POC diagnostics in pharmacy

Pharmacies have increasingly developed into health and communication centers in recent years. This includes medical services such as POC diagnostics with an analyzer, such as the BIOspeed Analyzer. The legal basis for pharmacies to perform these medical services is provided by § 1a of the Pharmacy Operations Ordinance (ApBetrO). This expressly includes the performance of simple health tests among the services customarily provided by pharmacies.

Pharmacies in particular can offer high quality medical services due to their ongoing commitment to quality assurance. The Pharmacy Operations Ordinance (ApBetrO) stipulates that, in addition to internal quality controls, regular participation in external quality controls should also take place as part of a quality management system (ApBetrO §2a). The interlaboratory tests conducted by the Central Laboratory of German Pharmacists (CL) are ideally suited to fulfill this requirement. The Federal Chamber of Pharmacists (BAK) recommends that every pharmacy participate once a year in an external quality control, a inter-laboratory comparison.

If the pharmacy successfully participates in the proficiency test, i.e. if it complies with the limit values specified in the Rili-BÄK, the pharmacy receives a corresponding certificate from the CL. The CL proficiency tests have also been accredited by the German Federal Chamber of Pharmacists as a continuing education event for pharmacists/PTA and have been awarded the corresponding continuing education points.

All pharmacies that routinely perform blood tests and have established or would like to establish quality assurance measures for this area are eligible to participate in the ZL proficiency tests.

For each registered device and parameter, the pharmacy receives two control samples with different concentrations of the respective analyses including consumables. The measurement of the test parameters is possible with all measuring devices available on the German market, including the BIOspeed Analyzer.

The following parameters can currently be tested in the ZL blood proficiency test:

GLC, CHOL, HDL,TG, UA, Crea, Alb, HbA1c, Hb, ALT/GPT, AST/GOT, GGT and CRP/hs-CRP.

The control samples are to be measured in the specified time period with the registered equipment under routine conditions and the values are to be transmitted to the CL. The device-specific evaluation is carried out according to the guideline of the German Medical Association for the quality assurance of laboratory medical examinations (RiliBÄK).

By offering screening tests with POC analyzers in local pharmacies, pharmacists contribute directly to disease prevention and patient satisfaction. In the long term, pharmacies thus also help to reduce healthcare costs.

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02-23-2022 |

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