Test for On-line Ethics Refresher Course

Please read the following scenario and answer the questions below.

Scenario #3 Easy Does It
While analyzing samples and ICP analyst noted that the method blank for one batch of samples contained concentrations of several target analytes at concentrations exceeding the reporting limit. The analyst rejected the data, and requested the re-digestion of the batch.

After the samples had been re-digested, the analyst noted that all the sample volumes were 90ml however, the method blank was 100ml. The analyst suspecting a shortcut, reported the observation to the Lab Director.

The Lab Director interviewed the technician, who had been employed by the laboratory for 6 months. The technician had received sample preparation training and ethics training during his first month on the job. The technician also had 8 years experience in environmental sampling and analysis. The technician admitted having simply transferred the original sample digestates into new containers and assigned a re-digestion batch number. The new “method blank” was acidified, deionized water.

The technician admitted to the shortcut, but claimed it was the first time they had ever done anything improper.

1. What types of improper practices have occurred? (check all that apply)
Fabrication of data or supporting information
Misrepresentation of QC samples results
Improper date/time setting
Improper calibration and verification
Improper alteration of analytical conditions
Fabricate or make up data (drylab)
Misrepresent QC Samples as digested or extracted when it has not been prepped

2. What specific red flag pointed to the problem?

3. What other red flags might have been apparent to either internal or external auditors? (check all that apply)
The analyst was female.
The time recorded for the digestion may have been too short to complete the digestion
The raw data associated with the blank for these samples may be uncharacteristically clean for a digested blank.

4. What are some laboratory quality system elements that can promote the early detection and correction of this type of improper practice? (check all that apply)
Providing explicit examples of things not to do
Ensure analysts are technically qualified to perform the analyses (documented training)
Make data integrity a common theme in laboratory meetings
Record keeping reviews
Routinely inspect data

5. What steps could the laboratory take to make sure this is an isolated incident, and not an indicator of a more serious vulnerability?
Data authenticity audits
Double blind PTs
Secondary data verification reviews
All the above