一项真正有益的认证：为什么 CCE 能提升质量和信誉.pdf

1、2/19/20261An Accreditation With Real Benefit:Why CCE Enhances Quality and CredibilityJoseph P.Navarra,RPh,FACA,FAPCOwner,Town Total Compounding CenterWhat is the Coalition for Compounding Excellence(CCE)?The short answer:A fresh,collaborative,affordablepathway to compliance and quality.122/19/20262W

2、hats“Fresh”About It?1.Broad scope2.Risk-based versus checklist-approach to auditing3.Collaborative approach4.Unprecedented auditor investment5.On-going monitoring and support6.Alignment with greater world of auditing1.Broad ScopePrepare clients for whomever might walk in the door:USPOBRA 90GDP Good

3、Documentation PracticesHIPAADEAFDA State boards of pharmacyNonresident licensure inspections342/19/202632.Risk-Based Versus Checklist-Approach to AuditingHow does CCE define“risk”?Based on FDAs ICH Q9(R1)definition:Risk=Severity X Probability X DetectabilityScope of risk:Patient harmWorker harmFinan

4、cial harmLitigationRegulatoryOperational efficiencyMore on this later!3.Collaborative ApproachPremium placed on providing suggestions and information,not just findingsDeficiency encountered?Auditor immediately clicks into“solution mode”with the clientMany pharmacies might be surprised at the number

5、of initial“findings”CCE is committed to help you create,complete effective plans of correction562/19/202643.Collaborative ApproachCCEs competitors either critique and“leave the building,”providing no insight into how to resolve deficiencies,or have such a high“pass rate”that the value of accreditati

6、on to stakeholders,providers,and the public is diminished.-Danny Barnes PharmD BCSCP,Chief Pharmacy Officer/President,Triangle Compounding Pharmacy,Cary NC4.Unprecedented Auditor InvestmentNo other 503A accreditor invests the number of auditor hours that CCE does:782/19/202655.On-Going Monitoring an