Dear API Abby

Dear API Abby:

Why does the laboratory have so much paperwork? It seems unnecessary to have all these folders and piles of paper everywhere. Can we clean up some of the paperwork we have collected for proficiency testing? What do we really need to keep?

Spring Cleaning

Dear Spring:

It’s always a great time for some spring cleaning but be sure not to discard anything essential. Start by checking with your accreditation agency to confirm which documents are required to be retained. You may also want to explore whether some records can be stored electronically—a tidier and more efficient option.

At a minimum, laboratories must keep the following proficiency testing (PT) records for two years:

• PT event raw data and worksheets
• Sample testing logs
• Graded scores from your PT provider
• Signed attestation statements
• Documentation of review by the laboratory director or technical supervisor
• Corrective action records, when applicable

Keep in mind that your state or accreditation agency may require longer retention periods, so always verify before discarding any records.

Electronic storage can be a helpful solution, provided you can retain or retrieve a copy of the original report. Scanned or native electronic reports are acceptable as long as they contain a signature that can only be applied by the signer and includes the time and date of signature. Implementing appropriate electronic signatures may require additional setup, but it’s a worthwhile step if your goal is to move toward a paperless laboratory. Just ensure that any electronic signature process you adopt is trustworthy, reliable, and meets the requirements outlined in regulation (21 CFR Part 11) for being equivalent to a handwritten signature.

Dear API Abby:

I’m beyond frustrated. I mailed my proficiency testing results on the due date. My PT provider said they received the results late, and because there was no postmark indicated on the envelope, they cannot accept the results. If I sent it on the due date and all the dates inside show it was done before the due date, shouldn’t that be enough?

Fran the Frustrated

Dear Fran:

I understand your frustration! When PT providers accept paper result forms, those forms must be postmarked on or before the due date. The postmark serves as the official documentation that the materials were mailed on time. Without it, your provider has no verifiable proof of when the packet was sent. Unfortunately, not all mail is automatically postmarked, so simply dropping your envelope in a mailbox can be risky.

You may find that submitting results electronically is the most reliable way to ensure they are received on time. If you must mail your forms due to computer downtime or another issue, send them via certified mail and make sure the postal receipt clearly shows the date the post office accepted the package. This gives you and your PT provider the documentation needed to verify timely submission.