The CDC would really like it's employees to follow protocol.

Not following protocol

http://www.theverge.com/2014/8/15/6007915/cdc-researcher-contaminated-bird-flu-sample-while-rushing-to-meeting

The Weakest Link: “Proper Procedures Were Not Followed”

The laboratory science world was aghast this week on the news from the U.S. Centers for Disease Control (CDC),  [Emphasis is on CONTROL] where researchers were exposed to Anthrax due to procedures not being followed. “Shortcuts may have been taken” and “untrained staff may have…” were phrases that peppered news accounts of the incident.  In the coming weeks and months we will hear the extent of their exposure.  At this writing the number of researchers exposed was raised from 75 to 84.  The CDC has been the global standard to protect (and advise) humankind in regards to health and safety threats.  With an annual budget of $11.3B they seem to be well funded to achieve their mission.

However that organization, along with all others, is only as strong as their weakest link. Please pardon the cliché’.  It seems in this case the weak link is not following procedures.  A few televised news reports placed blame on untrained staff.  I would like to assure you that there is also a procedure in place to train staff.  So rather than a training issue, it is actually a not following procedure issue.  Supervisor did not follow up on the employees?  Also a not following procedure issue.  I feel confident in saying that a Federal Investigation will ensue and blame will be officially placed.

The take home opportunity for those many of us who work in laboratory settings is to use this unfortunate story to reinforce with our staff the necessities for following Standard Operating Procedures (SOP’s).  While many SOP’s do not deal with such acute life and death scenarios they do speak directly to adherence to regulations and good scientific practices.

Partnership for Success: Laboratory Operations and Quality Assurance

A long while ago an employee told me, "QA forgot that we are working for the same company". His inference was that the Quality Assurance Unit was deliberately looking for faults within his department. GLP Compliance will be difficult to achieve if the Operations Group and the Quality Assurance Unit (QAU) do not understand and respect each other’s role.  Building an effective partnership involves investing time to train on the requirements that each area operates under.  Training the technical groups of GLP requirements by the QAU unit and educating the QAU on the technical subtleties by the Operations Group will ensure that each has full understanding of the required and feasible data documentation.  It should be the goal of the QAU and Ops Group to meet the GLP requirements on the front end rather than at the conclusion of the study. The technicians will become confused about data documentation when some pre-clinical studies are conducted GLP and others conducted [by design] Non-GLP. To that end Operations management must ensure that Standard operating procedures are adhered to, even when conducting non-GLP studies, so that data quality will remain consistently high.    Daily quality control inspection of the data by the Operations Group prevents voluminous QAU findings to correct at the conclusion of a study.  Tracking internal inaccuracies within the department will aid in preventing repeat errors.