Can an operating instruction according to the BioStoffV be provided digitally?
Dr. Alexander Heinick
Employers must create an operating instruction, but does this always have to be in paper form?
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According to Section 14 of the German BioStoffV (BioStoffV) "Working Instructions and Training of Employees," the employer must prepare written working instructions based on the risk assessment pursuant to Section 4 of the BioStoffV, prior to commencing work. This does not apply if only activities involving biological substances of the Risk group 1 without sensitizing or toxic effects. The operating instructions are employees and must be written in a form and language that is understandable to the employees. It also serves as a basis for training. However, must the long version of the operating instructions always be printed out and filed in a file in an office or even in the laboratory itself, or is it also possible to have the operating instructions digital to keep?
In TRBA 100 "Protective Measures for Activities with Biological Agents in Laboratories" and the Biological Agents Ordinance itself, nothing is found on the topic of "digital operating instructions." To answer these questions, however, one can also consult Information 213-016 of the German Social Accident Insurance (DGUV) "Operating Instructions in Accordance with the Biological Agents Ordinance." This information states that if the employer provides an electronic (digital) form of the documentation is used, it must be ensured that the documents are available at all times and protected against unauthorized changes**. This would mean that an operating instruction, for example, can also be saved digitally on the internal server, as long as all employees have the opportunity to access this otherwise protected against changes document (see above) from their digital access points (e.g. computers, laptops, tablets, etc.). If constant electronic (digital) availability cannot be guaranteed for everyone, employees must (additionally) be given access to the operating instruction in the form of the usual paper documentation. This also applies to the short operating instruction. However, there is nothing to prevent at least the short operating instruction from being displayed in every laboratory.
Thus, operating instructions can in principle be stored digitally and made available to employees in this form, but the Method of access always be clarified in advance.