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Guidelines for Private Medical Laboratory Services



 

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 Collection

·      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.)


3.  Human Resources:

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 Test Menu will depend on:

·         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.

  1. 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:

ï‚·
Alanine Aminotransferase
ï‚·
Ldl Cholesterol

(Sgpt)
ï‚·
Oral Glucose Tolerance
ï‚·
Albumin
ï‚·
Proteins(Total)
ï‚·
Amylase
ï‚·
Sodium
ï‚·
Aspartate
ï‚·
Triglycerids

Aminotransferase (Sgot)
ï‚·
Urea

Bilirubin (Total & Direct)
ï‚·
Uric Acid
ï‚·
Calcium
ï‚·
Urinary Potassium (Spot
ï‚·
Chloride

Sample)
ï‚·
Cholesterol
ï‚·
Alkaline Phosphate
ï‚·
Ck(Total)
ï‚·
Urinary Sodium (Spot
ï‚·
Ck Mb

Sample)
ï‚·
Creatinine
ï‚·
Urine For Bilirubin
ï‚·
Creatinine Clearance
ï‚·
Urine For Glucose
ï‚·  Fluid – Full Report
ï‚·  Urine For Ketone Bodies
ï‚·
Fluid – Protein
ï‚·
Urine For Proteins
ï‚·
Fluid – Sugar
ï‚·
Urine For Reducing
ï‚·
Gamma Glutamyl

Substances

Transferase (Ggt)
ï‚·
Urine For Urobilinogen
ï‚·
Glucose
ï‚·  Urine For Sdymorphic Red
ï‚·
Hdl Cholesterol

Cell



B.     HAEMATOLOGY

o   Full Blood Count

o   Erythrocyte Sedimentation
o   Rate (Esr)

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.


Uganda National Association of Private Hospitals (UNAPH)

P.O.Box 29324 Kampala, Tel: 256 772 632211 / 0704 762575, Lumumba Rd, Uweal Building, Medimark Suite, Email: unaph22@yahoo.com, unaphserv@gmail.com, 


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