HOW TO OPEN A MEDICAL LABORATORY | UPDATED 2022

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A medical laboratory is a laboratory where tests are carried out on clinical specimens to obtain information about the health of a patient to aid in diagnosis, treatment, and prevention of disease.

The Ethiopian standards agency provides minimum requirements for the establishment and maintenance of basic medical laboratory in order to protect the public interest by promoting the health, welfare, and safety of individuals which are described in this article.

A department head is assigned to each of the Basic medical laboratory and administrative departments. The responsibility of department heads includes at least the following:

  • Providing a written description of the services provided by the department
  • Ensuring coordination and integration of these services with other departments when relevant
  • Recommending space, staffing, and other resources needed to fulfill the department’s responsibility
  • Defining the education, skills, and education needed by each category of employee in the department
  • Ensuring that there is an orientation and continuing education program for the department’s employees
  • Developing and implementing a department quality improvement program

What services are given by medical laboratory?

The following shall be range of tests to be performed in a Basic Medical Laboratory

a) Hematology

  • White blood cell count
  • Hemoglobin
  • Hematocrit
  • Differential count
  • Platelet
  • Hemoparasite
  • RBC morphology
  • MCV
  • MCH
  • MCHC
  • Erythrocytic Sedimentation Rate (ESR)

b) Clinical Chemistry

  • Glucose
  • Uric Acid
  • Creatinine
  • Urea
  • Alkaline Phosphatase
  • Aspartate Aminotransferase(AST)
  • Alanine Aminotransferase (ALT)
  • Bilirubin(Direct ,Total)
  • Albumin
  • Globulin
  • Cholesterol
  • Triglycerides
  • High Density Lipoprotein(HDL)
  • Low Density Lipoprotein (LDL)
  • LDH
  • LDL/HDL Ratio
  • Sodium
  • Potassium
  • Chloride
  • γ-GT

c) Urine and body fluid analysis

  • Urine analysis Qualitative
  • Urine Microscopy
  • Body fluid Analysis

d) Parasitology

  • Stool Examination
  • Occult blood test

e) Bacteriological examination

  • Gram Stain
  • AFB Stain
  • Routine Bacteriologic Culture & DST*
  • KOH

f) Serological and other tests

  • Widal-welifliex
  • HBsAg
  • H.Pylori
  • RPR (syphilis)
  • C-reactive Proteins
  • ASO
  • RH (Rheumatoid factor)
  • HCG

General Requirements

  • No medical Laboratory professional shall practice his/her profession in the Basic medical laboratory without having professional license from the Appropriate organ. The Basic medical laboratory shall ensure that all health professionals recruited by the Basic medical laboratory are licensed as per the registration and licensing requirement of the Appropriate organ.

Room requirements

The laboratory shall be located and designed to

  • Provide suitable, direct access for patients
  • Allow reception of deliveries of chemicals
  • Allow safe disposal of laboratory materials and specimens.

Doors shall be located in places where entry and exit are easy and does not interfere with the laboratory benches or equipment and shall not be less than 1 m wide to allow easy access of equipment.

The following shall be minimum space for Basic Medical Laboratory;

Premises required No of rooms required

 

Area required

 

Reception & waiting room 1 12sq. m

 

Specimen collection room 1 9 sq. m
Hematology room 1 9 sq. m
Clinical chemistry room 1 9 sq. m
Medical Microbiology rooms 1 16 sq. m
Serology room 1 6 sq. m
Parasitology, urine & body fluid analysis room 1 9 sq. m,
Disinfection Sterilization, and media preparation room 1 6sq. m
Recording and reporting room 1 4 sq. m
Store room 1 8 sq. m,
Staff room and office 1 9 sq. m
Toilets for patients (Separate, 1 for Male and 1 for

female)

 

2 8 sq. m
Toilet with shower for staff (Separate for Male and

female)

 

2 8 sq. m
Emergency shower 1 4sq.m

Professionals required

Basic medical laboratory shall be directed by a licensed medical laboratory technologist with five years of experience.

In summary, the laboratory shall have the following professionals

  1. Laboratory Technologist #2
  2. Full time quality control officer (Laboratory technologist) #1
  3. Laboratory technicians #2
  4. Supportive staff (clerk, cleaner)

All medical Laboratory professionals shall have an occupational health screening by a physician or other qualified health professional prior to entering active status and at least once every Five (5) years thereafter.

Each staff member shall receive ongoing Continuing Professional Development (CPD) to maintain or advance his or her skills and knowledge.

The CPD shall be relevant to the setting in which they work as well as to the continuing advancement of the Basic medical laboratory.

Equipments required

The following minimum equipments and consumables shall be available in basic medical laboratory.

  • Tally counter #3
  • Automated clinical chemistry
  • analyzer
  • Electrolyte analyzer
  • Microscope #2
  • Biological safety cabinet
  • Routine Culture and Drug
  • sensitivity accessories (Package)
  • PH meter#2
  • Digital balance
  • Automatic Micropippet #5
  • Microhematocrit centrifuge
  • Microhematocrit reader
  • Differential counter #2
  • Automated Hematology analyzer
  • Deep freezer
  • Centrifuge #2
  • Timer #3
  • Refrigerator
  • Distillation unit
  • Bunsen burner
  • Autoclave
  • Dry oven
  • Blood roller/mixer
  • Shaker
  • Incubator

The Medical laboratory shall have the following adequate supplies and equipment needed for infection prevention and control practice.

Waste management equipment and supplies

  • Safety boxes
  • Garbage bins
  • Wheelbarrows
  • Large garbage bin
  • Plastic garbage
  • bags
  • Cleaning
  • Mop
  • Bucket
  • Broom
  • Dust mop
  • Cleaning cloth
  • Detergent
  • Bleach

Instrument processing

  • Autoclaves and steam sterilizers
  • Test strips
  • Boiler
  • Oven
  • Storage shelves for the medical equipment
  • Chemicals & disinfectants: 0.5% chlorine solution(diluted bleach)
  • Brushes (tooth brush for small items)

Hand hygiene

  • Sinks (ward & other areas)
  • Water container with faucet
  • Soap dispenser
  • Alcohol based hand rub
  • Personal Towels
  • Paper Towels

Personal Protective Equipment

  • Heavy duty glove
  • Surgical glove
  • Latex or Nitrile glove
  • Eye shield
  • Goggle
  • Visors
  • Dust mask
  • Respiratory mask
  • Other types of face mask
  • Plastic apron
  • Protective shoes
  • Caps
  • Face shield

The Medical laboratory shall have the following equipment and supplies required for sanitation activities but not limited to:

  • Incinerator
  • Safety boxes
  • Leak proof containers for waste
  • Trolley to transport waste
  • PPE (personal protective equipment)
  • Autoclave.
  • Pressure cooker/dry oven.
  • Cleaning supplies (detergents, disinfectants and other cleaning solutions) like mops and dust bins

This article is based on the guide published by the Ethiopian Standards Agency (ESA) 2020 edition.

For further information contact through the following address

Phone numbers: 011- 646 06 85, 011- 646 05 65, 011-646 08 80

Postal: 2310 Addis Ababa, Ethiopia

E-mail: info@ethiostandards.org,

Websitewww.ethiostandards.org

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