Equipment in doctor's offices: what problems may arise?
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The current medical legislation contains many loopholes, which at first glance look like liberalization in this sphere, but in practice, they can cause disputes with both patients and regulatory authorities. One of the common loopholes is the equipment of individual rooms where doctors and junior staff work with medical products and supplies.
How can you understand whether your office is equipped correctly and be sure that there will be no problems with government bodies in the future?
In this material, we will talk about both theoretical and practical points of:
- equipping cabinets in conditions of uncertainty;
- omissions of non-obvious equipment, the availability of which is taken notice of by the Ministry of Health;
- Declaring and operating the equipment not expressly provided for by regulatory orders of the Ministry of Health;
- The responsibility for non-compliance with the infrastructure technology, etc.
Where to look for the requirements for equipping medical rooms?
One of the striking examples of the lack of proper regulation of equipment is medical rooms in educational institutions.
Due to recent innovations, educational institutions such as schools, vocational schools, universities, institutes, etc., can set up medical rooms to provide their students with medical assistance. In practice, such assistance can be provided both by a doctor (for example, a pediatrician) or by a nurse or paramedic.
In the case of a doctor, the equipment sheet is fairly clear, but the activities of the junior medical staff are not regulated in terms of office equipment.
Related article: Some Requirements for Medical Equipment of Physicians in Ukraine
Where to look for answers, anyway?
The closest regulatory act to solve this problem is the joint order of the Ministry of Health and the Ministry of Education and Science of August 30, 2005 No. 432/496, which stipulates a timesheet for equipping a kindergarten. And although it concerns only one of the links in education, in practice it is used in equipping rooms for nurses and paramedics in all educational institutions.
A similar situation has developed not only with respect to the medical rooms of educational institutions but also in other specialties. Therefore, the decision to equip a medical room cabinet should be made taking into account both regulatory regulation and the practice of the regulatory body.
The above example demonstrates how the outstanding issues are normally resolved in practice.
Related article: Experience of licensing school infirmaries in ukraine
How to handle duplication of requirements for equipping medical rooms?
A good example of duplicating equipment orders is the specialty of dentistry. There are several orders in force, among others, No. 739 dated 10/31/2011, No. 153 dated June 5, 1998, No. 158 dated April 11, 2005, which overlap in the specialtys they regulate.
How to decide which legal act to be guided by?
In this case, judge by:
- completeness of equipment (for example, order No. 158 is the most detailed and the Ministry of Health usually indicates non-compliance with it, when considering licensing documents);
- the specifics of the procedures (for example, for surgical interventions with anesthesia, order 153 and other regulations should also be taken into account).
Similar principles for regulatory selection can be applied to most such situations.
What to do with "hidden equipment"?
Even in cases where there is a specific report card of medical equipment, doctors may find that there is not enough equipment in the office. The fact is that although the timesheets contain a list of equipment by specialtys, a number of items may be required due to other regulatory acts.
For example, in those medical rooms where medicines are stored, hygrometers and thermometers must be provided to comply with the humidity and temperature conditions specified by the manufacturer in the instructions.
Related article: Our lawyers helped to license a number of dental offices in Ukraine
The next controversial issue is equipping medical rooms first-aid kits for emergency medical care, which are not available in equipment sheets but are required by virtue of other regulatory acts of medical legislation, for example, licensing terms for medical practice.
This means that when equipping medical rooms, it is necessary to take into account the general requirements of regulatory legal acts that apply to all healthcare institutions and narrowly specific acts, relating to individual specialties.
What to do with the latest medical equipment?
The regulatory documents that regulate the equipping of medical rooms, most often lag behind real world practices. This may affect the process of replacing one equipment item with another more modern one. The question also arises whether it is possible to use items that are not provided for by item sheets.
In this case, the following requirements of the licensing terms of medical practice should be followed:
- compliance with standards and guidelines in the treatment of a disease, because they contain requirements for the resource support for the implementation of the guideline;
- use of items not prohibited by the Ministry of Health: not just use items that are not prohibited by the Ministry of Health, but rather those that are allowed to be used in Ukraine, as they have passed the declaration procedure;
- the use of items, taking into account the functional purpose, as well as the requirements of the manufacturer.
What could be the implications of the equipment failing to meet the requirements?
Failure of equipment to meet legal requirements can cause a number of implications. At the initial stage, when a specialist that is going to provide medical services f just gets a license, failure to meet the requirements can cause a refusal to issue a license, which will make medical practice impossible at all.
If the failure to meet requirements arises in the course of the operation of an already licensed entity, then this may be interpreted as an activity in violation of the licensing terms, which entails potential fines, instructions to eliminate violations, or cancellation of the license.
Related article: Why is it so important to apply in advance for legal assistance during the license inspection?
Conclusions
The issue of equipping medical rooms is a fairly common problem both when starting a business, and during carrying out of medical activities.
The most characteristic situations that can be encountered in practice are:
- lack of proper equipment sheets;
- the presence of several existing regulations that raise doubts about the priority of their implementation;
- the lack of a certain amount of necessary equipment that is not included in individual equipment sheets due to its mandatory nature for all specialties;
- the use of equipment that is not directly provided for by the equipment sheet but can be legally used in Ukraine for treatment or diagnosis according to the profile of a doctor.
In practice, the failure of equipment to meet legal requirements can cause:
- nongranting of a license;
- revocation of a license;
- imposition of fines.
Thus, without experience and in-depth knowledge in this specialty, it is difficult to figure out on your own exactly what equipment should be put in your office. You can always get help from qualified specialists who will prepare a ready-made list of equipment for you and draw a conclusion on the equipment that you already have.
We are ready to help you!
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