Ethan Frome - pSMILE
URINALYSIS – MICROSCOPIC EXAMINATION
|Author: Ali Elbireer |Document Number: |Pro68-11 |
| |Effective (or Post) Date: |20 Nov 2008 |
|Document Origin |Company: |MU-JHU Lab |
| |SMILE Approved by: |Jo Shim |
|Review by |Peggy Coulter |Review date |29 April 20 |
|pSMILE Comments: This document is provided as an example only. It must be revised to accurately reflect your lab’s specific |
|processes and/or specific protocol requirements. Users are encouraged to ensure compliance with local laws and study protocol |
|policies when considering the application of this document. If you have any questions contact your SMILE representative. |
Procedure: Urinalysis Microscopic Examination SOP
|ffective Date: |Revision #2 |Supersedes Rev# 1 |
|Jun 05, 2005 | |April 03, 2003 |
|Revised/Prepared By |Signature |Date |
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|Ali Elbireer | | |
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Principle
The microscopic examination is a vital part of the routine urinalysis. It is a valuable diagnostic tool for the detection and evaluation of renal and urinary tract disorders as well as other systemic diseases. Urine Microscopy will only be performed per physicians/primary care-giver request for clinical management or per study protocol requirements.
Specimen Collection and Handling
1. Patient Preparation: none for random, first-morning or post-prandial urine
2. Specimen Requirements: fresh, cleanly voided urine collected in a clean container
3. Specimen Volume: Optimum 20 mL, minimum 1 mL
4. Specimen Handling: Test as soon as possible after collection.
1. Optimum conditions: test within 1 hour of collection.
2. Option: refrigerate at 2-80C immediately and test within 12 hours.
3. Marginal: test upon receipt, note if specimens are un-refrigerated and >4 hours old.
1. Materials Required
1. Conical centrifuge tube, 15 mL
2. Microscope slides
3. Microscope cover slips
4. Plastic disposable pipette
5. Urine Controls, Hematronix Level 1 and 2 or equivalent
Equipment Required
6. Microscope
7. Centrifuge, 2000 rpm
2. Reagent Preparation – none
Storage and Stability
1. Hematronix Controls
1. Unopened product is stable up to the expiration date printed on the label when kept at 2-80C. Do not freeze.
2. Opened stability is 2 weeks at either 2-80C or 18 - 300C.
3. Do not store the control material in direct light.
4. Discard the controls if turbidity or evidence of microbial contamination is present.
5. Note: It is normal to observe cellular sedimentation in the bottom of the tube when stored for prolonged period.
Calibration – none
Quality Control
2. Run two (2) control levels each day of use.
3. Check the lot numbers / expiration dates of the controls are listed on the QC log and are current.
4. Record control values on QC log and check that the results are within the expected range.
5. If the QC results fall within the expected range, continue with patient testing.
6. If the QC results are not within range, repeat and consult with the LS/LSA for further action.
7. Document any QC problems or unexpected results on the Corrective Action Log.
Procedure
8. Note the color, clarity and volume of urine and record on the urinalysis worksheet.
8 The microscopic examination should be performed on a 10-15 ml centrifuged sample.
1. Mix the sample well and pour 10-15 mL into a 15 mL conical centrifuge tube.
2. Centrifuge at 2000 rpm for 5 minutes.
9. If the volume of specimen is too small to be centrifuged (< 0.5 mL)
1. Examine the sample directly.
2. Report the results are from an un-centrifuged urine under comments as ................
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