HEADER    STANDARD OPERATING PROCEDURES
        
  
     In compliance with Good Laboratory Practices (GLP) guidelines, CLASS Labs and CLASS Labs IT have developed a rich set of "Standard Operating Procedures" (SOPs) which are evaluated and updated on a routine basis. More than two hundred procedures, procedural policies, and procedural worksheets have been developed at CLASS describing in detail both CLASS Lab and IT operations; laboratory safety and training; universal precautions, biohazardous waste; collection kit manufacture, tracking and QC; inventory management; clinical site issues and inquiries; sample receipt and storage; sample processing; assays methods; quality control preparations and evaluation; freezer monitoring, alert and response; water purification; data analysis; and data preservation. (April 2007)
     An indexed catalog of these SOPs, complete with down load links, is provided below. All files are in Adobe Acrobat .PDF format and free tools for reading this format are also available from our links.
  
  QUICK INDEX
Section 1.0CLASS Operations
Section 2.0Module Manufacture
Section 3.0Sample Processing
Section 4.0ACS-180 Operation
Section 5.0Hamilton AT Plus Operation
Section 6.0Quality Control
Section 7.0Quality Assurance
Section 8.0Laboratory Information System
Section 9.0Data Preservation
Section 10.0Manual Assays
Section 11.0Instrument Maintenance
Section 12.0CLASS IT Policy SOPs
Section 13.0CLASS IT Operational SOPs
Section 14.0Centaur Operations
Section 15.0ACE Operations
Section 16.0Phlebotomy
Section TLSTools to open and read .PDF files
  
  FULL INDEX
  
Section 1.0    CLASS Operations      
    1.1New Employee Laboratory Training Procedural Worksheet  
    1.2Procedure for Personnel Sanitation and Safety  
    1.3Procedure for Universal Precautions  
    1.4Procedure for Disposal of Biohazardous Waste  
    1.5"Procedure for Transporting Biohazardous Materials and Reagents  
    1.6Procedural Worksheet for Chemical Spill and Response  
    1.7Procedure for Laboratory Clean Up  
    1.8Procedure for Ordering a Liquid Nitrogen Tank  
    1.11Procedure for Developing or Locating a Standard Operating Procedure  
    1.12Procedural Worksheet for Disseminating a New or Revised Standard Operating Procedure  
    1.13Procedure for Hazardous Waste Disposal  
    1.14Procedure for Employee Accident/Illness  
    1.15Procedural Worksheet for the Annual CLASS Lab Fire Extinguisher Training  
    1.16Procedural Worksheet for the Annual Auxiliary Services Fire Drill  
    1.17Procedural Worksheet to Assist Staff and Visitors with Disabilities in the Event of Emergency Evacuation  
    1.18Procedural Worksheet for Testing Emergency Eye Wash Station and Drench Hose  
    1.19Procedure for Labeling Secondary Reagent Containers  
    1.20Procedure for Reviewing Standard Operating Procedures  
    1.21Procedure for Retiring a Standard Operating Procedure  
    1.22Procedure for Electrical Requirements for Lab Equipment  
    1.23Procedure for Submitting Plant Work Request Orders  
    1.24Procedure for Mercury Thermometer Elimination  
    1.25Ergonomics Program  
    1.26Policy regarding New Director  
    1.27Procedural Worksheet for Assessing Competency  
    1.28Procedural Worksheet for Employee Input  
    1.29Procedure for Maintaining Records  
Section2.0  Module Manufacture    
    2.1Procedure for Inventory Management of Kit and Laboratory Supplies  
    2.2Procedure for Submitting Orders to be Processed  
    2.5Procedure for U01 Follow-up 2 Module Manufacture  
    2.6Procedure for U01 DHS Module Manufacture  
    2.7Procedure for Testing Proposed Changes in Serum Module/Urine Kit Manufacturing and Obtaining Subsequent Approval  
    2.8Procedure for Redistributing Kits within Multiple Site Projects  
    2.9Procedure for Recalling Kits  
    2.10Procedure for Recording Lost Kit Shipments  
    2.11Procedure for Clinical Sites to Perform a Quality Control Check on U01 Follow-up and DHS Kits  
    2.12Procedural Worksheet for Preparation of 50% glycerol solution  
    2.13Procedural Worksheet for Checking Label Sets  
    2.17Procedure for Brenner GLNE 001 Kit Manufacture  
    2.19Procedure for Hanash Kit Manufacture  
    2.25Procedure for Marrero Kit Manufacture  
    2.26Procedure for Elizabeth Barry Kit Manufacture  
    2.27Procedure for SWOG S0226 Kit Manufacture  
    2.28Procedure for Checking SWOG Kit Orders  
    2.29Procedure for Ordering Label Files from IT  
    2.30Procedure for Julie Douglas Kit Manufacture  
    2.31Procedure for Jackie Dahlgren Kit Manufacture  
    2.32Procedure for Michelle Anderson Kit Manufacture  
    2.33Procedure for Shane Kit Manufacture  
Section3.0  Sample Processing    
    3.1Procedure for U01 Sample Check-in  
    3.2Procedure for Processing Broken or Cracked Specimen Collection Tubes in U01Sample Check-in Receipt  
    3.3Procedure for Sample Retrieval from a Specified Storage Location  
    3.4Procedure for the Quick-thaw and Preparation of Clinical Research Samples for Assay  
    3.5Procedure for Snap Freezing Clinical Research Samples  
    3.6Procedure for Sample Return to a Specified Storage Location  
    3.7Procedure for Labeling a Freezer Storage Box Stored at -80 Degrees  
    3.8Procedure for EDRN Sample Check-In  
    3.9Procedure for Recording Sample Observations  
    3.10Procedure for Outside Project Sample Check-In  
    3.11Procedure for SWOG S0226 Sample Check-In  
    3.12Procedure for V-Sims Sample Check-In  
    3.13Policy re: Correction of Information on Sample Labels  
    3.14Procedure for the Rejection of Unacceptable Specimens  
    3.15Procedure for Projects to Request Sample Pull Services  
Section4.0  ACS-180 Operation    
    4.2Procedure for Adjusting the ACS-180 Sample Probe Height  
    4.3Procedure to Perform a Cortisol Assay  
    4.4Procedure to Perform a DHEA-S Assay  
    4.5Procedure to Perform an E1C Assay  
    4.6Procedure to Perform an E2-6 (off-line) Assay  
    4.7Procedure to Perform an FSH Assay  
    4.8Procedure to Perform an LH Assay  
    4.9Procedure to Perform a PDG Assay  
    4.10Procedure to Perform a Progesterone Assay  
    4.11Procedure to Perform a Prolactin Assay  
    4.12Procedure to Perform an SHBG Assay  
    4.13Procedure to Perform a Testosterone Assay  
    4.14Procedure to Perform a TSH Assay  
    4.15Procedure to Perform a uFSH Assay  
    4.16Procedure to Perform a uLH Assay  
    4.17Procedural Worksheet for ACS-180 Calibration  
    4.18Procedure for the Preparation of Bayer Tri-level Ligand Controls  
    4.21Procedural Outline for an ACS-180 Run Day.11.1.97  
    4.22Procedural Outline for an ACS-180 Run Day.11.10.00  
    4.23Procedure for the ACS-180 Daily Cleaning  
    4.24Procedure for Taking an ACS-180 Off-Line  
    4.25 Procedure for Placing an ACS-180 On-line  
    4.26Procedural Worksheet for the Preparation of ACS-180 Software Upgrades and Test Re-Entry of Development Test Definitions"  
    4.27Procedural Worksheet for the Preparation of FAE Reagent  
    4.28Procedural Worksheet for the Preparation of FMP Reagent  
    4.29Procedure for Checking the ACS-180 Probe Dispense  
    4.33Procedural Worksheet for DHEAS Standards  
    4.35Procedural Worksheet for Off-Line E2-6 Standards  
    4.37Procedural Worksheet for the Preparation of PRGE Standards For Lot #81913  
    4.38Procedural Worksheet for SHBG Standards  
    4.39Procedural Worksheet for Testosterone 45 Standards  
    4.40Procedural Worksheet for Urine FSH Standards  
    4.41Procedural Worksheet for Urine LH Standards  
    4.42Procedural Worksheet for Serum FSH Standards  
    4.43Procedural Worksheet for Serum LH Standards  
    4.45Procedural Worksheet for DPC Saliva Cortisol Standards  
    4.46Procedural Worksheet for Saliva Progesterone Standards  
    4.47Procedural Worksheet for Saliva Testosterone.Standards  
    4.48Procedural Worksheet for Urine E1C Standards  
    4.49Procedural Worksheet for Urine PDG Standards  
    4.50Procedure for Weekly ACS-180 Cleaning  
    4.51Procedure for Monthly ACS-180 Cleaning  
    4.52Procedure to Perform a Saliva Cortisol Assay  
    4.53Procedural Worksheet to Perform a TSH Linearity Check  
Section5.0  Hamilton AT Plus Operation    
    5.1Procedure to Perform a Creatinine Assay  
    5.2Procedure for Cleaning and Maintaining the Hamilton AT Plus  
Section6.0  Quality Control    
    6.0CLASS Staff Initial Six Month Performance Evaluation  
    6.1Procedure for Quality Control Preparations and Pools in ACS-180 Serum Assays  
    6.2Procedural Worksheet for the Receipt and Preparation of Quality Control Serum Pools  
    6.3Procedural Worksheet for the Evaluation of Quality Control Serum Pools and Subsequent Dispense  
    6.4Procedure for Quality Control Preparations and Pools in ACS-180 Urine Assays  
    6.5Procedural Worksheet for the Receipt and Preparation of QC Urine Preparation  
    6.6Procedure for Entering Quality Control Data into Statlia File and utilizing this file for calculations and Levy-Jennings graphs  
    6.7Procedure for Sign-off on Clinical Research Samples  
    6.8Procedural Worksheet for Actions Taken as a Result of Rejected QC Values  
    6.9Procedure for Notification of TSH Alert Values  
    6.10Procedure to Calculate Intra-assay CVs of Quality Control Data  
    6.11Procedure for Revising Subject Results  
    6.12Procedure for Notification of Alert Glucose and Cholesterol Values  
    6.13Procedure for Notification of Alert Triglyceride Values  
    6.14Procedural Worksheet to Assess QC Pool Results Across Instruments on a Bi-annual Basis  
Section7.0  Quality Assurance    
    7.1Procedure for Monitoring Room A122 Temperature at CLASS  
    7.2Procedure for Monitoring Freezers and Kelvinator Temperature  
    7.2a7.2a Procedural Worksheet for Documenting Gordinier Printouts  
    7.3Procedural Worksheet for Freezer Alert and Response  
    7.4Procedure for Re-reviewing Freezer Monitoring and Freezer Alert and Response  
    7.5Procedure for Maintaining the Revco Ultralow Condenser Filter Gasket and Battery  
    7.6Procedural Worksheet for Defrosting Freezers  
    7.7Procedure for Freezer Hookup Positioning Fill and Inventory  
    7.8Water Purification Informational Sheet and Procedure for the Assessment of Quality  
    7.9Procedure for Alarm System Operation  
    7.10Procedural Worksheet for the Performance Check of Alarm Zone 8  
    7.11Procedure for Generator Routine Maintenance and Service  
    7.12Procedure for CLASS Preparedness for Potential Y2K Scenarios  
    7.13Procedure for Storing Assaying and Reporting CAP Survey Materials  
    7.14Procedural Worksheet for CAP Survey Result Evaluation  
    7.15Procedural Worksheet for Validating Assay Performance Where Graded Proficiency Testing is Unavailable  
    7.17Procedural Worksheet for Reviewing Result Reports  
    7.18Evaluating Serum Carry-Over on Automated Instrumentation  
    7.19Procedural Worksheet for Identifying and Correcting Laboratory Problems  
    7.20Procedure for Glassware Washing  
    7.21Thermometer Information  
    7.22Procedure for Freezer Alert and Response in the Event of Y2K Electrical Power Outage  
Section8.0  Laboratory Information System    
    8.1 Procedure for Configuring the Immunoassay Results Integration System (IRIS) and Saving A Data File for an ACS-180 Run"  
    8.2Procedure for Data Analysis/Data Reduction using the StatLia Program  
    8.3Procedure for Sending Archived Results from the ACS-180 to the Immunoassay Results Integration System (IRIS)  
Section9.0  Data Preservation  
    9.6Using a USB Flash Drive with Windows XP  
    9.7Windows XP Backup for NIB Personnel  
Section10.0  Manual Assays    
    10.1Procedure to Perform the C2/C16 EIA Assay  
    10.2Procedure to Perform the IL-6 QuantiGlo Assay  
    10.3Procedure to Perform the TNFa QuantiGlo Assay  
    10.4Procedural Worksheet for the Preparation of Quanti-Glo TNFa Standards  
    10.5Procedural Worksheet for the Preparation of QuantiGlo IL-6 Standards  
    10.6Procedure to Extract Urine Samples for the 8-Isoprostane EIA  
Section11.0  Instrument Maintenance  
    11.1Procedure for Cleaning and Maintaining the Beckman Model TJ-6 Centrifuge  
    11.2Procedure for Placing Pipets into Service  
    11.3Procedure for Calibrating and Maintaining Pipets  
    11.4Procedural Worksheet for the Calibration of Pipets  
    11.5Procedure for Using the Sartorius Balance  
    11.6Procedure for Maintaining the Sartorius Balance  
    11.7Procedure to Check Maintain and Record Water Bath Temperature  
Section12.0  CLASS IT Policy SOPs  
    12.1Computer Access Security Procedures and Access Codes  
    12.2IT Infrastructure Backup Policies  
    12.3Installation of Software on CLASS Workstations  
    12.4Access Controls to Web and Database Confidential Subject Data  
    12.6Website Privacy Policy  
    12.7Website Terms and Conditions of Use  
    12.8CLASS Laboratory Computer Resource and Internet Access Policy  
Section13.0  CLASS IT Operational SOPs  
    13.1CLASS Computer Infrastructure Disaster Recovery  
    13.2Assay Results Data Range Testing and Verification  
    13.3SQL Test Procedures for Assay Results Data Range Verification  
    13.4Procedure for Backing up SWAN SQL Database  
    13.5Hardware and Software Installation and Configuration Protocol  
    13.6"CLASS Configuration Documentation Log  
    13.7Eudora Configuration Problems Windows XP/2000  
    13.8Transferring a Macintosh Eudora Account to Windows 2000  
    13.9Test Protocol for New CLASS Application Software  
    13.10CLASS IT New User Training  
    13.11How to Use CLASS OnLine Label Generation System  
    13.12How to Reload ID Databases Used by the CLASS Label Generation System  
    13.13Freezer Preparation for Shipping (Serum Simport)  
    13.14Freezer Preparation for Shipping (Urine)  
    13.15Creating Plans from Collection Data  
    13.16Sending Results to the Coordinating Center  
    13.17Programming the Gordinier Model 3200 Monitoring System  
    13.18Regression Testing Procedures for SQL and Other Data Files (MD5)  
    13.19The CLASS Computer Downtime Log Report (DLR)  
Section14.0  Centaur Operations  
    14.1Procedure for Centaur Daily Cleaning  
    14.2Procedure for Centaur Weekly Cleaning  
    14.3Procedure for Centaur Monthly Cleaning  
    14.4Procedural Worksheet for ADVIA-Centaur Calibration  
Section15.0  ACE Operations  
    15.1Procedure for ACE Daily Cleaning  
    15.2Procedure for ACE Weekly Cleaning  
    15.3Procedure for ACE Monthly Cleaning  
    15.4Procedural Worksheet for ACE Calibration  
    15.5Procedure to Perform the ACE Total Cholesterol Assay  
    15.6Procedure to Perform the ACE Glucose Assay  
    15.7Procedure to Perform the ACE HDL_CL Assay  
    15.8Procedure to Perform the ACE LDL_C Assay  
    15.9Procedure to Perform the ACE Triglyceride Assay  
    15.10Procedure to Prepare ACE Control Material  
    15.11Procedural Worksheet to Perform Linearity Checks on ACE Assays  
Section16.0  Phlebotomy  
    16.1Procedure to Perform Phlebotomy  
    16.2Procedure for Identifying Adverse Events Serious Adverse Events and Medical Device Reporting with respect to Devices Used in Phlebotomy  
  
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