Negative Control Contamination

The negative tested quite hot
From the same intermediate pot.
It was real, it was true,
All the positive, too,
But the SOP said negative’s not.

Batch seven-seven-one-four
Was released, and then released some more.
The control was a lie,
But it passed—here’s why:
The procedure said nothing to pour.

The deviation was filed, then refiled,
The second report was “revised original” styled.
Both exist in the database now,
QA accepts this somehow,
Though logic itself was defiled.

Said Kindy, “I’m not sure what’s true.
The batch was real. The control too.
The positive was real,
But the negative deal,
And I filed what I filed, me and you.”

Form 51-E asked the key question:
“Does this sample know what it’s guessing?”
Kindy checked the box,
The audits don’t squawk,
And “results may vary” — our confession.

The QA said this is just fine,
A documentation observation line.
The SOP’s not clear,
That’s what got us here,
And the next revision waits for a sign.

Revision Three’s been on the shelf
Since Revision Four failed all itself.
The next SOP draft
Will address the craft,
But released batches don’t wait to repent themselves.

The procedure that filed batch seven
Never said the control can’t be leaven.
It only described
What steps are prescribed,
Not what makes a control go to heaven.

First form said the batch was complete,
Second form was “revised,” a treat.
QA accepted the fiction,
That both had conviction,
And released was the now double-sheet.

One pot fed both control and the test,
A mistake, but the audit passed best.
The SOP said, “File.”
The QA said, “Smile.”
And pharma got dose to the chest.

Two deviations, both filed true,
Two forms that shouldn’t both be through.
The system records both,
Like they’re both a troth,
And the batch stays released, just as new.

The intermediates shared the same slot,
In a crowded and steaming-hot pot.
They contaminated deep,
While the SOPs sleep,
And QA called it “release what you’ve got.”