The "P's and Q's" of quality systems.

Abstract

Quality improvement in blood collection centers has been a priority of regulatory and accrediting agencies for the past several years. The Food and Drug Administration and the American Association of Blood Banks have developed guidelines for quality assurance activities. Inspection programs have focused on evaluation of processes and how they are controlled to assure the safety and efficacy of blood components. A review of Food and Drug Administration enforcement actions shows that all such actions cite similar deficiencies related to management control, personnel training, error, and record management policies. A quality program that includes management commitment to compliance and continuous improvement, defined personnel training, internal audit, and error management policies provides documented evidence to management and regulatory agencies that operations are in control.