The CPHL-Regulatory and Legal Framework department is providing a legal framework ensuring safe, quality laboratory operations and protecting the people from sub-standard and unethical laboratory practices. A national regulatory framework always establishes requirements for registration and licensing of laboratory facilities and the laboratory workforce. Registration is the official recognition that laboratories and laboratory workers have complied with the legal requirements to operate within a country. Licensure is the documented permission from the regulatory authority to carry out specific laboratory functions within a designated time period.
Laboratory services in Uganda are regulated under the Allied Health Professionals Act, of 1996. The Act mandates the Allied Health Professionals Council to register all laboratory professionals before they can practice. The council is also mandated under the same Act to register and license all laboratories, public, private as well as private not for profit. Pathologists who are medical doctors now practicing laboratory services are registered and licensed under the Medical Practitioner and Dental surgeon Act. The rest of the caders (Lab Assistants, Lab Technicians, Scientists and MLT’S) are registered under the Allied Registration Act
During the implementation of the current National Laboratory Strategic Plan for the Allied Health Professional Council is supporting to strengthen its capacity to register and license laboratories and their work force as well as monitor their operations. The council is able to hire a laboratory Quality Officer who is the liaison officer between the council and CPHL .It has also been able to expand its operations beyond the headquarters by establishing regional offices in several health regions. The Regional offices are utilizing the District Laboratory Focal Persons (DLFPs) to monitor laboratories.
As the CPHL transforms into the Uganda National Health Laboratory Services (UNHLS), a Bill has been drafted and is passing through the process of being enacted into an Act of Parliament. When passed, this Act is establishing UNHLS as an autonomous body undertaking and co-ordinating health laboratory services in Uganda; providing the purpose and functions of the Organization; a Board of Directors and its functions; its finances; legal rights and obligations and providing for connected matters.
The National Drug Authority (NDA) plays a role in regulating laboratory supplies, equipment and diagnostic devices is having its law reviewed. This affords an opportunity for it to be appropriately strengthened as currently its capacity to regulate laboratory commodities is weak. Supporting in terms of technical assistance and advocating will therefore be offering to influence the establishing of appropriate capacity at NDA regulating laboratory commodities and establishing working links with CPHL/UNHLS.