By decree No. 90-1465 of 9 November 1990, Medical analyses are biological acts that contribute to the diagnosis, treatment, and prevention of
These acts consist of:
-the examination of tissues, secretions, and excretions of the human or animal body and
the examination of tissues, secretions, and excretions of the human or animal body and body fluids using various chemical, microscopic, bacteriological, serological, immunological, and other manual or automated techniques:
-the preparation and standardization of reagents, standards, strains, and other products which are exclusively for the use of the laboratory;
– the collection and storage of samples.
A medical analysis laboratory may be opened and operated or directed by a natural or legal person.

The opening and operation of a medical analysis laboratory by a natural person are authorized by the order of the Minister of Public Health.
Obtaining the opening authorization is subject to the production of a  file including the following documents:
– a stamped application specifying, in addition to the surnames and forenames of the applicant, the categories of analyses to be carried out;
– copies of the required diplomas; – a certificate of presentation of the originals of the diplomas produced.
-an extract from the birth certificate
-an extract from the criminal record;
-the authorization to be entered on the roll of the Order;
– a plan of the premises where the laboratory is to be located and, if applicable, a copy of the lease
a plan of the premises to be used for the laboratory and, if applicable, a copy of the lease contract in lieu thereof;
– a list, with corresponding diplomas, of the required technical personnel to be used in the laboratory;
– a list of the main equipment to be acquired;
-the letter of agreement in principle of release from the employer, when the applicant is an employee.
The file referred to above shall be deposited with the departmental public health service with territorial jurisdiction, in return for a receipt.
The head of the departmental public health service has a period of thirty (30) days to transmit, under cover of the competent provincial delegate, to the Minister of Public Health, who in turn has a period of thirty (30) days to decide.
In all cases, the agreement or reasoned refusal of the Minister of Public Health must be given within ninety (90) days following the submission of the file to the departmental public health service. After this period, the opening authorization is deemed to have been granted.
Once the authorization has been granted, the laboratory is given a registration number by the
by the Minister of Public Health.
This number must appear on the analysis forms issued by the said laboratory in the following mandatory form: “Laboratory registered under number …”.

The change of the owner of a laboratory, the transfer of a laboratory, as well as any modification of the operating conditions of a laboratory, are authorized by decree of the Minister of Public Health.
The Minister of Public Health may, in the event of a duly established serious failure, order the temporary closure of a laboratory, following a reasoned opinion from the territorially competent health authorities.
He may, in the event of a particularly serious violation of the rules of professional ethics, proceed with the withdrawal, after a reasoned opinion from the provincial delegate of Public Health territorially competent, of the authorization to open and operate a laboratory.
Any medical analysis laboratory must include:
-a reception area
-a secretarial and archive office
-one or more sampling rooms for the isolation of patients
– one or more toilets.
Every medical analysis laboratory must have at least the following:
– a microscope with accessories essential to the performance of the laboratory’s procedures;

 – small staining glassware;
– equipment for obtaining distilled or purified water;
– an oven with an adjustable temperature of up to 120°;
– a refrigerator at -4° C;
– a freezer at -30° C;
– a sterilization device;
– a centrifuge with accessories;
– a centigram scale;
– a photo-meter
– a water bath.
The above-mentioned equipment must be supplemented as follows, taking into account the categories of analyses performed by the laboratories:

(a) Hematology
– equipment and apparatus for carrying out hematocrit tests;
-blood sedimentation apparatus;
-SAHLI equipment or photometers for the determination of hemoglobin.

b) Virology and Bacteriology-autoclave with temperature and pressure indicator;
– equipment for the culture of anaerobic germs;
– equipment for the culture of germs under CO2;
– inverted microscope, if the laboratory carries out virology examinations.

(c) Anatomical pathology
– paraffin microtome;
– paraffin-embedded material; d) Serology

(d) Serology Hot plate system with shakers for determination of rhesus factor, PTHA, HBS, Ag.

(e) Biochemistry
– Flame photometer allowing at least the determination of sodium and potassium;
– an electrophoresis device.

(f) Parasitology -centrifuge;
-magnifying glasses.

No equipment used for laboratory activities may be installed outside the premises described in the application for authorization to open and operate.

Private medical analysis laboratories must carry out at least one of the following biological procedures:
– microbiology
– serology;
– hematology, excluding the diagnosis of HIV-AIDS infection;
– parasitology;
– virology;
– diagnosis with radioactive substances;
– exclusion of paternity;
– any biological procedure which requires specialized qualification or which requires the use of products presenting a particular danger, exceptionally delicate techniques, or of recent origin.
No one may practice histopathology unless he/she holds a diploma in anatomy pathology.
The diagnosis of HIV infection in a private medical analysis laboratory is subject to special authorization from the Minister of Public Health.
To this end, the applicant must;
– undertake to ensure the confidentiality of the results;
– send all positive sera to the AIDS control department for confirmation (western blot)
confirmation (western blot);
– refer all HIV-positive persons to the local unit of the national AIDS control service, which will announce the result and ensure management;
– participate in quality control organized by the national AIDS service.

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