Process improvement strategy to prepare and administer bacillus Calmette-Guérin vaccine in compliance with United States Pharmacopeia chapter 800 standards.

Abstract

This case study describes a multidisciplinary initiative to promote the safe use, preparation, and administration of bacillus Calmette-Guérin (BCG) in patients with bladder cancer that is in compliance with United States Pharmacopeia chapter 800. After an evaluation of a hospital's medication-use process for the preparation and administration of BCG identified inconsistencies with guideline-based procedures for the safe handling and manipulation of hazardous drug products, a revised medication-use process promoting the inclusion of pharmacy services was developed by pharmacy and urology clinic leaders. Implementation of the enhanced medication-use process included (1) the shift of BCG vaccine preparation from urology clinic nurses to a pharmacy equipped with the appropriate engineering controls for the safe preparation of hazardous product, (2) greater involvement by pharmacists in BCG order justification and verification, and (3) a process that ensured just-in-time preparation and delivery of medication for enhanced patient satisfaction. After initial process changes resulted in increased turnaround time from preparation to administration, a study on time to preparation, delivery, and administration was conducted and resulted in complete reduction of turnaround times and increased patient satisfaction. Through a multidisciplinary initiative involving pharmacists, physicians, nurses, and leadership, a new process to promote the safe preparation and administration of the tuberculosis vaccine Mycobacterium bovis BCG was developed and implemented. The results of a post-implementation time study indicated that a standardized approach to scheduling, preparing, and administering BCG was effective in managing the operations of BCG through having high clinic and patient satisfaction.