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PubMedDate not supplied

Establishment of a central laboratory serum tumor marker service on a consolidated immunodiagnostic platform: development of practice standards, service improvements, and operational efficiency.

BACKGROUND: Laboratory testing for serum tumor markers traditionally has been performed in low volume in most hospitals. Many markers are sent out to reference laboratories. Over the past decade, serum tumor marker testing in patient management has become more defined, resulting in increasing test volume and wider availability of assays on automated immunodiagnostic platforms. METHODS: A retrospective review of laboratory operations, test volumes, and budgets over a 10-year period. Results of utilization initiatives as part of a clinical practice management team also were reviewed. RESULTS: The volume of serum tumor marker requests in our institution increased 2.25-fold over an 8-year period. In contrast, total laboratory test volume increased only 1.3-fold. Implementation of an on-site tumor marker laboratory using a consolidated platform (Elecsys 2010) decreased the average unit cost per test from $12.36/test to $6.79/test. This was accomplished by a combination of insourcing and by consolidation of multiple semi-automated instruments. Total savings were $219,972 per year, including direct budget reductions and cost avoidance due to volume increases. Various institutional practice standards were implemented, and turnaround time was markedly reduced for selected tests. CONCLUSIONS: Testing for serum tumor markers is becoming more established in large hospital laboratories. Increasing test volumes and the availability of consolidated instrument platforms with a broad menu of tumor marker tests (such as the Elecsys 2010) facilitates consolidation and insourcing of many tumor marker assays. This permits the laboratory to reduce unit and overall cost, to leverage excess capacity on existing instrumentation, and to create an opportunity to add value to the service by reducing turnaround time and implementing practice standards.

Academic Medical Centers↗
PubMedDate not supplied

[Laboratory variables and stratification of small-cell lung cancer patients: recommendations for therapeutic trials and for clinical practice guidelines].

OBJECTIVE: To identify, through a systematic review of the literature, the laboratory variables that, in addition to performance status and to extent of the disease, would allow a more accurate stratification of small-cell lung cancer patients who participate in chemotherapy trials, with or without radiotherapy. Secondary aim: to compare the results of our systematic review with the recommendations made in current clinical practice guidelines. METHODS: Update of two recently published systematic reviews, without meta-analysis, following the recommendations of the International Federation of Clinical Chemistry and Laboratory Medicine, and taking into account the Consolidated Standards of Reporting Trials statement. RESULTS: Of 1143 publications retrieved, exclusion and inclusion criteria allow us to include 13 studies in our review. The three variables which were the most often found significant in multivariate statistical analysis, were: pre-therapeutic levels of laboratory variables (13/13), performance status (12/13), and degree of tumour invasion (10/10). Among the laboratory variables, serum lactate dehydrogenase (LDH) is the only one that was quite consistently found to be of independent prognostic significance, with p values or hazard ratios quite close to those obtained with performance status, or with extent of the disease. The recommendations made in the four clinical practice guidelines that we retrieved, are often vague regarding laboratory variables, and sometimes they even contradict each others. CONCLUSIONS: Available evidence would support the recommendation that pretreatment LDH should be systematically measured in order to stratify patients in therapeutic trials. If other laboratory variables were to be measured in addition to LDH for this purpose, it seems that alkaline phosphatase (ALP), and to a lesser extent, sodium and white blood cell counts, might be the best suited ones. Nevertheless, further studies are necessary to more clearly support this latter recommendation. Available evidence would not support the measurement of any other laboratory variable in this context, before, during, or after treatment. Our recommendations are more in agreement with the recommendations made in the clinical practice guidelines that use evidence-based methods than with the guidelines that do not.

Carcinoma, Small Cell↗
PubMed2004

National laboratory inventory for global poliovirus containment--United States, November 2003.

In anticipation of the interruption of wild poliovirus (WPV) transmission, the United States has joined 122 other poliomyelitis-free countries in taking steps to minimize the risk for reintroducing WPV from laboratories to communities. In October 2002, a nationwide survey of laboratories and biomedical institutions (e.g., universities) that oversee multiple laboratories was conducted to identify those that might be holding WPV-containing materials and to establish a national inventory of institutions and laboratories retaining such materials. A total of 32,429 laboratories and biomedical institutions listed in multiple databases were mailed letters to alert laboratories of the impending global eradication of polio and encourage disposal of unneeded WPV-containing materials. The national inventory is a list of institutions and laboratories whose staff will be kept informed of eradication progress and appropriate WPV-containment procedures. This report summarizes use of the survey to create the national inventory.

Humans↗
PubMedDate not supplied

Health and safety in clinical laboratories in developing countries: safety considerations.

BACKGROUND: Clinical laboratories are potentially hazardous work areas. Health and safety in clinical laboratories is becoming an increasingly important subject as a result of the emergence of highly infectious diseases such as hepatitis and HIV. This is even more so in developing countries where health and safety have traditionally been regarded as low priority issues, considering the more important health problems confronting the health authorities in these countries. METHODS: We conducted a literature search using the medical subheadings titles on the INTERNET over a period of twenty years and summarized our findings. RESULTS: This article identifies hazards in the laboratories and highlights measures to make the laboratory a safer work place. It also emphasizes the mandatory obligations of employers and employees towards the attainment of acceptable safety standards in clinical laboratories in Third World countries in the face of the current HIV/AIDS epidemic in many of these developing countries especially in the sub-Saharan Africa while accommodating the increasing work load in these laboratories. CONCLUSION: Both the employer and the employee have major roles to play in the maintenance of a safe working environment. This can be achieved if measures discussed are incorporated into everyday laboratory practice.

Clinical Medicine↗
PubMed2004

Proficiency of determination of vancomycin susceptibility in enterococci by clinical laboratories in Taiwan.

Eighty clinical microbiology laboratories in Taiwan were evaluated for proficiency in the determination of vancomycin susceptibility of enterococci. Each laboratory was given 1 vancomycin-sensitive isolate and 3 vancomycin-resistant enterococci (VRE) isolates to determine the levels of vancomycin resistance. Among a total of 240 tests performed, 153 (63.8%) correctly determined the levels of vancomycin resistance of the survey isolates. Seventy eight (98%) of the 80 laboratories accurately identified the high level of vancomycin resistant isolates [Enterococcus faecalis; minimum inhibitory concentration (MIC) >256 microg/mL]. Seventy two laboratories (90%) correctly determined the level of vancomycin resistance of another VRE with a vancomycin MIC of 64 microg/mL. Only 3 of the 80 laboratories correctly determined the intermediate-level vancomycin resistant isolates (Enterococcus casseliflavus; MIC = 8 microg/mL). Eight laboratories reported the vancomycin-susceptible isolate as being vancomycin-resistant or of intermediate susceptibility. This survey demonstrated that clinical microbiology laboratories in Taiwan are proficient in detecting high-level but not low-level VRE, suggesting a need to improve their proficiency in VRE detection.

Enterococcus↗
PubMedDate not supplied

Case study: improving efficiency in a large hospital laboratory.

Saint Francis Health System (SFHS) consists of three hospitals and one clinic: Saint Francis Hospital (SFH); Broken Arrow Medical Center; Laureate Psychiatric Hospital; and Warren Clinic. SFHS has 670 physicians on staff and serves medical (oncology, orthopedic, neurology, and renal), surgical, cardiac, women and infant, pediatric, transplant, and trauma patients in Tulsa County, Oklahoma, which has a population of 660,000. SFH incorporates 706 staffed beds, including 126 pediatric beds and 119 critical care beds. Each year, the health system averages 38,000 admissions, 70,000 emergency department visits, 25,000 surgeries, and 3,500 births. Saint Francis Laboratory is located within the main hospital facility (SFH) and functions as a core lab for the health system. The lab also coordinates lab services with Saint Francis Heart Hospital, a physician-system joint venture. The Optimal Equipment Configuration (OEC) Project was designed by the Clinical Laboratory Services division of Premier, a group purchasing organization, with the goal of determining whether laboratories could improve efficiency and decrease unit cost by using a single-source vendor. Participants included seven business partners (Abbott, Bayer, Beckman/Coulter, Dade/Behring, J&J/ Ortho, Olympus, and Roche) and 21 laboratory sites (a small, mid-sized, and large site for each vendor). SFH laboratory staff embraced Premier's concept and viewed the OEC project as an opportunity to "energize" laboratory operations. SFH partnered with Abbott, their primary equipment vendor, for the project. Using resources and tools made available through the project, the laboratory was re-engineered to simplify workflow, increase productivity, and decrease costs by adding automation and changing to centralized specimen processing. Abbott and SFH shared a common vision for the project and enhanced their partnership through increased communication and problem solving. Abbott's area representatives provided for third-party design expertise and quarterly metric reporting through Argent Consulting. Abbott incorporated lessons learned from the SFH OEC project with organizational changes to improve the way they work with customers. Following is a step-by-step description of the OEC project to allow others to benefit from the experience (Figure 1).

Efficiency, Organizational↗
PubMedDate not supplied

The contribution of proficiency testing to improving laboratory performance and ensuring quality patient care.

The idea of comparing laboratories' test results against one another predated federal regulations by decades (1) and was initially used as an educational tool. The introduction of federal regulations altered the proficiency testing (PT) environment (2,3) and today there is concern that the regulatory requirements do not address extraneous factors that may adversely affect a laboratory's PT performance (6). This article aims to address these concerns and hopes to convince the reader that while the scope of PT has expanded beyond its original intent as an educational tool for the laboratory, PT can still function in that capacity. Improvements in laboratory performance and laboratory medicine as a whole continue to be supported by proficiency testing for numerous reasons. Several mistakes laboratories have made in the past are addressed and suggestions for improvement are given. Laboratory managers who take proactive steps to ensure quality patient test results should experience fewer PT failures, and in turn can focus more attention on the educational benefits that participating in PT can offer.

Efficiency, Organizational↗
PubMed2005

Laboratory diagnosis of von Willebrand disorder: use of multiple functional assays reduces diagnostic error rates.

Regular multilaboratory surveys of laboratories primarily in Australia, New Zealand, and Southeast Asia have been conducted over the past 8 years to evaluate testing proficiency in the diagnosis of von Willebrand disorder (VWD). We have reassessed the findings of these surveys with a particular emphasis on the diagnostic errors and error rates associated with particular tests or test panel limitations. The 37 plasma samples dispatched to survey participants include 9 normal samples, 4 type 1 VWD samples, 8 type 2 VWD samples (2A x 3, 2B x 3, 2M x 1, and 2N x 1), and 4 type 3 VWD samples. In addition to providing numerical test results, participant laboratories (average, n = 35) were asked to provide diagnostic interpretations of their test results regarding whether VWD was evident and, if so, the probable subtype. Although laboratories usually provided correct interpretative responses, diagnostic errors occurred in a substantial number of cases. On average, type 1 VWD plasma was misidentified as type 2 VWD plasma in 11% of cases, and laboratories that performed the ristocetin cofactor assay for von Willebrand factor (VWF:RCo) without performing the collagen-binding activity assay for VWF (VWF:CB) were 6 times more likely to make such an error than those that did perform the VWF:CB. Similarly, type 2 VWD plasma samples were misidentified as type 1 or type 3 VWD in an average of 20% of cases, and laboratories that performed the VWF:RCo without the VWF:CB were 3 times more likely to make such an error than those that performed the VWF:CB. Finally, normal plasma was misidentified as VWD plasma in an average of 5% of cases, and laboratories that performed the VWF:RCo without the VWF:CB were 10 times more likely to make such an error than those that performed the VWF:CB. We conclude that laboratories are generally proficient in their testing for VWD and that diagnostic error rates are substantially reduced when test panels are more comprehensive and include the VWF:CB.

Asia, Southeastern↗
PubMed2005

Implementation of laboratory order data in BioSense Early Event Detection and Situation Awareness System.

INTRODUCTION: Laboratory test orders constitute an early outbreak data source. CDC receives laboratory order data in HL7 format from the Laboratory Corporation of America (LabCorp) and plans to use the data in the BioSense Early Event Detection and Situation Awareness System. METHODS: These LabCorp data contain information on tests ordered and include the type of test ordered and the International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM)-coded reasons for the order. A consensus panel was formed to group test orders on the basis of expert opinion into eight standard syndrome categories to provide an additional data source for early outbreak detection. A laboratory order taxonomy was developed and used in the mapping consolidation phase. The five main classes of this taxonomy are miscellaneous functional tests, fluid screening tests, system-specific tests, tests for specific infections (by primary manifestation), and tests for specific noninfectious diseases. RESULTS: Summary of numbers of laboratory order codes in each syndrome category are fever (53), respiratory (53), gastrointestinal (27), neurological (35), rash (37), lymphadenitis (20), localized cutaneous lesion (11), and specific infection (63). CONCLUSION: With the daily use of laboratory order data in BioSense, the actual distribution of laboratory order codes in syndrome groups can be evaluated, allowing modification of the mapping.

Clinical Laboratory Information Systems↗
PubMed2000

Laboratory accidents--a matter of attitude.

This is a prospective study on accidents occurring in the Pathology laboratories of Hospital Ipoh over the 3-year period from January 1996 to October 1999. 15 mishaps were recorded. The location of the accidents were the histology (40%), microbiology (33%), haematology (20%) and cytology (7%) laboratories. No mishaps were reported from the clinical chemistry, blood bank and outpatient laboratories. Cuts by sharp objects were the most common injuries sustained (47%) followed by splashes and squirts by fluid such as blood or chemicals (27%). There was 1 case each of contact with biohazardous fluid, burn, allergy and accidental drinking of disinfectant. 67% of the accidents involved medical laboratory technicians, 20% involved attendants and the rest were medical officers and the junior laboratory technicians. Although the accidents reported appeared trivial, it is vital to document them and bring them to the attention of all concerned in the laboratory, in order to prevent major accidents and also because of medico-legal implications. The role of the Laboratory Safety Committee cannot be overemphasised. Modification of staff attitude is considered an important remedial goal.

Accidents, Occupational↗
PubMed2005

Performance evaluation of the latest fully automated hematology analyzers in a large, commercial laboratory setting: a 4-way, side-by-side study.

Gamma-Dynacare is a Canadian-based community laboratory partnership formed in the mid-1990s through the merger of 3 prominent Ontario medical diagnostic laboratories. Laboratory Corporation of America acquired an interest in the GD partnership in mid 2002. We service more than 10,000 community-based Canadian clinicians, hospital partners, and private clients with an integrated customer-focused system that includes specimen collection, transportation, and results reporting services. With more than 1,700 highly qualified medical, technical, and support staff and a network of laboratories, Gamma Dynacare aims to be at the forefront of technological innovation to better service the clinician base and ultimately deliver better patient care. We were looking for a hematology analyzer that would allow. (1) standardization throughout Ontario in our 4 largest sites and (2) better performance to effectively handle aged samples and minimize slide review. To select the best, most productive hematology analyzer for our environment, it was decided to perform a side-by-side comparison of the top hematology analyzers from Abbott (Cell-Dyn 3500), Beckman Coulter (LH 750), Bayer (Advia 120), and Sysmex (XE 2100), utilizing the same samples. CBC, differential and reticulocyte parameters were all evaluated according to CLSI (formerly NCCLS) and established hematology analyzer evaluation guidelines. We assessed each analyzer for precision, linearity, carryover, stability, differential capabilities, slide review rates, and throughput (clean bench studies). Two hundred samples were assessed for differential and morphology flagging on each analyzer using the reference 400 cell manual differential for comparison. Throughput was assessed by analyzing 700 consecutive samples representative of our workload mix. Stability studies at 24 hours showed that the Beckman Coulter LH 750 was least affected by EDTA, effect with minimal changes in the mean corpuscular volume (MCV) and hematocrit. Both the Bayer Advia 120 and Sysmex XE 2100 showed an elevation of the MCV (up to 5 fL) and Hematocrit over the 24 hours. Analysis of the 200 randomly selected patient samples showed that, while the false-negative rates on each of the instruments were comparable, there were significant differences in the false-positive rates. This has important implications for slide review rates. For our specimen mix, the Sysmex XE 2100 had the highest false-positive rate (15%), followed by the Cell-Dyn 3500 (8%), Advia 120 (6.5%) and the Beckman Coulter LH 750 (1.5%). Reticulocyte analysis performance was observed to be satisfactory with the Beckman Coulter LH 750, Cell-Dyn 3500, and XE 2100, while the Bayer Advia 120 showed a decrease in retic values after 12 hours. In conclusion, many laboratories will not be able to perform a 4-way evaluation such as described here due to time, space, and resource constraints. For our laboratories, result quality, sample stability performance, slide review rates, and efficiency were the primary criteria in selection of the most suitable hematology analyzer. Our 4-way evaluation resulted in selection of the Beckman Coulter LH 750 for Gamma-Dynacare Laboratories because it enabled the lowest slide review rate and handled aged samples better than the other analyzers.

Automation↗
PubMed2006

Phlebotomy issues and quality improvement in results of laboratory testing.

Laboratory testing is an integral part of the decision-making process, and results of laboratory testing often strongly influence medical diagnoses and therapies. There is a long history of quality requirements in laboratory medicine, which have mainly concerned the analytic phase of this process. Owing to the substantial advances in technology, laboratory automation and analytic quality, there is increasing evidence that further quality improvements should be targeted to extra-analytic phases of laboratory testing. Objective difficulties to monitor most of the preanalytic variables which lie outside the direct control or supervision of the laboratory personnel, such as phlebotomy, call for effective educational and preventive policies. Owing to high personnel turnover rates, lack of understanding about good laboratory practices, and inadequate training, there are several opportunities for making errors during phlebotomy, which mainly concern patient misidentification and collection of unsuitable specimens for testing due to unsuited venous accesses, venous stasis, inappropriate collection devices and containers. Improved standardization of phlebotomy techniques, along with operative guidelines dissemination, continuous education, certification, and training of health care professionals involved in blood drawing responsibilities would enhance the chance of obtaining specimens of consistent quality, with favorable revenues for the health care system and the patient's outcome.

Bloodletting↗
PubMed2006

[Status of the clinical laboratory in the mandatory postgraduate medical training system from the standpoint of the community hospital].

In city hospitals, it is difficult to develop an appropriate program for laboratory medicine. The ideal goal for the future on the basis of experience is that trainees study emergency tests, blood transfusion and microbiology as practical matters. In addition, it is effective to learn how to reply to consultations from physicians, to learn the laboratory flow, and to present interpretations of laboratory data with the laboratory physician at each case conference. The objectives of these training programs are to gain skills for appropriate laboratory utilization and interpretation, and develop communication and consultation with laboratory physician and medical technologists. The key points of success in training are that teaching divisions have confidence in the laboratory. Particularly, cooperation with medical technologists is necessary, and is essential medical practice for trainees because they will have to work together in the future. In addition, working with trainees increases the pride and dignity of medical technologists.

Education of Persons with Intellectual Disabilitie↗
PubMed2006

Effective laboratory communication...it's a two-way street.

Working as part of your team, your dental laboratory can increase your predictable success and decrease the stress of daily practice. This partnership should begin during the treatment planning phase and continue through to the insertion appointment. Many dentists are beginning to view their laboratory technician as a bonafide member of their patient care team. Thorough communication on both sides is crucial to reaching this predictable success. A trusting relationship will enable the dentist and the laboratory technician to communicate effectively. The laboratory must take the responsibility to communicate its concerns to the dentist, just as the dentist must take the responsibility to communicate effectively with the laboratory his or her needs and desires for each case. When effective communication techniques are followed, everyone is a winner. The dentist is more productive per hour and has reduced stress. The dental laboratory does not have to bear the burden of remakes, and spends less time on the phone or sending e-mail for routine cases. And most importantly, the patient receives an exceptional restoration that meets his or her expectations. In the end, the true measure of a great relationship between the dentist and the laboratory is happy patients who refer friends and family to your practice for years to come.

Communication↗
PubMed2006

How to utilize benchmarking in the clinical laboratory.

Benchmarking of clinical laboratory activities has become a tool used increasingly to enable administrators and managers to obtain an independent evaluation of the performance of the laboratory and identify opportunities for improvement. Benchmarking is particularly important because of the diversity and complexity of the various sections of the laboratory. The critical component of laboratory benchmarking is peer comparison, as solutions to shortcomings or problems can be titrated and planned through this process. The reliability of benchmarking must be supplemented and modified by the input of the manager's detailed understanding of local circumstances. At this critical moment, the changes in peer review strategies instituted by JCAHO, CAP, CLIA, and individual states create an urgent opportunity to assist medical directors and laboratory managers in maintaining an overview of the performance and quality of laboratory operations. Unannounced site visits will require prompt reports and alerts of undesirable changes in performance. The future goals of benchmarking must expand to include surveys of laboratory test utilization and patient outcomes as ultimate measures of test utility in the clinical process and important assessments of the quality of patient care.

Benchmarking↗
PubMed2006

An audit of the laboratory service provided to the Health Service Executive Orthodontic Department, St James Hospital, Dublin.

PURPOSE OF THE STUDY: To evaluate the service purchased from contracted orthodontic laboratories used by HSE (SWA) regional orthodontic unit, St. James's Hospital, Dublin and identify deficiencies in the current service. MATERIALS AND METHODS: A data collection questionnaire was designed and distributed to the departmental orthodontists for a period of three months (October-December 2004). Gold standards, drawn up based on the authors' ideal requirements and published guidelines, were supplied to grade the work returned. RESULTS: During the study period 363 items of laboratory work were requested. 20% of the laboratory work arrived late and most of the delayed work was delayed for more than 24 hours. Most laboratory delays occurred with functional appliances, retainers and study models. Prior to fit, 20% of the appliances required adjustments for more than 30 seconds. 65% of laboratory work returned to the department met all of the gold standards. 10% of appliances were considered unsatisfactory. Functional appliances were most often ill fitting accounting for almost half of the unsatisfactory laboratory work. CONCLUSIONS: The majority of the laboratory work returned to the department met our gold standards and arrived on time. Forty six percent of the appliances required adjustments. Functional appliances required the most adjustments; one in five of all functional appliances ordered were considered unsatisfactory.

Dental Audit↗
PubMed1991

The Air Force's central reference laboratory: maximizing service while minimizing cost.

The Laboratory Services Branch (Epi Lab) of the Epidemiology Division, Brooks AFB, Texas, is designated by regulation to serve as the Air Force's central reference laboratory, providing clinical laboratory testing support to all Air Force medical treatment facilities (MTFs). Epi Lab recognized that it was not offering the MTFs a service comparable to civilian reference laboratories and that, as a result, the Air Force medical system was spending hundreds of thousands of dollars yearly for commercial laboratory support. An in-house laboratory upgrade program was proposed to and approved by the USAF Surgeon General, as a Congressional Efficiencies Add project, to launch a two-phase initiative consisting of a 1-year field trial of 30 MTFs, followed by expansion to another 60 MTFs. Major components of the program include overnight air courier service to deliver patient samples to Epi Lab, a mainframe computer laboratory information system and electronic reporting of results to the MTFs throughout the CONUS. Application of medical marketing concepts and the Total Quality Management (TQM) philosophy allowed Epi to provide dramatically enhanced reference service at a cost savings of about $1 million to the medical system. The Epi Lab upgrade program represents an innovative problem-solving approach, combining technical and managerial improvements, resulting in substantial patient care service and financial dividends. It serves as an example of successful application of TQM and marketing within the military medical system.

Cost-Benefit Analysis↗
PubMed1990

Assessment of patient laboratory data in the acutely ill.

Laboratory test results are a valuable source of information. Nurses need to assess laboratory test results as part of the physical assessment of their patients. Comparison of laboratory test results and changes with abnormal physical findings provides the basis for changes in the nursing care plan. Progressive monitoring of laboratory results and prompt interventions might lessen the seriousness of the health problem. In acute care units, the initial group of laboratory tests serves as a baseline for assessing additional test results. Several reference values should be remembered, particularly the electrolytes (potassium, sodium, and calcium), glucose, BUN, creatinine, and albumin. Specific group profiles assist in identifying and in monitoring the patient's health status. Incorporating laboratory test results into the plan and evaluation of care will result in safer and more effective patient care. Referring to laboratory test findings and comparing them with physical assessment findings are required for the delivery of professional nursing care.

Acute Disease↗