=====SOP OF QUALITY CONTROL OF EXAMINATION=====

**A] INTERNAL QUALITY CONTROL**

1) Daily two  urinalysis control samples (Positive & Negative) run on automated urine analyzer
  *Use of the control is intended to monitor the precision of urine analysis test procedures
  *Two levels of controls are available to allow performance monitoring within the clinical range
  *INGREDIENTS:
  -Liquicheck control- negative control and positive control. 
  -Compatible Siemen’s 10 parameter strip. 






**PROCEDURE**
  *This is done by running the quality control samples (level 1& level 2) daily once on auto analyzer.
  *Put drops of control sample level 1 on each reagent area of  reagent strip with pipette.
  *Blot by touching the edge of strip to Tissue paper to remove excess control sample. 
  *Insert the Reagent Strip in the Space provided for the Strip with reagent side facing upwards.
  *Wait for Results to appear on Screen and to have results in printed format.
  *Repeat procedure for control sample level 2.

  *STORAGE & STABILITY:
  -Strips are stored at room temperature in a dark cabinet.
  -Controls are stored in a refrigerator at 2-80 C 

**LIMITAIONS** 
Substances that cause abnormal urine color may affect the readability of test pads on urinanalysis reagent strips. These substances  include visible levels of blood or bilirubin and drugs containing dyes, nitrofurantoin or riboflavin.
  *The materials to discard is disposed as per the SOP of BioMedical Waste disposal 
  *Results of control samples are compared with the reference range  given with the controls
  *The results of daily control run are plotted in table and are filed in CP:C/records/file/9/internal Quality control records-A  with the printed copies of analyzer.
  *If the values are not within the reference range look for the followings:
       *Integrity of control samples: refrigerator temperature, new QC vial, verify  the lot number, verify the expiry date, verify the date when sample opened.
       *Integrity of reagent strips- visually inspect the strip, see for expiry date, verify the date when the box of reagent strip is opened
       *Integrity of instrument- verify the results of another control
       *Procedure- interview the technician who performed the test and train them accordingly
       *If the problem continues call the manufacturer person for service.

2)Daily one random patient sample is analyzed by Two/Three parameter strips and multistix strips (8 parameters/10 parameters) and by automated analyzer. Every 6 months one random urine sample is also checked by manual method.
After analysis , the results are  recorded in record register.
CP: C/records/file/9/internal Quality control records- B.
  *If the values are not within the reference range look for the followings:
        *Integrity of control samples: refrigerator temperature, new QC vial, verifies the lot number, verify the expiry date, verify the date when sample opened.
        *Integrity of reagent strips- visually inspect the strip, see for expiry date, verify the date when the box of reagent strip is opened
        *Procedure- interview the technician who performed the test and train them accordingly
  *Reports of manual, strip method and automated methods are preserved in CP: /C/records/file/9/internal Quality control records-B.
  *If the results are not comparable identify the cause whether it is related to integrity of samples, procedure, reagents or instrument and solve the problem accordingly.
    

3)    Yearly twice precision check on automated analyzer.
Reports of comparative observation of  all strips are preserved in CP:C/records/file/9/Internal Quality control records-D

4)   Weekly, Physical, chemical & microscopic examination of one random urine     sample is done by two different Technicians & two different pathologists and results are compared to each other.
  *Reports of comparative observation of all doctor’s are preserved in CP:C/records/file/9/Internal Quality control records-E
(Inter analyst comparison: Physical & Microscopic examination)

**B]  EXTERNAL QUALITY CONTROL**
  *As an alternative approach to EQA  participation split sample testing is done by two different technicians once in 3 months. 
  *Samples are processed the same way as the patient samples on automated urine analyzer as per the SOP as well as by strip method along with microscopic examination.
  *Same result sheets are preserved in CP: C/records/file/2/Results of split sampling.