Doctor's practice hygiene plan 2022: What needs to be up to date since then

A hygiene plan in accordance with Section 36 Paragraph 1 No. 7 IfSG in conjunction with Section 23 IfSG is mandatory for medical practices and must be continuously adapted to the state of science and technology. Anyone who is still using a plan in the 2022 version in 2026 will have missed several relevant updates in the last four years: the updated KRINKO recommendation on surface disinfection and reprocessing of medical devices, the adjustments to the RKI recommendations on hand hygiene, the updates relating to SARS-CoV-2 as well as the requirements from the Medical Device Operator Ordinance in the 2021 version and subsequent clarifications. Supervisory authorities now evaluate the plan less based on scope, but rather based on timeliness, traceability and connection to real processes in registration, treatment, processing and disposal.

This article is aimed at practice owners, hygiene officers and practice management and shows in a structured manner which points of a 2022 hygiene plan will no longer be relevant in supervisory practice in 2026, which documents, instructions and evidence are expected today and how CIVAC can be used as a compliance platform and Officer-as-a-Service systematizes the update with audit templates, appointment certificates and reporting lines. The aim is to have a verifiable update in 2 working days, instead of a weekly project with an uncertain result and a significant burden on ongoing practice operations. The legal bases and recommendations mentioned are each located in the article with a paragraph or reference so that your own plan can be checked precisely against the specifications.

The central legal basis is Section 36 Paragraph 1 No. 7 IfSG, supplemented by the hygiene regulations of the federal states and the Medical Device Operator Ordinance (MPBetreibV). Section 23 IfSG obliges institutions to comply with the recommendations of KRINKO, the Commission for Hospital Hygiene and Infection Prevention at the Robert Koch Institute. These recommendations have the legal character of the recognised state of science and technology. Anyone who deviates bears the burden of justification.

There are also special standards. Section 8 MPBetreibV applies to the sterilization and reprocessing of medical devices with the obligation for validated reprocessing. The Drinking Water Ordinance and VDI 6023 apply to drinking water hygiene. The current version of LAGA M 18 applies to waste from medical facilities. The Biological Substances Ordinance and TRBA 250 Biological Agents in the Health Care System apply to occupational safety. Each of these sources creates requirements that must be reflected in the hygiene plan.

A hygiene plan that only cites Section 36 IfSG and attaches the KRINKO recommendation as an appendix does not fulfil the obligation. Specific, written regulations on surface disinfection, hand hygiene, preparation, laundry, waste, pest control, drinking water, employee hygiene and instructions are required. Each point requires a person responsible, a cycle and a verification structure. Only this specification makes the plan auditable and protects against complaints from the health department and the Association of Statutory Health Insurance Physicians as part of the quality inspection according to SGB V. A plan that reflects these requirements also serves as evidence within the framework of quality management according to § 135a SGB V and the quality management guidelines of the Federal Joint Committee, which has a relieving effect on KV audits and avoids duplication of work across several audit lines. As a result, the hygiene plan is not just an infection protection document, but a central component of the practice organisation and the liability situation of the practice management towards patients, staff and payers.

KRINKO updated several recommendations between 2022 and 2026. Particularly relevant for medical practices are the updates on hand hygiene with more precise requirements for skin protection and rubbing time, the updated recommendation for the reprocessing of medical devices with statements on the validation of manual steps and clarifications on surface disinfection in areas with different risk of infection. Anyone who uses the 2022 version usually overlooks the new validation requirements and the more precise risk classifications.

There are also adjustments to the epidemiological situation. The SARS-CoV-2 recommendations have been adjusted several times since 2022 and have been incorporated into general pandemic preparedness. In practical terms, this means that mask rules, ventilation concepts and patient control must now be differentiated according to seasonality and local infection rates, no longer as blanket pandemic appendixes. The recommendation for surveillance of multi-resistant pathogens (MRE) has also gained importance in supervision, especially for practices with frequent patient contact with nursing facilities or hospitals.

Finally, state health authorities have tightened their inspection practices. Random samples at practices with invasive procedures, outpatient operations or endoscopy are increasing. Documentation gaps in the processing logbook, missing instructions or outdated material data sheets regularly lead to complaints. Anyone who goes on an inspection in 2026 with a 2022 plan runs the risk that the health authority will set a deadline for updating, failure to do so will result in a fine in accordance with Section 73 IfSG and, if repeated, could affect the suitability of the practice management. In addition, the state health authorities are increasingly referring to the KRINKO federal health bulletin, in which new information appears every year. Anyone who does not systematically evaluate this information and incorporate it into the hygiene plan will regularly find themselves in need of explanation during an inspection because the supervisory authority expects a documented assessment procedure. A compact evaluation note for each new recommendation with file number, date and decision by the practice management is sufficient, but reliably protects against the accusation that the practice simply ignored recommendations.

An audit-proof hygiene plan for 2026 contains at least ten chapters. First: Organisation and responsibilities, with named hygiene officer and representation. Secondly: personal hygiene with hand hygiene, protective clothing, vaccination recommendations according to STIKO. Third: surface disinfection with cleaning and disinfection plans for each functional area. Fourth: Processing of medical devices in accordance with Section 8 MPBetreibV with validation, batch documentation and release.

Fifth: Laundry, waste, pests. Laundry according to RKI recommendations, waste according to LAGA M 18, pest monitoring. Sixth: Drinking water hygiene with sampling according to TrinkwV. Seventh, patient management with triage, isolation, routing and education. Eighth: Surveillance, i.e. recording and evaluating infections, MDROs and notifiable diseases in accordance with Section 6 IfSG. Ninth: Instructions in accordance with Section 35 IfSG and training, annually, with proof of participation and written confirmation.

Tenth: Emergency management in the event of outbreaks, contamination events or defects. Every chapter needs responsible people, rotation, evidence and escalation paths. We recommend an introductory chapter with the scope, legal basis and duration of validity, plus a final chapter with versioning. Anyone who maintains the plan in a compliance workspace can document each update with a time stamp, person responsible and reason. This is consistent with the health department's expectation that the plan be a living document and not a once-created folder. Audit-proof, documented, Section 36-proof. It also makes sense to dovetail with quality management in accordance with Section 135a SGB V and the G-BA's QM guidelines, so that hygiene and quality management do not run in parallel, but rather result in one set of files. Practices that choose this integrated approach save hours on inspections because the health department does not have to switch between folders. Internal audits by the hygiene officer also benefit because they can be based on a consistent set of files instead of distributed Excel lists and email attachments.

Even if the IfSG does not prescribe a hygiene officer for medical practices as it does for hospitals according to Section 23 Paragraph 5 IfSG, the appointment of a hygiene officer for the practice is a standard of care. KRINKO recommends a named function, and state health authorities expect a clear contact person during inspections. In practice, this role is often taken on by a medical assistant with additional qualifications or the practice management itself.

The hygiene officer's tasks include maintaining the hygiene plan, carrying out and documenting the annual instructions in accordance with Section 35 IfSG, the interface to the health department, monitoring the processing of medical devices, evaluating hygiene samples and reporting to the practice management. Without a named function, tasks are distributed informally, evidence is missing, and the gap becomes apparent in the audit. A named hygiene officer with a documented order creates responsibility, responsiveness and verifiability.

A written appointment certificate with a description of tasks, reporting line and period of validity is recommended for the order. The appointment certificate, signed, filed, verifiable. CIVAC provides a standardised appointment certificate for hygiene officers and maintains the documentation in the workspace with EU data residency. The order can be made by an internally qualified person or by an external representative. Licence the workspace for your internal representatives, or have our representatives order it. For practices without suitable internal resources, the external solution can be implemented in 2 working days, including file management, reporting lines and annual training planning. In this way, the function is filled even if an internal position is lost, goes on parental leave or the practice team changes, which regularly leads to documentation gaps without an external solution. For the practice management, this means predictable availability of the function regardless of the change of individual employees and a noticeable reduction in the effort for the annual care cycles.

The preparation of medical devices is the most common complaint during inspections. § 8 MPBetreibV requires validated processing with a documented cleaning, disinfection and, if necessary, sterilization chain. The process, chemicals, device, person responsible and batch must be documented for each processing step. The KRINKO recommendation on reprocessing in the current version must be applied because it reflects the state of science and technology.

Typical gaps in 2022 hygiene plans: no written risk assessment of the reprocessed medical devices, no validation protocols for cleaning and disinfection devices (RDG), incomplete batch documentation for sterilizers, missing release notes, outdated material data sheets for disinfectants. In addition, there is the topic of semi-critical B and critical B, i.e. endoscopes and semi-critical instruments, which receives increased attention in supervision and places special demands on reprocessing and documentation.

It makes practical sense to have a reprocessing register in the workspace, in which each batch is documented with receipt time, person responsible, device ID, batch ID and release. According to Section 7 MPBetreibV, the data must be stored for at least 5 years. With electronic management, audit-proof archiving must be ensured. CIVAC offers an integrated processing register in the workspace with an interface to the hygiene plan and annual instructions. This turns a decentralized paper process into an auditable file that can be presented immediately in the event of an infringement. The auditor calls, the evidence is ready. A consistent separation between purely technical processing logs and the evaluative release by a knowledgeable person also ensures the role clarity expected in accordance with Section 8 MPBetreibV and protects against the classic finding that processing and release take place in one hand and without a four-eye principle. In practices with higher processing frequency, it is also worthwhile to carry out a quarterly sample by a second knowledgeable person, the result of which is documented in the workspace.

§ 35 IfSG requires all employees who come into contact with patients or handle food to be given instructions. The initial instruction takes place before starting the activity, the repeat instruction takes place at least every 2 years. Annual training is recommended in the medical practice because recommendations and procedures change more frequently and the supervisory practice expects annual evidence. Contents include hygiene, reporting obligations according to Section 6 IfSG, activity bans according to Section 42 IfSG and practice-specific procedures.

The instructions must be documented. Date, content, instructor, participants, signatures and handing out an information sheet are required. Frequent complaints: missing signatures, unclear content, lack of repetition when returning to work after a long absence, lack of proof for temporary workers and trainees. A central filing and reminder mechanism in the workspace prevents appointments from being overlooked and staff changes leading to gaps.

Beyond Section 35 IfSG, training courses on hand hygiene (Clean Hands Campaign), reprocessing of medical devices, emergency management and data protection in accordance with Art. 32 GDPR are useful. CIVAC bundles these topics in an annual training plan with proof of participation, which simultaneously contributes to the ISMS according to ISO/IEC 27001:2022, provided the practice works with IT support. In this way, an obligation is created into an integrated bundle of evidence that can be proven in one go in an audit by the health authority, KV and data protection supervisory authority and relieves the operational burden on the practice team. Another advantage of this bundling: if you change the practice software or take on new employees, all training and instruction evidence is in one place and can be transferred without any search effort, which speeds up training and avoids gaps in documentation. At the same time, the cross-year versioning creates a picture of the training landscape, which in the audit provides a very credible answer to the question of whether the staff was trained regularly and comprehensibly.

Inspections by the health department take place on an ad-hoc basis or on a regular basis. In federal states with hygiene regulations for outpatient facilities, regular inspections are required; in others, this takes place in response to a complaint or as part of serial examinations. Typical test items include the hygiene plan, proof of instruction, processing documentation, drinking water protocols, waste disposal, pest monitoring and spatial conditions.

Good preparation includes three steps. First: Self-audit based on the KRINKO recommendations and the federal state's hygiene regulations, at least annually. Secondly: central storage location for all documents relevant to testing with a directory, responsible persons and version status. Third: short briefing for the team, who will receive the examiner, which rooms will be shown, who is responsible for questions. This way you avoid hectic pace on the day of the inspection and avoid complaints due to organisational gaps.

In the workspace, the inspection mode can be activated with one click: hygiene plan, instruction register, processing register, drinking water protocols and pest monitoring can be accessed in one view. This saves time during the appointment and increases the likelihood that the inspection will end without any conditions. If requirements are imposed, the deadline according to Section 16 IfSG must be observed. Deadline begins as soon as we become aware of it. A documented action plan with deadlines and responsible persons is the usual response that the health department accepts. CIVAC provides a template for requirements and measures for this process, which speeds up the health department process. It is important that each requirement is documented as a separate process, with a deadline, person responsible and proof of completion. This makes it possible to prove that the practice has implemented the requirement on time, which creates trust in subsequent inspections and reduces the risk of regulatory follow-up measures. In practice, it has proven useful to address each compliance requirement with a short written proof of implementation to the health department instead of waiting for the next inspection date. This active communication noticeably reduces the number of unannounced inspections and creates a constructive working relationship with the authority, which is valuable in the event of a dispute.

A comparison of 2022 plans with current requirements reveals recurring gaps. Firstly, there is often a lack of a clearly named hygiene officer with a written appointment document, job description and reporting line. Second, material data sheets for disinfectants are outdated because manufacturers are adjusting recipes and changing application times. Thirdly, there is no current risk assessment of the reprocessed medical devices according to the KRINKO classification into uncritical, semi-critical A/B and critical A/B.

Fourthly, the link between the hygiene plan and the drinking water test according to TrinkwV is often missing. Practices with large consumers such as treatment units in dentistry, dialysis or endoscopy have their own obligations that must be reflected in the plan. Fifthly, pest monitoring is often only formulated as a general statement and is not supported by rotation, service providers and report of findings. Sixthly, the SARS-CoV-2 section is either still oversized or completely removed, instead of being converted into a general respiratory infection concept.

Seventhly, there is no documented assessment of the recommendations from the KRINKO Federal Health Bulletin, which provides new information every year. Eighthly, interfaces to data protection are missing, for example when processing health data in electronic processing registers, which triggers its own requirements according to Article 9 GDPR and Section 22 BDSG. CIVAC addresses these gaps with an update module that brings the 2022 plan up to 2026 in a structured manner and continues the documentation in an audit-proof manner in the workspace without interrupting practical operations. In practice, the migration takes place in three stages: inventory of existing documents, mapping to the ten mandatory chapters and transfer of the content into a versioned file structure with defined responsible persons and deadlines. In this way, the tried and tested inventory is retained and at the same time raised to an auditable level. Anyone who carries out the migration properly will benefit in the following years from a platform that documents updates with just a few clicks and drastically shortens the annual maintenance cycles.

Updating a hygiene plan is not a major project if the structure, templates and responsibilities are clear. CIVAC sees itself as a compliance platform and officer-as-a-service. For medical practices, this specifically means: a workspace with hygiene plan templates, instruction and processing registers, a documented reporting line and EU data residence, plus the option to appoint an external hygiene officer function. In this way, the 2022 plan becomes an audit-proof plan for 2026 in less than two weeks.

Licence the workspace for your internal representatives, or have our representatives order it. Both paths lead to the same file management: appointment certificate, signed, filed, verifiable. The typical CIVAC SLA for appointing an external agent is 2 business days. This eliminates the need to spend weeks searching for a suitable person and the practice team can concentrate on patient contact. You can find an overview of the representative roles in a structured manner on the website.

Three steps for practice. First: self-check the current hygiene plan against the ten mandatory chapters and the current KRINKO recommendations. Secondly: appoint a hygiene officer or appoint an external person and document the appointment certificate. Third: Transfer the plan to the workspace, create instruction and preparation registers, set deadlines and responsibilities. Turn reading into an assignment. Contact us at info@civac.de or using the contact form. We will respond within 2 working days with a specific proposal for your practice, your premises and your processing setup. This turns the annual compulsory exercise into a reliable process in which the hygiene plan, instructions and preparation are kept as an integrated file and are immediately available in full in the event of an inspection. This turns the hygiene plan from an unpopular mandatory document into an active practice control instrument that combines hygiene, quality and data protection in a single file structure and is equally viable for future audits, KV checks and data protection reviews.