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, Dr. Jeffrey Massey, at MasseyJ@michigan.gov.

BLOODBORNE EXPOSURE

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 

CHEMICAL HYGIENE

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

CLIA LINKS

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

QUALITY ASSESSMENT

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 

QUALITY ASSESSMENT: RAPID HIV TEST

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

GUIDELINES

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

GUIDELINES: LEAD TESTING

RQA.21 LeadCare Validation Protocol 

FORMS & WORKSHEETS

FORMS: HIV RAPID TEST COMPARISON STUDY - updated 11/6/2008 

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 

FORMS: HIV TESTING

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 10/1/2008 
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 

FORMS: QUALITY ASSESSMENT ACTIVITIES

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 

WORKSHEETS

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  

WORKSHEETS: LEAD TESTING

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 

LABORATORY PROCEDURES

PROCEDURES: RAPID HIV

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

PROCEDURES: SPECIMEN COLLECTION

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 

PROCEDURES: LEAD TESTING

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

PROCEDURES

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. 05/14/2012