Blood Transfusion in a Private Clinic and Donor Blood Collection Licensing: What Is the Difference?
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Your clinic performs procedures involving significant blood loss, delivers babies, or treats oncology patients, and sooner or later the question arises: how can transfusion care be organized legally?
For surgical inpatient facilities, maternity hospitals, oncology centers, and other facilities where significant blood loss may occur, properly organized transfusion care is an important component of patient safety. At the same time, the handling of donated blood and blood components in Ukraine is regulated not only by the Licensing Conditions for Medical Practice, but also by special legislation governing the blood system.
The first instinctive thought is, “we need a license like a blood transfusion station.” This is precisely the mistake that can cost clinics months of delay and put their existing medical license at risk. Transfusing blood components to a patient at your clinic and collecting donated blood are two fundamentally different activities subject to different legal regimes. Confusing them may result either in spending resources on licensing you do not need or, conversely, starting transfusions without meeting mandatory requirements that do apply to your model.
Most private clinics do not collect blood themselves; they receive prepared components from licensed blood system entities. However, this does not mean that no specific legal requirements apply to them. An ordinary private clinic may arrange for the storage and use of blood components for patient transfusions provided that the applicable special requirements are met. By contrast, the collection and testing of donated blood is a separately licensed business activity and requires a different legal model.
Legal Boundaries for the Private Sector: What Is Permitted and What Is Prohibited
The first step is to determine the legal model: transfusion or blood collection.
The law distinguishes at least three categories of activities that should not be mixed:
- providing patients with blood and/or blood component transfusion services as part of medical practice;
- operation of a hospital blood bank and a transfusion immunology laboratory as internal units of a healthcare facility that support transfusion care within that facility;
- collection, testing, processing, storage, distribution, and sale of donated blood and blood components as activities of a blood system entity.
For most private medical centers, the practical model falls within the first two categories: the clinic does not collect donated blood but receives blood components from blood system entities, stores them in its own hospital blood bank, performs the necessary pre-transfusion testing, and uses the components exclusively to treat its own patients.
Law No. 931-IX establishes the basic model under which allogeneic donated blood is collected by state- and municipally owned blood system entities, while also providing a special legal mechanism for private entities.
Part Two of Article 22 of Law No. 931-IX allows private business entities to carry out the relevant activities under the conditions established by law, including where such entities use property belonging to state- or municipally owned blood system entities under a right of use, another property right, a concession, or other lawful grounds, including through a public-private partnership.
Accordingly, private ownership does not in itself create an absolute prohibition. At the same time, an ordinary private clinic cannot simply open a “donation point” under its medical practice license. If the business model involves collecting or testing donated blood, the clinic must separately meet the requirements applicable to a blood system entity and obtain the special license required under Resolution No. 621 of the Cabinet of Ministers of Ukraine.
Autologous Donation: Not a “Simple Exception” for a Private Clinic
Autologous donation means collecting blood or blood components from a person for a subsequent autologous transfusion to that same person. However, the fact that the donor and recipient are the same person does not automatically exempt the clinic from the special regulation governing blood collection and testing activities.
Resolution No. 621 of the Cabinet of Ministers of Ukraine regulates business activities involving the collection and testing of donated blood and blood components regardless of their ultimate intended use. Therefore, a preoperative autologous donation program should not be structured merely as an extension of ordinary medical practice. Before launching this model, compliance with Law No. 931-IX and Licensing Conditions No. 621 should be assessed separately.
Lawyer's conclusion: for a typical private clinic that does not have the status and license of a blood system entity, it is safer to organize transfusion care around receiving prepared blood components from properly licensed blood system entities rather than collecting blood itself.
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What a Private Clinic That Does Not Collect Donated Blood May Do
A private healthcare facility that holds the appropriate medical practice license and meets the special requirements for transfusion care may organize the full in-hospital cycle for handling blood components after receiving them from a blood system entity. In particular, the clinic may:
- receive or purchase donated blood and blood components under agreements provided for by Resolution No. 254 of the Cabinet of Ministers of Ukraine;
- store blood components in a hospital blood bank in compliance with established temperature conditions and traceability requirements;
- perform pre-transfusion isoserological and immunohematological testing in a transfusion immunology laboratory;
- release blood components to the facility's clinical departments and perform transfusions for patients when medically indicated;
- maintain records, traceability, and hemovigilance, and register and investigate serious adverse events and reactions in accordance with the prescribed procedure.
Licensing: Two Different Routes
Option 1: If the Clinic Only Provides Transfusions
To provide transfusions to patients, the facility operates under its medical practice license.
Since May 14, 2025, paragraph 13-1 of the Licensing Conditions approved by Resolution No. 285 of the Cabinet of Ministers of Ukraine expressly requires a licensee providing blood and/or blood component transfusion services to ensure:
- the availability and operation of a hospital blood bank;
- the availability and operation of a transfusion immunology laboratory;
- the availability and operation of a hospital transfusion committee;
- compliance with requirements for the traceability of donated blood and blood components and for the hemovigilance system.
In other words, legally providing transfusions requires more than a refrigerator and a doctor who technically performs the transfusion. The law requires an organized internal transfusion care system.
At the same time, it should not automatically be assumed that every clinic transfusing blood components must add the medical specialty of “Transfusiology” to its license. Whether the license must be expanded depends on the actual medical practice model, the declared specialties, the types of medical care provided, and the staffing structure. If the clinic plans to conduct medical practice in a new specialty or provide a new type of medical care, the license expansion procedure under paragraph 23-1 of Licensing Conditions No. 285 applies.
Option 2: If the Clinic Wants to Collect or Test Donated Blood Itself
This is a different licensing framework.
The collection and testing of donated blood and blood components, as well as related activities of a blood system entity, are governed by separate Licensing Conditions approved by Resolution No. 621 of the Cabinet of Ministers of Ukraine. A medical practice license does not replace this special license.
A legal audit should therefore always begin with one question: does the clinic only use prepared blood components to treat its own patients, or does it plan to perform collection/testing itself as a blood system entity? The answer determines the entire permitting route.
For more information on obtaining this license: License for a Blood Transfusion Station in Ukraine: How to Obtain It
Three Mandatory Elements of a Hospital Transfusion Service
Hospital Blood Bank (HBB)
Law No. 931-IX defines a hospital blood bank as a unit of a business entity that provides blood component transfusion services, stores and distributes blood components, and may perform compatibility testing of blood and blood components for use exclusively by that entity for transfusion to recipients.
Accordingly, an HBB is not merely a “designated area with a refrigerator,” but a formally organized unit with defined functions, a responsible person, and procedures for recordkeeping, storage, release, disposal, and traceability. The Model Regulation on a Hospital Blood Bank, approved by Ministry of Health Order No. 595, serves as a reference for the facility's internal regulation.
The equipment must ensure the prescribed storage conditions, temperature monitoring, and documentation, while measuring instruments and processes must be subject to proper control, calibration/qualification, and validation where required by the quality system.
Transfusion Immunology Laboratory
The transfusion immunology laboratory is a structural unit specifically defined by law. It may form part of the HBB or the clinical laboratory and performs isoserological and immunohematological testing before transfusions.
This element is often mistakenly omitted from the licensing and organizational models of private clinics. If a facility performs transfusions, it must not only determine where pre-transfusion testing is physically carried out, but also properly establish the relevant structure, staffing, equipment, SOPs, quality control, and interaction with the HBB in accordance with the law.
Hospital Transfusion Committee
The hospital transfusion committee is an internal body responsible for clinical and organizational oversight of transfusion practice. The head of the facility ensures that it is established and approves its membership.
It is advisable to involve specialists from clinical departments who actually prescribe or perform transfusions, persons responsible for the HBB and laboratory, quality service representatives, and other employees as appropriate to the facility's structure. The committee reviews the use of blood components, adverse reactions, compliance with procedures, and measures to improve safety.
Important Rule: Cold Chain, Equipment, and Quality System
For blood components, what matters is not only the presence of refrigeration equipment, but also the demonstrated ability of the system to keep components under the prescribed conditions throughout the entire cycle—from receipt to release for transfusion or disposal.
In practical terms, this requires:
- equipment required by the regulatory and model requirements for an HBB;
- temperature monitoring and documentation of readings;
- an action plan for emergency power outages or equipment failure;
- proper maintenance, calibration of measuring instruments, and qualification and validation of processes according to their nature;
- procedures for quarantine, rejection, return, write-off, and transfer of blood components for destruction.
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Entering the Unified Digital Environment: Connecting to the “eKrov” System
A private medical center should understand that registration in “eKrov” is not a separate authorization to perform transfusions and does not replace compliance with licensing, staffing, and organizational requirements. The system is used within a properly organized transfusion care framework.
For a clinic, the key function of “eKrov” is to ensure traceability of every dose of a blood component. The facility must be able to determine which blood system entity supplied a specific component, when it arrived at the Hospital Blood Bank, how it was stored, to whom it was released, and its final status—used for transfusion, returned, written off, or transferred for destruction.
The “eKrov” system provides for registration of the facility, its structural units, and authorized users. To work with the system, responsible employees must be designated and their access rights must be differentiated.
In practical terms, this means that the clinic must organize a unified and consistent record of the movement of blood components from receipt through final use or disposal. Data in the electronic system must correspond with primary medical records, Hospital Blood Bank documentation, and the actual movement of each dose.
“eKrov” also plays a separate role in the hemovigilance system. If a serious adverse reaction occurs after transfusion, the facility must be able to quickly identify the specific blood component, determine its origin, and reconstruct its entire chain of movement. Likewise, if information is received that certain components must be withdrawn from circulation, the clinic must promptly determine whether they remain in storage or have already been used for a specific patient.
For a private clinic, connection to “eKrov” should therefore be viewed not as a formal registration in an electronic system, but as part of the overall model of safe transfusion care.
Key Legal Risks and Common Mistakes
Problems most often arise not from the fact of transfusion itself, but from choosing the wrong legal model and from inconsistencies between the documentation and the way processes are actually organized. The following are several common mistakes we encounter in our work:
- Mixing two licensing regimes. A clinic attempts to arrange blood collection solely under its medical practice license or, conversely, assumes that routine in-hospital transfusions automatically require a separate license as a blood system entity.
- Missing one of the three mandatory elements: the HBB, the transfusion immunology laboratory, or the hospital transfusion committee.
- A purely formal structure “on paper”: orders exist, but the functions are not performed; SOPs do not reflect the actual routes of blood components; the committee does not operate; and staff do not know their responsibilities.
- An inadequate storage system: proper temperature monitoring is absent, there is no backup plan for equipment failure, or there are no documents confirming maintenance and control of measuring instruments.
- Breaches of traceability and hemovigilance: the movement of a component cannot be reconstructed from receipt to a specific recipient, write-off, or return; deviations and reactions are not documented in the prescribed manner.
- Launching a donation point or a blood collection/testing program without the special license and without complying with the legal model applicable to a blood system entity.
The legal consequences depend on the specific violation. They may include termination of the existing license, contractual and civil liability, administrative liability, and in certain cases even criminal liability.
It is always easier to prevent these problems than to address mistakes after they have occurred. This can be achieved by planning and legally structuring your activities correctly in advance.
How We Can Help
Our law firm provides comprehensive turnkey support, enabling a clinic to complete this process quickly and safely while ensuring compliance with the requirements of the Ministry of Health of Ukraine.
Our Key Services in Medical Law and Transfusiology
- Audit of the existing facilities, equipment, staffing, and premises for compliance with the requirements of Law of Ukraine No. 931-IX and the Licensing Conditions.
- Legal support for adding the specialty of “Transfusiology” and preparing the employment documentation for responsible personnel.
- Drafting the Regulation on the Hospital Blood Bank and the Order establishing a permanent Transfusion Committee.
- Preparation of customized Standard Operating Procedures (SOPs) for each stage, from receipt and maintenance of the cold chain to pre-transfusion testing and disposal.
- Preparation of specialized informed voluntary consent forms for transfusion and autologous donation designed to fully protect the clinic in court.
- Legal support for entering into agreements for the supply of blood components with state and municipal blood centers.
- Advisory support for the facility authorization procedure in the National “eKrov” Register.
Instead of experimenting at the risk of your license, entrust the legalization of transfusion care to experts who understand the nuances of regulatory practice and medical law.
Contact our specialists to receive a service cost estimate tailored to your clinic.
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