AM24-SN-16-O: A Quality Bootcamp for Facility Compliance and Conformance to AABB Standards and Federal Regulations (Enduring)

AABB Accreditation staff have identified high-risk areas for AABB-Accredited facilities to navigate when faced with the following accreditation and compliance situations: 

• Nonconformances to Blood/reagent storage devices and remote monitoring systems 
  • (BBTS Standard 3.9, IRL Standard 3.10, CT Standard 5.11.4, MT Standard 3.5, and 42 CFR 1271(c)(1)(2) ) 
• Quality Control for Blood Banking Procedures 
  • (42 CFR 493.1256(d)(3)(i) and (ii)) - Method Comparison Problems 
  • (BBTS Standard 5.1.2.4, IRL Standard 5.1.2.4, MT Standard 2.2.1, and 42 CFR 493.1281) 
• Responses to Proficiency Testing Failures 
  • (BBTS Standard 5.1.10, IRL Standard 5.1.10, MT Standard 5.1.2, CT Standard 5.1.2.3.1, and 42 CFR 493.1236) 
• Landmines for Laboratory Director Delegations 
  • (BBTS Standard 1.1.1, IRL Standard 1.1.1, CT Standards 1.1.4.1, and MT Standards 1.1.1, and 42 CFR 493 1407 and 1445) 
• How to avoid Repeat Non-Conformances to AABB standards. 

AABB Accreditation Staff will provide real-life objective evidence from assessments to support nonconformances documented to these Standards. The Accreditation Staff will then dissect the objective evidence, and provide some common themes. Examples of non-compliance will then be followed by examples of processes or procedures meeting the requirements of the related AABB Standard. Finally, non-conformance scenarios will be provided for small group discussions to be facilitated by Accreditation Staff. Using Quality Management and other tools to analyze nonconformances can assist in identifying best practices and mitigation for facilities to plan for AABB Standards implementation and conformance. The AABB Accreditation Staff will utilize quality tools available on the AABB website: https://www.aabb.org/standards..., Regulatory Toolkits, Commendable Practices, the CLIA Corner, and other identified tools for process improvement