A Q&A With James Linton at Canadian Blood Services: What Impact do Audits have on Biomeds

This week on the MedWrench Blog, we are discussing a topic with a large impact that is rarely

talked about throughout the industry: What impact do Audits have on Biomeds? We talked with

James Linton at Canadian Blood Services to answer this question once and for all!

1: What do audits mean to a biomed department?

Audits are completed for a variety of reasons ranging from health and safety to procedural and policy to general supplier audits and so forth. Each of these have very different missions but they all share the same principals of being in place to ensure all work an work related activities are performed as required.

In general audits however mean a stressful time for biomed managers and frontline staff as they may feel unfairly scrutinized. Quite often feelings of resentment or dread can occur prior, during or post audit, which lead to unnecessary stress. I say unnecessary because at their core the audit is to Right the ship and point out opportunities for improvement. In fact a well-run department may point an auditor at areas they are concerned with to have them help diagnose problems.

My advice is to welcome auditors with open arms and an open mind. In the end they are not there to discipline (which many believe can be the case) or cause chaos, but to improve the safety of the staff and equipment we are responsible for. It is vital that this message is believed at all levels of a biomed department to avoid any negative impacts.

2: What preparation can be done before an audit?

Prior to an audit a biomed department will likely be given a schedule showing the visit time, record review time and possibly areas they will be looking at. In fact many auditors will schedule an opening meeting and ask what areas if any you would like them to specifically look at. So

prior to an audit it is important to do the following:

- Share the audit schedule with all local Biomed staff

- Go over expectations (if they are allowed to answer questions or should defer to one

person etc&)

- Avoid any unnecessary time off approvals

- Review any training records and have them readily accessible

- Appoint a primary contact for the auditor and have them available at a moments notice

for the duration of the audit

- Perform a Gemba walk, just a quick walk around the shop to look for anything that sticks

out

- Clean up all work areas

3: What fallout can be expected from an audit observation?

Once an audit is completed a list of observations and opportunities to improve may be given to the department. Once this occurs the department will need to come up with an investigation, risk analysis, immediate and future corrections.

First and foremost do not over react. Assign a single point of contact to conduct a response and have them conduct an investigation followed by a draft response. Once this is done ensure that any corrections or changes are shared with the impacted frontline. This will garner buy-in from your fellow biomeds and allow them input that could drastically change the response.

Only once observations are corrected should opportunities for improvement be analyzed. With that in mind however many auditors will look at the previous years report prior to an audit to perform a check when they arrive on both observations and areas for improvement. Also allow a peer to review your response before submission and most importantly all targets needs to be SMART (Specific, measureable, Achievable, Relevant and Time limited). This will avoid observations that grow over time and are never able to be closed.

4: Every time we are audited we get an observation is this normal?

This is normal. In fact the more user friendly your systems are the more likely you will receive some type of observation. It is extremely rare that a site will not get at least one because the auditors are professionals that are trained to look for even the smallest deviance. So when a large

database or so forth are set in front of them they will almost assuredly be able to find something.

Again this is good! It should be taken as your auditor has done a great job and is helping advance the department. Now if you get the same observation every time or its because of the same process every time then I suggest spending more time in your investigation and corrective action

stages.

5: What else would you like the MedWrench community to know?

Stay positive and have an open dialogue involving all biomed staff from frontline to process improvement to management. An audit is to help and although too many can cause a fatigue effect it is important to remember they are to help a department improve and be safe. In my department each site is audited at least 3 times per year and letting everyone know they are in this together and that audits do not lead to punitive reactions is vitally important.