Manual Microscopic Urinalysis Exam - pSMILE



|Manual Urinalysis Microscopic Exam |Document Number: |Pro 68-0.1 |

|Author: Penny Stevens | | |

| |Effective (or Post) Date: |9 June 2008 |

|Document Origin |Company: |N/A |

|US Army Hospital Heidelberg, Germany | | |

| |SMILE Approved by: |Heidi |

|SMILE 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 directed to countercheck facts when considering their use in other applications. If you have any |

|questions contact SMILE. |

| |

Copy # _____ Effective Date: Date

U. URINALYSIS

U.02. MANUAL URINALYSIS MICROSCOPIC EXAM

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.

3. The macroscopic examination of urine includes physical appearance, such as color, character and clarity. See U.1 Manual Urinalysis Dipstick SOP for macroscopic testing and reporting procedures.

4. A qualitative chemical analysis of the urine is performed by using a multi-parameter test strip that measure pH, protein, glucose, ketones, bilirubin, urobilinogen, nitrite, blood, leukocyte esterase, and specific gravity. The test strips are dipped in the urine and read visually according to the color comparison chart printed on the side of the container at prescribed time intervals. See U.1 Manual Urinalysis Dipstick SOP for qualitative testing and reporting procedures.

U.2.2. PURPOSE - The microscopic examination of urine sediment.

U.2.3. SPECIMENS

1. Use fresh well-mixed urine collected by clean-catch method into a sterile container.

2. The specimen should be unpreserved and uncentrifuged.

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 to 8(C. (The specimen must be brought to room temperature before testing.)

5. The following urine samples are not satisfactory for testing:

1. Specimens received over two hours after collection.

2. Mislabeled samples.

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.

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 )|

| | |50/ HPF |

|LEUKOCYTES (WHITE BLOOD CELLS) |0-2 |0-2, 2-5, 5-10, 10-25, 25-50, or greater than (>)|

| | |50/ HPF |

|RED BLOOD CELLS |0-2 |0-2, 2-5, 5-10, 10-25, 25-50, or greater than (>)|

| | |50/ HPF |

|BACTERIA |None - Few |None, Few, Trace, Moderate or Many |

|MUCUS |None - Light |Light, Moderate or Heavy |

|Crystals |None |Few, Moderate or Many for each crystal type. |

|Spermatozoa |Males only: Few |Few, Moderate, or Many. |

|Yeast |None |Light, Moderate or Many. Report any budding |

| | |yeast or hyphea seen using comments as noted |

| | |below. |

|Trichomonas |None |Few, Moderate or Many. May only be reported if |

| | |motile. |

2. If budding yeast or hyphea are present, add the following canned comments:

2.1. [Budding] - Budding yeast present.

2.2. [Hyphea] - Hyphae present.

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.

4.3. Urine with crystals should have elevated specific gravity.

4.4. Urine with positive nitrite should have bacteria on the microscopic.

5. CRITICAL VALUES:

1. When the following values are encountered after a urinalysis testing, immediately notify the physician or senior ward/clinic nurse of the values encountered.

|Analyte |Critical Results: All ages unless otherwise noted |

| Waxy Casts |Any |

|Red Blood Cell Cast |Any |

|Cystine Crystals |Any |

|Tyrosine Crystals |Any |

|Leucine Crystals |Any |

|Sperm |Any - Females < 16yrs old |

5.2. Critical values must be reported in accordance with the laboratory critical value policy.

5.2.1. All critical microscopic sediment must be verified by the laboratory supervisor before reporting to the physician/nurse and before certifying results in the LIS.

5.2.2. All results must be read back by the physician/nurse and the notification & read back documented in the LIS.

5.2.3. The pathologist must also be notified within 2 hours and will determine if a pathologist review is required.

U.2.9. PROCEDURAL NOTES:

1. NORMAL CHARACTERISTICS OF THE URINE: The yellow color of the urine is due largely to the pigment urochrome and small amounts of urobilin and uroerythrin. Normal urine is essentially clear, and the presence of particulate matter in uncentrifuged urine needs to be explained microscopically. Normal urine has a faint, aromatic odor of undetermined source.

2. Microscopic Sediment:

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. 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.

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.

4. Casts: 0-1 hyaline cast/LPF is found in normal urine. Increased numbers or more advanced types indicate proteinuria.

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.

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 |

|Amorphous Urates |Amorphous Phosphates |Cystine |None |

|Uric Acid |Triple Phosphates |Tyrosine | |

|Calcium Oxalate |Ammonium Biurates |Leucine | |

| |Calcium Phosphates |Sulfonamide (Sulfadiazine) | |

| |Calcium Carbonates | | |

7. Mucus: Light mucus is normally found in urine and can sometimes be confused with hyaline casts.

8. Spermatozoa: A few are normally found in urine from normal males. Increased numbers are found in prostatic disease.

2.9. Trichomonas: Normally not found in urine. Presence of trichomonas is abnormal and may indicate infection.

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. Cast matrices:

5.11.1.1. Hyaline casts: Are translucent cylindrical structures composed of mucoprotein. Increased numbers are seen with renal diseases and transiently with exercise, fever, congestive heart failure, and diuretic therapy.

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.

5.11.2. Cast Inclusions:

5.11.2.1. Granular casts are semitransparent cylinders containing small (fine) or large (coarse) granules. These granules represent plasma protein aggregates. Granular casts appear with glomerular or tubular diseases.

5.11.2.2. Fatty casts: Are semitransparent or granular cylinders containing large highly refractive vacuoles or droplets. Visible fat droplets are triglycerides or cholesterol esters. These are commonly seen when there is heavy proteinuria and are a feature of the nephrotic syndrome.

5.11.2.3. Crystal Casts: Crystalline inclusion in a semitransparent or granular cylinder. These casts indicate disposition of crystals in the tubule or collecting duct.

5.11.3. Cast Pigments:

5.11.3.1. Hemoglobin (Blood) casts: Appears yellow to red; sometimes the color is very pale and difficult to interpret. These casts are associated with glomerular disease.

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.

5.11.4. Cellular Casts:

5.11.4.1. Erythrocyte (Red Blood Cell) casts: Semitransparent or granular cylinders containing distinct erythrocyte. Disorders reflected in the presence of erythrocyte casts in the sediment may include acute glomerulonephritis, IgA nephropathy, lupus nephritis, subacute bacterial endocarditis, and renal infarction.

5.11.4.2. Leukocyte (White Blood Cell) Casts: Semitransparent or granular cylinders containing leukocytes. They may be seen pyelonephritis, glomerular diseases, interstitial nephritis, lupus nephritis, and nephrotic syndrome.

6. SOURCES OF ERROR:

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.

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:

1. SOP Validation Form and SOP Change Control

1. SOP Approval

1. Urinalysis Normal Quality Control Worksheet

2. Urinalysis Abnormal Quality Control Worksheet

3. Quality Control Parallel Testing Worksheet

4. Patient Result Form

5. Urine Crystal Properties

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.

3. Multistix 10 with SG Package Insert, Bayer Corporation; Diagnostics Division, 1999.

4. Kova Trol: Human Urinalysis Controls Package Insert, Hycor Biomedical Inc., 2001.

5. Manual Urinalysis by Bayer 10-SG Multistix SOP, U.1.1

6. Specific Gravity Determinations by Refractometer SOP, U.5.1

7. Clinitest Determination of Reducing Substances in Urine SOP, U.6.1

8. Acetest Determination of Ketones in Urine SOP, U.8.1

9. Ictotest Determination of Bilirubin in Urine SOP, U.9.1

10. SSA Determination of Protein in Urine SOP, U.10.1

Appendix 1

SOP VALIDATION

|SOP NAME: |

|U.2. Manual Urinalysis Microscopic Exam |

|Clear and specific title and principle: yes / no |

|Comments: |

|All necessary supplies, equipment, and materials are listed: yes / no |

|Comments: |

| |

| |

| |

|SOP is sufficiently detailed to be understood but not overly complex: yes / no |

|Comments: |

| |

|SOP text adequately describes process/procedure: yes / no |

|Comments: |

| |

| |

| |

| |

|SOP accomplishes purpose: yes / no |

|Comments: |

|Reviewed by: (Name & Title) ) |

| |

|Signature: __________________ Date: __________________ |

SOP CHANGE CONTROL

Date Change QA OIC Med. Dir.

| | | | | |

| | | | | |

| | | | | |

| | | | | |

Appendix 2

SOP APPROVAL

SIGNATURE DATE

|PREPARER | | |

|QA COORDINATOR | | |

|LABORATORY OIC | | |

|MEDICAL DIRECTOR | | |

ANNUAL REVIEW

REVIEWER SIGNATURE DATE REVIEWER SIGNATURE DATE

| | | | |

| | | | |

| | | | |

| | | | |

DOCUMENT COPY CONTROL DATE: ___________ # COPIES __________

LOCATIONS

| | | | |

| | | | |

| | | | |

| | | | |

| | | | |

| | | | |

| | | | |

| | | | |

SUPERSEDES:

DATE SOP RETIRED: __________

Appendix 3

|Urinalysis Dipstick and Microscopic Normal Control Log |

|Normal Control Lot#: |

|Abnormal Control Lot#: |  |  |  |Expiration: |  |

|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.

|New Lot Acceptable: |Yes / No |

|Comments: | |

| |

|Tech Signature: | |Date: | |

|Supervisor review : | |Date: | |

|Supervisor Comments: | |

Appendix 6 - Patient Manual Urinalysis Result Report

| | | |

|Hyaline Casts / LPF: | |0-1 | |

| | | | |

|Comments: | |

| |

| |

|Tech Signature: | |Report Date/Time: | |

|Supervisor review required for all |Yes / No |Signature: |Date: |

|critical values. Required? | | | |

|Comments: | |

Appendix 7 - Urine Crystal Properties

[pic]

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Technician: _______________________________ Date: ___________________________________

New Control Lot#: __________________________ Exp. Date: _________________________________

Current Control Lot#: _________________________ Exp. Date: _________________________________

Sample Information:

Date Collected: ____________________________

Time Collected: ____________________________

Ordering Physician & Clinic: _____________________

Patient Information:

Patient Name: _____________________________

ID# ___________________________________

Date of Birth: ______________________________

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