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Pro68-01 Manual Urin Micro SOP1
Pro68-01 Manual Urin Micro SOP1
U. URINALYSIS
U.2.1. PRINCIPLE:
1. Routine Urinalysis consists of both physical and chemical analyses to assist physicians
in the diagnosis and treatment of renal and urinary tract diseases and in the detection
of metabolic or systemic disease processes not directly related to the kidney.
2. The microscopic examination of the centrifuged urine sediment includes the study of
formed elements, such as WBC’s, RBC’s, casts and crystals.
U.2.3. SPECIMENS
1. Use fresh well-mixed urine collected by clean-catch method into a sterile container.
3. All urine specimens should reach the laboratory within one (1) hour after collection
and be properly labeled.
4. Urine specimens should be tested within two (2) hours after collection. If urine
cannot be tested within two (2) hours, it may be stored for up to four (4) hours at 2
5.3. Improperly collected samples. For example, urine samples with preservatives,
specimens collected in non-sterile containers, or specimens collected in
containers with soap or detergent residues will not be accepted.
5.4. QNS (Quantity Not Sufficient) - The recommended minimum volume is 12 mL’s.
The required minimum volume for microscopic examination is 0.50 mL. In the
event that less than <0.50 mL is received, perform testing on uncentrifuged urine
and comment as noted in section U.2.7.
5.5. In the event that an unacceptable sample is received, another sample must be
requested. Document all action taken in the LIS.
1. Equipment:
2. Reagents - None
1.1. A Run in urinalysis is defined as all patient testing performed in a 24-hour period.
Quality Control must be performed under the following conditions.
1.2. A Normal and Abnormal Kova Control will be performed at least once every
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U.2. Manual Urinalysis Microscopic Exam
run.(see above)
1.3. Reconstitute new Kova controls with 60 mL Reagent Grade water according
to manufacturer’s instructions.
1.4. Perform the Kova controls in the same manner as patient samples. See section
U.2.7 for the patient testing procedure. Record the results on the Urinalysis
Quality Control Worksheets. See appendix 3 & 4.
1.5. All results must fall into the expected ranges, which are obtained from the
manufacturer’s insert for each control and recorded on the top of the Urinalysis
Quality Control Worksheets.
1.6. If all results are within expected ranges, proceed with patient testing.
1.8. Parallel Testing: All new quality control lots or separate shipments of current
lots will be tested against the current lots for performance verification before
performing patient testing. See the Parallel Testing form, Appendix 5. Results
are considered acceptable if they are within their lot number quality control
limits.
U.2.7. PROCEDURE
2. Positively identify the specimens using the patient name and date of birth.
3. Log the sample on the testing worksheet using the LIS generated patient label,
appendix 6.
4. Add the LIS generated label to the sample cup (not the sample lid). Any discrepancy
must be investigated before processing the specimen.
5. Mix patient urine sample by swirling. Mix control aliquots by inverting several times
to ensure homogeneity of the contents.
8. The Clinitest confirmatory test is required for all pediatric urine samples with
patients age 2 years old or younger, regardless of whether it was requested or not.
See Clinitest SOP U06.1.
10. Confirmatory tests are not required for TRACE results on PROTEIN or KETONES.
11. Microscopic examinations are required on the following specimens regardless of the
reagent strip results:
12. Pour 12-mL’s of specimen into a sterile Kova tube and label the tube with the LIS
specimen label. If the total specimen volume is 0.50 mL or less, do not pour the
sample into a Kova tube. Perform testing from the specimen cup as indicated in the
following steps.
13. Testing
13.2. Volumes less than 0.50 mL - swirl the sample in the specimen cup to mix well.
13.3. Use a Kova pipette to aspirate sample from the well mixed specimen.
13.4. Place one (1) drop of the sediment on the Kova slide so that the urine sediment
is drawn under the preformed Kova cover slip.
13.5. Place the Kova slide under the microscope with the low power objective (10X
lens) and observe the sediment for the presence of casts. Observe at least ten
(10) fields and take the average number of casts seen for each type.
13.6. Switch to high power objective (40X lens) to observe the sediment for the
presence of epithelial cells, WBCs, RBCs, bacteria, crystals, yeast, trichomonas,
mucus, and spermatozoa.
13.7. Scan approximately 8-10 fields and take the average per field for each type of
sediment.
13.8.1. If the volume was <12 mL but > 0.5 mL, enter [12ML] -
Minimum specimen volume is 12 mL. Urine sediment results
may be falsely decreased due to a submitted sample volume less
than 12 mL’s.
13.8.2. If the volume was <0.5 mL, enter [UNSPUN] - Testing performed
on uncentrifuged urine due to a submitted volume less than 0.5
mL. Minimum required specimen volume is 12 mL. Urine
sediment results may be falsely decreased.
13.9. Review the results and enter data on the manual microscopic patient result form
(appendix IV). See section U.2.8 for Expected and Critical Results - Abnormal
results will be flagged.
13.10. Enter all results in the LIS. Do not certify any results until all urinalysis
testing ordered on the patient sample is complete.
1. The following bolded analytes require a result entry during the microscopic results
even if they are not seen during the microscopic exam. Report “none” or 0-1 or 0-2 as
indicated. All other analytes are optional entry if seen during the microscopic exam.
2. If budding yeast or hyphea are present, add the following canned comments:
3. The presence of sperm in the urine of a female child under 16 years old is a critical
value. Supervisor confirmation is required before reporting any suspected sperm to
the physician. The physician must be notified in accordance with critical value
procedures before sperm is reported in the LIS. The urine must be retained at 2-10°C
until the patient’s physician and laboratory director authorizes disposal. In no instance
will the urine be destroyed until duly authorized.
4. If a urine dipstick is performed, compare the results obtained on the microscopic with
the multi-parameter reagent strip with the following facts in mind:
4.1. Urine with RBCs seen on the microscopic exam should have a positive occult
blood on the reagent strip.
4.2. Urine with casts should have elevated specific gravity and positive protein.
4.4. Urine with positive nitrite should have bacteria on the microscopic.
5. CRITICAL VALUES:
5.1. When the following values are encountered after a urinalysis testing,
immediately notify the physician or senior ward/clinic nurse of the values
encountered.
5.2. Critical values must be reported in accordance with the laboratory critical value
policy.
2. Microscopic Sediment:
2.1. RBCs: Normally 0-2 RBCs/HPF may be seen in urine from males and non-
menstruating females. Increased numbers may indicate renal hematuria.
2.2. WBCs: Normally 0-5 WBCs/HPF may be seen in urine of normal males with
slightly higher ranges in females. Increased numbers may indicate renal disease
or acute infection.
2.3. Epithelial cells: A few epithelial cells are normal and indicate normal sloughing
off of aging cells. Increased numbers may indicate renal disease, urinary tract
infection, or poor technique in specimen collection.
2.4. Casts: 0-1 hyaline cast/LPF is found in normal urine. Increased numbers or
more advanced types indicate proteinuria.
2.5. Bacteria: A few bacteria are normally seen due to poor technique in collection
of the specimen. Increased numbers may indicate kidney, bladder, or urinary
tract infection.
2.6. Crystals: The following crystals may be seen in normal or abnormal urine as
noted below. Use urine pH and solubility information (appendix 7) to aid in
identification, as needed. Also use appropriate image and literature resources to
assist with identification.
Normal Abnormal
Acidic Urine Alkaline Urine Acidic Urine Alkaline Urine
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U.2. Manual Urinalysis Microscopic Exam
2.7. Mucus: Light mucus is normally found in urine and can sometimes be confused
with hyaline casts.
2.8. Spermatozoa: A few are normally found in urine from normal males. Increased
numbers are found in prostatic disease.
5.10. Yeast: 0-1/HPF or few per high power field are normal in females. Increased
numbers indicates infection.
5.11. Casts are classified according to their matrix, inclusions, pigments and cells
present.
5.11.1.2. Waxy casts: These differ from hyaline casts in that they are
easily visualized because of their high refractive index. Waxy
casts are homogeneously smooth in appearance. Their margins
are sharp, their ends are blunt, and cracks or convolutions are
frequently seen along the lateral margins. Waxy casts are
commonly associated with tubular inflammation and chronic
renal failure. They are also found during acute or chronic renal
allograft rejection.
5.11.3.2. Myoglobin casts: These cast are red-brown in color and occur
with myoglobinuria following acute muscle damage.
5.11.3.3. Bilirubin and other drug casts: Bilirubin is seen in urine when
there is obstructive jaundice, and will color casts as deep yellow
brown. Drugs such as phenazopyridine (Pyridium) cause a
bright yellow to orange color in acid urine and will color casts
and cells.
6. SOURCES OF ERROR:
6.1. Urine should be tested within two (2) hours after collection. Prolonged testing
delay may result in cast dissolution, RBC crenation or bursting, increased
bacteria, and crystals dissolution.
6.2. Fill the Kova slide chamber with the pipette placed parallel to the slide and
dispense the specimen drop in the corner of the well. Samples placed in the
center of the well can cause air bubbles to form resulting in sample distortion
during examination.
U.2.10. APPENDICES:
U.2.11. REFERENCES:
1. Stransinger, Susan K., Urinalysis and Body Fluids, Third Edition, F.A. Davis Book
Publisher, 1994, Pages 1 to 10 and 51 to 74.
2. Haber, Meryl H., Urinary Sediment: A Textbook Atlas, American Society of Clinical
Pathologist Book Publisher, 1994.
4. Kova Trol: Human Urinalysis Controls Package Insert, Hycor Biomedical Inc., 2001.
Appendix 1
SOP VALIDATION
SOP NAME:
U.2. Manual Urinalysis Microscopic Exam
Appendix 2
SOP APPROVAL
SIGNATURE DATE
PREPARER
QA COORDINATOR
LABORATORY OIC
MEDICAL DIRECTOR
ANNUAL REVIEW
SUPERSEDES:
Acceptable
Date
Range:
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
31
Comments:
Refer to SOPs U.1.1 and U.2.1 for Urine Dipstick and Microscopic QC resulting procedures
Acceptable
Date
Range:
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
31
Comments:
Refer to SOPs U.1.1 and U.2.1 for Urine Dipstick and Microscopic QC resulting procedures
Appendix 5
Quality Control Parallel Testing Worksheet
Reagent Current Lot Current Lot New Lot Result Current Lot Acceptable
Result Acceptable Acceptable
Range Range
Red Blood Cells Yes / No
White Blood Cells Yes / No
Casts Yes / No
Crystals Yes / No
*Bacteria None None Yes / No
Yes / No
Yes / No
Yes / No
Yes / No
Yes / No
*Note: If bacterial presence is suspected in the quality control material, it is unacceptable for use. Notify the
supervisor immediately.
Comments:
Comments: