Nursing staff perceptions regarding the clinical audit tool used for relicensing inspections within eThekwini private hospitals in South Africa.

Purpose The purpose of this paper is to assess nursing staff perceptions regarding the clinical audit tool used for relicensing inspections within private hospitals in eThekwini district. Design/methodology/approach An exploratory sequential mixed method research design was used with a qualitative first phase involving a total population of 40 nurse managers through purposive sampling. Nurse managers ( n=24) were interviewed. This was followed by a quantitative phase in which a structured questionnaire was administered to nurses ( n=270) who were randomly sampled for the study from ( n=4) hospitals. Documentation review, a third phase was used to corroborate the findings of the first two phases of the study. Findings The results of the study showed that the participants perceptions of the selected private hospitals in eThekwini district is that they have not fully implemented the approach to practice standards and healthcare audits in relation to three clinical domains of the National Core Standards and the Batho Pele principles. These findings were significant and denoted the need for a standardised clinical audit tool for private hospitals in eThekwini district. Research limitations/implications This study was confined to an independent group of hospitals and the findings may not be suitable for generalising across all private hospitals in eThekwini district. Originality/value These findings led to the development of a clinical audit tool with measurements representing elements of care that are critical to the provision of safe, quality health care services.

How to build an allogeneic hematopoietic cell transplant unit in 2016: Proposal for a practical framework.

Allogeneic hematopoietic cell transplantation is part of the standard of care for many hematological diseases. Over the last decades, significant advances in patient and donor selection, conditioning regimens as well as supportive care of patients undergoing allogeneic hematopoietic cell transplantation leading to improved overall survival have been made. In view of many new treatment options in cellular and molecular targeted therapies, the place of allogeneic transplantation in therapy concepts must be reviewed. Most aspects of hematopoietic cell transplantation are well standardized by national guidelines or laws as well as by certification labels such as FACT-JACIE. However, the requirements for the construction and layout of a unit treating patients during the acute phase of the transplantation procedure or at readmission for different complications are not well defined. In addition, the infrastructure of such a unit may be decisive for optimized care of these fragile patients. Here we describe the process of planning a transplant unit in order to open a discussion that could lead to more precise guidelines in the field of infrastructural requirements for hospitals caring for people with severe immunosuppression.

Implementation of a nationwide trauma network for the care of severely injured patients.

BACKGROUND: Regional differences in the care of severely injured patients remain problematic in industrial countries. METHODS: In 2006, the German Society for Trauma Surgery initiated the foundation of regional networks between trauma centers in a TraumaNetwork (TNW). The TNW consisted of five major elements as follows: (a) a whitebook on the treatment of severely injured patients; (b) evidence-based guidelines (S3); (c) local audits; (d) contracts of interhospital cooperation among all participating hospitals; and (e) TraumaRegister documentation. TNW hospitals are classified according to local audit results as supraregional (STC), regional (RTC), or local (LTC) trauma centers by criteria concerning staff, equipment, admission capacity, and responsibility. RESULTS: Five hundred four German trauma centers (TCs) were certified by the end of December 2012. By then, 37 regional TNWs, with a mean of 13.6 TCs, were established, covering approximately 80% of the country's territory. Of the hospitals, 92 were acknowledged as STCs, 210 as RTCs, and 202 as LTCs.In 2012, 19,124 patients were documented by the certified TCs. Fifty-seven percent of the patients were treated in STCs, 34% in RTCs, and 9% in LTCs. The mean (SD) Injury Severity Score (ISS) was highest in STCs (21 [13]), compared with 18 (12) in RTCs and 16 (10) in LTCs. There were differences in expected mortality (based on Revised Injury Severity Classification) according to the differences in the severity of trauma among the different categories, but in all types, the expected mortality was significantly higher than the observed mortality (differences in STCs, 1.8%; RTCs, 1.4%; LTCs, 2.0%). CONCLUSION: According to our findings, it is possible to successfully structure and standardize the care of severely injured patients in a nationwide trauma system. Better outcomes than expected were observed in all categories of TNW hospitals. LEVEL OF EVIDENCE: Epidemiologic study, level III. Therapeutic/care management study, level IV.

[TraumaregisterTraumaNetwork DGU® und TraumaRegister DGU®. Success by cooperation and documentation]. / TraumaNetzwerk DGU® und TraumaRegister DGU®. Erfolge durch Kooperation und Dokumentation.

BACKGROUND: The TraumaNetwork DGU® (TNW) connects hospitals with different capacities for the treatment of severely injured patients who work together as superregional (STC), regional (RTC) and local trauma centres (LTC). The standards of treatment and equipment are defined on the basis of current guidelines as published in the"White book of the Treatment of Severely Injured Patients". An external audit process evaluates the organisation and structure of participating hospitals as well as the cooperation of the trauma centres within a regional TNW. RESULTS: In May 2013 a total of 618 hospitals were visited and assessed according to the White book and 39 fully certified regional TNWs covered around 85% of the area of Germany. Treatment quality in the certified TCs was analyzed on the basis of 25,249 severely injured patients in the TraumaRegister DGU® (2008-2011) and significant differences between the expected and observed mortality rates were found. These differences were most obvious in superregional and regional trauma centres. CONCLUSION: The TraumaNetwork represents an innovative, cooperative project for successfully improving the treatment of severely injured patients.

Licenced to transplant: UK overkill on EU Organ Directive provides golden opportunity for research.

Progress in transplantation outcomes depends on continuing research into both donor and recipient factors that may enhance graft and patient survival. A system of licencing for transplantation research, introduced by the Human Tissue Act 2004, which separates it from the transplantation process (then exempt from licencing), has damaged this vital activity by a combination of inflexible interpretation of the 2004 Act and fear of criminal liability on the part of researchers. Now, following the European Union (EU) Directive (2010) on standards of quality and safety of human organs intended for transplantation, new UK Regulations have been drafted, which are intended to implement it. These Regulations impose a compulsory licencing system, similar to that for research, on the whole transplantation process. This goes beyond what is required by the Directive and may even have an inhibitory effect similar to that already seen in research. Initial draft Regulations went further, imposing criminal sanctions for breaches. However, following a public consultation process, the Department of Health (DH) has recently stated that, as a result of the overwhelming view of respondents that the proposed licencing system was unnecessary, all sanctions under the final Regulations are now decriminalised, with the sole exception of operating without a licence. While this does not eliminate the negative effect of licencing, it does suggest an awareness of the DH that excessive regulation unnecessarily harms the transplantation process. An opportunity thus arises for the Human Tissue Authority (the regulatory body for both the new licences and research licences under the 2004 Act) to end the current illogical and harmful separation of transplantation and transplantation research by ensuring that all centres licenced for organ donation, retrieval and transplantation are also fully licenced for related research.

[Certification in the healthcare system. What happens when the certificate is not awarded?]. / Zertifizierungen im Gesundheitswesen. Was passiert, wenn das Zertifikat nicht erreicht wird?

A quality certification is nowadays an important competitive factor for clinics and other institutions in Germany. The best known procedures are certification according to the norm DIN EN ISO, the German certification procedure in the healthcare system KTQ (Cooperation for Quality and Transparency in Healthcare) and the procedures of the German Cancer Society or medical professional societies. The majority of German clinics, centers, practices and nursing institutions are certified according to one of these procedures. In some areas certification is mandatory and a prerequisite for patient care, e.g. for rehabilitation institutions. But even in the field of acute medicine certification is an important proof that quality requirements have been fulfilled and has an effect on the economic situation. The aim of a visitation or audit is always to check whether the requirements of the appropriate certification procedure have been fulfilled. The actual procedure and the course can however, be organized differently. The failure to obtain certification is a very unpleasant situation for all concerned and can have negative effects on the image of the institution. Such a failure can most probably be avoided by good preparation and if necessary external consultation or internal qualification by colleagues. In most cases the certificate can be successfully obtained at least by the second attempt. Appropriate regulations are made by all procedures. Basically a thorough cost-benefit analysis should be carried out before deciding to apply for certification.

[Certification of breast centers]. / Zertifizierung von Brustzentren.

The primary focus of the establishment and certification of specialized cancer centers in the context of the National Cancer Plan is to improve the quality of care for patients with various carcinoma entities. The era of organ center certification started with the establishment of specialized breast cancer centers in line with the high incidence of breast cancer, the high mortality rate and the high level of interdisciplinary cooperation in the diagnosis and therapy of breast cancer. The introduction of quality management and external monitoring aims to provide high quality care in the diagnosis and therapy of breast cancer and is expected to improve long-term quality data (disease-free survival and overall survival) and to reduce mortality rates by about 25-30%. Certification requires the implementation of a quality management system and care provision structures assuring diagnosis and therapy according to the quality guidelines and recommendations of the specialist societies. Basic requirements for improving the quality of breast cancer patient care are centralization, specialization and interdisciplinarity. It has been demonstrated that the improvement of overall survival is associated with an increasing annual case load of a center, an increasing case load per surgeon per year, study participation and interdisciplinarity. Tumor documentation will be harmonized in the future by the establishment of local clinical cancer registries and cross-linking them with the National Cancer Registry. The data collection and analysis of several quality markers and current follow-up and survival data for each breast cancer patient will allow direct comparison of participating institutions. Individual breast cancer centers may demonstrate quality improvement longitudinally. Both certification and specialization require additional services which are associated with a substantial increase in costs. Preliminary data suggest that certified breast cancer centers are dependent on cross-financing by the participating departments of a hospital. Up to now cost-effective analyses for certified breast cancer centers are not available due to a substantial lack of data defining the additional financial burden.

[Practical implementation of a quality management system in a radiological department]. / Praktische Umsetzung von Qualitätsmanagement in einer radiologischen Abteilung.

This article describes the architecture of a project aiming to implement a DIN EN ISO 9001 quality management system in a radiological department. It is intended to be a practical guide to demonstrate each step of the project leading to certification of the system. In a planning phase resources for the implementation of the project have to be identified and a quality management (QM) group as core team has to be formed. In the first project phase all available documents have to be checked and compiled in the QM manual. Moreover all relevant processes of the department have to be described in so-called process descriptions. In a second step responsibilities for the project are identified. Customer and employee surveys have to be carried out and a nonconformity management system has to be implemented. In this phase internal audits are also needed to check the new QM system, which is finally tested in the external certification audit with reference to its conformity with the standards.

[Certification of vascular centers. Influence on quality and healthcare structures]. / Zertifizierung von Gefäßzentren. Auswirkungen auf Qualität und medizinische Versorgungsstrukturen.

Diagnosis and therapy of vascular diseases are increasingly being performed following a multimodal, interdisciplinary and less invasive approach. The introduction of specialized, organ-related centers is a logical consequence in view of a better treatment quality and a more effective use of resources. The German societies of radiology, vascular surgery and angiology jointly developed a process of certification, which has been successfully applied to more than 100 units in Germany. In this article the terms and results of the process are described and possible effects on the quality and structures of the healthcare system are discussed.

[(No) Fear of audits? Control is good, trust is better. Audits as a core element of quality management]. / (K)eine Angst vor Audits? Kontrolle ist gut, Vertrauen ist besser. Audits als zentrales Qualitätsmanagementelement richtig anwenden.

Quality management (QM) cannot be successfully implemented and performed without audits. The PDCA (Plan-Do-Check-Act) cycle is the core component of QM systems. In this cycle an audit represents the crucial step "check". Audits verify whether the performed actions and their results conform to the requirements. It is especially important to verify whether the principles of QM are omnipresent and fully implemented in a department or institution. The announcement of an audit may cause mixed feelings or even anxiety among the personnel to be audited. Without previous information and training the audit may be perceived as an act of control and intrusion into departmental affairs. The colleagues often fear sanctions if lapses are found or consider the audit to be a cross-examination. However, an audit is rather meant to be a helpful aid and a chance to continuously improve the departmental QM system by means of a constructive communication among colleagues. In the year 2009 the European Commission published guidelines for the performance of clinical audits in medical radiology, including diagnostic radiology, nuclear medicine and radiation therapy (Council Directive 97 / 43 / EURATOM). The aim is an optimal protection of the individual from the hazards of ionizing radiation and the directive expects radiological departments to perform clinical audits in accordance with national procedures.

Hospital certification for optimizing cardiovascular disease and stroke quality of care and outcomes.

Cardiovascular disease and stroke remain leading causes of mortality, disability, and rising healthcare expenditures in the United States. Although a number of organizations provide hospital accreditation, recognition, and certification programs, existing programs do not address cardiovascular disease and stroke care in a comprehensive way. Current evidence suggests mixed findings for correlation between accreditation, recognition, and certification programs and hospitals' actual quality of care and outcomes. This advisory discusses potential opportunities to develop and enhance hospital certification programs for cardiovascular disease and stroke. The American Heart Association/American Stroke Association is uniquely positioned as a patient-centered, respected, transparent healthcare organization to help drive improvements in care and outcomes for patients hospitalized with cardiovascular disease and stroke. As a part of its commitment to promoting high-quality, evidence-based care for cardiovascular and stroke patients, it is recommended that the American Heart Association/American Stroke Association explore hospital certification programs to develop truly meaningful programs to facilitate improvements in and recognition for cardiovascular disease and stroke quality of care and outcomes. Future strategies should standardize objective, unbiased assessments of hospital structural, process, and outcome performance while allowing flexibility as technology and methodology advances occur.

Standardization of pathology laboratories in Pakistan: problems and prospects.

A Total Quality Management System with an internationally recognized accreditation process is the only guarantee of a reliable pathology service. However in a developing country like Pakistan nearly 90% of labs are small and without adequate physical and man power infrastructures. A modified plan may have to be tailored for them. A two tier system has been formulated. Accreditation based on ISO 15189 is to be introduced on voluntary basis. The labs which do not qualify for international standardization would be brought into quality net through a registration process. All such labs will be initiated into a simplified quality management system. Participation in proficiency testing program will be mandatory. They will be provided education and training to become eligible for accreditation. It is hoped that this simplified system will provide an impetus for evolving a workable and comprehensive mechanism through which pathology laboratories in the country will be able to offer better and more reliable services.

Neurosurgeon transition to retirement: results of the 2007 Congress of Neurological Surgeons Consensus Conference.

OBJECTIVE: Recent studies of age-related effects on cognition and performance have raised concerns about the appropriate timing and regulatory surveillance of retirement for surgeons. Little is known about the practice patterns and retirement plans of aging neurosurgeons. Analyses of informed opinions on possible regulatory options are also lacking. METHODS: During a consensus development workshop conducted at the 2007 Annual Meeting of the Congress of Neurological Surgeons, participants collected data regarding neurosurgeons' retirement plans, reviewed expert background information, and assessed opinions. Participants submitted data and discussion points throughout the session using digital handheld devices. These data were then statistically analyzed, with particular attention to shifts in opinion and emergence of consensus after the presentation of expert material and discussion. RESULTS: Neurosurgeons strongly oppose government regulation of retirement using uniform retirement age regulations. The most favored policy option, initially, particularly among older neurosurgeons, was status quo. After consensus development, the most favored policy option was local regulation by hospital privileging bodies. Neurosurgeon age, but not perceived ability to reach financial retirement goals, significantly influenced opinions. CONCLUSION: Retirement age is an area of active government regulation in other professions. Neurosurgeons seem to favor a flexible system of regulation based on local and quality standards, rather than national age-based thresholds. The Congress of Neurological Surgeons Consensus Conference process offers a viable methodology for initiating discussion of important policy issues facing organized neurosurgery, engaging the informed input of practicing neurosurgeons, and formulating preliminary strategies for pursuit by stakeholder neurosurgical policy organizations.

Reimbursement for carotid stenting: unique challenges for medical centers and physicians.

Carotid artery stenting has been identified as an important therapeutic option for patients with atherosclerotic occlusive disease of the extracranial carotid artery. While the preferred application of this technology remains an area of active clinical investigation and its optimal role may continue to evolve, a preponderance of opinion supports its present application in carefully selected patients. Enabling the introduction of this technology into the broader patient community mandated a consensus between a large number of specialty societies and the Centers for Medicare and Medicaid Services to define both currently acceptable procedures to be performed and appropriate clinical criteria for its suitable application. This report reviews the collaborative process, which evolved to achieve this consensus and the current guidelines for procedural coding, facility accreditation, and reimbursement for carotid artery stenting. Related requirements for Medicare coverage of patients in clinical trials and registries are also discussed.

What is the measure of a safe hospital? Medication errors missed by risk management, clinical staff, and surveyors.

Research in the last decade has identified medication errors as a more frequent cause of unintended harm than was previously thought. Inpatient medication errors and error-prone medication usage are detected internally by medication error reporting and externally through hospital licensing and accreditation surveys. A hospital's rate of medication errors is one of several measures of patient safety available to staff. However, prospective patients and other interested parties must rely upon licensing and accreditation scores, along with varying access to outcome data, as their sole measures of patient safety. We have previously reported that much higher rates of medication errors were found when an independent audit was used compared with rates determined by the usual process of self-report. In this study, we summarize these earlier findings and then compare the error detection sensitivity of licensing and accreditation surveys with that of an independent audit. When experienced surveyors fail to detect a highly error prone medication usage system, it raises questions about the validity of survey scores as a measure of safety (i.e., lack of medication errors). Replication of our findings in other hospital settings is needed. We also recommend measures for improving patient safety by reducing error rates and increasing error detection.