Assurance Function Research Articles

Quality Assurance for Worldwide Clinical Trials

The emphasis on quality and integrity over the past 15 years has led to the continual development of new compliance inspection initiatives by the Food and Drug Administration (FDA). Recently, for example, the FDA enacted the approval inspection process, which requires the local FDA district office to address good manufacturing practices (GMP) requirements prior to approval of an application. The European Community (EC) also recently enacted good clinical practice (GCP) guidelines for clinical trials. The pharmaceutical industry must effectively address all these requirements regarding quality to meet its future needs. Corporate commitment plus an experienced staff; standard operating procedures (SOP), and a good documentation system are essential to meet global regulatory requirements.The integration of SOPs with a well-defined training program will assure corporate or contract research organization preparedness for clinical trial success. The research quality assurance function should be a valuable tool ...

Local management of schools as an organizational form: theory and application

This paper sets out to understand local management of schools (LMS) in terms of the theory of organizational form. It is argued that the 1988 Education Reform Act was designed to change the LEA from a unitary form of organizational strucure to a multidivisional (M‐form), though the regulatory role of the LEA required in an M‐form organization was left underdeveloped. Without a quality assurance function for a regulatory body decentralized management structures approximate more closely to a holding company or H‐form organization. This interpretation of LMS is then applied to a case‐study LEA. The theory of organizational form provides an analytical framework for understanding the restructuring the education sector is undergoing, while the case study yields data for assessing the applicability to current organizational changes in education of the multidivisional form model and its claimed efficiency advantages. The M‐form model is offered as a resolution of the apparent paradox in the Education Reform Act b...

Improvements in the Management of Quality Costs by An Integrated Personal Computer System

Abstract The study analyses the advantages and problems of an integrated PC based computer system in the management of quality costs. A traditional problem is the flexible integration of ADP devices frontdifferent time periods and technologies. Before this development effort the contents of the quality costs suffered from insufficient guidelines, inability of the reportmaker and manuality of the system. The PC based program standardises the reporting and serves flexibly as a guideline some accounting and quality assurance functions can be integrated and a lot of tinle and money be saved. The first experiences of the developed system are now available

The characteristics of efficient software formal reviews

This paper puts forward the characteristics of efficient formal reviews that improve the quality assurance function of software in each phase of its lifecycle process. The paper identifies formal reviews objectives, responsibilities, participants, rules, agendas and feedback protocols.

Software safety analysis: The characteristics of efficient technical walkthroughs

Software safety is a relatively new concept in the software reliability and quality assurance disciplines. Several techniques for conducting software safety analysis are available, and include the following: Peer Circuit Analysis, Software Fault Trees, Nuclear Safety Cross-Check and Petri Nets. This paper puts forward Technical Walkthroughs as an effective method of the Peer Circuit Analysis technique. The paper emphasizes the characteristics of efficient technical walkthroughs that improve the safety and quality assurance function of software in each phase of its life cycle development process. The paper identifies walkthroughs objectives, responsibilities, participants, rules agendas and feedback protocols.

The Breast Cancer Screening Program in Rhode Island

The Rhode Island Department of Health has undertaken a Breast Cancer Screening Program which incorporates assessment, policy development, and assurance functions, following the model proposed in the Institute of Medicine (IOM) report, The Future of Public Health. With the community's help, projects have been implemented to increase screening capacity with dedicated, state-of-the-art equipment, to increase screening accessibility, to publicize the need for mammography, and to minimize false test results. In the program's first 15 months, the proportion of women ages 40 and over who were screened with mammography according to current guidelines increased from 35 to 46 percent (from 38 to 49 percent among women ages 40-49; from 31 to 43 percent among women ages 50 and over), including 15 percent who received their first screening mammogram. Providers' recommendations and knowledge of screening guidelines were important in explaining first-time use. The Department plans to apply the IOM model in other program areas. Its adoption by others is urged.

Getting Pathologists Onto Patient Floors: A Proposed, Proactive Quality Assurance Function for Pathologists

In accord with mandates of the College of American Pathologists and Joint Commission of Accreditation of Healthcare Organizations, we have developed a structured function that documents the quality assurance program of the Pathology Department. It is simple and easy to perform, promotes exposure of the department, serves as a database in patient care and laboratory administration, and has been well received by the clinical staff. The program is offered for consideration by other laboratories.

Formatting Departmental Quality Assurance Minutes to Meet Internal and External Needs

This article presents a method that is helpful in achieving compliance with the JCAHO medical staff monitoring standards. Since the QA activity of the medical staff is of great importance to the institution, it is imperative that monitoring activities are clearly documented and easily evaluated. Through the use of a standardized departmental minutes format, each clinical department is prompted to address the monthly activity relating to each of the basic quality assurance functions. These minutes can be "scored" using an evaluation tool suitable for review by the Medical Executive Committee. This enables the committee to track the status of each department's use of the "Ten Step Process." This method has successfully met the challenge of a recent JCAHO accreditation visit. The use of the standardized departmental minutes format and the evaluation tool provide a method to successfully meet the JCAHO medical staff quality assurance standards.

Integration of Quality Assurance Activities into a Computerized Patient Data Management System in an Intensive Care Unit

A prototype computer-based patient data management system (PDMS) was developed for a surgery-anesthesiology intensive care unit (ICU) to reduce the time and staff needed to implement quality assurance (QA) functions. Goals of the system were to make QA functions routine and minimally intrusive to the daily operation of the ICU. PDMS collects general data (eg, admissions and discharges, lengths of stay, and bed utilization rates) and specialized data (eg, specific indicators) unique to the ICU and performs prospective monitoring for the occurrence of specific events (occurrence screening) and retrospective examinations of patient records (targeted reviews). Preliminary results suggest that PDMS facilitates the acquisition and analysis of QA data and reduces the time needed to acquire these data. Research to validate these claims and efforts to improve and expand the prototype system with a permanent production system are in progress.

Clinical Quality Assurance: A Method for the Quantification of In-House Audits

The purposes of the clinical quality assurance function is to verify that standard operating procedures are being followed correctly and to provide information allowing a judgement on the quality of the clinical studies, independently from the staff directly involved in the clinical studies. The clinical quality assurance department audits the internal study files, the sites of studies, and the reports. The study centers to be audited are chosen at random or because of the questionable quality of a study site. A method for the quantification of in-house audits, using scores, is described. With the proper approach and support, the in-house audits are well accepted by the clinical research personnel, resulting in improved clinical research management systems

Managed Mental Health Care for Employees:

Managed mental health care has become an increasingly significant influence in the timely, appropriate and cost-conscious delivery of mental health and substance abuse services. Social workers are being presented with new career paths in the private sector as EAP programs and managed health care corporations Look to them to provide the case review, supervision, provider selection, and the quality assurance functions of a well integrated managed health care system.

The Cost of Quality Assurance: an Exploratory Study

This paper documents the resource consumption of the quality assurance program at St. Marys Hospital Medical Center, a 357-bed, community, acute care hospital located in Madison, WI. To date, little exists in the literature documenting the financial commitment of an institution to its quality assurance program. Furthermore, no standard with respect to appropriateness has been established, although 1% of the operating budget of an institution has been suggested. In 1986, St. Marys spent 0.6% of its operating budget on its quality assurance function. This calculates out to approximately $20 per admission. In addition, the medical staff and others contributed 1013 hr of time to the quality assurance program. It is important that institutions determine and document their resource commitment to the quality assurance function so that standards can be established and discussion with respect to appropriateness and efficiency can be stimulated. Finally, it is important to document this expenditure so that it can be contemplated in light of fiscal pressure and availability of service.

Construction of Port and Facilities on Horn of Africa—Lessons Learned

Due to the increasing strategic importance of the African continent, there has been an increase in demand for ports and port facilities along its coastline. Sea trade to and from ports all over the world tends to make the Horn of Africa a focal point for waterborne traffic of the world. The assurance of the highest possible quality per dollar spent on port construction is of utmost importance to the host country (owner). Use of the principles and insights, which were learned during performance of quality assurance function on port construction project in Somalia and are shared herein, will maximize the probability that the quality of work produced is that which was designed. Proven‐in‐action success techniques related to production are divulged which will help the contractor realize expeditious, economical field operations and solve construction problems before they occur by preparing himself in advance to deal with them.

Quantification of Quality Assurance in Clinical Studies

Standard Operating Procedures (SOP's), based on the FDA Good Clinical Practice (GCP) procedures, dealing with all aspects of the organisation of clinical trials, have been established in the Medical Department. The operation of GCP is described.The purpose of the clinical quality assurance function is to verify that SOP's have been followed correctly at all stages of the study. The aim of quality assurance is independently to provide information which will allow an informed judgment relevant to the quality of individual studies. The audit system is discussed.A method for the quantification of the performance of clinical studies, according to GCP, is described.The implementation of clinical quality assurance will improve the quality of management decisions and shorten the drug development process.

The cost of quality assurance: an exploratory study.

This paper documents the resource consumption of the quality assurance program at St. Marys Hospital Medical Center, a 357-bed, community, acute care hospital located in Madison, WI. To date, little exists in the literature documenting the financial commitment of an institution to its quality assurance program. Furthermore, no standard with respect to appropriateness has been established, although 1% of the operating budget of an institution has been suggested. In 1986, St. Marys spent 0.6% of its operating budget on its quality assurance function. This calculates out to approximately $20 per admission. In addition, the medical staff and others contributed 1013 hr of time to the quality assurance program. It is important that institutions determine and document their resource commitment to the quality assurance function so that standards can be established and discussion with respect to appropriateness and efficiency can be stimulated. Finally, it is important to document this expenditure so that it can be contemplated in light of fiscal pressure and availability of service.

Spacelab data processing facility (SLDPF) quality assurance expert systems development

The Spacelab Data Processing Facility (SLDPF) has developed expert system prototypes to aid in the performance of the quality assurance function of Spacelab and/or Attached Shuttle Payloads (ASP) processed telemetry data. The SLDPF is an integral part of the Space Shuttle data network for missions carrying scientific payloads. Its functions include the capturing, quality monitoring, processing, accounting and forwarding of data from Spacelab and ASP missions to various user facilities. The SLDPF consists of two functional elements: the Spacelab Input Processing System (SIPS) and the Spacelab Output Processing System (SOPS). The two expert system proto-types were designed to determine their feasibility and potential in the quality assurance of processed telemetry data. The SIPS expert system, Knowledge System Prototype (KSP) uses an IBM PC/AT with the commercial expert system shell OPS5+. Extraction of knowledge from SIPS experts was implemented emulating the duties of quality assurance analysts. In an interactive mode, an analyst responds to queries resulting in instructions and decisions governing the reprocessing, releasing or further analysis/troubleshooting of data. Released data are forwarded for further processing on the SOPS Sperry 1100/82. The data are edited, time ordered with overlapping data removed, decommutated and quality checked before shipment. The SOPS QA analysts isolate problems and select the appropriate action: either accept the data or request the data to be reprocessed. The SOPS expert system emulates this process by using an expert system shell, CLIPS, and the Macintosh personal computer. To date, these prototypes indicate potential beneficial results; e.g., increase analyst productivity, decrease the burden of tedious analysis, provide consistent evaluations of data, provide concise historical records, provide training for new analysts and expedite the operational retraining of reassigned Spacelab analysts. The logic implemented in the prototypes, the limitations of the personal computers utilized and the degree of accessibility to input data have led to an operational configuration. This configuration is currently under development and on completion will enhance the efficiency, both in time and quality, of releasing Spacelab/ASP data.

CAD in the CIM Environment: Where Do We Go From Here?

The importance of computer-aided design (CAD) has not been fully appreciated as it relates to computer integrated manufacturing (CIM). The CAD product definition model can provide essential information for many down-stream production, estimating, tooling, and quality assurance functions in the CIM environment. However, the product definition model may be inaccurate or incomplete, thus causing incomplete communication with possible scrap, re-work, and missed production deadlines. Other problems are related to the fact that many of our expert designers are retiring and taking their expertise with them. Merely being able to make 2D or 3D drawings on a CAD workstation does not make its operator a designer. A knowledge of production processes, tolerances, surface finish, and material selection is needed to supplement a designers knowledge of user needs, product functional requirements, operating conditions, cost, quality, and reliability targets. One of the most promising methods for providing timely and accurate information to the designer on an “as-needed” basis is through the use of expert design systems. Such systems promise to bridge the knowledge gap between CAD and CAM and help to incorporate these functions into the overall CIM environment.

Depth of Self‐Disclosure as a Function of Assured Confidentiality and Videotape Recording

Depth of self‐disclosure in a dyadic interview situation was assessed as a function of assurance versus nonassurance of confidentiality and as a function of a videotape versus nonvideotape condition.

The historical precedents for quality assurance in health care.

The evolution of quality assurance as an essential component of a scientific, objective approach to health care delivery, and its implications for the profession of occupational therapy are presented. A review is made of the economic, ethical, psychological, and legislative forces that have influenced the development of quality assurance over the past century, a development that has seen times of strong emphasis on quality assurance functions, as well as periods of minimal support and, even, obstacles to any activity. Quality assurance standards established by both The American Occupational Therapy Association and the Joint Commission on Accreditation of Hospitals (JCAH) are discussed. Results of commitment to these standards include improved effectiveness and efficiency of health care, better coverage and reimbursement from third-party payors, and greater professional growth. The need for commitment by occupational therapists to the most effective forms of quality assurance is recommended.

Nursing Quality Assurance

A meaningful quality assurance program comes only with appropriate knowledge, communication, and accountability for all quality assurance functions among nurses at all levels. Describing the implementation of their quality assurance program, these authors tell of their eventual realization that, in fact, they had merely implemented a quality assurance tool that brought the nursing staff little benefit and a lot of grief. Highlighting the identified problems, the factors contributing to the program's failure, and the actions they took to develop and meet appropriate objectives, they detail their later, successful implementation of the concept and the process of quality assurance. Their experience provides readers with food for thought and stimulus for critical evaluations of their own quality assurance programs.