Part 1 - PulseNet International

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PND10: Standard Operating Procedure for Database Training Standard Operating Procedures for the PulseNet USA QA/QC Program (PNQ) PNQ01: Standard Operating Procedure for TIFF Quality Grading Guidelines PNQ02: Standard Operating Procedure for Certification of PulseNet USA Personnel PNQ03: Standard Operating Procedure for Evaluation of Certification Files PNQ04: Standard Operating Procedure for the PulseNet USA Proficiency Testing Program PNQ05: Standard Operating Procedure for Laboratory In-House Gel Certification (pending) May 9, 2005 24
STANDARD OPERATING PROCEDURE FOR WRITING STANDARD OPERATING PROCEDURES CODE: PNG01 Effective Date: 05 09 05 1. PURPOSE: To describe the guidelines for the creation, review, and approval of procedures regulating PFGE activities used by PulseNet. 2. SCOPE: This procedure applies to all PulseNet procedures written in relation to the standardized PFGE protocols and analysis. 3. DEFINITIONS/TERMS: 3.1 SOP: Standard Operating Procedure 3.2 PFGE: Pulsed-field Gel Electrophoresis 3.3 Effective Date: the day the procedure will be in operation and from which any revisions, corrections, and distribution times may be calculated. 3.4 QA/QC: Quality Assurance/Quality Control 4. RESPONSIBILITIES: 4.1 The correct format for an SOP can be found in Appendix PNG01-1. 4.2 Assign a concise title to the procedure that gives a general idea of the procedure’s contents. 4.3 Assign a code to the procedure, containing five digits, assigned as follows: 4.3.1 Acronym PN, which refers to PulseNet, and either a G for General SOPs, L for Laboratory SOPs, D for Database SOPs, or Q for QA/QC SOPs. 4.3.2 Two digit consecutive number of the procedure. For example: The “STANDARD OPERATING PROCEDURE FOR WRITING STANDARD OPERATING PROCEDURES” is the first General procedure for PulseNet, so it has the code “PNG01.” 4.4 SOPs should be detailed enough to provide meaningful direction to personnel who conduct routine laboratory activities. 4.5 SOPs will be reviewed every two years after the effective date, although reviews may be done sooner if significant changes in the procedure occur. 4.5.1 SOPs will be reviewed by the original author or laboratory supervisor. 4.5.1.1 If changes in the procedure will represent a new standard protocol, the SOP should be reviewed and the revision approved. 4.5.1.2 If an exception to an SOP is to be made for an individual study, that exception must be authorized in writing by the laboratory chief or supervisor. 4.5.2 Any changes made must be documented in section 8 of the procedure Amendments. 4.5.3 Author and laboratory supervisor will sign and date in the appropriate areas. 4.5.4 Authorization will be signed and dated by the laboratory chief or director. 4.6 The page number will be written in the lower right corner of each page. 4.7 All personnel following the SOP must read, sign, and date the corresponding Reading Control Sheet (Appendix PNG01-2). 4.8 Personnel performing activities must have access to the related procedure. 4.8.1 The master of an SOP must be authorized, signed, and dated by the laboratory chief or supervisor, and an inventory should be kept of when, where, and to whom copies of the SOP have been distributed. 4.8.2 Electronic and hard copy versions of SOPs must be readily available to personnel. 4.8.3 No unauthorized copies should be made and/or distributed. This will provide better control over the distribution of SOPs, ensuring that all outdated versions of SOPs are retired. 4.8.4 All previous versions shall be retired when new revisions are distributed. 4.8.4.1 Retired SOPs must have the Out-of-Service date listed in red across the top of each page and be retained in the laboratory for two years from the retirement date. The master copy must be archived indefinitely. 4.9 The procedure must include: 4.9.1 PURPOSE: Describes in a clear and simple way the mission of the SOP. 4.9.2 SCOPE: Indicates the persons and/or activities concerned with the procedure. VERSION: REPLACED BY: AUTHORIZED BY: Page 1 of 5
Page 1 and 2: PulseNet Quality Assurance/Quality
Page 3 and 4: PNL21 PNL22 PNL23 PNL24 PNL25 PNL26
Page 5 and 6: Quality Assurance / Quality Control
Page 7 and 8: TABLE OF CONTENTS I. PREFACE II. IN
Page 9 and 10: Molecular subtyping by PFGE is used
Page 11 and 12: foodborne disease. The network perm
Page 13 and 14: 4.1 The quality assurance/quality c
Page 15 and 16: At least one person from each CDC P
Page 17 and 18: (c) S. Braenderup size standard cul
Page 19 and 20: STANDARD G.7 The laboratory shall m
Page 21 and 22: STANDARD J.1 Each certified PulseNe
Page 23 and 24: N. SAFETY M.1.1.2 The laboratory sh
Page 25 and 26: APPENDIX B May 9, 2005 21
Page 27: PNL10: Standard Operating Procedure
Page 31 and 32: STANDARD OPERATING PROCEDURE FOR WR
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Part 1 - PulseNet International

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