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Study offers solutions for bottlenecks: treat and move patients in record time.

The Clockwork ED Series on Eliminating Bottlenecks and Delays, developed by the Clinical Initiatives Center in Washington, DC, identified best practices for expediting admission and reducing wait times to see a physician and receive ancillary services. With bed control bypass, ED nurses fax or tube reports to inpatient nurses and send patients directly to inpatient beds. By giving ED physicians the authority to start the admission process, turnaround time for admits in Alton Ochsner Medical Foundation's ED in New Orleans was reduced from 5.5 hours to 2.8 hours. Implementing a "zero tolerance" policy for empty ED beds increases satisfaction and reduces wait times. Your ED should have a place for patients other than the waiting room, such as an observation unit.

Appointments and Schedules↗

Computer systems for facilitating management of the critically ill.

The Shock Research Unit has applied computer technology to the care of the critically ill and injured patient since 1961. The requirements for patient monitoring were initially explored with a process control computer (IBM) 1710). In the current system, a Xerox Sigma-5 computer is utilized for monitoring EKG, hemodynamic, respiratory, and biochemical signals. Electronic preprocessing increases the efficiency and speed of data acquisition and signal analysis. Provisions are made for recording narrative data as part of a commitment to evolve an automated patient record. Bedside displays include both tabular and graphic summaries of patient status and trends. A computer accessible archive of patient files is maintained. Clinical operation of the system has been facilitated by automation of afferent and efferent functions including flushing of catheters, servo-calibration of pressure measuring systems, automated urine collection and disposal, and computer controlled infusion of fluids and medications. We anticipate the continuing development of automated afferent and efferent components for feedback control of ventilators by automated sampling and measurement of arterial blood gases and infusion of fluids and medications in response to changes in monitored hemodynamic variables. Such automation, together with medical intelligence for priority alarms and interpretive displays, hold promise of increasingly potent and cost-effective systems to facilitate and improve care of the critically ill or injured patient.

Blood Gas Analysis↗

Interdisciplinary, functional approach to quality review.

Dramatic changes in the standards of the Joint Commission on Accreditation of Healthcare Organizations, as part of its "Agenda for Change," pose new challenges for health care managers. The goal of the "Agenda for Change" is to focus accreditation on the actual performance of important functions while continuously stimulating improvement in the organization's performance and outcomes of care. In 1994, seven important functions--improvement of performance, leadership, management of information, assessment of patients, education of patients and families, operative and other procedures, and treatment of patients--were identified by JCAHO. Performance, as defined by JCAHO, can be measured through observing specific dimensions, such as, availability, safety, timeliness, effectiveness, continuity, efficiency, and respect and caring. These are considered important elements in the determination of quality, value, cost, and patient outcome. In 1995, JCAHO identified 11 important functions--patient rights and organizational ethics, assessment of patients, care of patients, education, continuum of care, improving organizational performance, leadership, management of the environment of care, management of human resources, management of information, and prevention and control of infection. In addition each institution has the opportunity to decide by prioritization where it wants to devote resources. This article reports on one hospital's response to the new JCAHO initiatives.

Cardiology Service, Hospital↗

[Quality of medical records in the "Medical Information System Program": application of the lot quality assurance sampling method].

BACKGROUND: The aim of this study was to validate a new method of quality control of medical records of the "Medicalisation of Information System Program" (P.M.S.I.) in Limoges university hospital. METHODS: Lot quality assurance sampling (L.Q.A.S.), developed to meet industrial quality control needs, has been applied. This method allows to give an opinion on the quality of a lot from a sample randomised in this lot. Ten hospital units have been randomised. During three months, these medical units have recoded ten medical units abstracts (R.U.M.) which were randomised each month within their stays. If five or more R.U.M. had been modified on Principal Diagnosis (D.P.), Associated Significant Diagnosis (D.A.S.) or Diagnosis Related Group (D.R.G.), the lot was rejected. The hospital unit had then less 70% R.U.M. of good quality (alpha=5%). The global errors rates were compared to the results of usually performed quality control (1998). RESULTS: Nine hospital units were included. Hospital units which already had a low quality rate during the 1998 quality control had also an insufficient quality by L.Q.A.S. method. Among these, 33.7 [CI(95%): 21.6-45.8] R.U.M. have been modified. Medical units had a poorer data quality than surgical ones. No statistically significant difference was shown between 1998 errors rates and L.Q.A.S. rates, except for D.P. (p=0.002). CONCLUSION: L.Q.A.S. is easy to apply, could be repeated more frequently than usual controls, and allows to detect hospital units which require a faster action. This process could be applied to P.M.S.I., in which the search of quality is necessary because of the new cost model which includes secondary D.R.G.

Abstracting and Indexing↗

Developing case management plans using a quality improvement model.

Case management plans are viable tools currently used to control healthcare cost and improve quality. The authors present a quality improvement-case management framework to guide nursing and hospital administrators in the development of these plans and to answer any questions they might raise while struggling through the process.

Forms and Records Control↗

Control charts to monitor rates of adverse drug reactions.

We describe the use of control charts in monitoring rates of adverse drug reactions. Adverse drug reactions are recognized as important outcomes of patient care and are specifically associated with the process of medication use. The systematic monitoring of adverse drug reactions may allow one to identify opportunities to improve this process. Reported adverse drug reactions from 36 consecutive months at a university hospital were analyzed. The mean rate of adverse drug reaction reporting was 1.65% (denominator of patient admissions) and the 3 sigma upper and lower control limits were 3.22% and 0.08%, respectively. The mean rate of preventable adverse drug reactions was 21.25% (denominator of total reported adverse drug reactions) and the 3 sigma upper and lower control limits were 73.54% and < 0%, respectively. The experience described in this report suggests that monitoring adverse drug reactions using control charts, facilitates identification of trends in reporting and the actual incidence of adverse drug reactions, and allows identification of opportunities to improve the systems and processes of medication use.

Adverse Drug Reaction Reporting Systems↗

A controlled experiment to evaluate the use of a time-oriented summary medical record.

A randomized single-blind experiment was done in a medical subspecialty clinic in order to determine whether a flow-sheet type of summary medical record could validly serve as a means to communicate clinical information in the absence of the traditional medical record. Two groups of outpatient physician-patient encounters were compared: In the 68 study encounters (Group S), physicians were given a flow-sheet summary record with the option to receive the standard medical record if they desired; in the 27 control encounters (Group C), physicians were given the standard medical record plus the flow-sheet summary record. Fifty-nine per cent of study-group physicians did not choose to receive the full medical record. The study group was found not to differ (p = 0.013) from controls significantly with regard to the follow-up of clinical information as measured by pre- and post-encounter chart review. Physician providers in the study group were unable to detect by retrospective chart review overlooked clinical information with greater frequency than control group providers. We conclude that a flow-sheet type of summary medical record can serve as the sole source of clinical information in a substantial number of outpatient follow-up encounters in a medical subspecialty clinic without deterioration in the communication of clinical information.

Ambulatory Care Facilities↗

A hierarchical approach to coding chemical, biological and pharmaceutical substances.

This hierarchical coding system is designed to classify substances into successively subordinate categories on the basis of chemical, physical and biological properties. Although initially developed for occupational cancer epidemiological studies, it is general in nature and can be used for other purposes where a systematic approach is needed to catalogue or analyze large numbers of substances and/or physical properties. The coding system incorporates a multi level approach, where substances can be coded both on the basis of function and composition. On the first level, a three digit code is assigned to each substance to indicate its primary use in the occupational environment (e.g. pesticide, catalyst, adhesive). Substances can then be coded using a ten digit code to indicate structure and composition (e.g. organic molecule, biomolecule, pharmaceutical). Depending on the complexity required, analysis can incorporate the three digit code, ten digit code, or a combination of both. The approach to coding both chemical and biological agents is modeled in part after conventional approaches used by the International Union of Pure and Applied Chemists (IUPAC) and the International Union of Biochemists (IUB). Development of the coding system was initiated in the 1980's in response to a need for a system allowing analysis of individual agents as well classes or groups of substances. The project was undertaken as a collaborative venture between the BC Cancer Agency, Cancer Control Research program (then Division of Epidemiology) and the Department of Chemical and Biological Engineering at the University of British Columbia.

Drug-Related Side Effects and Adverse Reactions↗

Injury coding and hospital discharge data.

Data are currently inadequate to develop, implement, and evaluate injury prevention and control programs in the United States. Information about cause of injury, which is available for fatal injuries, is rarely available for severe nonfatal injuries. Although hospital discharge data systems contain much of the important information needed for injury prevention and control programs, they rarely are coded with information about the external cause of injury (E codes). E-coded hospital discharge data systems are potentially one of the most effective and feasible means available to collect data needed to prevent and control injuries. We recommend that E codes be required elements in hospital discharge data systems, that separate fields for E codes be created, and that E-code definitions and guidelines be developed.

Abstracting and Indexing↗

PREDICT: A simple risk score for clinical severity and long-term prognosis after hospitalization for acute myocardial infarction or unstable angina: the Minnesota heart survey.

BACKGROUND: We evaluated short- and long-term mortality risks in 30- to 74-year-old patients hospitalized for acute myocardial infarction or unstable angina and developed a new score called PREDICT. METHODS AND RESULTS: PREDICT was based on information routinely collected in hospital. Predictors abstracted from hospital record items pertaining to the admission day, including shock, heart failure, ECG findings, cardiovascular disease history, kidney function, and age. Comorbidity was assessed from discharge diagnoses, and mortality was determined from death certificates. For 1985 and 1990 hospitalizations, the 6-year death rate in 6134 patients with 0 to 1 score points was 4%, increasing stepwise to 89% for >/=16 points. Score validity was established by only slightly attenuated mortality prediction in 3570 admissions in 1970 and 1980. When case severity was controlled for, 6-year risk declined 32% between 1970 and 1990. When PREDICT was held constant, 24% of those treated with thrombolysis died in 6 years compared with 31% of those not treated. CONCLUSIONS: The simple PREDICT risk score was a powerful prognosticator of 6-year mortality after hospitalization.

Adult↗

Infection control during construction: planning is key.

With many hospital facilities under almost constant renovation or construction, the importance of planning precautions to protect surrounding areas from infection has never been greater. This document explains how one hospital campus plans for such precautions, and presents a case study on the issue.

Air Microbiology↗

Validation of a quality assurance program for autologous cultured chondrocyte implantation.

The use of living human cells to facilitate repair of defects in structural tissues is a rapidly emerging treatment option. A quality assurance program based on U.S. Food and Drug Administration good manufacturing practice regulations and other guidance was established and implemented in a program to use autologous cultured chondrocytes for repair of articular defects of the knee. The development of ex vivo cell therapies presents novel issues of quality assurance. The implementation and evaluation of this quality program was based on the implantation of 303 patients with autologous cultured chondrocytes, in which we analyzed a number of quantifiable parameters and which meets the unique challenges of autologous cell therapy within a rigorous regulatory framework. Application of well-accepted principles of quality assurance and quality control coupled with a thorough understanding of the cell culturing processes will result in a safe and efficacious cell therapy product.

Cartilage, Articular↗

The design of a case register for tuberculosis. A pilot study in the south-western Cape.

The development and piloting of a tuberculosis register that aims at providing a single source of information for the surveillance of tuberculosis and the measures for its control are discussed. Old-fashioned punch cards are appropriate in both isolated rural and sophisticated urban settings. The card system proved an effective and efficient clinic-based epidemiological tool but its implementation on a broad scale depends on the rationalisation of current administrative procedures.

Forms and Records Control↗

Impact of medication profile review on prescribing in a general medicine clinic.

The effect of medication profile review by a clinical pharmacist on prescribing in a general medicine clinic was studied. Patients who were receiving five or more prescription or nonprescription medications were randomly assigned to an intervention group (n = 315) or a control group (n = 257). A clinical pharmacist reviewed the medication profile of each intervention group patient on the day before the patient's clinic visit and attached a written profile review to the medical record for study by the physician during the visit. After each clinic day, the pharmacist obtained updated records of patients in both groups and collected data on the number and cost of medications ordered before and after the visits. After the clinic visits, the average number of medications and the average monthly medication cost per patient decreased by 0.21 and $0.60, respectively, for the intervention group, compared with increases of 0.48 and $3.31 for the control group. The net result of a single profile review was a decrease of 0.69 prescription per patient, for a monthly medication cost savings of $3.91. The number and cost of medications that were discontinued were significantly higher in the intervention group. The intervention group also had significantly fewer drugs added for previously documented medical problems. Medication profile review by a clinical pharmacist reduced both the number and cost of drugs for patients receiving five or more medications.

Clinical Pharmacy Information Systems↗

Consensus protocol for the flow cytometric immunophenotyping of hematopoietic malignancies. Working Group on Flow Cytometry and Image Analysis.

Flow cytometry has become the preferred method for the lineage assignment and maturational analysis of malignant cells in acute leukemias and lymphomas. Multiparametric immunophenotyping allows the detection of aberrant antigen coexpression and the analysis of heterogeneity and clonality of malignant cells in leukemias and lymphomas. The complexity of multiparameter analysis techniques and the multitude of available monoclonal antibodies demand a standardization of protocols for the use of flow cytometry in clinical laboratories in order to achieve interlaboratory reproducibility. Therefore, the Working Group on Flow Cytometry and Image Analysis has started an initiative in order to establish a consensus protocol on the current methods of the phenotyping of hematological neoplasias as a basis for quality assurance and support for upcoming technologies such as quantitative analysis of antigen densities and automated knowledge-based analysis software. In addition to general recommendations on assay procedures and quality control specific recommendations are given for the selection of two-color reagent panels and data interpretation in an attempt to define a basis for cross-evaluation against the different currently established laboratory protocols.

Acute Disease↗

Forms control and error detection procedures used at the Coordinating Center of the Multiple Risk Factor Intervention Trial (MRFIT).

Although methods used for data collection and quality assurance for large-scale clinical trials are important to critical reading of trial results and have been published, such reporting is the exception rather than the rule. In the MRFIT, systematic methods for processing large volumes of data over a long period of time were developed. The methods were designed to detect and control a variety of errors and to leave a complete audit trial of the processing of forms and corrections to forms. Many of these methods evolved and were refined during the course of the study as a result of trial and error. If one were to start over, the methods described herein would be modified. The field of data processing is evolving, and it is important for statistical and data processing staff of coordinating centers to recognize this and continually evaluate and update their methods. For example, the simultaneous entry and computer editing of forms is becoming more feasible with time. Also, more sophisticated intelligent data entry equipment is available for central use. Near the end of MRFIT, some data received at the Coordinating Center were entered and edited on a minicomputer. The parameter-driven edits described previously were performed at the time of data entry. Additional modifications to the content of the data dictionary for future studies are also being considered. The incorporation into the data dictionary of consistency checks (both deterministic and probabilistic) between fields on different forms would facilitate the specification of complex edit checks and would provide better documentation of the edit checks actually performed. Incorporating definitions of the numeric codes for each field would improve the documentation and facilitate reporting using statistical packages. Dedicated computer hardware should also be a major consideration of coordinating centers in future clinical trials. For MRFIT, a dedicated system was used from 1978 to the end of the trial. With the continued decline in hardware costs, dedicated systems can and should be considered, even for trials much smaller than MRFIT. We believe the system developed for processing data in the MRFIT has several advantages. It satisfies the requirements identified by Karrison or a system of data editing and control, it is largely self-documenting as a result of the data dictionary approach taken, and it is easily adaptable to other clinical studies.

Clinical Trials as Topic↗

Clinical coagulation laboratory and oral anticoagulant therapy treatment. Instrumentation and methodology.

To assess the organization and the quality of care of an anticoagulation clinic, the structure, the process of laboratory control and the clinical outcome in our Center are described. 1068 patients under control in 1994 (M/F 572/496; median age 63 range 6-91 ys., 74% in long-term prophylaxis) were evaluated. The clinic was run twice weekly by a physician, two nurses and a technician; management for emergencies was always warranted. Prothrombin time was carried out with a sensitive thromboplastin (ISI < 1.1) and a computer program provided calculation and graphical representation of INR, comparison with therapeutic range, automatic dosage prescription and print out. Laboratory quality of therapy was assessed by three different techniques: 'cumulative INR', 'last check in file' and 'linear change', yielding respectively 69% of laboratory controls, 71% of patients and 80% of days within the therapeutic range. The rate of thrombosis, major and total bleeding were respectively 0.2%, 0.2% and 12.5%. An anticoagulation clinic represents an effective organizational model for the management of patients taking oral anticoagulants.

Administration, Oral↗