POINT-OF-CARE TESTING - University of Michigan€¦ · Web viewPoint of Care Testing (POCT) is defined as testing that does not require permanent dedicated space. POCT refers to

Revised: 10/06/2005

POINT-OF-CARE TESTING

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 POINTS

APPLICABILITYPROFICIENCY TESTINGQUALITY MANAGEMENT

PROCEDURE MANUALSPECIMEN HANDLINGRESULTS REPORTINGREAGENTSINSTRUMENTS AND EQUIPMENT

PERSONNELQUALITY CONTROLCALIBRATION OF QUANTITATIVE SYSTEMS

BLOOD GAS SPECIMENSSAFETYPHYSICIAN-PERFORMED TESTING

POINT-OF-CARE TESTING Page 2 of 41


SUMMARY OF CHANGESPOINT-OF-CARE TESTING 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 POC.07850 10/06/2005POC.08870 10/06/2005POC.08925 10/06/2005POC.08980 10/06/2005POC.09035 10/06/2005POC.09090 10/06/2005POC.09145 10/06/2005

REVISED Checklist Questions

Question Effective Date POC.06800 10/06/2005POC.06900 10/06/2005

DELETED Checklist Questions

Question Effective Date POC.03750 10/06/2005POC.04350 10/06/2005POC.05020 10/06/2005POC.06280 10/06/2005POC.07200 10/06/2005POC.07500 10/06/2005POC.08800 10/06/2005POC.08900 10/06/2005



POC.09000 10/06/2005POC.09100 10/06/2005



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.

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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.

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.

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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APPLICABILITY

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DEFINITION OF POINT-OF-CARE TESTING

Point-of-Care Testing (POCT) is defined as testing that does not require permanent dedicated space. POCT refers to those analytical patient-testing activities provided within the institution, but performed outside the physical facilities of the clinical laboratories. Examples include kits and instruments that are hand-carried or otherwise transported to the vicinity of the patient for immediate testing at that site (e.g., capillary blood glucose) or analytic instruments that are temporarily brought to a patient care location (e.g., operating room, intensive care unit). POCT does NOT include limited service satellite laboratories with fixed dedicated testing space; these are covered under the Limited Service Laboratory Checklist.

This checklist does not cover patient self-testing. The CAP Laboratory Accreditation program does not inspect or accredit patient self-testing.

If a POCT site has a scope of service in a particular laboratory discipline that exceeds those addressed in this Checklist, then a section-specific Checklist (e.g., Hematology, Microbiology) may be required.

THIS CHECKLIST MUST ALWAYS BE ACCOMPANIED BY THE LABORATORY GENERAL CHECKLIST, AS THE CONTENTS OF THAT CHECKLIST APPLY TO ALL LABORATORY ACTIVITY, WHETHER OCCURRING IN DEDICATED SPACE OR NOT.

PRINCIPLES OF POCT OPERATIONS

Activities of the POCT programs must comply with all current Standards for Laboratory Accreditation of the College of American Pathologists (CAP), regardless of scope of testing. The POCT program may be centrally coordinated, with designated qualified personnel who review testing procedures and quality control, and conduct training of the testing personnel, although this is not a requirement. The CAP does not subclassify tests according to the Federal system of "waived," "moderate complexity," "high complexity," or "provider-performed microscopy" testing as defined under CLIA-88. All CAP Standards are considered "site-neutral" from the perspective that all tests must be correctly performed for patient care.



When records are maintained centrally by a designated coordinator or POCT Director, only one copy of this Point-of-Care Testing Checklist need be completed. The Inspector will review all centrally maintained records and visit at least a sampling of the testing sites in order to evaluate compliance with the Standards. If records are not maintained centrally, the Inspector must visit each POCT site, and a separate Checklist must be completed for each location. In the latter case, each POCT site will be inspected as an additional laboratory section.

To be accredited, all analytes being measured under the POCT program/site must be included in the on-site inspection and comply with the CAP Standards for Laboratory Accreditation. POCT programs may be inspected as sections of the central laboratory if they are registered under the same CLIA-88 number. In this circumstance, they are included in the Laboratory General Checklist used for the central laboratory. If the POCT sites are registered under separate CLIA numbers, a separate Laboratory General Checklist must be completed for each POCT program.

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PROFICIENCY TESTING

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POC.03200 Phase II N/A YES NO

Is the POCT program enrolled in the appropriate required CAP Surveys or a 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. The POCT program must enroll in surveys with analytes matching those for which patient testing is performed (e.g., patient whole blood glucose testing requires enrollment in CAP survey WBG or approved equivalent). Participation in proficiency testing may be through CAP Surveys or a CAP-approved proficiency testing provider. POCT programs will not be penalized if they are unable to enroll in an oversubscribed PT program. If unable to enroll, however, the POCT program 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.

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]; 2) Tholen DW. Reference values and participant means as targets in


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


proficiency testing. Arch Pathol Lab Med. 1993;117:885-889; 3) Jones BA, et al. Bedside glucose monitoring. A College of American Pathologists Q-Probes study of the program characteristics and performance in 605 institutions. Arch Pathol Lab Med. 1993;117:1080-1087; 4) Howanitz PJ, Jones BA. Bedside glucose monitoring. Comparison of performance as studied by the College of American Pathologists Q-Probes program. Arch Pathol Lab Med. 1996;120:333-338; 5) NCCLS. Continuous quality improvement: essential management approaches and their use in proficiency testing; proposed guideline GP22-P. Wayne, PA: NCCLS, 1997; 6) Novis DA, Jones BA. Interinstitutional comparison of bedside glucose monitoring. Characteristics, accuracy performance, and quality control documentation: a College of American Pathologists Q-Probes study of bedside glucose monitoring performed in 226 small hospitals. Arch Pathol Lab Med. 1998;122:495-502; 7) College of American Pathologists, Commission on Laboratory Accreditation. Standards for laboratory accreditation, standard III. Northfield, IL: CAP, 1998; 8) College of American Pathologists. Surveys hematology glossary. Northfield, IL: CAP, 1999.


For tests for which CAP does not require PT, does the POCT program 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):3650[42CFR493.1236(c)]; 2) Novis DA, Jones BA. Interinstitutional comparison of bedside glucose monitoring. Characteristics, accuracy performance, and quality control documentation: a College of American Pathologists Q-Probes study of bedside glucose monitoring performed in 226 small hospitals. Arch Pathol Lab Med. 1998;122:495-502; 3) 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; 4) NCCLS. Assessment of Laboratory Tests When Proficiency Testing is Not Available; Approved Guideline. NCCLS document GP29-A [ISBN 1-56238-479-1]. NCCLS, 940 West Valley Road, Suite 1400, Wayne, PA 19087-1898 USA, 2002.




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

NOTE: Replicate analysis of samples is acceptable only if patient specimens are routinely analyzed in the same manner. Further, these proficiency testing samples should be periodically rotated among all analyzers used and among all personnel who routinely test patient specimens. The educational purposes and documentation of proficiency are best served by a rotation that allows all testing personnel 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 those individuals performing testing. If physicians perform patient testing, they should also participate in proficiency testing (except for tests covered by the Physician-performed Testing (PPT) section of this checklist). There must not be any interlaboratory communication on proficiency testing data before results are reported to the provider. In the specific case of photomicrographs of clinical samples, 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 render morphologic assessments 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.


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 assessment 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 POCT program receives its 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) 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)(4)(iv)]; 2) NCCLS. Using proficiency testing (PT) to improve the clinical laboratory; approved guideline GP27-A. Wayne, PA: NCCLS, 1998; 3) Shahangian S, et al. Toward optimal PT use. Med Lab Observ. 2000;32(4):32-43.


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

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):7173 [42CFR493.1407(e)(4)(iii)]; 2) NCCLS. Using proficiency testing (PT) to improve the clinical laboratory; approved guideline GP27-A. Wayne, PA: NCCLS, 1998; 3) Shahangian S, et al. Toward optimal PT use. Med Lab Observ. 2000;32(4):32-43.

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QUALITY MANAGEMENT

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All quality management (QM) questions in the Laboratory General Checklist pertain to POCT.


Does the point-of-care testing program have a written QM program?

NOTE: The QM program for POCT 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, and processing; and accurate result reporting. The program must be capable of detecting problems and identifying opportunities for system improvement. The POCT program must be able to develop plans of corrective/preventive action based on data from its QM system.



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):7177 [42CFR493.1449]; 2) Guidelines for near patient testing: haematology. Near patient testing working party. General haematology task force of BCSH. Thrombosis and haemostasis task force of BCSH. Clin Lab Haematol. 1995;17:301-310; 3) Parvin CA, et al. Impact of point-of-care testing on patients' length of stay in a large emergency department. Clin Chem. 1996;42:711-717; 4) Foster JA, et al. An academic medical center's performance improvement to point-of-care testing. Am J Clin Pathol. 1997;108:106; 5) Novis DA, Jones BA. Interinstitutional comparison of bedside glucose monitoring. Characteristics, accuracy performance, and quality control documentation: a College of American Pathologists Q-Probes study of bedside glucose monitoring performed in 226 small hospitals. Arch Pathol Lab Med. 1998;122:495-502; 6) NCCLS. Point-of-care in vitro diagnostic (IVD) testing; approved guideline AST2-A. Wayne, PA: NCCLS, 1999; 7) NCCLS. Wellness testing; approved guideline AST3-A. Wayne, PA: NCCLS, 1999; 8) Kilgore ML, et al. Continuous quality improvement for point-of-care testing using background monitoring of duplicate specimens. Arch Pathol Lab Med. 1999;123:824-828; 9) Witte DL, VanNess SA. Frequency of unacceptable results in point-of-care testing. Arch Pathol Lab Med. 1999;123:761; 10) Harvey MA. Point-of-care laboratory testing in critical care. Am J Crit Care. 1999;8(2):72-83; 11) Kendall JM, et al. Point of care testing in the accident and emergency department: a cost analysis and exploration of financial incentives to use the technology within the hospital. J Health Serv Res Policy. 1999;4:33-38; 12) Schallom L. Point of care testing in critical care. Crit Care Nurs Clin North Am. 1999;11:99-106; 13) Collinson PO. The need for point of care testing: an evidence-based appraisal. Scand J Clin Lab Invest Suppl. 1999;230:67-73; 14) Galloway MJ, et al. An audit of waiting times in a hematology clinic before and after the introduction of point-of-care testing. Clin Lab Haematol. 1999;21:201-205; 15) Janssen HW, et al. Point-of-care testing: the views of the working group of the Dutch Association of Clinical Chemistry. Clin Chem Lab Med. 1999;37:675-680; 16) Murray RP, et al. Effect of point of care testing on length of stay in an adult emergency department. J Emerg Med. 1999;17:811-814; 17) Howanitz PJ, Jones BA. Comparative costs of central laboratory and bedside glucose monitoring in 445 institutions. Clin Chem. 2000;46:A2; 18) Sevens C, Libeer JC. Point-of-care testing (POCT) regulations in hospitals. The Belgian approach. Clin Chem. 2001;47(suppl):A185.


Is there a documented procedure describing methods for patient identification, patient preparation, specimen collection and labeling, and specimen preservation (if applicable) before testing?

COMMENTARY:

N/A




Is there a documented system in operation to detect and correct significant clerical and analytical errors, and unusual or unexpected test results?

NOTE: This system may need to include feedback from clinicians, with subsequent investigation and monitoring of patient results for unusual patterns (e.g., a series of unexplained hypoglycemic values) suggesting analytic error. Where POCT personnel are also the individuals who will act upon test results (e.g., by altering insulin dosage in response to whole blood glucose results, or altering heparin dosage in response to activated clotting time or aPTT), there should be defined criteria for correlating unexpected test results with other clinical findings to validate such results whenever possible.

COMMENTARY:

N/A


Is there an appropriate person available on all shifts to assist with troubleshooting or other unusual situations?

NOTE: This individual may be from the nursing service, laboratory, or medical staff. The intent is to ensure that resources are available to quickly assist with unusual problems to minimize any adverse impact on patient care.

COMMENTARY:

N/A

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PROCEDURE MANUAL

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The procedure manual should be used by testing personnel 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 POCT program. 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 ensure that all significant information and instructions are included, and that actual practice matches the contents of the procedure manuals. Manufacturer’s instructions must be followed except when less stringent than CAP checklist requirements.




Is a complete procedure manual available in the work areas?

NOTE 1: The use of inserts provided by manufacturers is not acceptable in place of a procedure manual, but inserts may be used as part of a procedure description if the insert accurately and precisely describes the procedure as performed in the POCT program. Inserts must be current. Any 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 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, so long as the electronic versions are readily available to all personnel. Such electronic versions must be subjected 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). Current 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:

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):3706[42CFR493.1251]; 2) Borkowski A, et al. Intranet-based quality improvement documentation at the Veterans Affairs Maryland health care system. Mod. Pathol. 2001;14:1-5; 3) NCCLS. Clinical laboratory technical procedure manuals - fourth edition; approved guideline GP2-A4. Wayne, PA: NCCLS, 2002.




Is there documentation of at least annual review of all policies and procedures for POCT by the current 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. Review must ensure that all package inserts in use are current. 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:

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):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:

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):3706[42CFR493.1251(d)].


Does the POCT program have a system documenting that all personnel are knowledgeable about the contents of procedure manuals (including changes) 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:

N/A


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

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):3706 [42CFR493.1251(d)].


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:

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):3706 [42CFR493.1251(e)].

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SPECIMEN HANDLING

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Proper specimen collection and handling are critical for correct laboratory results. The proximity of testing to the patient does not allow compromises in standard laboratory practice. Specific instructions for the proper collection and handling of specimens must be made available to POCT personnel.




Is an appropriate patient-specific specimen identification and accessioning system in use and consistently applied?

NOTE: The proximity of the patient to POCT test systems does not preclude the need for proper identification systems to prevent reporting of one patient's result to another's record. The specific selection of identifiers is at the discretion of the director. Refer to the Phlebotomy section of the Laboratory General checklist for additional information.

Identification requirements apply to aliquots as well as to primary specimens.

COMMENTARY:

N/A

REFERENCES: 1) NCCLS. Evacuated tubes for blood specimen collection - fourth edition; approved standard H1-A4. Wayne, PA: NCCLS, 1996; 2) NCCLS. Procedures for the collection of diagnostic blood specimens by venipuncture - fourth edition; approved standard H3-A4. Wayne, PA: NCCLS, 1998.

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RESULTS REPORTING

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Is the system for reporting results adequate (i.e., are results clear and retained in the permanent medical record)?

NOTE: While POCT results are often initially reported orally or in temporary written form (e.g., instrument printout or log sheet), these results must be appropriately and promptly recorded in the permanent medical record.

COMMENTARY:

N/A

REFERENCES: 1) Friedman BA, Mitchell W. Integrating information from decentralized laboratory testing sites. The creation of a value-added network. Am J Clin Pathol. 1993;99:637-642; 2) Hortin GL, et al. Managing information from bedside testing. Med Lab Observ. 1995;27(1):28-32; 3) Jones JB. The importance of integrating POCT data into an organized database. Advance/Lab. 1999;8(9):8-10; 4) DuBois JA. Getting to the point: integrating critical care tests in the patient care setting. Med Lab Observ. 2000;32(6):52-56; 5) NCCLS. Point of care connectivity; approved standard POCT1-A.



Wayne, PA: NCCLS, 2002; 6) Piscitelli J, et al. Are data obtained from a nonintegrated point-of-care glucose monitoring system reliable and accessible? Arch Pathol Lab Med. 2002;126:787.


When applicable, are all patient results reported with accompanying reference (normal) intervals or interpretive ranges?

NOTE: Age- and/or sex-specific reference ranges (normal values) or interpretive ranges must be reported with patient test results, as applicable. It is not necessary to include reference intervals when test results are reported as part of a treatment protocol that includes clinical actions, which are based on the test result.

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):3713 [42CFR493.1291(d); 2) NCCLS. How to define and determine reference intervals in the clinical laboratory; approved guideline C28-A2. Wayne, PA: NCCLS, 2000.


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

NOTE: If a formal reference interval study is not possible or practical, then the POCT site should carefully evaluate the use of published data for its own reference ranges, and retain documentation of this evaluation.

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):3707 [42CFR493.1253(b)(1)(ii) and 42CFR493.1251(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 critical limits established for the results of certain tests important for prompt patient management decisions?

NOTE: Critical limits must be established for appropriate tests (such as glucose) so that immediate notification of a physician or other clinical personnel responsible for patient care occurs. These may be indicated in the procedure manual and/or in a separate manual or policy. The analysts must be familiar with critical limits for procedures that they perform.

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):3706 [42CFR493.1251(b)(13)]; 2) Steindel SJ, Heard NV. Critical values: data analysis and critique. Q-probes 92-04. Northfield, IL: College of American Pathologists, 1992; 3) Kost GJ. Using critical limits to improve patient outcome. Med Lab Observ. 1993;25(3):22-27; 4) 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; 5) Emancipator K. Critical values. ASCP practice parameter. Am J Clin Pathol. 1997:108:247-253; 6) Dalton-Beninato K. Critical value notifications are never welcome news. Lab Med. 2000;31:319-323; 7) 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 notification of the physician or other clinical personnel responsible for patient care of results of all critical values?

NOTE: These records must include: date, time, responsible testing individual, person notified and test result(s).

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):3713 [42CFR493.1291(g)]; 2) Steindel SJ, Heard NV. Critical values: data analysis and critique. Q-probes 92-04. Northfield, IL: College of American Pathologists, 1992; 3) Kost GJ. Using critical limits to improve patient outcome. Med Lab Observ. 1993;25(3):22-27; 4) Kaufman HW, Collins C. Notifying clients of life-threatening results. Med Lab Observ. 1994;26(8):44-45; 5) Emancipator K. Critical values. ASCP practice parameter. Am J Clin Pathol. 1997:108:247-253; 6) Halpern NA,



Brentjens T. Point of care testing informatics. The critical care-hospital interface. Crit Care Med. 1999;15:577-591; 7) Dalton-Beninato K. Critical value notifications are never welcome news. Lab Med. 2000;31:319-323; 8) Froom P, et al. Effect of urgent clinician notification of low hemoglobin values. Clin Chem. 2001;47:63-66.


Do records indicate (by initials, signature, etc.) who performed each test?

NOTE: It is not necessary to have this information in the chartable patient report, but an audit trail must be kept.

COMMENTARY:

N/A

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REAGENTS

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The verification of reagent performance is 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 being placed in service. 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 calibrators, 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 the user4. 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 if opening the container changes the expiration date, storage requirement, etc.

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):3706 [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 - fourth edition; approved guideline GP2-A4. Wayne, PA: NCCLS, 2002.


Are all reagents used within their indicated expiration date?

COMMENTARY:

N/A



Are all reagents stored as recommended by the manufacturer?

COMMENTARY:

N/A

REFERENCE: Gonzales Y, Kampa IS. The effect of various storage environments on reagent strips. Lab Med. 1997;28:135-137.


Has the POCT program established criteria for acceptability of new reagent lots and/or shipments to ensure that patient reference ranges and quality control ranges are similar to those from the previous lot?

COMMENTARY:



N/A


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

COMMENTARY:

N/A


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INSTRUMENTS AND EQUIPMENT

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There is a wide variety of instruments in use in POCT, and some questions may not apply to every instrument. These questions check factors common to most instruments, and inspectors should exercise judgment in applying the questions to the particular instruments in use. The procedures and schedules for instrument maintenance must be as thorough and as frequent as specified by the manufacturer.


Is the equipment in use approved by the laboratory director or designee?

COMMENTARY:

N/A

REFERENCE: Sevens C, Libeer JC. Point-of-care testing (POCT) regulations in hospitals. The Belgian approach. Clin Chem. 2001;47(suppl):A185.


Is there a schedule or system for the regular checking of the critical operating characteristics of all instruments in use?



NOTE: This must include, but is not limited to, electronic, mechanical, and operational checks, with documentation of compliance.

COMMENTARY:

N/A


Is there evidence of ongoing evaluation of results of instrument maintenance and function, temperature, etc. for all procedures on all shifts?

COMMENTARY:

N/A


Are maintenance records available and are they periodically reviewed on a scheduled basis by qualified supervisory personnel?

NOTE: A complete record of date of purchase, serial number and all repairs and routine service procedures must be maintained for all instruments, with evidence of supervisory data review.

COMMENTARY:

N/A

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PERSONNEL

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Is the director of the POCT program a physician (preferably a pathologist) or a doctoral scientist?

NOTE: The director is responsible for all aspects of testing in the POCT program.

COMMENTARY:



N/A


Is there evidence that testing personnel have adequate, specific training to ensure competence?

COMMENTARY:

N/A

REFERENCES: 1) Lamb LS, et al. Current nursing practice of point-of care laboratory diagnostic testing in critical care units. Am J Crit Care. 1995;4:429-434; 2) Miller CM, et al. Decentralized lab testing. A collaborative approach to point of care testing. Hosp Top. 1995;73:23-27; 3) Summers SH, et al. Who performs point-of-care testing? Lab Med. 1998:29:85-88.

**REVISED** 10/06/2005


Is there a current list of POCT personnel that delineates the specific tests that each individual is authorized to perform?

COMMENTARY:

N/A

**REVISED** 10/06/2005


Is there a documented program to ensure that each person performing POCT maintains satisfactory levels of competence?

NOTE: The records must make it possible for the Inspector to determine what skills were assessed and how those skills were measured. Some elements of competency assessment include, but are not limited to:

1. Direct observations of routine patient test performance, including patient preparation, if applicable, specimen handling, processing and testing

2. Monitoring the recording and reporting of test results3. Review of intermediate test results or worksheets, quality control records, proficiency

testing results, and preventive maintenance records4. Direct observation of performance of instrument maintenance and function checks



5. Assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples; and

6. Evaluation of problem-solving skills

For personnel performing tests of moderate and high complexity (as defined by CLIA-88), competency must be reassessed at least annually. During the first year that an individual is performing such patient testing, competency must be assessed every six months. All of the above elements that are applicable to an individual’s duties must be evaluated for that individual.

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(Oct 1):1065-66 [42CFR493.1453] and 1053-4 [42CFR493.1413]; 2) Zaloga GP, et al. Near-patient blood gas and electrolyte analyses are accurate when performed by non-laboratory-trained personnel. J Clin Monit. 1993;9:341-346; 3) Kilgore ML, et al. Continuous quality improvement for point-of-care testing using background monitoring of duplicate specimens. Arch Pathol Lab Med. 1999;123:824-828; 4) Witte DL, VanNess SA. Frequency of unacceptable results in point-of-care testing. Arch Pathol Lab Med. 1999;123:761; 5) Boone DJ. Assessing laboratory employee competence. Arch Pathol Lab Med. 2000;124:190-191; 6) Howanitz PJ, et al. Employee competence and performance-based assessment. A College of American Pathologists Q-Probes study of laboratory personnel in 522 institutions. Arch Pathol Lab Med. 2000;124:195-202; 7) Kost GJ. Preventing medical errors in point-of-care testing. Arch Pathol Lab Med. 2001;125:1307-1315; 8) Deobald GR, et al. Two approaches to competency assessment for point of care testing. Clin Chem. 2001;47(suppl):A187.

POC.06950 Phase I N/A YES NO

Are POCT personnel tested for difficulty with visual color discrimination?

NOTE: Formal color-blindness testing is not required for personnel who do not perform laboratory tests requiring color discrimination. Functional testing limited to discrimination of those colored items pertinent to the job is sufficient.

COMMENTARY:

N/A




Do the POCT director, technical consultant, clinical consultant, technical supervisor, and general supervisor meet all of the position qualifications and range of responsibilities as outlined in the Laboratory General Checklist?

NOTE: These US federal categories are applicable only for laboratories subject to CLIA-88 regulations. The Inspector must identify any specific deficiencies in the Inspector's Summation Report.

COMMENTARY:

N/A

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QUALITY CONTROL

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Are controls run daily for quantitative and qualitative tests?

NOTE: For quantitative tests, 2 controls at 2 different concentrations must be run daily, except for coagulation and blood gas testing. For coagulation tests, 2 levels of control must be run every 8 hours. Refer to the blood gas section of this checklist for control requirements for blood gas testing. For qualitative tests, a positive and negative control must be run daily.

As an exception to this general practice, the specific frequency of such controls for multiparameter urine chemistry dipsticks may vary according to workload and testing location, and may not occur with each run. However, the frequency must be defined and followed by the POCT program. (This exception also applies to urine dipsticks and pH paper used to assess pH of body fluids.)

Daily controls may be limited to electronic/procedural/internal controls for test systems that meet all of the following criteria:

1. The system is FDA-cleared or approved2. The system is classified as waived or moderately complex under CLIA-883. The POCT program has performed and documented studies to validate the adequacy of

limiting daily QC to the internal controls4. External controls are run for each new lot number or shipment of test materials

For other test systems, 2 levels of external/liquid control material must be run daily for quantitative systems, and a positive and negative external control must be run daily for qualitative assays.



In all cases, the laboratory may not reduce the frequency of external or internal controls to less than test system manufacturers’ recommendations.

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):3708 [42CFR493.1256(d)(3)(ii)]; 2) LaBeau KM, et al. Quality control of test systems waived by the clinical laboratory improvement amendments of 1988. Perceptions and practices. Arch Pathol Lab Med. 2000;124:1122-1127.


For tests that DO include internal controls, are external controls tested with each new kit lot number or separate shipments of a given lot number?

NOTE: External controls must be run no less frequently than with each new kit lot number or shipment. Two levels of external/liquid control material must be run for quantitative systems, and a positive and negative external control must be run for qualitative assays. For panels or batteries, controls must be employed for each antigen or antibody sought in clinical specimens.

COMMENTARY:

N/A


Are quality control data evaluated daily to detect instrument or process failure?

NOTE: Quality control data must be reviewed daily by testing personnel or supervisory technical staff to detect problems, trends, etc. The laboratory director or designee must review QC data at least monthly. 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

REFERENCES: 1) Herring K, et al. QC and the new technology. Do the old rules still apply? Med Lab Observ. 1993(Sep):25(9S):7-14; 2) NCCLS. Statistical quality control for quantitative measurements: principles and definitions - second edition; approved guideline C24-A2. Wayne, PA: NCCLS, 1998.




Are tolerance limits defined for control procedures?

NOTE: The POCT program must verify the tolerance limits for control materials that have numeric limits established by the manufacturer. For unassayed control materials, a valid acceptable range must be established by repetitive analysis in runs that include previously tested control material.

COMMENTARY:

N/A

REFERENCE: Ross JW, Lawson NS. Analytic goals, concentration relationships, and the state of the art for clinical laboratory precision. Arch Pathol Lab Med. 1995;119:495-513.


Is there evidence of corrective action when control results exceed defined tolerance limits?

COMMENTARY:

N/A


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

NOTE: Quality control (QC) specimens must 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 processes may differ from those encountered with patients.

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):3708 [42CFR493.1256(d)(8)].




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

NOTE: It is implicit in quality control that patient test results will not be reported when controls yield unacceptable results.

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):3708[42CFR493.1256(f)].


For quantitative tests, if the laboratory/POCT program uses more than one instrument to test for a given analyte, are the instruments checked against each other at least twice a year for correlation of patient results?

NOTE: This includes the same or different instrument makes/models. The use of fresh human samples (whole blood, serum, plasma, urine, etc.), rather than stabilized commercial controls is important to directly address the issue of whether a patient sample yields the same results on all instruments. Statistical agreement of commercial control materials across instruments does not guarantee comparability of patient specimen results because of potential matrix effects. In cases when pre-analytical stability of patient specimens is a limiting factor, alternative protocols based on QC or reference materials may be necessary but the materials used should be validated to have the same response as fresh human samples for the instruments/methods involved.

Single use devices (also known as unit use devices), such as POCT glucose devices, are a special case in which a large number of devices may be in use in an institution. In this case alternate approaches are acceptable for documenting correlation of patient results among the devices and with the main laboratory. One approach is to document for a lot of reagent strips/cartridges the agreement between patient results for a laboratory method and representative POCT device(s) and simultaneously collect results for QC materials run on the POCT devices. Other POCT devices can be validated from the agreement of QC results for the same lots of reagent strips and QC materials. If more than one device type or lot of reagent strips is used, this process would be repeated for each combination.

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):3712 [42CFR493.1281(a)]; 2) Podczasy JJ, et al. Clinical evaluation of the Accu-Check Advantage blood glucose monitoring system. Lab Med. 1997;28:462-466; 3) Koerner SD, Fuller RE. Comparison of a portable capillary whole blood coagulation monitor and standard laboratory methods for determining international normalized ratio. Mil Med. 1998;163:820-825; 4) Chance JJ, et al. Technical evaluation of five glucose meters with data management capabilities. Am J Clin Pathol. 1999;111:547-556; 5) Parsons M, et al. Performance of a reagent strip device for quantitation of the urine albumin:creatinine ratio in a point of care setting. Clin Nephrol. 1999;51:220-227; 6) Bingham D, et al. The portable laboratory: an evaluation of the accuracy and reproducibility of i-STAT. Ann Clin Biochem. 1999;36:66-71; 7) Hudson MP, et al. Cardiac markers: point of care testing. Clin Chim Acta. 1999;284:223-237; 8) Louie RF, et al. Point-of-care glucose testing. Effects of critical care variables, influence of reference instruments, and a modular glucose meter design. Arch Pathol Lab Med. 2000;124:257-266; 9) Ng VL, et al. The rise and fall of i-STAT point-of-care blood gas testing in an acute care hospital. Arch Pathol Lab Med. 2000;114:128-138; 10) Boyd JC, Bruns DE. Quality specifications for glucose meters: assessment by simulation modeling of errors in insulin dose. Clin Chem. 2001;47:209-214; 11) NCCLS. Point-of-care blood glucose testing in acute and chronic care facilities; approved guideline-second edition C30-A2. Wayne, PA: NCCLS, 2002; 12) NCCLS. Quality management for unit-use testing; approved guideline EP18-A. Wayne, PA:NCCLS, 2002.


If applicable, are all stains (except Gram stains) checked for intended reactivity each day of use?

NOTE: Gram stains must be checked at least weekly, and with each new batch of stains, using known gram-positive and gram-negative organisms.

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):3708 [42CFR493.1256(e)(2)].

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CALIBRATION OF QUANTITATIVE SYSTEMS

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Definitions:

CALIBRATION: The set of operations that establish, under specified conditions, the relationship between reagent system/instrument response and the corresponding concentration/activity values of an analyte. Calibration procedures are typically specified by a method manufacturer, but may also be established by the laboratory.



CALIBRATION VERIFICATION: The process of confirming that the current calibration settings remain valid for a method.

ANALYTICAL MEASUREMENT RANGE (AMR): The range of analyte values that a method can directly measure on the specimen without any dilution, concentration, or other pretreatment not part of the usual assay process.

Further discussion of the above concepts may be found in the Chemistry and Toxicology checklist.

**NEW** 10/06/2005


For FDA-cleared/approved single use devices, are manufacturers’ instructions followed for calibration, calibration verification, and related procedures, with documentation of results?

COMMENTARY:

N/A

The remaining questions in this section (Calibration of Quantitative Systems) are not applicable to FDA-cleared/approved single use devices with manufacturer instructions for calibration, calibration verification, and related procedures. (All applicable checklist questions in the Laboratory General checklist do apply to such devices.)


Are calibration procedures for each method adequate, and are the calibration results documented?

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):3707 [42CFR493.1255]; 2) Department of Health and Human Services, Centers for Medicare & Medicaid Services. Medicare, Medicaid and CLIA Programs; Laboratory Requirements Relating to Quality Systems and Certain Personnel Qualifications; Final Rule. Fed Register. 2003(Jan 24):3707 [42CFR493.1255]; 3) NCCLS. Evaluation of matrix effects; proposed guideline EP14-P. Wayne, PA: NCCLS, 1998; 4) Chance JJ, et al. Technical evaluation of five glucose meters with data management capabilities. Am J Clin Pathol. 1999;111:547-556; 5) Kroll MH, et al. Evaluation of the extent of nonlinearity in reportable range studies. Arch Pathol Lab Med. 2000;124:1331-1338.




Are high quality materials with method- and matrix-appropriate target values used for calibration and calibration verification whenever possible?

NOTE: Calibration materials establish the relationship between method/instrument response and the corresponding concentration/activities of an analyte. They have defined analyte target values and appropriate matrix characteristics for the clinical specimens and specific assay method. Many instrument systems require calibration materials with system-specific target values to produce accurate results for clinical specimens.

COMMENTARY:

N/A

REFERENCE: NCCLS. Evaluation of matrix effects; approved guideline EP14-A. Wayne, PA: NCCLS, 2001.


Are criteria established for calibration verification, and is compliance documented?

NOTE: Criteria typically include:

1. At changes of reagent lots, unless the user 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, or the control value

2. When indicated by quality control data3. After major maintenance or service4. As recommended by the manufacturer5. At least every six months

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):3707 [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.




Are test systems recalibrated when calibration verification fails to meet the established criteria of the POCT program?

COMMENTARY:

N/A


Are upper and lower limits of the ANALYTICAL MEASUREMENT RANGE (AMR) for all analytes defined, so that results falling outside these limits are appropriately reviewed and reassayed if necessary before reporting?

NOTE: In many cases, the manufacturer specifies the AMR, and the user must validate this parameter. The AMR must be revalidated at least every 6 months, and following changes in lots of analytically critical reagents (as determined by the user) or major system components.

Apparent analyte concentrations that are lower or higher than the AMR do not routinely require repeat analysis if the result is reported as less than the lower limit, or greater than the upper limit, respectively, and the laboratory has evidence that the low result is not due to sampling/dilution errors, immunologic "hook effects," etc.

The AMR does not apply to coagulation clot-based tests (e.g., prothrombin time test, activated partial thromboplastin time, and thrombin clotting time).

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):3707 [42CFR493.1253].


Is validation of the analytic measurement range (AMR) performed with matrix-appropriate materials of known analyte value appropriate to the AMR of the instrument, and is the process documented?

NOTE: If the materials used for calibration or for calibration verification include low, midpoint, and high values that are near the AMR, and if calibration verification data are within the user’s acceptance criteria, the AMR has been validated; no additional procedures are required. If the



calibration and/or calibration verification materials do not include the full AMR, the AMR must be validated by assaying additional materials reasonably near the lowest and highest values of the AMR.

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):3702 [42CFR493.2]; 2) NCCLS. Point-of-care blood glucose testing in acute and chronic care facilities; approved guideline-second edition C30-A2. Wayne, PA:NCCLS, 2002.


Are criteria established for validating the analytical measurement range (AMR), and is compliance documented?

NOTE: The AMR must be revalidated every 6 months, and when any of the following criteria are met:

1. A change in major test system components2. A change in lots of chemically or physically active reagents (unless the laboratory can

show that changing lots does not affect the range used to report patient results)

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):3702 [42CFR493.2].


If the POCT program reports numeric test results that fall outside the limits of the AMR, are dilution protocols and diluents (or concentration protocols) specified?

NOTE: When a test result exceeds the AMR, the user may dilute or concentrate the specimen to adjust the analyte content to be within the AMR, then repeat the assay to obtain a quantitative result. The procedure manual must include the protocol for dilution or concentration, any diluents or other components used in the process, and the calculation of the final reportable result.

COMMENTARY:

N/A



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BLOOD GAS SPECIMENS

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Are personnel performing arterial punctures knowledgeable about the more significant complications of this procedure compared with venipuncture?

COMMENTARY:

N/A

REFERENCES: 1) NCCLS. Blood gas preanalytical considerations: specimen collection, calibration, and controls; approved guideline C27-A. Wayne, PA: NCCLS, 1993; 2) NCCLS. Procedures for the collection of arterial blood specimens - third edition; approved standard H11-A3. Wayne, PA: NCCLS, 1999.


For radial artery sampling, is a test for collateral circulation performed before arterial puncture, as applicable?

NOTE: The various technologies available have been evaluated in the published literature. Consensus should be established between the laboratory and involved clinicians to define in which patients and under what circumstances such a test is medically useful in averting potential patient injury.

COMMENTARY:

N/A

REFERENCES: 1) Vaghadia H, et al. Evaluation of a postocclusive circulatory hyperaemia (PORCH) test for the assessment of ulnar collateral circulation. Can J Anaesth. 1988;35:591-598; 2) Cheng EY, et al. Evaluation of the palmar circulation by pulse oximetry. J Clin Monit. 1989;5:1-3; 3) Levinsohn DG, et al. The Allen's test: analysis of four methods. J Hand Surg. 1991;16:279-282; 4) Fuhrman TM, et al. Evaluation of collateral circulation of the hand. J Clin Monit. 1992;8:28-32; 5) Furhman TM, et al. Evaluation of digital blood pressure, plethysmography, and the modified Allen's test as a means of evaluating the collateral circulation to the hand. Anaesthesia. 1992;47:959-961; 6) Fuhrman TM, McSweeney E. Noninvasive evaluation of the collateral circulation to the hand. Acad Emerg Med. 1995;2:195-199; 7) O'Mara K, Sullivan B. A simple bedside test to identify ulnar collateral flow. Ann



Intern Med. 1995;123:637; 8) Starnes SL, et al. Noninvasive evaluation of hand circulation before radial artery harvest for coronary artery bypass grafting. J Thorac Cardiovasc Surg. 1999;117:261-266; 9) Cable DG, et al. The Allen test. Ann Thorac Surg. 1999;67:876-877.


Is there a system to prevent ambient air contamination of blood gas samples before analysis?

COMMENTARY:

N/A

REFERENCES: 1) Ishikawa S, et al. The effects of air bubbles and time delay on blood gas analysis. Ann Allergy. 1974;33:72-77; 2) Mueller RG, et al. Bubbles in samples for blood gas determinations. Am J Clin Pathol. 1976;65:242-249; 3) Madiedo G, et al. Air bubbles and temperature effect on blood gas analysis. J Clin Pathol. 1980;33:864-867; 4) Biswas CK, et al. Blood gas analysis: effect of air bubbles in syringe and delay in estimation. Brit Med J. 1982;284:923-927; 5) McKane MH, et al. Sending blood gas specimens through pressurized transport tube systems exaggerates the error in oxygen tension measurements created by the presence of air bubbles. Anesth Analg. 1995;81:179-182; 6) Astles JR, et al. Pneumatic transport exacerbates interference of room air contamination in blood gas samples. Arch Pathol Lab Med. 1996;120:642-647.

**NEW** 10/06/2005


Are there documented procedures for operation, calibration, and function checks of all blood gas instruments?

COMMENTARY:

N/A

**NEW** 10/06/2005


Are the materials used for calibration of the pH, CO2, and O2 sensors either in conformance with the instrument manufacturer's specifications or traceable to NIST Standard Reference Materials?

COMMENTARY:



N/A

**NEW** 10/06/2005


Is the calibration rechecked periodically, using barometric pressure if appropriate?

NOTE: Instruments used continually must be recalibrated periodically. Instruments used infrequently must be recalibrated each time of use. Some instruments are self-calibrating; however, there must be a procedure for verifying the reliability of this process. For all instruments, calibration and calibration verification must be performed according to manufacturer's specifications with at least the frequency recommended by the manufacturer.

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):3709 [42CFR493.1267(a)].

**NEW** 10/06/2005


Is a minimum of 1 quality control specimen for pH, pCO2 and pO2 (tonometered sample or liquid control material) analyzed at least every 8 hours of operation when patient specimens are tested?

COMMENTARY:

N/A

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) [42CFR493.1267(b)]; 2) NCCLS. Statistical quality control for quantitative measurements: principles and definitions - second edition; approved guideline C24-A2. Wayne, PA: NCCLS, 1998.



**NEW** 10/06/2005


Do the control materials for pH, pCO2 and pO2 represent both high and low values on each day of patient testing?

COMMENTARY:

N/A

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) [42CFR493.1267(b)]; 2) NCCLS. Statistical quality control for quantitative measurements: principles and definitions - second edition; approved guideline C24-A2. Wayne, PA: NCCLS, 1998; 3) Ng VL, et al. The rise and fall of i-STAT point-of-care blood gas testing in an acute care hospital. Am J Clin Pathol. 2000;114:128-138.

**NEW** 10/06/2005


Is at least one sample of control material for pH, pCO2 and pO2 included each time patient specimens are tested, except for automated instruments that internally calibrate at least once every 30 minutes of use?

COMMENTARY:

N/A

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): 3709 [42CFR493.1267(c)]; 2) NCCLS. Statistical quality control for quantitative measurements: principles and definitions - second edition; approved guideline C24-A2. Wayne, PA: NCCLS, 1998.

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SAFETY

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

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PHYSICIAN-PERFORMED TESTING

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The following section applies to physician-performed testing (PPT) only. PPT is defined by the College of American Pathologists as testing that is personally performed by a physician in conjunction with the physical examination or treatment of a patient, and is limited to the tests below. Patient management is often facilitated by immediate and direct physician performance of certain laboratory tests at the time of a patient encounter. Although these tests may be simple to perform, standards must be maintained to ensure correct results. The other sections of the Point-of-Care Testing checklist do NOT apply to PPT.

This section should be completed only if both of the following conditions are true:

1. The laboratory director is responsible for PPT in the institution (When the laboratory director is not responsible for PPT in the institution, then PPT must be performed under a CLIA number different from that of the clinical laboratory), and

2. The laboratory director is responsible for competency assessment of the physicians.

If the competency of physicians is established and monitored by the credentialing process of the institutional medical staff, then this section may be omitted.

This PPT category is NOT the same as the U.S. CLIA-88 term “provider performed microscopy” (PPM), which allows certain tests to be performed by non-physicians. Rather, it includes (but may not be limited to) both “waived” tests under CLIA-88 and PPM, but only when either is performed by a licensed physician. PPT is currently limited to the following tests:

1. Amniotic fluid pH2. Vaginal pool fluid smears for ferning3. Fecal leukocytes4. Gastric biopsy urease5. Nasal smears for eosinophils6. Occult blood, fecal and gastric7. Pinworm examination8. Post-coital mucus examination9. Potassium hydroxide (KOH) preparations10. Semen analysis, qualitative11. Synovial fluid for crystals12. Urine dipstick13. Urine sediment microscopy



14. Vaginal wet mount microscopy


Is there a policy outlining the nature of laboratory testing that may be personally performed by physicians within their scope of clinical practice?

NOTE: The College of American Pathologists will only accredit physician-performed testing for those tests listed above.

COMMENTARY:

N/A


Is there a PPT technical procedure manual that includes specimen handling information?

COMMENTARY:

N/A


Does an effective quality management program, appropriate for the nature of the testing performed, exist and include the following items, as applicable?

1. Quality control of reagents, including stains2. Instrument maintenance (centrifuges, microscopes, etc.)3. Review and corrective action of quality control and/or reagent failure

COMMENTARY:

N/A


Is there a documented process for training physicians in the performance of specific tests?

COMMENTARY:

N/A




Is there evidence of competency assessment specific to the type(s) of laboratory testing performed by each physician?

NOTE: The frequency of competency assessment is at the discretion of the laboratory director. Annual competency assessment of physicians is not required by the CAP for purposes of PPT laboratory accreditation.

COMMENTARY:

N/A

POC.09700 Phase I N/A YES NO

Is the system for reporting PPT results adequate?

NOTE: The following elements are the usual components of a chartable result:

1. Patient identifier2. Test ordered/performed and physician’s name/identifier3. Date/time of specimen collection4. Test result5. Reference interval or interpretive notes, as appropriate6. Any additional comments on specimen quality

COMMENTARY:

N/A
