The quality systems approach.

Health care as an industry is going through an evolution similar to that experienced by manufacturing and other service sectors of the world economy. When competition threatens, the traditional management approach is slash-and-burn to manage costs. This approach affects people, services, and facilities. When the slash-and-burn method runs out of fuel, organizations start to merge, thinking that bigger is better. Just getting bigger only looks like change, with a new cast of fewer people and organizational structure. The root cause for existing problems has not been fixed. The only real solution, as manufacturing and services learned, is to understand and improve work processes to ensure that the right work is being done in a high-quality manner and at a competitive price. The era of quality systems is just dawning in health care. The focus must remain on quality patient outcomes at a competitive price by improving supporting systems and processes to accomplish these goals.

ISO 9000 case study: the role of the external consultant.

BACKGROUND: Increasingly, blood centers worldwide are turning toward the ISO (International Organization for Standardization) 9000 Quality System Standards to meet regulatory demands of public authorities, competitive demands within their industry, and cost requirements from their customers. CASE REPORT: The South Texas Blood and Tissue Center is the first blood center in North America to achieve registration to the ISO 9002 Quality System Standards. The role of the external consultant in initiating the process and as a facilitator during the implementation process is examined. CONCLUSION: To ensure the long-term success and viability of any quality system, it is necessary for an organization to develop and implement its own program. External consultants can assist in many ways, but it is important that their role be a supporting one rather than one of direct implementation.

Quality pays--in every business!

For the past few years, blood banks within and outside of hospitals have been required to develop a documented quality assurance/quality improvement program to comply with regulator guidelines and accreditation standards. Concerns have been raised that the cost of compliance could exceed any plausible return on this investment. Unfortunately, little data exist in blood bank literature or are currently being captured to support or refute this contention. This article describes an approach for capturing the cost of quality based on models from the manufacturing industry, suggests how blood banks could document the cost and benefit of their quality efforts and presents some unpublished data on the impact of tracking the cost of poor quality in one blood bank.

ISO 9000 quality standards: a model for blood banking?

The recent American Association of Blood Banks publications Quality Program and Quality Systems in the Blood Bank and Laboratory Environment, the FDA's draft guidelines, and recent changes in the GMP regulations all discuss the benefits of implementing quality systems in blood center and/or manufacturing operations. While the medical device GMPs in the United States have been rewritten to accommodate a quality system approach similar to ISO 9000, the Center for Biologics Evaluation and Research of the FDA is also beginning to make moves toward adopting "quality systems audits" as an inspection process rather than using the historical approach of record reviews. The approach is one of prevention of errors rather than detection after the fact (Tourault MA, oral communication, November 1994). The ISO 9000 series of standards is a quality system that has worldwide scope and can be applied in any industry or service. The use of such international standards in blood banking should raise the level of quality within an organization, among organizations on a regional level, within a country, and among nations on a worldwide basis. Whether an organization wishes to become registered to a voluntary standard or not, the use of such standards to become ISO 9000-compliant would be a move in the right direction and would be a positive sign to the regulatory authorities and the public that blood banking is making a visible effort to implement world-class quality systems in its operations. Implementation of quality system standards such as the ISO 9000 series will provide an organized approach for blood banks and blood bank testing operations. With the continued trend toward consolidation and mergers, resulting in larger operational units with more complexity, quality systems will become even more important as the industry moves into the future.(ABSTRACT TRUNCATED AT 250 WORDS)

Maintaining quality in blood banking.

Regulation of transfusion or blood banking facilities has followed, rather than preceded the regulation of the pharmaceutical industry and today we find, in Europe and the United States, the basic regulations developed for the pharmaceutical industry being extended to blood transfusion centres (BTC)*. In this article we explore the role of voluntary accreditation or registration to quality systems standards such as ISO 9000 and discuss how these can be used to advantage and how these standards can provide a substantial base for meeting legislative requirements. In the UK there is also a voluntary accreditation procedure available for all clinical laboratories, known as Clinical Pathology Accreditation (CPA). Comparisons between ISO 9000, CPA and other standards are made. We also discuss how voluntary registration, particularly to ISO 9000 can provide an excellent basis for moving into more extensive and progressive Total Quality Management (TQM) programmes which in turn bring a variety of benefits, not least of which is increased staff involvement in your organisation. Experience of the route to quality through voluntary accreditation suggests that external assessment delivers new insights into the organisation that cannot easily be supplanted by internal audit. In Europe legislation relating to pharmaceuticals has steadily increased in scope and in detailed requirements from those set out in the 1965 Directive 65/65/EEC. The legislative framework has steadily increased, bringing plasma and plasma products as well as others such as radiopharmaceuticals, into the product licensing requirements. The progression of legislation seems unlikely to cease and it is debatable how long the Medicines Control Agency (MCA) and its Inspectorate will accept that BTCs can operate at a level which is different from that of the majority of pharmaceutical manufacturers. The change in emphasis in legislation particularly in Europe means that harm that is caused to a patient by a blood component will warrant redress. The degree of fault attributed to the producer will in part depend on whether they have met the best available standards at all stages in the preparation of the product. If a Transfusion Service can show that it's operation has external accreditation, particularly to an internationally recognised standard such as ISO 9000 and they can show that staff have been properly trained, that equipment is properly supplied and maintained and that the facility is appropriate to the work being carried out, then the liability that exists when something goes wrong will be reduced.(ABSTRACT TRUNCATED AT 400 WORDS)

Quality systems and total process control in blood banking.

Blood banking has dramatically changed in the past few years. Is the old business hierarchy and medical model for management still workable? How do we want to organize our work today for success in the future? Implementation of quality systems may seem overwhelmingly complex at this time to many blood banking establishments. However, by methodically adhering to the requirements of organization development described in this review, blood centers can achieve goals of quality improvement and TPC. The FDA and the pharmaceuticals and medical device industries have set the direction and provided guidance to blood establishments. The AABB, American Society for Quality Control, the American Society for Training and Development, and numerous other professional organizations can contribute information and materials. The FDA's document on quality assurance and the CFR are the basic texts guiding the approach presented in this paper. The organization's structure and processes may need to be reengineered to meet the requirements of a culture based on quality and process control.

Laboratory apprenticeships: a look back in history or a new paradigm?

The reality of the world and the workplace is changing rapidly, and continuing the "old" ways will not provide the solutions needed to address the problems the health-care industry faces today. "The organization of the laboratory, as we now know it, will change. An environment in which every instrument is run by highly trained medical technologists is not likely to be the norm. Instead, laboratories will be staffed by lesser trained technicians under the direction of a limited number of medical technologists.... Licensing and regulatory trends for laboratories will support the downgrading of the average level of laboratory expertise required to perform tests". Similarly, in 1993 a regional director of the National Labor Relations Board (NLRB) ruled that many medical technologists do not meet the NLRB definition of professional because they perform highly automated and routine work that does not require the consistent exercise of discretion and judgment. Does the laboratory industry need to have all of its work done by highly trained medical technologists? A look at current laboratories would seem to answer that question as "no." On the other hand, do we need highly trained medical technologists in the laboratories? The answer is yes, but it is apparent that medical technologists of the future need to prepare themselves in new ways to address future demands on the profession.(ABSTRACT TRUNCATED AT 250 WORDS)

Evaluation of enzyme immunoassay for anti-HBc IgM in the diagnosis of acute hepatitis B virus infection.

Corzyme-MTM (Abbott Laboratories, North Chicago, IL), a newly introduced kit for the measurement of serum IgM antihepatitis B core antigen by enzyme immunoassay, was evaluated for the diagnosis of acute B-viral hepatitis (AVH-B). The study included 175 acute viral hepatitis patients with transient hepatitis B surface antigen (HBsAg). Sera from 160 were tested on multiple occasions until their HBsAg cleared. IgM anti-HBc was found in 171 of 175 patients (98.4%) during the acute phase. The serum samples from 42 patients with liver biopsy-proven chronic active hepatitis, type B (CAH-B), and 18 patients with persistent hepatitis, type B (PH-B), were analyzed for the presence of IgM anti-HBc, using the same technic. None of the sera from 42 patients with CAH-B and only 2 of the 18 patients with PHB had IgM anti-HBc. Thus, the measuring IgM anti-HBc using Corzyme-M kit is helpful in the diagnosis of AVH-B and in the discrimination of acute from chronic HBV infections.

Student evaluation of instruction: a challenge to medical technology educators.

Through ever increasing political and economic pressures, accountability is in the foreground of higher education today. Demands are increasing for formal evaluation of instructor effectiveness in classrooms and laboratories. The general concept of teacher evaluation by students is discussed and a form which can be used for evaluation is presented.

The response of C3H mice to streptozotocin. I. Thymic depression and leukocyte toxicity.

Streptozotocin, an antibiotic with reported antileukemic activity, was administered to C3H mice to evaluate the response of peripheral blood leukocytes and thymic lymphocytes. The hematologic effects of a single diabetogenic dose of streptozotocin include an absolute neutropenia and a depression of tritiated thymidine incorporation into thymic lymphocytes.