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)

Both inherited HLA-haplotypes are important in the predisposition to rheumatoid arthritis.

The distribution of the HLA-DR allele frequencies of 105 RA patients has been compared with the expected distribution under recessive and dominant modes of inheritance using control data from 2041 controls and the antigen genotype frequency among patients methodology. The observed distribution was compatible with a recessive mode of HLA-linked inheritance in RA, with a dominant mode rejected, whether HLA-DR4 was considered alone, or HLA-DR4 and HLA-DR1 were combined as if they were behaving as a single predisposing gene. Mean sibship concordance rates (MSCRs) were calculated for categories of proband HLA-DR genotypes. The highest MSCR was for HLA-DR4 homozygous probands, and the lowest for HLA-DR2 or 7/non-4 genotypes. These combined observations suggest that interactions between both inherited HLA-haplotypes are important in the predisposition to RA.

Regional transfusion centre preoperative autologous blood donation programme: the first two years.

OBJECTIVE: To assess the efficacy of a regional autologous blood donation programme. DESIGN: Clinical and laboratory data were collected and stored prospectively. Transfusion data were collected retrospectively from hospital blood bank records. SETTING: Northern Region Blood Transfusion Service and 14 hospitals within the Northern Regional Health Authority. SUBJECTS: 505 patients referred for autologous blood donation before elective surgery. MAIN OUTCOME MEASURES: Patient eligibility, adverse events from donation, autologous blood units provided, and autologous and allogeneic blood units transfused within 10 days of operation. RESULTS: Of 505 patients referred, 354 donated at least one unit. 78 of 151 referred patients who did not donate were excluded at the autologous clinic, mostly because of anaemia or ischaemic heart disease. In 73 cases the patient, general practitioner, or hospital consultant decided against donation. 363 autologous procedures were undertaken. In 213 (59%) cases all requested units were provided. The most common reasons for incomplete provision were late referral or anaemia. Adverse events accompanied 24 of 928 donations (2.6%). Transfusion data were obtained for 357 of the 363 procedures. 281 donors were transfused; autologous blood only was given to 225, autologous and allogeneic blood was given to 52, and allogeneic blood only was given to four. 648 of 902 (72%) units of autologous blood were transfused. Complete provision of requested autologous units was followed by allogeneic transfusion in 12 of 208 procedures (5.8%). Incomplete provision was followed by allogeneic transfusion in 44 of 149 procedures (30%). CONCLUSIONS: This study shows the feasibility of a regional autologous transfusion programme. Autologous donors only infrequently received allogeneic transfusion. Patients should be appropriately selected and referred early.