Help, the health department is coming

What should I do first, and what do they want?

During a practice inspection in podiatry, the health department checks various aspects to ensure that the practice complies with the required hygiene and safety standards. Here is a list of possible inspection points:

Hygiene Practices:

The health department checks whether the practice implements appropriate hygiene measures. This includes correct hand hygiene of the staff, availability of hand washbasins, disinfectants, and disposable gloves.

Sterilization and Disinfection:

It is checked whether instruments and equipment are properly sterilized and disinfected. This includes, for example, scalpels, tweezers, nail clippers, and burrs. The practice should be able to demonstrate an appropriate sterilization process and the use of disposable items.

Waste Disposal:

The health department checks whether the practice has appropriate waste containers and disposal methods to correctly dispose of contaminated or medical waste.

Infection Prevention:

It is checked whether the practice implements measures to prevent infections. This includes, for example, proper cleaning of surfaces, protection against cross-contamination, and the presence of disposable covers or coverings.

Spatial Requirements:

The health department inspects the practice rooms to ensure that they meet the requirements for cleanliness, ventilation, and lighting. It also checks whether there is sufficient space for performing podiatric treatments.

Documentation:

The practice should have protocols and records that document the implementation of hygiene measures, sterilization techniques, and other relevant aspects. The health department checks this documentation to verify compliance with the standards.

Training and Continuing Education:

It is checked whether the staff is regularly trained and up-to-date on hygienic procedures and regulations. This can be proven by training documents, certificates, or training protocols.

Compliance with Legal Regulations:

The health department checks whether the practice complies with all relevant legal regulations, such as the Medical Device Operator Ordinance, the Infection Protection Act, and other local regulations.

Here are some additional possible questions:

Do you have employees or do you work alone?

What additional training has been acquired since the last time?

What is the workflow?

Do you collect the instruments?

How often is the bucket reprocessed and how often is it permitted?

Always close the lid to prevent drying out

How and when is the ultrasound filled?

What concentration do you use?

Is the agent VAH listed and is it suitable for ultrasound?

Wrapping of instruments?

Sterilization documentation?

How is it assigned to the customer?

How and how often do you disinfect the treatment room?

How do you clean the floor?

Where are the customer toilets?

Where is the staff toilet?

When were the devices validated?

Validation protocol?

Hygiene plan with risk assessment?

Soaps must not be refilled!

What do you use for skin disinfection?

Where is the first aid kit for the staff?

Storage of work clothes?

Which gloves are used?

What does the PPE consist of?

Where are the workflows and work instructions written down?

Documentation of employee instruction?

etc...

Please note that the exact inspection points may vary depending on the country, federal state, or region. It is advisable to familiarize yourself with the specific regulations and requirements of the relevant authority.

Approximately one week later, the decision will arrive. The next steps will be based on the list provided in the decision.

Confirm the changes in writing and send them back to the health department.

The health department is subject to the over-regulation law, which means that a change that is too expensive for the benefit it brings can be challenged with an objection. Small changes should be made simply.