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Bassett Healthcare Network Laboratory:

Point of Care:

Title: ClinitekStatusProcedure

Revision: 1.0

Created By: Sharp, Lorie(Technical Specialist POC)

Last Approved Time: 6/4/2020 2:19:52 PM

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AUTOMATED & VISUAL URINE ANALYSIS Clinitek Status & Clinitek Status Plus

A. PURPOSE:

Urine is an ultrafiltrate of plasma continuously formed by the kidneys and consists of organic and inorganic chemical compounds dissolved in water. Urine is readily

available and easily collected and reveals much information about many of the body’s metabolic functions. A urine specimen submitted for routine analysis will have a dipstick macroscopic analysis performed. Examination of the concentrated urine sediment is

performed at the discretion of the ordering provider when a positive result is obtained. With the exception of a confirmatory test for bilirubin (submit to the clinical lab),

positive results are considered definitive for purposes of patient care and diagnoses. As a screen for UTI, positive results are followed up by culture confirmation. Confirmatory testing is referred to the Laboratory.

B. PRINCIPLE:

Automated Urine Chemistry Analyzer – Siemens Healthcare Diagnostics Clinitek Status and Clinitek Status Plus Reflectance Photometer. This method employs plastic strips (Multistix 10 SG) bearing pads impregnated with specific reagents to determine the

presence of various chemical substances in urine. The methodology permits detection and semiquantitation of the following:

pH Leukocyte Esterase Glucose Urobilinogen Protein Ketones

Bilirubin Blood Nitrite Specific gravity

*See package insert for specifics on testing methodology - (Addendum A) C. SPECIMEN COLLECTION AND REQUIREMENTS:

1. Any single-voided urine specimen can be tested. 2. Urine may be collected in a sterile (required if culture is also needed) or non-sterile

container. Label with the patient label which includes name, medical record # or DOB. Collector will document time, date and collector’s initials.

3. Do not modify the urine with any chemical preservative.

4. If testing cannot be done within one hour (when urine may be submitted for culture) or a maximum of two hours without culture after voiding, refrigerate the specimen

immediately; maximum refrigeration storage time is 24 hours. Return to room temperature and mix well prior to testing.

D. REAGENTS AND MATERIALS: 1. Multistix 10 SG – Siemens Healthcare Diagnostics (Warehouse item, Stock #26042).

Storage temperature is 15 to 30°C. Stability is to manufacturer’s outdate or failed QC (inspect the pads on the reagent strip for faded color). Document opened and expiration date, and initials on each bottle with the outdate labels provided by POC.

Recommended Procedures for Handling Multistix 10 SG

Do not store the bottle in direct sunlight.

Store the bottle tightly capped at all times.

Do not remove the desiccant insert.

Do not remove strip from bottle until immediately before it is to be used for

testing.

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Do not touch reagent areas of the strip.

Dip test areas in urine completely, but briefly, to avoid dissolving out the reagents.

Document opened and expiration date and initials on each bottle.

All unused strips must remain in the original bottle. Transfer to any other

container may cause reagent strips to deteriorate and become unreactive.

2. Alta Diagnostic Urine Controls – Positive and Negative (Requisition for POC

Supplies). Storage temperature is 2 to 8°C until manufacturer outdate or 15 to 27°C for eight weeks when stored away from ultraviolet light. Discard the control if turbid

or any evidence of microbial contamination is present. Do not freeze.

3. Instrumentation: Clinitek Status or Clinitek Status Plus Urine Chemistry Analyzer –

Siemens Healthcare Diagnostics. Ambient operating temperature range is 18 to 30°C. The instrument performs a system test each time it is turned on. Then, each time a test

is run, the instrument automatically calibrates. The white calibration bar (on the test table) provides NIST traceable calibration.

4. Timer – calibrated (obtain from Point of Care).

5. Printer paper (warehouse order #06F17-11) E. QUALITY CONTROL:

The control is designed specifically to react with commercial dipsticks to register known responses on the color pads. The Urine Controls should be used in the same manner as a

patient sample and routinely used for day-to-day quality control of the assay system. Frequency

Two levels of quality control, a negative and a positive, must be run each day of patient testing at the beginning of the work shift for both automated and visual

(only if testing patients visually).

Two levels of quality control, a negative and a positive, must be run with each

new bottle of the same lot Multistix 10 SG.

Two levels of quality control, a negative and a positive, must be run with each

new shipment of the same lot Multistix 10 SG.

Two levels of quality control, a negative and a positive, must be run with each

new lot number of Multistix 10 SG.

Two levels of quality control, a negative and a positive, must be run monthly if reagents are stored for more than 30 days.

1. Quality Control:

Document opened and expiration date and operator’s initials on each bottle using outdate labels provided.

Bring controls to room temperature for 15 minutes prior to testing. Mix well prior to testing.

Immediately recap the controls and return them to 2-8C when not in use, or store at 15-27°C for 8 weeks.

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2. Expected Values: A reference sheet for each lot and quality control documentation logs are provided by

the POC Office when your QC is distributed. Document all QC results on the appropriate logs. Indicate on the QC log if visual QC is done by checking the box for

visual. The values assigned to each constituent are derived from the assay of multiple vials that are representative of the lot. Results for each level of control should fall within expected ranges. Out of range results are repeated and documented. Failure to

obtain expected results or difficulty with instrument function (if applicable) necessitates corrective action prior to analyzing patient samples. Do not proceed with

patient testing if any values are out of range. If the problem cannot be resolved on site, please contact the Point of Care office X6728 and send patient samples to the clinical laboratory for testing.

3. Warnings and Precautions:

Potentially Biohazardous Material – wear PPE when handling. This product contains human source materials. No known test method can assure that a product derived from human source does not contain hepatitis or HIV-1 virus.

WARNING: HANDLE AS IF CAPABLE OF TRANSMITTING INFECTION.

F. PROCEDURE – QC:

1. Turn the instrument on by pressing the on/off button located on the front of the instrument.

2. System Test – this is the first screen that is displayed. The analyzer will run an automatic system diagnostic test.

3. To begin testing a urinalysis strip test, touch Strip Test on the analyzer touch screen. 4. Next select “Enter Operator ID”, enter your M# as the operator ID and select “Enter”

(the keypad can be set to default to numeric in instrument set up).

5. On the next screen that appears, select “Enter New Patient ID”. The QC information must be documented in both fields. In the first screen, “Enter Patient Name” enter

“Positive or Negative” depending on level run, select “Enter”. In the second screen, “Enter Patient ID”, enter the “Alta QC Lot #”, select “Enter”.

6. Remove a strip from the bottle and replace the cap.

7. If you are ready to begin testing, touch the Start button. You now have 8 seconds to complete the next four steps.

8. Remove dropper bottle cap, invert (do no shake) and apply control material directly onto the dipstick. With the tip of the bottle not touching the dipstick, draw the tip across all of the reagent pads, while gently squeezing the sides of the dropper bottle

including the ID band (reagent strips with ID bands provide auto check including automatic strip identification and quality checks).

9. Excess control material may be removed by tilting the dipstick on edge and briefly resting on a paper towel.

10. Place the reagent strip in the channel of the table with the test pads facing up. Slide

strip to the end of the channel. 11. At the end of the 8-second countdown, the test table and strip will automatically be

pulled into the analyzer. *If analyzer does not initially read the strip, discard the test strip. Correct the malfunction and retest with a freshly dipped reagent strip.

12. A timer will count down the time remaining in analyzing the strip results. The operator will enter the color as yellow and the clarity as clear via the touch screen.

13. Results will print via the internal printer. They will also be visible on the analyzer screen

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14. Remove the reagent strip and discard in the proper container. 15. Wipe the test strip table with a damp, lint free tissue after each test strip.

16. Document the QC results on the corresponding Alta QC Log by lot # and corresponding QC level.

G. PROCEDURE FOR AUTOMATED PATIENT TESTING

1. Turn the instrument on by pressing the on/off button located on the front of the

instrument. 2. System Test – this is the first screen that is displayed. The analyzer will run an

automatic system diagnostic test. 3. To begin testing the sample use a well-mixed urine (do not centrifuge). 4. Touch “Strip Test” on the analyzer screen.

5. Next select “Enter New Operator Name”, enter your M# as the operator name and select “Enter” (the keypad can be set to default to numeric in instrument set up).

6. On the next screen that appears, select “Enter New Patient”. The patient ID must have two forms of identification. In the first screen, “Enter Patient Name” enter last name, first name, select “Enter”. In the second screen, “Enter Patient ID”, enter the

CSN #, select “Enter”. 7. Remove a strip from the bottle and replace the cap.

8. If you are ready to begin testing, touch the Start button. You now have 8 seconds to complete the next four steps.

9. Immediately dip the reagent strip into a well-mixed urine sample wetting all pads,

including the ID band (reagent strips with ID bands provide auto check including automatic strip identification and quality checks). Immediately remove the strip from

the urine. 10. Drag the edge of the strip against the side of the sample container as you remove it. 11. Excess control material may be removed by tilting the dipstick on edge and briefly

resting on a paper towel. 12. Place the reagent strip in the channel of the table with the test pads facing up. Slide

strip to the end of the channel. *If analyzer does not initially read the strip, discard the test strip. Correct the malfunction and retest with a freshly dipped reagent strip.

13. At the end of the 8 second countdown, the test table and strip will automatically be

pulled into the analyzer. 14. A timer will count down the time remaining in analyzing the strip results. The

operator will assess color and clarity, then enter color and clarity into the analyzer via the touch screen.

15. Results will print via the internal printer. They will also be visible on the analyzer

screen. The test pads are “read” by the instrument and the results are displayed or printed as soon as they are available in semi-quantitative units of measure.

16. Remove the reagent strip and discard in the proper container. 17. Wipe the test strip table with a damp, lint free tissue after each test strip. Also, wipe

the table after testing a urine that is visibly bloody or that gives a very high result on

any test pad. Heavily mucoid or bloody urines may require an additional feed table daily cleaning procedure.

18. Store Clinitek printouts for patient testing and QC for duration of two years.

H. PROCEDURE FOR VISUAL PATIENT AND QC TESTING

With visual use, results are obtained in clinically meaningful units directly from the Color Chart comparison.

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1. Remove one strip from bottle and replace cap. Completely immerse reagent areas of the strip into a well-mixed urine, remove immediately to avoid dissolving out

reagents or dispense the QC from the tip of the dropper bottle. Start the timer. 2. While removing, run the edge of the strip against the rim of the urine container to

remove excess urine or remove excess control material by tilting the dipstick on edge and briefly resting on a paper towel.

3. Hold the strip in a horizontal position to prevent possible mixing of chemicals from

adjacent reagent areas and/or contaminating the hands with urine. 4. To read visually, compare reagent areas to corresponding Color Chart on the bottle

label at the time specified starting with the shortest time analyte, glucose.

Read the glucose and bilirubin tests at 30 seconds

Read the ketone test at 40 seconds

Read the specific gravity test at 45 seconds

Read the pH, protein, urobilinogen, blood, and nitrite at 60 seconds

Read the leukocytes at two minutes

Hold strip close to color blocks and match carefully. Read the pads in good light. Avoid laying the strip directly on the color chart, as this will result in the urine

contaminating the Multistix 10SG vial. Proper read time is critical for optimal results. Color changes that occur after two minutes are of no diagnostic value.

5. Have a second person record the results as they are being read.

When reading visually:

After dipping the strip, check the pH area. If the color on the pad is not uniform, repeat testing.

I. REFERENCE RANGE

Microscopic

Parameter Population Units Reference Range Color All populations None Yellow, straw or

colorless

Appearance All populations None Clear Specific Gravity All populations None 1.003-1.024

pH All populations None 5.0-8.0 Protein All populations mg/dL Negative

Glucose All populations mg/dL Negative

Ketone All populations mg/dL Negative Bilirubin All populations None Negative

Blood All populations None Negative Urobilinogen All populations Eu/dL < 1.0

Nitrite All populations None Negative Leuk Esterase All populations None Negative

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J. CRITICAL VALUE

Urine Glucose – Pediatrics (< 17) and OB > 100 mg/dL

Urine Ketones – Pediatrics (< 17) and OB > 40 mg/dL

Follow critical value policy for provider notification and documentation.

K. RESULTS DOCUMENTATION: EPIC order – POCT Urinalysis Dipstick (POC5)

Results are reported in Epic. The test is ordered and released. Enter the required data through the Enter/Edit Results function. Complete all fields with a RED STOP SIGN. Accept filed data when completed. See example below.

Critical Values Document Critical Values under the Narrative tab, enter POC in the smart text box. Select ***, accept. Use the F2 key to complete the documentation where the *** appear.

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Downtime Log – In the event of EPIC or a network downtime, testing is ordered and

results are documented on the Point of Urinalysis (H8519). This record is scanned into the patient’s EPIC chart for a permanent record.

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L. LIMITATIONS: For limitations of each analyte refer to package insert attached to this

procedure (Addendum A) or by contacting the Point of Care Office. Limitations given for the reagents include specific substances and conditions that may affect the test results.

As with all laboratory tests, definitive diagnostic or therapeutic decisions should not be based on a single results or method.

Substances that cause abnormal urine color may affect the readability of test pads on urinalysis reagent strips. These substances include visible levels of blood or bilirubine

and drugs containing dyes (e.g., Pyridium, Azo Gantrisin, Azo Gantano), nitrofurantoin (Macrodantin, Furadantine), or riboflavin. Levels of ascorbic acid normally found in urine do not interfere with these tests.

Indications of Deterioration: Discoloration or darkening of reagent areas may

indicate deterioration. If this is evident, or if test results are questionable or inconsistent or if QC is out of range with expected finding:

Confirm that the product is within the expiration date shown on the label. Check performance with control strips. If problem cannot be resolved, open new bottle of strips.

If still a problem, consult the POC office.

Do not read any test pad after 2 minutes, color changes that occur after this time are of no diagnostic value.

Contamination of the urine specimen with skin cleansers containing chlorhexidine

may affect protein (and to a lesser extent specific gravity and bilirubin test results). The user should determine whether use of such skin cleansers is warranted.

It is especially important to use fresh urine to obtain optimal results with the tests for bilirubin and urobilinogen, as these compounds are very unstable when exposed to

room temperature and light.

M. MAINTENANCE:

1. Daily: The test strip table must be kept clean if the instrument is to provide accurate test

results and operate correctly. Clean the table insert and check the white bar at the end of every day. Do not touch the white bar. Clean the entire table periodically, at

least weekly, or if visibly soiled. a) Remove the table insert daily and thoroughly clean by rinsing both sides under

running water. Dry and replace.

b) Remove the test strip table by slowly pulling it straight out of the instrument. c) Wet a cotton-tipped stick with water. Thoroughly scrub the trough and

surrounding areas. Rinse the entire table (both top and bottom) with water. d) Dry the table thoroughly (except for the white bar) with a soft cloth or lint-free

tissue.

e) Check the white bar for dust, marks, or scratches. If it is dirty, wet a new cotton-tipped stick and gently wipe the bar. Allow the white bar to air dry and check it

again. If it is scratched or scuffed, or if it cannot be cleaned, replace the table. Do not use anything that will scratch the white bar. Do not use solvents of any kind to clean the bar.

f) Record maintenance performed on Health Center Maintenance Log with date and initials.

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2. Periodic cleaning: a) Disinfecting the Test Table and Test Table Insert – see Operator’s Manual.

b) Cleaning the White Calibration Bar – see Operator’s Manual.

3. Changing paper - see Operator’s Manual. N. TROUBLESHOOTING:

Refer to the Operator’s Manual for Error Codes and possible solutions. If problem cannot be resolved, an alternate testing method can be used. If for any reason the

analyzer is inoperable, or the controls are not within acceptable range, urinalysis is to be done visually providing visual QC is acceptable. Contact the POC office 547-6728 for assistance.

O. REFERENCES:

1. Modern Urine Chemistry – a guide to the diagnostics of urinary tract diseases and metabolic disorders, Ames Division, Miles Laboratory, Elkart, IN, 1979.

2. Strasinger, S.: Urinalysis and Body Fluids, F.A. Davis Co, Philadelphia, PA, pages 2-

8, 1985. 3. Todd, J., and Sanford, A.: Clinical Diagnosis by Laboratory Methods, W.B.Saunders

Co., pages 559-631, 1979. 4. A Handbook of Routine Urinalysis, J.B. Lippencott Co., Philadelphia, PA, 1983. 5. Siemens Healthcare Diagnostics Multistix 10 SG product information and instruction

sheet, # AN30516G, revision 04/99. 6. Alta Diagnostics product information sheet, revision 10/25/11.

7. Siemens Healthcare Diagnostics Clintek Status Operator Manual 10490853 Rev.C, 2011-12.

8. Siemens Multistix 10 SG package insert 7/2017.

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ADDENDUM A

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Title: ClinitekStatusProcedure Created Time: 6/1/2020 5:44:47 PM

Original Approver: Dr. Samantha Davenport

Metatags: Automated and visual

Approval Workgroup: POC Network Major Approval Groups

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Last Approved By: Chapman , Timothy MD(Sr. Attending Physician, Lab) (6/4/2020 2:19:52 PM)

Spoon, Victoria(Manager, Pathology/Cytol.) (6/2/2020 9:16:10 AM)

Davenport, Samantha MD(Chief of Service, Laboratory) (6/2/2020 9:05:59 AM)

Bush, Valerie PhD(Clinical Director) (6/2/2020 7:59:49 AM)

Fisk, John MD(Sr Attending Physician, Path) (6/2/2020 7:42:54 AM)

Sastry, Simha MD(Sr Attending Physician, Path) (6/19/2020 3:02:26 PM)

Sharp, Lorie(Technical Specialist POC) (6/1/2020 5:46:11 PM)

Last Updated Time: 6/19/2020 3:02:26 PM

Folder Name: POC\POC Network 14 of 14