NATIONAL LABORATORY OF PUBLIC HEALTH

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NATIONALLABORATORY OF PUBLIC HEALTH
Presented by CHUOP SOKHENG
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COUNTRY EXPERIENCE WITH DEVELOPMENT OF SOPS
CAMBODIA

• Until 2002 SOPs were not in use at NLPH. Only
  specific procedures were copied from WHO book,
  MoH book or package insert
• In 2002 we started writing own SOPs by using NLPH
  -, WHO-book or package insert as reference.

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WHY SOPs?

• To improve and maintain the quality of laboratory
  services
• To standardize laboratory working practices and
  performance
• To assure quality laboratory results
• To assure quality of public health care

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2002 SOPS

• SOPs content
• - Extract from laboratory documents (NLPH , MOH
  etc.)
• - Safety rules
• - Type of working material
• - Methodology
• Calculation of results (validation)
• Control runs

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2003 SOPs

• SOPs content
• - Principle of test
• - Specimen
• - Equipment
• - Reagent
• - Control
• - Method of test
• - Sources of error
• - Code number and version

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STANDARD OPERATING PROCEDURES

• The standard operating procedures are the most
  important documents in a laboratory
• It describes in detail the complete technique for
  test performance
• Lab staff must fully understand and follow
  rigorously
• SOPs are extremely important to ensure that
  consistent and reproducible results are generated

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IMPORTANT FEATURES OF SOPs

• Applicable and achievable in the laboratory in
  which they will be used
• Clearly written and easy to understand and
  follow
• Kept up to date using appropriate technologies.

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PREPARING SOPs

• COVER SHEET
• - Name of Lab
• -Title of SOP
• -Authorized signature and date
• -Prepared by and date
• -Revised by and date
• -Approved by and date

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PRINCIPLE OF TEST

• Brief description of each test principle
• ie SOP ISE chemistry for the Lisa 500
• Lisa 500 is a bench top, automated, random
  access chemistry analyzer.The instrument
  performs 15 colorimetric chemistry assays and 3
  assays using an ion selective electrode module
  (ISE) ?(Na, K and Cl-)?.
• ?Refer to Lisa Manual Version Date is issued in
  October 1998 by Hycel company?.

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SPECIMEN

• Type of specimen (e.g anticoagulant used)
• Volume required
• Collection of specimen
• Time of collection
• Transportation time
• How container should be labeled
• Arrival time in the laboratory
• Criteria of specimen rejection.

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EQUIPMENT

• Material needed ( Pipette, incubator, water
  bath).
• Daily-start up Machine
• Daily maintenance
• Weekly maintenance
• Monthly maintenance
• Temperature monitoring

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REAGENTS

• How to store reagents
• Monitoring (temperature, precipitation etc.)
• How to prepare the reagent
• Check expiry date
• Shelf life of reagent (opened/unopened)
• Reagent consumable/test (Master reagent)

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CONTROLS

• For chemistry Zymotrol control and calibration
  for GPT/ALAT, GOT/ASAT
• QC everyday (2 level or 3 level)
• Hematology QC everyday (3 level)
• Serology Positive and Negative controls every
  test run
• Record control results and sources of control

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METHOLOGY

• Describes performance of the test.
• Detail of control
• Detail of calibration
• Used factor
• Safety
• Daily Start Up machine

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REPORTED RESULTS

• Validate the test (controls in the correct
  range?)
• Unit
• Normal range
• Panic Value
• Cross check

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SOURCES ERROR

• Monitoring all step
• Specimen collection
• Criteria of type specimen rejection
• Cross check

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SOPS IN LABORATORY PROVINCES OF CAMBODIA

• In the past, provincial lab staff did not use
  SOPs nor specific procedures. Only TB , Malaria
  (book or flipchart) or package insert were known
• 2002 NLPH started to introduce SOPs to assure QA
  in provincial laboratories.

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NLPH PROVIDES TRAINING FOR PROVINCIAL LAB STAFF

• What is a SOPs ?
• Why we need a SOPs ?
• How to write SOPs for own laboratory?
• Who has to follow SOPs?

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SOP CONTENT PROVINCIAL USE

• 1. Extract from book NLPH or MOH
• 2. Safety rules
• 3. Material- available
• 4. Method (different e.g. chamber count)
• 5. Calculation of test
• 6. Reagent preparation

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SINCE 2002

• Lab staff in the provinces are trained to
  write own SOPs adapted to the material and
  equipment available (WBC, HCT, differential cell
  count, PLT, Malaria and TBetc)
• Criteria
• - Easy to implement
• - Easy to follow.
• - Easy to understand
• - Khmer language

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Thank You