In order for a national Vigilance and Surveillance (V&S) scheme to be effective, the following key elements should be in place.
- Serious adverse occurrence reporting must be required
- Rapid alert systems, with 24/7/365 availability, are essential and should be developed
- Standardized reporting by clinicians should be expected
- Clinicians are the first to acquire information when a recipient has been harmed and are usually those who initiate reporting
- Based on a consensus of subject matter experts, it is necessary to determine what is important and what is essential for reporting
- Education for clinicians should be provided with clearly described and concise guidance for identification and reporting
- There should be feedback regarding the information collected and how it has been used to influence patient safety and changes to practice
- Cooperation among governments / competent authority, professional associations and clinicians is essential
- There is a need to identify the key contact for the reporting of adverse occurrences. This may be an organization, or formal system, a coordinating body, or a registry which is responsible for the collection of information as it occurs (for evaluation by specialists)
- MPHO V&S systems can be set up based on the extensive experience from the blood donation/transfusion V&S (haemovigilance) systems that already exist
- Traceability requirements must be in place by all stakeholders. Time-sensitive capabilities such as the use of quick and easy tracking systems should be promoted.
These systems should make use of computerized databases and machine-readable labeled bar codes, which promote unique identification on the MPHO.
The alternative is to rely on time-insensitive, laborious, manual searching of handwritten logs, donor records, distribution records, inventory records or individual recipient records
- Although there may be different oversight bodies for cells/tissues and organs within a Member State, their vigilance and surveillance systems should be linked directly to optimize response;
- Inspections for licensing, accreditation, certification, etc., must include evaluation of the V&S system in place.
- Provision of training and education for all stakeholders is necessary
- Traceability and reporting systems must include consideration of compliance to the expectations in the country receiving/using the MPHO as well as its country of origin.
Neither system should be compromised.
- A global V&S data collection system for MPHO is desirable and can be coordinated by WHO.