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PubMed2003

Voluntary accreditation of cellular therapies: Foundation for the Accreditation of Cellular Therapy (FACT).

Voluntary accreditation of cells, tissues, and cellular and tissue-based products intended for human transplantation is an important mechanism for improving quality in cellular therapy. The Foundation for the Accreditation of Cellular Therapy (FACT) has developed and implemented programs of voluntary inspection and accreditation for hematopoietic cellular therapy, and for cord blood banking. These programs are based on the standards of the clinical and laboratory professionals of the American Society of Blood and Marrow Transplantation (ASBMT), the International Society for Cellular Therapy (ISCT), and NETCORD. FACT has collaborated with European colleagues in the development of the Joint Accreditation Committee in Europe (jACIE). FACT has published standards documents, a guidance manual, accreditation checklists, and inspection documents; and has trained as inspectors over 300 professionals active in the field. All inspectors have a minimum of 5 years' experience in the area they inspect. Since the incorporation of FACT in 1996, 215 hematopoietic progenitor cell facilities have applied for FACT accreditation. Of these facilities, 113 are fully accredited; the others are in the process of document submission or inspection. Significant opportunities and challenges exist for FACT in the future, including keeping standards and guidance materials current and relevant, recruiting and retaining expert inspectors, and establishing collaborations to develop standards and accreditation systems for new cellular products. The continuing dialogue with the Food and Drug Administration (FDA) is also important to ensure that they are aware of the accomplishments of voluntary accreditation, and keep FACT membership alerted to FDA intentions for the future. Other potential avenues of communication and cooperation with FDA and other regulatory agencies are being investigated and evaluated.

Accreditation↗
PubMed1996

Primary prevention in a high-risk group: smoking habits in adolescents with homozygous alpha-1-antitrypsin deficiency (ATD).

The serious form of alpha-1-antitrypsin deficiency (ATD) Pi ZZ strongly predisposes the individual for pulmonary emphysema and premature death in adulthood, especially if exposed to tobacco smoking. General screening of all new-born children was conducted in Sweden during 1972-1974, the major purpose being to reduce exposure of the child to parental smoking while growing up and to prevent the child from starting to smoke. Sixty-one children with ATD neonatally identified through mass-screening, and their families, have been compared with a demographically matched control group regarding smoking habits, as studied through interviews and questionnaires on two occasions. When the children were 5-7 years old, the smoking rates among parents of the ATD children and especially among the ATD fathers exceeded smoking rates for controls. Thirteen years later no differences in parental smoking were found between the groups. At 18-20 years of age the ATD children reported smoking significantly less than the control children (p < 0.05). From the perspective of prevention, the goal of the neonatal screening to reduce the smoking rates among the parents of the ATD children was not attained, while it was achieved among the ATD children. The results indicate that a screening program with early detection of ATD effectively prevents adolescent children from starting to smoke. From ethical, medical and psychological points of view, a voluntary screening program for ATD in pre-adolescence is recommended.

Adolescent↗
PubMed1993

Geneticists approach ethics: an international survey.

Fletcher, Berg and Tranøy (1985) proposed that medical geneticists around the world would benefit from collective reflection on their preferred approaches to the most frequent of the difficult moral choices in practical genetics. In 1985-86, Wertz & Fletcher undertook a survey of geneticists' views in 19 nations. Results were widely disseminated. In this paper, the authors describe a new survey that they are conducting in 37 nations.

Attitude of Health Personnel↗
PubMed1989

The legal response to AIDS in Australia.

This article examines the laws in Australia which relate to AIDS, and considers whether they help or hinder the community health concern of containment of fatal diseases. The laws relating to notifications, blood and organ donations, discrimination and other provisions are canvassed. The author concludes that the legal response to AIDS in Australia is generally characterised by inconsistency, inaccuracy and confusion. The result is that the law is often counter-productive in the social and medical battle against AIDS.

Acquired Immunodeficiency Syndrome↗
PubMed2003

Public mistrust: the unrecognized risk of the CDC Smallpox Vaccination Program.

Phase 1 of the CDC's Smallpox Vaccination Program has foundered because of a lack of volunteers. However, despite the enrollment of fewer than 10% of the projected number of hospital employees in Phase 1, and recent recommendations of two advisory groups, CDC and DHHS officials recently announced plans to expand this vaccination program. During Phase 2 of the Smallpox Vaccination Program, an additional 10 million health care and emergency workers are scheduled to receive vaccination. This paper reviews reasons why state health departments and hospitals rejected participation in Phase 1. It urges the federal government to take account of these problems before proceeding to Phase 2 and argues that the flaws in this program not only threaten bioterrorism preparedness efforts but, more importantly, might endanger trust in public health initiatives.

Bioterrorism↗