Health Laboratory Establishment and Operation: Introduction, Space, Equipment, and Human Resource

Introduction of Health Laboratory Establishment and Operation

As we know, ‘Laboratory Diagnosis’ is the third eye of doctors/clinicians that confirms the cause of pathology/ disease. It highlights the importance of Health Laboratory Establishment and Operation for better service. Here, we discuss in brief the national guidelines of Nepal and the Laboratory setup completely depending on the level of the medical/ clinical laboratory. For example, A category laboratory needs more requirements as compared to low-level laboratory-like B, C, D, and E.

Health Laboratory Establishment and Operation
Fig. Health Laboratory Establishment and Operation

Laboratory-wise Space, Equipment, and Human Resource

Laboratory-wise space, equipment, and human resource with examples are as follows-

Level of Laboratory SetupSpaceEquipmentHuman ResourceTest ServicesExample
E150 sq. ft. or moreEquipment/consumables
/reagent/Kits: As required
to perform designated
tests. Modern/advanced technology should be adopted.
Minimum 2The range of clinical laboratory tests to be provided by these laboratories includes-
Hematology stream: TC, DC, hemoglobin, ESR, blood grouping for non-transfusions
purpose, BT, CT
Biochemistry section: Sugar, Urea, Bilirubin & D, S. Uric Acid, Total protein, serum
albumin
Microbiology section: sputum AFB stain (z-N stain)
Tests by RDTS: With simple interpretation
Miscellaneous: Routine urine analysis, routine stool analysis, urine
pregnancy test, and Stool for reducing substances.
Government Health Post (HA) Laboratory and Private Laboratory
D250 sq. ft. or more with designated areas for sample collection, sample processing, and reportingEquipment/consumables
/reagent/Kits: As required
to perform designated
tests. Modern/advanced technology should be adopted.
Minimum 4, 1 of whom should be Lab Medical Lab Technologists
or above
The range of assays to be provided by these laboratories include all the
services/tests approved for “E” category (Basic) laboratories plus the following:
Hematology: RBC count, PT, APTT, Platelet count, Hematocrit, Red cell
indices
Biochemistry SGOT, SGPT, ALP, lipid profile, creatinine, sodium, potassium
Microbiology: Gram stain and KOH mount for fungi
Serological tests: RPR, Widal test, ASO Titer, RA Factor, CRP,
Tests by RDTS: All
Miscellaneous: Stool for occult blood, Urine ketone bodies, urobilinogen,
bile salt, bile pigment, Bence Jones protein (BJP)
Government Primary Health Care(PHC) Laboratories and Private Laboratory
C400 sq. ft. or more with designated areas for sample collection, sample
processing and reporting
Equipment/consumables
/reagent/Kits: As required
to perform designated
tests. Modern/advanced technology should be adopted.
Minimum 6 with at least 50% technical manpower should
be having a bachelor’s degree or above with at least one having Masters
Degree or above depending upon the nature of the tests
Range of tests: To be provided by these laboratories include all the
services/tests approved for “D” category (intermediate) laboratories plus the
following:
Hematology: Absolute counts, Blood grouping for transfusion purposes,
Cross-matching, reticulocyte count, peripheral blood smear
examination
Biochemistry: Cardiac Enzymes, other enzymes, Thyroid Function Test ( T3,
T4, TSH )
Microbiology: All Routine bacteriology cultures, ELISA for infectious disease,
e.g. HlV, HBSA and HCV, etc.
Histopathology/Cytopathology, Bone Marrow aspiration, and biopsy service
Miscellaneous: CSF and body fluid analysis, Semen analysis
50 Bedded General Hospital/ Government District Hospital/ Private Laboratory
B1000 square feet or more with adequate rooms required for all specialized
laboratory services (depending on the type of services).
In the case of a general hospital, the laboratory should have at least three departments among four like
(microbiology, Histo- cytology, hematology, and biochemistry). If there is a standalone laboratory that can choose one stream mentioned above spending on specialization.
There should be adequate space for Sample collection,
information/reception/cash counter, reporting room, QC unit, library, meeting
hall and office of the laboratory heads.
Equipment/consumables
/reagent/Kits: As required
to perform designated
tests. Modern/advanced technology should be adopted.
12 or 4 per discipline with 50% technical manpower
should be having Bachelor’s Degree or above with at least three having Masters
Degree or above depending upon the nature of the tests
To be provided by these laboratories include all the services and tests approved
for “C” category (Standard) laboratories. ln addition,
these specialized laboratories can provide all services including special
coagulation profile, hormone analysis, Immuno-histochemistry (lHC), Tumor
markers, Advance C/S (anaerobic culture, fungus culture), hemolytic profile,
tests performed by ELISA/CLIA technique as per requirement,
51-200 Bedded General Hospital/Zonal Hospital/Regional Hospital/ Hospital-Based
Laboratory/Standalone Laboratory/Polyclinic Based Laboratory
ASpacer 2000 square feet or more (depending upon the number of specialized
services). There should be adequate space for sample collection,
information/reception/cash counter, reporting room, QC unit, library, meeting
hall, and office.
Equipment/consumables
/reagents/Kits: As required
to perform designated
tests. Modern/advanced technology should be adopted.
Minimum 24 or 6 per discipline (Hematology,
Biochemistry, Microbiology, Histo-cytopathology) with 50% technical manpower
should be having Bachelor’s Degree or above with at least one per department
having Masters’s Degree or above depending upon the nature of the tests
The range of tests: Laboratories will provide advanced-level/sophisticated
technologies in all the services
tests approved for the “B” category (Specialized)
laboratories, molecular tests, super-specialized tests like flow cytometry,
genetic study. ln addition to this, some special tests services provided by “A”
category lab includes super-specialized services in different disciplines.
In the case of a general hospital, the laboratory should have at least three departments among four (microbiology, Histo-cytology, hematology, and biochemistry). If there is a standalone laboratory that can choose one stream mentioned above spending on specialization.
200 Bedded Government and Private General Hospital/Central Hospital / Hospital-Based
Laboratory/Standalone Laboratory/>50 Bedded Special
Service Providing Hospital/Medical College Based Hospital Laboratory
Table of the brief guidelines on Health Laboratory Establishment and Operation

Keynotes on Medical Laboratories

  • NPHL itself is a sentinel/national reference laboratory which has the following units and departments-
  1. The National Influenza Centre
  2. National External Quality Assurance Scheme (NEQAS)
  3. Serology
  4. National Bureau for Blood Transfusion Services (NBBTS)
  5. Biomedical Engineering and maintenance
  6. Quality Control and Training Section
  7. Biochemistry
  8.  Japanese Encephalitis, Measles and Rubella Laboratory (JE/Measles Polio Department)
  9. Endocrinology
  10. Hematology
  11. National Reference Laboratory for AIDS and STD Control (HIV Reference Laboratory)
  12. Oncopathology
  13. Immunology
  14. Microbiology
  15. Non-Communicable Disease Department (Four sections e.g. Hematology, Biochemistry, Endocrinology, and Histo-Cytopathology)
  • The vision of NPHL is to develop it as the center of excellence in diagnosis.
  • The major goals of NPHL are to extend laboratory services in all hospitals and health care institutions up to the PHC level for the development of NPHL as a national reference laboratory for diagnostic and public health services and to address the diagnostic needs due to emerging and re-emerging diseases.
  • Major Routine Activities of NPHL are as follows-
  1. Routine and specialized diagnostic services including services of referral laboratory.
  2. Public health-related activities (laboratory-based surveillance [Acute encephalitis syndrome (AES)/Japanese encephalitis, measles/rubella, polio, antimicrobial resistance (AMR), influenza)], HIV reference unit, National Influenza Center, Biosafety level 3 (BSL-3) laboratory and outbreak investigation).
  3. Training and workshops.
  4. Logistics procurement and supply and laboratory refurbishment.
  5. Supervised and monitored, licensing lab, and Blood Transfusion Service Centers (BTSCS).
  6. National External Quality Assurance Scheme (hematology, biochemistry, gram stain, microbiology, AMR on selected bacterial pathogens and transfusion-transmitted infections (TTIs).
  7. Polio containment and its accreditation.
  8. Assisting the Ministry of Health and Population (MoHP) in preparing medical laboratory-related, policies, legislation, and guidelines.
  9. Procurement of special types of kits and reagents and equipment for provincial and local level government laboratories.
  10. General administration functions
  11. AMR Surveillance activities
  • Provincial Public Health Laboratories (PPHLs) are also available in Nepal at the state level to strengthen the NPHL.
  • If any update is lacking in the provided list, kindly mention it in a comment box and no doubt, we will definitely add it to the list.
  • C, D, and E categorized laboratories are registered in local government bodies and PPHL.

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