As a Quality Advisor I spend a lot time speaking with labs that are either brand new, in the process of getting started, or laboratories that have been in operation for years. One interesting thing I find is that, regardless of whether the lab is new or has been accredited for years, there are some common areas where labs tend to have deficiencies and therefore receive citations. Here’s some insight into what I’ve designated as the Top 5 Deficiencies for Laboratories and How to Prevent Them.
Personnel: This area tends to be one of the top cited; one reason is lack of awareness about personnel requirements for the complexity of the testing being performed. Another reason is personnel files not being complete, often the files are missing the correct type of proof of education (Diploma, Transcript), the training checklist for when the employee was first hired (or training that took place when new tests were added) or a job description. Competency Assessment also tends to get included in this category. The requirement for Competency is to have an assessment done six months post hire and then yearly after that. To prevent deficiencies in this area ensure that you are familiar with CLIA, State and your specific Accreditation Agency’s personnel requirements for the complexity level of your lab (waived, moderate, and high). Also, make sure to have a robust Competency Assessment plan and a calendar or reminders in place to ensure assessments are done on time.
Proficiency Testing: When it comes to deficiencies in Proficiency Testing (PT) what I see most often is labs not treating proficiency testing samples the same as patient samples. Sometimes this can be a source of confusion for labs. The Physician Office laboratories (POLs), as well as labs that are short staffed or have staff working less than full time, have to ensure everybody who performs patient testing has an opportunity to participate in performing Proficiency Testing. Attestation forms not being signed and corrective action not being performed for failed PT events are also among the most common reasons why this area may be deficient. To prevent deficiencies in PT, ensure that attestation forms are signed by both testing personnel and the lab director. Also, ensure that Proficiency Testing samples are treated the same as patient samples. A schedule must be devised to ensure that part time staff gets to participate in PT. Remember, Proficiency Testing serves as a test of your laboratory’s processes, the competency of your staff and is a good indicator of the level of quality in your lab.
Quality Control (QC): For QC the issue encountered most often is lack of appropriate corrective action. Running a control repeatedly until it comes in does not fix the problem! A root cause analysis must be done to determine the real reason behind the QC failure. If the lab has documented corrective action consistently, sometimes by reviewing the corrective action log one can determine what the real problem is. In other instances, a more in depth investigation may be needed. Another situation I see often is laboratories that choose to run QC and patients simultaneously. For some systems running QC before running patients is just not time efficient or even possible. But if the system allows it, my recommendation is to always run QC first and make sure that it is in PRIOR to running patients.
Stay tuned for Part II of this blog where we will touch on Calibration and Quality Assurance. How does this compare with your experience of the most common areas where labs tend to have deficiencies? Which ones would you have selected?