Hygiene in the doctor's office: The practical guide 2026

According to Section 23 IfSG and the respective state medical hygiene regulations, medical practices in Germany must maintain a written hygiene plan, update it annually and adapt it to the requirements of the guidelines of the Commission for Hospital Hygiene and Infection Prevention (KRINKO) at the Robert Koch Institute. Anyone who performs outpatient surgery or invasive procedures is also subject to Appendix 1 MedHygVO with specific requirements for rooms, preparation and personnel. A hygiene inspection by the health department usually checks between 12 and 18 points, from the hand disinfection plan to the processing of medical devices according to KRINKO/BfArM recommendations. An average inspection lasts 2 to 4 hours and ends with a protocol that records deficiencies and deadlines.

This guide bundles the central duties and structures for 2026: hygiene plan, appointment of a hygiene officer in the practice, training, preparation, surface cleaning, waste disposal and documentation. You will receive concrete information about which topics need to be checked and at what frequency, when an externally appointed hygiene officer makes sense and how the documentation can be managed so that the next inspection takes place without rework. In the end, you know the building blocks that cannot be missing in an audit-proof practice, can realistically assess your own status and know which flat rates make an external mandate economically comparable to a purely internal solution.

Hygiene in the doctor's office rests on three legal pillars. Firstly, the Infection Protection Act (IfSG), in particular Section 23 IfSG, which obliges facilities for outpatient surgery and comparable facilities to take the measures required by the state of medical science to prevent nosocomial infections. Secondly, the state medical hygiene regulations, which have been issued in all 16 federal states and specify obligations regarding the hygiene plan, hygiene commission, risk assessment and personnel qualifications. Thirdly, the guidelines and recommendations of the KRINKO at the Robert Koch Institute, which are considered a scientific benchmark for the necessary measures and are used as a reference in the inspection process.

For medical practices without outpatient surgery, Section 36 IfSG and the information in the KRINKO recommendation for infection prevention in medical practices, in the current version, apply primarily. Anyone who performs outpatient surgery or endoscopy also falls under the stricter requirements of Annex 1 MedHygVO with requirements for rooms, preparation and staff appointments. Violations of § 23 or § 36 IfSG can be punished with fines of up to 25,000 euros in accordance with § 73 IfSG, and in repeated cases with consequences of approval or with an order to refrain from certain activities until the defects have been corrected.

In addition, the relevant association of statutory health insurance physicians checks as part of the hygiene quality inspection in accordance with § 135b SGB V whether the Medical devices are processed according to KRINKO/BfArM recommendations 2012. Anyone who orders an external hygiene officer as an officer-as-a-service documents these requirements uniformly and reduces the coordination effort between the health department, KV and practice management. CIVAC is a compliance platform and officer-as-a-service. The appointment certificate, signed, filed, verifiable, forms the starting point of every reliable audit. Anyone who operates several locations or several disciplines under one roof should also name the hygiene responsibilities separately for each location and combine them in a common reporting line in order to avoid gaps in responsibility in the case of representation or restructuring.

The hygiene plan is the central document for practice hygiene. According to Section 23 Paragraph 5 IfSG and the KRINKO recommendations, it must be available in writing, accessible to all employees and updated annually. Mandatory content is: hand hygiene with a detailed hand disinfection plan, surface disinfection with wiping and spraying instructions, preparation of medical devices with proof of expertise, protective clothing, waste disposal, laundry management, food hygiene if relevant and the vaccination status of the staff in accordance with Section 23a IfSG. Each practice keeps the plan in a fixed location and ensures that it is accessible on every shift.

Each of these building blocks consists of three elements: a procedural instruction (what needs to be done), a responsibility regulation (who does it) and a documentation sheet (where the evidence is kept). Procedural instructions for hand disinfection contain the indications according to the WHO's 5 moments of hand hygiene, the exposure time, the product with spectrum of action and VAH listing as well as information on when hygienic and when surgical hand disinfection is necessary. The documentation is carried out via sample protocols and the annual training requirement for all employees, including cleaning staff.

The plan must be adjusted with every relevant change: new medical device, new room structure, new KRINKO recommendation. A mere annual update is not sufficient if procedures change during the year or new recommendations are published. Audit-proof, documented, Section 23-proof. Practices with multiple locations benefit from a central template that each location adapts to its spatial characteristics and maintains a uniform version. The CIVAC workspace contains 490 ready-to-use audit templates from which a hygiene plan can be derived for primary care, specialist and outpatient practices, each with procedural instructions, responsibility matrix and documentation sheet as well as a clear reporting line to the practice management.

A hygiene officer in the practice is required by the state medical hygiene regulations in facilities for outpatient surgery and in comparable facilities. General practitioner and specialist practices without invasive procedures are not formally required to order, but benefit significantly from the order because the hygiene plan, training and documentation can be bundled into one roll. The order is made in writing, with a catalogue of tasks, reporting line and proof of expertise. Expertise is acquired through structured curricula (40 teaching units basic course, 200 teaching units for the function in hospitals and outpatient surgical centres) and must be proven in the personnel file.

The tasks include creation and maintenance of the hygiene plan, supervision of inspections by the health department, annual training of staff in accordance with Section 23 IfSG, risk assessment of new procedures and medical devices, support of reprocessing processes and outbreak management nosocomial clusters. In smaller practices, these tasks are completed in 4 to 8 hours per month; in outpatient facilities, the effort is 12 to 24 hours per month. In addition, there are special appointments for room changes, new equipment or officially ordered key tests.

In 2026, an externally appointed hygiene officer typically costs between 300 and 800 euros net per month for general practice and between 800 and 1,500 euros for outpatient facilities. Licence the workspace for your internal representatives or have our representatives order it. Others run compliance like a filing cabinet. We run it like software. The external order has the advantage of permanent accessibility, uniform training standards and audit-proof reporting lines to the practice management, without having to spend internal hours on curricula, further training and continuous KRINKO reading. There is also no special protection against dismissal for internal representatives, which increases flexibility in small structures.

The reprocessing of medical devices is the most common point during inspections where complaints are recorded. Section 8 of the Medical Device Operator Ordinance (MPBetreibV) and the joint KRINKO/BfArM recommendation 2012 (in the current version) are relevant. Before the first reprocessing, each practice must carry out a written risk assessment and classification of the product: non-critical (contact with intact skin), semi-critical (contact with mucous membranes) or critical (penetration into tissue, injury to intact skin). This classification is the basis for all subsequent steps and must be presented in writing at every inspection.

The permissible processing procedures follow from the classification. Semi-critical products with increased requirements (endoscopes, oral mirrors in contact with mucous membranes) require documented mechanical processing in a cleaning-disinfection device (RDG) with periodic validation. Critical products require sterilization in a validated process, usually steam sterilization according to DIN EN ISO 17665, with batch documentation. Each batch is documented with date, loading, process parameters, release and person responsible. The validation of RDG and sterilizer takes place after initial commissioning and periodically thereafter, usually annually for renewed performance qualification.

Practices with their own reprocessing must also prove their expertise: 40-hour specialist course according to KRINKO/BfArM for personnel with reprocessing responsibility. Anyone who outsources the processing checks the ZLG recognition with the service provider and enters into a contract in accordance with Section 8 Paragraph 7 MPBetreibV with clear responsibilities. The FAQ for appointing a representative classifies which tasks in preparation are carried out by the hygiene representative and which remain with the practice management. The auditor calls, the evidence is ready. Consistent batch documentation with approval for each process is the basis of every inspection and should be stored digitally and in an audit-proof manner.

Staff in medical practices must be instructed on hygiene annually in accordance with Section 23 Paragraph 8 IfSG. The training includes at least hand hygiene, surface disinfection, personal protective equipment, handling of infectious material, preparation and behaviour in the event of suspected nosocomial cases. The training is documented with the date, content, duration, speaker and signature of the participants. Practical exercises, such as the rubbing technique with fluorescent disinfectant, are part of the standard canon of inspections and should take place regularly. New employees also receive complete instruction within the first two weeks, documented before starting their first patient-related activity.

In addition to the training, the vaccination status must be checked. Section 23a IfSG allows the employer to record vaccination and serostatus if this is necessary to assess suitability. According to STIKO recommendations, relevant vaccinations for practice staff are hepatitis B, measles (obligation to provide proof according to the Measles Protection Act), influenza, pertussis and, depending on the activity, hepatitis A. For practices with patient contact under 1-year-old children or with immunocompromised patients, extended obligations regarding measles immunity apply in accordance with Section 20 Paragraph 8 IfSG. Missing evidence is regularly criticized during the inspection and leads to deadlines for improvements.

The initial examination by the company doctor and the occupational health check according to ArbMedVV are also part of the personnel file. Practices with more than two employees who carry out activities with biological substances also need a risk assessment in accordance with BioStoffV and TRBA 250. The reporting line between the hygiene officer, company doctor and practice management is stored in the CIVAC workspace with clear escalation steps, so that vaccination abnormalities, training gaps and preventive appointments can be controlled in a single view. A consolidated view reduces duplication of work and makes the personnel file fully accessible for inspections.

Surface cleaning and surface disinfection follow a two-stage concept: routine cleaning with cleaning agents and targeted disinfection of surfaces close to patients with listed agents (VAH list). The KRINKO recommendation distinguishes surfaces that are touched with high frequency (examination couch, door handles, light switches, keyboard) from surfaces with a lower probability of contact. The cleaning plans document frequency, means, concentration, exposure time and responsibility. Visual cleanliness alone is not enough; The inspection checks the plan, means, wiping technology and documentation equally. When using external cleaning service providers, the plan is available in the practice and is compared with the service provider annually.

Indoor air hygiene is becoming increasingly important, especially in outpatient operating rooms. Here, Annex 1 MedHygVO requires requirements for the ventilation system (RLT) depending on the room class (I, II, III), with annual maintenance, filter testing and hygiene inspection according to VDI 6022. Sterilization and processing rooms have defined minimum dimensions, separate accesses for unclean and clean goods and a clear spatial or temporal separation of the work steps. The inspection checks whether spatial separation is actually being practiced or is just on the agenda.

Laundry management includes collection, transport, processing and storage. Dirty laundry is transported in closed containers, stored separately from clean laundry and processed in a process according to the RKI list (chemothermic or thermal). External laundries require a contract with proof of hygiene. The clock starts on awareness. Hidden processing in private rooms, as occurs when small practices are handed over, is reliably visible during the inspection and is prohibited. Such constellations can only be avoided through consistent spatial separation and written procedural instructions. An annual laundry inspection with a documented process check also protects against surprises if a service provider changes its procedures without notifying the practice.

Practice waste is classified according to LAGA enforcement aid 18. Domestic waste goes into normal household waste. Materials contaminated with blood or body fluids fall under waste code 18 01 04, provided they are not infectious within the meaning of 18 01 03. Pointed and sharp objects go into puncture-proof and break-proof containers and are disposed of separately. Stricter requirements apply to the disposal of infectious waste (18 01 03) with approved transporters and recyclers. The disposal receipts are filed in the practice and required during the inspection as proof of correct disposal.

Hazardous substances in the practice are primarily disinfectants, cleaning agents and processing chemicals. According to the Hazardous Substances Ordinance (GefStoffV), a list of hazardous substances must be kept, a safety data sheet must be kept for each product and operating instructions must be drawn up with annual training for employees. For quantities over 1,000 liters per year, a hazardous substances officer can be useful, but usually not in small practices. Central storage with access control and appropriate labelling reduces the risk of mix-ups with frequently changing products.

Reporting channels concern, on the one hand, legally reportable diseases in accordance with Sections 6 and 7 IfSG, which must be reported immediately to the health authority, and, on the other hand, nosocomial clusters in accordance with Section 23 Paragraph 4 IfSG. A cluster of two or more nosocomial infections with a probable epidemiological connection must be reported. The documentation of these reports and the measures taken is part of the inspection documents and is regularly inspected by the health department. A standardised template for the report speeds up the response and avoids formal complaints, especially for time-critical reports outside regular office hours. CIVAC provides a template in the workspace that records the date, pathogen, number of cases, measures and report recipients in a structured manner so that the report is managed in the same logic as the rest of the hygiene plan.

Inspections by the health department usually take place 1 to 4 weeks in advance, and in special cases also unannounced. The hygiene plan, proof of training, processing documentation, staff vaccination status, RDG and sterilizer validation, spatial separation, waste disposal and procedural instructions are checked. A complete visit takes 2 to 4 hours. Defects are recorded in a protocol with a deadline of 4 to 12 weeks to rectify, and in serious cases with an immediate order in accordance with Section 16 IfSG. Repeated defects can lead to extended requirements and, in individual cases, to restrictions on activities.

Structured preparation significantly reduces rework. We recommend an internal preliminary inspection 8 weeks before the official appointment, ideally by the externally appointed hygiene officer or by a colleague shadowing from another practice. It is checked whether every plan is in the current version, whether every employee is trained, whether the preparation is completely documented and whether the spatial separation is visibly working. A two-hour advance appointment finds most of the gaps that would otherwise be recorded in a real inspection. The results flow into a short action plan with responsible persons and deadlines, which is checked a few days later and corrected if necessary.

In the CIVAC workspace, inspection templates can be maintained as 490 structured audit templates, from the hand disinfection plan to the processing logbook, including the validation dates for the WD and sterilizer. The reporting line between the hygiene officer and practice management is maintained with the date, person responsible and completion status. Other representative mandates, such as a data protection officer, can also be managed in the same platform, which reduces the coordination effort for inspections with combined test parts (hygiene plus data protection, for example with electronic patient files). Turn reading into an assignment.

If you, as a practice manager, want to structure your own hygiene management, start with three steps. First: Inventory of the current hygiene plan, with comparison against the KRINKO recommendation in the current version and the state medical hygiene regulations in your federal state. Second: Determination of responsibilities in a matrix in which each hygiene component is assigned to a representative person. Third: Audit plan over the year with quarterly priorities (Q1 preparation, Q2 training, Q3 areas and rooms, Q4 waste and laundry). Such a quarterly logic avoids last-minute expenses before the official inspection.

If you would like to fill the role of hygiene officer externally, CIVAC, as a compliance platform and officer-as-a-service, checks the individual requirements of your practice. Licence the workspace for your internal representatives or have our representatives appointed, depending on the size of the practice and the range of activities. You will receive the appointment certificate, catalogue of tasks, training plan and audit calendar in one mandate, with an SLA of 2 working days and EU data residency. Changing from an existing external mandate can also be implemented within 14 days, including handover and initial audit. The connection of additional representative roles, such as a data protection officer for the electronic patient file or a person responsible for hazardous substances for the processing chemicals, runs in the same workspace and relieves the practice management of redundant reports.

For a non-binding comparison of your current setup, write to info@civac.de or use the contact form on the role overview. Within 2 working days you will receive a concrete offer including a draft appointment certificate, hygiene plan template and training schedule, each tailored to general practitioner, specialist or outpatient surgery. In the initial consultation, we discuss the practice structure, range of activities, scope of preparation and desired audit frequency. If requested, we can add a calculation with a comparison between internal and external solutions, based on the number of employees, rooms and number of medical devices processed per quarter. Turn reading into an assignment.