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Developing key laboratory performance indicators: a feasibility study. Potential roles for CLMA.

The challenges (and opportunities) for laboratory management posed by cost control, managed care, information networks, and health system integration call for both short- and long-term responses. In rapidly evolving markets, new measures are needed to assess how effectively laboratories manage the information process. The objective of the research described in this report was to determine the feasibility of a system that would collect, analyze, and report nationally standardized indicators of laboratory performance and that would meet the needs of health system executives, managed care plans, and external agencies, as well as laboratory service providers. The feasibility study involved extensive interviews with a broad cross-section of the health-care industry, as well as a literature search of journals, newspapers, marketing brochures, and other documents addressing comparative performance assessment in the health-care industry. The study investigated the current status of comparative performance assessment in the health-care industry. We found that there are several important lessons laboratorians can learn from the experiences of others involved in key indicator development and performance assessment: Key indicators must measure those aspects of performance that are important and meaningful to laboratory customers. Indicators developed for laboratory management performance should be compatible with performance criteria established in other health-care sectors, particularly those that represent managed care and other customers of laboratory services. The identification of participants in the process of consensus development should be as inclusive as possible if the indicators are to gain wide acceptance. Standardized definitions and data collection rules are essential for data comparability. Credibility is key. It is necessary that the chosen measures be not only reliable, valid, and easy to implement, they must also be demonstrably related to patient care outcomes. In order to make meaningful interlaboratory comparisons, an effective system for peer groupings is also required. Currently available systems for collecting and reporting laboratory performance data were also reviewed.(ABSTRACT TRUNCATED AT 400 WORDS)

Clinical Laboratory Information Systems↗

Restructuring of laboratory services at the Detroit Medical Center. Process and outcomes.

Following an era of "do more, earn more," the health-care industry, including physicians and hospitals, has been faced with cost-containment measures. With this in mind, the Detroit Medical Center (DMC) embarked on a laboratory consolidation initiative to achieve this objective in 1985. The DMC entered into a partnership with Damon Clinical Laboratories, forming Damon Clinical Laboratories at the Detroit Medical Center. This partnership resulted in the consolidation of laboratory services within the DMC and the establishment of an outreach activity. In December 1992, it was decided that the partnership would be dissolved, with the DMC assuming full ownership and responsibility for the management of laboratory services. Thus, DMC University Laboratories was created and is currently in its third year of operation. This article presents how the decision to consolidate laboratory services within the DMC was made, along with the process and outcomes of consolidating the operations of seven hospital laboratories.

Communication↗

Implementing complex networking laboratory information systems in a health maintenance organization.

Kaiser Permanente, Northern California Region (KPNCR) currently consists of 17 medical centers and 28 medical office building clinical laboratories plus a large, centralized reference laboratory. Before 1977, KPNCR processed laboratory information manually. With the opening of the Kaiser Permanente Regional Laboratory in Berkeley in 1977, a card punch system was used to capture that laboratory's data. In 1985, the Regional Laboratory installed a mini-mainframe system. In 1990, KPNCR Implemented a Region-wide Integrated Laboratory Information System. The software used was manufactured by Cerner Corporation, Kansas City, Missouri. The hardware platform consisted of for DEC VAXs. The decision was based on flexibility, supportability, and well established customer base. Work on the database began in September of 1991. The first "go-live" was in August of 1992. All facilities--46 laboratories--were "live" by February of 1995. Total implementation time was 27 months.

California↗

Benchmarking hospital laboratory financial and operational performance.

The movement toward more integrated delivery systems requires hospital administrators, medical staffs, and health care network organizations to consider strategies that will meet the future challenges facing laboratory services. Many health care experts predict that the number of hospital inpatient days, staffed acute care beds, and length of stay will continue their precipitous decline, and then stabilize during the next four to five years. Hospitals should carefully evaluate how their laboratories might be affected as a result of the decline in inpatient services and the integration of health care services at all levels. Hospital executive management must find a way to manage staffing levels and technical resources in order to maintain quality patient services in the face of declining test volume. This Special Report discusses relevant benchmarks intended to help hospital administrators and laboratory directors identify "best practices" in hospital laboratories so that comparisons of patterns of care and financial operations can be made. Benchmarking the relative financial and operational performance of hospital laboratories allows health care planners to design the most appropriate laboratory services delivery system for future hospital inpatient and outpatient market demands. Factors influencing financial and operation performance will be investigated, including utilization, testing costs, staffing mix, productivity, and organizational structure. This will be followed by a discussion on the future of laboratories and the trend toward regional laboratories owned by hospital consortiums.

Clinical Laboratory Techniques↗

External quality assessment scheme and laboratory accreditation in Indonesia.

The National Program on External Quality Assessment Scheme (NEQAS) in Indonesia was first started in 1979, organized by the Indonesian Ministry of Health collaborating with professional bodies. The first trial was for clinical chemistry test with 2 cycles per year, followed by the hematology NEQAS in 1986 in collaboration with WHO-Royal Post Graduate Medical School London. After that, the schemes for serology, microbiology and parasitology were also organized. Around 500-600 laboratories throughout Indonesia participated each year in these quality control schemes, 2-4 cycles per year. Samples would be sent to participants and results will be given back to each laboratory. Poor performers should participate in the workshop or training course conducted by the Central Health Laboratory to improve their results. Participation in this NEQAS is mandatory for obtaining the laboratory license, and the Ministry of Health uses these schemes as one of the means for monitoring and coordinating the performance of laboratories throughout Indonesia. There are also some other EQAS (External Quality Assessment Scheme) programs conducted by professional bodies, such as for hemostasis, clinical chemistry and serology. During the course of conducting these schemes, it could be observed that manual methods were gradually changed to the automatic methods, especially for the clinical chemistry and hematology laboratories, which counts also for improvements of their results. Since the last 6 years, the Ministry of Health also began to conduct the Accreditation System evaluation for hospitals, including the laboratory departments. There are 7 standards that were evaluated, such as the aspect of the organization, administration and management, staffing, facilities and equipment, standard operating procedures, research and developments and quality control. This accreditation program is still in progress for all public and private hospital laboratories.

Chemistry, Clinical↗

Toxoplasmosis and laboratory workers: a case-control assessment of risk.

The health risks to staff employed in a toxoplasma reference unit were studied. Sixteen laboratory staff exposed to Toxoplasma gondii and age/sex-matched controls from the general population and a routine microbiology laboratory were assessed. Multiple assays were performed to establish the presence of toxoplasma infection, and laboratory workers were questioned regarding environmental and work-related exposure to the parasite. Details of all of environmental exposure to toxoplasma between the two groups of laboratory personnel, and seroprevalence rates were comparable in all three groups. Three laboratory accidents were recorded, a rate of one per 9300 hours exposure. One case of presumed work-related infection was identified, but significant illness was not observed. Given adequate training, strict adherence to conventional laboratory protocols and medical supervision, laboratory accidents are infrequent and work-associated toxoplasma infection is uncommon. The risks associated with occupational exposure to T. gondii have been over-estimated and we conclude that this organism does not represent a significant health hazard to laboratory technicians.

Case-Control Studies↗

[What laboratories in hospitals should be?--report from a teaching hospital].

The author gave personal opinions regarding what the clinical laboratory in a teaching hospital should be. It is very important to raise the level of medical care and maintain it in city hospitals. The success of teaching programs depends on a high level of medical care. The author would like to emphasize several policies for the management of the clinical laboratory: 1) establishment of routine works, considering that the field of the clinical laboratory is "from patient to patient", not "from receipt to report", 2) change of the position on medical care from one of support to one of connection, 3) use of intelligence and arts (technologies) that medical technologists and laboratory physicians have acquired through the practices of the clinical laboratory, for example, quality control, system making, objective analysis of data, high mobility, etc., and 4) teaching the methods of the clinical laboratory to young trainees and professionals. The clinical laboratory in a hospital should contribute to raising the level of medical care, and medical technologists and laboratory physicians should perform tasks with spirit, humility and responsibility as professionals.

Clinical Laboratory Techniques↗

Mentoring for retention and advancement in the multigenerational clinical laboratory.

Retention of recent graduates and other laboratory practitioners in the workplace will play a key role in addressing current and projected shortages of clinical laboratory scientists (CLS) and technicians (CLT). In addition, with overrepresentation of the aging Baby Boomer generation in laboratory supervisory and management positions, it is crucial not only to retain younger practitioners, but to prepare them for assuming these important functions in the future. Mentoring, a practice commonly employed in other professions, is widely considered to be useful in employee retention and career advancement. Mentoring has probably been used in the clinical laboratory profession, but has not been well documented. In the clinical laboratory environment, potential mentors are in the Veteran and Baby Boomer generations, and new practitioners who could benefit from mentoring are in Generation X. Generational differences among these groups may present challenges to the use of mentoring. This article will attempt to provide a better understanding of generational differences and show how mentoring can be applied in the setting of the clinical laboratory in order to increase retention and promote career advancement of younger practitioners. A panel of five laboratory managers provided examples of mentoring strategies. Definitions, benefits, and examples of mentoring are addressed in the accompanying article, "Passing the Torch: Mentoring the Next Generation of Laboratory Professionals".

Cultural Diversity↗

Risk factors of job-related depression in laboratory technicians in Hospital Universiti Sains Malaysia (HUSM) and Kementerian Kesihatan Malaysia (KKM) hospitals in Kelantan.

A cross-sectional study was conducted to determine the risk factors of job-related depression in laboratory technicians in Hospital Universiti Sains Malaysia (HUSM) and Kementerian Kesihatan Malaysia (KKM) Hospitals in Kelantan, between September 2001 and February 2002. One hundred and two laboratory technicians from HUSM and 79 from KKM Hospitals were selected and 84 (82.4%) from HUSM and 71 (89.9%) from KKM Hospitals were recruited as study subjects. Data were collected by self-administered questionnaire using the validated Malay version of the Job Content Questionnaire (JCQ), originally developed by Robert Karasek. The results indicated significant associations between the risk factors of job-related depression, and low social support, and high psychological demands (OR 3.0, 95% CI 1.1-8.8) in laboratory technicians in HUSM. However, for laboratory technicians in KKM Hospitals, the significant association was between job-related depression, and low social support and low decision authority (OR 9.7, 95% CI 1.1-91.1). Low social support was highly associated with job-related depression in laboratory technicians in HUSM and KKM Hospitals. We, therefore, conclude that low social support positively predicted depression in laboratory technicians in HUSM and KKM Hospitals. In addition, high psychological demands also significantly predicted depression in laboratory technicians in HUSM; however, for laboratory technicians in KKM Hospitals, low decision authority was the significant predictor of depression.

Adult↗

[Analysis of the competences of workplace inspecting laboratories for the determination of free crystalline silica (FCS), based on proficiency testing results].

BACKGROUND: The aim of the study was to evaluate and analyze the technical competences of workplace inspection laboratories for the determination of free crystalline silica (FCS). MATERIAL AND METHODS: The study was based on the results of two series of control determinations carried out under the proficiency testing scheme in 2005 and the outcome of the questionnaire on analytical details and the quality system of laboratories. The mean values of proficiency indicies and the frequency of the obtained satisfactory performances were adopted as the basis of laboratory competences comparisons. RESULTS AND CONCLUSIONS: In total, 138 laboratories participated in the study, including 104 laboratories covered by one series and 34 by both series of determinations. Satisfactory technical competences were found in 77% of laboratories, regardless of their type and analytical methods applied. It was shown that the positive proficiency appraisal was linked with the regular application of quality control methods, i.e. internal control of FCS determination quality, the participation in laboratory proficiency testing and laboratory accreditation. The analytical equipment and mode of determining crystalline silica with use of the chemical method had no significant effect on the analytical performance.

Air Pollutants, Occupational↗

Control of laboratory acquired hemorrhagic fever with renal syndrome (HFRS) in Japan.

By the end of 1985, 126 human cases of laboratory acquired hemorrhagic fever with renal syndrome (HFRS) were recorded in Japan. Seroepidemiological studies revealed that laboratory rats exhibited high IFA titers against Hantaan or related viruses at locations where HFRS patients occurred. Laboratory researchers contracted HFRS more frequently than laboratory animal technicians or caretakers, although a laboratory animal caretaker died of the disease. Inhalation of HFRS-virus contaminated air in an animal facility is the likely cause of infection with this virus. Wound infection during animal experiments may be another important route of infection. Infection of laboratory rats can occur by transferring animals from contaminated to other animal facilities. Tissue fragments or cells of transplantable animal tumors are a potential source of spreading the HFRS virus. Eradication of HFRS virus from a contaminated animal facility can be achieved best by elimination of all animals in the room, especially when human HFRS is associated with an infected colony. In some cases, when IFA titers of the sera of the rats tested were low, infection apparently disappeared without instituting any particular control measures other than ordinary procedures for care and management of laboratory animals. HFRS viruses have not yet been eradicated from all animal facilities in Japan. Therefore, serological monitoring of laboratory rats continues.

Animals↗

Data management in the vascular laboratory.

As the clinical workload in the vascular laboratory increases and as the demand for additional documentation by hospital oversight committees and outside agencies grow, the need for computerized data management will become obvious. Although there are no generic, broadly applicable software programs to automate the laboratory's operations, applications can easily be developed using any of the current database programs to meet the needs of most laboratories. Fortunately, the intense competition in the microcomputer industry has recently made very powerful systems that are capable of providing the necessary computing support increasingly affordable. Such systems can be very simple or incredibly complex depending on the available local expertise and each laboratory's specific needs. In addition to facilitating the laboratory's daily operations, such a system will inevitably expedite the implementation of the laboratory's quality assurance program and will maximize utilization of existing personnel. This type of cost-effective solution to the ever-increasing demand for service will become increasingly important in maintaining the laboratory's fiscal viability. Although the prospects of undertaking such a task might seem daunting, especially to the computer novice, it is important to begin. Keep the system simple, at first, and allow it to develop as local expertise and confidence develop. The only prospect more frightening that sitting down to develop a computerized system for managing the laboratory's data, is the prospect of trying to continue without one!

Clinical Laboratory Information Systems↗

[Laboratory testing virtually centralized to benefit both patients and drug research].

Laboratory analyses in multicentre safety studies of new drugs usually are performed in central laboratories outside the Netherlands. Patient care requires local (hospital) laboratory tests. In the so-called Virtually Centralized Laboratory the Dutch local laboratories report their results after data communication and data transformation in such a way that they seem to form one laboratory. The local analytical results are transformed by calibrating the local methods using standard preparations, thus reducing the inter laboratory variation. This concept may lead to one set of national reference values for all general clinical chemical and haematological laboratory tests.

Blood Chemical Analysis↗

[Evaluation of the reliability of serological diagnostic tests for Mycoplasma pneumoniae infection carried out by laboratories in sanitary epidemiological stations (WSSE)].

In the action undertaken for evaluating of the reliability of serological tests for M. pneumoniae infection 33 laboratories of the Sanitary Epidemiological Stations participated. Every laboratory had to determine twice at an interval of 2-4 weeks the level of mycoplasma antibodies by the complement fixation test in serum samples divided into 4 groups: sera not containing these antibodies-titre < 5, or containing them in titres of 60, 120 and 320. The correct results of the determinations were obtained in 27 laboratories (81.8%) for samples without M. pneumoniae antibodies, and in 22 (66.6%) and 14 (42.4%) for samples with titres of 60 and 120, and 320 respectively. Only 4 laboratories (12.1%) obtained correct results of these determinations for every sample and in both testing series. In these series considered separately correct results were obtained in 9 (27.3%) and 8 (24.2%) laboratories. Faulty results in all samples in both testing series were reported from 2 (6.1%) laboratories. In the individual series all false results were obtained in 4 (12.1%) and 3 (9.1%) laboratories. The study showed that for raising of the quality and reliability level of serological investigations for M. pneumoniae infection a permanent practice should be periodic training of laboratory workers and frequently repeated interlaboratory controls of the reliability of test results.

Bacteriology↗

Investigating clandestine drug laboratories: adverse medical effects in law enforcement personnel.

A retrospective cohort study was conducted among an international group of 46 law enforcement chemists and 13 Washington State clandestine drug laboratory investigation team members with more than 2,800 combined investigations. Each participant completed a questionnaire concerning previous drug laboratory investigations and adverse health effects during response activities. Methamphetamine laboratories accounted for 81-97% of all responses. Total illness incident rates varied between 0.75-3.4% of responses. Most exposures were through inhalation, and many occurred in the years prior to use of personal protective equipment. Symptoms were primarily those of headache and respiratory, mucous membrane, and skin irritation. Most illness episodes occurred during the processing phase of laboratory responses, and none occurred during the entry phase. A majority of illness episodes occurred in laboratories with leak/spills, fire/explosion, or uncontrolled reactions. Responding to an active laboratory was associated with a 7 to 15-fold risk of becoming ill as compared with setup, in-transit, or former (equipment removed) laboratory responses. No other laboratories characteristics were consistently associated with a significantly elevated relative risk of adverse health effects.

Accidents, Occupational↗

Mortality and cancer incidence in biomedical laboratory personnel in Sweden.

BACKGROUND: The work in biomedical laboratories is associated with exposure to a mixture of known and potential chemical carcinogens, mutagens, and teratogens. Previous studies have suggested an excess of brain tumors and hematopoietic system malignancies as well as breast cancers in women. METHODS: This retrospective cohort study investigated the standardized mortality ratio (SMR) and the standardized incidence ratio (SIR) for cancer in biomedical research laboratory personnel in Swedish universities 1970-1992. The cohort comprised 5,035 laboratory and, as an internal reference group, 2,923 nonlaboratory employees. RESULTS: The overall death rate was lower in both groups than in the general population. The SIR for brain tumors among male laboratory workers was 1.69 (0.62-3.68) and among male laboratory scientists, after more than 10 years of work (4 cases), it was 3.11 (0.85-7.56). There was an elevated SIR for malignant melanoma among female scientists in laboratories (3.51, 0.96-8.98) and for male scientists in nonlaboratory departments (2.86, 1.05-6.22). The SIR for breast cancer among female laboratory scientists was 1.62 (0.78-2.98). CONCLUSIONS: The present findings lend some support to an excess of brain tumors among male scientists and of breast cancer in female scientists in biomedical research laboratories.

Adult↗

Specimen adequacy evaluation in gynecologic cytopathology: current laboratory practice in the College of American Pathologists Interlaboratory Comparison Program and tentative guidelines for future practice.

Routine specimen adequacy evaluation, as advocated by The Bethesda System (TBS), can play an important role in improving the sensitivity and accuracy of cervical cytopathology screening. The effectiveness of this measure, however, has been limited by the lack of uniform criteria for adequacy. Practice parameters are now emerging, through TBS development of tentative criteria and interlaboratory comparison of adequacy practices. This study reviews 1) nationwide responses to surveys of laboratory practices in the College of American Pathologists Interlaboratory Comparison Program in Cervicovaginal Cytology (CAP PAP); 2) the definitions of adequacy based on TBS; and 3) the results of implementation of these criteria in a private independent laboratory, university hospital laboratory, and private nonprofit hospital laboratory. In the initial CAP PAP survey in 1990, 35% of responding laboratories routinely reported specimen adequacy, increasing to 66% in 1991 and 85% in 1992. Interlaboratory variations in adequacy practices were observed, however, underscoring the need for consensus criteria. The experience in the authors' laboratories indicates that TBS criteria can serve as a sound guideline. Effective implementation of adequacy assessment in the individual laboratory requires careful attention to ensuring the quality of adequacy ratings, correlating clinical and prior laboratory information, issuing clear and concise reports, and giving recommendations judiciously. Through interlaboratory comparison and consistent intralaboratory emphasis on specimen adequacy, greater uniformity of adequacy assessment can be achieved, and adequacy evaluation can achieve its promise of improving the quality of cervical cytopathology.

Clinical Laboratory Techniques↗

Basic principles of laboratory safety.

Laboratory safety is a concern to scientific personnel conducting research or safety testing, laboratory directors responsible for institutional liability for employees, and to individuals working or residing near the laboratory. A strategy for safe laboratory operations requires an understanding of industrial hygiene, engineering, and the regulations associated with the use of hazardous chemicals. This review describes many of the basic principles involved in laboratory safety. It provides general information on the use of personal protective equipment, selection of laboratory safety equipment, laboratory design, disposal of hazardous waste, and the regulations and guidelines affecting laboratory operations.

Accident Prevention↗