GUIDELINES FOR OPENING A PRIVATE LABORATORY
There have been several stakeholders asking about the procedures to follow in order to establish a private health laboratory, but detailed answers to meet their needs have not been available. Therefore, I decided to contribute a little in this area.
Here I will discuss Laboratory Type C - these are the type of laboratories found in our streets where you go to test for a certain disease and get your results. There are different types according to the Ministry's decision.
PART A: PROCEDURES FOR ESTABLISHING A PRIVATE HEALTH LABORATORY (PRIVATE HEALTH LAB TYPE C)
The following are the procedures for establishing a private health laboratory (Private Health Lab Type C);
One, the Location: Once you have found the location where you plan to open the Laboratory, you must write an application letter to the leadership of the respective village (Chairman) requesting to open a Laboratory in their area. If they agree in writing, you proceed to the next step.
Two, the letter you received from the Village Chairman, you will attach it to another letter requesting a permit to open a Laboratory and submit it to the District Laboratory Coordinator (DLT).
THE LABORATORY BUILDING:
Before the District Laboratory Coordinator comes to inspect, your building must meet the following criteria;
- The building should have three rooms: Reception, Store, and Working Room (Main Laboratory).
- The building should have tiles or a clean floor and smooth walls.
- The building should have large windows (5" by 6") for light.
- You must have an Incinerator.
- The building is required to have a fence, especially if it borders residential areas.
- Separate toilets for men and women.
- The building should have a liquid Fire Extinguisher (not powder), and a Suggestion Box.
- Two wash sinks - one at Reception and one in the Working Room (Main Laboratory).
- A clean, running water system (tap water).
- A sewage system.
- A patient waiting area.
- A sample collection area (Phlebotomy).
- A signboard showing the Laboratory's name, services, hours/days of operation, and contact information (this should be placed a bit away from the Building).
ESSENTIAL EQUIPMENT (MACHINES) TO HAVE:
- Binocular powered Microscope (electric or light)
- Centrifuge machine (electric or manual)
- HB machine
- Glucose machine
- Refrigerator with deep freezer NB: These are just the essential machines needed to be allowed to start operations, but you can add more based on needs, for example;
- BP machine - for measuring blood pressure
- Waterbath - for Typhoid tests
- Urine analyser - for urine chemistry
- Hot oven - for warming crystallized chemicals, sterilizing equipment, etc.
FURNITURE TO HAVE:
a. Reception desk
b. Reception chairs
c. Chair for the laboratory attendant (working room)
d. Laboratory table (working room) with a smooth, waterproof top
e. Bench for the customer waiting area
f. Three Dustbins - one for general waste, one for hazardous waste, and another for used needles (Safety box)
LABORATORY STAFF AND THEIR QUALIFICATIONS:
· Laboratory Practitioner: Must have a Certificate or higher and must have a Council Registration Certificate (License).
· Laboratory Supervisor: Must have a Diploma in Laboratory and a Council registration certificate. This person does not necessarily need to be present every day working; they are the supervisor of work procedures and will come at least once a month to inspect the laboratory. If inspectors come and find things are not right, this person will be held accountable.
· Cleaner/Cashier: This is not mandatory; it depends on your agreement. If the Laboratory Practitioner can handle cleaning and also receive payments, you can utilize them for that as well.
Note 1: If the Laboratory Practitioner you hire has a Diploma and Certificate, you can also discuss with them to become the Supervisor of your Laboratory.
IMPORTANT DOCUMENTS TO HAVE:
- Employment contracts for the staff mentioned above
- NIDA numbers for the staff mentioned above
- TIN number for your business
- A map/sketch of your Laboratory building
- Staff certificates and their licenses.
- Their phone numbers.
Additional Explanations;
Regarding how the building should be set up and other small details, you will be guided by the District Laboratory Coordinator, DLT (where you sent the application letter). They will come to inspect you several times to ensure compliance with the instructions they gave you.
The documents I mentioned above will need to be entered into the system once you receive instructions from the District Laboratory Coordinator to make your Application for Registration.
There are small supplies; these include gloves, gauze, cotton, needles, reagents, etc. You will purchase these once you are given a permit to start, and you will sit with the staff you have hired who will list all the necessary requirements.
Therefore, for anyone who wants to open a Laboratory, whether they are a Laboratory professional (meaning they studied it) or not a professional but wants to be an owner, this is the procedure.
PART B:
1: THE BUILDING:
Here are three ways to obtain a laboratory building;
· Building a new structure yourself - here the cost will depend on the location you are building on, the size of the building, and its design.
· Renovating a building to meet laboratory criteria - here it will depend on your agreement with the building owner on who bears the cost.
· Renting a building that already has Laboratory status, where you will pay rent at the end of the month.
For this building aspect, you will see that it's difficult to get an exact estimate because the cost depends on many factors. Therefore, I will provide an estimate here, assuming you have found a building and make minor modifications, of Tshs 4,000,000/= (Four million).
2: ESSENTIAL MACHINES
· Binocular Microscope ....... Tshs 1,000,000
· Centrifuge machine ........... Tshs 300,000
· HB Machine ........................ Tshs 300,000
· Glucose Machine ................ Tshs 70,000
· Refrigerator ........................ Tshs 300,000
· Total for Machines we get Tshs 1,970,000/=
3: CHAIRS AND TABLES
· 2 Large plastic tables ...... Tshs 200,000
· 4 Plastic chairs ................ Tshs 100,000
· 1 Laboratory table ............. Tshs 200,000
· 1 Laboratory chair ............. Tshs 100,000
· 2 Customer benches ............. Tshs 100,000
· Estimate here is Tshs 700,000/=
4: LICENSES AND TAXES
· Application fee ........
· Annual Laboratory Fee .......
· Laboratory License (District) ........
· Income Tax ..............
· Let's put an estimate here of Tsh 500,000/=
5: SUPPLIES
These are very many; I will mention just a few
I. Racks
II. Pipettes
III. Red tubes
IV. Purple tubes
V. Glass slides
VI. Cotton
VII. Gauze
VIII. Syringes and needles
IX. H.I.V kits
X. H.Pylori kits
XI. MRDT kits
XII. UPT kits
XIII. Urine and stool containers
XIV. Kidney dishes
XV. Prickers
XVI. Chemicals (Giemsa, Gram stain, Immersion oil, etc.)
· Here I put an estimate for purchasing sufficient stock at Tshs 1,000,000/=
6: OTHER COSTS:
These are costs that exist but you cannot directly quantify easily because they depend on many things
· Transportation of equipment
· Facilitating Inspectors to conduct inspections
· Staff salaries
· Preparing employment contracts
· Advertising your laboratory
· Working capital
· Taking Firefighters to inspect the Laboratory to get a certificate and buy the Extinguisher from them
· Making a suggestion box
· Other miscellaneous expenses
· Here I have put an estimate of Tsh 2,000,000/=
GRAND TOTAL
Therefore, the estimated Total for Building and Establishing a Laboratory is;
4,000,000
1,970,000
700,000
500,000
1,000,000
2,000,000
So, when I add up, the Grand Total we get is Tsh 10,170,000 (Ten million, one hundred and seventy thousand only).
The estimates I have provided here can go up or down due to various reasons including finding a building, price differences for machines based on quality and capacity. For example, the HB machine I listed is the small one called Mission Plus, but if you decide to buy a Homecue, it reaches up to 800,000 or more. Similarly, with Microscopes, there are cheaper ones than what I listed, but there are more expensive ones reaching up to 2 Million, for example, Olympus.
DISEASES YOU CAN TEST FOR WITH THE EQUIPMENT I MENTIONED ABOVE:
· HB - Blood count/Anaemia
· Glucose level - Sugar levels in the body
· Malaria
· U.T.I (Urinary Tract Infection)
· Urine
· Stool
· H.I.V / PITC
· H.Pylori - Stomach ulcers
· VDRL (Syphilis)
· BS (Blood Smear/Parasites)
· Urinalysis (Biochemistry)
I have provided this contribution. Therefore, anyone with an addition to what I have written is welcome.
Cc. Please would you add something or advise there if something is missing or not correct, or any one please .... I thank you in advance.
By: Saniru Bia Kimweri – Laboratory Medicine Academician