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A relatively small percentage of hospitals have fully integrated systems. The term "completeness of record" takes on entirely new meaning. Vendors play critical role in the new world of electronic data capture.
Since there was a scientific need to conduct electrophysiology measurements to detect possible ocular (electroretinography, ERG), central neurotoxic (quantitative electroencephalography, qEEG), and cardiac (electrocardiography, ECG) effects in animals used in certain regulatory studies, the acquisition of suitable automated PC software systems were required. This article describes the process by which these systems were validated to ensure that they met the scientific requirements, while also addressing the principles of Good Automated Laboratory Practices (GALP). After a thorough search of existing commercial packages, a plan was developed specific for each PC-based collection system selected for evaluation. The common elements of each plan included consideration of both scientific and GALP elements, such as necessary biological response variables, raw data acquisition and identification, acceptance criteria, security, protection, storage media, data integrity, audit requirements and standard operating procedures. The authors' approach to validation for each electrophysiology system was to determine scientific needs for accuracy, precision, and detection limit of biological effects concurrent with GALP requirements. The selected software systems were employed in separate scientific GLP studies conducted in dogs, rats, and mini-pigs to demonstrate the ability to detect cholinesterase effects due to multiple infusions of physostigmine, based on parallel measurement of cholinesterase biomarkers. Since the systems were designed for human usage, certain adaptations were necessary. A critical assumption to be tested was the ability of the system's algorithms to adequately capture and assimilate the data in an accurate fashion. Concomitantly, the related GALP needs, such as data integrity, security, CD-ROM archive, and personnel training requirements were evaluated, implemented, and defined to accommodate the application and process needs. The biological approach to validation of these PC-based electrophysiology systems met the necessary scientific acceptance criteria as well as compliance requirements in order to be used in regulatory studies.
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The overall purpose of this study was to explore nurses' feelings about the applicability and adequacy of a pilot model of nursing assessment (PMNA) developed for coronary care units (CCU) in order to obtain data that could help in establishing a definitive model. The evaluation, performed by 11 CCU nurses, showed that they considered the development and implementation of PMNA as valuable, and that its design was adequate for interviewing cardiac patients. These results will be employed in the elaboration of a definitive model of nursing assessment.
An aminoglycoside dosing service (ADS) has been in existence at the Hospital since 1984. As part of an overall Quality Assurance (QA) plan for the service, an audit was conducted to ensure that all necessary data were available to allow for proper interpretation of the serum aminoglycoside levels. The initial audit revealed complete documentation of required data in 75% of PRE-dose levels and 63% of POST-dose levels drawn. Several problems were identified: staff were not aware of procedures on how to complete the serum antibiotic level requisition forms; inaccurate assumptions of infusion times were made by pharmacists; and discrepancies were found to exist in the Hospital's Laboratory Manual and Pharmacy Intravenous Medication Manual. Corrective action was initiated through: education on proper documentation on the serum antibiotic level requisition forms through the hospital-wide distributed Pharmacy Bulletin; revision of the Hospital's Laboratory Manual and Pharmacy Intravenous Medication Manual; communication with head nurses to emphasize the need for documentation of infusion times; and active follow-up with nurses on missing information by the clinical pharmacist. A re-audit was initiated following implementation of the corrective actions. Complete documentation of required data increased to 93% with PRE-dose levels and 84% with POST-dose levels. This improvement was statistically significant (p less than 0.001).
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Quality improvement for cardiac surgery focuses on perfusion services. National and regional projects are taking a closer look at morbidity and mortality associated with extracorporeal perfusion. Find out how researchers in New England are gathering and using data to give a detailed picture of risks the life-saving technology may introduce.
A hospital pharmacy department's experience in selection and use of indicators for measuring quality of care is described. At a 410-bed community teaching hospital, indicators were selected that would use data the department was already collecting. For the first indicator, "Patients on total parenteral nutrition (TPN) experiencing acid-base disorders," the goal was for no more than 20% of patients on TPN to have blood pH values outside the normal range, but 35% of patients were found to be outside the range. The standard TPN formula was examined and changed, after which only 16% of patients had pH values outside the normal range. For the second indicator, "Patients on TPN having negative nitrogen balance results," and the next two indicators, based on data available from the department's pharmacokinetics service, a similar process was followed. The department next examined incident reports and adverse drug reaction reports, categorized the drug-related problems represented, and established the indicator, "Patients on [nursing unit X] experiencing category 4 drug-related errors." Problems with indicator use included determining how an indicator relates to the quality of care and knowing how to analyze the data once they are collected. To maintain stature within their institutions by helping with the overall quality improvement effort, pharmacy departments need to expeditiously institute the use of indicators.
This study examines the incidence in Australia of "serious" occupational injuries, arbitrarily defined as those which resulted in absence from work for six months or more. The raw data were contained in computer print-outs specially prepared by the State offices of the Australian Bureau of Statistics (ABS) and the study includes analyses by age, sex, occupation and industry of the injured person. The unexpectedly large total of 14,281 high-severity injuries cannot be supported with confidence since the principal finding was the large and consistent variation in injury rates between the States. For males, the overall injury rates (per 10,000 persons) for Victoria, South Australia and Tasmania were in the range 11 to 16: those for Queensland and Western Australia were in the high 30s; whilst that for New South Wales exceeded 50. A similar ranking of injury rates prevailed in almost every subset. The highest rates arose in New South Wales, Queensland and Western Australia in six of the seven occupation groups, in nine of the ten industry groups and in all eleven age groups. It is difficult to find any scientific explanation for these variations in terms of levels or extent of exposure to risk. In the opinion of this author, these variations should be attributed to differences in the institutional arrangements for the coverage, collection and/or compilation of compensation data.(ABSTRACT TRUNCATED AT 250 WORDS)