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    CHKLST Intr QC

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    ARIF AHAMMED P
    The document provides a checklist for study site standard operating procedure required elements for internal quality control. It describes how internal quality control procedures should be developed for qualitative and quantitative analytic procedures, including selecting controls, establishing acceptance criteria, documenting and evaluating results, and corrective actions.

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    © All Rights Reserved
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    CHKLST Intr QC

    Uploaded by

    ARIF AHAMMED P
    59 views3 pages
    The document provides a checklist for study site standard operating procedure required elements for internal quality control. It describes how internal quality control procedures should be developed for qualitative and quantitative analytic procedures, including selecting controls, establishing acceptance criteria, documenting and evaluating results, and corrective actions.

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    Chklst_Intr_QC.doc

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    The document provides a checklist for study site standard operating procedure required elements for internal quality control. It describes how internal quality control procedures should be developed for qualitative and quantitative analytic procedures, including selecting controls, establishing acceptance criteria, documenting and evaluating results, and corrective actions.

    Copyright:

    © All Rights Reserved
    Download as DOC, PDF, TXT or read online from Scribd
    Download as doc, pdf, or txt
    59 views3 pages

    CHKLST Intr QC

    Uploaded by

    ARIF AHAMMED P
    The document provides a checklist for study site standard operating procedure required elements for internal quality control. It describes how internal quality control procedures should be developed for qualitative and quantitative analytic procedures, including selecting controls, establishing acceptance criteria, documenting and evaluating results, and corrective actions.

    Copyright:

    © All Rights Reserved
    Download as DOC, PDF, TXT or read online from Scribd
    Download as doc, pdf, or txt
    of 3

    SMILE

    Johns Hopkins University


    Baltimore, MD USA

    Author: Jo Shim Document Number: Pro71-21


    Effective Date: 6 August 2009
    Review History Date of last review: 20 May 2010
    Reviewed by: Heidi Hanes
    SMILE Comments: This document is provided as an example only. It must be revised to
    accurately reflect your lab’s specific processes and/or specific protocol requirements. Users are
    directed to countercheck facts when considering their use in other applications. If you have any
    questions contact SMILE.

    CHECKLIST FOR STUDY SITE SOP REQUIRED ELEMENTS


    Internal Quality Control

    Element
    CONTENT-SPECIFIC REQUIRED ELEMENTS
    Present
    Internal Quality Control – Quantitative
    The SOP describes how:
    1. 1. Internal quality control procedures are developed for all qualitative analytic
    procedures or specific QC information is included in individual test SOPs.
    2. The frequency of QC testing is determined and how many levels of control material
    2. are run. It is recommended that at least one control approximate the medical
    decision point. The frequency should meet the standards outlined in the current
    version of the DAIDS GCLP Standards document.
    3. 3. Control materials are selected, obtained, prepared, labeled and stored.
     If QC materials are aliquoted they must be labeled so that they are traceable
    to the lot, date of preparation, expiration date and technologist.
    4. Acceptability criteria are established by the laboratory director and require that no
    4.
    patient results be released if acceptability criteria are not met.
     The procedure for establishing QC ranges should be outlined as part of
    the procedure.
    5. 5. QC results are documented, monitored, and evaluated for acceptability.
     Describes the use of LJ charts as appropriate
     Describes the selection and use of Westgard rules
    6. 6. Requires that all QC results, including those that exceed acceptable parameters, be
    documented. Documentation requirements include the initials of the individual who
    conducted the testing and the lot numbers of QC materials and reagents.
    7. 7. QC results are reviewed and signed by the laboratory director or designee monthly.
    8. 8. The follow-up of QC failures and the procedure for corrective actions that are to be
    performed and documented for any out of range results.
    9. 9. The laboratory director or designee is to be notified immediately of any QC
    problems and is required to review the corrective actions at least monthly.
    10. 10. QC records are to be stored and the required retention time for the documents.

    Comments:

    407522932.doc V1.0 Page 1 of 3


    SMILE
    Johns Hopkins University
    Baltimore, MD USA

    Internal Quality Control – Qualitative


    The SOP describes how:
    1. 1. Internal quality control procedures are developed for all qualitative analytic
    procedures or specific QC information is included in individual test SOPs.
    2. Internal quality control procedures are developed for all qualitative procedures,
    2. including running both positive negative controls and the frequency of testing
    controls. The frequency should meet the standards outlined in the current version of
    the DAIDS GCLP Standards document.
    3. 3. Control materials are selected, obtained, and stored.
     If QC materials are aliquoted they must be labeled so that they are traceable
    to the lot, date of preparation, expiration date and technologist.
    4. Acceptability criteria are established by the laboratory director and require that no
    4.
    patient results be released if acceptability criteria are not met.
    5. 5. QC results are documented, monitored, and evaluated for acceptability. Requires
    that all QC results, including those that exceed acceptable parameters, be
    documented.
    6. 6. Documentation requirements include the initials of the individual who conducted the
    testing and the lot numbers of QC materials and reagents.
    7. QC results are reviewed and signed by the laboratory director or designee monthly.
    7.
    8. Corrective actions are to be performed and documented for any out of range results.
    8. The laboratory director or designee is to be notified immediately of any QC
    problems and is required to review the corrective actions at least monthly.
    9. 9. QC records are to be stored and the required retention time for the documents.

    Comments:

    References:
     Code of Federal Regulations (CFR) Title 42: Public Health, Part 493 - Laboratory Requirements,
    18 February 2004
     Code of Federal Regulations (CFR) Title 21: Food and Drugs, Part 58 – Good Laboratory Practice
    for Non-clinical Laboratory Studies, 18 February 2004
     College of American Pathologists (CAP), Laboratory General Checklist, www.cap.org, 6 October
    2005
     Good Clinical Laboratory Practice Standards (DAIDS), Version 1.0, 30 June 2008
     ICH E6 Good Clinical Practice: Consolidated Guidance (GCP)
     HPTN Manual of Operations, Johns Hopkins Hospital HIV laboratory
     Westat SOP checklist General Required Elements

    407522932.doc V1.0 Page 2 of 3


    SMILE
    Johns Hopkins University
    Baltimore, MD USA

     Berte, L. A World Wide Approach to Laboratory Quality Management – Session 1.


    Teleconference sponsored by ASCP on 06-Dec-2005.
     CLSI document GP2-A5. Wayne, Pennsylvania: Clinical and Laboratory Standards Institute;
    2006.
     CLSI. Management of Nonconforming Laboratory Events; Approved Guideline. CLSI document
    GP32-A. Wayne, Pennsylvania: Clinical and Laboratory Standards Institute; 2007.
     ISO. Medical laboratories – Particular requirements for quality and competence. EN/ISO15189.
    Geneva: International Organization for Standardization; 2003.
     NCCLS. Application of a Quality Management System Model for Laboratory Services –
    Approved Guideline – Third Edition. NCCLS document GP26-A3. Wayne, Pennsylvania:
    NCCLS; 2004.
     NCCLS. A Quality Management System Model for Health Care; Approved Guideline – Second
    Edition. NCCLS document HS1-A2. Wayne, Pennsylvania: NCCLS; 2004.
     NCCLS. Continuous Quality Improvement: Integrating Five Key Quality System Components;
    Approved Guideline – Second Edition. NCCLS document GP22-A2. Wayne, Pennsylvania:
    NCCLS; 2004.

    Review Comments/Recommendations to the Site: Further Revisions Needed


    No Further Revisions Needed

    Review by:
    Date of Review:

    Response from Site:

    Final Review Comments/Recommendations to the Site: Further Revisions Needed


    Approved – Minor Revisions

    Final Review by:


    Date:

    407522932.doc V1.0 Page 3 of 3

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