# Presentation: 504273

## NATIONALLABORATORY OF PUBLIC HEALTH

- Presented by  CHUOP SOKHENG

## 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. **

## 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 **

## 2002 SOPS

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

## 2003 SOP’s

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

## 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**

## 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.**

## 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**

## 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********.**

## 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.**

## EQUIPMENT

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

## 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**)

## 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**

## METHOLOGY

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

## REPORTED RESULTS

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

## SOURCES ERROR

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

## 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.**

## 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?**

## 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**

## 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 TB...etc)**
**Criteria:**
**    ****- Easy to implement **
**	****- Easy to follow.**
**	****- Easy to understand**
**	****- Khmer language**

## Thank You