At BC Solutions, we consider ourselves a part of the transfusion medicine community. Our services help the community with safety and efficacy of their software systems and this in turn leads to increased patient safety.
Many people hear the word “audit” and cringe. They have visions of inspectors combing through files just to find something to complain about. But quality audits are a critical and often times misinterpreted part of compliant blood bank systems. In fact, the audit is a vital part of any quality program. Regular audits show that a facility has a healthy continuous improvement program.
A good auditor will examine a program and understand how it works as a system and offer recommendations for improvement. The auditor will start with an opening meeting to discuss how the audit will proceed. Following the opening meeting the auditor will review the quality manual and in particular those parts that relate to the blood bank’s automated software system.
During the audit, the auditor will interview personnel to understand their knowledge of the quality system and how the facility operates. The auditor will follow paths in the system to ensure it functions as described in documented policies and procedures. Any failures of the system will be noted and brought to the attention of the system owners. If the blood bank has had process failures in the past, the auditor will inspect the quality system to insure that the failures were detected. The auditor also confirms that the change control system fully implements any fixes required in accordance with documented policies and procedures.
The auditor should conclude with a closing meeting to discuss major findings. In the closing meeting the auditor will discuss all findings and observations from the audit. This is the blood bank staff’s chance to be certain they understand in detail all that was found. Staff members should ask the auditor to summarize the status of the quality system they observed and request any recommendations for improvement. Staff should refrain from justification questions and ask only questions for detail and clarity. This will give the blood bank of a complete and unbiased assessment of their system.
A compliance quality program should be ready for an audit at any time.
Please do not hesitate to call or email BC Solutions with any questions you may have concerning compliance quality audits or any other compliance matter.
Call us at 480-346-7011, or email firstname.lastname@example.org for more information.