Forms and Records Control ; Humans ; Qualitative Research ; Software

Data authenticity is the basic requirement of clinical studies. In actual clinical conditions how to establish formatted case report forms (CRF) in line with the requirement for data authenticity is the key to ensure clinical data quality. On the basis of the characteristics of clinical data in actual clinical conditions, we determined elements for establishing formatted case report forms by comparing differences in data characteristics of CRFs in traditional clinical studies and in actual clinical conditions, and then generated formatted case report forms in line with the requirement for data authenticity in actual clinical conditions. The data of formatted CRFs generated in this study could not only meet the requirement for data authenticity of clinical studies in actual clinical conditions, but also comply with data management practices for clinical studies, thus it is deemed as a progress in technical methods.
Electronic Health Records ; standards ; Forms and Records Control ; Humans ; Quality Control

Intake and Output (I/O) records in hospitals were often found to be incomplete and illegible. The form used to record I/O is not user-friendly — i.e., they feature miniscule boxes, ‘total’ lines that do not correspond with shift changes and lack of instructions. Complaints often received from Specialists & Doctors regarding calculation errors or no totalling of I/O. Moreover, Nursing Sisters objective rounds often saw incompleteness of I/O chart. This study aims to identify the types of mistakes in recording the existing I/O chart. The second aim is to find out whether shift totalling of I/O chart helps in reducing mistakes. We try to determine whether the identified mistakes were repeated in the new I/O Chart. This study was conducted from October till December 2010 in 9 selected wards in Sibu Hospital. Data collection was divided into 3 phases. A pre-implementation audit using a checklist was carried out. The compliance rate of completeness of documentation of I/O Chart was 63%. A one month trial of new I/O chart was being done in the selected 9 wards. Post implementation audit showed a significant improvement of compliance rate (88%). Feedback from health care workers (N=110) showed that, 89% of doctors (n=17) and 60% of nurses (n=93) in the sample prefer to use the new format as more practical and relevant to the changing shift of nurses and doctors’ ward round. It is suggested to implement the new format to increase compliance rate of documentation of I/O charting. Briefing should be given to nurses periodically and the new format should be introduced to nursing students in nursing colleges.
Documentation ; Forms and Records Control ; Nursing Records ; Charts ; Medical Errors

The objectives of QMS for quality assurance of products are achieved by formulation, implement, and management of document system. Document (includes record) system is important constituent part of QMS. In this paper, the important issues and relative requirements of GMP on the establishment and management of documentation within quality management system (QMS) of medical device enterprises are discussed with the aim of providing reference for relative enterprises to build and improve their QMS and to implement GMP.
Equipment and Supplies ; Forms and Records Control ; methods ; Quality Control

Forms and Records Control ; methods ; Humans ; Pathology, Clinical ; methods

This paper presents a method based on NLP to realize structuralization of digestive endoscopy reports. The method is taking advantage of existing NLP's processing technologies and introducing minimal standard terminology (MST) to transform a narrative gastroscopy report into the structuralization report based on MST, whose accuracy rate is 92.3%.
Endoscopy, Gastrointestinal ; methods ; Forms and Records Control ; Medical Records Systems, Computerized ; Terminology as Topic ; Vocabulary, Controlled

The CHITS (Community Health Information and Tracking System), the first electronic medical record system in the Philippines that is used widely, has persevered through time and slowly extended its geographic footprint, even without a national policy. This study describes the process of CHITS development, its enabling factors and challenges affecting its adoption, and its continuing use and expansion through eight years of implementation (2004 to 2012) using the HOT-fit model. This paper used a case study approach. CHITS was developed through a collaborative and participative user-centric strategies. Increased efficiency, improved data quality, streamlined records management and improved morale among government health workers are benefits attributed to CHITS. Its longevity and expansion through peer and local policy adoption speaks of an eHealth technology built for and by the people. While computerization has been adapted by an increasing number of local governments, needs of end-users, program managers and policy-makers continue to evolve. Challenges in keeping CHITS technically robust, up-to-date and scalable are already encountered. Lack of standards hampers meaningful data exchange and use across different information systems. Infrastructure for electricity and connectivity especially in the countryside must be established more urgently to meet over-all development goals specially. Policy and operational gaps identified in this study have to be addressed using people-centric perspective and participatory strategies with the urgency to achieve universal health care. Further rigorous research studies need be done to evaluate CHITS' effects on public health program management, and on clinical outcomes.

An informed consent is a document signed by the patient or the patient's legal guardian(s) that signifies the acceptance that the patient will undertake a specific medical treatment suggested and explained by the health care provider(s). Recently, there have been an increasing number of circumstances where obtaining an informed consent is mandatory. However, a standard form and required content of the informed consent, as well as laws, regulations, and analyses regarding the concept of informed consent are not available. This article introduces an observation of the legal force of informed consent forms that are used in practice, and of the legal issues in connection with them.
Consent Forms ; Delivery of Health Care ; Humans ; Informed Consent* ; Jurisprudence ; Medical Records ; Social Control, Formal

According to the circumstance of hospital equipment maintenance, we designed a computer program for management of hospital equipment maintenance process by Java programming language. This program can control the maintenance process, increase the efficiency; and be able to fix the equipment location.
Equipment and Supplies, Hospital ; Forms and Records Control ; Maintenance and Engineering, Hospital ; organization & administration ; Software Design

OBJECTIVETo investigate the factors related to delay in pathology reporting and to improve the quality of pathology service.

METHODSA total of 24 months pathology reports (total number = 21,038) issued by Department of Pathology, Dongyang People's Hospital (randomly selected during the period from 1999 to 2006) were analyzed. The timeliness of these reports was studied with respect to the types of specimens (biopsy versus surgical versus frozen section). The causes for delay in reporting were statistically analyzed.

RESULTSAmong all the cases studied, 19,579 reports were timely issued (timeliness rate = 93.06%), whereas 1459 reports were delayed (delay rate = 6.94%). Of the 1459 delayed reports, routine biopsy specimens accounted for 6.02% (665/11,052), surgical specimens for 7.26% (643/8858) and frozen section specimens for 13.39% (151/1128). The main causes for delay in reporting were technical (1158 cases or 79.37%), including requests of immunohistochemical staining, intradepartmental or external consultation, patient contact and discussion with requesting clinicians. Factors related to responsibility, such as inadequate clinical information in the pathology request forms, were identified in 301 cases (20.63%). The delay in reporting was mainly due to factors occurring within the pathology department (which accounted for 1048 cases or 71.83% (P < 0.05) and most were technical (1017 cases or 97.04%). Extradepartmental factors, mainly related to responsibility, were noted in 270 cases (65.69%, chi2 = 709.59, P < 0.05).

CONCLUSIONFactors related to delay in pathology reporting can be categorized into technical and responsibility. The former can be rectified by improvement of laboratory procedures, while the latter needs education of the personnel concerned.