Please use this forum to ask questions and discuss topics regarding GCP and GCLP
Here's the scenario that Ken introduced at the workshop yesterday. I will post his questions for you to answer below, as well as some of your responses:
You are the Clinical Laboratory Manager in the Medical Research Centre. The Chemistry instrument needed replacement of laser/filter. The Engineer was informed upon which he flew and replaced the part and flew back. Since he did not wish to miss his flight, he said he will send the worksheet when he reach his office. The Lab staff on late shift reported to work after Engineer had left and he immediately processed 13 samples he found stored in the refrigerator 2-8C. The Lab Tech, analyzed the samples, reported and released results to the Clinician on call. The Clinician on call noticed an elevated ALT, AST and gamma GT on 3 different results. The Clinician called the Lab to confirm the 3 results since they were not correlating with the patient conditions.
Question 1: What factors could have contributed to this scenario?
Question 2: How will you investigate this occurrence?
Question 3: Should the Doctor trust the other 10 results?
Question 4: Which phase of Quality System did this error occur?
Question 5: As the Laboratory Manager, what measures will you put in place to prevent this from recurring?
This is a very interesting scenario, see my answers to the questions below;
1. Lack of well defined contract with the engineer led to him leaving without a service report
No proper hand over during shift changes led to staff running the 13 samples without QC
2. In my investigation the Clinician query on the 3 results can be treated as a customer complaint which will be investigated by coming with a root cause using a brain storming session with the staff in the chemistry section
3. I would advise the doctor not to act on the other 10 results, the results will be recalled by the laboratory pending further investigations and fresh samples collected from the patients for retesting
4. This occurred in the Preanalytical phase
5. The measures i would put in lace will include;
-staff shift hand over book
-Review contracts with engineers to ensure that service reports are left after service
-training for staff on equipment management procedures