In the Federal Republic of Germany, point-of-care systems appear to be mainly used within hospitals and medical practices. Other medical situations where POCT may be used include outpatient nursing care, home visits and pharmacies (lipid testing). Self-monitoring for glucose and INR are also common.111

Junker etal, in a detailed review of POCT in teaching hospitals and primary care state German medical device regulations and the German law on liability do not distinguish between conventional laboratory analyses and POCT.111 In addition, “the 2008 Directive of the German Medical Association on the Quality Assurance of Tests in Laboratory Medicine (RiliBAK 2008) does not stipulate any special regulations for POCT in comparison to those for a medical laboratory, the only exception being the unit use systems. Part A of the RiliBAK contains the fundamental requirements for quality assurance,” … “and applies both in hospitals and practices. Part B1 contains the specific requirements for the quality assurance of quantitative laboratory tests”. A computerized English translation of the RiliBAK is available on the internet.39

The term RiliBAK, which is used to describe the minimum quality requirements for medical laboratory tests actually means “guidelines” of the German Federal Medical Council (BAK).