Chemistry Case Presentation

A manufacturer/vendor of intact parathyroid hormone (PTH) in vitro testing reagents published a field safety notice (recall) describing a performance shift, which had the potential to cause erroneous patient results. Established reference ranges could also be impacted. The Italian Health Ministry (the Italian equivalent to the US FDA) followed a few days later with a recall notice of its own. Eighteen Italian laboratories involved did not recognize any problem with the PTH assay prior to the manufacturer field safety notice. In hindsight, it was discovered that third-party controls were not used by these labs; medical laboratories accredited according to the international ISO 15189 standards have procedures in place for such recall events. The authors of this article indicated that the Italian laboratories involved were not accredited under this standard, and were therefore unable to recognize the problem before the recall. Thus, patient safety was adversely affected.

The manufacturer/vendor issued a field safety notice (recall). The recall described a performance shift in the assay. Kit-included controls did not detect the shift. Kit inventory (reagent, calibrator, and control) was impacted by the recall. This recall adversely impacted patient safety.

The manufacturer/vendor recall was initiated. The Italian government followed with its own recall. The laboratories performed corrective actions. However, the 18 Italian laboratories that were unable to recognize the problem needed to completely replace their intact PTH method after the recall. Thus, requiring reference intervals to be revised accordingly.

The laboratories could have prevented their errors by following ISO 15189 standards. They would be advised to work closely with manufacturers/vendors in validating/verifying methods, as well as during those times when technical bulletins or recalls are announced. Communication with the manufacturer/vendors (who are experts) might have helped to avoid this patient safety event. In addition, the authors recommend certain changes in the provision of kit quality control materials, as well as harmonization among test manufacturers.