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The CNR external quality assessment program for immunoassays: statistical analysis and reports for participants.

The results collected in the CNR/Tecno-standard external quality assessment (EQA) program for immunoassays of hormones and tumor markers are computer-processed to prepare a "periodic" report and an "end-of-period" report to be sent back to the participants in the survey. The aim of the periodic report is to allow comparison between the result obtained by a laboratory on a single EQA sample with those of all the other laboratories and with the users of the same method/kit; the report contains a histogram of all results and the mean, SD, CV, median and range (computed after trimming of outliers). The same statistics are also reported for data grouped according to the method/kit used. The end of period report provide the participant with a scored estimate of individual analytical performance (average bias and average imprecision) achieved assaying all the EQA samples dispatched in the control cycle (usually a six-month period during which 12-18 samples have been assayed); this cumulative report contains estimates of the performance of those kits more widely used in the survey. Beside helping laboratories to monitor their performance against an external reference, the EQA allows the collection of a large amount of data from which the state of the art and trends in the quality of immunoassays can be soundly evaluated and documented. To achieve this aim, the average total variability is computed from all data collected in the EQA cycle; this index is used for comparing the between-laboratory agreement of different immunoassays and for demonstrating trends of the quality over time.(ABSTRACT TRUNCATED AT 250 WORDS)

Analysis of Variance↗

Total quality management and statistical quality control: practical applications to waste stream management.

TQM offers a completely new approach to problem solving in health care. The approach requires dedication and persistence in monitoring, understanding, and changing systems at a level that has never been reached before in the United States' health care system. Materiel management, purchasing, nursing, housekeeping, and administration now have the necessary tools to centrally study the medical waste stream flow at their facilities. The intent of this article is to display how TQM techniques can be applied to minimize a hospital's medical waste stream. The approach of studying medical waste as a defect generated during the process of delivering high-quality care enables a hospital to pinpoint causes of these defects, modify the parent system of the defect, and lessen the generation of medical waste defects. Successful implementation of these techniques as a continuous process will enable hospitals to be leaders in the preservation of their host communities' environments.

Data Collection↗

Impact of a pharmacist on the educational value of pharmaceutical industry film showings.

A controlled trial was performed to assess the impact of drug information provided by a pharmacist on the educational value to physicians of pharmaceutical manufacturers' film showings. The trial consisted of two teams of physicians who attended pharmaceutical manufacturers' films and who afterward answered multiple choice questions on the drug being promoted. In one group, the liaison pharmacist, who had no knowledge of the content of the questionnaire, presented information on the drug being featured prior to the film showing while the control group did not have a pharmacist presentation. Out of a perfect score of five, there was a higher test score in the group of physicians who attended the pharmacist presentation/film showing (n = 75) than in the group which only attended the film (n = 65) (3.3 +/- 1.1 versus 2.8 +/- 1.2, respectively (p = 0.017)). While there was no difference in the scores obtained by the clerks, interns and residents (3.2 +/- 1.1, 3.3 +/- 0.9, 3.4 +/- 1.2 respectively) when a pharmacist was present, in his or her absence the scores for clerks, interns and residents were 2.5 +/- 1.3, 2.8 +/- 1.0, 3.6 +/- 1.2 respectively with residents scoring higher than clerks (p = 0.047). A pharmacist can enhance the educational value of a pharmaceutical manufacturer's film showing.

Attitude of Health Personnel↗

RepGene: a spreadsheet template for the management of reporter gene assays.

One of the most powerful techniques in molecular biology is the controlled expression of specific proteins by transfection of eukaryotic cells. This method has become feasible and highly sensitive and, thus, suitable for high-throughput reporter gene assays in basic and applied research. Moreover, the limiting factors are neither the transfection efficiency nor the functional analysis, but rather the ability to manage complex experimental protocols when multiple genes are co-transfected and/or when the effects of several chemical compounds are investigated within the same experiment. Here, we describe an easy-to-use and highly flexible spreadsheet template intended to rationalize and expedite the organization and data management of multi-step reporter gene assays. The objectives of this spreadsheet template are the design of the transfection protocol, the coordination of the administration of test compounds, and the graphical presentation and statistical analysis of the results.

Data Display↗

Standardised coding of diet records: experiences from INTERMAP UK.

Coding diet records is a basic element of most dietary surveys, yet it often receives little attention even though errors in coding can lead to flawed study results. In the INTERnational study of MAcro- and micronutrients and blood Pressure (INTERMAP study), efforts were made to minimise errors in coding the 18, 720 diet records. Staff were centrally trained and certified before being able to process study data and ongoing quality control checks were performed. This involved the senior (site) nutritionist re-coding randomly selected diet records. To facilitate standardisation of coding in the UK, a code book was designed; it included information about coding brand items, density and portion size information, and default codes to be assigned when limited information was available for food items. It was found that trainees, despite previous experience in coding elsewhere, made coding errors that resulted in errors in estimates of daily energy and nutrient intakes. As training proceeded, the number of errors decreased. Compilation of the code book was labour-intensive, as information from food manufacturers and retailers had to be collected. Strategies are required to avoid repetition of this effort by other research groups. While the methods used in INTERMAP to reduce coding errors were time consuming, the experiences suggest that such errors are important and that they can be reduced.

Diet↗

Pain management.

Successful management of pain can be accomplished in nearly all terminally ill patients. Pain must be assessed in terms of its physical, psychological and social components. Spiritual care and control of environmental factors are just as important as drug therapies. Once the cause of the pain is identified, an individualized plan of treatment can be developed. Nondrug therapies are tried first. When drugs must be used, the pain is treated by regular dosing to prevent recurrent breakthroughs--no PRN orders are used. The pain is blocked and its memory erased so that continued, uninterrupted relief is given. Drug management should provide ease of administration to maintain patient independence, unclouded and normal affect, and minimal troublesome side effects. Anticipatory treatment of expected problems with constipation and nausea should be done. By using a reproducible pain measurement scale, titration of drugs is carried out in a stepwise fashion, increasing dosage or potency until the desired effect is achieved. With multimode therapy, no patient should have to suffer the aching/agony pain cycle of terminal illness with cancer.

Analgesics↗

[Use of elements from the ISO 90000 system in Spanish hemotherapy].

PURPOSE: To evaluate the prevalence of all twenty elements of ISO 9000 in the practice of the Blood Banks of Spain independently of being certified or not to ISO system. MATERIALS AND METHODS: By a survey sent in november 1996 to the Hospital-Based Blood Bank and Transfusional Services of 225 hospitals with more than 100 beds, and to 25 Community Blood Centers. The survey had 38 questions on the all elements of the ISO system and on other aspects of quality no directly related with it, as to be accredited by transfusional accreditation Committee, to have an hospital transfusion committee, informed consent of the transfusion and guidelines for using hemoderivatives. RESULTS: The survey was answered by 53 (21%) of hospitals and Community Blood Centers. None of the participant were certified to ISO system. The elements more used were the documentation of adverse reactions, procedures manual, validation of blood components, control of nonconforming products, and product identification and traceability, all of them used for more than 80% of participants. On the contrary, the elements less used were to have a quality unit, equipment manual, to validate the computer system, internal quality audits, criteria on purchasing, training and quality manual, all of them used by less than 30% of the participants. CONCLUSIONS: Generally speaking the elements of the ISO system more commonly used are those related to the basic ones of daily work and the least used are those related to the organisation aspects of quality. The Community Blood Centers score higher than hospital blood banks and among these, the best results are in the blood banks of hospitals more than 500 beds and the hospital accredited for teaching.

Blood Banks↗

Using a preprinted order sheet to reduce prescription errors in a pediatric emergency department: a randomized, controlled trial.

OBJECTIVE: Medication errors are common among pediatric patients and in emergency departments (EDs). Such errors may lead to prolonged hospitalization, unnecessary diagnostic tests and treatments, and death. The objective of this study was to determine whether the use of a structured order sheet reduces the incidence of medication errors in a pediatric ED. METHODS: The study was a randomized, controlled study that was conducted in a tertiary care pediatric hospital. Eighteen days were randomized into 2 study groups: days during which the regular blank order sheets were used and days during which preprinted, formatted, order sheets were used. All patients' charts from these days were reviewed by 2 medical students, who extracted demographic, clinical, and therapeutic data into a database. Two pediatric emergency physicians, blinded to the form used, reviewed the database and independently decided whether an error had occurred and the severity of the error. RESULTS: Within the study period, there were 2157 visits to the ED. A total of 2058 (95.4%) charts were available for review. A total of 411 (52.2%) orders for drugs in the ED were ordered on the regular form, and 376 (47.8%) were given on the new form. Drug errors were identified in 68 (16.6%) orders when the regular form was used and in 37 (9.8%) of the orders on the new form. Using the new form was associated with a significant reduction in the risk for an error (odds ratio: 0.55; 95% confidence interval: 0.34-0.90). CONCLUSIONS: The use of a preprinted structured order form significantly reduces medication errors among pediatric patients in the ED.

Child↗

[Report on the activity of the blood bank accreditation program (1987-1995)].

PURPOSE: To show the incidence of the deficiencies detected in the Blood Banks for the accreditation by the Transfusion Accreditation Committee (CAT), previously named PABAS. MATERIALS AND METHODS: Analysis of the reports of the accreditation of 85 Blood Banks made by the PABAS during the period 1987-1995. RESULTS: Eighty-five (20.8%) of the 407 Community Blood Centers, Hospital-Based Blood Banks and Transfusional Services of Spain had been surveyed. There were 244 deficiencies, of which 31 (12.7%) were of the equipment, 114 (46.7%) of the procedures used, and 99 (40.6%) of the documentation. The activities with more incidence of faults were: Control of the temperatures of the storage of units 53 (21.7%), label of the components 38 (15.5%), quality system of the institution surveyed 32 (13.1%), transfusional procedures 30 (12.3%), and on the procedure of the selection of donors 29 (11.9%). By contrary, the areas of work with fewer incidences of faults were those related with the collection of the blood and components 10 (4.1%) and the laboratory 14 (5.7%). CONCLUSIONS: Low percentage of the Community Blood Centers, Hospital-Based Blood Banks and Transfusional Services, which ask to be accredited by the Transfusion Accreditation Committee. The 83.7% of the errors detected are of the procedures and documentation, which could be easily corrected by the training and continuous improving of the quality, and without need of new inversions in equipment.

Accreditation↗

[Evaluation of aa tracking system for labile blood products in the Midi-Pyrenes region].

At the request of the regional authority, the system of traceability of blood products in the Midi-Pyrenees area in France was assessed using available documentation, visits and interviews of participants. We studied the time needed to obtain traceability data in the Blood Banks and the reactivity of the system defined as the time needed to carry out a simulated descending transfusional survey. This information allowed us to assess usefulness and cost of the system, its applicability and the timeliness of information, according to the criteria of the Centers for Disease Control. The system is based on a standardized nominative form for the delivery of blood products and specific feedback. For the participants, traceability makes transfusional surveys easier and improves transfusions safety. In two of the 130 hospitals, the system is linked to the "program of medicalization of information systems". In the 2nd semester of 1996, the traceability proportion was 97%. For a given date of distribution, 75% of blood products were traced in 14 days and 83% in a month. The study of reactivity showed that all donations coming from two randomly chosen blood collection sites could be traced in about 2 hours. This first evaluation of a regional system of traceability showed its feasibility and acceptability, based on evaluation criteria of a public health surveillance system. A continuous evaluation process would be necessary to assess the good functioning of the system and to detect and prevent possible deficiencies.

Blood Banks↗

State long-term care screening and assessment programs.

Long-term care screening and assessment programs were designed by states to control long-term care costs and to prevent unnecessary institutionalization of Medicaid participants. This study reports data collected by telephone survey of state officials in all 50 states and Washington, D.C. on state variation in LTC screening and assessment programs. The majority of the state screening and assessment programs cover an array of LTC services but this has resulted in multiple separate screening programs for different long-term care services and eligibility groups. Only three states coordinated screening and assessment across long-term care programs by operating a single state administrative agency, using uniform need criteria and standard tools, and having automated databases (Arizona, Colorado, and Maine). The design and implementation of multiple and separate screening and assessment programs in most states may create potential barriers to client access, information about services and choice of services.

Activities of Daily Living↗

Low-cost comprehensive data system for cardiac patients.

Functional systems to collect, store and retrieve clinical, hemodynamic, and angiographic information are needed to serve clinical research and quality control in the cardiac laboratory. Computers are ideally suited for this application, but high investment and maintenance costs are a barrier for their wider use. A low-cost data processing and procedure reporting system was developed using a programmable calculator, a floppy disk drive, and a printer. Files have been started on 750 consecutive adult patients undergoing cardiac catheterization and angiography. Each file contains a clinical profile (CP), angiographic interpretation (Al), and hemodynamic data. CP and Al are coded according to a data base definition appropriate for patient care (procedure report) and research analysis. Data input is simplified by the use of multiple choice forms and prompts appearing on the calculator alphanumeric display. One floppy disk may hold 400 patient files. Immediate access to stored information for cross reference, computations, and statistical work is possible in all patients, a patient category, or an individual case. Stored items may be retrieved in coded form for analysis or translated into sentences to generate a multiple-copy procedure report. Follow-up information may be subsequently added to the patient file. Operation requires minimal training and little expertise in computer technology.

Coronary Disease↗

The failure of a preprinted order form to alter physicians' antimicrobial prescribing pattern.

Use of antimicrobial agents is highly effective in reduction of morbidity and mortality due to infectious disease. There is, however, evidence that the use of such agents is frequently inappropriate worldwide. Several methods were tried to rationalize the use, and, among these, the preprinted order form (P.O.F.) offered the simplest and most efficient way. We studied the use of the P.O.F. in Siriraj Hospital, Bangkok Thailand, where there was overuse of antimicrobial agents using a historical-controlled intervention study. In period I (no P.O.F.), the antimicrobial overuse was 35 per cent, and this was not reduced by using the P.O.F. in period II (32%), which was one year apart. There was no difference in overuse after adjustment for differences in base-line characteristics which were thought to affect antimicrobial prescriptions i.e. physicians' workload, physicians' knowledge and the method of diagnosis of infectious disease. Reasons for failure of the P.O.F. in unclear. Misdiagnosis was unlikely since the correct diagnosis as revised by attending physicians and specialists was as high as 83 per cent. The fear of malpractice suits was also not the reason because defensive medicine is not a problem in Thailand. The nature of the diseases, which lower the threshold to treat, the clinical immaturity and other unknown factors were thought to play a part in deviation from responsibility to perform according to written-justification.

Adult↗

Securing interoperability between chip card based medical information systems and health networks.

Health information systems supporting shared care are going to be distributed and interoperable. Dealing with sensitive personal medical information, such information systems have to provide appropriate security services, allowing only authorised users restricted access rights to the patients' data according to the 'need to know' principle. Especially in healthcare, chip card based information systems occur in the shape of patient data cards providing informational self determination and mobility of the users as well as quality, integrity, accountability, and availability of the data stored on the card, thus improving the shared care of patients. The DIABCARD project aims at the implementation and evaluation of a chip card based medical information system (CCMIS) for facilitating communication and co-operation between health professionals in different organisations or departments caring the same patient with diabetes as an example. In co-operation with the EC-funded TrustHealth(2) project, communication and application security services needed are provided like strong authentication as well as the derived services such as authorisation, access control, accountability, confidentiality, etc. The solution is based on Health Professional Cards and Trusted Third Party services. In addition to the secure handling of the patient's chip card and data in DIABCARD workstations, the secure communication between these workstations and related departmental systems has been implemented. Based on the results of this feasibility study, an enhanced security services specification for the DIABCARD example of a CCMIS is provided which will be implemented in the framework of a health network being established in the German federal state Bavaria. Beside the preferred solution of a combination of Patient Identification Card and Patient Data Card, lower level alternatives using card-verifiable certificates are explained in some details. Finally, a few legal issues, future trends like the XML standard set and their implications for the solution presented as well as for distributed health information systems in general are shortly discussed.

Computer Security↗

Evaluation of a new integrated discharge prescription form.

OBJECTIVE: To determine whether a new discharge prescription form which integrates admission medications, in-hospital changes, and discharge medications could enhance the accuracy of information in patient profiles in community pharmacies after hospital discharge. DESIGN: Nonrandomized, prospective, multi-site study. SETTINGS: Internal medicine wards of the three teaching hospitals (1200 beds) of the Centre Hospitalier de l'Université de Montréal. SUBJECTS: Patients admitted to the internal medicine wards between January 4 and 31, 1999, at St.-Luc and Notre-Dame Hospitals formed the control group and received a usual discharge form (UD). Those admitted between February 1 and 28,1999, received the new discharge prescription form (DPF) capturing the list of admission medications and revisions during hospitalization; they served as the experimental group. METHODS: Patient profiles were reviewed to calculate conformity rates of community pharmacy patient profiles after discharge and the rate of overall conformity for each group in the study. Each drug in the patient profile was assessed according to six criteria. Healthcare providers' satisfaction with the DPF was assessed via a written questionnaire. RESULTS: Eighty-nine patients and 669 discharge medications were studied. The patient profiles had a higher conformity rate in the DPF group than in the UD group (82% vs. 40%; p < 0.001); improvement could be attributed to higher conformity rates, particularly for two criteria (medications stopped in hospital and dose changes in hospital). CONCLUSIONS: Integration of admission medications, in-hospital changes, and discharge medications on a single form increases the conformity rates of community pharmacy patient profiles after hospitalization. This tool is well accepted by both pharmacists and physicians and may lead to a major decrease in drug-related problems.

Attitude of Health Personnel↗

[Impact of a quality approach for transfusion safety on prescription, circuit optimization, traceability].

The Quality Assessment Program undertaken at the Regional University Hospital of Lille benefits from previous experience making management of this project possible: continuing education, preliminary initiation into the quality approach, and existing reference systems. The aims are to master the rates of outdated and no longer efficient red cell concentrates, to control red cell concentrate delivery time, to validate the refrigeration line integrity and to ensure a flawless marking out process. The process studied is transverse, with those taking part in it belonging to several professional categories. The method will consist in a process identification, its description and characterization according to FMECA (Failure Mode Effects and Criticality Analysis), the creation of a new process and its improvement. Thus failures should be identified and classified hierachically. The corrective actions will consist in communication aids, an education program, blood product transport and blood depot reorganization, data processing improvement and medical equipment acquisition. Quality indicators are developed according to the objectives of the study, and progress indicators are developed as a periodical assessment of blood transfusion practice. This ambitious project relies on the involvement of Hospital Management and referent network. These referents facilitate the improvement processes for those taking part in this process.

Blood Transfusion↗

The role of the data manager in clinical cancer research. An opportunity for nurses.

A clinical trial is a research study conducted in humans and designed to answer specific questions using scientifically controlled methods. These trials require considerable effort to assure that the data obtained are reliable, reproducible, and readily available. Data managers play a key role in this research effort. A nurse with a clinical background, computer knowledge, and some experience in the research environment is well suited for the role of data manager. The data manager performs a variety of tasks in this position that will enhance the quality of the data gathered in a research study. These responsibilities include designing forms, monitoring protocol accrual, abstracting data, entering data onto protocol-specific forms and/or specifically designed computerized data-entry screens, assuring the quality and the integrity of the data, and providing investigators with interim and summary reports. In addition, the data manager can be responsible for the management of a computerized clinical data base system, including the training of users and the designing of basic reports for the investigators. A nurse, functioning as a data manager, who understands research methodology, is detail oriented, and is well organized, could be a valuable asset to the clinical trials team in the successful management of any clinical study.

Clinical Trials as Topic↗

Pharmacy-controlled documentation of drug allergies.

The implementation of a pharmacy-enforced policy for documenting drug allergies is described. After two incidents at a 600-bed teaching hospital in which patients experienced severe allergic reactions to drugs, an audit was conducted to evaluate the existing drug allergy documentation policy. Physicians documented allergies in medical charts and treatment orders for 68% and 78% of patients, respectively; no initial drug orders contained this information. Nurses documented allergies in admission assessments, medication records, and charts for 71%, 61%, and 15% of patients, respectively. Only 2% of pharmacy computerized drug profiles contained allergy information. A new policy for drug allergy documentation was instituted. Physicians provide allergy information on the first written drug order. Nurses independently solicit allergy information and check it against that provided by the physician. Pharmacists enter the information into the patient's drug profile. If the information has not been obtained, the drug is not dispensed. Repeat audits two months and one year after the policy was put in place showed significant improvements in the completeness and accuracy of drug allergy documentation by pharmacists and physicians. In general, documentation by nurses did not improve to the degree found for pharmacists and physicians. A policy that gave pharmacists the primary responsibility for ensuring that drug allergy information was obtained before drugs were dispensed was effective in improving allergy documentation by physicians and pharmacists.

Chicago↗