Labelle Christyne, Macpherson Douglas W
Public Health Agency of Canada, Ottawa, Canada.
J Travel Med. 2005 Jul-Aug;12(4):180-3. doi: 10.2310/7060.2005.12402.
Health Canada regulates the designation of yellow fever vaccination centers (YFVCs) in Canada to ensure a national standard in the safe, effective, and appropriate use of yellow fever vaccine for Canadian travelers. The process for the designation of YFVC has evolved over the years, particularly with the development and implementation of specific criteria for designation. Standardized site visits in 1999 to 2001 demonstrated that noncompliance with the criteria jeopardized the objectives of the federal program.
A pilot evaluation questionnaire was developed and tested in seven YFVCs. The results provided the data necessary to appropriately adapt the questionnaire for on-site evaluations. The final questionnaire captured graded data on professional training, reference sources, services provided, and physical facilities and supplies. A minimum of 60% was needed to pass the evaluation. The YFVCs were given individual feedback on their results and the opportunity to comply with standards.
During the period of 2000 to 2001, 183 YFVCs were in operation in Canada. A random sample of 69 YFVCs were visited and evaluated for compliance to the circulated criteria. Fifty-two (75%) of the YFVCs received satisfactory results (range 70% and higher), and specific remedial recommendations were made to 8 (12%) clinics with a borderline result (range 60-69%). Nine (13%) of the YFVCs failed (range 0-59%) the evaluation, with consequences ranging from notification of the infractions in writing to decertification.
Although a majority of YFVCs met the evaluation criteria, a significant percentage (25%) of unsatisfactory and borderline compliance with Health Canada's criteria for designation of YFVCs means that there is a need for greater clarity and communication of the criteria and inspections for designated centers. To ensure that previously designated YFVCs and centers seeking designation consistently fulfill all the requirements, Health Canada is developing new methodologies of evaluation. The authors anticipate that all new and existing YFVCs will fully comply with the objective and specific criteria for designation.
加拿大卫生部对加拿大境内黄热病疫苗接种中心(YFVCs)的指定进行监管,以确保在为加拿大旅行者安全、有效且适当地使用黄热病疫苗方面达到国家标准。多年来,YFVCs指定流程不断演变,尤其是随着指定的具体标准的制定和实施。1999年至2001年的标准化实地考察表明,不符合标准会危及联邦计划的目标。
制定了一份试点评估问卷,并在7个YFVCs中进行了测试。结果提供了必要的数据,以便对问卷进行适当调整以用于实地评估。最终问卷收集了有关专业培训、参考资料、提供的服务以及物理设施和用品的分级数据。评估通过至少需要60%的分数。向YFVCs提供了关于其结果的个人反馈以及符合标准的机会。
在2000年至2001年期间,加拿大有183个YFVCs在运营。随机抽取了69个YFVCs进行实地考察,并评估其是否符合分发的标准。52个(75%)YFVCs获得了满意的结果(分数范围为70%及以上),对8个(12%)处于临界结果(分数范围为60 - 69%)的诊所提出了具体的整改建议。9个(13%)YFVCs评估未通过(分数范围为0 - 59%),后果从书面通知违规行为到取消认证不等。
虽然大多数YFVCs符合评估标准,但仍有相当比例(25%)的YFVCs对加拿大卫生部YFVCs指定标准的遵守情况不理想或处于临界状态,这意味着需要更明确地传达标准并对指定中心进行检查。为确保先前指定的YFVCs和寻求指定的中心始终满足所有要求,加拿大卫生部正在开发新的评估方法。作者预计所有新的和现有的YFVCs都将完全符合指定的目标和具体标准。