Guidelines for Private
Medical Laboratory Services
1.
Laboratories in the private sector could
be classified depending on the type of tests and number of tests performed.
i.
Small Lab: –
·
Basic
Tests
·
Performing
0-100 tests per day
ii.
Medium Lab: –
·
Basic tests and tests which have to
perform in a semi-automated lab.
·
Performing
101-500 tests per day
iii.
Large Lab: -
·
Basic tests, tests which have to perform
in a semi-automated lab and tests which have to perform in an automated lab.
·
Performing
more than 500 tests per day.
iv.
Collecting Centers – Places which
collect samples. These centers are not permitted to perform any kind of lab
tests.
2.
Basic
Requirements
i.
Space: The space required by a
laboratory shall be commensurate with the number, type and range of tests
performed, the level of automation available, degree of computerization,
workload and manpower. Adequate space should be provided to enable efficient maintenance
of equipment and ensure safety of personnel. Each laboratory, however, must
ensure adequate provision of space for the following:
·
Patient
Reception
·
Sample analysis
· Storage
of samples, reagents, chemicals, spares, stationery and records
·
Washing
·
Toilets
The Laboratory should have adequate
lighting, power plugs and uninterrupted power supply. All computers,
peripherals, equipment and communication devices should be supported in such a
way that service is not likely to be interrupted. The Laboratory shall have
procedures in place to ensure the integrity of refrigerated and/or frozen
stored samples/reagents/consumables in the event of an electrical failure and
emergency exist. The accommodation and environmental conditions are also
applicable to primary sample collection facilities as sites other rather than
the permanent laboratory facility.
ii.
Layout of the
Laboratory
·
There shall be a waiting area for the
service recipients to wait till their turn comes. This waiting area shall have
no access to the testing area.
·
Bleeding room shall be separated from
the sample room where samples are stored for retained. There should not be beds
or other furniture used for bleeding purpose inside the sample room.
·
The laboratory shall limit and restrict
entry to unauthorized personnel to testing areas to ensure confidentially and
safety of patients and visitors.
·
Sample testing area maybe demarcated and
separated by Cubicles or Particle Board or Glass partitioning depending on size
of Lab and number of samples received. However all areas of testing must be
clearly marked depending on the tests being carried out.
iii.
Environment:
Laboratory must be well-lit and
ventilated to provide a healthy environment. Toilets shall be clean and
properly washed to assure sanitation of service recipients. It is preferable,
if there are no water taps inside the sample taking area of toilets.
iv.
Medical Waste
Disposal:
Method of general and
clinical waste disposal.(According to National Environment Management Authority
Requirements.)
Supervisory, Technical
and Non-technical staff should be available according to the size of the
Laboratory and type of tests performed.
4. Equipment:
The
Laboratory must be equipped with basic instruments listed below.
§ Colorimeter
§ Spectrophotometer
§ Glucometer
§ Hemcytometer
§ Microscope
§ Oven
§ Incubator
§ Centrifuge
§
Distilled
Water Plant
§
Vortex
Mixer
§
Rotary
Shaker
Depending
on the test menu being offered other Semi-automated and Fully Automated
Instruments can be installed. These include but are not limited to Biochemistry
Analyzers, Hematology Cell Counters, Coagulation Analyzers, Immunoassay
Analyzers, Coagulation Analyzers and Histopathology Processing Instruments.
5. Test Menu:
·
The
Location of the Lab
·
Category
of Lab
·
Other medical facilities being offered
by the Hospital such as ICU, Fertility Centre, Diabetes Centre, Heart Centre.
Laboratories catering to these specialized facilities should be equipped with
Point of Care Testing (POCT) tests and instruments, such as Glucometers, Blood
Gas Analyzers.
·
Size of the Lab, depending on number of
requests per day
·
Equipment
·
Supervisory Personnel
However
if the Laboratory is not directly supervised by a Consultant Pathologist, but
by a Registered Medical Laboratory Technician (MLT), then the following Tests
can be performed by Laboratories under supervision of a Registered MLT and
released under the authority of a Registered MLT. All other specialized and
highly specialized Tests must be carried out and reports released under
supervision of a Consultant Pathologist.
The following
is a List of Tests to be carried out and released under authority of a
Registered MLT.
- Clinical Biochemistry And Chemical Pathology: Profiles:
§ Cardiac
Profile: Sgot, Ck(Total), Ck-Mb
§ Lipid
Profile: Cholesterol, Triglycerides, Hdl Cholesterol,Ldl
Cholesterol, Cholesterol/Hdl Cholesterol Ratio
§ Liver
Profile: Sgpt, Sgot, Alkaline Phosphate, Ggt, Bilirubin,Total
Proteins
§ Renal
Profile: Bul, Creatinine,Electrolytes, Calcium,Phosphorus,
Uric Acid
TESTS:
|
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Alanine
Aminotransferase
|
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|
Ldl
Cholesterol
|
|
|
(Sgpt)
|
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|
Oral
Glucose Tolerance
|
|
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|
Albumin
|
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|
Proteins(Total)
|
|
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|
Amylase
|
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Sodium
|
|
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|
Aspartate
|
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|
Triglycerids
|
|
|
Aminotransferase
(Sgot)
|
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|
Urea
|
|
|
Bilirubin
(Total & Direct)
|
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|
Uric
Acid
|
|
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|
Calcium
|
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|
Urinary
Potassium (Spot
|
|
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|
Chloride
|
|
Sample)
|
|
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|
Cholesterol
|
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|
Alkaline
Phosphate
|
|
ï‚·
|
Ck(Total)
|
ï‚·
|
Urinary
Sodium (Spot
|
|
ï‚·
|
Ck
Mb
|
|
Sample)
|
|
ï‚·
|
Creatinine
|
ï‚·
|
Urine
For Bilirubin
|
|
ï‚·
|
Creatinine
Clearance
|
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|
Urine
For Glucose
|
|
ï‚·
Fluid – Full Report
|
ï‚· Urine For Ketone Bodies
|
||
|
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|
Fluid – Protein
|
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|
Urine For Proteins
|
|
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|
Fluid
– Sugar
|
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|
Urine
For Reducing
|
|
ï‚·
|
Gamma
Glutamyl
|
|
Substances
|
|
|
Transferase
(Ggt)
|
ï‚·
|
Urine
For Urobilinogen
|
|
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|
Glucose
|
ï‚· Urine For Sdymorphic Red
|
|
|
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|
Hdl
Cholesterol
|
|
Cell
|
B. HAEMATOLOGY
o
Full
Blood Count
o
Erythrocyte
Sedimentation
o
Packed Cell Volume
o
Reticulocyte Count
o
Absolute Eosinophil Count
o
Plasma Hemoglobin
o
Urine Hemosiderin
o
Prothrombin Time
o
Partial Thromboplastin Time
o
Bleeding And Clotting Tiime
o
Blood Picture
o
Platelet Count
o
Blood Group
o
Malarial/Filarial Parasite
B.
MICROBIOLOGY
§ Identification
Of Microorganisms In Sterile Fluids E.G. Csf, Pus, Pleural Fluid
§
Hanging
Drop Preparation For Vibrio Cholerae
§ Bacteriology
Culture: Blood, Csf, Other Sterile Fluids, Urine, Sputum, Stools, Throat Swab
§
Csf
Microscopy
§
Stools:
Parasites, Over And Cysts
§
Sputum
For Afb
§
Urine
Full Report
§
Stool
Aoc
§
Occult
Blood
C.
SEROLOGY
§ Anti
Sterptolysin O Titre (Latex Agglytination Test)
§ Salmonella
Agglutination Test
§ Vdrl
§ Pregnancy
Test (Rapid Immunochromatographic Method)
§ Hiv
I & Ii (Rapid Immunochromatographic Method)
§ Hbsag
(Rapid Immunochromatographic Method)
§ Dengue
Antibodies (Rapid Immunochromatographic Method)
6. Quality Control
Quality Control in a Laboratory should
include Internal and External Quality Assessment. Quality Assurance (QA) is a
comprehensive term that refers to allaspects of operation
from preparation of the patient to sample collection, sample analysis,
recording of the result and its dispatch. The result of analysis must be
available within a reasonable period so as to be useful for patient management.
All QA procedures shall be documented. Stages of QA include pre-analytical and
post analytical.
7. Minimum requirements for
Registration.
o
Small Lab –Availability
of a qualified registered MLT.
o
Medium Lab –Availability
of a qualified registered MLT &one of the Medical Laboratory Consultants
full time or part time.
o
Large Lab –Availability
of a qualified registered MLT fulltime and all Medical Laboratories consultants
full time or part time.
o
Collecting Centre –
§
Responsible MO’s details or MLT’s details (Uganda
Private Medical and Practitioners Council )
Medical
Council registration certificate with the renewal – Certified copies)
·
Details of the trained person/s available
·
Place of where the tests are being done and whether
it is a UMDPC or UNAPH registered institution?
·
Clarification from the concerned institution.
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