quality assurance guidelines for testing using · web viewa. introduction and background 1. purpose...

Quality Assessment Manual for Rapid HIV Testing RQA0105Michigan Regional Laboratory System Effective Date November 14 2008ltInsert name of the local health departmentgt of 26

Quality Assessment Manual for Rapid HIV Antibody Tests

A Introduction and Background1 Purpose

This document provides guidance on quality assessment (QA) practices for sites using or planning to use rapid test kits to detect antibodies to the human immunodeficiency virus (HIV) waived under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations

Quality Assessment is a series of planned step-by-step activities that ensure testing is being carried out correctly results are accurate and mistakes are found and corrected in a timely fashion to avoid adverse outcomes These activities must be followed during the entire testing process from the time a person agrees to be tested until after the test results are reported

2 Elements of a QA program a Organization of the QA programb Testing personnel

1) Training2) Competency

c Process control1) Before testing2) During testing3) After testing

d Proficiency Testinge Documents and recordsf QA evaluation and troubleshooting

B Organization of the QA Program1 Site Coordinator

Each organization must appoint a site coordinator responsible for providing oversight of the rapid HIV testing program and ensuring that the necessary personnel and supplies are available This individual is responsible for the following activitiesa Verify the accuracy of the testing process by reviewing QC logs on

a monthly basisb Ensure that procedures (step-by-step instructions) are downloaded

from the Michigan Regional Laboratory website and placed into a procedures manual

c Ensure that all procedures are reviewed annually by the laboratory director and made available to all personnel involved in testing

d Ensure that all personnel know how to perform each proceduree Create mechanisms for communication so that personnel are `

informed about problems when they are identified

Quality Assessment Manual for Rapid HIV Testing RQA0105Michigan Regional Laboratory System Effective Date November 14 2008ltInsert name of the local health departmentgt Page 2 of 26

f Have a CLIA Certificate of Waiver if performing only waived rapid HIV antibody or other waived tests or be included under an organization with a CLIA exception for limited public health or mobile testing

g Implement mechanisms developed by the Michigan Regional Laboratory system to ensure that the site meets all applicable Federal State and other regulatory requirements This includes requirements for biohazard and chemical safety

2 Verification of the testing processBefore offering the test to clients each site must ensure that the entire testing process works as planned The laboratory must ensure thata Personnel have been trained and are able (competent) to perform their

assigned tasks b Test kits work as expected (eg give accurate results for a referenced

panel of nonreactive weakly reactive and reactive specimens) c Logistics are in place for providing confirmatory testing of

preliminary positive test results and handling biohazardous waste

3 Written testing instructionsTesting personnel must follow instructions for each test Step-by-step written instructions must be made available to all personnel performing testing Procedures must be downloaded from the Michigan Regional Laboratory website signed by the laboratory director placed into a procedures manual by the site coordinator and reviewed by staff on an annual basis Test procedures must include the following informationa The manner how clinic staff provide required pretest information

to test subjectb Instructions for maintenance of sufficient supplies of unexpired

test and control kits and adherence to manufacturerrsquos temperature ranges for storage and testing areas

c Specimen collection instructions test performance interpretation criteria reporting test results and resolution of problems (troubleshoot) before reporting results

d Quality control criteria such as the requirement to check performance of new test kit lots and shipments frequency of routine QC testing and actions to take if controls do not work

4 Site-specific written proceduresWritten site-specific procedures describing other operations must be made available to help ensure personnel know how to perform additional QA tasksa Personnel training and competency procedures that describe how

to train and assess competency of employees Competency


assessments of all testing personnel are to be performed in the following timeframe1) Initial competency upon completion of initial training2) Competency performed six (6) months after initial training3) Competency performed twelve (12) months after initial

training and annually thereafterb Safety procedures that describe how to use gloves and other

personal protective equipment (PPE) safely dispose of biohazard waste including used lancets or other sharps used for blood collection

c Reporting criteria that describe how to report results including confirmatory results if applicable

d Confirmatory testing criteria that describe how to refer specimens or test subjects for confirmatory testing manage test results

e Documentation criteria that describe how to keep records and timelines for review and destruction when outdated

5 Testing Personnel QualificationsThere are no Federal requirements for who can perform waived tests however it is recommended that certain qualities be considered when selecting personnel to perform rapid HIV antibody testing The following list of desirable qualities is based on practical considerations and expert opiniona Sincerity and commitment ndash A dedication to performing testing

accurately according to defined proceduresb Literacy ndash The ability to read instructions and record results is

criticalc Organizational skills ndash The level of skill necessary will depend on

the number and complexity of tasks an individual performs in the testing process If test volume is high and the individual performing testing is doing several tests or managing several other tasks simultaneously organizational skills can be critical

d Decision-making skills ndash Testing personnel should be able to interpret results and be able to recognize and handle problems that might arise

e Communication skills ndash If the person performing the test also is the one who shares results or other information with the person being tested being able to communicate clearly is important

6 Components of TrainingPersonnel must be fully trained on how to perform their assigned tasks and responsibilities Training must be documented for each individual using training checklists available on the regional laboratory website (wwwmichigangovmdchlab) The key components to include in a training program are


a The importance of QA and the elements of the sitersquos QA programb How testing is integrated into the overall programc Steps to perform the entire test procedure from specimen collection

to reporting of results 1) Read the instructions for performing the test2) Watch someone perform the test or view a video of

someone performing the test3) Practice performing the test with positive and negative

control materials4) Practice performing the venipuncture finger-stick andor

oral fluid collection procedure5) Review the procedures and forms on how to document

testingd The use and importance of blood and body fluid precautions and

biohazard safety (See Biohazard SafetyUniversal [Standard] Precautions)

7 Competency assessmenta Frequency of competency assessments

1) Initial Comptency Before a trainee is permitted to perform testing unsupervised for the first time his or her ability to conduct the test should be demonstrated and documented

2) Six Month Competency This assessment must be carried out six months after initial training

3) Annual Competency This assessment must be carried out 12 months after initial training and annually thereafter

b Competency assessment must include direct observation of all steps of the testing process The laboratory director site coordinator or other testing personnel trained in the procedure must perform the assessment

c To assess competency personnel must be directly observed as they perform the following steps1) Check and record the temperatures of the testing and

storage areas2) Set up the testing area label the test device and prepare

control and test results log sheets3) Run the external controls and record results4) Perform specimen collection and handling 5) Perform the test procedure on a clientpatient If such

observation will interfere with the actual client-provider interactions test performance may be observed on a volunteer

6) Evaluate the use of Standard (Universal) Precautions and procedures for biohazard and sharps (eg lancets needles) waste disposal


7) Appraise the individualrsquos ability to interpret results This might include using previously used test devices or pictures of devices that show nonreactive weakly reactive reactive and invalid results

8) Review test records and quality control results for proper documentation

9) Observe oral reporting of results to a test subject (if traineersquos responsibility)

10) If confirmatory test specimens are collected on-site observe the collection and handling of venous blood andor oral fluid specimens for referral If the frequency of reactive rapid test results is low the trainee should be observed collecting blood andor oral fluid from a volunteer staff member and demonstrate how it is processed for confirmatory testing

11) Verify that confidentiality is maintained

C Process ControlProcess control refers to the activities and techniques that are carried out to ensure that the testing procedures are performed correctly the environment is suitable and the test kit works as expected to produce accurate and reliable results1 Before Testing The laboratory must ensure that the conditions at which

the test kits and controls are stored and tests are performed are suitable the test area and the test subject are prepared and the test is working appropriatelya Check storage and room temperatures daily

1) Test and control kits storage Test kits and controls must be stored within the temperature ranges specified by the manufacturer These ranges vary with different test kits Place thermometers in refrigerators and monitor areas where kits are stored Check and record temperatures of the storage area on a log sheet each day testing is performed NOTE ldquoMin-Maxrdquo thermometers maintain a record of the highest and lowest temperature recorded during the observation period and can be very helpful to monitor storage conditions

2) Temperature control - testing area The temperature in the area where the test will be performed must be within the range specified by the manufacturer For testing carried out in the field (not onsite) monitor the temperature of the test and control kits in their portable storage containers and check the temperature where testing will be performed if it appears to be outside the specified range

3) When temperatures are out of range If the temperature falls outside of the specified range take action as needed to


adjust the temperature If there are doubts about the testing area temperature or whether test kits have stayed within the appropriate temperature range run external controls as described in the QC section to ensure that test devices are in satisfactory condition

b Check inventory and test kit lots as neededInventory control The laboratory must establish procedures to ensure adequate supplies of unexpired test kits controls and other materials These steps must include1) Rotating inventory to ensure the oldest kits are used first2) Adhering to shelf life limitations defined by the

manufacturera) Test or control kits should never be used beyond

their expiration datesb) Discard any test kits that are past their expiration

datec) Once control vials are opened their shelf life is

reduced The laboratory must record on the control vial the date it is opened and the date after which the opened control expires

NOTE It is useful to document on a log sheet when test and control kits are received their lot numbers and their expiration dates

c Receive request for testingd Provide HIVAIDS test information to the test subject

Manufacturers of rapid HIV tests provide a subject information pamphlet that must be given to each person prior to performing the HIV rapid test in accordance with FDA sales restrictions Each site may provide additional information For further details see the CDC website httpwwwcdcgovhivpubsrt-counselinghtm and applicable State or local rules

e Set up test area and label test device1) Setting up the testing area The testing area must be

prepared according to the specific site procedure which includes directions fora) Setting up the workspace and organizing suppliesb) Ensuring lighting is adequate to interpret rapid HIV

test results As a rule of thumb lighting is sufficient if standard newsprint held next to the test device can be read without difficulty

c) Preparing the test kit components and controlsd) Completing report formsNOTE Test kits test devices and controls should be brought to room temperature before performing the test

2) Specimen identification and labeling the test device


The laboratory must correctly identify each person to be tested and to ensure that proper identification of the specimen is maintained throughout the testing process Label components of the test (eg vials of developer solution test device and test result logs) with the name or identifying number of the person being tested after collecting the specimen

f Perform external QC according to the manufacturersquos and the sitersquos instructions1) Waived rapid HIV tests include two types of QC

a) Internal controls are controls built into each testing device and verify that the specimen was adequate and the solution flowed through the device as intended

b) External controls are known reactive and nonreactive liquid samples (controls) that are either provided in each test kit or purchased separately from the manufacturer External controls are surrogate samples used to evaluate the integrity of the test system and verify that the person conducting the test has performed it correctly

2) External quality controlTo verify that test devices accurately detect antibodies to HIV external positive and negative controls must be tested on a weekly basis The test kit manufacturer provides external controls containing HIV antibody-negative (nonreactive) and positive (reactive) human plasma compatible with its test system Before using external controls from a different source contact the test manufacturer to verify they are compatible with the specific test system being used and evaluate them in the testing site Controls may be ordered separately from the test kit depending on the manufacturer

3) Run external controls according to the manufacturerrsquos instructionsFollow the manufacturerrsquos instructions for proper use of negative and positive controls External controls must be run under the following circumstancesa) Each week of testing (Monday ndash FridaySaturday)

before any client samples are testedb) By each new operator prior to performing testing on

clientspatients for the first timec) When opening a new test kit lot (a test kit lot is

defined as boxes of test devices that have the same lot number label on the outside of the box)


d) Whenever a new shipment of test kits is received (even if it is the same kit lot number in current use)

e) If the temperature of the testing area falls outside of the range specified by the manufacturer

4) Incorrect control results troubleshootingIf external controls do not give the correct result steps must be taken to determine the source of error by following the external control kit troubleshooting instructions Troubleshooting steps help determine if the source of error is the test kit the external controls or operator technique When necessary contact the manufacturer for assistance andor to report defective test system components Document all steps take to resolve the problem using Michigan Regional Laboratory System form RLF-20 (Continuous Quality Improvement Form)

2 During Testing This phase of the testing process involves running the test and interpreting the results Activities during testing include collecting the specimen performing the test interpreting the internal control and clientpatient test results and following biohazard safety guidelinesa Follow biohazard safety precautionsb Collect the blood or oral fluid specimen

Follow the written procedure for whole blood or oral fluid specimen collection labeling and handling Further information on collecting blood by skin puncture can be found in Procedures and Devices for the collection of Diagnostic Capillary Blood Specimens Approved Standard ndash Fifth Edition5

c Perform the test and interpret the resultsFollow the manufacturerrsquos step-by-step instructions for performing the test and interpreting the results Interpreting rapid HIV tests requires good eyesight and adequate lighting The test should be read from a comfortable distance without manipulating the test device If supplemental lighting such as a flashlight is necessary care should be taken to avoid shadows or reflections that might lead to an incorrect interpretation of the test (A flashlight should never be used to shine light through the test device to accentuate the test result) Test results can be one of the following1) Nonreactive (report as negative)2) Reactive (report as preliminary positive)3) Invalid (the test result is inconclusive and cannot be

interpreted)d Internal controls

Each rapid test device includes a built-in (internal) control Internal controls in test devices vary among test manufacturers therefore it is important to read and understand the manufacturerrsquos explanation


of the location and functioning of internal controls for the test being used

e Evaluating internal control resultsInternal control results are evaluated with every test If the internal control does not produce the expected result the test result for the client is invalid cannot be reported and the test must be repeated If a second invalid result occurs external controls should be evaluated as described below before repeating the test a third time

f Running external controls to troubleshoot invalid or suspicious resultsIf repeatedly invalid test results or an unexpectedly high number of reactive results are obtained during testing sessions external controls should be run to help find out if problems are due to faulty test kits improper testing procedures or something to do with the patient specimen It is important to run the positive and negative controls whenever two consecutive invalid test results are obtained on a person being tested If the external control results are valid the problem may be due to interfering substances in the clientrsquos specimen

g Biohazard safetyUniversal (Standard) precautionsAll specimens and materials contacting specimens must be handled as if they are capable of transmitting an infectious organism Each site must ensure that the Occupational Safety and Health Administration (OSHA) bloodborne pathogens standards are met Persons doing the testing must know how to safely handle potentially infectious specimens Also according to Universal Precautions all human blood and certain body fluids should be treated as if know to be infectious for HIV hepatitis B virus hepatitis C virus and other bloodborne pathogens Sites must have available and follow procedures for biohazard safety to include instructions for the use of gloves hand washing sharps and biohazardous waste disposal spill containment and disinfection A different pair of gloves should be worn for collecting a specimen from each person being tested Used gloves should be handled as biohazardous waste For further details on these precautions see the manufacturerrsquos package insert OSHA regulations and guidelines on Universal and Standard Precautions2678

3 After Testinga Document resultsb Report results to test subject Reporting procedures must describe

how results are provided to the person being tested (verbal andor written results) and how results are documented in the personrsquos chart and in the test result logs


c Collect process and transport confirmatory test specimens or refer clients for followup Whenever a rapid HIV test result is reactive (preliminary positive) follow-up testing must be performed to confirm that the person being tested is infected with HIV Therefore each site must have established procedures for referral of either test specimens or persons being tested for confirmatory testing when rapid test results are reactive Collecting confirmatory specimens on-site may improve follow-up since some clients may not go elsewhere for the testing or to obtain results However if the site is not able to collect confirmatory test specimens a procedure must be in place for referring clients to another site to obtain this testingNOTE If the client refuses confirmatory testing this should be documented in the test results log

d Clean up and dispose of biohazardous wastee Manage confirmatory test results

1) If specimens are collected on-site the site must establish procedures describinga) How to collect label process store and document

specimen transferNote It must be indicated on the referral laboratory test requisition that the specimen is from an individual who has had a reactive rapid HIV test result

b) Transportation of the confirmatory test specimens to the site where they will be tested

c) How confirmatory results are obtained to give to the clientpatient

d) How to report confirmed positive HIV results to your state health department as required

2) Confirmatory testing protocols for a reactive rapid HIV testa) All reactive (preliminary positive) rapid test results

must be followed up with an approved supplemental test such as a Western blot an immunofluorescent assay (IFA) or an RNA 910 test for confirmation

b) Confirmatory testing can be done on blood (plasma serum or dried blood spots) or oral fluid specimens though blood specimens have higher accuracy than oral fluid specimens Urine should not be used for confirmatory testing because of its lower sensitivity Performing an enzyme immunoassay (EIA) screening test prior to a confirmatory test is optional Even if the EIA is nonreactive the specimen must proceed to confirmatory testing with a Western blot IFA or RNA


3) Follow-up testing for a negative confirmatory resultA negative confirmatory test result indicates one of three possibilities specimen mix-up early seroconversion (too early for antibody detection by Western blot or IFA) or false positive rapid test result If the initial confirmatory test is negative it is recommended thata) For blood specimens a repeat confirmatory test

with a new blood specimen should be done to rule out specimen mix-up or early infection

b) For oral fluid specimens a repeat confirmatory test with a blood specimen should be done because the Western Blot test is less accurate with oral fluid than it is with blood

4) Follow-up testing for an indeterminate confirmatory test resulta) If the initial confirmatory test was conducted on

blood the person should be advised to return for repeat confirmatory testing in one month or a test for HIV RNA may be performed

1048707 If the initial confirmatory test was conducted on oral fluid a repeat confirmatory test (Western blot IFA or RNA) should be conducted using a blood specimen See CDCrsquos Revised Guidelines for HIV Counseling Testing and Referral found at httpwwwcdcgovmmwrpreviewmmwrhtmlrr5019a1htm

5) Handling confirmatory test result discrepanciesProcedures should describe how to handle result discrepancies when the rapid test result was reactive and the confirmatory test was negative or indeterminate If the laboratory providing confirmatory testing performed an EIA test only and reported a nonreactive or negative result the testing site should contact the confirmatory testing laboratory and request a Western blot IFA or RNA test If the original specimen is not available a new specimen will need to be collected to be used for confirmatory testing

D External Proficiency TestingExternal Proficiency Testing (PT) an evaluation of the testing process by an impartial outside source is a way to evaluate how well testing is being performed and whether it is being performed reliably PT can help to identify existing or potential problems Moreover information gathered can provide an educational tool to improve performance The laboratory must participating in a proficiency testing (PT) program An overall score 80 is required for successful performance Any incorrect PT results must be investigated and the source of the


error must be determined The investigation must be documented using forms available on the Michigan Regional Laboratory System website (RLF-7 Continuous Quality Improvement-Investigation of Unsatisfactory PT Performance or RLF -13 ndash Continuous Quality Improvement-Investigation of Ungraded Proficiency Testing)

E Documents and Records1 Overview

One of the hallmarks of an adequate QA program is comprehensive documentation Sites using waived rapid HIV tests must have policies and procedures describing what QA records are required and how and when they are reviewed stored and destroyed The site coordinator must review QA records on a quarterly basis QA records must be retained for two years QA records include the following documentation (these forms are available on the Michigan Regional Laboratory websitendashsee Appendix 1)a) Training documentation b) Temperature logs these must include a daily record of the

refrigerator andor room temperature where test kits and external controls are stored and the temperature of the testing area Thermometers must be placed in each location Laboratory grade thermometers which can be purchased from medical or laboratory supply houses are recommended and their accuracy checked periodically (eg every six months) by comparison with another thermometer

c) External control result logs these must include the date and time of control testing lot number and expiration date of the test kit lot number and expiration date of the controls control results and corrective action taken if control results are unacceptable Control records must be kept in the order in which they were completed so they can be easily compared with the test records This will help find answers if there are questions about testing performed within a specific time frame

d) Test result logs these must include the date and time of testing an identifier for the person being tested a test kit lot number and expiration date test result action taken if the result was invalid identification of the person who performed the test whether confirmatory testing was requested including the type of specimen sent for confirmation (eg oral fluid blood) and the confirmatory test results when they are available If more than one person is conducting testing there should be a mechanism to chronologically link the test record log sheets to detect problems such as invalid results occurring repeatedly with the same test kit lot number


e) Specimen transfer logs these must be used to track the transfer of specimens for confirmatory testing and the document when confirmatory test results are received

F QA Monitoring and Troubleshooting1 Overview

Each site must establish protocols to identify key QA measures that are routinely monitored and evaluated and have corresponding troubleshooting procedures to resolve problems that may occur Significant problems especially those concerning the accuracy of the rapid HIV test in use should be immediately reported to the site coordinator and the laboratory director The local or state HIV test coordinator and the manufacturer should be notified when appropriate

2 QA monitoringSite coordinators must routinely monitor and evaluate QA measures Some suggested measures include the followinga Number of tests or external control materials that expired before

use or occurrences of expired tests used for diagnostic or QC purposes

b Number of days tests or QC materials were stored or used outside of temperature specifications

c Frequency of external QC testing compared with test site procedure

d Frequency of invalid or incorrect results for external control testing or client testing

e Proportion of negative and preliminary positive patientclient results

f Proportion of reactive rapid test results confirmed positive of all reactive rapid test results

3 TroubleshootingTroubleshooting procedures must be available to all testing personnel and include the followinga When to discontinue testing for example when the external

control results are unacceptable as described in the package insertb How to take corrective action or an action taken in response to a

problem such as contacting the manufacturer when the external control results are unacceptable and following the advice provided

c How to document problems and actions taken such as a logbook where problems and corrective actions can be recorded

d How to verify the corrective actions taken addressed the problem4 Expired tests or QC materials

On a monthly basis the site coordinator must verify that test kits and external controls are used before they reach the expiration date specified by the manufacturer If it is determined that expired test kits or controls have been used and client results have been reported the laboratory


director will be notified The following actions will be taken by the site coordinator if it is determined that expired test kits or external controls expire have been used for testinga Inventory management ordering procedures and storage

procedures will be reviewed to ensure that all materials currently in stock have a reasonable shelf life

b Instruct staff that the use of expired test kits and control materials is not permitted under any circumstances

c If needed adjust ordering procedures revise QA protocols or retrain staff

5 Tests or QC materials stored or used when temperatures are outside of specifications stated by the manufacturerOn a monthly basis the site coordinator will verify that test kits and external controls are used and stored within of the manufacturerrsquos temperature specifications When it is verified that test kits andor controls are stored outside these temperature limits the laboratory director will be notified and the following actions takena Determine the cause for out-of-range temperature(s) and ensure

corrective measures have been takenb Confirm whether tests were used in out-of-range temperatures if

procedures were followed and if testing personnel were aware of temperature conditions

c Determine whether external QC tests were performed to verify the test could be performed and correctly interpreted

d If needed modify procedures and retrain staff on temperature control specifications

6 Incorrect or invalid QC test resultsOn a monthly basis the site coordinator will evaluate the accuracy of quality control results The site coordinator will ensure that only unexpired controls are used for testing all external and internal controls yield the expected results and testing personnel are properly evaluating QC results before client samples are tested The laboratory director will review all QC results on a quarterly basis The laboratory director should take the following steps when incorrect or invalid QC test results are observeda Evaluate procedures for testing external controls and review

records of control resultsb Perform troubleshooting procedures in accordance with the

manufacturerrsquos control kit instructions to determine the source of the incorrect or invalid result

c If test devices used with valid external control materials provide invalid or incorrect results discontinue testing and contact the manufacturer

d Resume testing only after tests on external control materials provide correct results and document corrective actions


e If needed modify the QA protocol andor retrain staff on appropriate testing of external controls

7 Invalid patientclient test resultsOn a quarterly basis the site coordinator will determine the validity of client test results by comparing the results of the rapid HIV test to the results of confirmatory testing A minimum of ten (10) client charts will be evaluated The laboratory director must review the results of this audit The laboratory director should consider the following actions when invalid client test results are observeda If possible observe specimen collection testing and result

interpretation to confirm test procedures are performed correctlyb Confirm the test device(s) used had not expiredc Review documentation of testing to ensure procedures are being

followedd Determine whether external controls were tested after the second

invalid test result and if troubleshooting procedures were followed If not perform external QC testing using test devices from the same kit or lot to determine proper functioning of the test device

e Perform troubleshooting procedures according to the manufacturerrsquos instructions

f If test results using valid external control materials provide invalid results testing should be discontinued

g If the test kitlot is determined to be faulty notify the manufacturer

h Resume testing only after tests on external controls provide correct results and document corrective actions

l If needed retrain staff on appropriate testing proceduresm if appropriate notify local or state health department HIV test

manager8 Excessive false positive patientclient test results

On a quarterly basis the site coordinator will compare the total number of reactive rapid test results with the number of confirmed positive results The results of this audit will be conveyed to the laboratory director If the resulting ratio of false-positive rapid test results suggests the test is not performing according to manufacturer specifications (refer to the product insert for population prevalence and performance data) the laboratory director should consider the following actionsa Evaluate the expiration dates of test kits and temperatures of the

storage and testing areas for test kit lots that produced and did not produce false positive test results

b Review records of external control testing for test devices of the same lot and subjected to the same temperature conditions

c Perform additional troubleshooting procedures in accordance with manufacturer instructions


d Evaluate facility testing procedures and if appropriate modify the QA protocol andor retrain staff on appropriate testing procedures

e If necessary inform the manufacturer and appropriate local or state health department HIV test managers If appropriate consider discontinuation of testing or changing to another waived test vendor

References1 Clinical Laboratory Improvement Amendments of 1988 42 USC 263a PL100-

578 (1988)2 CLSI document HS1-A2 A quality system model for health care Approved

guideline ndash Second edition CLSI Wayne PA 20043 CDC Good Laboratory Practices for Waived Testing Sites MMWR

Recommendations and Reports 2005 RR-54134 CLSI document GP21-A2Training and competence assessment Approved

guideline ndash Second edition CLSI Wayne PA 20045 CLSI document H4-A5 Procedures and devices for the collection of diagnostic

capillary blood specimens Approved standard guideline CLSI Wayne PA 2004

6 Occupational Safety and Health Administration regulations 29CFR Part 1910 Available from httpwwwoshagovSLTCbloodbornepathogensindexhtml

7 CDC Perspectives in disease prevention and health promotion update Universal precautions for prevention of transmission of human immunodeficiency virus hepatitis B virus and other bloodborne pathogens in health-care settings MMWR 1988 37(24)377-88

8 Garner JS Hospital Infection Control Practices Advisory Committee Guideline for isolation precautions in hospitals Infect Control Hosp Epidemiology 19961753-80 and Am J Infect Control 19962424-52

9 CDC CDC Revised Guidelines for HIV Counseling Testing and Referral MMWR Recommendations and Reports 2001 RR-1950

10 APTIMAreg HIV-1 RNA Qualitative Assay package insert Gen-Probereg San Diego CA 92121 2006

11 Uni-Goldtrade Recombigenreg HIV package insert Trinity biotech USA St Louis MO 63114 2004

12 OraQuickreg ADVANCE Rapid HIV-12 Antibody Test package insert OraSure Technologies Inc Bethlehem PA 18015 2005

13 HIV-12 STAT-PAKTM Assay package insert Chembio Diagnostic Systems Inc Medford NY 11763 2006

NOTE This manual was adopted for use in the Michigan Regional Laboratory System from Quality Assurance Guidelines for Testing Using Rapid HIV Antibody Tests Waived Under the Clinical Laboratory Improvement Amendments of 1988 US Department of Health and Human Services Centers for Disease Control and Prevention 2007


Appendix 1 Procedures and forms on the Michigan Regional Laboratory website

FORMS HIV RAPID TEST COMPARISON STUDY

Comparison Study Data Log Staff Questionnaire ClearView Daily Client Log UniGold Daily Client Log Consent form for HIV Testing Universal Precautions PowerPoint - Judy SmithHIV Quality Assurance PowerPoint - Dr John DykeQuality Control PowerPoint - Barbara WebermanClearView PowerPoint UniGold PowerPoint UniGold Training Guide

FORMS HIV TESTING

RLF0102 Organization Structure Waived Test Sites - updated 1112007 RLF02 Log Sheet - Lab Directors Visits RLF03 Waived Testing Personnel Report Form RLF04 Initial Training Checklist for the OraQuick Advance RLF05 Competency Checklist for the OraQuick Advance RLF08 Log Sheet - Quality Control - OraQuick Advance RLF09 Log Sheet - Client Daily - OraQuick Advance - updated 5312006 RLF10 OraQuick Advance Inventory Sheet RLF11 Discordant Results Report 1 RLF12 Discordant Results Report 2

FORMS CONTINUOUS QUALITY IMPROVEMENT

RLF07 Corrective Action Form for Unacceptable Proficiency Test RLF13 Corrective Action Form for Ungraded Proficiency Test RLF20 Corrective Action Form - General Purpose

PROCEDURES RAPID HIV

RL0303 HIV-1 and 2 Rapid Test OraQuick Advance - updated 1262007 RL0701 Flow Diagram for Rapid HIV OraQuick Advance - Blood RL0801 Flow Diagram for Rapid HIV OraQuick Advance - Oral Fluid RL0901 OraQuick Advance Test Algorithm - Blood RL1001 OraQuick Advance Test Algorithm - Oral Fluid RL1102 Uni-Gold Recombigen HIV-1 - updated 1112007 RL5301 Clearview HIV 12 Stat-Pak - updated 2122008


Summary Quality Assessment

The following is a summary of the Quality Assessment Plan of this agency All personnel involved in the testing process are required to be familiar with the entire plan and to refer to it whenever additional information is required All site coordinators are also encouraged to refer to the Michigan Regional laboratory System website at wwwmichigangovmdchlab to download forms which are designed to document the QA activities summarized in this document

Quality Policy The primary goal of each clinic performing testing is to provide high quality results that accurately reflect the clinical status of the client Each clinic must have a plan that monitors each test on a daily basis The goal of this plan is to ensure that testing is performed accurately each and every day

Personnel Training and Competency All personnel performing testing must be thoroughly trained in each laboratory procedure assigned to them before they start testing client samples and on an ongoing basis The ability of each individual to accurately perform each step of testing (ie their competency) must be evaluated annually

Laboratory Facility and Safety Precautions bull Each clinic must have sufficient space for all necessary tests being performedbull Staff must be familiar with all safety precautions required for proper handling of

chemicals and have annual training in chemical safetybull Staff must be familiar with all safety precautions required for biohazardous material

and bloodborne pathogens and have annual bloodborne pathogen training

Laboratory Instrumentationbull All instruments must be kept in good working order bull All instruments must be cleaned as required by either laboratory policy or

manufacturer recommendations (some instruments require cleaning each day testing is performed other instruments require weekly or monthly cleaning)

bull Document all problems and repairs

Laboratory Reagentsbull No testing is permitted if reagents have exceeded their expiration datebull Label each reagent with the date it was opened or prepared and initialbull Some reagents will have a new expiration date after being opened (eg 30 days after

opening Write both the date opened and the new expiration date on the vial and initial

bull Write the date of receipt into the clinic on the outside of each box of reagentsbull Monitor conditions where reagents are stored (eg temperature)bull Discard expired reagents as soon as possible

Laboratory Procedure Manual bull Everyone performing testing must follow each procedure exactly as written


bull No modifications are permitted ndash there are no exceptionsbull All procedures must be approved by the laboratory director The signature of the

clinical consultant or medical director or other agency manager does not supersede or replace the approval of the laboratory director

Proficiency Testingbull Proficiency testing programs are intended to determine if the test site can produce the

correct resultbull PT samples are tested in the same exact manner as client samplesbull Document PT results on daily test logs AND the score sheet supplied with the

samplesbull Rotate PT among all personnel performing testingbull PT results are due within the time frame required by the PT agency (usually 10

working days after receipt of the sample)bull Staff may not consult with others in the clinic unless this is part of the normal testing

processbull The individual who tests the PT sample and the site coordinator must sign a statement

which acknowledges that testing was performed in the same manner by which they normally test client samples

bull After results have been submitted left over PT samples may be used to assess competency NOTE Proficiency testing is not the same as competency evaluations or training

bull Corrective action is required whenever an incorrect result is obtained on a PT samplebull All testing personnel need to review the PT scoring and sign an acknowledgement of

review

Quality Controlbull QC verifies that test results are valid by assessing the reliability of three aspects of the

testing process- The reliability of test reagents- The integrity of instrumentation- The ability of the tester to perform the test accurately

bull The frequency for running controls for each test procedure is specified in the QA plan

bull QC must be acceptable before testing andor reporting of results is permitted Any results obtained when QC is unacceptable or not performed are invalid and must be repeated There are no exceptions

bull The person performing testing must evaluate QC results and make a determination of pass or fail before client samples may be tested

bull Some tests (eg strep A urine pregnancy hemoccult) have an internal procedural control Results of the internal control must be documented for each control and client tested

bull QC logs must include lot number and expiration date of all reagents used in the testbull QC logs must include the lot number expiration date and acceptable ranges of all

controls


bull Corrective action must be taken whenever controls fail to give expected resultsbull Do not repeat QC testing until an acceptable result is generated Unacceptable QC

results indicate a problem with the test system Determine the nature of the problem before proceeding

New Test Introduction The clinic must validate the accuracy and reliability of each new instrument or new test procedure before testing is permitted The laboratory director will provide specific requirements of the validation study

Laboratory Recordsbull All test results must be accurately and legibly written on daily test logsbull All test results must be accurately and legibly transcribed from daily test logs to client

chartsbull All test results written in client charts must follow the reporting criteria contained in

the procedure manualbull Whenever transcriptional errors are made draw a single line through the incorrect

entry and write the correct entry next to it Initial and date the change Do not use ldquoWhite Outrdquo or totally obscure the incorrect entry

bull All laboratory records are kept for two years and then discarded

Documentation of Complaints and Communications The clinic must document all communications or complaints from individuals outside the clinic which deal with laboratory results

Data Review and Internal Chart Audits The site coordinator must perform a review of test records and client charts on a quarterly basis to ensure that laboratory results are accurately transcribed into client charts

Corrective Action Whenever a laboratory test fails to give the expected result (eg QC out-of-control proficiency testing etc) laboratory staff must bull Identify the problembull Investigate what went wrong and try to identify the causebull Implement a plan to correct the problem and prevent it from happening againbull Identify someone who will monitor laboratory results to ensure the problem doesnrsquot

happen againbull Document each step of the investigation on the appropriate form (RLF-20)

20 General Overview

This section is an overview of the requirements of a written Quality Assessment (QA) Plan and how it is to be utilized within the Michigan Regional Laboratory System The Clinical Laboratory Improvement Amendments (CLIA) classifies laboratory tests as either waived or non-waived Non-waived tests are further divided as either moderately complex or highly complex Most tests performed with the Regional Laboratory System are classified as waived The notable exception is wet mount analysis which is a non-


waived moderately complex test While not strictly required by CLIA for waived category tests the QC protocols utilized by the regional laboratory system are more stringent those required by the CLIA regulations Dual level (lowhigh for quantitative assays and positivenegative for qualitative) controls are required for all tests at an interval based on the perceived stability of the test This is based on standard laboratory procedures for good laboratory practice

Quality assessment activities are based upon the three phases of laboratory testing ndash pre-analytical analytical and post-analytical 1 The pre-analytical phase involves the steps taken before testing starts 2 The analytical phase includes the actual testing process 3 The post-analytical phase includes the recording and reporting of test resultsThe documentation tools contained in this QA plan will allow testing personnel to evaluate each phase of testing

There are two broad categories of laboratory tests quantitative and qualitative 1 Quantitative tests are used to determine the actual concentration of a material

(ldquohow muchrdquo or ldquohow littlerdquo) is present in the test sample A numeric value is produced Cholesterol is a typical quantitative test

2 Qualitative tests attempt to determine whether or not a specific condition exists (ldquopositiverdquo or ldquonegativerdquo) Urine pregnancy is a typical qualitative test

Qualitative and quantitative tests have separate requirements for quality control 1 Quantitative tests should be challenged with controls that evaluate both the high

and low range of the test methodology a Most compounds in the blood have a normal range which is typically seen

in healthy individuals Test results which fall above or below the normal value are considered to be clinically significant

b Control materials are chosen which will fall at the low end and the high end of the test methodology This ensures that the laboratory is capable of detecting abnormal results in client samples

2 Control materials for qualitative tests utilize material which will yield a positive or a negative result This depends on whether the target is present or absent in the control material

Some test kits have ldquointernal QC indicatorsrdquo eg most pregnancy tests The results of the internal indicators of both QC and patient test should be documented since this certifies that the test result is valid While internal controls demonstrate that each individual test is performing as required they do not take the place of challenging the test with known positive and negative controls Similarly some instruments are equipped with a calibration cuvette or check strip which tests the electrical components of the instrument This electronic control mechanism does not verify the accuracy of the reagents used in the testing process


Standardized QC materials can be obtained from a commercial manufacturer for most tests Certain tests most notably fecal occult blood (eg hemoccult or hemawipe) do not have external quality controls Instead the internal quality control results must be observed and documented for all client samples

Laboratory staff must be able to recognize whenever a test fails to perform as expected This is accomplished by complying with the following requirements1 The entire testing process must be continually monitored to ensure that laboratory

errors are promptly identified and corrected before a laboratory result is reported and entered into the clientrsquos clinical history

2 Staff members must demonstrate competence in all steps of all procedures to which they have been assigned

3 Documentation must be available at each site where testing is performed which shows that each individual performing testing has been properly trained and states they are capable of performing the procedure according to written instructions

4 Staff must be monitored on an ongoing basis to demonstrate that they are competent to perform each test for which they have been trained

5 Written procedures must be reviewed and signed by the laboratory director on an annual basis and placed in a lab manual available to staff at each testing site

6 The procedure must adhere to all requirements specified by the manufacturer of the test kit or control

7 All test materials (controls reagents and supplies) must be stored in accordance with the conditions specified in the procedure

8 Staff members may not exchange reagents from one kit with another Likewise do not use expired materials for patient testing

9 No test will ever be performed on clinical specimens if the QC test(s) has not been performed or is unacceptable

10 Staff must initiate and document corrective action whenever a quality control result is out-of-range or whenever a test fails to give expected results


This page left intentionally blank

This material reviewed and approved for use without modification

Review DateSignature ______________________________________________________________





Review DateSignature ______________________________________________________________RL0105 Quality Assurance Guidelines ndash HIVRev 112008


Site Coordinator reviews all QC records prior to forwarding to lab directortech consultant Errors on QC logs will require corrective action by the site coordinator Specific activity will depend upon the nature of the error Follow this flow chart to determine the appropriate corrective action to be taken

Was the correct form used AND was it the most recent version

Was all required QC information documented(ie expiration date lot control ranges)

Incomplete Record1 Identify the testing personnel who failed to document all data2 Instruct the testing person in question to include all data3 Document your corrective actions amp save the documentation4 If the expiration dates are wrong or not written down then assume that expired reagents were used and all client results are invalid Corrective action required (see below)

Were all results for optic check highlow controls internal controls etc recorded

Incomplete Record1 Identify the testing person who failed to document QC results2 Instruct the testing person in question to include all data3 Document your corrective actions amp save the documentation4 If observed results are not recorded then assume that controls were not tested and all client results are invalid Corrective action required (see below)

Incorrect Form1 Identify the testing personnel who used the out of date form2 Instruct the testing person in question to use the correct form3 Supply them with the correct form4 Remove older versions of the form5 Document your corrective actions amp save the documentation

QC FAILURE1 Identify testing personnel who filled out the form2 Retrain testing person in question on criteria for passfail determination for QC results3 Retrain testing person in question on proper handling and correct usage of QC material and test reagents Give particular emphasis on documentation of correct expiration and review of QC results4 Written corrective action required

Were the reagents within allowable dates AND were ALL QC results acceptable (ie within range) Was a correct determination of QC acceptability made

1 Any patient testing done must be considered invalid2 Pull all client charts for those tested with expired of out-of-control QC Complete form RLF-733 Recall and retest clients4 Alternatively medical director should compare test results to clinical status Retest any clients whose test results are inconsistent with clinical status5 Document the process and send to lab director for review and signature

1 Client status not affected2 State that no clients were tested in the corrective action report3 Send to lab director for review and signature

Were any patients tested while reagents were expired not recorded or out of controlNo further action required

No Yes

Yes

Yes

Yes

Yes

No

No

continue

continue

No

No

continue

If either the test reagents or the quality control reagents are out of date or fail to perform within specifications then the result is INVALID and must not be used for client management

Quality Control Corrective Action Flow Sheet


Quality Control Troubleshooting Flow SheetPage 1

1 Start on Page 1 if Instrument Function check required(Optic Check Calibration Check etc)2 Start on Page 2 if no instrument function checks are required

Did the instrument function check yield the expected results

The instrument is functioning as expected 1 Document results of optic check calibration check etc on test records2 Proceed to testing controls

The instrument is NOT functioning as expected1 Document results of optic check calibration check etc on test records2 Do not test controls yet3 Check expiration date of optic check or calibration strip

Yes No

ExpiredNot expired

Clean instrument amp repeat testing

Bad News1 Order new supplies at once2 Do not use this instrument until new shipment is received3 Start at the beginning when new supplies received

Did the instrument function check yield expected results on retest

Yes

Bad News1 Document results of optic check calibration check etc on test records2 Document what was done to try to correct the problem3 Call technical support4 DO NOT USE THIS INSTRUMENT UNTIL THE PROBLEM IS CORRECTED5 Complete a corrective action report and contact your technical consultant or laboratory director

Proceed to TESTING CONTROL REAGENTS (continued on next page)

No



1 Start on Page 2 once the Instrument Function check is successful 2 Start on Page 2 if no instrument function checks are required

Testing Control ReagentsTest high (abnormal) controlsTest low (normal) controls

1 Document results of controls on the QC log2 Compare actual results to expected values3 Make a determination of PASSFAIL on the QC log4 Do the results for BOTH controls fall within the expected range

YES NO

QC is ACCEPTABLEOK to start testing

How many controls were out of range

One Two

1 Re-test the control using the SAME vial of control and the SAME lot number of test kit (eg cuvettes cassettes etc)2 Document results

1 Re-test both controls using a DIFFERENT pair of controls and the SAME lot number of test kit (eg same cuvettes cassettes etc2 Document results

Does the repeat test fall within the expected range


Yes No No Yes

Retest using a NEW LOT NUMBER of CONTROL REAGENT

Problem may be pipetting error Review your technique Record corrective action in QC log

Initial controls are bad Discard them

Retest using a NEW LOT NUMBER of TEST Kit or REAGENT



Yes No No Yes

Initial test kits or reagents may be bad Discard them Retest

EQUIPMENT FAILURE1 Contact technical support for repairs2 DO NOT USE this instrument for clinical testing3 Document corrective action in QC log4 Notify lab director immediately


f Have a CLIA Certificate of Waiver if performing only waived rapid HIV antibody or other waived tests or be included under an organization with a CLIA exception for limited public health or mobile testing

g Implement mechanisms developed by the Michigan Regional Laboratory system to ensure that the site meets all applicable Federal State and other regulatory requirements This includes requirements for biohazard and chemical safety

2 Verification of the testing processBefore offering the test to clients each site must ensure that the entire testing process works as planned The laboratory must ensure thata Personnel have been trained and are able (competent) to perform their

assigned tasks b Test kits work as expected (eg give accurate results for a referenced

panel of nonreactive weakly reactive and reactive specimens) c Logistics are in place for providing confirmatory testing of

preliminary positive test results and handling biohazardous waste

3 Written testing instructionsTesting personnel must follow instructions for each test Step-by-step written instructions must be made available to all personnel performing testing Procedures must be downloaded from the Michigan Regional Laboratory website signed by the laboratory director placed into a procedures manual by the site coordinator and reviewed by staff on an annual basis Test procedures must include the following informationa The manner how clinic staff provide required pretest information

to test subjectb Instructions for maintenance of sufficient supplies of unexpired

test and control kits and adherence to manufacturerrsquos temperature ranges for storage and testing areas

c Specimen collection instructions test performance interpretation criteria reporting test results and resolution of problems (troubleshoot) before reporting results

d Quality control criteria such as the requirement to check performance of new test kit lots and shipments frequency of routine QC testing and actions to take if controls do not work

4 Site-specific written proceduresWritten site-specific procedures describing other operations must be made available to help ensure personnel know how to perform additional QA tasksa Personnel training and competency procedures that describe how

to train and assess competency of employees Competency






















































































































































































FORMS HIV TESTING
































review








controls














20 General Overview

















































No Yes

Yes

Yes

Yes

Yes

No

No

continue

continue

No

No

continue









Yes No

ExpiredNot expired




Yes



No






YES NO



One Two





Yes No No Yes







Yes No No Yes
























































































































































































FORMS HIV TESTING
































review








controls














20 General Overview

















































No Yes

Yes

Yes

Yes

Yes

No

No

continue

continue

No

No

continue









Yes No

ExpiredNot expired




Yes



No






YES NO



One Two





Yes No No Yes







Yes No No Yes





























review








controls














20 General Overview

















































No Yes

Yes

Yes

Yes

Yes

No

No

continue

continue

No

No

continue









Yes No

ExpiredNot expired




Yes



No






YES NO



One Two





Yes No No Yes







Yes No No Yes
















20 General Overview

















































No Yes

Yes

Yes

Yes

Yes

No

No

continue

continue

No

No

continue









Yes No

ExpiredNot expired




Yes



No






YES NO



One Two





Yes No No Yes







Yes No No Yes


















































No Yes

Yes

Yes

Yes

Yes

No

No

continue

continue

No

No

continue









Yes No

ExpiredNot expired




Yes



No






YES NO



One Two





Yes No No Yes







Yes No No Yes









Yes No

ExpiredNot expired




Yes



No






YES NO



One Two





Yes No No Yes







Yes No No Yes








YES NO



One Two





Yes No No Yes







Yes No No Yes

