J V Linden1, G B Schmidt. 1. Blood and Tissue Resources Program, Wadsworth Center, New York State Department of Health, Albany, NY 12201-0509, USA.
Abstract
OBJECTIVE: New York State must provide effective oversight for more than 400 facilities that provide blood services, ensuring the safety of transfusion recipients. PROGRAM STRUCTURE: Oversight is based on educated, trained program staff; a council of transfusion medicine experts; regulations governing laboratories and blood banking services; proficiency testing; requirements for reporting transfusion-related errors and incidents; tracking collection, testing, and disposition of all blood; inspections; partnership with the Food and Drug Administration; and investigation of incident reports. Policy letters and guidelines (eg, umbilical cord blood, transfusion-associated infections, intraoperative blood recovery) supplement regulations. OBSERVATIONS: Standards are maintained through education by a responsive, proactive oversight program. Areas warranting stricter regulation or supplemental educational guidelines are identified by periodic assessment of standards of practice and review of reported information. CONCLUSION: The multifaceted oversight program contributes to efforts to improve transfusion medicine.
OBJECTIVE: New York State must provide effective oversight for more than 400 facilities that provide blood services, ensuring the safety of transfusion recipients. PROGRAM STRUCTURE: Oversight is based on educated, trained program staff; a council of transfusion medicine experts; regulations governing laboratories and blood banking services; proficiency testing; requirements for reporting transfusion-related errors and incidents; tracking collection, testing, and disposition of all blood; inspections; partnership with the Food and Drug Administration; and investigation of incident reports. Policy letters and guidelines (eg, umbilical cord blood, transfusion-associated infections, intraoperative blood recovery) supplement regulations. OBSERVATIONS: Standards are maintained through education by a responsive, proactive oversight program. Areas warranting stricter regulation or supplemental educational guidelines are identified by periodic assessment of standards of practice and review of reported information. CONCLUSION: The multifaceted oversight program contributes to efforts to improve transfusion medicine.