Hygiene and washing hands in the company: obligations, RKI recommendations, audit evidence

The recommendation of the Commission for Hospital Hygiene and Infection Prevention (KRINKO) at the Robert Koch Institute names hygienic hand disinfection as the most effective individual measure for preventing nosocomial and workplace infections since the 2016 update. § 36 IfSG and the TRBA 250 oblige health care, nursing, child day care and food establishments in accordance with § 43 IfSG to regulate hand hygiene in hygiene plans and instructions.

Practice shows: Many companies keep soap, disinfectants and notices on hand, but fail in the audit on three points - lack of proof of instruction, unclear responsibility and lack of effectiveness control. This article explains the legal basis, the role of the hygiene officer, the five RKI indications, the requirements for funds and donors as well as the documentation that provides reliable support in the event of an audit.

The obligation to practice hand hygiene results from several standards. Section 36 IfSG obliges hospitals, prevention and rehabilitation facilities, facilities for outpatient surgery, dialysis facilities as well as nursing and child day care facilities to define internal procedures for infection hygiene in hygiene plans. § 23 IfSG supplements the obligation for medical facilities to monitor nosocomial infections.

§ 42 and § 43 IfSG as well as EU Regulation 852/2004 on food hygiene apply to food establishments. People who work with perishable food need to be informed by the health department before starting the job and every two years thereafter. The instruction also documents the obligation to practice hand hygiene.

TRBA 250 “Biological agents in health care and welfare” applies to general occupational safety. It specifies the biological substances regulation and names hand hygiene as a protective measure according to Section 9 BioStoffV. Section 4 ArbSchG obliges every employer to carry out a risk assessment, within the framework of which infection risks must be assessed. Anyone who appoints a hygiene representative bundles responsibility for the hygiene plan, training and audit templates in a clearly assigned role.

The WHO published a “Five Moments for Hand Hygiene” model in 2009, which KRINKO and RKI adopted for German institutions. The five indications are a mandatory part of every instruction in healthcare and nursing. First: before patient contact. Second: before aseptic activities. Third: after contact with potentially infectious material. Fourth: after patient contact. Fifth: after contact with the immediate patient environment.

An adapted logic applies in food companies: before starting work, after using the toilet, after breaks, after contact with raw materials, after cleaning work and before contact with ready-to-eat products. The order belongs in the hygiene plan and in the notices at washing areas. Similar indications apply in daycare centres with additional training for children as part of health education.

The choice between hand washing and hygienic hand disinfection follows a simple rule: If there is visible contamination or after contact with spores such as Clostridioides difficile, washing with soap and water is necessary. For all other indications, alcohol-based hand disinfection is more effective and skin-friendly. According to the RKI recommendation, the reaction time is 30 seconds; a sufficient amount of the product is rubbed into dry hands.

Auditors check three levels. Firstly, the means: hand disinfectants used must meet the requirements of the EU Biocide Regulation 528/2012 and be approved for the respective indication (limited virucidal, limited virucidal plus, virucidal). The effectiveness is proven by listing in the VAH lists or by test reports according to EN 1500.

Secondly, the dispensers: Sensory or elbow-operated dispensers avoid recontamination and must be kept in locks, sanitary areas, patient rooms, treatment rooms, kitchens and break areas. Dispensers must be regularly cleaned, disinfected and filled with original containers. Transferring from large containers is only permitted under validated conditions. The skin protection plan supplements hand disinfection with skin cleansers, skin protection cream before work and skin care cream afterwards. Specifications for this can be found in TRGS 401 and DGUV Information 250-001.

Thirdly, effectiveness control: random compliance observations according to WHO methodology document whether the indications are actually being adhered to. The quota is specified in the hygiene plan; a target value of 80 percent is considered a realistic practical value in the healthcare system. Audit-proof, documented, IfSG-proof. Anyone who names compliance values ​​without a basis for data collection will fail in supervisory control.

The hygiene plan is the central document according to Section 36 IfSG. Mandatory contents are: scope of application, responsibilities, structural and equipment requirements, personal hygiene with hand hygiene and skin protection, cleaning and disinfection of surfaces, processing of medical devices, laundry and waste disposal, drinking water hygiene, pest monitoring as well as procedures for outbreaks and notifiable diseases in accordance with Sections 6 and 7 IfSG.

The plan is updated at least annually, in addition after each relevant incident, after changes to the premises, after the introduction of new procedures and after updating the KRINKO recommendations. The responsibility lies with the facility management, the creation is carried out in collaboration with the hygiene officer and in larger facilities with the hospital hygienist and the hygiene specialist in accordance with Section 23 IfSG.

In food companies, the HACCP concept according to VO 852/2004 takes over the function of the hygiene plan. It identifies critical control points, limit values, monitoring procedures and corrective actions. Hand hygiene is a personal hygiene component and is documented in the training documents for instruction in accordance with Section 43 IfSG. The auditor calls, the evidence is ready. - this applies to the hygiene plan as well as the training certificates from the past 24 months.

§ 12 ArbSchG obliges every employer to instruct employees before starting work and regularly thereafter, at least annually. The content includes the hazards in the workplace and the protective measures in health and food establishments, including hand hygiene. The instruction is given in a language that the employees can understand, the content is documented, and participation is confirmed with a signature.

TRBA 250 supplements this general obligation for activities involving biological agents. § 14 BioStoffV requires occupational health care, which is specified in the ArbMedVV. Mandatory precautions are required in the healthcare system, for example when carrying out activities involving blood contact. The precautionary measures also document the condition of the employees' skin, which is relevant for hand disinfection.

The hygiene officer coordinates training, maintains evidence of instruction, plans effectiveness checks and reports to the facility management. Classic lead time for the initial appointment of a hygiene officer: two to six weeks. CIVAC shortens this route to two working days. The 490 audit templates contain the appointment certificate, hygiene plan framework, instruction protocol and compliance checklist. Licence the workspace for your internal representatives or have our representatives order it. In both variants you access prepared templates that correspond to the RKI recommendation and TRBA 250.

A supervisory audit according to Section 16 IfSG by the health department typically checks six points. First: Is there a current hygiene plan? Secondly: Is the hygiene officer appointed and qualified? Third: Are the instruction records from the last two years complete? Fourth: Are compliance observations available with date, observer, observation situation and quota? Fifth: Are cleaning and disinfection plans posted and are they demonstrably implemented? Sixth: Is the procedure for outbreaks and reportable illnesses regulated?

Food supervision and the Federal Office for Agriculture and Food also check the instructions in accordance with Section 43 IfSG, the HACCP documentation and personal hygiene. As part of the ASA meetings, professional associations check the instruction documentation in accordance with Section 12 ArbSchG and the risk assessment.

The appointment certificate, signed, filed, verifiable. This logic also applies here: The evidence belongs in an audit-proof compliance storage with version management, timestamps and access rights. The CIVAC workspace with ISO/IEC 27001:2022 ISMS and EU data residency meets these requirements. The 93 controls according to ISO 27001:2022 ensure confidentiality, integrity and availability of the documents and thus also availability in the event of an audit.

The WHO methodology for compliance observation provides for standardised observation units lasting 20 minutes. During this time, a trained person records how many of the required hand hygiene indications are actually carried out. The quota results from the actions performed divided by the actions required. The audit asks: Who observed, when, where, how often? A credible compliance survey covers several shifts, several professional groups and several days of the week.

The condition of the employees' skin is also monitored. An increased rate of skin diseases can be an indication of incorrect products, incorrect application or inadequate skin protection. Occupational dermatological prevention according to G 24 is regulated in the ArbMedVV. Skin diseases can be recognised according to BK list No. 5101, which triggers reporting obligations to the professional association.

Others run compliance like a filing cabinet. We run it like software. In the workspace, compliance observations are recorded as structured entries, quotas are automatically calculated, and trends are visualized. The hygiene officers derive concrete measures from this: additional training, donor optimization, adjustment of skin protection plans. This creates an effective control instrument from the mandatory documentation.

If nosocomial infections occur in a facility, Section 6 Para. 3 IfSG applies. A report by name to the health department is required if two or more nosocomial infections occur in which an epidemic connection is likely or suspected. The report is made immediately, at the latest within 24 hours of becoming aware of it. Deadline begins as soon as we become aware of it. Anyone who has established a hygiene officer and a clear reporting path routinely fulfils the obligation.

In pandemic situations or the occurrence of reportable pathogens in accordance with Section 7 IfSG, such as norovirus, rotavirus, influenza or MRSA, additional measures are required. KRINKO publishes pathogen-specific recommendations in which hand hygiene indications and the choice of disinfectant are specified. If C. difficile is suspected, washing hands with soap and water is preferable to disinfecting with alcohol, as spores are alcohol-resistant.

The reporting line between the hygiene officer, facility management and the health department must be regulated and documented. CIVAC maps this path in the workspace, with a time stamp, person responsible, processing status and audit trail. The 24/72 early warning follow-up message logic from the NIS 2 context can be structurally transferred to IfSG messages.

Hand hygiene is not a question of posters, but of control. Six building blocks turn a facility with soap dispensers into an audit-proof operation: a current hygiene plan, an appointed hygiene officer, documented instructions, compliance observations with a survey basis, skin protection plan and a regulated reporting path for outbreaks and reportable illnesses.

CIVAC is a compliance platform and officer-as-a-service for exactly this path. The appointment certificate, hygiene plan template, instruction protocol and compliance form are available in the workspace. The 490 audit templates include training matrix, cleaning and disinfection plans and reporting forms for nosocomial clusters. The ISMS according to ISO/IEC 27001:2022 with EU data residency ensures audit-proof storage. Licence the workspace for your internal representatives or have our representatives order it. The initial setup typically takes two to six weeks, with CIVAC two working days.

Turn reading into a mandate. Write to info@civac.de or use the contact form on civac.de. An initial conversation clarifies the ordering process, hygiene plan status and training path, and within a few days you will have a reliable compliance structure for the next regulatory review.