PROCEDURE: NUMBER: DATE: PAGE: VERSION: URINE MACROSCOPIC CN-UR4000 February 2001 1 OF 5 3 URINE MACROSCOPIC PURPOSE: To accurately perform a macroscopic examination of urine using: Urine dipsticks: Uristix® 4 and Multistix® 10 SG. This procedure has been prepared for the University Hospital (UUHSC) and Clinics. PRINCIPLE: Urinalysis is an aid in the evaluation of diseases of the urinary tract and other organ systems. It consists of quantitative and semi-quantitative physical and chemical determinations. The analysis consists of some or all of the following tests, according to your laboratory and methodology: Glucose: Measurement is based on a sequential reaction of two enzyme reactions. When glucose is present in the urine being tested, glucose oxidase catalyzes the production of gluconic acid and peroxide. Peroxidase reduces the peroxide with the simultaneous oxidation of a chromogen. Bilirubin: Based on the coupling of bilirubin with diazotized dichloroaniline in a strongly acid medium. Ketone: Measurement is based in principle on the reaction where sodium nitroferricyanide and glycine buffer react with acetoacetate in an alkaline medium to form a violet dye. Specific Gravity: This is measured on the reagent strip by the pKa change method. Blood: Detection is based on the pseudoperoxidase activity of hemoglobin, which catalyzes the reduction of peroxide and the simultaneous oxidation of a chromogen. pH: Based on the double indicator (methyl red and bromthymol blue) method. Protein: Detected by the protein-error-of-indicators principle. Urobilinogen: The test is based on a modified Ehrlich reaction in which ρ-diethylaminobenzaldehyde in conjunction with a color enhancer in an acid medium produces a pink-red color. Nitrite: Depends upon the conversion of nitrate (derived from the diet) to nitrite by the action of gram negative bacteria in the urine. At the acid pH of the reagent area, nitrite in the urine reacts with -arsanilic acid to form a diazonium compound. This compound couples with 1,2,3,4-tetra-hydrobenzo quinolin-3-ol to produce a pink color. Leukocytes: Granulocytic WBC’s contain esterases that catalyze the hydrolysis of the derivatized pyrrole amino acid ester to liberate 3-hydroxy-5-phenyl pyrrole. This pyrrole then reacts with a diazonium salt to produce a purple product. SCOPE: This procedure applies to personnel performing waived testing in the University Hospital (UUHSC) and Clinics. D:\533565823.doc PROCEDURE: NUMBER: DATE: PAGE: VERSION: URINE MACROSCOPIC CN-UR4000 February 2001 2 OF 5 3 URINE MACROSCOPIC PERSONAL PROTECTIVE EQUIPMENT: Performance of this procedure will expose testing personnel to biohazardous material and possible chemical hazards. This procedure may expose you to: [X] Hazardous reagents To perform this procedure, you must use: [X] Gloves [X] Protective Clothing (scrubs, lab coats..) Disinfect following procedure: [X] Sodium Hypochlorite, (Diluted bleach)- a 10% solution made fresh daily [X] Amphyl References for spill/decontamination: [X] MSDS [X] Chemical hygiene plan REAGENTS AND EQUIPMENT: NOTE: Be sure to label any reagents/controls with the open date and operator initials. Timing device (e.g. timer or watch) Multistix® 10 SG or Uristix® 4 reagent strips: 1. Store at Room temperature (15-30 C). 2. Store out of direct sunlight. 3. Store at all times with the cap tightly closed. 4. Good until expiration date on the container. KOVA Liqua-Trol (assayed) normal and abnormal controls: 1. Store at refrigerator temperature (2-8 C). 2. Store until expiration date on the box. Plastic transfer pipettes (optional) SPECIMEN COLLECTION: Collect: 10 mL aliquot of a random urine in a sterile container. Acceptable: 5 mL aliquot. Unacceptable: Frozen specimens Stability: Ambient: 1hour Refrigerated: 24 hours If testing cannot be done within an hour after voiding, refrigerate the specimen immediately and let sample return to room temperature before testing. D:\533565823.doc PROCEDURE: NUMBER: DATE: PAGE: VERSION: URINE MACROSCOPIC CN-UR4000 February 2001 3 OF 5 3 URINE MACROSCOPIC QUALITY CONTROL: Daily: 1. Record the storage conditions of all opened vials on the dipstick storage sheet each day the facility is open. When Opening New vials: 1. Urine controls need to be performed with each new vial of dipsticks. a) KOVA Liqua-trols are used and read like a patient sample (see the section titled PROCEDURE). b) Use the reference control sheet located in the KOVA Liqua-trol control box to determine if all constituents are within recommended range. 2. The results of the KOVA Liqua-trol normal and abnormal controls should be recorded on the appropriate MediTape report form. 3. If any results are out of range, remove another dipstick from the vial and repeat the same control solution. Note: If results are still out of range, open a new bottle of reagent strips and retest. If results are still out, open a new set of controls, and retest with the new reagent strips. If results still fall outside of range, DO NOT report out patient results. Send urine to the University of Utah Hospital Clinical Laboratory for testing. (Besure to document any corrective action that was taken for out of range controls). PROCEDURE: 1. Wear gloves when handling urine and Kova control solutions. 2. Check the sample and requisition for correct patient identification number. Allow urine to come to room temperature if previously refrigerated. 3. Mix sample well. Record color and appearance of urine as: Color: colorless, straw, yellow, brown, orange, red, green/blue orblack. Appearance: clear, hazy, turbid or cloudy. 4. Remove a dipstick from the container and replace cap. Completely immerse reagent areas of the strip in urine, (or if the sample is insufficient, place a small drop of urine on each test patch). Blot the urine dipstick (on one edge) on a paper towel to remove any excess urine and to prevent “run-over”. D:\533565823.doc PROCEDURE: NUMBER: DATE: PAGE: VERSION: URINE MACROSCOPIC CN-UR4000 February 2001 4 OF 5 3 URINE MACROSCOPIC 5. Using the timing device, read and record the results of the various chemical tests at the appropriate times: glucose: 30 seconds bilirubin: 30 seconds ketone: 40 seconds specific gravity: 45 seconds blood: 60 seconds pH : 60 seconds protein: 60 seconds urobilinogen: 60 seconds nitrite: 60 seconds leukocytes: 120 seconds (2 minutes) 6. Compare the results of the immersed dipstick to the color chart located on the side of the dipstick container and record the appropriate color changes. Note: Hold the strip close enough to color blocks and match carefully. Avoid laying the strip directly on the color chart, as this will result in the urine soiling the chart. REPORTING AND INTERPRETING RESULTS AND REFERENCE RANGES: Record the patient’s name, medical record number or DOB, testing location, date, time, patient’s result and performing individual’s initials on the appropriate MediTape or Clinic Specific report form. NORMAL OR REFERENCE RANGES: Specific gravity: pH: leukocytes: nitrite: protein: glucose: ketone: urobilinogen: bilirubin: blood: color: appearance: 1.001-1.035 4.5-8.0 negative negative negative negative negative up to 1 mg/dl negative negative yellow clear PROCEDURAL NOTES: 1. Unusually dark colored urines (bilirubin or hemolysis), or substances that cause abnormal urine color (pyridium®) may affect the readability and interpretation of the reagent pad. If colors cannot be read with certainty, report them as “Unable to interpret due to color interference”. D:\533565823.doc PROCEDURE: NUMBER: DATE: PAGE: VERSION: URINE MACROSCOPIC CN-UR4000 February 2001 5 OF 5 3 URINE MACROSCOPIC 2. Atypical colors on the bilirubin test pad, (colors that are unlike the negative or positive color blocks shown on the Color Chart) may indicate that bilirubin-derived bile pigments are present in the urine sample and may be masking the bilirubin reaction. These colors may indicate bile pigment abnormalities and the urine specimen should be tested further in the Clinical Laboratory. 3. Elevated levels of Ascorbic Acid/Vitamin C (greater than 50 mg/dl) may cause false negative results in specimens containing small amounts of glucose (75-125 mg/dL). 4. The glucose reactivity of the dipstick decreases as the specific gravity increases. 5. Elevated specific gravity readings may be obtained in the presence of moderate quantities (100-750 mg/dL) of protein. 6. The reactivity of the blood patch of the dipstick decreases as the specific gravity increases. 7. Microbial peroxidase associated with urinary tract infection (a positive Nitrite), may cause a false positive reaction on the blood reagent pad. 8. Myoglobin in the urine will result in a false positive test for blood. 9. Excess urine that remains on the strip (a phenomenon known as “runover”) may occur, causing the acid buffer from the protein reagent pad to run onto the pH area. This will cause a false lowering of the pH result. LIMITATIONS: 1. Do not store dipsticks in direct sunlight. 2. Do not use product after expiration date. 3. Strips need to be stored with the cap closed and at room temperature (15-30 F). REFERENCES: Clinical Diagnosis and Management by Laboratory Methods, John B. Henry, MD, 19th Edition, WB Saunders Co., 1996 Urinalysis and Body Fluids, Susan King Strasinger, ed. 2; 1989 Multistix® 10 SG product insert, Bayer Corp. Rev. 9/95 KOVA Liqua-trol Procedure (CN-UR2004 version 1). CLINICS USING THIS PROCEDURE: Family Practice (Wasatch) Women's Health and Breastcare University Hospital Clinics 2, 4, 6 Sugarhouse Family Clinic Emergency Room Dumke Building OB Care Now D:\533565823.doc PROCEDURE: NUMBER: DATE: Prepared by: Approved by: URINE MACROSCOPIC CN-UR4000 February 2001 Jane Bommersbach Kristin Baer URINE MACROSCOPIC APPROVED BY: DATE APPROVED: TECHNICAL SUPERVISOR APPROVAL: GROUP MANAGER APPROVAL: DATE ADOPTED: RETIRED: Copy # 1 2 REPLACES: October 1998 Location Master SOP Manual Family Practice, Women's Health and Breastcare at Wasatch Clinic, University Hospital Clinics 2, 4, 6, Sugarhouse Family Clinic, Emergency Room, Dumke Building, OB Care Now REVIEWED: Date ____________ By ____________________________ Comments ________________________________________ Date ____________ By ____________________________ Comments ________________________________________ Date ____________ By ____________________________ Comments ________________________________________ Date ____________ By ____________________________ Comments ________________________________________ AUTHORIZED TO APPROVE: Medical Director Assistant Medical Director AUTHORIZED TO REVIEW: Medical Director Assistant Medical Director Group Manager D:\533565823.doc