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    Regional Laboratory Manual


    The CLIA '88 legislation requires that each site performing clinical tests have a procedure manual which includes safety instructions, specific instructions for each test performed, and instructions for quality control. The attached group of files have been developed for the Michigan Regional Laboratory System. Each Regional Laboratory Site is expected to have a copy of each procedure they use, all guidelines and whatever worksheets they use.  Like all laboratory documents, the files listed here are 'works in progress.' As new versions become available, they will replace older versions on this site. The files may be viewed and/or downloaded. They are in Microsoft Word or pdf format. If you would like to receive these files in WordPerfect format, or have comments or suggestions regarding these files, e-mail your request to the Regional Laboratory System Coordinator, Martha Boehme, at


    RQA.03      Generic Bloodborne Exposure Control Plan 
    RQA.04      Instructions for Modifying Generic Bloodborne Exposure Control Plan (v. 030805) 
    RQA.05      Sharps Injury Control Log (v. 020426) 
    RQA.15.02 Centrifuges and The Centrifuging of Whole Blood Samples - updated 11/22/2006 


    RQA.06 Generic Chemical Hygiene Plan for Local Health Departments 
    RQA.07 Instructions for Modifying Generic Chemical Hygiene Plan 


    CLIA Application (CMS-116) - updated 11/6/2006 
    CLIA Personnel Report (CMS-209) - updated 11/6/2006  
    CLIA Interpretive Guidelines - updated 11/6/2006 


    RQA.08.04  Generic Quality Assurance Manual - updated 3/24/2011
    QC Addendum to QA Manual- 
    updated 3/24/2011
    RQA.02      Instructions for Customizing the QA Manual 
    RQA.16.03  Competency Evaluation for Personnel Performing Clinical Testing - updated 3/4/2008 
    RQA.17.02  External Proficiency Testing - updated 11/22/2006 
    RQA.19.02  Internal Proficiency Testing - updated 11/22/2006 


    RQA.01.05    Quality Assurance Manual for Rapid HIV - updated 11/14/2008 


    RQA.18 General Laboratory Safety 
    RQA.22 Hemocue 201+ Validation Protocol 


    RQA.21 LeadCare Validation Protocol 



    Comparison Study Data Log 
    Staff Questionnaire 
    ClearView Daily Client Log 
    Consent form for HIV Testing 
    Universal Precautions PowerPoint - Judy Smith
    HIV Quality Assurance PowerPoint - Dr. John Dyke
    Quality Control PowerPoint - Barbara Weberman
    ClearView PowerPoint 
    Consent form for StatPak 


    RLF.01.02  Organization Structure Waived Test Sites - updated 1/11/2007 
    RLF.02       Log Sheet - Lab Directors Visits- updated 10/1/2008 
    RLF.03       Waived Testing Personnel Report Form 
    RLF.04       Initial Training Checklist for Clearview HIV 1/2 Stat-Pak - updated 10/1/2008 
    RLF.05       Competency Checklist for Clearview HIV 1/2 Stat-Pak - updated 10/1/2008 
    RLF.08       Log Sheet - Quality Control - Clearview HIV 1/2 Stat-Pak - updated 6/13/2013
    RLF.09       Log Sheet - Client Daily - Clearviw HIV 1/2 Stat-Pak - updated 10/1/2008 
    RLF.10       Clearview HIV 1/2 Stat-Pak Inventory Sheet- updated 10/1/2008 
    RLF.11       Discordant Results Report #1- updated 10/1/2008 
    RLF.12       Discordant Results Report #2- updated 10/1/2008 


    RLF.06 Corrective Action Form - General 
    RLF.07 Corrective Action Form for Unacceptable Proficiency Test- updated 9/4/2008
    RLF.13 Corrective Action Form for Ungraded Proficiency Test - updated 9/5/2008 
    RLF.14 Annual Site Competency Evaluation - updated 11/9/2006 
    RLF.16 Attendance Sheet - updated 6/12/2006 
    RLF.17 Autoclave Operation Log - updated 11/9/2006 
    RLF.19 Communication and Complaint Log - updated 11/9/2006 
    RLF.20 Corrective Action Form - General Purpose - updated 9/5/2008 
    RLF.23 Daily Client Log - DCA hemoglobin 
    RLF.24 Daily Client Log - ESA Lead - updated 11/9/2006 
    RLF.25 Daily Client Log - HemoCue - updated 6/12/2006 
    RLF.26 Daily Client Log - Whole Blood Glucose - updated 11/9/2006 
    RLF.28 Drying/Sterilization Oven Log v.2 - updated 11/9/2006 
    RLF.29 Equipment Maintenance Log - updated 11/9/2006 
    RLF.30 Equipment Monitoring Record - updated 11/9/2006 
    RLF.31 Equipment Pre-purchase Check List - updated 11/9/2006 
    RLF.33 Individual Competency Evaluation - updated 11/9/2006 
    RLF.35 Lab Personnel Report for Waived Testing - updated 11/9/2006 
    RLF.36 Monthly Report Site Summary - updated 11/9/2006 
    RLF.38 New Test Introduction or Modification Check List - updated 6/12/2006 
    RLF.60 Chart Audit - updated 12/14/2007 
               Instructions - Chart Audit (RLF-60) - updated 9/7/2006 
    RLF.68 Hemocue 201+ Daily Client Log - updated 11/9/2006 
    RLF.69 Site Information - updated 12/29/2006 
    RLF.70 New Test Validation Form - updated 12/29/2006 
    RLF.73 Chart Review - updated 12/14/2007 
    RLF.75 Trichomonas Daily Client Log - updated 4/12/2011 


    RLF.42 Combination Urine Dipstick & Pregnancy Test Control Log 
    RLF.44 HemoCue Monthly Control Log, version b 
    RLF.45 Hemoglobin A1 Control Log 
    RLF.46 LDX Monthly Control Log v.4
    RLF.47 Monthly Temperature Control Log A 
    RLF.48 Monthly Temperature Control Log B 
    RLF.49 Occult Blood Control Log 
    RLF.50 Pregnancy Test Control Log 
    RLF.51 Urine Dipstick Control Log 
    RLF.52 Wet Mount Control Log 
    RLF.53 Whole Blood Glucose Control Log 
    RLF.57 Wet Mount Test Log 
    RLF.58 HemoCue 201+ QC Form 
    RLF.59 HemoCue 201+ PM Log 
    RLF.61 Daily Patient Log Sheet- updated 9/20/2006 
    RLF.62 OneStep+ Strep A Patient Test Log - updated 9/20/2006 
    RLF.63 QuickVue Strep A QC Log - updated 9/20/2006 
    RLF.71 Oxidase - Gram Stain QC Worksheet - updated 5/25/2007 
    RLF.72 Modified Thayer Martin Media Tracking QC Record- updated 5/25/2007
    RLF.74 Trichomonas QC Trichomonas Test QC Log - updated 4/12/2011
    RLF.76 Whole Blood Glucose Ascencia Contour QC Log - updated 5/14/2012  


    RLF.54 LeadCare Client Log 
    RLF.55 LeadCare Training Check List 
    RLF.56 LeadCare WSLH Proficiency Log 
    RLF.65 Lead Care II QC Log - updated 10/11/2006 
    RLF.66 Lead Care II Daily Client Log - updated 10/11/2006 
    RLF.67 Lead Care II Training Form - updated 10/11/2006 



    RL.53.02 Clearview HIV 1/2 Stat-Pak - updated 5/4/2010 


    RL.04.02 Specimen Collection by Finger Puncture- updated 5/28/2008 
    RL.05.04 Specimen Collection by Venipuncture - updated 12/22/2009 
    RL.06.01 Specimen Collection Oral Fluid for Rapid HIV Advan. 
    RL.13.01 Specimen Collection: Oral Transudate for OraSure HIV 
    RL.14.03 Specimen Collection: Chlamydia and Neisseria by GenProbe Aptima Amplified Assays- updated 12/8/2010 


    RL.16.01 LeadCare Blood Testing Procedure 
    RL.42.02 Lead Care II Blood Lead Procedure  - updated 09/23/2011 


    RL.18.02 Cholestech LDX: Lipid Profile and Glucose  - updated 7/27/2007 
    RL.19.02 Fecal Occult Blood - Hemoccult - updated 8/2/2007 
    RL.20.02 Gram Stain - updated 8/2/2007 
    RL.21.03 HemoCue Cleaning and Maintenance - updated 5/28/2008 
    RL.22.03 Hemoglobin A1c in Blood by DCA 2000+ - updated 7/15/2008 
    RL.23.03 Hemoglobin Determination by HemoCue Photometer - updated 5/28/2008 
    RL.24.02 Neisseria gonorrhoeae Identification - updated 5/25/2007 
    RL.26.02 Pregnancy Test - ATI hCG - updated 12/12/2006 
    RL.27.03 Pregnancy Test - Mainline Confirm hCG for Urine - updated 03/02/2010 
    RL.29.02 Pregnancy Test - Quick Vue - updated 12/12/2006 
    RL.33.03 Urine Chemistry by Dipstick - updated 3/15/2010 
    RL.34.03 Wet Mount Microscopy- updated 4/1/2009 
                  Wet Mount Procedure - Figures 
    RL.36.01 Wet Mount Analysis - pH and Amine ("Whiff") Analysis 
    RL.37.03 Hemoglobin by HemoCue 201+ - updated 5/28/2008 
    RL.38.02 HemoCue 201+ Cleaning- updated 5/28/2008 
    RL.39.02 Pregnancy Test - PolyStat hCG - updated 12/7/2010
    RL.40.01 OneStep+ Dipstick Strep A Test - updated 9/20/2006 
    RL.41.01 QuickVue InLine Strep A Test - updated 9/20/2006 
    RL.42.02 Pregnancy Test - RefuAH hCG- updated 9/23/2011
    RL.43.01 Pregnancy Test - Rapid Vue hCG - updated 12/12/2006 
    RL.44.02 Mainline Maxie hCG Pregnancy Test - updated 11/9/2009 
    RL.45.01 ASI ProPhase Plus hCG Pregnancy Test - updated 12/29/2006 
    RL.46.01 Fecal Occult Blood - Hema Screen - updated 8/2/2007 
    RL.47.01 Whole Blood Glucose - Ascencia DEX2 - updated 8/2/2007 
    RL.48.01 Whole Blood Glucose - Ascencia Breeze - updated 8/2/2007 
    RL.49.01 Whole Blood Glucose - Ascencia Contour- updated 8/2/2007 
    RL.50.01 Whole Blood Glucose - Lifescan One Touch II - updated 8/2/2007 
    RL.51.01 Whole Blood Glucose - Lifescan One Touch Ultra - updated 8/2/2007 
    RL.52.01 Urine Pregnancy Test - iPregnancy hCG One Step - updated 1/8/2008 
    RL.54.01 Urine Pregnancy Test - Stanbio True One Step - updated 3/14/2008 
    RL.55.01 Urine Pregnancy Test - Clearview hCG Urine Cassette - updated 3/14/2008 
    RL.56.01 Whole Blood Glucose - Abbott Optium - updated 3/14/2008 
    RL.57.01 Bacterial Vaginosis Detection - OSOM BV Blue Test - updated 7/14/2008
    RL.58.01 Fecal Occult Blood by Henry Schein One Step - updated 9/4/2008
    RL.59.01 INRatio - updated 3/9/2009
    RL.60.01 Supply Experts hCG Urine Dipstick - updated 3/9/2009 
    RL.61.01 Apothecus One Step Pregnancy Test - updated 9/1/2009
    RL.62.01 Preganacy Test - New Choice-Pro - updated 11/9/2009
    RL.63.01 ICON DS Direct Group A Strep Test - updated 12/1/2009
    RL.64.01 Genzyme Diagnostics OSOM Trichomonas Rapid Test - updated 4/12/2011




    Rev. 02/07/2014

    Related Content
     •  Michigan Regional Laboratory System Map
     •  Laboratory Accreditation Tools
     •  Internal Proficiency Program for Wet Mount Microscopy
     •  Regional Laboratory System
     •  Regional Laboratory Directory
     •  Foodborne Illness Testing - Improving Local Capacity
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