As a fitting end to my previous 3-part series on how to prepare for and survive your regulatory inspections, one of the hospitals we provide consulting services to was just visited by The CAP. Overall we did great and I’m proud of everyone there, but the inspectors found a weak area for us to improve upon that others may be struggling with as well: documentation of training and competency.
It is a common misnomer that training and competency are equivalent and essentially the same thing. Whether you’re subject to CLIA, CAP or your local state DOH requirements, you will be required to provide proof (documentation) of both training AND competency for each employee, for each task that they perform. This is not just limited to your technical staff, but also includes non-technical personnel (phlebotomists, lab assistants, LIS personnel,transport couriers, etc.), as well as staff outside of the immediate laboratory testing area (respiratory clinics with blood gas analyzers, Point of Care testing, etc.).
Simply put, training is coaching, mentoring, and teaching someone step-by-step how to perform a specific task. Proper documentation of this training includes:
- Objectives for the training (i.e., “After completing training, staff will understand howto successfully perform maintenance tasks on the hematology CBC analyzer.”)
- Identification of the methods to be used during the training (direct observation, monitoring recording & reporting of results, review of worksheets & preventive maintenance records, evaluation of problem solving skills)
- Identification of the materials to be used during the training (cleaning agents, QC samples, previously tested & scored proficiency testing material)
- Criteria used to assess the effectiveness of the training (minimum score of 90% on critical thinking quiz, ±10% correlation with previously tested sample)
- Signature of both the trainee and trainer confirming that training was completed, and when
In addition to the obvious routine tasks a lab professional will need to perform (running QC, instrument maintenance, running patients), don’t forget to document their training for the low frequency tasks performed as well. Based on an employee’s job description, they may be involved in additional tasks such as specimen handling, safety precautions, packing and shipping of samples to reference labs, computer system training, telepathology training, and supervisory functions. These tasks too will require documentation of training.
Documentation of all of these tasks can be organized through the use of a departmental orientation checklist. This will help you keep track of what each staff members’ specific job junctions will include that they need to be trained on, and which tasks have been completed by each trainer. Depending on the task, training can be completed quickly after several minutes of demonstration (waived urine hCG testing), or may take several weeks for staff to fully understand and master the task (flow cytometry leukemia work-up). Keep in mind that until a staff member has documented training followed by successful assessment of competency of that task, they should not be permitted to perform or result patient testing independently of their trainer.
Once training has been completed and documented, you must then assess each staff member’s ability to successfully perform these tasks. This is their competency, where you assess if the training was successful and staff are able to perform each assigned task correctly. To fully demonstrate successful competency of non-waived tests, all 6 of the following elements must be documented for each employee, for each task:
- Direct observation of patient test performance, including patient identification, specimen collection, handling, processing and testing.
- Monitoring the recording & reporting of test results, including when appropriate the handling of critical results.
- Review of testing worksheets, QC records, proficiency testing results, and preventive maintenance records.
- Direct observation of performance of instrument maintenance and function checks.
- Assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples.
- Evaluation of problem-solving skills.
- Observation of compliance with safety protocols (based upon your specific local state DOH regulations).
The documentation of your competency elements should include the date each item was evaluated, as well as a way to identify and recreate the test performance if asked by an inspector. This is most easily accomplished with the specimen ID number, or PT survey name so records can be located or reprinted.
Be mindful of your local state regulations regarding the specific requirements for who can perform a competency assessment. In many cases, assessors will need an additional supervisor competency for themselves to confirm they are able to successfully assess the performance of their peers. If weaknesses are identified during the competency assessment, additional training should be performed with appropriate corrective actions documented. Competency should be reassessed to ensure staff are correctly performing all duties, prior to them resuming patient testing.
So to summarize:
During training, I am showing you how to do something. I will document all aspects of the training steps that I reviewed with you. When I assess your competency, you are showing me that you know how to do the task correctly. You will document your results as you were trained how to do, and I will validate the accuracy of your work.
-Kyle Nevins, MS, MLS(ASCP)CM is one of ASCP’s 2018 Top 5 in the 40 Under Forty recognition program. She has worked in the medical laboratory profession for over 18 years. In her current position, she transitions between performing laboratory audits across the entire Northwell Health System on Long Island, NY, consulting for at-risk laboratories outside of Northwell Health, bringing laboratories up to regulatory standards, and acting as supervisor and mentor in labs with management gaps.
Lablogatory 
How does this work when it is a brand new test to the lab? The vendor trains a select few and then what? There is no one in the lab to access competency as this is a new test. How does that work?
We typically set up a “train the trainer” session, where the vendor will train and certify select team members (lead techs, supervisors, educators), and then those people will go and train the rest of the staff. The vendor can sign off on training documents for the staff members they train, with your administrator or medical director co-signing to confirm that all of your specific training requirements were satisfied (direct observation, review of procedure steps, reading the SOP, etc).
Competency is thankfully less subjective; meaning that each tester must successfully run and pass QC, they must run a blind patient or proficiency testing sample with successful results, perform and document maintenance tasks, etc. For your initial trainers, again, your medical director (and administrative director if so delegated) has the authority to sign off on competency forms after confirming that all tasks have been satisfactory performed and completed.
The rules unfortunately may vary depending on specific state regulations and complexity of the testing being introduced, so you can always reach out to your local department of health for guidance on the best way to satisfy their specific requirements.