Master

Urinalysis Checklist
CAP Accreditation Program

College of American Pathologists

325 Waukegan Road
Northfield, IL 60093-2750
www.cap.org 12.26.2024
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Urinalysis Checklist 12.26.2024

Disclaimer and Copyright Notice

CAP inspections are performed with the edition of the Checklists mailed to a facility at the completion
of the application or reapplication process, not necessarily those currently posted on the website. The
checklists undergo regular revision and a new edition may be published after the inspection materials
are sent.

For questions about the use of the Checklists or Checklist interpretation, email accred@cap.org or call
800-323-4040 or 847-832-7000 (international customers, use country code 001).

The Checklists used for inspection by the College of American Pathologists' Accreditation Programs
have been created by the CAP and are copyrighted works of the CAP. The CAP has authorized copying
and use of the checklists by CAP inspectors in conducting laboratory inspections for the Council on
Accreditation and by laboratories that are preparing for such inspections. Except as permitted by section
107 of the Copyright Act, 17 U.S.C. sec. 107, any other use of the Checklists constitutes infringement
of the CAP's copyrights in the Checklists. The CAP will take appropriate legal action to protect these
copyrights.

All Checklists are ©2024. College of American Pathologists. All rights reserved.
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Urinalysis Checklist

TABLE OF CONTENTS

SUMMARY OF CHANGES....................................................................................................................4
INTRODUCTION.................................................................................................................................... 6
QUALITY MANAGEMENT.....................................................................................................................6
SPECIMEN COLLECTION AND HANDLING......................................................................................................................6
CONTROLS AND STANDARDS – WAIVED TESTS..........................................................................................................7
CONTROLS AND STANDARDS – NONWAIVED TESTS.................................................................................................. 9
Calibration...................................................................................................................................................................... 9
Controls for Nonwaived Tests..................................................................................................................................... 10
INSTRUMENTS AND EQUIPMENT.................................................................................................................................. 13
PROCEDURES AND TEST SYSTEMS...............................................................................................13
URINALYSIS PARAMETERS............................................................................................................................................ 13
URINALYSIS - MANUAL MICROSCOPY..........................................................................................................................14
AUTOMATED AND SEMI-AUTOMATED SYSTEMS........................................................................................................ 16
Dipstick Readers..........................................................................................................................................................16
Automated Microscopy Systems................................................................................................................................. 17
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ON-LINE CHECKLIST DOWNLOAD OPTIONS

Participants of the CAP accreditation programs may download the checklists by logging into cap.org and going
to e-LAB Solutions Suite - Accreditation Checklists. They are available in different checklist types and formatting
options, including:
●
Master — contains ALL of the requirements and instructions available in PDF, Word/XML or Excel formats
●
Custom — customized based on the laboratory's activity (test) menu; available in PDF, Word/XML or Excel
formats
●
Changes Only — contains only those requirements with significant changes since the previous checklist
edition in a track changes format to show the differences; in PDF version only. Requirements that have
been moved or merged appear in a table at the end of the file.

CHECKLIST ACCREDITATION RESOURCES

CAP accredited laboratories have access to additional checklist accreditation tools and resources found on
the CAP website (cap.org) by logging into e-LAB Solutions Suite - Accreditation Resources. Content found in
Accreditation Resources includes:
●
A library of past Focus on Compliance webinars and laboratory inspection preparation videos
●
Answers to the most common checklist questions
●
Customizable templates and forms (eg, competency assessment, personnel, validation/verification, quality
management)
●
Proficiency testing (PT) frequently asked questions, forms, and troubleshooting guides
●
IQCP eligibility, frequently asked questions, forms, templates, and examples
●
Laboratory director education and resources
●
Quality management resources
●
Inspector training and inspection tip sheets
●
Self and post inspection toolbox

SUMMARY OF CHECKLIST EDITION CHANGES

Urinalysis Checklist
12/26/2024 Edition

The information below includes a listing of checklist requirements with significant changes
in the current edition and previous edition of this checklist. The list is separated into three
categories:
1. New
2. Revised:
●
Modifications that may require a change in policy, procedure, or process for continued compliance; or
●
A change to the Phase
3. Deleted/Moved/Merged:
●
Deleted
●
Moved — Relocation of a requirement into a different checklist (requirements that have been
resequenced within the same checklist are not listed)
●
Merged — The combining of similar requirements

NOTE: The requirements listed below are from the Master version of the checklist. The customized checklist
version created for inspections and self-evaluations may not list all of these requirements.

Previously Cited Checklist Requirements

●
The inspector's version of the checklist contains a listing of previously cited checklist requirements.
Specific information on those citations, including the inspection date and inspector comments, is included
following each related requirement within the checklist.
●
Laboratories can access data on previously cited deficiencies by logging into e-LAB Solutions Suite on
cap.org and going to Accreditation Reports - Inspection Summation Report.
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NEW Checklist Requirements

None

REVISED Checklist Requirements

None

DELETED/MOVED/MERGED Checklist Requirements

None
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INTRODUCTION

This checklist is used in conjunction with the All Common and Laboratory General Checklists to inspect a
urinalysis laboratory section or department.

Certain requirements are different for waived versus nonwaived tests. Refer to the checklist headings and
explanatory text to determine applicability based on test complexity. The current list of tests waived under CLIA
may be found at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfClia/analyteswaived.cfm.

Policy/Procedure icon - The placement of this icon next to a checklist requirement indicates that a written
policy or procedure is required to demonstrate compliance with the requirement. The icon is not intended to
imply that a separate policy or procedure is required to address individual requirements. A single policy or
procedure may cover multiple checklist requirements.

Laboratories not subject to US regulations: Checklist requirements apply to all laboratories unless a specific
disclaimer of exclusion is stated in the checklist. When the phrase "FDA-cleared/approved test (or assay)" is
used within the checklist, it also applies to tests approved by an internationally recognized regulatory authority
(eg, CE-marking).

QUALITY MANAGEMENT

SPECIMEN COLLECTION AND HANDLING

Inspector Instructions:
●
Sampling of urinalysis specimen collection and handling policies and procedures

●
Urine collection instructions for patients

●
What is your course of action when you receive unacceptable urine specimens?

URN.22000 Urine Specimen Collection Phase II

Written instructions are provided to patients and personnel for the proper collection of
clean voided urine specimens (ie, in nursing procedure manual or in specimen collection
area).
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NOTE: Proper collection of urine specimens is important to avoid contamination, or deterioration

of constituents. Instructions must be available to all personnel that collect urine specimens to
outline proper specimen collection. While not required, the CAP suggests having instructions in
foreign languages common to the population served by the laboratory.
REFERENCES
1) Clinical and Laboratory Standards Institute (CLSI). Urinalysis; Approved Guideline - Third Edition. CLSI Document GP16-A3. (ISBN
1-56238-687-5). Clinical and Laboratory Standards Institute, 940 West Valley Road, Suite 1400, Wayne, PA 19087-1898, USA, 2009.

URN.22300 Urine Specimen Examination Phase II

Urine specimens without chemical preservative or refrigeration are examined within two
hours of collection.
Evidence of Compliance:
✓ Records of time of collection and examination
REFERENCES
1) Haber MH. Quality assurance in urinalysis. Clinics in Lab Med. 1998;8:432-436
2) Clinical and Laboratory Standards Institute (CLSI). Urinalysis; Approved Guideline - Third Edition. CLSI Document GP16-A3. (ISBN
1-56238-687-5). Clinical and Laboratory Standards Institute, 940 West Valley Road, Suite 1400, Wayne, PA 19087-1898, USA, 2009.
3) Howanitz PJ, et al. Timeliness of urinalysis. A College of American Pathologists Q-Probes study of 346 small hospitals. Arch Pathol
Lab Med. 1997;121:667-672
4) Semeniuk H, et al. Evaluation of the leukocyte esterase and nitrite urine dipstick screening tests for detection of bacteriuria in women
with suspected uncomplicated urinary tract infections. J Clin Microbiol. 1999;37:3051-3052

URN.22400 Urine Preservation Phase II

The laboratory uses defined methods for urine preservation (refrigeration or specified
preservative) for all tests when analysis will be delayed.

NOTE: If testing is unavoidably delayed (night collection, etc.), the laboratory must define the
method for appropriate preservation of specimens to maintain integrity of cells and formed
elements.
●
Refrigeration of urine may be acceptable because it inhibits bacterial growth; however, it
does not prevent the lytic effects of low specific gravity or alkaline pH and may induce urine
crystal formation.
●
Preparations that contain boric acid/sorbitol or release formaldehyde may be effective
preservatives for some, but not all, urine tests. If preservatives are used, the procedure
must include instructions to indicate which preservative was added. In addition, the testing
procedure must also identify any pre-analytic errors attributable to such preservatives.
REFERENCES
1) Delanghe JR, Speeckaert MM. Preanalytics in urinalysis. Clin Biochem. 2016;49(18):1346-50.
2) Clinical and Laboratory Standards Institute (CLSI). Urinalysis; Approved Guideline - Third Edition. CLSI Document GP16-A3. (ISBN
1-56238-687-5). Clinical and Laboratory Standards Institute, 940 West Valley Road, Suite 1400, Wayne, PA 19087-1898, USA, 2009.
3) Howanitz PJ, et al. Timeliness of urinalysis. A College of American Pathologists Q-Probes study of 346 small hospitals. Arch Pathol
Lab Med. 1997;121:667-672

CONTROLS AND STANDARDS – WAIVED TESTS

Inspector Instructions:
●
Sampling of quality control policies and procedures
●
Sampling of QC records
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●
Sampling of QC materials (labeling, storage)

●
How do you determine when quality control is unacceptable and when corrective actions
are needed?

●
Review a sampling of QC data over the previous two-year period. Select several
occurrences in which QC is out of range and follow records to determine if the steps
taken follow the laboratory procedure for corrective action

URN.24320 QC - Waived Tests Phase II

The laboratory follows manufacturer's instructions for quality control, reviews results, and
records acceptability prior to reporting patient results.

NOTE: Quality control must be performed according to manufacturer's instructions. To detect

problems and evaluate trends, testing personnel or supervisory staff must review quality control
data on days when controls are run prior to reporting patient results. The laboratory director or
designee must review QC data at least monthly or more frequently if specified in the laboratory
QC policy.
With respect to internal controls, acceptable control results must be recorded, at a minimum,
once per day of patient testing for each device.*
*Acceptable internal control results need not be recorded, if (and only if) an unacceptable
instrument control automatically locks the instrument and prevents release of patient results.
Evidence of Compliance:
✓ Records showing confirmation of acceptable QC results

URN.24330 QC Corrective Action - Waived Tests Phase II

The laboratory performs and records corrective action when control results exceed
defined acceptability limits.

URN.24342 Calibration, Calibration Verification - Waived Tests Phase II

For waived tests, the laboratory follows manufacturer's instructions for calibration,
calibration verification, and related functions.
Evidence of Compliance:
✓ Records for calibration/calibration verification/related functions documented as required by
the manufacturer AND
✓ Records of recalibration or other appropriate corrective action when calibration verification is
unacceptable
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CONTROLS AND STANDARDS – NONWAIVED TESTS

CALIBRATION

NOTE: Explanatory notes on calibration may be found in the Chemistry checklist.

Inspector Instructions:
●
Sampling of calibration policies and procedures
●
Sampling of calibration/calibration verification records

●
What is your course of action when calibration is unacceptable?
●
When was the last time you performed a calibration procedure and how did you verify the
calibration?

●
Further evaluate the responses, corrective actions and resolutions for unacceptable
calibration results

URN.24345 Calibration Procedure Phase II

The laboratory calibrates each test system as defined and reviews the calibration records
for acceptability.

NOTE: Calibration is the process of adjusting an instrument or test system to establish a

relationship between the measurement response and the concentration or amount of an analyte
that is being measured by the test procedure.
Calibration of FDA-cleared/approved methods must be performed following the manufacturer's
instructions, at minimum, including the number, type, and concentration of calibration materials,
frequency of calibration, and criteria for acceptable performance.
REFERENCES
1) Department of Health and Human Services, Centers for Medicare and Medicaid Services. Clinical laboratory improvement
amendments of 1988; final rule. Fed Register. 2003(Jan 24): [42CFR493.1255]

URN.24355 Calibration/Calibration Verification Criteria Phase II

Criteria for the frequency and the acceptability of calibration or calibration verification are
defined and followed.

NOTE: Laboratories must either recalibrate or perform calibration verification at least every six
months and if any of the following occur:
1. At changes of reagent lots unless the laboratory can demonstrate that the use of different lots
does not affect the accuracy of patient/client results
2. If QC shows an unusual trend or shift or is outside of acceptable limits, and the system
cannot be corrected to bring control values into the acceptable range
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3. After major maintenance or service

4. When recommended by the manufacturer
Evidence of Compliance:
✓ Records of calibration verification at defined frequency
REFERENCES
1) Department of Health and Human Services, Centers for Medicare and Medicaid Services. Clinical laboratory improvement
amendments of 1988; final rule. Fed Register. 2003(Jan 24):7165 [42CFR493.1255]
2) Miller WG. Quality control. In: Henry's Clinical Diagnostic and Management by Laboratory Methods, 21st Edition, ed McPherson RA,
Pincus MR, Saunders Elsevier, 2007:99-111.

URN.24365 Recalibration Phase II

The test system is recalibrated when calibration verification fails to meet the established
criteria of the laboratory.
Evidence of Compliance:
✓ Records of recalibration, if calibration or calibration verification has failed
REFERENCES
1) Department of Health and Human Services, Centers for Medicare and Medicaid Services. Clinical laboratory improvement
amendments of 1988; final rule. Fed Register. 2003(Jan 24):7165 [42CFR493.1255]

CONTROLS FOR NONWAIVED TESTS

Inspector Instructions:
●
Sampling of quality control policies and procedures
●
Sampling of QC records, including external and internal quality control processes

●
How do you determine when QC is unacceptable and when corrective actions are
needed?
●
How does your laboratory verify or establish acceptable quality control ranges?

●
Review a sampling of QC data over the previous two-year period. Select several
occurrences in which QC is out of range and follow records to determine if the steps
taken follow the laboratory procedure for corrective action
●
Use QC data to identify tests that utilize internal quality control processes to confirm
that any individualized quality control plan (IQCP) is used as approved by the laboratory
director

URN.24370 Daily QC - Nonwaived Tests Phase II

The laboratory performs controls for quantitative and qualitative tests each day of testing,
or more frequently if specified in manufacturer's instructions, laboratory procedure, or the
CAP Checklist, and when changes occur that may impact patient results.

NOTE: The laboratory must define the number and type of quality control used and the frequency
of testing for each test performed. Control testing is not required on days when patient testing is
not performed.
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Controls must be run prior to resuming patient testing when changes occur that may impact
patient results, including after a change of analytically critical reagents, major preventive
maintenance, change of a critical instrument component, or with software changes, as
appropriate.
Daily quality controls must be run as follows:
●
Quantitative tests - two controls at different concentrations at least daily
●
Qualitative tests - a negative control and a positive control (when applicable) at least daily
If an internal quality control process (eg, electronic/procedural/built-in) is used instead of an
external control material to meet daily quality control requirements, the laboratory must have
an individualized quality control plan (IQCP) approved by the laboratory director defining the
control process, including the frequency and use of external and internal controls. At a minimum,
external control materials must be analyzed with new lots and shipments of reagents or more
frequently if indicated in the manufacturer's instructions. Please refer to the IQCP section of the
All Common Checklist for the eligibility of tests for IQCP and requirements for implementation
and ongoing monitoring of an IQCP.
Evidence of Compliance:
✓ Records of QC results including external and internal control processes AND
✓ Manufacturer product insert or manual
REFERENCES
1) Department of Health and Human Services, Centers for Medicare and Medicaid Services. Clinical laboratory improvement
amendments of 1988; final rule. Fed Register. 2003(Jan 24):3708 [42CFR493.1256(d)(3)(ii)], [42CFR493.1256(d)(6)].
2) Clinical and Laboratory Standards Institute (CLSI). Evaluation of Qualitative, Binary Output Examination Performance; 3rd ed. CLSI
document EP12. Clinical and Laboratory Standards Institute, Wayne, PA; 2023.
3) Department of Health and Human Services, Centers for Medicare and Medicaid Services. S & C: 16-20-CLIA: Policy Clarification on
Acceptable Control Materials Used when Quality Control (QC) is Performed in Laboratories. April 8, 2016.

URN.25280 Control Range Establishment or Verification Phase II

The laboratory establishes or verifies an acceptable control range for each lot of control
material.

NOTE: For unassayed control materials, the laboratory must establish an acceptable control
range by repetitive analysis in runs that include previously tested control material. For assayed
control materials, the laboratory must verify control ranges supplied by the manufacturer.
Control values supplied by the manufacturer may be used without verification for qualitative (eg,
positive or negative) testing.
Evidence of Compliance:
✓ Records for control range establishment or verification of each lot

URN.25287 Alternative Control Procedures Phase II

If the laboratory performs test procedures for which control materials are not
commercially available, the laboratory performs and records alternative control
procedures to detect immediate errors and monitor test system performance over time.

NOTE: "Performance" includes elements of accuracy, precision, and clinical discriminating

power. The following are examples of alternative procedures: split sample testing with another
method or with another laboratory, the testing of previously tested patient specimens in duplicate,
testing of patient specimens in duplicate, or other defined processes approved by the laboratory
director.
Evidence of Compliance:
✓ Records of alternative control procedures
REFERENCES
1) Department of Health and Human Services, Centers for Medicare and Medicaid Services. Clinical laboratory improvement
amendments of 1988; final rule. Fed Register. 2003(Jan 24): [42CFR493.1256(h)].
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URN.25300 QC Corrective Action Phase II

The laboratory performs and records corrective action when control results exceed
defined acceptability limits.

NOTE: The actions taken must be consistent with the laboratory's quality control program
(GEN.30000). Patient test results obtained in an analytically unacceptable test run or since the
last acceptable test run must be evaluated to determine if there is a significant clinical difference
in patient results. Re-evaluation may or may not include re-testing patient samples, depending on
the circumstances.
The corrective action for tests that have an IQCP approved by the laboratory director must
include an assessment of whether further evaluation of the risk assessment and quality control
plan is needed based on the problems identified (eg, trending for repeat failures, etc.).
Evidence of Compliance:
✓ Records of corrective action for unacceptable control results
REFERENCES
1) Department of Health and Human Services, Centers for Medicare and Medicaid Services. Clinical laboratory improvement
amendments of 1988; final rule. Fed Register. 2003(Oct 1):1046[42CFR493.1282(b)(2)]
2) Department of Health and Human Services, Centers for Medicare and Medicaid Services. Clinical laboratory improvement
amendments of 1988; final rule. Fed Register. 2003(Oct 1):[42CFR493.1282(b)(1)(i)].

URN.25350 QC Handling Phase II

The laboratory tests control specimens in the same manner and by the same personnel as
patient samples.

NOTE: Personnel who routinely perform patient testing must analyze QC specimens; however,
this does not imply that each operator must perform QC daily. Personnel must participate in QC
on a regular basis. To the extent possible, all steps of the testing process must be controlled.
Evidence of Compliance:
✓ Records reflecting that QC is performed by the same personnel performing patient testing
REFERENCES
1) Department of Health and Human Services, Centers for Medicare and Medicaid Services. Clinical laboratory improvement
amendments of 1988; final rule. Fed Register. 2003(Jan 24):7166 [42CFR493.1256(d)(7) and (8)].

URN.25400 QC Confirmation of Acceptability Phase II

Personnel review control results for acceptability before reporting patient results.
Evidence of Compliance:
✓ Records of control result approval
REFERENCES
1) Department of Health and Human Services, Centers for Medicare and Medicaid Services. Clinical laboratory improvement
amendments of 1988; final rule. Fed Register. 2003(Jan 24):7166 [42CFR493.1256(f)]

URN.25750 Monthly QC Review Phase II

The laboratory director or designee reviews and assesses quality control data at least
monthly.

NOTE: The reviewer must record follow-up for outliers, trends, or omissions that were not
previously addressed.
The QC data for tests performed less frequently than once per month may be reviewed when the
tests are performed.
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The review of quality control data for tests that have an IQCP approved by the laboratory director
must include an assessment of whether further evaluation of the risk assessment and quality
control plan is needed based on problems identified (eg, trending for repeat failures, etc.).
Evidence of Compliance:
✓ Records of QC review AND
✓ Records of corrective action taken when acceptability criteria are not met

INSTRUMENTS AND EQUIPMENT

The checklist requirements in this section should be used in conjunction with the requirements in the All
Common Checklist relating to instruments and equipment.

Inspector Instructions:
●
Refractometer calibration check records

●
How do you verify the function of the refractometer?

URN.26100 Refractometer Calibration Check Phase I

Refractometers with specific gravity capability are checked at least annually with
appropriate solutions of known specific gravity and/or refractive concentration index.

NOTE: This annual calibration check is required in addition to the daily QC requirement for non-
waived testing.
REFERENCES
1) Haber MH. Quality assurance in urinalysis. Clinics in Lab Med. 1988;8:432-436
2) Clinical and Laboratory Standards Institute (CLSI). General Laboratory Equipment Performance Qualification, Use, and Maintenance.
2nd ed. CLSI guideline QMS23. Clinical and Laboratory Standards Institute, Wayne, PA, 2019.

PROCEDURES AND TEST SYSTEMS

URINALYSIS PARAMETERS

The elements of a macroscopic urinalysis vary according to the patient population served by a laboratory and
the needs of clinicians. A complete routine urinalysis should include at least the following: glucose, protein,
blood/hemoglobin, leukocyte esterase, specific gravity, and nitrite. Other analytes (eg, color, clarity, turbidity,
bilirubin, ketones, pH and urobilinogen) are optional for CAP accreditation, but their utility should be reviewed
with the medical staff served by the laboratory. There are few occasions when the color, clarity, and odor of
urine are of clinical significance.
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Inspector Instructions:
●
Sampling of urinalysis policies and procedures
●
Sampling of patient reports with appropriate reportable parameters

URN.30425 Microscopic Exam Correlation Phase II

The laboratory correlates microscopic sediment findings (such as casts, RBC or WBC)
with macroscopic results (presence of protein, positive occult blood, positive leukocyte
esterase, etc.).
REFERENCES
1) van Nostrand JD, et al. Poor predictive ability of urinalysis and microscopic examination to detect urinary tract infection. Am J Clin
Pathol. 2000;113:709-713
2) Department of Health and Human Services, Centers for Medicare and Medicaid Services. Clinical laboratory improvement
amendments of 1988; final rule. Fed Register. 2003(Jan 24): [42CFR493.1281(b)]

URN.30700 Microscopic Exam Phase II

Microscopic examination of urine sediment is performed as part of complete urinalysis
testing or following written criteria defining the circumstances under which the
microscopic examination may be omitted/abbreviated.

NOTE: Random urinalysis screening (hospital admissions, insurance physicals) of urines that are
yellow and clear and have normal chemical reactions have a markedly low yield on microscopic
examination. The laboratory may define protocols for when microscopic examination of urine
sediment should or should not be done.
Evidence of Compliance:
✓ Patient reports with microscopic results OR records reflecting procedure for abbreviated
testing
REFERENCES
1) Wenz B, Lampasso JA. Eliminating unnecessary urine microscopy. Results and performance characteristics of an algorithm based
on chemical reagent strip testing. Am J Clin Pathol. 1989;92:78-81
2) Schumann GB, Friedman SK. Comparing slide systems for microscopic urinalysis. Lab Med. 1996;27:270-277
3) Hooper DW. Detecting GD and preeclampsia: effectiveness of routine urine screening for glucose and protein. J Reprod Med.
1996;41:885-888
4) Jou WW, Powers RD. Utility of dipstick analysis as a guide to management of adults with suspected infection or hematuria. South
Med J. 1998;91:266-269
5) van Nostrand JD, et al. Poor predictive ability of urinalysis and microscopic examination to detect urinary tract infection. Am J Clin
Pathol. 2000;113:709-713
6) Ringsrud KM. Cells in the urine sediment. Lab Med. 2001;32:153-155
7) Roggeman S, Zaman Z. Safely reducing manual urine microscopy analyses by combining urine flow cytometer and strip results. Am
J Clin Pathol. 2001;116:872-878
8) Clinical and Laboratory Standards Institute (CLSI). Physician and Nonphysician Provider-Performed Microscopy Testing; Approved
Guideline - Second Edition. CLSI document POCT10-A2. Clinical and Laboratory Standards Institute, Wayne, PA, 2011.

URINALYSIS - MANUAL MICROSCOPY

Inspector Instructions:
●
Sampling of urinalysis policies and procedures
●
Sampling of records of morphologic observation consistency evaluation
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●
Reference materials (atlas, photomicrograph, chart available)

●
How does your laboratory ensure consistency among personnel performing urine
sediment morphology?

URN.30725 Azoospermic Specimen Result Reporting Phase I

For azoospermic and post-vasectomy seminal fluid specimens, the laboratory clearly
communicates the findings of the assay and either employs a concentrating technique on
seminal fluid or includes a comment in the patient report indicating that a concentrating
technique was not performed.

NOTE: Without a concentration technique, the laboratory may not detect the presence of both
motile and non-motile sperm. The patient report must clearly communicate the method for
detection of motile and non-motile sperm and the laboratory findings so that the clinician can
interpret the results in context to the method performed. The laboratory, in consultation with the
medical staff served, must determine the method used and extent of testing to be performed.
The American Urological Association (AUA) Vasectomy Guideline recommends a careful
evaluation of an uncentrifuged specimen and does not recommend centrifugation of the
specimen for further assessment. The AUA Guideline also recommends reporting both the
presence and absence of sperm and presence or absence of sperm motility on the patient report.
If no sperm are seen in the uncentrifuged specimen, the guideline recommends reporting that the
presence of sperm is below the limit of detection.
Evidence of Compliance:
✓ Patient report with concentration findings or appropriate comment indicating that
concentration was not performed
REFERENCES
1) Schlegel PN, Sigman M, Collura B, et al. Diagnosis and treatment of infertility in men: AUA/ASRM Guideline Part I. J Urol.
2021;205(1):36-43.
2) Vasectomy Update 2010. Can Urol Assoc J. 2012 October; 4(5):306-309.

URN.30750 Reference Materials Phase I

Reference materials (atlases, charts or photomicrographs) are available to assist in the
microscopic identification of urine sediment.
REFERENCES
1) Haber MH, Blomberg D, Galagan K, Glassy EF, Ward PCJ. Color Atlas of the Urinary Sediment: An Illustrated Field Guide Based on
Proficiency Testing. Northfield, IL: College of American Pathologists; 2010.
2) Etzell JE, Bradley KT, Keren DF, et al. Urinalysis Benchtop Reference Guide: An Illustrated Guide for Cell Morphology. Northfield, IL:
College of American Pathologists; 2014.
3) Graff L. A handbook of routine urinalysis. Philadelphia, PA: JB Lippincott, 1983
4) rd
Brunzel NA. Fundamentals of urine and body fluid analysis.3 ed. Philadelphia, PA: Elsevier Health Sciences, 2012
5) King C. Comparison of methods for detecting indinavir crystals in urine. Am J Clin Pathol. 1998;110:540
6) Hortin GL, et al. Detection of indinavir crystals in urine. Dependence on method of analysis. Arch Pathol Lab Med. 2000;124:246-250

URN.30800 Morphologic Observation Evaluation Phase II

The laboratory evaluates consistency of morphologic observation among personnel
performing urine sediment microscopy at least annually.
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NOTE: The laboratory must ensure the identification of urine sediment constituents is reported
consistently amongst all personnel performing the microscopic analysis.
Suggested methods to accomplish this include:
1. Circulation of a pre-graded set of preserved urine sediments with defined abnormalities
involving leukocytes, erythrocytes, casts, bacteria, yeast, etc.
2. Multi-headed microscopy
3. Use of urine sediment photomicrographs with referee and consensus identifications (eg,
former CAP surveys clinical microscopy photomicrographs)
4. Digital images
5. Enrollment and participation of all personnel in an external assessment program for
morphologic observation for urine sediment microscopy.
The laboratory director or designee must determine acceptability criteria for agreement. The
laboratory must maintain records of performance and record corrective actions taken for
personnel demonstrating significant discrepancies from the group consensus.
Evidence of Compliance:
✓ Records of evaluation AND/OR
✓ Records of enrollment/participation of staff in an external assessment program
REFERENCES
1) Haber MH, Blomberg D, Galagan K, Glassy EF, Ward PCJ. Color Atlas of the Urinary Sediment: An Illustrated Field Guide Based on
Proficiency Testing. Northfield, IL: College of American Pathologists; 2010.
2) Etzell JE, Bradley KT, Keren DF, et al. Urinalysis Benchtop Reference Guide: An Illustrated Guide for Cell Morphology. Northfield, IL:
College of American Pathologists; 2014.
3) Astion ML, et al. A web-based system for assessing competency in microscopic urinalysis. Clin Chem. 2000;46:A36
4) Kim A, et al. Web-based competency assessment system for microscopic urinalysis. Clin Chem. 2002;48:1608-1611

AUTOMATED AND SEMI-AUTOMATED SYSTEMS

DIPSTICK READERS
Inspector Instructions:
●
Sampling of urinalysis policies and procedures

URN.31250 Erroneous Dipstick Reader Results Phase I

The laboratory follows written criteria for identifying urine specimens that may give
erroneous results by the dipstick reader and evaluates those specimens by alternate
means (visual examination or other confirmatory method).

NOTE: Intensely colored urine specimens may result in false positive dipstick reactions with
automated reflectance readers. However, the anomalous color will be apparent when visual
evaluation is performed.
REFERENCES
1) De Buys Roessingh AS, et al. Dipstick measurements of urine specific gravity are unreliable. Arch Dis Child. 2001;85:155-157
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AUTOMATED MICROSCOPY SYSTEMS

Inspector Instructions:
●
Sampling of urinalysis policies and procedures
●
Sampling of automated microscopy QC results, if applicable

●
How did your laboratory establish reportable range limits for your instrument?

URN.31400 Erroneous Morphology Results Phase II

The laboratory follows written criteria for identifying urine specimens that may give
clinically relevant erroneous results.

NOTE: Excessively turbid urine samples may block aperture flow or interfere with visual detection
of pertinent microscopic elements. Manual microscopic examination must be performed if
problems are noted with accurate identification or classification of clinically important urine
structures, such as casts.
REFERENCES
1) Elin RJ, et al. Comparison of automated and manual methods for urinalysis. Am J Clin Pathol. 1986;86:731-737
2) Wargotz ES, et al. Urine sediment analysis by the Yellow Iris automated urinalysis workstation. Am J Clin Pathol. 1987;88:746-748
3) Carlson DA, Statland BE. Automated urinalysis, In Haber MH, Corwin HL (eds). Urinalysis. Clinics in Lab Med. 1988;8:449-461

URN.31425 Carryover Detection Phase II

The laboratory has a process to detect and evaluate potential carryover for the automated
microscopy system.

NOTE: The laboratory must have records of carryover studies performed as part of the initial
evaluation of an instrument and after major maintenance or repair of the pipetting assembly of
the instrument.
If carryover is detected or cannot be evaluated (eg, spermatozoa), the test procedure must
include criteria for identifying results that may be affected and define actions to be taken to
prevent the release of incorrect results (eg, run blank samples after a turbid or bloody sample,
reflex to manual microscopic review).
Evidence of Compliance:
✓
Records of reassessment of samples with potential carryover
REFERENCES
1) Clinical and Laboratory Standards Institute (CLSI). General Laboratory Equipment Performance Qualification, Use, and Maintenance.
2nd ed. CLSI guideline QMS23. Clinical and Laboratory Standards Institute, Wayne, PA, 2019.
2) Clinical and Laboratory Standards Institute (CLSI). Preliminary Evaluation of Quantitative Medical Laboratory Measurement
Procedures. 4th ed. CLSI guideline EP10. Clinical and Laboratory Standards Institute, Wayne, PA; 2024.

URN.31600 Daily QC - Automated Microscopy Systems Phase II

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The laboratory performs controls at two different levels each day of patient testing to
detect instrument malfunction on automated microscopy systems.

NOTE: Accumulation of sediment can block the flow aperture, leading to spuriously low counts.
Evidence of Compliance:
✓ Records of daily QC results

URN.31700 Reportable Range Phase II

Upper and lower limits of all quantitative reportable parameters on automated microscopy
systems are defined, and results that fall outside these limits are reported properly.

NOTE: The laboratory must initially establish or verify the reportable range for each parameter of
its automated microscopy system. The laboratory may report counts that are lower or higher than
the reportable range as "less than" the lower limit or "greater than" the higher limit. Alternatively,
when clinically appropriate, the laboratory may dilute samples with results exceeding the
higher limit to bring the value within the defined analytical measurement range, and apply the
appropriate dilution factor.
Evidence of Compliance:
✓ Record of action taken when limits are exceeded, including the reporting of results
REFERENCES
1) Department of Health and Human Services, Centers for Medicare and Medicaid Services. Clinical laboratory improvement
amendments of 1988; final rule. Fed Register. 2003(Jan 24):7164 [42CFR493.1253]