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Is your document control out of control? Complying with document control regulations.

Clinical laboratories, faced with new or changing regulations and shortages in trained laboratory staff, may find it difficult to comply with guidelines related to document control, upkeep of standard operating procedure manuals, and documentation of quality programs or competency reviews. Now, more than ever, it is critical to keep documents, procedures, and training material organized and accessible to busy laboratory staff and inspectors. The key may be the ability to use existing software programs available to industry for similar compliance issues. The laboratory's ability to change and update quickly with limited staffing may depend on electronic solutions to the complexities of document control. Several software programs have merit and can be integrated into a clinical laboratory.

Arizona↗

[Development and organization of a knowledge-based documentation system for ophthalmologic video documentation].

We introduce a system for documentation of ophthalmological video tapes. This system can be implemented without regarding the German data security law (Bundesdatenschutzgesetz), because the documentation of the patient identification and the video tape identification number is done manually and separated from the EDP-supported documentation of the video tape identification number and the contents of the tape. But the use of a controlled vocabulary framework for diagnosis and surgery can be considered as the main advantage of this system. This enables a complete and fast retrieval to all records containing the terms searched for. Our system provides additional space for non-standardized text-documentation, e.g. comments etc... The implemented search-editor allows a fast retrieval to all records by input of strings, which can be connected by boolean expressions.

Computer Security↗

Nursing process documentation--effects on workload and quality when using a computer program and a key word model for nursing documentation.

In 1993 the federation of County Councils commissioned Spri to carry out a broadly based study aimed at investigating individualised patient care as described in the notes kept at various care units using computers to support documentation of the nursing process. The wards involved in the study represented various disciplines such as surgery, obstetrics, internal medicine, geriatrics and psychiatry. During the study period certain measures designed to improve the documentation were implemented i.e. a special computer program and structured nursing documentation following the VIPS-model. Interviews with staff at the units confirm that the introduction of computers, in combination with the structure of the VIPS-model and training in nursing documentation, has made changes possible to working procedures and brought greater goal orientation to the activity of care. The overall examination of the nursing entries in the patients' notes showed that the language has improved. The entries were to a greater extent expressed clearly and distinctly.

Computer User Training↗

HL7 document patient record architecture: an XML document architecture based on a shared information model.

The HL7 SGML/XML Special Interest Group is developing the HL7 Document Patient Record Architecture. This draft proposal strives to create a common data architecture for the interoperability of healthcare documents. Key components are that it is under the umbrella of HL7 standards, it is specified in Extensible Markup Language, the semantics are drawn from the HL7 Reference Information Model, and the document specifications form an architecture that, in aggregate, define the semantics and structural constraints necessary for the exchange of clinical documents. The proposal is a work in progress and has not yet been submitted to HL7's formal balloting process.

Humans↗

Falls documentation in nursing homes: agreement between the minimum data set and chart abstractions of medical and nursing documentation.

OBJECTIVES: To assess the agreement between falls as recorded in the Minimum Data Set (MDS) and fall events abstracted from chart documentation of elderly nursing home (NH) residents. DESIGN: Secondary analysis of data from a longitudinal panel study. SETTING: Fifty-six randomly selected NHs in Maryland stratified by facility size and geographic region. PARTICIPANTS: Four hundred sixty-two NH residents, aged 65 and older, in NHs for 1 year. MEASUREMENTS: Falls were abstracted from resident charts and compared with MDS fall variables. Fall events data obtained from other sources of chart documentation were matched for the corresponding periods of 30 and 180 days before the 1-year MDS assessment date. RESULTS: For a 30-day period, concordance between the MDS and chart abstractions of falls occurred in 65% of cases, with a kappa coefficient of 0.29 (P<.001), indicating fair agreement. Concordance occurred between the sources for 75% of cases for a 180-day period, with a kappa of 0.50 (P<.001), indicating moderate agreement. During the 180-day period, chart abstractions showed that 49% of the sample fell, whereas the MDS revealed that only 28% fell. An analysis of residents whose falls the MDS missed indicated that these residents had significantly more activity of daily living impairment and significantly less unsteady gait and cane/walker use. CONCLUSION: The MDS underreported falls. Nurses completing MDS assessments must carefully review residents' medical records for falls documentation. Future studies should use caution when employing MDS data as the only indicator of falls.

Accidental Falls↗

Comparison of event rates and survival in patients with unexplained syncope without documented ventricular tachyarrhythmias versus patients with documented sustained ventricular tachyarrhythmias both treated with implantable cardioverter-defibrillators.

Patients with unexplained syncope and inducible ventricular tachyarrhythmias during electrophysiologic testing have an increased cardiac mortality rate. We compared event rates and survival of 178 patients with unexplained syncope and no documented ventricular arrhythmias (syncope group) versus 568 patients with documented sustained ventricular tachycardia (VT or fibrillation (VF) (VT/VF group) treated, as part of a lead (Ventritex TVL) investigation, with similar implantable cardioverter-defibrillators (ICDs) capable of extensive data storage. The 2 groups shared similar clinical characteristics. The mean follow-up was 11 months for the syncope group and 14 months for the VT/VF group. The mean time from device implantation to first appropriate therapy was similar in the 2 groups (109 +/- 140 vs 93 +/- 131 days, p = 0.40). Actuarial probability of appropriate ICD therapy was 49% and 55% at 1 and 2 years, respectively, in syncope group and 49% and 58% in VT/VF group (p = 0.57). Recurrent syncope was associated with ventricular tachyarrhythmias in 85% and 92% of the syncope group and VT/VF group, respectively (p = 0.54). At 2 years, actuarial survival was 91% in the syncope group and 93% in VT/VF group (p = 0.85). We conclude that patients treated with ICD with unexplained syncope and induced VT/VF have an equally high incidence of appropriate ICD therapy and low mortality compared with similar patients with documented VT/VF. These findings, plus the high association between recurrent syncope and ventricular arrhythmias, indicate that VT/VF are likely etiologies in selected patients with unexplained syncope and support ICD therapy in such cases.

Aged↗

[Quality assurance and documentation for community mental health services cooperative (GPV). A standardized procedure for regional health care documentation and planning].

This paper describes a standardized assessment-procedure for the so-called "Gemeindepsychiatrische Verbünde" in Germany (GPV-Documentation), which are regional combines of community-based mental health care services. It is the first procedure in Germany which puts data on psychiatric care offers, needs for care and service utilization of all sectors and services in community-based mental health care into standardized measures, thus making offers and care of these services comparable. The procedure can be applied to the daily routine of catchment areas. From a methodical point of view the GPV-Documentation keeps a functional approach to community-based mental health care, but additionally it enables services to describe their specific contribution to regional care separately from others. Annual follow-ups make the GPV-Documentation an ideal tool for planning purposes, care management and quality assurance. Cross-regional comparisons of standards of care are possible. The implementation will also enhance the quality of governmental health reports on the care of chronically mentally ill in Germany remarkably.

Community Mental Health Services↗

Inter-document coreference resolution of abnormal findings in radiology documents.

In the clinical environment, it is often necessary to track the progression of a condition or various pertinent findings over time. Establishing automatic mechanisms for tracking pertinent findings can aid in the management of a condition as well as provide feedback for treatment outcomes assessment. This work focuses on the challenge of correlating observation of pertinent findings, specifically lung masses, across documents from serial computed tomography examinations for lung cancer patients. A probabilistic model is presented to characterize the likeliness of two observed findings from different documents referring to the same entity. A greedy algorithm is also presented that utilizes the probabilistic model to establish coreference links between findings. Results from a preliminary evaluation of this methodology show a precision of 72% and a recall of 63% for the described inter-document coreference resolution task.

Algorithms↗

[A standardized documentation structure for data documentation in echocardiography. Work Team on Standards and LV Function of the Work Group on Cardiovascular Ultrasound of the German Society of Cardiology, Heart and Circulation Research].

Presently, there are no well-defined standards for documentation of echocardiographic studies. Nevertheless, standards are essential to provide comparability of data and to realize electronic communication, both essential for quality management in echocardiography. Therefore, the working group "Standards and LV function" of the German Society of Cardiology developed a consensus for documentation of echocardiographic studies. In the present paper this consensus is presented and illustrated by typical clinical examples. Additionally, a prototype of a user-oriented software based on this data set is presented. The complete data set for transesophageal and transthoracic echocardiography and the software prototype can be downloaded at http:@echo.ma.uni-heidelberg.de.

Aortic Valve Stenosis↗

Comparison of motor vehicle damage documentation in emergency medical services run reports compared with photographic documentation.

STUDY OBJECTIVE: To determine whether emergency medical services (EMS) run reports adequately document vehicle damage when compared with vehicle photographs by using a traffic accident scoring system. DESIGN: A prospective study consisting of three phases: photographing motor vehicle collisions and collecting their respective EMS run reports, traffic accident damage score development, and comparison of photographs to the run reports by emergency medical technicians using the traffic accident damage score. SETTING: Data were collected in North Carolina and Ohio from motor vehicle crashes to which nine different EMS squads responded during a three-year period. TYPE OF PARTICIPANTS: EMS squads ranged from basic to paramedic levels of training. MEASUREMENTS AND MAIN RESULTS: Three emergency medical technicians were unable to determine the area of vehicle damage in 48% and the severity of damage in 61% of the EMS run reports. In contrast, there were no instances in which all three emergency medical technicians were unable to determine both area and severity of damage from the photographs. CONCLUSION: Most EMS run reports do not document vehicle damage adequately.

Accidents, Traffic↗

[30 years of computer-based clinical documentation at the Heidelberg University Orthopedic Clinic. From basic documentation to medical controlling].

An overview of the 30 years history and development of documentation and information systems in the Orthopedic University Hospital Heidelberg is presented. Since the foundation in 1967 four developmental phases can be described: first initiatives of medical doctors, establishment of a basic documentation system for scientific purposes, strategic information system planning and realisation of information systems with the possibility of controlling in medical areas and thereby steering of the services. Planning and realisation were accomplished within the framework of the masterplans and concepts of the university clinics of the state of Baden-Württemberg.

Academic Medical Centers↗

[Clear text-oriented documentation in hand surgery--integrated in the medical routine documentation service].

For reasons of contents and economy, the construction of medical documentation should be integrated into the secretary's routine work. An efficient and inexpensive microcomputer is able to facilitate and accelerate the typing work of a hand surgical section by the use of a modern data processing system. At the same time important data can be stored for documentation without being coded and with hardly any additional effort. The dates can be analysed according to different criteria (e.g. statistics of diagnosis/therapy, the recall of data of patients with certain diagnosis, yearly statistics and so on). Knowledge of data processing is not necessary.

Computers↗

[Research in alternative medicine. What is documented, and what is documentation?].

A study of the literature describing research on alternative medicine showed that, in general, the research was of poor quality. Any clinical effect of kinesiology had not been documented. Only few studies on reflexology had been controlled. Several controlled studies on healing showed significant effect, mainly in patients with psychosomatic disorders, or when the patient had great faith in the healer. Acupuncture seems to be effective against nausea, in patients with chronic pain and in patients who have had stroke. The data do not support the claim that acupuncture is effective for asthma or addiction. In the case of homeopathy the evidence from clinical trials is positive but not sufficient to draw a definite conclusion, for example, is it better than placebo? The majority of studies seems to disregard the principle of homeopathy, i.e. that the treatment should be individualised. Even if the documented effect of alternative medicine is not convincing, the effect is favourable empirically and may in itself be sufficient to give practitioners of alternative medicine an authorization. The term "alternative medicine" should be replaced by "complementary medicine".

Complementary Therapies↗

Documents and documentation in laparoscopy.

Some form of documentation of laparoscopic findings is essential in the proper management of the patient. We have found a simple outline form with a schematic drawing of the pelvis to be invaluable in emphasizing the need for a systematic and thorough endoscopic examination and in providing an excellent method of recall. Photographic documentation is primarily of value to those physicians involved in research or educational programs. In addition, we have found it helpful to give the patients a printed description of the procedure beforehand, as well as written instructions concerning preoperative arrangements and postoperative care.

Humans↗

[The Multiple Sclerosis Documentation System MSDS. Discussion of a documentation standard for multiple sclerosis].

The MSDS (multiple sclerosis documentation system) has been developed at the Department of Neurology, Technical University of Dresden, Germany, during the last 4 years. The first version of this database application has been in use since October 2000. The MSDS manages information on MS patients, their treating physicians, patient history (symptoms, other diseases, biographical history, family history, habits, medication), clinical signs, results of laboratory examinations (blood chemistry, autoantibodies, borrelia serology, evoked potentials, cranial and spinal cord magnetic resonance imaging), clinical scores relevant for MS, and biosamples. In principle, MSDS allows online data input and semiautomatically generates reports to all general practitioners and neurologists treating the respective patient. Patient information sheets and internal treatment guidelines are part of the system. During a 3-month evaluation, the first version of MSDS was tested at eight university multiple sclerosis ambulatory care units and one general neurology hospital. The overall judgement was favorable. Suggestions for changes and improvements, as well as practical experiences, were considered when developing MSDS 2.0, which will be available by the end of 2001.

Ambulatory Care↗

[Labor documentation system: a simplified method of documentation and quality control in obstetrics].

A simple on-line data collection system was developed for facilitating documentation and quality assessment in perinatal medicine. A microcomputer is used for acquisition of the most important obstetrical data. The system substitutes the handwritten birth notification form and permits automatic medical reporting. In addition an information system for day-to-day clinical routine is provided. Special programmes allow the compilation of statistical analysis as requested by the government as well as for internal quality assessment.

Computers↗

[Transmission of Dusseldorf Integrated Medical Documentation data by a personal computer. A new concept in the flexibility of the Dusseldorf Integrated Medical Documentation system].

The software package HOST PC was created as an important expansion of the oncological aftercare program INMEDD (Integrated Medical Documentation Düsseldorf). INMEDD itself provides only small evaluation capabilities. HOST PC is able to transmit data from INMEDD on a host computer to a personal computer. This transmission is fully automated. On the personal computer the data is stored in a database, which is completely compatible with the standards of dBase III. These created databases can be evaluated and analyzed by a lot of standard software packages. Therefore a wide range of individual statistical evaluation, analyzing with optional criteria and graphic presentation can be realized with small expenses of time and money. HOST PC increases the attractiveness of INMEDD and therefore improves the aftercare of cancer patients.

Aftercare↗