The Health Institutions and Facilities Act, 2011 (Act 829) established the Health Facilities Regulatory Agency (HeFRA) in PART ONE of the Act. HeFRA was set up to license facilities for the provision of public and private health care services.
The object of the Agency is to license and monitor facilities for the provision of public and private health care services.
HeFRA’s mandate is from the Health Institutions and Facilities Act, 2011 (Act 829) Section 11 (1 and 2) which states;
That a person shall not operate a facility unless the facility is licensed under this Act.
That a person shall not operate equipment in a facility specified in the first schedule unless the facility in which the person operates is licensed under this Act.
How To Register a Health Facility in Ghana
To obtain a license, visit any HeFRA office around the country in order to secure an approved application form. The form can also be downloaded from our website. www.hefra.gov.gh. The client has few days within which to submit the completed application and required documents.
There are particular requirements that ought to be met by the facility ranging from proof that the facility is registered as an entity, planning approval for the facility building, clearance from the Environmental Protection Agency, plans for the disposal of medical waste, copies of the professional certificates and evidence of at least five years of working experience for key staff, description of services and equipment to be provided at the facility, evidence of financial capacity and a Ghanaian professional partner in the case of non-citizens.
To register to operate a facility
REGISTRATION
A person shall apply to the Agency for a licence at HeFRA office address indicated above or if possible at a HeFRA approved office within the area in which the practice is to be operated in the form determined by the Board.
There shall be attached to the application:
- The block plan of the facility for the practice
- Preliminary approval from the District/Municipal/Metropolitan planning authority of the District/Municipal/ Metropolitan Assembly on the suitability of the land or facility to be used for the practice
- Clearance from the Environmental Protection Agency
- Plans for the disposal of medicals waste
- Copies of certificates of proposed practitioners in the practice and proof of their up to date registration with their professional bodies
- List of the types of services to be rendered
- List of equipment
Evidence of financial capability for the ownership and operation of the practice applied for (audited accounts, statement of account)
The prescribed fees
- A yearly retention fee will be paid depending on the type of facility
- Original copies of business registration Certificates from the Registrar General Department.
- Approved certification for facilities with X-ray imaging from the Nuclear Regulation Authority.
- Evidence of continues submission of Health Service data to Ministry of Health every 3 months. (Existing facilities only)
- A clearance certificate from Ghana Fire Service
- A valid work permit issued by ministry of interior (non-Ghanaian only)
The Board may on its own or on the recommendation of zonal committee revoke or refuse to renew a license for a practice.
The state of the facility disqualifies the licensee from being granted a license or it has reasonable grounds to believe that the continues operation of the practice by the licensee will create a risk to public health, public safety or is indecent
NOTE: a license issued shall be displayed in a prominent place which is accessible to patients and the general public in the premises of the practice
INSPECTION
The registrar after receiving all documents of a facility, issue an inspection letter to the facility. The time and date for inspection is scheduled between the Agency and the facility. After the inspection is done, a report is submitted to the Agency by the team of inspectors.
The registrar reviews report and recommend to the board the following:
That the facility be issued short term license (6month)
That the facility be issued long term license (3 years)
That the facility be refused a license
The inspection of the facility allows the Agency to check if the place is up to standard.
If the inspection indicates the facility is well designed and with the required staff to operate then a license is issued to enable the operations of the facility continue. In cases where the inspection raises areas for further work or of concern then a period of time is given to the client to address issues raised.
LICENSING
The board reviews the recommendations of the registrar and decides the following:
Whether the facility be given a short-term license
Whether the facility be given a long-term license
Whether the facility be refused licensed
The process of licensing begins with the purchase of an application form from HeFRA. ( The applicant has a 90 day period within which to submit the completed application form with all required documents)
Following completion of the submission process, an inspection letter is issued to the facility to prepare for an inspection to be carried out.
New facilities are not allowed to operate until they have been accredited.
If HeFRA confirms a positive recommendation for the facility to operate, then a license is issued to enable the facility to operate.
In case where HeFRA finds the inspection report unsatisfactory, a period of time is given to the facility to address these issues satisfactorily for re-inspection.
Facilities to be licensed
Medical and Dental (Health centres, Clinics and hospitals)
Eye care clinic
Convalescent and nursing homes
Geriatric homes
Maternity homes
Occupational therapy clinic
Physiotherapy clinics
Dental technology laboratory
Clinical and biomedical laboratory
Medical assistant clinic
Diagnostic- imaging technology clinic
Pharmacist and chemical shops
Osteopathy clinic
Prosthetics and orthotics clinic
MONITORING
HeFRA regulates and monitor activities in a practice to determine the adequacy and standard of health care provided. The board will be responsible for the organization and execution of all monitoring tasks related to its licensing mandate. This entails that HeFRA will be responsible for all baseline assessments of facilities, repeat assessments, inspections, and Monitoring & Evaluation visits to optimize Agency’s processes.
Requirements Processing
HeFRA minimum requirements processing under the agency sections of personnel, premises, safety and equipment.