Pro7.1-021 SOP Checklist - Internal Quality Control



|Author: Jo Shim |Document Number: |Pro71-21 |

| |Effective Date: |6 August 2009 |

|Review History |Date of last review: |3 April 2020 |

| |Reviewed by: |Heidi Hanes |

|pSMILE 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 encouraged to ensure compliance with local laws and study protocol policies when considering the |

|application of this document. 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: |

| |Internal quality control procedures are developed for all qualitative analytic procedures or specific QC information is|

| |included in individual test SOPs. |

| |The frequency of QC testing is determined and how many levels of control material 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. |

| |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. |

| |Acceptability criteria are established by the laboratory director and require that no patient results be released if |

| |acceptability criteria are not met. |

| |The procedure for establishing QC ranges should be outlined as part of the procedure. |

| |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 |

| |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. |

| |QC results are reviewed and signed by the laboratory director or designee monthly. |

| |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. |

| |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. |

| |QC records are to be stored and the required retention time for the documents. |

|Comments: |

| |

|Internal Quality Control – Qualitative |

| |The SOP describes how: |

| |Internal quality control procedures are developed for all qualitative analytic procedures or specific QC information is|

| |included in individual test SOPs. |

| |Internal quality control procedures are developed for all qualitative procedures, 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. |

| |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. |

| |Acceptability criteria are established by the laboratory director and require that no patient results be released if |

| |acceptability criteria are not met. |

| |QC results are documented, monitored, and evaluated for acceptability. 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. |

| |QC results are reviewed and signed by the laboratory director or designee monthly. |

| |Corrective actions are to be performed and documented for any out of range results. 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. |

| |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, , 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 |

|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: | |

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