How to choose premises for the practice to pass KHS approval

Imagine a young doctor, Anna, who has decided to make her dream come true and open her own practice. At first glance, she found the ideal premises in the city centre - affordable, with a pleasant waiting room and at a reasonable rent. However, her joy soon passed when she discovered that the premises did not meet all health regulations. The surgery lacked a hand-washing sink and the whole building was licensed as a residential area. So Anna had to invest additional time and money in modifications and permits. How to avoid a similar scenario? In this article, we'll give you advice on what to look out for when choosing a practice space so that you can pass the regional health authority's (KHS) approval right first time.

Author of the article: ​ARROWS (Mgr. Dita Zbožínková, LL.M., office@arws.cz, +420 245 007 740)

 

Legal requirements: hygiene first

Before you get excited about a particular regulation, it is important to remember that the operation of a medical facility is subject to strict legal standards. Act No. 258/2000 Coll. on the Protection of Public Health, together with the implementing Decree No. 306/2012 Coll. set out the hygiene requirements for doctors' offices. In practice, this means that the surgery must be equipped and operated in such a way as not to endanger the health of patients or persons. For example, there must be separate toilets for staff and patients, hand sanitizers must be available and, of course, there must be a source of drinking water on the premises. Emphasis is also placed on the proper management of biological waste (e.g. used needles, bandages) and the hygienic handling of medical laundry. These requirements are not just bureaucracy on paper - they aim to prevent the spread of infections and ensure a safe environment for patients.

To this end, the hygiene regulations require that every health service provider has a practice operating procedure in accordance with Section 15 of Act No. 258/2000 Coll. The operating procedure is a document that describes in detail the operating conditions of your practice - what procedures you will perform, what equipment you use, how you provide disinfection and sterilization, how you handle waste, the staffing of the practice, etc. These operating rules must be approved by the relevant regional health authority (KHS) before you can start operating. Without approved operating rules, the regional authority will not issue you with a licence to provide health services. Hygiene really does come first - you must have the "blessing" of the KHS before you can see your first patient.

In addition to the Act on the Protection of Public Health, there is also Act No 372/2011 Coll., on Health Services, which imposes an obligation on providers of health services to ensure the personnel, material and technical equipment of the surgery. Details are set out in Decree No. 92/2012 Coll. on minimum equipment for health care facilities. You don't need to study every decree in detail, but it's good to know that there are official minimum standards - for example, what devices and aids you must have for a given specialty, or what minimum space is needed. All of these regulations have a common goal: that your practice's facilities, equipment and staff meet the conditions for safe operation. Summary? When selecting and setting up a practice, you need to think not only about comfort and design, but more importantly that the premises meet the hygiene standards set by laws and regulations.

Practice premises through the eyes of hygiene (KHS)

So what exactly do health officers look at when you apply for approval of surgery premises? The KHS focuses on the technical and operational requirements to make your future "second home" - the surgery - hygienic. There are several key areas that emerge from the practice of hygiene stations:

• Layout and size of rooms: the outpatient care facility (i.e. a regular surgery) should form a closed functional unit within the building. The surgery should be located in non-residential premises (not in a flat) and must meet general building requirements - for example, sufficient headroom, lighting, ventilation and

The minimum area of a doctor's office is 13 m², which is intended to ensure that there is enough space for the doctor, nurse, patient and necessary equipment. Of course, the surgery doesn't have to be huge, but if you can barely turn around the couch, it's a problem.

The waiting room should be at least 7 m² if it is only for your practice; at least 10 m² is required for a shared waiting room for multiple practices. In addition to the examination room and waiting room itself, the regulations also require a toilet for patients and separate facilities for staff - i.e. an additional toilet and washroom for staff, or a changing room or nurse's rest area. Hygienists also check that, for example, the door to the toilet does not lead directly into the surgery or waiting room (ideally there should be a small anteroom area with a sink between the toilet and waiting room). These layout requirements are often a stumbling block in unsuitable areas.

• Equipment for hygiene: A handwashing basin for staff must be available in the practice, equipped with running drinking water (hot and cold) and ideally a touchless or lever tap for hygienic handwashing. If the practice handles biological material or instruments (e.g. suturing wounds, harvesting, minor surgical procedures), a separate sink for washing and disinfecting the instruments used is also required. Furthermore, it is necessary to have adequate containers for sorting - waste, especially lockable containers for infectious and hazardous waste (needles, contaminated material). There should be no unnecessary textiles, carpets or upholstery in the practice that cannot be properly disinfected - floors and work surfaces should have a washable surface to allow regular cleaning and disinfection procedures. The KHS will also be interested in how you have hand sanitisation (sanitizer containers, disposable towels) and other personal protective equipment (gloves, mouthpieces, etc.) where appropriate. Don't forget about ventilation - the surgery must have either a window or forced ventilation to ensure fresh air supply.
• Operational facilities: Hygiene will examine where and how you will store clean and dirty linen (e.g. clean sterile drapes vs. used linen to be washed), whether you have a place to disinfect and sterilize instruments, or where the sterilizer/autoclave is located. Some smaller practices contract for sterilization off-site - this is also possible, but you must state this in the operating rules and document how sterilization will be provided. It is also assessed whether there is a cleaning room or at least a designated area for storing cleaning products and a sink for pouring dirty water. The premises should have a connection to drinking water and hot water - i.e. a working tap and water heating; a connection to the sewerage system is of course also a must. Electrical wiring must meet the requirements (electrical inspection, sufficient sockets for medical

instruments, etc.). The heating of the surgery should ensure thermal comfort for patients even in winter and at the same time not create a dusty environment. KHS may also be concerned with lighting - the surgery should have sufficient daylight or adequate artificial lighting that meets the standards for healthcare workplaces.

• Safety and infection prevention: The county health department also checks that processes are set up for regular cleaning, disinfection and waste disposal. Part of the approval is the aforementioned operating rules, where you must describe the frequency of cleaning, disinfectants used, procedures for cleaning up biological contaminants, etc. In addition, the Regional Hygiene Department looks at circumstances such as washable wall paint, ease of disinfection of surfaces (no cracks, carpets or dust-catching curtains) and perhaps the ability to separate patient movement - for example, infectious patients should ideally not sit in the same room as others for long periods of time (in practice, this is dealt with by ordering sequence or separate rooms if space allows). While compliance with and documentation of hygiene procedures (keeping records of sterilisation of instruments, regular cleaning, etc.) is more likely to be addressed by the KHS during follow-up inspections of the facility, you may already be asked at the time of approval how you will ensure these things. It is therefore a good idea to have everything thought out and set up from the start.

Of course, the requirements may vary according to the specialty and size of the practice - a dentist will have different equipment to a GP, some specialties (e.g. minor surgery) may require additional rooms such as an operating theatre etc. In general, however, the practice should be designed to be clean, easy to maintain, functional and safe. If the space you are looking for does not meet these criteria at first glance (e.g. a damp basement with no windows, a fifth-floor flat with no lift, or a small office with no possibility of building a second toilet), you are better off looking further afield. The KHS will most likely reject such a proposal.

The most common mistakes when choosing a practice space

 Let's take a look at the most common mistakes doctors make when choosing and setting up their first practice. You may be surprised by some of them - and you may recognize yourself in them. The good news is that you can learn from the mistakes of others in time.

1. Choosing an inappropriately licensed space: a common mistake is to rent a space that is listed as a residential unit or office and assume that it can be used as a surgery without any modifications. Each space has a designated use, known as an occupancy permit. If it hasn't been approved as a medical facility (surgery), you will face a change of use of the building - a process where you have to prove to the building authority that you will adapt the space to comply with all the regulations for a surgery (including a statement from KHS). For example, a normal flat will not have two toilets or wheelchair access. So an uninformed doctor may sign a lease and only then find out that they have to invest in building alterations and paperwork for a re-occupation. The solution? Ask the landlord in advance if the space can be officially used as a doctor's office, or under what conditions. Ideally, choose a space that is already licensed for medical purposes or one where the landlord anticipates modifications and change of use.
2. Underestimating layout and sanitary facilities: many doctors get excited about the location or the rental price and fail to check the layout. It's not until later that you discover, for example, that there's no second toilet for staff or that the shared waiting room doesn't have

the appropriate size. Also, the absence of a sink in the surgery is a common problem in those originally designed for, say, an office - retrofitting water and waste can be a construction challenge, if not impossible. Therefore, before signing a lease, always make sure that the layout at a minimum allows for: an examination room large enough for the necessary equipment, a waiting room, a patient toilet and facilities for staff. If something is missing, find out whether it can be built (e.g. a second toilet) and who will pay for it. The most common mistake is to rely on one shared toilet - but health regulations require separate toilet facilities unless it is a really small practice with one member of staff and there is a special permit. Don't count on exceptions; rather, insist on full facilities.

3. Ignoring accessibility and access: today, the emphasis is on making healthcare facilities accessible for disabled patients. Newly built surgeries should have wheelchair access, which means no stairs or at least an elevator/ramp. If you rent space on a floor without a lift, you are potentially limiting some patients (e.g. older, less mobile). In terms of regulations, while this may not completely prevent you from opening the practice (if the existing building and technology cannot make the lift, the hygiene department may tolerate it), reputationally and operationally it is a minus. A common mistake is not to think about accessibility - until then the first patient rings downstairs saying they can't get upstairs. Avoid this and look for spaces where everyone can get in. While it's not always mandatory to have a wheelchair accessible toilet for patients in a GP surgery, if you can have one, it's a big plus for patient comfort.
4. Unrealistic timelines: another mistake is thinking that you will open a practice "as soon as I find space". Administration and adjustments take more time than it seems. It usually takes a month to get the KHS operating regulations approved, and another one to two months for the procedure for authorization to provide health services at the regional office. Add to this the time for any building alterations, equipping the surgery with furniture and equipment, revisions of technology, etc. The mistake of many doctors is to underestimate this preparatory phase - for example, to give notice at work, knowing that in a month they will be practicing "on their own". The reality is that from the moment you find a space to the day you welcome your first patient, four or even six or more months may pass. Especially if KHS discovers deficiencies and demands that they be corrected, the process will be prolonged. Therefore: plan with reserve and be prepared for the authorities to have their own deadlines.
5. Trying to circumvent or cheat the rules: Sometimes there are those who say, "I'll just have to retype this, just make sure I open it as soon as possible." Maybe they don't set up a second toilet and hope that the hygiene department will overlook it, or they start practicing before they have all their paperwork together. That's a very risky approach. The KHS is not usually lenient during inspections - if it finds that a practice is operating in substandard conditions, it can order immediate remedial action, impose a penalty and, in extreme cases, temporarily close the practice until the deficiencies are corrected. So it does not pay to take risks. Unfortunately, some doctors get burned - they invest in equipment, pay rent, but are not allowed to practice because they underestimated the formalities.
6. Lack of professional help: Setting up a practice is a complex project involving building modifications, legal issues, health regulations, dealing with authorities, purchasing equipment, etc. The mistake is made by those who try to manage everything on their own without consulting experts. An architect or planner can help you design the modifications to the space to meet the regulations (avoiding, for example, a blind corner where the hygiene might want a sink, etc.). An attorney specializing in health law can advise you on

paperwork, contracts and communication with the authorities. And feel free to contact KHS beforehand - they will often consult the surgery plans in advance and tell you what the problem might be. Many doctors don't take advantage of this and prefer to "shoot blind". The result can then be a rejected application and a waste of time. So don't be afraid to ask for advice; preventing problems is always easier than solving them.

Practical advice for choosing a practice space

 Now that we know what to avoid, let's review some practical tips to help you choose the right space for your future practice:

• Make a list of requirements before you search. Ideally, create a check-list containing all the important items: minimum size of the surgery and waiting room, number of rooms (surgery, waiting room, storerooms, toilets), need for water supply to the surgery, possibility of a second toilet, etc. When you then go to inspect the space, you tick off what it meets. This will save you the disappointment of a space that would otherwise seem attractive but would not meet one key requirement.
• Prefer premises already approved or used for healthcare. If you have a choice, choose a surgery in a medical house, clinic or a building where a medical facility has already been operating. You have a much higher chance that the layout and technical parameters will be suitable. On the other hand, a "raw" space that has never had a doctor's office can hide many obstacles. Sometimes it pays to negotiate with your colleagues - the practice you are taking over from a retiring doctor may already have everything approved and you are just arranging the transfer. If you're buying or taking over an existing practice, make sure the operating rules are up to date and plan to update them if necessary (changing doctors, new equipment, etc. require a change in operating rule approval). It is not uncommon for legislation to have changed over the years and for the current requirements to be more stringent than the originally issued health code.
• Check the connections and infrastructure. When inspecting the premises, find out: Where are the water and waste risers (to connect sinks)? Are there enough working sockets in the space and does the wiring match the needs of the appliances? Is the heating and ventilation working? Is there a communal boiler or hot water boiler in the house? How is cleaning of common areas handled (if the waiting room is shared, who will clean and disinfect it)? These details will determine whether the operation will be smooth or a misery. For example, if you find that there is no water supply in the room at all and the nearest riser is one floor down, this means a major structural intervention. Better to look for a space where these basic things are sorted out.
• Think of the future. For example, if you are planning to expand your practice by adding another doctor or services (e.g., a sampling room, sonography, etc.), choose your space with an eye on the future. It's better to rent a slightly larger practice than to find out in a few years that you won't fit and have to move elsewhere. At the same time, be aware of the surroundings - is there parking for patients? Will the neighborhood (e.g., a noisy bar below you) interfere with traffic? While KHS does not primarily address these things, they are equally important to you and your patients.
• Preliminary consultation with hygiene. As has already been said, there is nothing wrong with approaching the county hygiene station before submitting an application. You can present them with a plan of the space, describe how you want to arrange the practice and ask for their opinion. This will save you the surprise of a negative opinion. The KHS can warn you

For example, "You should complete the cloakroom here" or "Be careful, you must have a sink in the waiting room if you put a toilet there". That way you know what you're getting into.

• Don't save in the wrong places. We understand that the budget of a start-up practice is tight. Still, there are places where saving money doesn't pay off. For example, good quality flooring and washable wall paint - it can be tempting to leave older paint, but health regulations speak clearly and cleaning will be easier. Also, good quality medical furniture (recliners, worktops) with a certificate of washability and resistance to disinfection is a better choice than home furniture. Be aware that the KHS will also assess details such as the condition of the sink, the surface of the walls and so on. By equipping your practice correctly from the start, you'll avoid future inspection problems and extend the life of the facility.
• Prepare your documents and be patient. Once you have the space, the permit round awaits you. Draw up the operating rules (or have them drawn up by a specialist) in accordance with Decree 306/2012 Coll. and submit them to the KHS for approval. Prepare all attachments - e.g. situation and description of the premises, documentation for the equipment (safety certificate), hazardous waste disposal contracts, etc. as the hygiene may want to look into these things as well. Once the operating rules have been approved, apply to the regional authority for a permit to provide health services

- you will provide evidence of professional competence, staffing and, most importantly, the KHS decision to approve the operation. In the meantime, you can deal with contracts with insurance companies, liability insurance and other formalities. Be patient - the authorities have deadlines and it is common for the whole process of setting up a practice to take several months. It's important not to forget anything; every addition of documents means a delay.

Consequences of not approving the premises and why not to underestimate it

 What happens if KHS does not approve your premises? Ideally, Hygiene will issue you with a list of deficiencies to correct and give you a chance to fix them. But this means an inevitable delay in opening your practice - you may have to redo the floors, add a sink or amend the operating rules and reapply. This wastes time and, of course, money (the lease runs, but you can't practice and make money). If you try to practice underground without a license, you risk immediate action by the authorities. The KHS has the power to order the closure of an establishment that does not meet the hygiene conditions, and your actions would be classified as an offence under the Public Health Protection Act. The penalties can be very significant - according to Act No. 258/2000 Coll., fines for health service providers range from hundreds of thousands to millions of crowns, depending on the nature of the offence. For example, operating a healthcare facility in breach of hygiene regulations or without approved operating rules can result in a fine of up to CZK 1,000,000.

Another consequence is that without approval of the premises you will not get contracts with health insurance companies. In fact, the regional authority will not issue you with a health service licence unless you have everything in line with hygiene.

Unapproved or inadequate premises also pose an increased risk to patients. Hygiene rules are not there to inconvenience doctors, but to protect the health of everyone involved. For example, if you were to practice in an environment where instruments cannot be properly sterilized or where traffic mixes with infectious waste, you are putting patients at risk and potentially facing lawsuits or other legal recourse in the event of harm.

The summary is simple: don't underestimate the hygiene requirements or the "paperwork" with KHS. Every penny and hour invested in properly selecting and preparing the premises will come back to you in peace of mind and a smooth start to your practice. If you ignore the hygiene standards, you risk delaying the opening of your practice for months, unnecessary expenses for remodeling, fines, and in extreme cases, the closure of an already running practice while you negotiate a remedy. These are all scenarios that can be avoided by thorough preparation and working with professionals.

Who can you turn to?

Final recommendation

 Opening your own practice is an exciting milestone in a doctor's career. However, in order for the dream not to become a nightmare, attention must be paid to the legal and hygienic aspects of the operation from the very beginning. If you follow a systematic approach - from choosing the right premises, to consulting with the hygiene department, to carefully fulfilling all the requirements - you don't have to worry about KHS approval. Think of the hygiene station as a partner to help you set up your operation safely, rather than as a bureaucratic bogeyman.

If you're not sure, don't hesitate to reach out to professionals. Our law firm has extensive experience with the agenda of setting up practices and we will be happy to advise you or help you with communication with the authorities. Likewise, architects, planners or specialist firms can ensure that your surgery is satisfactory in every respect. Investing in expert advice is well worth it - you can be sure that no important detail will be missed and you can concentrate on what's important, namely the care of your patients.

Finally, we wish you the best of luck in building your new practice. If you do not underestimate the hygiene requirements and have the right mentors by your side, you will have a successful start without unnecessary complications. Your future patients and colleagues will appreciate the fact that you run a practice that is safe, professionally run and compliant with all regulations. And you can rest easy knowing you've done your best. Good luck!

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