The protocol provides a standardised methodology to Member States and hospitals in response to article II.8.c of Council Recommendation 2009/C 151/01 of 9 June 2009 on patient safety, including the prevention and control of healthcare-associated infections. It also integrates the main variables of the ESAC hospital PPS protocol, thereby providing support to Council Recommendation 2002/77/EC of 15 November 2001 on the prudent use of antimicrobial agents in human medicine.