SMILE

JohnsHopkinsUniversity

Baltimore, MDUSA

Author:Erin Gover / Document Number: / Pro71-17
Effective (or Post) Date: / 7 August 2008
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

Technical Testing Procedures

Element
Present / CONTENT-SPECIFIC REQUIRED ELEMENTS
TESTING PROCEDURES
SOPs follow a consistent format. Tables can be used to list analytes on a common instrument.
Step-by-step instrument start-up (*).
Step-by-step instructionsto run Quality Control, if different (*).
Step-by-step instrument operation (*).
Step-by-step instrument shut-down (*).
Contains calibration information.
Maintenance requirements (daily, weekly, monthly, quarterly, etc.) (*).
A description of the reportable range.
A description of interfering substances.
Instrument operational requirements such as temperature and humidity range (*).
Comments: (*)Whenever possible, reference instrument user manual for step-by-step instructions and information. Just be sure to include any deviations from manual directions.

SAFETY

Describes safety considerations specific to the test method that might not otherwise be included in the lab’s safety manual
Includes general safety information or provides a reference to the lab’s safety manual. (See the Safety SOP checklist for specific safety requirements if needed)
Comments:

SAMPLE REQUIREMENTS

Describes the necessary specimen type. Includes tube additive, minimum volume, and specimen condition limitations (i.e., storage temperature and testing time limitations)
Describes special specimen collection, processing and handling, if applicable, or references another procedure if needed.
Includes conditions for dilution, if applicable, along with the dilution procedure, fluid and calculations as necessary.
Comments:
EQUIPMENT AND REAGENTS
Includes a complete equipment and reagent list to include consumables.
Includes complete reagent preparation instructions or references reagent preparation instructions.
Includes equipment service or maintenance requirements and the schedule.
Includes maintenance steps or references another procedure and operator’s manual.
Reagent logs and formsare included or referencedwith instructions for use. (i.e., type, lot number, exp. date, etc).
Manufacturer package inserts for each reagent lot in use is retained with QC data.
Includes documentation to record reagent use (i.e., lot number, when placed in and out of service.)
Describes the reagent and consumable inventory control process or refers to another procedure.
Describes contingency plans if reagents or consumables outdate or run out and includes vendor contact information or refers to another procedure for the information.
Comments:

Quality Control (QC)

Specifies theexternal QC materials used.
Specifies the internal QC materials used.
Provides references to the internal and external QC manuals as needed.
Requires expiration date verification and disallows the use of expired materials.
Requires that QC materials be documented when placed in service.
Requires that manufacturer’s package inserts for each lot of QC placed in use be retained with QC data.
Specifies the frequency and composition of QC runs.
Includes criteria for accepting or rejecting of QC run.
Forbids testing and reporting participant results when QC does not meet the acceptability criteria.
Includes steps and requirements for plotting QC information on Levey-Jennings charts.
Describes the corrective action requirements for unacceptable results and identifies the corrective action log or form to be used.
Requires indefinite QC record retention for all QC data, including failed runs.
Describes the QC inventory controlprocess or refers to another procedure.
Describes contingency plans if QC material outdates or runs out and includes vendor contact information or refers to another procedure for the information.
Comments:

PARALLEL TESTING

Parallel Testing may or may not be included. If included, refer to the Parallel Testing SOP Checklist for requirements

Calibration

Specifies the calibration materials used.
Requires expiration date verification and disallows the use of expired calibrators.
If calibrators can be used as QC, requires thatthey be from different lots.
Requires thatcalibration materials be documented when placed in service.
Requires that manufacturer’s package inserts for each lot of calibrator placed in use be retained with QC data.
Specifies the frequency and procedure for performing calibration.
Includes criteria for accepting or rejectingcalibration.
Forbids testing and reporting participant results on unacceptable or expired calibrations.
Describes the corrective action requirements for unacceptable results and identifies the corrective action log or form to be used.
Describes the calibrator inventory control process or refers to another procedure.
Describes contingency plans if calibration material outdates or runs out and includes vendor contact information or refers to another procedure for the information.
Comments:

RESULT evaluation

Includes reporting units for analyte(s).
Describesthe result evaluation process. Includes criteria for accepting, rejecting or repeatingresults.
Describe process for double checking results before reporting.
Includes the expected or normal values.
Includes result interpretation, if needed for reporting purposes.
Includes the reportable range and provides retesting or reporting instructions for results that fall outside of the reportable range.
Includescritical or panic values and the procedure used to verify critical results.
Describes the process for documenting and reporting critical or panic values.
Comments:

LIMITATIONS AND SOURCES OF ERROR

Includes limitations to the procedure.
Includes potential problems (sources of error) and appropriate action if those problems are encountered.
Comments:
INSTRUMENT DATA STORAGE
Includes a description of how the instrument data, printouts, and/or worksheets are stored (e.g., data back-up, storage location, room security, locked file cabinets, accessibility, etc).
Includes the laboratory’s record retention policy or a reference to it.
Includes the laboratory’s process for retrieving stored documents or a reference to it.
Comments:
REFERENCES AND APPENDICES
Includes a list of current and appropriate references.
Includes a list of appendices as cited in the body of the procedure.
Comments:
References:
  • ICH E6 Good Clinical Practice: Consolidated Guidance (GCP)
  • 42 CFR 493: Laboratory Requirements
  • Clinical Laboratory Improvement Amendments (CLIA) Self-Assessment Questionnaire
  • College of American Pathologists (CAP), Laboratory General Checklist for Laboratory Accreditation Program
  • 21 CFR Part 58: Good Laboratory Practice for Nonclinical Laboratory Studies (GLP)

Pro7.1-17 SOP Checklist - Technical Testing Procedures.DOCVersion#: 1.0Page 1 of 5