Assuring quality of health care. An overview.

This article reviews currently used quality assurance techniques. It assumes a broad definition of quality that includes attention to the content and professional judgment exercised in the provision of health services, as well as the appropriateness of resource utilization. Emphasis is on more or less generic approaches to review that can be applied regardless of the specific health profession involved. After describing and contrasting various quality assurance techniques, the article concludes with a general discussion of effectiveness, problems in initiating behavior change, and opportunities for further research and evaluation.     

The use of Minilabs to improve the testing capacity of regulatory authorities in resource limited settings: Tanzanian experience

The Tanzania Food and Drugs Authority piloted the use of Minilab kits, a thin-layer-chromatographic based drug quality testing technique, in a two-tier quality assurance program. The program is intended to improve testing capacity with timely screening of the quality of medicines as they enter the market. After 1 week training of inspectors on Minilab screening techniques, they were stationed at key Ports-of-Entry (POE) to screen the quality of imported medicines. In addition, three non-Ports-of-Entry centres were established to screen samples collected during Post-Marketing-Surveillance. Standard operating procedures (SOPs) were developed to structure and standardize the implementation process. Over 1200 samples were tested using the Minilab outside the central quality control laboratory (QCL), almost doubling the previous testing capacity. The program contributed to increased regulatory reach and visibility of the Authority throughout the country, serving as a deterrent against entry of substandard medicines into market. The use of Minilab for quality screening was inexpensive and provided a high sample throughput. However, it suffers from the limitation that it can reliably detect only grossly substandard or wrong drug samples and therefore, it should not be used as an independent testing resource but in conjunction with a full-service quality control laboratory capable of auditing reported substandard results.     

The influence model of sponsorship. A Catholic hospital is now part of the "Mayo Clinic"

Saint Marys Hospital was founded in Rochester, MN, in 1889. Constructed by the Sisters of St. Francis, it was staffed by physician members of the local Mayo family. The Mayo practice grew into an association of many physicians and medical residents who later began to staff Rochester Methodist Hospital also; the three healthcare institutions became collectively known as the "Mayo Clinic." By the mid-1980s, billing was so complex for the three still-independent facilities that their leaders decided to integrate more formally. This was done in three phases and resulted in the creation of a single institution known as the Mayo Medical Center. From Saint Marys' standpoint, the facilitating document in this process was a "Sponsorship Agreement" whose purpose was to maintain the sponsor's interests and obligations in the integrated structure. A Sponsorship Board was created to continue the hospital's Catholic tradition, including maintaining its chaplaincy, chapels, religious symbols, and special funds. The Sponsorship Board views the new environment as a special challenge. Its members know that Catholic sponsorship: Comforts patients, who realize they are in the hands of people motivated by the Christian ethic Creates an atmosphere in which patients and their families can seek the spiritual support that often aids healing Strengthens a sense of community among physicians, hospital staff, and administrators The Sponsorship Board hopes the sponsor's influence may come to affect the whole Mayo Medical Center, bringing patients, family members, and staff an "added dimension" of care.     

Quality assurance for a nutritional support service.

Quality assurance programs may significantly influence patient care by providing a systematic mechanism of self-assessment. An effective program should improve the level of care and have a positive effect on the fiscal base of a health care institution. The design of a useful quality assurance program is not a trivial matter. This report describes the details of a functioning quality assurance program developed for a multidisciplinary nutrition support service. The effect that such a program may have on patient care is also illustrated.     

Privately funded quality health care in India: a sustainable and equitable model.

OBJECTIVE: As the cost and degree of training necessary to provide state of the art health care has increased throughout the world, the present challenge in health care is to establish institutions that are financially sound and responsive to the dynamic needs of the communities in which they exist. As public funds have diminished, the role of the private sector in estabhshing innovative health care institutions has increased. SETTING AND STUDY PARTICIPANTS: This paper reviews the case of the LV Prasad Eye Institute (LVPEI), an ophthalmologic institute in Hyderabad, India, that is financially sound and medically vital. With an annual budget of US$3 million, 180 000 patients are seen and 23 000 surgeries are performed at the Institute and its satellites each year. MAIN MEASURES: The Institute provides patient care at a ratio of 1:1 non-paying to paying patients through fee cross-subsidization. The Institute uses a combination of financial modalities, including donations, grants and fees to administer its non-patient care programs. Non-clinical programs of the Institute include a paramedical training program and a fellowship in ophthalmology, an internationally accredited eye bank for the preservation of corneal tissues, a rural out-reach and education program, a basic science and epidemiology program that directs health policy activities of the Institute and a rehabilitation program for patients with incurable visual deficits. To evaluate its effectiveness, LVPEI uses quality improvement measures, including patient surveys, post-operative outcomes studies and service utlization reviews. CONCLUSION: This case report of a privately-funded medical institution describes a successful model through which high-quality, equitable health care can be provided in a developing country. The LVPEI's active program of quality management, its academic commitment and programmatic relevance to the needs of its community should be modularized and replicated to establish equitable, efficient and effective health care institutions in the developing world.     

Connecting values and program development. A Canadian hospital's experience with mission integration

Catholic values distinguish Catholic healthcare facilities, their staff members like to say. But those values can remain merely rhetorical unless they are integrated into the facility's actual programs. The staff of St. Joseph's Hospital, Hamilton, Ontario, has been encouraged to express the facility's values in everyday language. More important, the staff has had an opportunity to employ those values--a belief in the sacredness of life and the dignity of the person; a special obligation to the poor and vulnerable; and a commitment to treat the "whole person"--in two new programs. One is for women who have miscarriages. The hospital's Obstetrics Department, realizing that society often fails to recognize the deep grief involved, developed a program for women experiencing early pregnancy loss (EPL). The EPL protocol stresses the uniqueness of each patient and the importance of support, continuity, appropriateness of care, and postdischarge follow-up for her. The hospital has also emphasized Catholic values in developing a set of guidelines for the examination of patients. St. Joseph's found that publicity about sexual abuse was making both patients and medical practitioners wary of physical examinations. The guidelines, called "Culture and Sensitivity," remind care givers that patients feel vulnerable and should be treated with respect and care, on one hand. On the other hand, the guidelines say, appropriate reassuring touch remains part of the healing process.     

Pre-clinical and clinical evaluation of new infant formulas

Due to the importance of infant formulas as the primary source of nutrition for many infants, responsible infant formula manufacturers utilize a program of extensive premarket testing to evaluate the safety, reliability, and nutritional adequacy of such products. Based on the results of these studies, it is possible to document the usefulness of each formula in meeting infants' and parents' needs, and to provide physicians, nurses, dietitians, and regulatory agencies assurance of the appropriateness and safety of these products.     

Was ist gute Wissenschaftliche Politikberatung?

Scientific advice to politics is a primary function of governmental research. The advisory process is, in the ideal situation, a collective duty of science and politics. The final decision rests ultimately with politicians. An understanding of the differences between science and politics is necessary for successfully providing advice to politicians. The requirements necessary to allow politics to substantially follow the advice of scientists are multifarious. The first of these is trust from the side of politics and the public and from the side of science competitive research, respect and communication skills, neutrality and integrity. From these requirements it is possible to derive criteria for quality assurance in advice to politics. The maintenance of scientific expertise at the competitive international level demands independent, qualified and adequately financed research. Governmental institutes have an antenna function: they have to recognize in good time whether risks are increasing, whether the government has to be informed and whether there is a need for action. The continuing maintenance of excellence requires measures of quality assurance at all levels. Evidence for the quality of advice to politics can, for example, be found in the good reputation of an institution and its prominent representatives. Success in research is an indirect quality criterion that can be and should be measured to a certain extent. The influence of advisory activities on political decisions is direct evidence for the quality of the advice. A classic example of highly successful policy advice is the development of the German AIDS policy.     

Economic Analysis of Vaccination Programs

This report provides recommendations for budget holders and decision makers in high-, middle, and low-income countries requiring economic analyses of new vaccination programs to allocate scarce resources given budget constraints. ISPOR’s Economic Evaluation of Vaccines Designed to Prevent Infectious Disease: Good Practices Task Force wrote guidelines for three analytic methods and solicited comments on them from external reviewers. Cost-effectiveness analyses use decision-analytic models to estimate cumulative changes in resource use, costs, and changes in quality- or disability-adjusted life-years attributable to changes in disease outcomes. Constrained optimization modeling uses a mathematical objective function to be optimized (e.g. disease cases avoided) for a target population for a set of interventions including vaccination programs within established constraints. Fiscal health modeling estimates changes in net present value of government revenues and expenditures attributable to changes in disease outcomes. The task force recommends that those designing economic analyses for new vaccination programs take into account the decision maker’s policy objectives and country-specific decision context when estimating: uptake rate in the target population; vaccination program’s impact on disease cases in the population over time using a dynamic transmission epidemiologic model; vaccination program implementation and operating costs; and the changes in costs and health outcomes of the target disease(s). The three approaches to economic analysis are complementary and can be used alone or together to estimate a vaccination program’s economic value for national, regional, or subregional decision makers in high-, middle-, and low-income countries.     

儿童保健系统管理质量保证体系的建立和运行

【目的】 建立质量保证体系,正确履行系统保健的问询检查、判断评估及保健指导等7大功能,为儿童提供规范、便捷、全面的保健服务。 【方法】 以系统保健过程为对象,以相关文件和规程为指南,对系统保健质量体系的构成要素进行分析,在此基础上,从运行主体、过程方法、支持条件和监测评估4个方面进行设计。 【结果】 建立了基于“测查-评价-指导”一体化及其相应支持要素的儿童保健系统管理质量保证体系,该体系涵盖了系统保健的全部关键质量控制点,解决了系统保健中的质量控制和执行规范的难点。 【结论】 建立儿童保健系统管理质量保证体系并遵照执行,是系统保健行之有效的质量管理手段。     

瓦里安Eclipse DX治疗计划系统的质量保证与质量控制

目的:探讨瓦里安Eclipse DX治疗计划系统(TPS)质量保证(QA)和质量控制(QC)的主要内容及检测方法,以保证临床放疗的稳定性,提高放疗实施的准确性和精度。方法:从瓦里安Eclipse DX TPS系统文档、用户培训、验收、常规QA和QC、患者治疗计划的检查等方面分析确认QA和QC的主要内容和检测方法。结果:得出了瓦里安EclipseDX TPS QA和QC的主要内容和检测方法。结论:作为TPS QA和QC的主要内容及检测方法,对各级放射治疗单位TPS OA体系的建立具有现实指导作用。     

Self-assessment in graduate public health programs: characteristics and constraints

The purpose of this paper is to discuss the characteristics and constraints of internal appraisals or self-assessments in Graduate Public Health Programs, conducted through a study of the report on 25 programs participating in the three-year CAPES evaluation (2001-2003). Three main aspects were considered: (a) tools and/or procedures employed; (b) self-assessment procedures; (c) products for upgrading program quality. The findings indicate that different tools are employed and used improperly. For most of the programs, it is not clear how ongoing processes take place, as the products presented are not directly related to the process as performed and the program quality assurance procedures. The importance of self-assessment is discussed as a tool for exploring the possibilities and boundaries of a process or an institution, as well as for taking decisions. A suggestion is presented: setting up a basic structure with working groups and a self-assessment coordination team; real participation and commitment among staff members and decision-makers; reliable data with effective use of the findings.     

A case mix procedure for matching the clinical characteristics of patients with dual disorders to planned treatment and treatment costs

A procedure for matching the clinical characteristics of patients with a dual substance abuse psychiatric disorder to planned treatment resource consumption is described. The procedure uses current standards and practices within the mental health literature on dual diagnosed patients, providing an empirical basis for quality assurance, utilization review, and program evaluation. These procedures permit an empirical linking of clinical service performance to the costs of clinical resources, thereby providing a means of: (a) evaluating program costs in terms of the specific clinical characteristics of patients and (b) planning budgets based on the patients’ clinical needs. The methods are sufficiently flexible so that as new clinical research recommend changes in assessment and treatment, the case mix definitions and evaluation procedures can be easily modified.     

A trust relationship. A medical advisory board builds physician commitment to a healthcare facility

Today physicians and hospitals are in competition. To ensure consistent physician input and a forum for two-way communication, St. Edward Mercy Medical Center, Fort Smith, AR, has established a medical staff board. The medical staff board was organized so physicians could formally address managers' concerns without duplicating work done by other medical staff committees (e.g., executive committee, medical staff sections, hospital committees). Membership on the 24-member board was limited to the active staff. A two-year term was established, allowing for two consecutive terms to ensure continuity. The chief of staff and chief executive officer (CEO) are ex-officio members. Some of the issues of interest to physicians include how well informed operating room personnel were on current technology and procedures, how effective the emergency department could be, having been designed almost 20 years ago, and how volume purchasing affects physician familiarity with certain products. St. Edward's medical staff board has the potential to enhance the physician-hospital relationship and to serve as an effective tool in building commitment to the medical center.     

海口市不同级别公立医疗机构门诊患者公益性评价

目的了解海口市不同级别公立医疗机构门诊患者的满意度, 提出有关公益性评价的政策建议。方法采用典型抽样的方法,分别选取海口市一级、二级、三级医疗机构共9家,进行门诊患者满意度问卷调查。问卷具体化为3 个维度（服务质量、服务适宜性、职业道德维度）和 12 个指标。结果三类医疗机构接受调查的患者在年龄、居住地、医保情况、职业、自报月收入和医疗服务方式等方面存在差异。门诊患者对医疗机构的公益性的综合评价得分为1.77±0.837分,不同级别公立医疗机构总体公益性评价得分,以及公益性评价子项目差异均有统计学意义（P<0.05）。患者对公立医疗机构的公益性评价在服务质量维度、服务适宜性维度方面,三级公立医疗机构要低于一、二级公立医疗机构。结论门诊患者对不同级别医疗机构的公益性评价存在差异,加强公立医院的公益性应该着重提高医疗服务的适宜性和公平性。在患者对公益性评价的服务质量维度中,建议增加“诊疗时间、医患沟通质量”评价指标,以体现对患者的“尊重与关心”,从而彰显“以人为中心”的诊疗模式和个体化医疗精神。公立医疗机构公益性回归是政府良治的迫切需求。     

Accreditation in the allied health professions

Specialized accreditation in the allied health professions can and will fulfill its basic purpose if its efforts are guided by the principle that evaluation must place its emphasis on the outcome of the educational process, no matter how difficult it may be to assess. This requires the commitment and cooperation of both the accrediting body and the institution and program under review. Accreditation is a vitally important and valuable system in higher education in general, and the allied health professions are no exception. If the system is to be effective, however, every temptation must be resisted by all involved parties to debase it by using it for self-serving purposes. A recognized accrediting agency not only has the right, but indeed the responsibility, to ensure that the graduates of a program under review possess the prerequisite knowledge and skills essential for entrance into a given allied health profession. In cases where that minimal standard is not attained, the program should be required to remove those deficiencies in a timely manner or, if sufficiently serious, have its accreditation withheld or withdrawn. There should be no exceptions to this course of action. Every standard or essential adopted should be defensible on sound educational grounds, and every program should be evaluated according to whether it is in compliance. Accrediting bodies must direct their efforts toward evaluating educational quality. They must respect institutional rights and responsibilities and not even attempt to prescribe what will be taught or by whom, or who will administer a given program. The entire accreditation process must account for institutional diversity and should not discourage experimentation, innovation, or modernization. However, the standards and essentials that are ultimately adopted must be applied uniformly and fairly and not in an arbitrary or capricious manner. Hence, it is imperative that the standards and essentials be stated in such a way that they are clear and understandable. For those programs in which an enhancement or upgrading is deemed necessary for one or more aspects of the educational experience, it would be a genuine service to the institution and its consistuency if the accrediting agency could offer sound advice and suggestions for remedying those factors that may be causing or contributing to the observed deficiencies in the educational outcome. Any responsible institution would welcome such an approach, and the outcome should be an upgrading of the program under review with a concomitant enhancement of the profession involved.(ABSTRACT TRUNCATED AT 400 WORDS)     

NLRB's St. Francis decision signals broader-based bargaining units

The number of potentially appropriate bargaining units in a hospital has been sharply reduced by the National Labor Relations Board's recent St. Francis decision. Following a series of rejections by the U.S. Courts of Appeals, the NLRB has abandoned its previous position and adopted new standards that it believes are more in keeping with Congress' directive to prevent the proliferation of bargaining units in the health care industry. The new standards require that there be unusually sharp differences between the wages, hours, working conditions, etc., of employees requesting a separate bargaining unit and those in an overall professional or nonprofessional unit. As a result, hospital bargaining units will become much more broadly based. The St. Francis decision does not, however, invalidate previous NLRB certification or relieve a hospital of established bargaining obligations. To establish the appropriateness of broader based units, employers can ensure that employees in such a proposed unit are covered by a centrally administered wage and salary program with common wage scales, labor grades, pay increments, and job performance evaluation standards. Functional integration, continuing education and training, job transfers, shared facilities and activities, and centralized personnel policies and procedures are also areas in which employees' mutuality of interest can be established, thereby supporting the creation or maintenance of broad units.     

The logical underpinnings and benefits of pooled pharmaceutical procurement: A pragmatic role for our public institutions?

Multi-national pharmaceutical companies have long operated across national boundaries, and exercised significant leverage because of the breadth and depth of their market control. The goals of public health can be better served by redressing the imbalance in market leverage between supply and demand. Consolidation of purchasing power across borders, as well as within countries across organizational entities, is one means to addressing this imbalance. In those existing pooled procurement models that consolidate purchasing across national boundaries, benefits have included: 1) reductions in unit purchase prices; 2) improved quality assurance; 3) reduction or elimination of procurement corruption; 4) rationalized choice through better-informed selection and standardization; 5) reduction of operating costs and administrative burden; 6) increased equity between members; 7) augmented practical utility in the role of the host institutions (regional or international) administering the system; and finally, 8) increased access to essential medical products within each participating country. Many barriers to implementation of a multi-country pooled procurement system are eliminated when the mechanism is established within a regional or international institution, especially where participating countries are viewed (and view themselves) as clients/members of the institution, so that they have some sense of ownership over the procurement mechanism. This review article is based on two literature reviews, conducted between 2007 and 2009 (including publications from 1996 through 2009), and interviews with key informants.