Guideline for applied hygiene in dialysis: What facilities must check

According to KRINKO recommendations (Bundesgesundheitsblatt 2016), hemodialysis is one of the invasive procedures with a high risk of infection. Over 80,000 people in Germany are chronically dialyzed; each treatment creates contact with blood, water with a pharmaceutical grade of purity and mechanically connected circuits. Section 23 IfSG obliges all facilities in which dialysis is provided to draw up a written hygiene plan, appoint a hygiene officer and structure the recording of nosocomial infections and multi-resistant pathogens. In addition, there are the requirements from Section 4 MPBetreibV for medical devices, the DIN EN ISO 23500 series for dialysis fluids and pure water as well as the TrinkwV with sampling requirements. State law and state hygiene regulations close the gaps left open by federal law.

This article explains how a reliable guideline for applied hygiene in dialysis is structured, which modules it includes and how the hygiene officer provides evidence in the audit. CIVAC is a compliance platform and officer-as-a-service. Licence the workspace for your internal representatives, or have our representatives order it. You will find out which templates have to be run every day, how the reporting line to the medical management is organised and which documents must be available immediately during an inspection by the health department. The article is written as an operational guide for medical management, nursing service management and hygiene officers and provides concrete information for audit preparation.

The legal basis of hygiene in dialysis consists of four layers. Firstly, the Infection Protection Act (IfSG), in particular Section 23, which stipulates the creation of a written hygiene plan, the appointment of a hygiene officer and the surveillance of nosocomial infections. Secondly, the recommendations of the Commission for Hospital Hygiene and Infection Prevention (KRINKO) at the Robert Koch Institute. The 2016 KRINKO recommendation for infection prevention in hemodialysis is the central professional reference framework and is regularly cited in inspections. Thirdly, the Medical Device Operator Ordinance (MPBetreibV), which regulates the processing of medical devices in Section 4 and the application support in Section 11. Fourth, the normative specifications of DIN EN ISO 23500-1 to 5 for water treatment, dialysis fluid and microbiological limit values. These four layers intertwine and are referenced in the hygiene plan.

In addition, there are state law and sub-legal requirements. The Drinking Water Ordinance (TrinkwV) regulates sampling and limit values ​​for the feed water of treatment plants, the Hazardous Substances Ordinance and TRGS 401 cover skin protection during disinfection, and the Occupational Safety and Health Act with the Biological Substances Ordinance addresses employee protection. Section 33 IfSG also covers reporting obligations for nosocomial outbreaks, and Section 36 covers the requirements for community facilities with dialysis stations. Whoever draws up the guidelines must harmonise all four layers. A hygiene plan that only references the IfSG does not meet the KRINKO recommendation. Anyone who orders the hygiene officer via a platform will receive the cross-references between IfSG, KRINKO and ISO 23500 as a verified template, which will be versioned in the next KRINKO update. This is exactly what saves the regular 20 to 40 hours that manual maintenance takes up every year. Audit-proof, documented, § 23 IfSG-proof. Anyone who consolidates the sources will be able to examine the facts more quickly during the inspection.

A hygiene plan for a dialysis facility typically includes twelve modules. Module one is the risk analysis with an assessment of the procedures, the patient population and the structural conditions. Module two is personal hygiene measures, including hand disinfection according to EN 1500, personal protective equipment and clothing changes. Module three is surface hygiene with disinfection plans for patient chairs, machines, door handles and sanitary areas. Module four is the processing of medical devices in accordance with Section 4 MPBetreibV with validated procedures and release protocols. Module five is water treatment with sampling according to DIN EN ISO 23500 and microbiological examination. Module six is ​​dialysate production, including purity, endotoxin limit and conductivity control. Each module must be provided with responsibilities, frequencies and templates.

Module seven includes patient isolation for hepatitis B, hepatitis C, HIV and multi-resistant pathogens. Module eight is waste disposal according to LAGA guideline M18, separated according to waste codes. Module nine is pest control and cleaning of air conditioning systems. Module ten is the training concept with mandatory instructions and repeat training in accordance with Section 23 IfSG. Module eleven is the surveillance of nosocomial infections and multi-resistant pathogens in accordance with Section 23 Paragraph 4 IfSG, with reporting to the health department in the event of clusters. Module twelve is the emergency organisation in the event of hygiene incidents, including blocking machines, informing the medical management and escalating to authorities. Each module must be versioned, released and actively trained. Others run compliance like a filing cabinet. We run it like software. A platform with 490 audit templates maps the twelve modules in a structured manner; each change creates a new version with a release workflow and proof of training. This means that the guidelines are not a folder, but a living document in which every measure is assigned a responsibility and a deadline and in which the training status of the employees can be seen in real time.

The biggest silent danger in dialysis is water. An average hemodialysis patient is exposed to 120 to 150 liters of pure water crossing the dialysis membrane per treatment. Even low levels of endotoxin or bacteria lead to pyrogen reactions and chronic inflammatory conditions. DIN EN ISO 23500-3 sets a microbiological limit value of less than 100 CFU/ml and an endotoxin limit value of less than 0.25 EU/ml for pure water. For ultra-pure dialysate, the limit is less than 0.1 CFU/ml and less than 0.03 EU/ml. These values ​​require a consistently controlled treatment chain from feed water through pretreatment, reverse osmosis, permeate distribution to the dialysis machine. Each station in this chain is a potential weak point and must be monitored separately.

In practice, this means weekly to monthly sampling, documented disinfection cycles with peracetic acid, hot water or citric acid and full validation. Every sample taken must be documented in a sample collection protocol; any deviation requires an escalation to the hygiene officer and the medical management. The KRINKO recommendation also requires a structural separation between the processing system and the patient room, clear signage and an emergency plan for water outages. Anyone who takes the hygiene plan seriously stores every sample, every measure and every responsible person in a digital workspace with a date, responsible person and release stamp. The auditor calls, the evidence is ready. A platform with a sample calendar, escalation rules and versioning prevents a missing sample from being noticed in the audit three months later. This is the difference between a formal compliance file and an actual chain of protection for patients. Anyone who consistently documents the chain from feed water to dialysate not only gains compliance, but also measurably reduces the frequency of pyrogen reactions.

The hygiene representative must be appointed in accordance with Section 23 Paragraph 3 IfSG, in dialysis facilities usually supplemented by a hygiene specialist with qualified further training according to the DKG or DGKH curriculum. The main tasks are divided into four areas. Firstly, the creation and maintenance of the hygiene plan including all twelve modules, with annual reviews and adjustments as necessary. Secondly, the training of all staff in accordance with Section 23 IfSG, usually twice a year for nursing staff, once a year for medical staff and in more detail for new employees before their first patient contact. Thirdly, the inspections in-house with documented audit reports, list of defects and follow-up submissions. Fourthly, the surveillance of nosocomial infections with recording, assessment and reporting according to the case definitions of the KISS modules.

In addition, there is the reporting line to the medical management, regular reporting to the management and participation in inspections by the health department. The order is made in writing, with an appointment certificate, description of tasks and named representation regulations. The appointment certificate, signed, filed, verifiable. Licence the workspace for your internal representatives, or have our representatives order it. CIVAC offers both models. In the platform model, the internal hygiene officer maintains the plan, training and surveillance digitally; in the officer model, an external hygiene officer provides advice, reporting and attendance at inspections. Both models use the same template base with sample calendar, training register, audit log and list of defects. The effort is typically reduced by 30 to 45 percent compared to Excel and folder solutions because repetitive activities and reminder routines are automated. The hygienist can use the time gained for patient surveillance, employee coaching and improvement projects instead of for record maintenance. Anyone who additionally commissions the external hygiene officer with an audit plan will receive a documented inspection log with a list of defects, follow-ups and an action plan every quarter, which is stored in version form in the workspace and is available to management in a summarized quarterly report.

Training is the most common complaint in inspections. Section 23 Paragraph 3 IfSG requires regular training, the KRINKO recommendation specifies frequency and content. In practice, this means compulsory training twice a year for all nursing staff with a focus on hand disinfection, surface hygiene, handling shunt and catheter access, water treatment and surveillance. Medical staff are trained once a year, with additional modules on antibiotic stewardship and multi-resistant pathogens. New employees receive a structured briefing before their first patient contact, with a signature on a documented briefing checklist. External service providers, such as cleaning staff and service technicians, are trained as needed and at least once a year.

Providing evidence is crucial to success. Every training course must be documented with date, content, participants, speakers and duration. During the inspection, the health department typically requests the training register for the last twelve months, and often also sample evidence for individual employees. Anyone who works with Excel here risks gaps and incomprehensible statuses. A platform with a training register and automatic reminders of overdue repetitions significantly reduces the risk. Licence the workspace for your internal representatives, or have our representatives order it. The training register in the CIVAC workspace displays a version of each training course, generates certificates of participation and provides an overview for the inspection at the push of a button. The auditor calls, the evidence is ready. In this way, compulsory training becomes reliable evidence that operationally supplements the hygiene officer's appointment certificate. Audit-proof, documented, § 23 IfSG-proof. If you transparently track the training status of each individual nursing staff, you can also make personnel decisions, transfers and vacation planning without any compliance risk. An additional weak point in many facilities is the training of external service providers such as cleaning staff and service technicians. This group of people must also be demonstrably trained; the workspace provides a separate area related to the contract for this.

Section 23 Paragraph 4 IfSG obliges dialysis facilities to continuously record nosocomial infections and selected multi-resistant pathogens. In practice, this means structured surveillance of catheter-associated bacteremia, shunt infections and HCV/HBV seroconversions. The data must be evaluated at least once a year, compared with previous periods and benchmarks and documented in writing. Clusters require an outbreak investigation with hypothesis generation, sampling and immediate action. Section 6 (3) IfSG requires immediate reporting to the health department in the event of two or more nosocomial infections with a probable epidemic connection. The report is made without delay, usually by telephone and at the same time in writing.

Reliable surveillance requires clear case definitions, documented survey methods and a constant reference base, such as treatment cases per quarter. The KISS modules from the National Reference Centre provide recognised methodology for this. Anyone who conducts surveillance without a structured tool will lose track after a few months. A platform integrates the case definitions, automates the reference base and reports clusters directly to the hygiene officer. The reporting line to the medical management is documented in the workspace, escalations are carried out with a time stamp and responsibility. During an outbreak investigation, this documentation serves as a line of defence against regulators and patient advocates. CIVAC bundles these functions with 490 audit templates that are KRINKO-compliant. Anyone who orders a hygiene officer via the platform receives surveillance and reporting from a single source, including the template for the immediate report to the health department in accordance with Section 6 (3) IfSG. Deadline begins as soon as we become aware of it. If you plan the evaluation quarterly and not just annually, you will recognise trends earlier and avoid accumulations before they become reportable. This is exactly where the platform logic pays off because it automates data maintenance and evaluation.

Inspections are usually carried out every three to five years, regardless of the reason, or in the event of an increase in complaints, complaints or information. Section 16 IfSG gives the health department comprehensive powers, from entering rooms to inspecting documents. In practice, the office typically requests a fixed set of documents. Firstly, the current hygiene plan with versioning and release note. Secondly, the appointment certificate for the hygiene officer and the hygiene specialist. Thirdly, the training register for the last twelve months. Fourth, the water test results from the last twelve months with sampling protocols. Fifth, the previous year's surveillance reports. Sixth, the cleaning and disinfection protocols. Seventh, the processing documentation in accordance with Section 4 MPBetreibV. Eighth, the list of defects with resubmission and proof of completion.

Anyone who does not submit these eight documents in full within 24 hours risks conditions, orders according to Section 16 Paragraph 6 IfSG or, in the event of a repeat case, a fine according to Section 73 IfSG. In special cases, the office can shut down a business or suspend treatment. The appointment certificate, signed, filed, verifiable. A platform with a central client area creates an inspection package at the push of a button in which all eight documents are sorted chronologically, indexed and versioned. Licence the workspace for your internal representatives, or have our representatives order it. In the second model, the external hygiene officer is personally present during the inspection if requested; in the first model, the workspace provides the documents sorted. This means that inspections that previously took two weeks to prepare can be carried out in one morning. The auditor calls, the evidence is ready. If you immediately check the list of defects in the workspace after the inspection and add deadlines, you can make the transition to the next inspection without any outstanding points.

Recurring vulnerabilities appear in evaluations of inspection logs. First, outdated hygiene plans that do not reflect KRINKO updates 2016 or later updates. Secondly, incomplete training registers in which individual employees are not recorded or repeat training is missing. Thirdly, gaps in sampling for water and dialysate, often during vacation weeks or when employees change. Fourth, undocumented reprocessing approvals for medical devices, which directly violates Section 4 MPBetreibV. Fifthly, missing appointment certificates, often with expiring representation regulations. Sixth, inadequate surveillance without a clear reference basis and without a documented description of the methodology. Seventhly, incomprehensible escalations in the event of abnormalities, eighthly, unclear responsibilities in the event of water disruptions, ninthly, a lack of training certificates for external service providers.

Each of these weak points can be structurally addressed in a digital workspace. Versioning closes the gap in the hygiene plan, automatic reminders close training gaps, a sample calendar reminds of appointments, a release workflow records every preparation, a role manager monitors appointment certificates and representations, case definitions with a fixed reference basis ensure surveillance, and every escalation is documented as a traceable process. Others run compliance like a filing cabinet. We run it like software. Anyone who works with a KRINKO-compliant template and 490 audit templates will see the difference in effort in the first quarter. The operational time for the hygienist is reduced by an average of 8 to 14 hours per week, which are no longer needed for administrative searches, Excel maintenance and inspection preparation. This time goes into actual patient safety rather than record maintenance. The contribution to quality can be measured in surveillance, the contribution to compliance in inspection. This makes the workspace an operational tool, not a pure documentation add-on. A tenth weak point, which appears less frequently in inspections but is significant, is the reaction time to water deviations. Anyone who keeps the sample calendar with escalation rules in the workspace documents every measure with a time stamp and responsibility so that supervisors and auditors can fully understand the reaction.

CIVAC is a compliance platform and officer-as-a-service with 25 officer roles, 93 ISO/IEC 27001:2022 controls and 490 ready-to-use audit templates, several of which are KRINKO-compliant for dialysis and hospital hygiene. Licence the workspace for your internal representatives, or have our representatives order it. In the first case, CIVAC sets up a client area with hygiene plan modules, training register, sample calendar, surveillance templates and inspection package for your hygiene specialist and your hygiene representative. In the second case, we appoint an experienced hygiene officer with DGKH qualifications who takes over the reporting line to the medical management, inspects annually, is responsible for all training courses and is present at official inspections.

The initial order is ready for handwriting within 2 working days instead of the classic 2 to 6 weeks. The appointment certificate, signed, filed, verifiable. If you need a Quality Management Officer or a Data Protection Officer in parallel, you can combine the roles in the same workspace at a reduced licence price. Data protection is a mandatory topic in dialysis because special data categories according to Art. 9 GDPR and health data are processed in every shift. Turn reading into an assignment. Write to info@civac.de or use the contact form on civac.de. Feedback will be provided within one working day; the data sheet with flat rate, hourly rate and scope of services will be available on the second working day. Experience shows that the transition to the platform is completed within four weeks, including data migration from existing folders, training of the hygienist and the first sample calendar for the current quarter. The investment usually pays for itself within two quarters through reduced administrative effort and avoided inspection defects. Anyone who also bundles the training register, surveillance and inspection package in one system gains a uniform reporting view for management, which can be used in the monthly quality circle or in the annual hygiene report without additional preparation.