REPORT to CBBS BOARD of DIRECTORS -Example of Format

CALIFORNIA BLOOD BANK SOCIETY 1000 Q Street, Suite 203, Sacramento, CA 95811 Return to Kacy Wallis – [email protected] no later than September 12, 2016

COMMITTEE REPORT TO CBBS BOARD OF DIRECTORS

Period of Activity: July 1 to Sept. 2, 2016 Date of Report: 09132016 Committee Name: Quality and Safty Committee Chair: Catherine Mazzei, MD Committee Members: Theresa Dunning, Dara Johnson, Heidi Shafi, MD, Chhavy Thang, Carol Wilson Board Liaison: Robert Bayer

Committee Meeting Dates and Minutes

CBBS QSC Con Call 07012016 Annual Meeting Topic Discussion: Responsibilities of a CLIA Medical Director or CLIA 101: (Speakers - Chaffin, Li, Penny, Shu-lon Quan, etc) · What are they? · How does this apply to Competency testing? · How many labs can one Lab Dir have and how do we manage this? · Definitions of other categories within CLIA MSM: · How are we managing these? · Are we reinstating donors · How does this impact plasma fractionators Zika: · How does this impact a transfusion service · IND

CBBS QSC Con Call 07152016 Second Annual Meeting Topic Discussion: 1. Deviation management 2. Case studies of changes made due to errors/deviations 3. A review of Competency, and PT 4. Massive Transfusion: ethical considerations and communications 5. 7 day platelets-implementation 6. Biological Product Deviations -- what qualifies, who sees them at the FDA, will the FDA come to inspect us because of our BPDs, if we followed our SOP but unsafe blood was issued is it reportable? a. It would also be good to follow up with root cause process improvement. b. BPD due to QC failure -- is a patient look back required (New AABB standards --- now require assessment of patient impact!) 7. CA state biological licenses -- do they apply to a transfusion service? how does CA state differ from FDA registration (CA state requires bio lic for 5 day FFP and aliquoted infant products, FDA does not....etc. 8. TRALI -- does the FDA need to know about TRALI diagnosis? 9. Fatality Reporting: what qualifies to be reported to the FDA? 10. Disaster planning - review of developing a plan to include current issues with terror attacks. 11. Medical Device Reporting... (might fold this into another topic) What happens when you can't trust your BB analyzer and antibodies are missed by the analyzer and patients impacted? 12. Product recalls -- Either Blood Supplier or BB instrument vendor -- when either questionable blood products or question reagents or BB instrument function fail when, how and why do we need to do patient look back? How to make a tough job easier, what do we tell our clinical physicians. 13. Patient Look back policies -- what should a transfusion service include from among the many letters from their blood supplier -- which are the important ones that require a formal look back (other than HCV and HIV)? 14. MLT medical laboratory technicians -- what can they do in the transfusion service?

Committee Report to CBBS Board of Directors Revised October 2015 CALIFORNIA BLOOD BANK SOCIETY 1000 Q Street, Suite 203, Sacramento, CA 95811 Return to Kacy Wallis – [email protected] no later than September 12, 2016

Several topics were agreed upon and the template was submitted.

CBBS QSC Con Call 09022016 Annual Meeting Speaker Discussion: C. Mazzei, R. Bayer, D. Johnson, T. Dunning

ABCs of BPDs Someone from CBER/FDA Maryann Silva Kim Rioux

CA State Biologics License State inspector familiar with the California state biologics license (Ron Harkey?) Ann Sintef

Next meeting to discuss Regional Seminar TBD

Committee Report to CBBS Board of Directors Revised October 2015