Laboratory research license

How to open a private laboratory?

When you have decided to open a private laboratory, first of all, you need to register a legal entity, while the easiest and most convenient way is to register a limited liability company. It is best to register a legal entity before signing the lease contract. To do this, you should contact the Center for Administrative Services Provision, or the state registration department with a relevant application and the Articles of association of your legal entity. Next, you need to obtain a license for the laboratory.

After registering a business entity (enterprise), you need to take care of the premises where you, in fact, plan to conduct medical practice and provide medical services. The premise in which the activities are planned to be carried out must meet the sanitary standards, which is confirmed by the act of sanitary and epidemiological inspection of the facility by the State Service of Ukraine on Food Safety and Consumer Protection (the SES act).

The next step will be to obtain accreditation to engage in activities related to laboratory research. At the same time, it is first necessary to introduce the DSTU EN ISO 15189: 2015 standard, as well as the internal verification of the laboratory compliance with the adopted state and international standards.

Who regulates the rooms activities?

The legislation of Ukraine provides that the National Accreditation Agency of Ukraine (NAAU) exercises control over the compliance of application documents when they are submitted for accreditation. After submitting the necessary documents, the NAAU checks them, after which it draws up a Document Analysis Act, which is sent to the applicant. Next, an on-site assessment of the applicant is carried out.

After assessing the applicant, the NAAU provides you with an assessment plan (F-08.xx.26).

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What documents are required

To obtain a license to carry out laboratory research, it is necessary to prepare the following documents:

  • Document confirming the ownership or lease of real estate (laboratory premises);
  • Extract on registration of a legal entity;
  • Documents confirming ownership or lease of equipment used in laboratory activities.
  • Data on the institution structure and the personnel;
  • Performance data and reports on previous research activities for the previous three years (for 2 years, in the case of the first laboratory accreditation);
  • Protocols of laboratory tests;
  • Working schedule of specialists and so on.

To obtain accreditation for a laboratory, you need to submit:

  • Application for accreditation (F-08.00.02);
  • Questionnaire (F-08.17.15);
  • Scope of accreditation of the medical laboratory (F-08.13.17);
  • Passport of the medical laboratory (F-08.17.19);
  • Questionnaire of the medical laboratory (F-08.17.20);
  • Data of the methods evaluation of the medical laboratory (F-08.13.33);
  • Notarized copy of statutory documents or its electronic version;

Requirements for the premises

It should be taken into account that the laboratory premises must comply with the standards specified in the SBN (State Building Norms) B.2.2-10-2001. Buildings and constructions. Health care institutions and SBN В.2.2-15: 2019 Residential buildings. Basic provisions.

Thus, the laboratory premises cannot be located in a residential building; they must have a separate exit and an emergency exit. In this case, it is necessary to equip the following premises:

  • waiting room for patients;
  • room for the collection of analyzes;
  • washing room;
  • laboratory room;
  • rest room;
  • room for storing inventory;
  • bathroom.

It is also necessary to pay attention to the lighting and ventilation of the room, the condition of the water supply system. Do not forget to conclude an agreement with a company that will ensure the disposal of medical waste, garbage disposal, disinfection, disinfestation, flushing, etc. After that, contact the territorial department of the State Service of Ukraine on Food Safety and Consumer Protection or the local subdivision of the laboratory center of the Ministry of Public Health of Ukraine to obtain an act on the sanitary and epidemiological state of the laboratory premises.

Cost and terms

The terms for obtaining a license, accreditation for carrying out the activities of a medical laboratory very much depend on the legal competence of the applicant. The best solution would be to contact a specialist in this field of law, otherwise the opening of a medical laboratory may take many months. In turn, in the case of a well-chosen strategy, the process of registering all the necessary documents can take from 3 to 5 weeks.

The cost of opening a medical laboratory, in addition to the cost of renting premises and covering utility costs, includes the administrative fee, for October 2021, in the amount of 2379 hryvnas. This fee is paid within 10 days after the decision of the commission of the Ministry of Public Health on the granting of a medical license.

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