Quality Control of Norwegian Pharmacy HbA1c Testing: A Modest Beginning.

BACKGROUND

Many pharmacy services involve laboratory testing using point-of-care (POC) instruments. Our aim was to describe the implementation of quality control of the HbA1c POC instruments and investigate the performance in internal quality control (IQC) and external quality control (EQA) for HbA1c POC instruments in Norwegian community pharmacies.

METHODS

Two project pharmacists from each of 11 pharmacies participated in a training program covering capillary blood sampling, how to use the POC HbA1c instrument (DCA Vantage) and IQC and EQA. The pharmacies were enrolled in an EQA program for HbA1c, and their performance was compared with that of general practitioners' (GP) offices.

RESULTS

Two of 89 (2.2%) IQC measurements were outside the acceptance interval. Seven out of 11 pharmacies sent in results in EQA in all the three surveys during six months. Two pharmacies did not analyze the control material in any of the surveys, one pharmacy analyzed the control material in one of the surveys, and one pharmacy analyzed two of the surveys. Of these pharmacies, 56-100% obtained "very good" evaluation for trueness and 71-100% obtained "very good" evaluation for precision. The corresponding numbers for GP offices were 75-87% for trueness and 84-94% for precision. No pharmacies obtained a "poor" evaluation.

CONCLUSIONS

Norwegian community pharmacies can perform IQC and EQA on a HbA1c POC instrument, and the performance is comparable with that of GP offices. The compliance in the EQA surveys was modest, but the duration of the study and participation in the EQA program was probably too short to implement all the new procedures for all pharmacies.