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 Information Sheet - updated 11/6/2006
CLIA Interpretive Guidelines - updated 11/6/2006

QUALITY ASSESSMENT

RQA.08.03  Generic Quality Assurance Manual - updated 1/8/2008
RQA.2      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

RL.01.03    Quality Assurance Manual for Rapid HIV - updated 1/11/2007
RQA.02.01 Competency Evaluation for Personnel Performing Rapid HIV

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 10/16/2007

Comparison Study Data Log
Staff Questionnaire
ClearView Daily Client Log
UniGold 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
UniGold PowerPoint
UniGold Training Guide

FORMS: HIV TESTING

RLF.01.02  Organization Structure Waived Test Sites - updated 1/11/2007
RLF.02       Log Sheet - Lab Directors Visits
RLF.03       Waived Testing Personnel Report Form
RLF.04       Initial Training Checklist for the OraQuick Advance
RLF.05       Competency Checklist for the OraQuick Advance
RLF.08       Log Sheet - Quality Control - OraQuick Advance
RLF.09       Log Sheet - Client Daily - OraQuick Advance - updated 5/31/2006
RLF.10       OraQuick Advance Inventory Sheet
RLF.11       Discordant Results Report #1
RLF.12       Discordant Results Report #2

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.34 Laboratory Director's Log
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

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

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.03.03 HIV-1 and 2 Rapid Test OraQuick Advance - updated 1/26/2007
RL.07.01 Flow Diagram for Rapid HIV OraQuick Advance - Blood
RL.08.01 Flow Diagram for Rapid HIV OraQuick Advance - Oral Fluid
RL.09.01 OraQuick Advance Test Algorithm - Blood
RL.10.01 OraQuick Advance Test Algorithm - Oral Fluid
RL.11.02 Uni-Gold Recombigen HIV-1 - updated 1/11/2007
RL.53.01 Clearview HIV 1/2 Stat-Pak - updated 2/12/2008

PROCEDURES: SPECIMEN COLLECTION

RL.04.02 Specimen Collection by Finger Puncture- updated 5/28/2008
RL.05.03 Specimen Collection by Venipuncture - updated 3/14/2008
RL.06.01 Specimen Collection Oral Fluid for Rapid HIV Advan.
RL.13.01 Specimen Collection: Oral Transudate for OraSure HIV 
RL.14.02 Specimen Collection: Chlamydia and Neisseria by GenProbe Aptima Amplified Assays- updated 6/19/2008

PROCEDURES: LEAD TESTING

RL.16.01 LeadCare Blood Testing Procedure
RL.42.01 Lead Care II Blood Lead Procedure  - updated 10/11/2006

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.27.02 Pregnancy Test - Mainline Confirm hCG for Urine - updated 12/4/2006
RL.29.02 Pregnancy Test - Quick Vue - updated 12/12/2006
RL.33.02 Urine Chemistry by Dipstick - updated 8/1/2006
RL.34.01 Wet Mount Microscopy
              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.39.01 Pregnancy Test - PolyStat hCG - updated 9/20/2006
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.42.01 Pregnancy Test - RefuAH hCG- updated 12/12/2006
RL.43.01 Pregnancy Test - Rapid Vue hCG - updated 12/12/2006
RL.44.01 Mainline Maxie hCG Pregnancy Test - updated 12/29/2006
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

Rev. 9/5/2008