Mycology quality assurance

RiliBÄK is a guideline of the German Medical Association for quality assurance, a "sub-legal norm" or "quasi-law" that every physician in Germany must implement in his or her practice for laboratory examinations. Part B3 RiliBÄK came into force on April 1, 2013. A transition period of 2 years is provided for.

Note: The requirements of this quasi-law must be implemented in practice and clinic by 1. 4. 2015 at the latest.

All persons carrying out laboratory medical examinations must establish and maintain a quality assurance system based on a generally recognised state of the art in medical science and technology. The purpose of RiliBÄK is to maintain the required quality, safety and performance in the use of in vitro diagnostic medical devices and to ensure the reliability of the results obtained therefrom.

RiLiBÄK is divided into a valley A and a part B.

• Part A describes the basic requirements for premises and equipment (e.g. keeping of equipment documentation; written specified pre-analytical measures, etc.). Furthermore measures for quality assurance (e.g. establishment of a quality management system). These include, among other things, instructions for the preparation of work and equipment instructions for the individual laboratory tests carried out in a practice or laboratory (identical conditions apply to both), as well as staff training. These instructions apply to all laboratoriumsmed. examinations, also for mycological. examinations (see below mycology examination methods).
• If further requirements are described in the special part B1 to B5 of the RiliBÄK for the examinations carried out, these must be fulfilled in addition to part A. Compared to previous guidelines, the requirements for the quality assurance of laboratory medical examinations are significantly extended.
• Note: RiLiBäk does not differentiate between laboratory and medical practice.

In part B2 of the RiLiBäk there are no requirements for the areas:

• quantitative laboratory tests (part B1) and
• qualitative laboratory tests (Part B2)

Minimum requirements for internal and external quality assurance are defined.

Qualitative laboratory medical examinations

In a practice, qualitative laboratory medical examinations are then carried out as soon as the laboratory tests show a result such as: "negative or positive" or "detectable/not detectable".

Part B2 of RiLiBÄK concerns:

• the internal
• and
• external quality assurance.

Table B2-1 - "Internal Quality Assurance" contains a total of 50 measurements for which the German Medical Association specifies minimum requirements for the frequency of internal quality control (see e.g. under Mycology Examination Methods). Table B2-2 -External Quality Assurance- lists 39 measurement parameters. These are subject to external quality assurance. This means that participation in interlaboratory comparisons will be mandatory in the future! The frequency of participation in interlaboratory comparisons is shown in the table.

The manufacturer's specifications must be observed, i.e. the specifications in the package insert of the test you use! If the measurand is listed in the RiLiBÄK table B2-1, the specifications made there must also be observed. The stricter specification in each case is binding. If there are no manufacturer's specifications and also no specifications from the RiLiBÄK table, the internal quality assurance must be carried out according to medical necessity and the frequency of examination of patients samples. For this purpose, an internal specification in practice is required in writing in the work instructions for the corresponding laboratory tests.

Additional control measurements are necessary according to

• Restart after complete shutdown of the device
• Calibration
• Performing repair or maintenance
• Reagent batch change

The control material should: be as similar as possible to the patient sample to be tested, contain a known result, be within the range of the physician's decision, be used in different ranges of results (if available), differ from the calibration material.

The evaluation or analysis of the control sample measurement is performed immediately after the results are available, based on the specification of the control material. If this specification is not fulfilled, patient results must not be released. Instead, the cause for the deviation must be clarified and eliminated.

The entire procedure must be documented in writing and kept for 5 years. Specification for the content of the documentation see RiLiBÄK, part B2, 2.1.3.

External quality assurance (interlaboratory comparisons): An external quality assurance must be carried out for the mycological examination programme (mycological examination is listed in the RiLiBÄK table B2-2). Participation in interlaboratory comparisons is mandatory. Registration is made with one of the current reference institutions (INSTAND e. V. or Reference Institute for Bioanalytics). After application of the respective interlaboratory comparison by the practice, samples are sent by the respective reference institute, which are analysed by a practice team under routine conditions. The results are sent back and evaluated by the reference institute. After evaluation of all data, the practice receives a certificate if it passes, and a certificate of participation if it fails. In your practice the cause must be determined, eliminated and documented in writing.

1. http://www. German Medical Association.de/downloads/Rili-BAek-Laboratory_092013.pdf)

2. Kargl A et al.(2014) Quality assurance in mycology. Requirements according to RiLiBÄK in the mycological practice laboratory. Derm 20: 2-5