Management system integration
This infection risk management standard is compatible with various World Health Organization (WHO) and US Centers for Disease Control (CDC) guidelines, together with requirements from a variety of internationally recognized management standards, including ISO 9001.
Application
The requirements of this standard are generic and are intended to be applicable to all healthcare organizations handling infectious materials, including patients and patient samples.
Where any requirements of this standard cannot be applied due to the nature of the organization and its processes, this can be considered for exclusion. Where exclusions are made, claims of conformity to this standard are not acceptable, unless such exclusions do not affect the organization’s ability or responsibility to manage infection risk in the manner required by this standard. Any claims of exclusion shall be detailed and justification provided.
Compliance with national and local regulatory standards, regulations and requirements are of primary importance in any program. Where any part of this standard is in conflict with any legal requirement, the conflicting part of the standard may be eligible for exemption if the legal requirement meets or exceeds the intent of this standard.
All organizations face challenges in putting the management system requirements of this standard in place. For small organizations the challenges are potentially greater due to minimal available resources, costs involved and difficulty in understanding and applying the standard. Small organizations are typically ones in which only a few people are involved, there is a simple communication flow and individuals undertake a wide variety of tasks. Decisions are made by just a few people. Small organizations should analyze each requirement clause of the standard and determine in which manner they can interpret and comply with it to suit the objective of the standard in identification and control of infection risk.
The more challenging requirement clauses in this respect may be the ones related to continual improvement. The organization should regard this as a recurring, step-by-step activity. When opportunities for improvement are identified, and justified, the organization needs to decide how they are to be implemented based on the available resources. The justification should be founded on an analysis of the potential gains in terms of improved control of risk. Improvements may typically address issues like:
o training and awareness programs;
o internal communications;
o effectiveness of reviews;
o preventive actions;
o effectiveness of follow-up activities;
o documented procedures and instructions.