A Changing Landscape - Compliance
In the US, as of December 2006,
27 states 
had passed legislation or regulation related to hospital reporting of adverse events to a state agency. Many of these new laws and regulations are intended to hold health care facilities accountable for weaknesses in their systems. They also have the potential to improve patient safety through event report analysis and by dissemination of best practices and lessons learned.
In addition to state reporting, there are also federal mandates on reporting serious adverse events to the FDA and JCAHO.
On the horizon is mandatory reporting for infection control incidents, nosocomial infections, sharps logs and adverse event reporting for clinical trials and dietary supplements.
Safepost Facilitates Reporting Compliance
When an event qualifies as reportable by type or severity, Safepost prompts for and produces the
appropriate reporting form that then can be submitted electronically or printed and faxed to the
regulatory agency.
A complete history of an event will include any electronic submissions or notes related to submissions.
Reports can be submitted or generated for the following:
- Medwatch 3500,
- MedWatch 3500A,
- Vaccine Adverse Event Reporting System (CDC/FDA)
- USP Medication Error Reporting Program (US Pharmacopeia)
- Veterans Administration Patient Safety Reporting System - Form F6
- MedSun - Medical Product Surveillance Network (if a participant)
- JCAHO Root Cause Analysis Tool
