Sterilization facilities in a clinic: when is a service contract sufficient, and when is an in-house unit required?

Opening a clinic involves choosing suitable premises, recruiting specialists and purchasing equipment. Arrangements for sterilization also need to be established at this stage. Must the clinic have its own sterilization unit, or can it use the services of another organization?

The answer depends on the medical services the clinic intends to provide. Clarifying the requirements early helps owners plan the premises, estimate costs and prepare for licensing.

Ilxambek Baltaniyazov, Chief Specialist at the Center for Licensing and Accreditation of Medical Organizations, explains:

Medical licensing requirements are set out in Annex 27 to the Unified Regulation approved by Cabinet of Ministers Resolution No. 80 of 21 February 2022. For therapeutic and diagnostic specialties, the requirements provide for either a contract for sterilization services or a sterilization unit. For surgical specialties, including dentistry, a sterilization unit is required. Source: Lex.uz.

An entrepreneur planning to provide therapeutic and diagnostic services can therefore consider two ways of organizing sterilization. Practical factors include the volume of services, instrument reprocessing needs and the external provider’s ability to complete the work on time.

Where sterilization is contracted out, the operational arrangements should also be considered in advance. Who will hand over and receive the instruments? How will transport be organized? How will the clinic maintain its services if the provider experiences delays? Clear answers help make the arrangement workable in practice.

Those planning to provide surgical or dental services should allow for a sterilization unit when selecting the building and planning the layout. Addressing this only after renovation has been completed may lead to additional costs and the need to modify the premises.

Staff training is also important. The licensing requirements specify that, where a sterilization unit is present, the medical worker must have documentation confirming training in the operation of sterilization equipment. Applicable sanitary and technical requirements for the premises and equipment must also be considered. Source: Annex 27.

The issue also has direct clinical significance. The World Health Organization’s guidance on decontamination and reprocessing of medical devices addresses the infrastructure and standard procedures needed for effective sterilization. This approach highlights the importance of organizing the entire workflow alongside purchasing the necessary equipment. Source: WHO guidance.

Requirements for laboratory services should be assessed according to the specific tests planned and the applicable sanitary rules. The provision cited above does not establish a blanket requirement for every laboratory to have a separate sterilization unit.

When a clinic expands its services, its sterilization arrangements need to be reassessed. For example, a service contract used to support therapeutic care does not replace the sterilization unit required when introducing surgical or dental services.

The first step for a prospective clinic owner is therefore to define the services and specialties to be offered. Premises, equipment, staffing and sterilization arrangements can then be planned together. This sequence helps the clinic meet the established requirements and create the conditions needed to provide safe medical care.