Ask the Expert: The Halloween Edition: Scary Things That Affect Your Lab Inspections

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Halloween is here! In honor of the holiday, we are going to look at scary things that affect the lab and how they affect your inspections.


SCARY: These are items that have little chance of affecting patient care, but are still red flags for an inspector.

  1. Missing temperature documentation – If you are required to keep temperature logs, nothing stands out more than missing temps. Although minor, this leads inspectors to dig deeper for other items missed.
  2. Missing received and opened dates – When new kits, reagents, controls, etc. are received in the lab, they are supposed to be marked with a received date and then an opened date once they are put into use. The inspector always checks the refrigerator looking for proper dating.


FRIGHTENING: These are items that have the potential to affect patient care, and are considered major citations

  1. Missing personnel documentation – If the employees running the non-waived testing do not have copies of their educational diplomas on hand, this is considered a major violation. You will have a short period of time to produce the copies of the diploma or the employee will be deemed an unqualified operator.
  2. Missing calibrations or controls when patient testing took place – If patient test were performed and required controls/calibrations were not performed, this is considered a major deficiency. A review of all patients’ records for the affected time period will be required to determine if the ordering physician would have changed his diagnosis and treatment of the patient based on the fact the results could be in error.


TERRIFYING: These are items that can result in the shutdown of the laboratory.

  1. Proficiency Testing violations – The following monkey business related to proficiency testing can result in your lab being shut down.
    • Sending PT specimens to a reference lab for analysis
    • Obtaining results for PT testing from another lab that uses the same PT company as you
    • Running PT repeatedly and using an average as your results. PT specimens must be treated in the same manner as patient specimens. You don’t run your patients specimen 10 times, then take an average before reporting out the results
  2. Patient-centered fraud or negligence – The following items can also result in lab closure or sanctions.
    • Incorrect results being reported for a patient with no corrective actions. Things such as mislabeled specimens resulting in the wrong results being reported with no corrective action, physician notification or follow up.
    • Fraudulent results, also known as “sink testing”. This is when patient testing does not take place, but results are “made up” and reported out.


These things should have definitely made your hair turn white. Remember, this list is just few examples of items that cause problems and is by no means a comprehensive list.


If you are doing anything I listed, correct these problems immediately. A patient’s life or well being can be determined by your actions.


My old business cards had the tagline, “It’s not a specimen, it’s a person.”


Happy Halloween and don’t forget to vote! It is a right and a privilege to be able to do so. Many lives have been lost to continue to preserve this freedom.