URINALYSIS · Web viewDoes the urinalysis section of the laboratory have a defined, documented...

Revised: 10/06/2005

URINALYSIS

This College of American Pathologists (CAP) Laboratory Accreditation Program (LAP) Checklist is provided as a Microsoft® Word 2000 electronic file for convenience and for educational purposes. It represents the fully-approved version for use in the LAP as of the date given in the header.

Newer approved versions of this Checklist may be found via the Internet at the CAP Web site (http://www.cap.org/apps/docs/laboratory_accreditation/checklists/checklistftp.html) for both viewing and download to your computer.

If you are currently enrolled in the CAP LAP and are preparing for an inspection, please note:

The Checklists undergo frequent revision, and the contents may have changed after you receive your inspection packet. If a Checklist has been updated since receiving your packet, you will be inspected based upon the Checklists that were mailed to you in your application or reapplication packet.

For questions about the use of Checklists in the inspection process, please e-mail the CAP at [email protected], or call (800) 323-4040, ext. 6065. Suggestions for content improvement should be sent by e-mail to LAP at [email protected].

All checklists are © 2005 College of American Pathologists. All rights reserved.

http://www.cap.org/apps/docs/laboratory_accreditation/checklists/checklistftp.html

College of American Pathologists Revised: 10/06/2005

OUTLINE

SUMMARY OF CHANGESINSPECTION TECHNIQUES – KEY POINTSPROFICIENCY TESTINGQUALITY CONTROL AND QUALITY MANAGEMENT

SUPERVISIONPROCEDURE MANUALSPECIMEN COLLECTION AND HANDLINGREPORTING OF RESULTSREAGENTSCONTROLS AND STANDARDSINSTRUMENTS AND EQUIPMENT

PROCEDURES AND TEST SYSTEMSURINALYSIS PARAMETERSURINALYSIS - MANUAL MICROSCOPYAUTOMATED AND SEMI-AUTOMATED SYSTEMS

Dipstick ReadersMorphology Systems

PERSONNELPHYSICAL FACILITIESLABORATORY SAFETY

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SUMMARY OF CHANGESURINALYSIS Checklist

10/6/2005 Edition

The following questions have been added, revised, or deleted in this edition of the checklist, or in the two editions immediately previous to this one.

If this checklist was created for a reapplication, on-site inspection or self-evaluation it has been customized based on the laboratory's activity menu. The listing below is comprehensive; therefore some of the questions included may not appear in the customized checklist. Such questions are not applicable to the testing performed by the laboratory.

Note: For revised checklist questions, a comparison of the previous and current text may be found on the CAP website. Click on Laboratory Accreditation, Checklists, and then click the column marked Changes for the particular checklist of interest.

NEW Checklist Questions

Question Effective Date URN.25293 03/30/2005URN.30725 12/29/2004

REVISED Checklist Questions

Question Effective Date URN.31220 03/30/2005URN.31250 03/30/2005URN.31350 03/30/2005URN.31600 03/30/2005

DELETED Checklist Questions

Question Effective Date URN.20200 03/30/2005URN.25290 03/30/2005URN.60000 12/29/2004

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The checklists used in connection with the inspection of laboratories by the Commission on Laboratory Accreditation (“CLA”) of the College of American Pathologists have been created by the College and are copyrighted works of the College. The College has authorized copying and use of the checklists by College inspectors in conducting laboratory inspections for the CLA 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 College’s copyrights in the checklists. The College will take appropriate legal action to protect these copyrights.

IMPORTANT: The contents of the Laboratory General Checklist are applicable to the Urinalysis section of the laboratory.

NOTE: Material on Body Fluids (Clinical Microscopy) has been relocated to the Hematology Checklist.

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INSPECTION TECHNIQUES – KEY POINTS

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I. READ – OBSERVE – ASK – the three methods of eliciting information during the inspection process. These three methods may be used throughout the day in no particular order. Plan the inspection in a way that allows adequate time for all three components.

READ = Review of Records and DocumentsDocument review verifies that procedures and manuals are complete, current, available to staff, accurate and reviewed, and describe good laboratory practice. Make notes of any questions you may have, or processes you would like to observe as you read the documentation.

OBSERVE – ASK = Direct Observation and Asking QuestionsObserving and asking questions accomplish the following:

1. Verifies that the actual practice matches the written policy or procedure2. Ensures that the laboratory processes are appropriate for the testing performed3. Ensures that outcomes for any problem areas, such as PT failures and issues/problems

identified through the quality management process, have been adequately investigated and resolved

4. Ensures that previously cited deficiencies have been corrected

Use the following techniques: Observe laboratory practices – look at what the laboratory is actually doing. Compare the

written policy/procedure to what you actually observe in the laboratory to ensure the written policy/procedure accurately reflects laboratory practice. Note if practice deviates from the documented policies/procedures.

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Ask open ended, probing questions – these are starting points that will allow you to obtain large amounts of information, and help you clarify your understanding of the documentation you’ve seen and observations you’ve made. This eliminates the need to ask every single checklist question, as the dialogue between you and the laboratory may address multiple checklist questions.

Ask open-ended questions that start with phrases such as “show me how…” or “tell me about …” or “what would you do if…”. By asking questions that are open-ended, or by posing a hypothetical problem, you will avoid “cookbook” answers. For example, ask “Could you show me the specimen transport policy and show me how you ensure optimum specimen quality?” This will help you to determine how well the technical staff is trained, whether or not they are adhering to the lab’s procedures and policies, and give you a feel for the general level of performance of the laboratory.

Ask follow-up questions for clarification. Generally, it is best not to ask the checklist questions verbatim. For example, instead of asking the checklist question “Is there documentation of corrective action when control results exceed defined tolerance limits?” ask, “What would you do if the SD or CV doubles one month?” A follow-up probing question could be, “What would you do if you were unable to find a cause for the change in SD or CV?”

II. Evaluate Selected Specimens and Tests in Detail

For the Laboratory General Checklist: Follow a specimen through the laboratory. By following a specimen from collection to test result, you can cover multiple checklist questions in the Laboratory General checklist: questions on the specimen collection manual; phlebotomy; verbal orders; identification of patients and specimens; accessioning; and result reporting, including appropriate reference ranges, retention of test records, maintaining confidentiality of patient data, and proper handling of critical values and revisions to reports.

For the individual laboratory sections: Consult the laboratory’s activity menu and focus on tests that potentially have the greatest impact on patient care. Examples of such tests include HIV antibodies, hepatitis B surface antigen, urine drugs of abuse, quantitative beta-hCG, cultures of blood or CSF, acid-fast cultures, prothrombin time and INR reporting, and compatibility testing and unexpected antibody detection. Other potentially high-impact tests may be identified by looking at very high or low volume tests in the particular laboratory, or problems identified by reviewing the Variant Proficiency Testing Performance Report.

To evaluate preanalytic and postanalytic issues: Choose a representative specimen and “follow" the specimen through the laboratory or section of the laboratory, reviewing appropriate records in the preanalytic and postanalytic categories.

To evaluate analytic processes: Choose 2 or 3 analytes and perform a comprehensive review of records, including procedure manuals, quality control and proficiency testing records, instrument maintenance records and method performance validations for the last 2 years, selecting timeframes at the beginning, mid-point, and end of this timeframe. Compare instrument print-outs to patient reports and proficiency testing results to ensure accurate data entry. If problems are identified, choose additional tests or months to review.

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III. Verify that proficiency testing problem have been resolved: From the inspector’s packet, review the Variant PT Performance Report that identifies, by analyte, all of the PT scores below 100%. Correlate any PT problems to QC or maintenance records from the same time period. Be thorough when reviewing these representative records, selecting data from the beginning, middle and end of the period since the last on-site inspection.

IV. Review correction of previous deficiencies: Review the list of deficiencies from the previous on-site inspection provided in the inspector’s packet. Ensure that they have been appropriately addressed.

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PROFICIENCY TESTING

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CAP-accredited laboratories must participate in the CAP Surveys or a CAP-approved alternative proficiency testing program. This must include attempted enrollment in programs with graded analytes matching those for which the laboratory performs patient testing.

URN.10500 Phase II N/A YES NO

Is the laboratory enrolled in the appropriate required CAP Surveys or CAP-approved alternative proficiency testing (PT) program for the patient/client testing performed?

NOTE: The list of analytes for which CAP requires proficiency testing is available on the CAP website [http://www.cap.org/apps/docs/laboratory_accreditation/ptgraded.html] or by phoning 800-323-4040 (or 847-832-7000), option 1. The laboratory’s participation in proficiency testing must include all analytes on this list for which it performs patient testing. Participation in proficiency testing may be through CAP Surveys or a CAP-approved proficiency testing provider. Laboratories will not be penalized if they are unable to enroll in an oversubscribed program. If unable to enroll, however, the laboratory must implement an alternative assessment procedure for the affected analytes. For regulated analytes, if the CAP and CAP-approved alternative PT programs are oversubscribed, CMS requires the laboratory to attempt to enroll in another CMS-approved PT program.

For purposes of photomicrograph identification in CAP Surveys, it is strongly recommended that the current CAP Surveys Hematology Glossary be readily available to the bench technologist in the section. This manual provides descriptions of urine sediment elements, vaginal wet preparations, stained stool, nasal smears, KOH preparations for fungi, and other body fluids.

COMMENTARY:

N/A

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http://www.cap.org/apps/docs/laboratory_accreditation/ptgraded.html


REFERENCES: 1) Department of Health and Human Services, Health Care Financing Administration. Clinical laboratory improvement amendments of 1988; final rule. Fed Register. 1992(Feb 28):7146 [42CFR493.801]; 2) Westgard JO, et al. Laboratory precision performance. State of the art versus operating specifications that assure the analytical quality required by clinical laboratory improvement amendments proficiency testing. Arch Pathol Lab Med. 1996;120:621-625; 3) NCCLS. Continuous quality improvement: essential management approaches and their use in proficiency testing; proposed guideline GP22-P. Wayne, PA: NCCLS, 1996; 4) College of American Pathologists, Commission on Laboratory Accreditation. Standards for laboratory accreditation; standard III. Northfield, IL: CAP, 1998; 5) College of American Pathologists. Surveys hematology glossary. Northfield, IL: CAP, current edition.


For tests for which CAP does not require PT, does the laboratory at least semiannually 1) participate in external PT, or 2) exercise an alternative performance assessment system for determining the reliability of analytic testing?

NOTE: Appropriate alternative performance assessment procedures may include: split sample analysis with reference or other laboratories, split samples with an established in-house method, assayed material, regional pools, clinical validation by chart review, or other suitable and documented means. It is the responsibility of the laboratory director to define such alternative performance assessment procedures, as applicable, in accordance with good clinical and scientific laboratory practice. Participation in ungraded/educational proficiency testing programs also satisfies this checklist question.

COMMENTARY:

N/A

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):7184 [42CFR493.1236(c)(1)]; 2) Shahangian S, et al. A system to monitor a portion of the total testing process in medical clinics and laboratories. Feasibility of a split-specimen design. Arch Pathol Lab Med. 1998;122:503-511; 3) Souter VL, et al. Laboratory techniques for semen analysis; a Scottish survey. Health Bull (Edinb). 1997;55:140-149; 4) NCCLS. Validation of laboratory tests when proficiency testing is not available; proposed guideline GP29-P. Wayne, PA: NCCLS, 2001.


Does the laboratory integrate all proficiency testing samples within the routine laboratory workload, and are those samples analyzed by personnel who routinely test patient samples, using the same primary method systems as for patient samples?

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NOTE: Replicate analysis of proficiency testing samples is acceptable only if patient specimens are routinely analyzed in the same manner. If the laboratory uses multiple methods for an analyte, proficiency testing samples should be analyzed by the primary method. There must not be any interlaboratory communication on proficiency testing data before results reporting. The educational purposes of proficiency testing are best served by a rotation that allows all technologists to be involved in the proficiency testing program. Records of these studies must be kept and can be an important part of the competency and continuing education documentation in the personnel files of the individuals. In the specific case of urine sediment and body fluid photomicrographs, reported identifications must be made by a single individual who normally performs such identifications in patient samples. Responsibility for identifications should be rotated over time among all staff that identify cells and formed elements in clinical samples. Group review and consensus identifications are permitted only for those unknown samples that would ordinarily be reviewed by more than one person in an actual patient sample. When external proficiency testing materials are not available, the semi-annual alternative performance assessment process should also be integrated within the routine workload.

COMMENTARY:

N/A

REFERENCES: 1) Department of Health and Human Services, Centers for Medicare and Medicaid Services. Clinical laboratory improvement amendments of 1988; final rule. Fed Register. 1992(Feb 28):7146 [42CFR493.801(b)]; 2) Shahangian S, et al. Toward optimal PT use. Med Lab Observ. 2000;32(4):32-43; 3) Ringsrud KM. Cells in the urine sediment. Lab Med. 2001;32:153-155.


Is there evidence of evaluation and, if indicated, corrective action in response to "unacceptable" results on the proficiency testing reports and results of the alternative performance system?

NOTE: The evaluation must document the specific reason(s) for the "unacceptable" result(s) and actions taken to reduce the likelihood of recurrence. This must be done within one month after the laboratory receives its proficiency testing evaluation. In addition, each ungraded challenge, each educational challenge, and each episode of nonparticipation must be reviewed and corrective action instituted as appropriate.

COMMENTARY:

N/A

REFERENCES: 1) NCCLS. Using proficiency testing (PT) to improve the clinical laboratory; approved guideline GP27-A. Wayne, PA: NCCLS, 1998; 2) College of American Pathologists, Commission on Laboratory Accreditation. Standards for laboratory accreditation; Standard III. Northfield, IL: CAP, 1998; 3) Shahangian S, et al. Toward optimal PT use. Med Lab Observ. 2000;32(4):32-43.

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Is there documented evidence of ongoing evaluation by the laboratory director or designee of the proficiency testing and alternative performance assessment results?

COMMENTARY:

There must be evidence of ongoing evaluation by the laboratory director or designee of proficiency testing and alternative performance assessment results.

REFERENCES: 1) Ehrmeyer SS, et al. Performance of external quality control systems. Lab Med. 1989;20:428-431; 2) Savage RA. Proficiency testing and laboratory quality. Lessons from the Ontario program. Arch Pathol Lab Med. 1989;20:428-431; 3) Cembrowski GS, et al. The detection of problem analytes in a single proficiency test challenge in the absence of the Centers for Medicare and Medicaid Services rule violations. Arch Pathol Lab Med. 1993;117:437-443; 4) Hwu S-EL, et al. External quality survey of urinalysis in Taiwan. Clin Lab Sci. 1994;7:353-357; 5) NCCLS. Continuous quality improvement: essential management approaches and their use in proficiency testing; proposed guideline GP22-P. Wayne, PA: NCCLS, 1997; 6) NCCLS. Using proficiency testing (PT) to improve the clinical laboratory; approved guideline GP27-A. Wayne, PA: NCCLS, 1998.

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QUALITY CONTROL AND QUALITY MANAGEMENT

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SUPERVISION

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Does the urinalysis laboratory have a written QC/QM program?

NOTE: The QM/QC program in the urinalysis laboratory must be clearly defined and documented. The program must ensure quality throughout the preanalytic, analytic, and post-analytic (reporting) phases of testing, including patient identification and preparation; specimen collection, identification, preservation, transportation, and processing; and accurate, timely result reporting. The program must be capable of detecting problems in the laboratory’s systems, and identifying opportunities for system improvement. The laboratory must be able to develop plans of corrective/preventive action based on data from its QM system.

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Appropriate laboratory personnel must judge QC data acceptable before patient results are reported. The laboratory director or designee must review QC data at least monthly. Beyond these specific requirements, a laboratory may (optionally) perform more frequent review at intervals that it determines appropriate. Because of the many variables across laboratories, the CAP makes no specific recommendations on the frequency of any additional review of QC data.

COMMENTARY:

N/A

Before patient results are reported, QC data must be judged acceptable. The laboratory director or designee must review QC data at least monthly. Beyond these specific requirements, a laboratory may (optionally) perform more frequent review at intervals that it determines appropriate. Because of the many variables across laboratories, the CAP makes no specific recommendations on the frequency of any additional review of QC data.

All quality improvement (QI) questions in the Laboratory General Checklist pertain to the urinalysis laboratory.


Are tolerance limits for quality control procedures defined and documented?

COMMENTARY:

Tolerance limits for quality control procedures must be defined and documented.


Is there a documented system in operation to detect and correct significant clerical errors that could affect patient management?

COMMENTARY:

The laboratory must have a documented system in operation to detect and correct significant clerical errors that could affect patient management. One common method is a review of the final results by a qualified person (technologist, supervisor, pathologist) before release from the laboratory, but there is no requirement for supervisory review of all reported data. The selective use of delta checks also may be useful in detecting clerical errors in consecutive samples from the same patient. In computerized laboratories, there should be automatic "traps" for improbable results.

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Is there a documented system in operation for each laboratory test or instrument to detect significant analytical errors or interferences?

COMMENTARY:

The laboratory must have a documented system in operation for each laboratory test or instrument to detect significant analytical errors or interferences. When possible, strategies to identify the more common analytical errors and interferences must be developed. Alternate methods of testing or even inability to report the test result may be necessary when interfering substances substantially alter results.


Is there a documented system in operation for each laboratory test or instrument to verify unusual laboratory results?

COMMENTARY:

The laboratory must have a documented system in operation for each laboratory test or instrument to verify unusual laboratory results. Extremely aberrant analytical results must be re-checked, analyzed by an alternate method, or correlated with other patient results. Unusual subjective results (e.g., identification of unusual microscopic findings) must be referred to a supervisor, pathologist, or designated experienced technologist.


Do the laboratory systems for detection of clerical or analytical errors provide for timely correction of erroneous results?

COMMENTARY:

The system for detecting clerical errors, significant analytical errors, and unusual laboratory results must provide for timely correction of errors, i.e., before results become available for clinical decision making. For suspected errors detected by the end user after reporting, corrections must be promptly made if such errors are confirmed by the laboratory.


In the absence of on-site supervisors, are the results of tests performed by personnel reviewed by the laboratory director or general supervisor within 24 hours?

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NOTE: The CAP does NOT require supervisory review of all test results before or after reporting to patient records. Rather, this question is intended to address only that situation defined under CLIA-88 for "high complexity testing" performed by trained high school graduates qualified under 42CFR493.1489(b)(5) when a qualified general supervisor is not present.

COMMENTARY:

In the absence of on-site supervisors, the results of tests performed by personnel must be reviewed by the laboratory director or general supervisor within 24 hours. The CAP does not require supervisory review of all test results before or after reporting to patient records. Rather, this question is intended to address only that situation defined under CLIA-88 for "high complexity testing" performed by trained high school graduates qualified under 42CFR493.1489(b)(5) when a qualified general supervisor is not present.

REFERENCE: Department of Health and Human Services, Centers for Medicare and Medicaid Services. Clinical laboratory improvement amendments of 1988; final rule. Fed Register. 1992(Feb 28):7182 [42CFR493.1463(a)(3) and 42CFR493.1463(c)]: 7183 [42CFR493.1489(b)(1) and 42CFR493.1489(b)(5)].

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PROCEDURE MANUAL

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The procedure manual should be used by personnel at the workbench and should include: test principle, clinical significance, specimen type, required reagents, test calibration, quality control, procedural steps, calculations, reference intervals, and interpretation of results. The manual should address relevant pre-analytic and post-analytic considerations, as well as the analytic activities of the laboratory. The specific style and format of procedure manuals are at the discretion of the laboratory director.

The inspection team should review the procedure manual in detail to understand the laboratory's standard operating procedures, ensure that all significant information and instructions are included, and that actual practice matches the contents of the procedure manuals.


Is a complete procedure manual available at the workbench or in the work area?

NOTE 1: The use of inserts provided by manufacturers is not acceptable in place of a procedure manual. However, such inserts may be used as part of a procedure, if the insert accurately and precisely describes the procedure as performed in the laboratory. Any

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variation from this printed procedure must be detailed in the procedure manual. In all cases, appropriate reviews must occur.

NOTE 2: A manufacturer's procedure manual for an instrument/reagent system may be acceptable as a component of the overall departmental procedures. Any modification to or deviation from the procedure manual must be clearly documented.

NOTE 3: Card files or similar systems that summarize key information are acceptable for use as quick reference at the workbench provided that:

a. A complete manual is available for referenceb. The card file or similar system corresponds to the complete manual and is subject to

document control

NOTE 4: Electronic (computerized) manuals are fully acceptable. There is no requirement for paper copies to be available for the routine operation of the laboratory, so long as the elec-tronic versions are readily available to all personnel. Such electronic versions must be sub-jected to proper document control (i.e., only authorized persons may make changes, changes are dated/signed (manual or electronic), and there is documentation of periodic review). Cur-rent paper copies of electronically stored procedures should be available at the time of the CAP inspection, or rapidly generated at the request of the Inspector.

COMMENTARY:

A documented procedure manual must be developed for the urinalysis/clinical microscopy section of the laboratory and be available at the workbench. Its elements should include: test principle, clinical significance, specimen type(s), required reagents, calibration, quality control, procedural steps, calculations, reference intervals, and interpretation, as applicable.

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 [42CFR493.1251]; 2) van Leeuwen AM. 6 Steps to building an efficiency tool. Advance/Lab. 1999:8(6):88-91; 3) Borkowski A, et al. Intranet-based quality improvement documentation at the Veterans Affairs Maryland health care system. Mod. Pathol. 2001;14:1-5; 4) NCCLS. Clinical laboratory technical procedure manuals - fourth edition; approved guideline GP2-A4. Wayne, PA: NCCLS, 2002.


Is there documentation of annual review of urinalysis/clinical microscopy policies and procedures by the laboratory director or designee?

NOTE: The director must ensure that the collection of policies and technical protocols is complete, current, and has been thoroughly reviewed by a knowledgeable person. Technical approaches must be scientifically valid and

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clinically relevant. To minimize the burden on the laboratory and reviewer(s), it is suggested that a schedule be developed whereby roughly 1/12 of all procedures are reviewed monthly. Paper/electronic signature review must be at the level of each procedure, or as multiple signatures on a listing of named procedures. A single signature on a Title Page or Index of all procedures is not sufficient documentation that each procedure has been carefully reviewed. Signature or initials on each page of a procedure is not required.

COMMENTARY:

There must be documentation of at least annual review of all policies and procedures in the urinalysis/clinical microscopy laboratory section by the current laboratory director or designee. The director is responsible for ensuring that the collection of technical protocols is complete, current, and has been thoroughly reviewed by a knowledgeable person. Technical approaches must be scientifically valid and clinically relevant. To minimize the burden on the laboratory and reviewer(s), it is suggested that a schedule be developed whereby roughly 1/12 of all procedures are reviewed monthly. Paper/electronic signature review must be at the level of each procedure, or as multiple signatures on a listing of named procedures. A single signature on a title page or index of all procedures is not sufficient documentation that each procedure has been carefully reviewed. Signature or initials on each page of a procedure is not required

REFERENCES: 1) Department of Health and Human Services, Centers for Medicare and Medicaid Services. Clinical laboratory improvement amendments of 1988; final rule. Fed Register. 1992(Feb 28):7173 [42CFR493.1407(e)(13)]; 2) Borkowski A, et al. Intranet-based quality improvement documentation at the Veterans Affairs Maryland health care system. Mod. Pathol. 2001;14:1-5.


Does the director or designee review and approve all new policies and procedures, as well as substantial changes to existing documents, before implementation?

NOTE: Current practice must match the policy and procedure documents.

COMMENTARY:

The director or designee must review and approve all new policies and procedures, as well as substantial changes to existing documents before implementation. Current practice must match these documents.

REFERENCE: 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 [42CFR493.1251(d)].

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If there is a change in directorship, does the new director ensure (over a reasonable period of time) that laboratory procedures are well-documented and undergo at least annual review?

COMMENTARY:

If there is a change in directorship of the laboratory, the new director must ensure (over a reasonable period of time) that all urinalysis and clinical microscopy procedures are well-documented and undergo at least annual review.



When a procedure is discontinued, is a paper or electronic copy maintained for at least 2 years, recording initial date of use, and retirement date?

COMMENTARY:

A paper or electronic copy of a discontinued procedure must be maintained for at least 2 years, recording initial date of use, and retirement date.

REFERENCE: 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 [42CFR493.1105(a)(2)].


Does the laboratory have a system documenting that all personnel are knowledgeable about the contents of procedure manuals relevant to the scope of their testing activities?

NOTE: This does not specifically require annual procedure sign-off by testing personnel. The form of this system is at the discretion of the laboratory director.

COMMENTARY:

The laboratory must have a system documenting that all personnel are knowledgeable about the contents of procedure manuals relevant to the scope of their testing activities. This does not specifically require annual procedure sign-off by testing personnel. The form of this system is at the discretion of the laboratory director.

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SPECIMEN COLLECTION AND HANDLING

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Are instructions provided for patients for proper collection of clean voided urine specimens (i.e., in nursing procedure manual or in specimen collection area)?

COMMENTARY:

Proper collection of urine specimens is important to avoid contamination, or deterioration of constituents. Documented instructions must be prepared for the proper collection of a clean voided urine specimen. These instructions must be available to nurses or aides collecting specimens in the hospital and posted in the ambulatory patient collection area to instruct patients on proper technique; graphic instructions are often quite useful.

REFERENCE: NCCLS. Routine urinalysis and collection, transportation, and preservation of urine specimens – second edition; approved guideline GP16-A2. Wayne, PA: NCCLS, 2001.


Are instructions provided for proper collection of timed urine specimens?

COMMENTARY:

Documented instructions must be prepared for the proper collection of timed urine specimens.

REFERENCE: NCCLS. Routine urinalysis and collection, transportation, and preservation of urine specimens – second edition; approved guideline GP16-A2. Wayne, PA: NCCLS, 2001.


Are documented instructions provided for proper preservation and storage of urine when specimens are collected for special tests?

COMMENTARY:

Documented instructions must be provided for proper storage and preservation of urine when specimens are collected for special tests. This is particularly important for the collection of 24-hour urine specimens.

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REFERENCES: 1) NCCLS. Routine urinalysis and collection, transportation, and preservation of urine specimens – second edition; approved guideline GP16-A2. Wayne, PA: NCCLS, 2001; 2) Rafael J, et al. Is a preservative required for routine urinalysis? Am J Clin Pathol. 1997;108:344.


Are urine specimens examined within 1-2 hours of collection?

NOTE: If testing is unavoidably delayed (night collection, etc.), provisions must be made for appropriate preservation of specimens to maintain integrity of cells and formed elements.

COMMENTARY:

Urine specimens either must be examined within 1-2 hours after collection or, if delayed, must be properly preserved. Refrigeration of urine may be acceptable since it inhibits bacterial growth, but it does not prevent the lytic effects of low specific gravity or alkaline pH. Urine crystal formation may be induced by refrigeration. Preparations that contain boric acid/sorbitol or release formaldehyde may be effective preservatives for some, but not all, urine tests. There should be a method of indicating whether preservative has been added to the sample, and the laboratory should have specified any preanalytical errors attributable to such preservatives.

REFERENCES: 1) Weinstein MP. Clinical evaluation of a urine transport kit with lyophilized preservative for culture urinalysis and sediment microscopy. Diag Microbiol Infect Dis. 1985;3:501-508; 2) Haber MH. Quality assurance in urinalysis. Clinics in Lab Med. 1998;8:432-436; 3) NCCLS. Routine urinalysis and collection, transportation, and preservation of urine specimens – second edition; approved guideline GP16-A2. Wayne, PA: NCCLS, 2001; 4) 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; 5) Rafael J, et al. Is a preservative required for routine urinalysis? Am J Clin Pathol. 1997;108:344; 6) 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.


Is there a documented policy defining the method for urine preservation (refrigeration or specified preservative) within the laboratory for all tests when analysis is to be delayed?

COMMENTARY:

N/A

REFERENCES: 1) Weinstein MP. Clinical evaluation of a urine transport kit with lyophilized preservative for culture, urinalysis and sediment microscopy. Diag Microbiol Infect Dis. 1985;3:501-

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508; 2) Haber MH. Quality assurance in urinalysis. Clinics in Lab Med. 1988;8:432-436; 3) NCCLS. Routine urinalysis and collection, transportation, and preservation of urine specimens – second edition; approved guideline GP16-A2. Wayne, PA: NCCLS, 2001; 4) 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; 5) Rafael J, et al. Is a preservative required for routine urinalysis? Am J Clin Pathol. 1997;108:344.


Are there documented criteria for the rejection of unacceptable specimens or the special handling of sub-optimal specimens?

NOTE: This question does not imply that all "unsuitable" specimens are discarded or not analyzed without explanation. If, for example, a specimen for routine urinalysis is received several days after collection, there must be a mechanism to notify clinical personnel, and explain the unsuitability of such a specimen. Similarly, delayed transport of an unpreserved urine may lead to loss of red cell casts and other formed elements. If the treating physician desires the result, then the laboratory must note the condition of the sample on the report. The laboratory may wish to record that a dialogue was held with the physician, when such occurs.

COMMENTARY:

N/A

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):7183 [42CFR493.1249(a) and (b)]; 2) NCCLS. Routine urinalysis and collection, transportation, and preservation of urine specimens – second edition; approved guideline GP16-A2. Wayne, PA: NCCLS, 2001.


Is the disposition of all unacceptable specimens documented in the patient report and/or quality management records?

COMMENTARY:

A record of all rejected specimens must be maintained in the patient report and/or quality management records. This information is essential to proper patient test management and to the laboratory quality management program.

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REPORTING OF RESULTS

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Where possible, are all patient results reported with accompanying reference (normal) intervals or interpretations?

COMMENTARY:

Where possible, all patient results must be reported with accompanying qualitative and/or quantitative reference (normal) intervals or interpretations. This is important to allow proper interpretation of patient data. In addition, the use of high and low flags (generally available with a computerized laboratory information system) is recommended.


Are reference intervals (normal ranges) established or verified by the laboratory for the population being tested?

COMMENTARY:

Age- and sex-specific reference intervals (normal values) must be verified or established by the laboratory, if feasible. If a formal reference interval study is not possible or practical, then the laboratory should carefully evaluate the use of published data for its own reference ranges, and retain documentation of this evaluation.

REFERENCES: 1) Department of Health and Human Services, Centers for Medicare and Medicaid Services. Medicare, Medicaid and CLIA programs; CLIA fee collection; Correction and final rule. Fed Register. 2003(Jan 24):5231 [42CFR493.1253(b)(1)(ii) and (b)(2)(vi)]; 2) Knight JA. Laboratory issues regarding geriatric patients. Lab Med. 1997;28:458-461; 3) NCCLS. How to define and determine reference intervals in the clinical laboratory; approved guideline C28-A2. Wayne, PA: NCCLS, 2000.


Are documented criteria established for immediate notification of a physician or other clinical personnel responsible for patient care when results of certain urine tests exceed critical limits important for prompt patient management?

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NOTE: May be indicated either in the procedure manual and/or in a separate manual. The bench technologists must be familiar with critical limits for procedures that they perform. This question does not imply that all reportable results necessarily have critical limits; such criteria are typically established by the laboratory director in consultation with clinicians.

COMMENTARY:

There must be documented criteria established for immediate notification of a physician or other clinical personnel when results of certain urine tests exceed critical limits important for prompt patient management. These may be indicated in the procedure manual and/or in a separate manual or policy. The bench technologists must be familiar with critical limits for procedures that they perform. This does not imply that all reportable results necessarily have critical limits; such criteria are typically established by the laboratory director in consultation with clinicians.

REFERENCES: 1) Kost GJ. Critical limits for urgent clinician notification at US medical centers. JAMA. 1990;263:704-707; 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):[42CFR493.1291(g)]; 3) Steindel SJ, Heard NV. Critical values: data analysis and critique. Q-Probes 92-04. Northfield, IL: College of American Pathologists, 1992; 4) Kost GJ. Using critical limits to improve patient outcome. Med Lab Observ. 1993;25(3):22-27; 5) Tate KE, Gardner RM. Computers, quality, and the clinical laboratory: a look at critical values. Proc Annu Symp Comput Appl Med Care. 1993;193-197; 6) Kaufman HW, Collins C. Notifying clients of life-threatening results. Med Lab Observ. 1994;26(8):44-45; 7) Emancipator K. Critical values. ASCP practice parameter. Am J Clin Pathol. 1997:108:247-253; 8) Dalton-Beninato K. Critical value notifications are never welcome news. Lab Med. 2000;31:319-323; 9) Howanitz PJ, et al. Laboratory critical values policies and procedures. A College of American Pathologists Q-probes study in 623 institutions. Arch Pathol Lab Med. 20002;126:663-669.


Is there documentation of prompt notification of the physician (or other clinical personnel responsible for patient care) of results of all critical values?

NOTE: In addition, the laboratory should document any failure of attempts to notify the appropriate person of critical results, and document the action taken to prevent recurrence of this problem.

COMMENTARY:

Records must be maintained indicating the notification of the appropriate clinical individual promptly after observing results in critical range. These records should include: date, time, responsible laboratory individual, person notified and test results. In addition, the laboratory should document any failure of attempts to notify the appropriate person of critical results, and document the action taken to prevent recurrence of this problem.

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REFERENCES: 1) Kost GJ. Critical limits for urgent clinician notification at US medical centers. JAMA. 1990;263:704-707; 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):[42CFR493.1291(g)]; 3) Steindel SJ, Heard NV. Critical values: data analysis and critique. Q-Probes 92-04. Northfield, IL: College of American Pathologists, 1992; 4) Kost GJ. Using critical limits to improve patient outcome. Med Lab Observ. 1993;25(3):22-27; 5) Tate KE, Gardner RM. Computers, quality, and the clinical laboratory: a look at critical values. Proc Annu Symp Comput Appl Med Care. 1993;193-197; 6) Kaufman HW, Collins C. Notifying clients of life-threatening results. Med Lab Observ. 1994;26(8):44-45; 7) Emancipator K. Critical values. ASCP practice parameter. Am J Clin Pathol. 1997:108:247-253; 8) Dalton-Beninato K. Critical value notifications are never welcome news. Lab Med. 2000;31:319-323; 9) Howanitz PJ, et al. Laboratory critical values policies and procedures. A College of American Pathologists Q-probes study in 623 institutions. Arch Pathol Lab Med. 20002;126:663-669.


Are routine and STAT results available within a reasonable time?

NOTE: A reasonable time for routine daily service, assuming receipt or collection of specimen in the morning is 4 to 8 hours. Emergency or STAT results that do not require additional verification procedures should be reported within 1 hour after specimen receipt in the laboratory.

COMMENTARY:

Routine and stat results must be available within a reasonable time. A reasonable time for routine daily service, assuming receipt or collection of specimen in the morning, is 4 to 8 hours. Emergency or stat results that do not require additional verification procedures should be reported within 1 hour after specimen receipt in the laboratory.

REFERENCES: 1) 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; 2) Steindel SJ, Novis DA. Using outlier events to monitor test turnaround time. A College of American Pathologists Q-Probes study in 496 laboratories. Arch Pathol Lab Med. 1999;123:607-614; 3) Manor PG. Turnaround times in the laboratory: a review of the literature. Clin Lab Sci. 1999;12(2):85-89.

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REAGENTS

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The laboratory has the responsibility for ensuring that all reagents used, whether purchased or prepared by the laboratory, are appropriately reactive. The verification of reagent performance is

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required and must be documented. Any of several methods may be appropriate, such as direct analysis with reference materials, parallel testing of old vs. new reagents, and checking against routine controls. The intent of the questions is for new reagents to be checked by an appropriate method and the results recorded before patient results are reported. Where individually packaged reagents/kits are used, there should be criteria established for monitoring reagent quality and stability, based on volume of usage and storage requirements. Processing of periodic "wet controls" to validate reagent quality and operator technique is a typical component of such a system.


Are reagents and solutions properly labeled, as applicable and appropriate, with the following elements?

1. Content and quantity, concentration, or titer2. Storage requirements3. Date prepared or reconstituted by laboratory4. Expiration date

NOTE: The above elements may be recorded in a log (paper or electronic), rather than on the containers themselves, providing that all containers are identified so as to be traceable to the appropriate data in the log. While useful for inventory management, labeling with "date received" is not routinely required. There is no requirement to routinely label individual containers with "date opened"; however, a new expiration date must be recorded on the container if opening the container changes the expiration date, storage requirement, etc. The inspector will describe specific issues of non-compliance in the Inspector's Summation Report.

COMMENTARY:

All reagents must be properly labeled, as applicable and appropriate, with the following elements.

1. Content and quantity, concentration, or titer2. Storage requirements3. Date prepared or reconstituted by laboratory4. Expiration date

The above elements may be recorded in a log (paper or electronic), rather than on the containers themselves, providing that all containers are identified so as to be traceable to the appropriate data in the log. While perhaps useful for inventory management, labeling with "date received" is not routinely required. There is no requirement to routinely label individual containers with "date opened"; however, a new expiration date must be recorded on the container if opening the container changes the expiration date, storage requirement, etc. One or more of the above elements were absent during the on-site inspection. Details are provided in the Inspector's Summation Report.

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

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24):7164 [42CFR493.1252(c)]; 2) Gonzales Y, Kampa IS. The effect of various storage environments on reagent strips. Lab Med. 1997;28:135-137; 3) NCCLS. Clinical laboratory technical procedure manuals - third edition; approved guideline GP2-A3. Wayne, PA: NCCLS, 1996.


Are all reagents used within their indicated expiration date?

NOTE: The laboratory must assign an expiration date to any reagents that do not have a manufacturer-provided expiration date. The assigned expiration date should be based on known stability, frequency of use, storage conditions, and risk of contamination.

COMMENTARY:

Reagents must not be used beyond their stated or assigned expiration date.



Are new reagent lots and/or shipments checked against old reagent lots or with suitable reference material before or concurrently with being placed in service?

NOTE: For qualitative tests, minimum cross-checking includes retesting at least one known positive and one known negative patient sample from the old reagent lot or shipment against the new reagent lot, ensuring that the same results are obtained with the new lot. Good clinical laboratory science includes patient-based comparisons in many situations, since it is patient results that are "controlled". The use of QC material is acceptable, but the laboratory should be aware that matrix interference may affect such material and mask a change in patient results caused by a reagent lot change. A weakly positive sample should also be used in systems where patient results are reported in that fashion.

COMMENTARY:

N/A

URN.24300 Phase I N/A YES NO

Are common interferences evaluated for all analytes measured with each reagent system, or is credible information available?

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NOTE: NCCLS Guideline EP7-P (Interference Testing In Clinical Chemistry) is a useful reference source. Neither this document nor its methods are mandatory for CAP accreditation.

COMMENTARY:

Common interferences should be evaluated for each analyte measured with each reagent system, or information should be available that is consistent with NCCLS guideline EP7-P.

REFERENCE: NCCLS. Interference testing in clinical chemistry; proposed guideline EP7-P. Wayne, PA: NCCLS, 1986.

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CONTROLS AND STANDARDS

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Controls are samples that act as surrogates for patient specimens. They are periodically processed like a patient sample to monitor the ongoing performance of the entire analytic process.

Most quantitative tests are traditionally monitored with 2 levels of liquid control material (procedural control). This is done at a frequency within which the accuracy and precision of the measuring system is expected to be stable (based upon manufacturer's recommendations), but at least each day that patient testing is performed. The daily use of two levels of liquid control may NOT be required for certain test systems, where the daily use of instrument and/or electronic controls is demonstrably sufficient to validate that calibration status is maintained within acceptable limits.

The daily use of 2 levels of instrument and/or electronic controls as the only QC system is acceptable only for unmodified test systems cleared by the FDA and classified under CLIA-88 as "waived" or "moderate complexity". The laboratory is expected to provide documentation of its validation of all instrument-reagent systems for which daily controls are limited to instrument and/or electronic controls, and the Inspector will review these data to assess the adequacy of the QC system. This documentation must include the Federal complexity classification of the testing system AND data showing that calibration status is monitored.

For unmodified multiparameter qualitative urine dipstick tests, the laboratory must have and follow a protocol involving the processing of known QC materials (commercial or prepared in-house). Distilled water may be used as a negative control. The specific frequency of such testing for multiparameter urine chemistry dipsticks may vary according to workload and testing location, and need not occur with each run. However, the frequency must be defined and followed by the laboratory.

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For QUANTITATIVE tests, are control materials at more than one concentration (level) used at least daily?

NOTE: The daily use of 2 levels of instrument and/or electronic controls as the only QC system is acceptable only for unmodified test systems cleared by the FDA and classified under CLIA-88 as "waived" or "moderate complexity". The laboratory is expected to provide documentation of its validation of all instrument-reagent systems for which daily controls are limited to instrument and/or electronic controls. This documentation must include the federal complexity classification of the testing system and data showing that calibration status is monitored.

For unmodified multiparameter qualitative dipstick tests, the laboratory must have and follow a protocol involving the processing of known QC materials (commercial or prepared in-house). Distilled water may be used as a negative control if permitted by the instrument manufacturer. The specific frequency of such testing for multiparameter urine chemistry dipsticks may vary according to workload and testing location, and need not occur with each run. However, the frequency must be defined and followed by the laboratory.

COMMENTARY:

N/A

REFERENCES: 1) Hoeltge GA, Ersts A. A quality control system for the general urinalysis laboratory. Am J Clin Pathol. 1980;73:403-408; 2) Department of Health and Human Services, Centers for Medicare and Medicaid Services. Medicare, Medicaid and CLIA programs; CLIA fee collection; correction and final rule. Fed Register. 2003(Jan 24):5232 [42CFR493.1256(d)(3)(i)]; 3) NCCLS. Statistical quality control for quantitative measurements; principles and definitions - second edition; approved guideline C24-A2. Wayne, PA: NCCLS, 1998.


Are controls or reference materials used regularly to check reactivity and accuracy of qualitative/semiquantitative dipstick procedures ?

NOTE: The specific frequency of such testing for multiparameter urine chemistry dipsticks may vary according to workload and testing location, and may not occur with each "run", as mandated for other qualitative tests. However, the frequency must be defined and followed by the laboratory.

COMMENTARY:

Controls or reference materials must be used regularly to check reactivity and accuracy of qualitative/semi-quantitative dipstick urinalysis procedures. The specific frequency of such testing may vary according to workload and testing location, and may not occur with each "run", as mandated for other qualitative tests. However, the frequency must be defined and followed by the laboratory.

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For QUALITATIVE tests other than multiparameter chemistry dipsticks, is a positive and negative control included with each run of patient specimens?

NOTE: Controls may be liquid/external, procedural/internal, or electronic. An analytical run is the interval within which the accuracy and precision of the measuring system is expected to be stable, based upon manufacturer's recommendations, and shall not exceed 24 hours.

COMMENTARY:

For qualitative tests other than multiparameter chemistry dipsticks, a positive and negative control must be included with each run of patient specimens.

REFERENCE: 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)(3)(ii)].


For quantitative tests, has a statistically valid target range (e.g., mean, SD, CV) been verified or established for each lot of control material by repetitive analysis in runs that include previously tested control materials?

COMMENTARY:

N/A


Are the results of quality control results documented?

COMMENTARY:

Quality control results must be recorded and available for reference.


If there are multiple components of a reagent kit, does the laboratory use components of reagent kits only within the kit lot unless otherwise specified by the manufacturer?

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COMMENTARY:

If there are multiple components of a reagent kit, the laboratory must use components of reagent kits only with other kits that are in the same lot number, unless otherwise specified by the manufacturer.


**NEW** 03/30/2005


Are upper and lower limits of all reportable parameters on cell counting instruments defined, so results that fall outside these limits are verified before reporting?

NOTE: The laboratory must initially establish or verify the reportable range for each parameter of its automated or semi-automated cell counter. Apparent cell counts that are lower or higher than the reportable range may be reported as "less than" the lower limit or "greater than" the higher limit. Alternatively, when clinically appropriate, samples with results exceeding the higher limit may be diluted so that the value falls within the established analytic range, and appropriate multipliers applied.

COMMENTARY:

N/A

REFERENCE: 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].


Is there documentation of corrective actions taken when control values exceed defined tolerance limits?

NOTE: 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.

COMMENTARY:

N/A

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REFERENCE: 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)].


Are control specimens tested in the same manner and by the same personnel as patient samples?

COMMENTARY:

It is implicit in quality control that control specimens be tested in the same manner as patient specimens. Moreover, QC specimens must be analyzed by personnel who routinely perform patient testing - this does not imply that each operator must perform QC daily, so long as each instrument and/or test system has QC performed at required frequencies, and all analysts participate in QC on a regular basis. To the extent possible, all steps of the testing process must be controlled, recognizing that pre-analytic and post-analytic variables may differ from those encountered with patients.

REFERENCE: 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)(8)].


Are the results of controls verified for acceptability before reporting results?

COMMENTARY:

Controls must be reviewed before reporting patient results. It is implicit in quality control that patient test results will not be reported when controls yield unacceptable results.

REFERENCE: 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)].

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INSTRUMENTS AND EQUIPMENT

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A variety of instruments and equipment are used to support the performance of analytical procedures. All instruments and equipment should be properly operated, maintained, serviced, and monitored to ensure that malfunctions of these instruments and equipment do not adversely affect the analytical results. The inspection team should review the procedures for instrument/equipment operations,

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maintenance, and monitoring records to ensure that these devices are properly used. The procedures and schedules for instrument maintenance must be as thorough and as frequent as specified by the manufacturer.


Are refractometers or dipsticks with specific gravity capability checked periodically with appropriate solutions of known specific gravity and/or refractive index?

NOTE: Distilled water (sp. gr. = 1.0000) and 5% NaCl (sp. gr. = 1.0225) can conveniently verify total solids (T.S.) meter calibration. For sp. gr. by dipstick, follow manufacturers' recommendations.

COMMENTARY:

Refractometers or dipsticks with specific gravity capability must be checked periodically with appropriate controls. Distilled water (sp.gr.=1.0000) and 5% NaCl (sp.gr.=1.0225) can verify total solids (T.S.) meter calibration. For dipsticks, follow manufacturers' recommendations.

REFERENCE: Haber MH. Quality assurance in urinalysis. Clinics in Lab Med. 1988;8:432-436.


Is there a documented routine maintenance and function verification schedule for all instruments and equipment in the urinalysis and clinical microscopy section(s) of the laboratory?

COMMENTARY:

There must be a documented routine maintenance or function verification schedule available and in use.


Are there records documenting all routine instrument maintenance and nonscheduled service and repairs?

COMMENTARY:

Records documenting routine instrument maintenance, nonscheduled service, or repairs must be maintained.

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Is there evidence of ongoing evaluation of records of controls, instrument maintenance and function, temperature, etc., for all procedures as required?

COMMENTARY:

N/A


Are instrument maintenance, service and repair records (or copies) promptly available to, and usable by, the technical staff operating the equipment?

NOTE: The effective utilization of instruments by the technical staff depends upon the prompt availability of maintenance, repair, and service documentation (copies are acceptable). Laboratory personnel are responsible for the reliability and proper function of their instruments and must have access to this information. Off-site storage, such as with centralized medical maintenance or computer files, is not precluded if the inspector is satisfied that the records can be promptly retrieved.

COMMENTARY:

N/A


Are criteria established for frequency of calibration or calibration verification, and the acceptability of results?

NOTE: Criteria typically include:

1. At changes of reagent lots for chemically or physically active or critical components, unless the laboratory can demonstrate that the use of different lots does not affect the accuracy of patient test results and the range used to report patient test data

2. QC fails to meet established criteria3. After major maintenance or service4. When recommended by the manufacturer5. At least every 6 months

COMMENTARY:

Criteria must be established for calibration or calibration verification.

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A laboratory must also have documented criteria for acceptable calibration verification results. When calibration verification criteria are exceeded, the laboratory must recalibrate.

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 Professional practice in clinical chemistry: a companion text, ed DR Dufour. Washington, DC: AACC Press, 1999:12-1 to 12-22.


Is the method system recalibrated when calibration verification fails to meet the established criteria of the laboratory?

COMMENTARY:

The method system must be recalibrated when calibration verification fails to meet the established criteria of the laboratory.


Are documented calibration procedures for each method adequate, and is calibration recorded?

COMMENTARY:

Calibration procedures for each method must be documented and adequate for the system employed. Calibration is the process of testing and adjusting a test system to provide a known relationship between the response measurement and the value of a substance measured by the procedure. Calibration is mandated to be in accordance with and with at least the frequency of manufacturer's instructions. Calibration must also be performed when calibration verification fails to meet acceptable limits.

Calibration verification is mandated whenever there is a significant change in the instrument/reagent system, and it must not exceed 6 months.

REFERENCE: 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].


Are pipettors and dilutors (fixed volume or adjustable) checked before being placed in service and at specific defined intervals for volumetric accuracy and reproducibility, and results recorded?

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COMMENTARY:

Pipettors and dilutors (fixed volume or adjustable) must be checked before being placed in service and at specific defined intervals for volumetric accuracy and reproducibility, and results of such testing recorded.

REFERENCES: 1) Curtis RH. Performance verification of manual action pipets. Part I. Am Clin Lab. 1994;12(7):8-9; 2) Curtis RH. Performance verification of manual action pipets. Part II. Am Clin Lab. 1994;12(9):16-17; 3) Perrier S, et al. Micro-pipette calibration using a ratiometric photometer-reagent system as compared to the gravimetric method. Clin Chem. 1995;41:S183; 4) Bray W. Software for the gravimetric calibration testing of pipets. Am Clin Lab. Oct 1995 (available on the internet at http://www.labtronics.com/pt_art.htm); 5) Kroll MH, et al (eds). Laboratory instrument evaluation, verification & maintenance manual, 5th edition. Northfield, IL: College of American Pathologists, 1999:126-127; 6) Johnson B. Calibration to dye for: Artel's new pipette calibration system. Scientist. 1999;13(12):14; 7) Connors M, Curtis R. Pipetting error: a real problem with a simple solution. Parts I and II. Am Lab News. 1999;31(13):20-22; 8) Skeen GA, Ashwood ER. Using spectrophotometry to evaluate volumetric devices. Lab Med. 2000;31:478-479.


Is volumetric glassware of certified accuracy (Class A) or checked by the laboratory to verify accuracy?

COMMENTARY:

Volumetric glassware must be certified for accuracy (Class A) or checked for accuracy before being placed in service. Disposable micropipettes must be examined visually for uniformity of length of column and a representative sample checked before the box is placed in service.

REFERENCES: 1) Curtis RH. Performance verification of manual action pipets. Part I. Am Clin Lab. 1994;12(7):8-9; 2) Curtis RH. Performance verification of manual action pipets. Part II. Am Clin Lab. 1994;12(9):16-17; 3) Perrier S, et al. Micro-pipette calibration using a ratiometric photometer-reagent system as compared to the gravimetric method. Clin Chem. 1995;41:S183; 4) Bray W. Software for the gravimetric calibration testing of pipets. Am Clin Lab. Oct 1995 (available on the internet at http://www.labtronics.com/pt_art.htm); 5) Kroll MH, et al (eds). Laboratory instrument evaluation, verification & maintenance manual, 5th edition. Northfield, IL: College of American Pathologists, 1999:126-127; 6) Johnson B. Calibration to dye for: Artel's new pipette calibration system. Scientist. 1999;13(12):14; 7) Connors M, Curtis R. Pipetting error: a real problem with a simple solution. Parts I and II. Am Lab News. 1999;31(13):20-22; 8) Skeen GA, Ashwood ER. Using spectrophotometry to evaluate volumetric devices. Lab Med. 2000;31:478-479.

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Are microscopes clean, adequate (i.e., low, high dry and oil immersion lens), and properly maintained with documentation of preventive maintenance?

COMMENTARY:

Microscopes must be clean, optically aligned, and have an adequate selection of objective lenses appropriate for the specimens examined. This equipment must be properly maintained, with documentation of preventive maintenance. Koehler illumination must be maintained for optimal resolution.

REFERENCE: Vetter JP. Solving problems with illumination, focus, and detail in color photomicrography. Lab Med. 1997;28:719-723.

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PROCEDURES AND TEST SYSTEMS

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URINALYSIS PARAMETERS

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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, and nitrite. Other analytes (e.g., color, clarity, turbidity, specific gravity, 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.


Does the routine dipstick urinalysis (whether read manually or by electronic reader) include, as clinically applicable?

1. Glucose2. Protein3. Blood or hemoglobin4. Nitrite5. Leukocyte esterase

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NOTE: The Inspector must provide specific details of any deficiencies in Part B (Deficiency Summary) of the Inspector's Summation Report.

COMMENTARY:

The elements of a macroscopic urinalysis may vary according to the patient population served by a laboratory. A complete routine urinalysis should include at least the following: glucose, protein, blood/hemoglobin, leukocyte esterase, and nitrite. Other analytes (e.g., color, clarity, turbidity, specific gravity, bilirubin, ketones, pH and urobilinogen) are optional for CAP accreditation, but their utility should be reviewed with the medical staff served by the laboratory. One or more of the following dipstick parameters should be included in the routine urinalysis.

1. Glucose2. Protein3. Blood or hemoglobin4. Nitrite5. Leukocyte esterase

Specific details of non-compliance are identified in part B (Deficiency Summary) of the Inspector's Summation Report.

REFERENCES: 1) 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; 2) De Buys Roessingh AS, et al. Dipstick measurements of urine specific gravity are unreliable. Arch Dis Child. 2001;85:155-157; 3) Voinescu GC, et al. The relationship between urine osmolality and specific gravity. Am J Med Sci. 2002;323:39-42.


Is there a documented policy indicating when pediatric specimens should be tested for reducing substances other than glucose?

NOTE: Such a policy should be based on consultation with the pediatric clinical staff. The policy should include instructions for dealing with those urines tested and found to be negative with glucose-specific tapes or strips. There is no requirement for routine performance of reducing substance testing in adult urines.

COMMENTARY:

There must be a clearly defined procedure relative to testing pediatric urine specimens for the presence of reducing substances other than glucose. Such a policy may be based on consultation with the pediatric staff. The policy should include instructions for dealing with those urines tested and found to

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be negative with glucose-specific tapes or strips. There is no requirement for routine performance of reducing substance testing in adult urines.

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URINALYSIS - MANUAL MICROSCOPY

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Are manual microscopic examinations of urine sediment performed as part of complete urinalysis testing, or are there specific, documented criteria defining the circumstances under which the microscopic examination may be omitted?

NOTE: There is evidence that in random urinalysis screening (hospital admissions, insurance physicals), urines that are yellow and clear and have negative chemical reactions have a markedly low yield on microscopic examination. Optimal service may entail protocols defining when microscopic examination of urine sediment should or should not be done.

COMMENTARY:

The microscopic examination of urine sediment should be a part of the complete routine urinalysis procedure unless specific documented procedures define the circumstances under which the microscopic exam may be omitted.

There is evidence that in random urinalysis screening (hospital admissions, insurance physicals), urines that are yellow and clear and have negative chemical reactions have a markedly low yield on microscopic examination. Optimal service may entail protocols defining when microscopic examination of urine sediment should or should not be done.

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.

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**NEW** 12/29/2004


For post-vasectomy checks for reproductive sterility, is a concentrating technique employed on seminal fluid?

NOTE: For post-vasectomy checks for reproductive sterility, a concentrating technique must be employed on the seminal fluid sample. Without such an approach, the presence of both motile and non-motile sperm may not be detected.

COMMENTARY:

N/A

REFERENCES: 1) Jones CD, Cornbleet PJ. Wright-Giemsa cytology of body fluids. Techniques for optimal cytocentrifuge slide preparation. Lab Med. 1997;28:713-716; 2) Jaffe TM, et al. Sperm pellet analysis: a technique to detect the presence of sperm in men considered to have azoospermia by routine semen analysis. J Urol. 1998;159:1548-1550.


Are reference materials (atlases, charts or photomicrographs) available to assist in the microscopic identification of sediment constituents?

COMMENTARY:

Graphic reference materials such as atlases, charts, or photographic transparencies must be available to assist in the identification of sediment constituents.

REFERENCES: 1) Jao W, et al. An atlas of urinary sediment. Chicago, IL: Abbott Laboratories, 1980; 2) Haber MH. Urinary sediment: a textbook atlas. Chicago, IL: American Society of Clinical Pathology, 1981; 3) Graff L. A handbook of routine urinalysis. Philadelphia, PA: JB Lippincott, 1983; 4) Bradley M. Urine crystals - identification and significance. Lab Med. 1982;13:348-353; 5) Zaharopoulos P, Wong JY. Matrix crystals in urine sediments. Lab Med. 1988;19:429-431; 6) Brunzel NA. Fundamentals of urine and body fluid analysis. Philadelphia, PA: WB Saunders, 1994; 7) King C. Comparison of methods for detecting indinavir crystals in urine. Am J Clin Pathol. 1998;110:540; 8) College of American Pathologists. Surveys hematology glossary. Northfield, IL: CAP, 1999:27-36; 9) Hortin GL, et al. Detection of indinavir crystals in urine. Dependence on method of analysis. Arch Pathol Lab Med. 2000;124:246-250; 10) Ringsrud KM. Cells in the urine sediment. Lab Med. 2001;32:153-155; 11) Ringsrud KM. Casts in the urine sediment. Lab Med. 2001;32:191-193.

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Does the urinalysis section of the laboratory have a defined, documented system to ensure consistency of morphologic observations among all personnel performing urine sediment microscopy?

NOTE: Suggested methods to accomplish this include:

1. Circulation of preserved urine sediments with defined abnormalities involving leukocytes, erythrocytes, casts, bacteria, yeast, etc.

2. Multi-headed microscopy3. Use of urine sediment photomicrographs with referee and consensus identifications

(e.g., former CAP surveys clinical microscopy photomicrographs)

COMMENTARY:

The urinalysis laboratory must have a documented system that ensures that all personnel report microscopic morphologic data on patient samples in a similar fashion. For initial accuracy, as well as consistency in serial samples from the same patient, the laboratory must be able to document that all of its staff are consistent with respect to morphologic classification. Suggested methods to accomplish this include:

1. Circulation of preserved urine sediments with defined abnormalities involving leukocytes, erythrocytes, casts, bacteria, yeast, etc.

2. Multi-headed microscopy3. Use of urine sediment photomicrographs with referee and consensus identifications

(e.g., former CAP Surveys clinical microscopy photomicrographs)

REFERENCES: 1) College of American Pathologists. Surveys hematology glossary. Northfield, IL: CAP, 1999:27-36; 2) Astion ML, et al. A web-based system for assessing competency in microscopic urinalysis. Clin Chem. 2000;46:A36; 3) Ringsrud KM. Cells in the urine sediment. Lab Med. 2001;32:153-15; 4) Ringsrud KM. Casts in the urine sediment. Lab Med. 2001;32:191-193; 5) Kim A, et al. Web-based competency assessment system for microscopic urinalysis. Clin Chem. 2002;48:1608-1611.


Is there a documented procedure for correlation of microscopic sediment findings (such as casts, RBC, or WBC) with macroscopic results (presence of protein, positive occult blood, positive leukocyte esterase, etc.)?

COMMENTARY:

The accuracy of microscopic identification must be checked by correlation with other results, such as the presence of protein with casts, positive occult blood with red cells, and positive leukocyte esterase

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with white cells. The laboratory must have documentation of a procedure for microscopic-macroscopic correlation.

REFERENCE: 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.

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AUTOMATED AND SEMI-AUTOMATED SYSTEMS

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Dipstick Readers

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Is the instrument calibrated and/or calibration verified at appropriate intervals?

COMMENTARY:

The instrument used for chemical dipstick analysis must be calibrated and/or have calibration verified at appropriate intervals. These intervals are specified by the manufacturer, although the laboratory may specify alternate intervals based on its own performance experience.


Are negative and positive controls analyzed each day of use?

COMMENTARY:

Negative and positive controls must be analyzed on the automated dipstick reader on each day of use.


Are tolerance limits defined for controls?

COMMENTARY:

Tolerance limits must be defined and/or documented for controls on the automated dipstick reader.

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Is there documentation of corrective action taken when controls exceed defined tolerance limits?

COMMENTARY:

There must be adequate documentation of corrective action taken when controls exceeded defined tolerance limits.

**REVISED** 03/30/2005


Before placing a new dipstick reader into service, has the laboratory performed comparisons between the new instrument and a manual method or another automated method?

NOTE: When changing readers (same or different manufacturer), a new comparative study should be performed between the new instrument(s) and either a manual method or another automated method. The laboratory should have the results of its evaluation studies, either in summary form or actual data, available to the Inspector for review.

COMMENTARY:

N/A

REFERENCES: 1) Ng RH, et al. Multicenter evaluation of a urine analyzer. Lab Med. 1993;24:783-789; 2) Dias VC, et al. Evaluation of the CLINITEK ATLAS for routine macroscopic urinalysis. Clin Biochem. 1996;29:217-223; 3) Penders J, et al. Quantitative evaluation of urinalysis test strips. Clin Chem. 2002;48:2236-2241.

**REVISED** 03/30/2005


Are there criteria for identifying urine samples that may give erroneous results by the dipstick reader and thus require evaluation by alternate means (visual examination or other confirmatory method)?

NOTE: Criteria should be given for identifying urine samples that may give erroneous results by the dipstick reader, and thus require confirmation by other means, such as visual examination. Intensely colored urine samples may result in false positive dipstick reactions with automated reflectance readers. However, the anomalous color will be apparent when visual evaluation is performed.

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COMMENTARY:

N/A

REFERENCE: 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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Morphology Systems

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**REVISED** 03/30/2005


When an automated urine sediment method is introduced, is the method evaluated against either manual microscopic analysis, or another automated method, before being placed into routine use?

NOTE: The evaluation must be documented.

COMMENTARY:

N/A

REFERENCES: 1) Williams KH. Comparison of automated and manual microscopy. Am J Clin Pathol. 1991;96:421; 2) Bartlett RC, et al. Screening for urinary tract infection with the Yellow Iris. Lab Med. 1992;23:599-602; 3) Kutter D. An approach to clinical evaluation of the automated urine sediment analyzer Sysmex UA-1000. Sysmex J Int. 1991;1:49-58; 4) Muranaka K. Clinical uses of the UF-100 for the diagnosis of urinary tract infection. Sysmex J Int. 1996;6:46-50; 5) King C. Comparison of methods for detecting indinavir crystals in urine. Am J Clin Pathol. 1998;110:540; 6) Ben-Ezra J, et al. Evaluation of the Sysmex UF-100 automated urinalysis analyzer. Clin Chem. 1998;44:92-95; 7) Kouri T, et al. Evaluation of Sysmex UF-100 urine flow cytometer vs chamber counting of supravitally stained specimens and conventional bacterial cultures. Am J Clin Pathol. 1999;112:25-35; 8) Langlois M, et al. Automated flow cytometry compared with an automated dipstick reader for urinalysis. Clin Chem. 1999;45:118-122; 9) Delanghe JR, et al. The role of automated urine particle flow cytometry in clinical practice. Clin Chim Acta. 2000;301;1-18; 10) Holleman CM, Sedor FA. Evaluation of automated urinalysis vs manual microscopy. Clin Chem. 2000;46:A30; 11) Okada H, et al. Automated urinalysis. Evaluation of the Sysmex UF-50. Am J Clin Pathol. 2001;115:605-610; 12) 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.

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Based on any limitations detected in the initial evaluation, are criteria established for identifying urine specimens that may give clinically relevant erroneous results?

COMMENTARY:

Criteria for identifying urine specimens that may give clinically relevant erroneous results should be established. Excessively turbid urine samples may block aperture flow or interfere with visual detection of pertinent microscopic elements. Manual microscopic examination should be performed if problems are noted with accurate identification or classification or 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.


Are cell count controls analyzed?

COMMENTARY:

Cell count controls must be analyzed on the automated imaging system used for microscopic urinalysis.


Are tolerance limits defined for cell count controls?

COMMENTARY:

Tolerance limits must be defined for cell count controls.


Is there documentation of corrective action taken when controls exceed defined tolerance limits?

COMMENTARY:

There must be documentation of corrective action taken when controls exceed defined tolerance limits.

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**REVISED** 03/30/2005


Are two cell count controls at different levels run each day of patient testing to detect instrument malfunction?

NOTE: Cell count controls should be analyzed no less frequently than each day of patient testing to detect instrument malfunction. Accumulation of sediment can block the flow aperture, leading to spuriously low counts.

COMMENTARY:

N/A

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PERSONNEL

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Does the person in charge of technical operations in urinalysis have education and experience equivalent to an MT (ASCP) and at least 4 years experience (one of which is in urinalysis) under a qualified director?

COMMENTARY:

N/A

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PHYSICAL FACILITIES

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Is there sufficient space for the number and types of tests performed in the urinalysis and clinical microscopy section(s)?

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COMMENTARY:

The amount of space provided should be consistent with the workload of the department.


Is the space available such that there is no compromise of the quality of work, safety of personnel, or limitation of quality control activities?

COMMENTARY:

Existing space limitations were so severe as to interfere with the quality of work, the safety of personnel, and/or the ability of personnel to carry out adequate quality control procedures with appropriate documentation. These matters must be addressed.


Have ergonomic aspects of desks (or benches), chairs, and microscopes been evaluated for good posture and comfort?

COMMENTARY:

Ergonomic aspects of desks (or benches), chairs, and microscopes should be evaluated for good posture and comfort.

REFERENCES: 1) Krueger H, et al. Besondere Belastungen am Mikroskoparbeitsplatz [Special stresses at microscopy work places]. Soz Praventivmed. 1986;31:250-251; 2) Krueger H, Conrady P. Untersuchung zur Ergonomie der Sehbedingungen bei Mikroskoparbeit [Ergonomic aspects of visual conditions in microscope work]. Biomed Tech (Berl). 1988;33(9):196-202; 3) James TM. An ergonomic approach to modifying microscope design for increased comfort: a case study. Proc Human Factors Ergonom Soc. 1995;39th annual meeting; 4) Rorer ML. Safety first - a lesson in ergonomics. Advance/Lab. 1997(March):38-43; 5) Scott FI, Jr. The changing face of clinical microscopy: meeting new optical and ergonomic challenges. Am Clin Lab. 1998;17(2):8-9; 6) Vratny M. Considerations in microscope design to avoid cumulative trauma disorder in clinical laboratory applications. Am Clin Lab. 1999;18(3):8.


Are floors, benches, and sinks clean and free of clutter?

COMMENTARY:

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Floors, benches, and sinks should be kept clean and free of clutter.


Are utilities adequate for the extent and types of services offered?

COMMENTARY:

Service utilities (power and water, etc.) should be adequate for the needs of the laboratory.


Are temperature and ventilation adequately controlled?

COMMENTARY:

Control of temperature and ventilation should be satisfactory.

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LABORATORY SAFETY

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The inspector should review relevant questions from the Safety section of the Laboratory General checklist, to assure that the urinalysis laboratory is in compliance. Please elaborate upon the location and the details of each deficiency in the Inspector's Summation Report.


Are warning labels affixed to collection containers when acid preservatives are used?

NOTE: This does not apply to commercially available small-volume containers with liquid or lyophilized boric acid preservatives to stabilize urine.

COMMENTARY:

Warning labels must be affixed to collection containers containing acid preservatives. This does not apply to commercially available small-volume containers with liquid or lyophilized boric acid preservatives to stabilize urine.

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