Summer Regulatory Review

InFocus  •  Summer 2025 Issue  •  September 12, 2025

July was an intense month for regulatory review. While the HUP Transfusion Medicine team was being inspected by AABB/CAP on July 1 and 2, they were simultaneously joined by the FDA for an unannounced, routine visit the same day. The team did an excellent job addressing the needs of both inspection teams and emerged with only two AABB/CAP findings. Next, on July 16-17, seven of the HUP (5) and Presby (2) laboratories were visited by a team of 19 inspectors, led by Dr. Jack Maggiore from Loyola University Medical Center, for their routine CAP inspection. The teams were very well prepared and emerged with only 31 findings, 11 of which were corrected onsite. Then, on July 21-22, the PPMC Blood Bank had a successful AABB/CAP inspection with only three findings. The month ended with the Joint Commission on July 28-31 at HUP. In contrast to prior years, there was a lot of attention to laboratory spaces in addition to the expected attention on point-of-care testing. The only TJC finding for lab was related to cleaning of glucometers.

In summary, the teams did extremely well with all of the inspections. Given the enormous list of items that AABB, FDA, CAP, and Joint Commission review (collectively >6000 items), this is a tremendous success and reflects the excellence of the attention to detail and the service that the clinical operational teams provide every day. A huge thank you to all of the Penn PLM operational teams for their daily efforts for our patients!

- Authored by Dr. Charlene Bierl and Cara McLaughlin