one of the nine clinics participating in this study. In all cases, one tube of blood from each patient was sent to a commercial referral laboratory, and the other tube(s) forwarded to the laboratory that routinely tested specimens for the clinic (participating laboratory) for analysis. Each participating laboratory removed a preanalysis and sometimes a post-analysis aliquot from each specimen and forwarded these to the referral laboratory for analysis. SETTING: The study was conducted in six physician office laboratories (three serving 1 to 4 [mean, 2.7] internists and three serving 3 to 24 [mean, 12] family physicians) and three hospital laboratories (serving hospitals with 100 to more than 700 beds). PATIENTS: Study patients were voluntary participants and provided informed consent. Patient age ranged from 18 to 80 years, and for all the laboratory test was specifically ordered for clinical reasons. Patients who were unable or unwilling to provide informed consent, those for whom testing would require that they provide more than 100 mL of blood, those whose blood was being collected by fingerstick, and those with results that were part of a laboratory test profile were excluded. MAIN OUTCOME MEASURES: Two main outcome measures were assessed: (1) percent differences between split-specimen results exceeding the maximum allowable imprecision level, which was based on published biological variation data (defined as one-half of the intraindividual percent coefficient of variation), for each analyte (result discrepancies); and (2) all "problems" (defined as departures from standard operating procedures) that could be documented by retrospective review of all relevant medical and laboratory records. RESULTS: The rate of result discrepancies was 1 in 20 (5%) for patients in whom hemoglobin was analyzed, 12 in 57 (21%) for patients in whom potassium was analyzed, and 1 in 60 (2%) for patients in whom total cholesterol was analyzed. Results of samples obtained during the aliquoting and storage phases of the total testing process were subject to study-induced problems and were generally not useful in tracing problems to specific stages of the testing process. A total of 28 problems (involving 26 patients) were documented, but only 6 problems were due to routine testing processes. CONCLUSIONS: The feasibility and limitations of a split-specimen design to detect result discrepancies were demonstrated. Most documented problems (22 of 28, or 79%) were study induced. To assess integrity of the total testing process, such problems need to be avoided.

Adolescent↗
PubMed1995

Physician office laboratory education and training in primary care residency programs.

OBJECTIVE: To assess the status of office laboratory residency education and training in family practice, internal medicine, obstetrics and gynecology, and pediatric residency programs. DESIGN: A single mailed survey to 1299 residency programs from December 1992 to February 1993. PARTICIPANTS: Primary care residency directors from 507 (39%) of 1299 programs. INTERVENTIONS: A 27-item survey of residency-based office laboratory practices, education, training, and resources. MAIN OUTCOME MEASURES: Differences between specialties in provision and quantity of office laboratory education and training, presence of a residency-based office laboratory, laboratory classification under the Clinical Laboratory Improvement Amendments, and available laboratory tests. RESULTS: Of those responding, office laboratories were present in 89% of family practice, 19% of internal medicine, 29% of obstetrics and gynecology, and 24% of pediatrics residency programs. Laboratory training was available at 60% of family practice, 16% of internal medicine, 15% of obstetrics and gynecology, and 30% of pediatrics programs. The median number of hours of formal skills training was 10 hours for family practice residency programs but less than 2 hours for the other specialties. Only 25% of the programs reported educational assistance from pathologists. Merely 4% of the programs had postassessment examinations and 2% awarded certificates of achievement. A majority of family practice programs performed waivered tests and physician-performed microscopy tests, but moderately complex tests were performed in less than 50% of family practice programs. CONCLUSIONS: Family practice residency programs provide more office laboratory training for residents than other specialties. There is a need for improved residency training in the basics of office laboratory practice.

Curriculum↗
PubMed2001

Further round-robin tests to improve the comparability between laboratories of the measurement of carbon in diesel soot and in environmental samples.

OBJECTIVES: An informal European coordination group organized two round-robin tests on filters collected from environmental, workplace and diluted diesel emissions. Previous inter-laboratory comparisons have shown that experimental samples give reasonably good results in terms of the dispersion around the mean, from all the participating laboratories. However, there were significant differences between the laboratories owing to a narrow distribution of the results within a single laboratory. In order to gain a better understanding of the differences obtained between the laboratories, it was decided to carry out more round-robin tests and to investigate further the possible factors which may influence the results. METHODS: The first round-robin (RRT3) was performed on six different samples (eight replicates) analyzed by ten laboratories. The range of loading was 40 to 138 micrograms cm-2 of total carbon (TC). Laboratories used their own thermal procedure parameters. The second round-robin test (RRT4) was performed on three different diluted diesel emissions (two replicates) samples analyzed by 13 laboratories. The range of loading was 21 to 37 micrograms cm-2 TC. Laboratories analyzed samples using imposed temperatures (500, 650 and 800 degrees C) and imposed duration (12 min). RESULTS: Inter-laboratory coefficients of variation for diluted diesel emission samples were 10% for RRT3 and ranged from 6 to 19% for RRT4. The influence of the desorption temperature was clearly demonstrated and the results tended to show that a desorption temperature of 650 degrees C could be an acceptable compromise. The influence of the organic carbon/elemental carbon (OC/EC) ratio was shown to be insignificant with pure diesel soot samples. CONCLUSIONS: It was expected that a significant improvement would be seen in the inter-laboratory dispersion by the use of a common standardized thermal desorption program, but the objectives of these RRTs were only partly reached. This paper provides new information that will be useful in the elaboration of a standardized procedure for the European Normalisation Centre (CEN TC 137 WG2--General requirements for measuring procedures).

Carbon↗
PubMed2005

Bacterial analysis by MALDI-TOF mass spectrometry: an inter-laboratory comparison.

Bacterial analysis by matrix-assisted laser desorption/ionization time-of-flight (MALDI-TOF) mass spectrometry has been demonstrated in numerous laboratories, and a few attempts have been made to compare results from different laboratories on the same organism. It has been difficult to understand the causes behind the observed differences between laboratories when different instruments, matrices, solvents, etc. are used. In order to establish this technique as a useful tool for bacterial identification, additional efforts in standardizing the methods by which MALDI mass spectra are obtained and comparisons of spectra from different instruments with different operators are needed. Presented here is an extension of our previous single-laboratory reproducibility study with three different laboratories in a controlled experiment with aliquots of the same bacterial culture, matrix stock solution, and calibrant standards. Using automated spectral collection of whole-cell bacteria and automated data processing and analysis algorithms, fingerprints from three different laboratories were constructed and compared. Nine of the ions appeared reproducibly within all three laboratories, with additional unique ions observed within each of the laboratories. An initial evaluation of the ability to use a fingerprint generated within one laboratory for bacterial identification of a sample from another laboratory is presented, and strategies for improving identification rates between laboratories is discussed.

Bacterial Proteins↗
PubMed2006

Laboratory parameter profiles among patients with cystic fibrosis.

BACKGROUND: Clinical trials in cystic fibrosis (CF) currently use laboratory-specific reference ranges to evaluate chemistry and hematology measurements. Laboratory-specific normal reference ranges may not accurately reflect what is abnormal but clinically insignificant among CF patients. METHODS: To address this concern, data from the Phase III trial of inhaled tobramycin in CF patients was used to describe the distribution and variability of laboratory parameters. The laboratory specimens were analyzed at a central laboratory after being obtained at baseline and throughout the 24-week trial. RESULTS: At the time of entry into the clinical trial, 91% (463 of 508) of patients had at least a single value outside the normal range. Liver function tests (AST, ALT) were above the normal range in 16% and 12% of the patients respectively, with 2.4% of patients having an AST>2.0 times the upper limit of normal. Of the 243 patients on placebo, 242 (99.6%) had at least one laboratory parameter that changed from normal to abnormal during the 24-week follow-up period. Of those same placebo patients, 11.5% (N=28) had a laboratory parameter change from a Common Toxicity Criteria (CTC) grade 0 to grade 2 or higher during follow-up. CONCLUSIONS: Patients with CF frequently have laboratory values outside the normal range and have significant longitudinal variability of laboratory values. Interpretation of adverse events in the clinical trial setting may be complicated by the underlying high rates of some laboratory abnormalities in the CF population. This data was presented in poster format at the American Thoracic Society International Conference, Atlanta, USA, 2002, appearing subsequently in the Conference proceedings [Goss CH, Mayer-Hamblett N, Yunker A, Waltz DA, Kronmal RA, Ramsey BW. Laboratory parameter profiles among patients with cystic fibrosis. Am J Rep Crit Care Med 2002;165(8):A283].

Adolescent↗
PubMed2026

Survey of diagnostic laboratories highlights need for improved standards in somatic genomic testing and reporting.

There is a growing international need to support somatic genomic testing, standardised variant curation and improved patient access to molecular profiling for somatic conditions, including cancer. We conducted a survey of scope, curation, reporting and sharing practices of diagnostic laboratories performing somatic testing in Australia and New Zealand. Laboratories with accreditation (n = 41) were invited in 2023 to complete a semi-structured, 25-question interview. Responses were received for 27 laboratories (66% response rate) offering solid tumour, haematological malignancy and non-cancer services. Only 36% of laboratories offered tests capturing the full breadth of variants, from single-nucleotide variants to gene fusions. Knowledge sharing was rare, with only one laboratory submitting variant classifications to a public knowledge base. Most laboratories (96%) conducted somatic testing in oncology. Of cancer laboratories, 35% offered testing considered capable of comprehensive genomic profiling (CGP). Almost half of cancer laboratories had already adopted the 2022 ClinGen/CGC/VICC oncogenicity guidelines, and 84% were using AMP/ASCO/CAP 2017 clinical significance guidelines. Only 47% of mixed discipline cancer laboratories reported biomarkers such as tumour mutational burden, with wide variation in reporting of matched therapy options. Our study has generated a unique overview of somatic laboratory practices in the region, and areas for global standardisation in somatic molecular testing and reporting. We also provide a model for practice and guideline uptake assessment, for application by other country-wide networks. This is particularly relevant in anticipation of CGP mainstreaming, with the increasing complexity of sequencing interpretation for laboratories and clinicians.

Humans↗
PubMedDate not supplied

Evaluation of CFTR gene mutation testing methods in 136 diagnostic laboratories: report of a large European external quality assessment.

Within the framework of the European Concerted Action on Cystic Fibrosis (Biomed-2, BMH4-CT96-0462) a quality assessment was set up for 135 European and one Australian laboratory. Six DNA samples were sent to the various laboratories. These samples carried the following CFTR genotypes: dF508/N1303K; dI507/wild; dF508/G551D; dF508/621 + 1 GtoT; R553X/wild and 1717-1 GtoA/wild. Each laboratory was asked to process the samples as they routinely do, whether they checked for all mutations or not. More than 75% of the laboratories screened for at least six of these mutations. Heteroduplex analysis was the most frequently used primary testing method (47%), in many instances followed by restriction enzyme digestion. Only a minority of the laboratories made use of a commercial CFTR mutation detection kit. On average, 91% of the laboratories correctly typed both alleles of a given DNA sample. However, 35% of the laboratories incorrectly typed one or more alleles from a total of 12 alleles included in the trial. One laboratory even failed to identify four of the different alleles correctly. The genotyping error frequency tended to be lower in laboratories which perform more than 200 CFTR mutation analyses per year. The results of this quality control trial suggest that there are many laboratories (35%) which have a percentage of errors unacceptable in a routine testing setting. The development of a consensus testing strategy for routine diagnostic laboratories and centralised mutation analysis facilities for rare or country-specific mutations in a limited number of expert centres, in combination with regular training sessions and quality assessments, should further improve genotyping.

Australia↗
PubMed2006

Formaldehyde exposure in a gross anatomy laboratory--personal exposure level is higher than indoor concentration.

GOAL, SCOPE AND BACKGROUND: Cadavers for gross anatomy laboratories are usually prepared by using embalming fluid which contains formaldehyde (FA) as a principal component. During the process of dissection, FA vapors are emitted from the cadavers, resulting in the exposure of medical students and their instructors to elevated levels of FA in the laboratory. The American Conference of Governmental Industrial Hygienists (ACGIH) has set a ceiling limit for FA at 0.3 ppm. In Japan, the Ministry of Health, Labour and Welfare has set an air quality guideline defining two limit values for environmental exposure to FA: 0.08 ppm as an average for general workplaces and 0.25 ppm for specific workplaces such as an FA factory. Although there are many reports on indoor FA concentrations in gross anatomy laboratories, only a few reports have described personal FA exposure levels. The purpose of the present study was to clarify personal exposure levels as well as indoor FA concentrations in our laboratory in order to investigate the relationship between them. METHODS: The gross anatomy laboratory was evaluated in the 4th, 10th and 18th sessions of 20 laboratory sessions in total over a period of 10 weeks. Air samples were collected using a diffusive sampling device for organic carbonyl compounds. Area samples were taken in the center and four corners of the laboratory during the entire time of each session (4-6 hours). Personal samples were collected from instructors and students using a sampling device pinned on each person's lapel, and they were 1.1 to 6 hours in duration. Analysis was carried out using high performance liquid chromatography. RESULTS AND DISCUSSION: Room averages of FA concentrations were 0.45, 0.38 and 0.68 ppm for the 4th, 10th and 18th sessions, respectively, ranging from 0.23 to 1.03 ppm. These levels were comparable to or relatively lower than the levels reported previously, but were still higher than the guideline limit for specific workplaces in Japan and the ACGIH ceiling limit. The indoor FA concentrations varied depending on the contents of laboratory sessions and seemed to increase when body cavity or deep structures were being dissected. In all sessions but the 4th, FA levels at the center of the room were higher than those in the corners. This might be related to the arrangement of air supply diffusers and return grills. However, it cannot be ruled out that FA levels in the corners were lowered by leakage of FA through the doors and windows. Average personal exposure levels were 0.80, 0.45 and 0.51 ppm for instructors and 1.02, 1.08 and 0.89 ppm for students for the 4th, 10th and 18th session, respectively. The exposure levels of students were significantly higher than the mean indoor FA concentrations in the 4th and 10th sessions, and the same tendency was also observed in the 18th session. The personal exposure level of instructors was also significantly higher than the indoor FA level in the 4th session, while they were almost the same in the 10th and 18th sessions. Differences in behavior during the sessions might reflect the differential personal exposure levels between students and instructors. CONCLUSION: The present study revealed that, if a person is close to the cadavers during the gross anatomy laboratory, his/her personal exposure level is possibly 2 to 3-fold higher than the mean indoor FA concentration. This should be considered in the risk assessment of FA in gross anatomy laboratories. RECOMMENDATION AND OUTLOOK: If the risk of FA in gross anatomy laboratories is assessed based on the indoor FA levels, the possibility that personal exposure levels are 2 to 3-fold higher than the mean indoor FA level should be taken into account. Otherwise, the risk should be assessed based on the personal exposure levels. However, it is hard to measure everyone's exposure level. Therefore, further studies are necessary to develop a method of personal exposure assessment from the indoor FA concentration.

Air Pollution, Indoor↗
PubMed2006

Quality assurance program for pharmacokinetic assay of antiretrovirals: ACTG proficiency testing for pediatric and adult pharmacology support laboratories, 2003 to 2004: a requirement for therapeutic drug monitoring.

Proficiency testing (PT) is a mandated requirement for clinical laboratories doing therapeutic drug monitoring and is an invaluable tool to help laboratories identify and correct problems in analytical procedures. The AIDS Clinical Trial Group Pharmacology Quality Assurance Committee implemented a new antiretroviral PT program for all currently available antiretroviral drugs in 2001. The PT program was designed for the AIDS Clinical Trial Group Pharmacology Specialty Laboratories actively involved in assaying these drugs in clinical trial samples so as to comply with the Clinical Laboratory Improvement Amendments. Results from the first 3 rounds of PT have been analyzed and reported and provided support for formalizing the guidelines of the PT testing program. The PT program has expanded with the addition of nucleoside reverse transcription inhibitors (NRTIs) and atazanavir. This report includes results from rounds 4 to 7 over 2 additional years of standard operations. Additionally we include results from NRTIs for all rounds and atazanavir for a single round. There were 9 participating laboratories. Eight used high-performance liquid chromatography as the primary method of detection and 2/8 also reported LC-MS-MS results. One laboratory used LC-MS-MS as their primary detection method. All laboratories measured protease inhibitors, most measured at least 1 non-nucleoside reverse transcription inhibitor and 5 had NRTI capabilities. Results were normally distributed and the acceptance range of +/-20% best corresponded to a 95% confidence interval. Overall score for 9 participating laboratories was 96% correct out of 1826 challenges over 4 rounds. Laboratories scored 95, 98 and 97% correct for protease inhibitors, non-nucleoside reverse transcription inhibitorss and NRTIs, respectively. Three laboratories reporting LC-MS-MS results had 92% correct (347/378) challenges for all drugs. The percentage of correct results is about the same as previously reported. There is a continued need for a PT program to help participating laboratories maintain essential quality assurance and quality control.

Anti-HIV Agents↗
PubMedDate not supplied

Dentist communication with the dental laboratory for prosthodontic treatment using implants.

PURPOSE: A questionnaire was sent to U.S. dental laboratories to evaluate the level of communication between dentists and laboratory technicians and to determine trends in procedures and materials used in fixed and removable implant restorations. METHODS AND MATERIALS: Dental laboratories were randomly chosen from the National Association of Dental Laboratories for each of the 50 states. The questionnaire was mailed to the laboratory directors for 199 dental laboratories. One hundred fourteen dental laboratories returned the survey, yielding a response rate of 57%. Of those laboratories, 37 indicated that they did not participate in the fabrication of fixed implant restorations, yielding a response rate of 39%. Forty-two dental laboratories indicated that they did not participate in the fabrication of implant-retained overdenture prostheses, yielding a response rate of 36%. RESULTS: Results from this survey show inadequate communication by dentists in completing work authorization forms. Custom trays are used more frequently for implant-retained overdenture impressions and stock trays for impressions of fixed implant prostheses. Poly(vinyl siloxane) is the material most commonly used for both fixed and removable implant-supported prostheses. Two implants with stud attachments are used more widely than those with bar attachments for implant-retained overdentures. CONCLUSIONS: Most laboratories working on implant prosthodontic cases report inadequate communication between the laboratory and dentists related to materials and techniques used in fabrication of implant restorations.

Communication↗
PubMed1997

Are clinical laboratories in California accurately reporting vancomycin-resistant enterococci?

In order to determine whether hospital-based clinical laboratories conducting active surveillance for vancomycin-resistant enterococci in three San Francisco Bay area counties (San Francisco, Alameda, and Contra Costa counties) were accurately reporting vancomycin resistance, five vancomycin-resistant enterococcal strains and one vancomycin-susceptible beta-lactamase-producing enterococcus were sent to 31 of 32 (97%) laboratories conducting surveillance. Each strain was tested by the laboratory's routine antimicrobial susceptibility testing method. An Enterococcus faecium strain with high-level resistance to vancomycin (MIC, 512 microg/ml) was correctly reported as resistant by 100% of laboratories; an E. faecium strain with moderate-level resistance (MIC, 64 microg/ml) was correctly reported as resistant by 91% of laboratories; two Enterococcus faecalis strains with low-level resistance (MICs, 32 microg/ml) were correctly reported as resistant by 97 and 56% of laboratories, respectively. An Enterococcus gallinarum strain with intrinsic low-level resistance (MIC, 8 microg/ml) was correctly reported as intermediate by 50% of laboratories. A beta-lactamase-producing E. faecalis isolate was correctly identified as susceptible to vancomycin by 100% of laboratories and as resistant to penicillin and ampicillin by 68 and 44% of laboratories, respectively; all 23 (74%) laboratories that tested for beta-lactamase recognized that it was a beta-lactamase producer. This survey indicated that for clinically significant enterococcal isolates, laboratories in the San Francisco Bay area have problems in detecting low- to moderate-level but not high-level vancomycin resistance. Increasing accuracy of detection and prompt reporting of these isolates and investigation of cases are the next steps in the battle for control of the spread of vancomycin resistance.

Ampicillin↗
PubMed2001

Ability of laboratories to detect emerging antimicrobial resistance: proficiency testing and quality control results from the World Health Organization's external quality assurance system for antimicrobial susceptibility testing.

The accuracy of antimicrobial susceptibility data submitted by microbiology laboratories to national and international surveillance systems has been debated for a number of years. To assess the accuracy of data submitted to the World Health Organization by users of the WHONET software, the Centers for Disease Control and Prevention distributed six bacterial isolates representing key antimicrobial-resistance phenotypes to approximately 130 laboratories, all but one of which were outside of the United States, for antimicrobial susceptibility testing as part of the World Health Organization's External Quality Assurance System for Antimicrobial Susceptibility Testing. Each laboratory also was asked to submit 10 consecutive quality control values for several key organism-drug combinations. Most laboratories were able to detect methicillin (oxacillin) resistance in Staphylococcus aureus, high-level vancomycin resistance in Enterococcus faecium, and resistance to extended-spectrum cephalosporins in Klebsiella pneumoniae. Many laboratories, particularly those using disk diffusion tests, had difficulty in recognizing reduced susceptibility to penicillin in an isolate of Streptococcus pneumoniae. The most difficult phenotype for laboratories to detect was reduced susceptibility to vancomycin in an isolate of Staphylococcus epidermidis. The proficiency testing challenge also included a request for biochemical identification of a gram-negative bacillus, which most laboratories recognized as Enterobacter cloacae. Although only a small subset of laboratories have submitted their quality control data, it is clear that many of these laboratories generate disk diffusion results for oxacillin when testing S. aureus ATCC 25923 and S. pneumoniae ATCC 49619 that are outside of the acceptable quality control range. The narrow quality control range for vancomycin also proved to be a challenge for many of the laboratories submitting data; approximately 27% of results were out of range. Thus, it is important to establish the proficiency of laboratories submitting data to surveillance systems in which the organisms are tested locally, particularly for penicillin resistance in pneumococci and glycopeptide resistance in staphylococci.

Anti-Bacterial Agents↗
PubMed2004

Corrections of clinical chemistry test results in a laboratory information system.

CONTEXT: The recently released reports by the Institute of Medicine, To Err Is Human and Patient Safety, have received national attention because of their focus on the problem of medical errors. Although a small number of studies have reported on errors in general clinical laboratories, there are, to our knowledge, no reported studies that focus on errors in pediatric clinical laboratory testing. OBJECTIVE: To characterize the errors that have caused corrections to have to be made in pediatric clinical chemistry results in the laboratory information system, Misys. To provide initial data on the errors detected in pediatric clinical chemistry laboratories in order to improve patient safety in pediatric health care. DESIGN: All clinical chemistry staff members were informed of the study and were requested to report in writing when a correction was made in the laboratory information system, Misys. Errors were detected either by the clinicians (the results did not fit the patients' clinical conditions) or by the laboratory technologists (the results were double-checked, and the worksheets were carefully examined twice a day). No incident that was discovered before or during the final validation was included. On each Monday of the study, we generated a report from Misys that listed all of the corrections made during the previous week. We then categorized the corrections according to the types and stages of the incidents that led to the corrections. RESULTS: A total of 187 incidents were detected during the 10-month study, representing a 0.26% error detection rate per requisition. The distribution of the detected incidents included 31 (17%) preanalytic incidents, 46 (25%) analytic incidents, and 110 (59%) postanalytic incidents. The errors related to noninterfaced tests accounted for 50% of the total incidents and for 37% of the affected tests and orderable panels, while the noninterfaced tests and panels accounted for 17% of the total test volume in our laboratory. CONCLUSION: This pilot study provided the rate and categories of errors detected in a pediatric clinical chemistry laboratory based on the corrections of results in the laboratory information system. A direct interface of the instruments to the laboratory information system showed that it had favorable effects on reducing laboratory errors.

Child↗
PubMed1981

Medicare and Medicaid programs; reimbursement for clinical laboratory services: Health Care Financing Administration. Final rule with comment period.

These regulations implement section 918 of Public Law 96-499, the Omnibus Reconciliation Act of 1980, which establishes the payment criteria for laboratory services billed by physicians under the Medicare and Medicaid programs. Specifically, these amendments provide that: (1) laboratory tests performed by a physician, or personnel under his or her supervision, will be paid on the basis of the reasonable charge for the service (determined under the usual Medicare rules on reasonable charges); (2) laboratory tests performed by an independent laboratory, but billed by a physician who identifies the laboratory and the amount the laboratory charged him or her, will be paid on the basis of the lesser of (a) the laboratory's reasonable charge for the service, or (b) the amount the laboratory charged the physician for the service; and (3) if the physician does not identify the laboratory and the amount it charged him or her for the test, payment will be based on the lowest amount at which the Medicare carrier estimates the test could have been obtained by the physician from a laboratory serving the physician's locality. These rules should result in lower Medicare and Medicaid payments since they limit recognition of markups of bills from physicians for services performed by independent clinical laboratories and enable the programs to benefit from discontinued rates obtained by physicians.

Hospitals↗
PubMed1999

[A role of clinical pathologists in Laboratory Information (Consulting) Center].

In the 21st Century, laboratory scientists must change their concepts and attitude in order to supply services and information of great value. The laboratory tests comprise an increasing volume, and medical workers frequently need consultation on these tests. Effective utilization of laboratory data are important aspects of evidence-based medicine, and will also contribute to the efficiency of hospital practice and management. Clinical Laboratory of Kitasato University Hospital opened the "Clinical Laboratory Information (Consulting) Center" in July 1995 to respond to the increasing demand for consultation. It has been supporting medical care and research. The Center is located on the second floor of the Clinical Laboratory building of Kitasato University Hospital, and is staffed by one medical technologist and a clinical pathologist specialized in laboratory medicine. The Center staff consults by telephone from 9 am to 5 pm on weekdays, and get inquiries after-work hours and during weekends either by e-mail or fax. The Center aims to improve medical care by providing accurate and up-to-date information on clinical laboratory tests and interpretations. The clinical pathologist of the Center attempts to advise physicians regarding appropriate tests for particular patients. This avoids the ordering of unnecessary tests, which benefits the patient, the physician, and the hospital. The clinical pathologist should keep abreast of new findings on a wide array of clinical laboratory tests. The clinical pathologist should respond immediately to requests and complaints, thereby always seeking to improve oneself and the Center. Our Center is the first clinical laboratory in Japan staffed by both a clinical pathologist and a medical technologist, and our Center could be a pilot study for a new service of hospital clinical laboratories.

Clinical Laboratory Information Systems↗