Background: 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.
Methods: 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.
Results: 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.
Conclusions: 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.