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Question

Solstas Lab Partners​WI-HEM-052​
Title: Urinalysis Quality Control  
1.0 Purpose:
The purpose of this work instruction is to define the procedure for performing Urinalysis Quality Control.
2.0 Scope:
This work instruction covers the Laboratory personnel in the Hematology Department.
3.0 Definitions:
3.1 ml = Milliliter
3.2 RPM = Revolutions per Minute
3.3 C = Centigrade
3.4 UA = Urinalysis
4.0 Procedures:
4.1 Principle
MAS Liquid Urinalysis Control is intended for use in the clinical laboratory as a urine control for qualitative urinalysis procedures and microscopic sediment analysis.
4.2 Reagents and Equipment
4.2.1 MAS Liquid Urinalysis Control Level 1
4.2.2 MAS Liquid Urinalysis Control Level 3
4.2.3 Centrifuge
4.2.4 Urine centrifuge tubes
4.2.5 Urinalysis Reagent Strips
4.2.6 Icto test tablets and mats
4.2.7 Clinitest tablets
4.2.8 16x100 test tubes
4.2.9 pipettes or Kova petters 
4.2.10 glass slide and coverslip or Kova slide
4.2.11 Microscope
4.3 Frequency
The controls for instrument urinalysis and microscopic analysis should be run once each day of testing in the morning, and again every 8 hours.  
4.4 Procedural Steps
4.4.1 Compare the lot number printed on the MAS Liquid UA Control insert in the package with the lot number of the appropriate bottle of MAS control; they should match.  
4.4.2 Thoroughly mix the contents of the vial before each use by gently inverting the vial several times.
4.4.3 After labeling a clean centrifuge tube for the control to be tested, open the vial and pour 12ml of the appropriate MAS control into it.   Allow the control in the tube to equilibrate to room temperature and test in the same manner as an unknown specimen; follow the directions for using the Urisys 2400 (see Urinalysis procedure), refractometer, clinitest tablets (when applicable), and ictotest tablets (when applicable) (see Back up Urinalysis procedure).
4.4.4 Return the unused portion of control to storage between 2-8°C. immediately after removing the above amount.  It will remain stable for 30 days if stored between 2-8°C. and kept tightly capped.
4.4.5 Centrifuge the MAS control for 5 minutes at 1500 rpms and examine microscopically in the same manner as an unknown.
4.5 Reagent Lot Change
4.5.1 If urine reagent lots change, a new calibration must be performed and (dipsticks, alternate test reagent lots, etc…) QC must be run on UA controls and compared to the new lot readings. This is to verify the performance of the new reagent lot. Log the lot number of the new reagent on the logsheet and the results.
4.6 Expected Results
The lot number specific MAS control expected results are printed on the corresponding value sheet insert found in each box of MAS control bottles.
Form number F-WI-HEM-052-A is used to record all Urinalysis control results.  Use the following procedure to complete form F-WI-HEM-052-A.
4.6.1 At the beginning of each month, fill in the following information across the top of form F-WI-HEM-052-A for each level of control to be used.
4.6.1.1 Month and Year
4.6.1.2 Level of control being tested
4.6.1.3 Lot number and expiration date of the control
4.6.1.4 Transpose the Reagent Strip/Method specific
                     expected range for each parameter being used in
                     Urinalysis testing from the corresponding lot
                     number/control level value sheet.
4.6.2 On the line corresponding to the current date and time (am or pm) of use, record the results of each parameter tested into the appropriate column.  Review ranges for each parameter to ensure that the control is achieving the expected value.
4.6.3 Record the result of all refractometer testing, Icto test (when applicable), and clinitest (when applicable) into the appropriate column across from the day of testing.  Review ranges to ensure that the control is achieving the expected value.
4.6.4 Record the microscopic test results for WBC and RBC into the appropriate column across from the day (am only) of testing.
4.6.5 The person who performs the test is to place their initials in the Tech column for the current day and time (am or pm) of use to signify that the control ran as expected and patient testing can be performed.  If the control fails to perform as expected, rerun the testing on a fresh aliquot of control.  If it again fails to perform as expected, obtain a new bottle of control and retest on an aliquot from the new bottle.  If after rerunning the test on the fresh bottle the results are still out of expected range, notify supervisor and discontinue patient testing.
4.7 Reference
MAS Liquid Urinalysis Control Insert; Medical Analysis Systems, Inc; Camarillo, California; Part No. UA1-INS Rev. October 2000; ISO 9001 Certified Company.
Review by Performing Lab’s Medical Director or Designee
See previous hard copies with Department Mgr and  PDF files in WI Directory for reviews prior to 2011
Electronic signatures:
Reviewing Authority
Date
Christopher DeMoro, MLS (ASCP)  
9/23/11
Document Change History: 9/23/11: Name Change
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Answer 1

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