Is it True Hypoparathyroidism? A Root Cause Analysis of Unusually Low Intact Parathyroid Hormone (iPTH) at a Clinical Laboratory.

Introduction: Intact Parathyroid Hormone (iPTH) has a short half-life i.e. two to four minutes therefore the sampling regimen has to pass through a stringent pre-analytical process control. The aim of this study was to identify the causes of apparently falsely low iPTH encountered while signing out Laboratory reports by the Clinical Chemistry professionals.

Material and methods: This report was conducted at the section of Clinical Chemistry, The Aga Khan University Hospital (AKUH) Karachi Pakistan from July to December 2017. Audit tool utilized was Plan-Do-Check-Act Cycle. After correlating with available clinical details and lab parameters, all low iPTH values (<16 pg/ml) were investigated by phone interview. A fresh sample was requested for non-correlating cases.Appropriate interventions were undertaken and a re-assessment was done from January to March 2018.

Results: During the audit, 2559 iPTH samples were analyzed. 110 (4.3%) were identified as apparently falsely low. After recollection, the above 110 samples were immediately centrifuged, and cold chain maintained until re-analysis. 60 (2.4%) resulted with normal or elevated levels. The causes identified were poor compliance of staff with pre-analytical steps including delayed sample separation and unfavorable temperature chain maintenance. Interventions included online meetings with the staff country-wide and circulation of flyers detailing the pre-analytical steps via emails and hard copies. Re-audit showed reduction in number of apparently falsely low results to 30 out of a total of 1448 samples and 14 (0.96%) were investigated to be falsely low.

Conclusion: Stringent pre-analytical process control is vital for quality reporting and patient safety.