Quality Assessment Manual for Rapid HIV Testing RQA.01.05 Michigan Regional Laboratory System

Quality Assessment Manual for Rapid HIV Testing
RQA.01.05
Michigan Regional Laboratory System
Effective Date: November 14, 2008
<Insert name of the local health department>
Page 1 of 26
Quality Assessment Manual for Rapid HIV Antibody Tests
A.
Introduction and Background
1.
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.
B.
Elements of a QA program
a.
Organization of the QA program
b.
Testing personnel
1)
Training
2)
Competency
c.
Process control
1)
Before testing
2)
During testing
3)
After testing
d.
Proficiency Testing
e.
Documents and records
f.
QA evaluation and troubleshooting
Organization of the QA Program
1.
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 activities:
a.
Verify the accuracy of the testing process by reviewing QC logs on
a monthly basis.
b.
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 procedure.
e.
Create mechanisms for communication so that personnel are `
informed about problems when they are identified.
Quality Assessment Manual for Rapid HIV Testing
RQA.01.05
Michigan Regional Laboratory System
Effective Date: November 14, 2008
<Insert name of the local health department>
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f.
g.
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.
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 process
Before offering the test to clients, each site must ensure that the entire
testing process works as planned. The laboratory must ensure that:
a.
Personnel have been trained and are able (competent) to perform
their assigned tasks,
b.
Test kits work as expected (e.g., 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 instructions
Testing 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 information:
a.
The manner how clinic staff provide required pretest information
to test subject.
b.
Instructions for maintenance of sufficient supplies of unexpired
test and control kits and adherence to manufacturer’s 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 procedures
Written site-specific procedures describing other operations must be made
available to help ensure personnel know how to perform additional QA
tasks:
a.
Personnel training and competency procedures that describe how
to train and assess competency of employees. Competency
Quality Assessment Manual for Rapid HIV Testing
RQA.01.05
Michigan Regional Laboratory System
Effective Date: November 14, 2008
<Insert name of the local health department>
Page 3 of 26
b.
c.
d.
e.
assessments of all testing personnel are to be performed in the
following timeframe:
1)
Initial competency upon completion of initial training.
2)
Competency performed six (6) months after initial training.
3)
Competency performed twelve (12) months after initial
training and annually thereafter.
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.
Reporting criteria that describe how to report results including
confirmatory results, if applicable.
Confirmatory testing criteria that describe how to refer specimens
or test subjects for confirmatory testing; manage test results.
Documentation criteria that describe how to keep records and
timelines for review and destruction when outdated.
5.
Testing Personnel Qualifications
There 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
opinion:
a.
Sincerity and commitment – A dedication to performing testing
accurately, according to defined procedures.
b.
Literacy – The ability to read instructions and record results is
critical.
c.
Organizational skills – 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 – Testing personnel should be able to
interpret results and be able to recognize and handle problems that
might arise.
e.
Communication skills – 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 Training
Personnel 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
(www.michigan.gov/mdchlab). The key components to include in a
training program are:
Quality Assessment Manual for Rapid HIV Testing
RQA.01.05
Michigan Regional Laboratory System
Effective Date: November 14, 2008
<Insert name of the local health department>
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a.
b.
c.
d.
7.
The importance of QA and the elements of the site’s QA program
How testing is integrated into the overall program
Steps to perform the entire test procedure from specimen collection
to reporting of results.
1)
Read the instructions for performing the test.
2)
Watch someone perform the test or view a video of
someone performing the test.
3)
Practice performing the test with positive and negative
control materials.
4)
Practice performing the venipuncture, finger-stick and/or
oral fluid collection procedure.
5)
Review the procedures and forms on how to document
testing.
The use and importance of blood and body fluid precautions and
biohazard safety. (See Biohazard Safety/Universal [Standard]
Precautions.)
Competency assessment
a.
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 steps:
1)
Check and record the temperatures of the testing and
storage areas.
2)
Set up the testing area, label the test device and prepare
control and test results log sheets.
3)
Run the external controls and record results.
4)
Perform specimen collection and handling.
5)
Perform the test procedure on a client/patient. 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 (e.g., lancets, needles)
waste disposal.
Quality Assessment Manual for Rapid HIV Testing
RQA.01.05
Michigan Regional Laboratory System
Effective Date: November 14, 2008
<Insert name of the local health department>
Page 5 of 26
7)
8)
9)
10)
11)
C.
Appraise the individual’s 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.
Review test records and quality control results for proper
documentation.
Observe oral reporting of results to a test subject (if
trainee’s responsibility).
If confirmatory test specimens are collected on-site,
observe the collection and handling of venous blood and/or
oral fluid specimens for referral. If the frequency of
reactive rapid test results is low, the trainee should be
observed collecting blood and/or oral fluid from a volunteer
staff member and demonstrate how it is processed for
confirmatory testing.
Verify that confidentiality is maintained.
Process Control
Process 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 results.
1.
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
appropriately.
a.
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: “Min-Max” 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
Quality Assessment Manual for Rapid HIV Testing
RQA.01.05
Michigan Regional Laboratory System
Effective Date: November 14, 2008
<Insert name of the local health department>
Page 6 of 26
b.
c.
d.
e.
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.
Check inventory and test kit lots, as needed
Inventory control: The laboratory must establish procedures to
ensure adequate supplies of unexpired test kits, controls, and other
materials. These steps must include:
1)
Rotating inventory to ensure the oldest kits are used first.
2)
Adhering to shelf life limitations defined by the
manufacturer.
a)
Test or control kits should never be used beyond
their expiration dates.
b)
Discard any test kits that are past their expiration
date.
c)
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.
Receive request for testing
Provide HIV/AIDS 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 http://www.cdc.gov/hiv/pubs/rt-counseling.htm and
applicable State or local rules.
Set up test area and label test device.
1)
Setting up the testing area: The testing area must be
prepared according to the specific site procedure, which
includes directions for:
a)
Setting up the workspace and organizing supplies,
b)
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 controls,
d)
Completing report forms.
NOTE: Test kits, test devices, and controls should be
brought to room temperature before performing the test.
2)
Specimen identification and labeling the test device
Quality Assessment Manual for Rapid HIV Testing
RQA.01.05
Michigan Regional Laboratory System
Effective Date: November 14, 2008
<Insert name of the local health department>
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f.
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 (e.g., 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.
Perform external QC according to the manufacture’s and the site’s
instructions
1)
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 control
To 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 manufacturer’s
instructions
Follow the manufacturer’s instructions for proper use of
negative and positive controls. External controls must be
run under the following circumstances:
a)
Each week of testing (Monday – Friday/Saturday)
before any client samples are tested.
b)
By each new operator prior to performing testing on
clients/patients for the first time.
c)
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).
Quality Assessment Manual for Rapid HIV Testing
RQA.01.05
Michigan Regional Laboratory System
Effective Date: November 14, 2008
<Insert name of the local health department>
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d)
2.
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: troubleshooting
If 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
and/or 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).
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
client/patient test results, and following biohazard safety guidelines
a.
Follow biohazard safety precautions
b
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 – Fifth Edition.5
c.
Perform the test and interpret the results
Follow the manufacturer’s 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 following:
1)
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 manufacturer’s explanation
Quality Assessment Manual for Rapid HIV Testing
RQA.01.05
Michigan Regional Laboratory System
Effective Date: November 14, 2008
<Insert name of the local health department>
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e.
f.
g.
3.
of the location and functioning of internal controls for the test
being used.
Evaluating internal control results
Internal 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.
Running external controls to troubleshoot invalid or suspicious
results
If 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 client’s
specimen.
Biohazard safety/Universal (Standard) precautions
All 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
manufacturer’s package insert, OSHA regulations and guidelines
on Universal and Standard Precautions.2,6,7,8
After Testing
a.
Document results
b.
Report results to test subject: Reporting procedures must describe
how results are provided to the person being tested (verbal and/or
written results) and how results are documented in the person’s
chart and in the test result logs.
Quality Assessment Manual for Rapid HIV Testing
RQA.01.05
Michigan Regional Laboratory System
Effective Date: November 14, 2008
<Insert name of the local health department>
Page 10 of 26
c.
d.
e.
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 testing.
NOTE: If the client refuses confirmatory testing, this should be
documented in the test results log.
Clean up and dispose of biohazardous waste
Manage confirmatory test results
1)
If specimens are collected on-site, the site must establish
procedures describing:
a)
How to collect, label, process, store, and document
specimen transfer.
Note: 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
client/patient.
d)
How to report confirmed positive HIV results to
your state health department, as required.
2)
Confirmatory testing protocols for a reactive rapid HIV test
a)
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 9,10 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.
Quality Assessment Manual for Rapid HIV Testing
RQA.01.05
Michigan Regional Laboratory System
Effective Date: November 14, 2008
<Insert name of the local health department>
Page 11 of 26
3)
4)
5)
D.
Follow-up testing for a negative confirmatory result
A 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 that:
a)
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.
Follow-up testing for an indeterminate confirmatory test
result
a)
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.
�
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 CDC’s Revised Guidelines for HIV
Counseling, Testing and Referral found at
http://www.cdc.gov/mmwr/preview/mmwrhtml/rr50
19a1.htm
Handling confirmatory test result discrepancies
Procedures 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.
External Proficiency Testing
External 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
Quality Assessment Manual for Rapid HIV Testing
RQA.01.05
Michigan Regional Laboratory System
Effective Date: November 14, 2008
<Insert name of the local health department>
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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 – Continuous Quality Improvement-Investigation of Ungraded
Proficiency Testing).
E.
Documents and Records
1.
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 website–see Appendix 1).
a)
Training documentation
b)
Temperature logs: these must include a daily record of the
refrigerator and/or 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 (e.g., 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 (e.g., 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.
Quality Assessment Manual for Rapid HIV Testing
RQA.01.05
Michigan Regional Laboratory System
Effective Date: November 14, 2008
<Insert name of the local health department>
Page 13 of 26
e)
F.
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.
QA Monitoring and Troubleshooting
1.
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 monitoring
Site coordinators must routinely monitor and evaluate QA measures. Some
suggested measures include the following:
a.
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 patient/client
results
f.
Proportion of reactive rapid test results confirmed positive of all
reactive rapid test results
3.
Troubleshooting
Troubleshooting procedures must be available to all testing personnel and
include the following:
a.
When to discontinue testing, for example, when the external
control results are unacceptable as described in the package insert
b.
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 problem
4.
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
Quality Assessment Manual for Rapid HIV Testing
RQA.01.05
Michigan Regional Laboratory System
Effective Date: November 14, 2008
<Insert name of the local health department>
Page 14 of 26
5.
6.
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 testing:
a.
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.
Tests or QC materials stored or used when temperatures are outside of
specifications stated by the manufacturer
On a monthly basis, the site coordinator will verify that test kits and
external controls are used and stored within of the manufacturer’s
temperature specifications. When it is verified that test kits and/or
controls are stored outside these temperature limits, the laboratory director
will be notified and the following actions taken:
a.
Determine the cause for out-of-range temperature(s) and ensure
corrective measures have been taken.
b.
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.
Incorrect or invalid QC test results
On 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
observed:
a.
Evaluate procedures for testing external controls and review
records of control results.
b.
Perform troubleshooting procedures in accordance with the
manufacturer’s 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.
Quality Assessment Manual for Rapid HIV Testing
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Michigan Regional Laboratory System
Effective Date: November 14, 2008
<Insert name of the local health department>
Page 15 of 26
e
7.
8.
If needed, modify the QA protocol and/or retrain staff on
appropriate testing of external controls.
Invalid patient/client test results
On 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 observed:
a.
If possible, observe specimen collection, testing, and result
interpretation to confirm test procedures are performed correctly.
b.
Confirm the test device(s) used had not expired.
c.
Review documentation of testing to ensure procedures are being
followed.
d.
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
manufacturer’s instructions.
f.
If test results using valid external control materials provide invalid
results, testing should be discontinued.
g.
If the test kit/lot 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 procedures.
m
if appropriate, notify local or state health department HIV test
manager.
Excessive false positive patient/client 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 actions:
a.
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.
Quality Assessment Manual for Rapid HIV Testing
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Michigan Regional Laboratory System
Effective Date: November 14, 2008
<Insert name of the local health department>
Page 16 of 26
d
e.
Evaluate facility testing procedures and, if appropriate, modify the
QA protocol and/or retrain staff on appropriate testing procedures.
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.
References
1.
Clinical Laboratory Improvement Amendments of 1988, 42 U.S.C. 263a PL100578 (1988).
2.
CLSI document HS1-A2. A quality system model for health care; Approved
guideline – Second edition. CLSI, Wayne, PA, 2004.
3.
CDC. Good Laboratory Practices for Waived Testing Sites. MMWR
Recommendations and Reports. 2005; RR-54:13.
4.
CLSI document GP21-A2.Training and competence assessment; Approved
guideline – Second edition. CLSI, Wayne, PA, 2004.
5.
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 http://www.osha.gov/SLTC/bloodbornepathogens/index.html
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
1996;17:53-80, and Am J Infect Control 1996;24:24-52.
9.
CDC. CDC Revised Guidelines for HIV Counseling, Testing, and Referral.
MMWR Recommendations and Reports. 2001; RR-19:50.
10.
APTIMA® HIV-1 RNA Qualitative Assay package insert. Gen-Probe®, San
Diego, CA 92121, 2006.
11.
Uni-Gold™ Recombigen® HIV package insert. Trinity biotech USA, St. Louis,
MO 63114, 2004.
12.
OraQuick® ADVANCE Rapid HIV-1/2 Antibody Test package insert. OraSure
Technologies, Inc., Bethlehem, PA 18015, 2005.
13.
HIV-1/2 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, U.S.
Department of Health and Human Services, Centers for Disease Control and
Prevention, 2007
Quality Assessment Manual for Rapid HIV Testing
RQA.01.05
Michigan Regional Laboratory System
Effective Date: November 14, 2008
<Insert name of the local health department>
Page 17 of 26
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 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
RLF.02
RLF.03
RLF.04
RLF.05
RLF.08
RLF.09
RLF.10
RLF.11
RLF.12
Organization Structure Waived Test Sites - updated 1/11/2007
Log Sheet - Lab Directors Visits
Waived Testing Personnel Report Form
Initial Training Checklist for the OraQuick Advance
Competency Checklist for the OraQuick Advance
Log Sheet - Quality Control - OraQuick Advance
Log Sheet - Client Daily - OraQuick Advance - updated 5/31/2006
OraQuick Advance Inventory Sheet
Discordant Results Report #1
Discordant Results Report #2
FORMS: CONTINUOUS QUALITY IMPROVEMENT
RLF.07
RLF.13
RLF.20
Corrective Action Form for Unacceptable Proficiency Test
Corrective Action Form for Ungraded Proficiency Test
Corrective Action Form - General Purpose
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
Quality Assessment Manual for Rapid HIV Testing
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Effective Date: November 14, 2008
<Insert name of the local health department>
Page 18 of 26
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
www.michigan.gov/mdchlab 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 (i.e., their competency) must be evaluated annually.
Laboratory Facility and Safety Precautions:
• Each clinic must have sufficient space for all necessary tests being performed.
• Staff must be familiar with all safety precautions required for proper handling of
chemicals and have annual training in chemical safety.
• Staff must be familiar with all safety precautions required for biohazardous material
and bloodborne pathogens and have annual bloodborne pathogen training.
Laboratory Instrumentation
• All instruments must be kept in good working order
• 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).
• Document all problems and repairs.
Laboratory Reagents
• No testing is permitted if reagents have exceeded their expiration date.
• Label each reagent with the date it was opened or prepared and initial.
• Some reagents will have a new expiration date after being opened (e.g. 30 days after
opening. Write both the date opened and the new expiration date on the vial and
initial.
• Write the date of receipt into the clinic on the outside of each box of reagents.
• Monitor conditions where reagents are stored (e.g., temperature).
• Discard expired reagents as soon as possible.
Laboratory Procedure Manual:
• Everyone performing testing must follow each procedure exactly as written.
Quality Assessment Manual for Rapid HIV Testing
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Effective Date: November 14, 2008
<Insert name of the local health department>
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•
•
No modifications are permitted – there are no exceptions.
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 Testing
• Proficiency testing programs are intended to determine if the test site can produce the
correct result.
• PT samples are tested in the same exact manner as client samples
• Document PT results on daily test logs AND the score sheet supplied with the
samples.
• Rotate PT among all personnel performing testing.
• PT results are due within the time frame required by the PT agency (usually 10
working days after receipt of the sample).
• Staff may not consult with others in the clinic unless this is part of the normal testing
process.
• 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.
• 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.
• Corrective action is required whenever an incorrect result is obtained on a PT sample.
• All testing personnel need to review the PT scoring and sign an acknowledgement of
review.
Quality Control
• 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
• The frequency for running controls for each test procedure is specified in the QA
plan.
• QC must be acceptable before testing and/or 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.
• The person performing testing must evaluate QC results and make a determination of
pass or fail before client samples may be tested.
• Some tests (e.g., strep A, urine pregnancy, hemoccult) have an internal procedural
control. Results of the internal control must be documented for each control and
client tested.
• QC logs must include lot number and expiration date of all reagents used in the test.
• QC logs must include the lot number, expiration date, and acceptable ranges of all
controls.
Quality Assessment Manual for Rapid HIV Testing
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Michigan Regional Laboratory System
Effective Date: November 14, 2008
<Insert name of the local health department>
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•
•
Corrective action must be taken whenever controls fail to give expected results.
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 Records
• All test results must be accurately and legibly written on daily test logs
• All test results must be accurately and legibly transcribed from daily test logs to client
charts.
• All test results written in client charts must follow the reporting criteria contained in
the procedure manual.
• 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
“White Out” or totally obscure the incorrect entry.
• 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 (e.g., QC
out-of-control, proficiency testing, etc,) laboratory staff must:
• Identify the problem
• Investigate what went wrong and try to identify the cause
• Implement a plan to correct the problem and prevent it from happening again
• Identify someone who will monitor laboratory results to ensure the problem doesn’t
happen again
• Document each step of the investigation on the appropriate form (RLF-20)
2.0
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-
Quality Assessment Manual for Rapid HIV Testing
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Michigan Regional Laboratory System
Effective Date: November 14, 2008
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Page 21 of 26
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 (low/high for quantitative
assays and positive/negative 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 – preanalytical, 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 results.
The 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
(“how much” or “how little”) 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
(“positive” or “negative”). 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 “internal QC indicators”, e.g. 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.
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Effective Date: November 14, 2008
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Standardized QC materials can be obtained from a commercial manufacturer for most
tests. Certain tests, most notably fecal occult blood (e.g., 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 requirements.
1.
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 client’s 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.
Quality Assessment Manual for Rapid HIV Testing
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Effective Date: November 14, 2008
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***********************************************************************************
This material reviewed and approved for use without modification:
Review Date/Signature: ______________________________________________________________
Review Date/Signature: ______________________________________________________________
Review Date/Signature: ______________________________________________________________
Review Date/Signature: ______________________________________________________________
Review Date/Signature: ______________________________________________________________
Review Date/Signature: ______________________________________________________________
RL.01.05 Quality Assurance Guidelines – HIV
Rev. 11/2008
Quality Assessment Manual for Rapid HIV Testing
RQA.01.05
Michigan Regional Laboratory System
Effective Date: November 14, 2008
<Insert name of the local health department>
Page 24 of 26
Quality Control Corrective Action Flow Sheet
Site Coordinator reviews all QC records prior to forwarding to lab director/tech. 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?
Yes
Was all required QC
information documented?
(i.e., expiration date, lot #,
control ranges?)
Yes
Were all results for optic check,
high/low controls, internal
controls, etc. recorded?
Yes
Were the reagents within
allowable dates AND were ALL
QC results acceptable (i.e.,
within range)? Was a correct
determination of QC
acceptability made?
No
Incorrect Form
1. Identify the testing personnel who used the out of date form.
2. Instruct the testing person in question to use the correct form.
3. Supply them with the correct form.
4. Remove older versions of the form.
5. Document your corrective actions & save the documentation.
continue
No
continue
No
Incomplete Record
1. Identify the testing personnel who failed to document all data.
2. Instruct the testing person in question to include all data.
3. Document your corrective actions & save the documentation.
4. If the expiration dates are wrong or not written down, then assume that
expired reagents were used and all client results are invalid. Corrective actio
required (see below).
Incomplete Record
1. Identify the testing person who failed to document QC results.
2. Instruct the testing person in question to include all data.
3. Document your corrective actions & save the documentation.
4. If observed results are not recorded, then assume that controls were not
tested and all client results are invalid. Corrective action required (see below
continue
QC FAILURE!
No
1. Identify testing personnel who filled out the form.
2. Retrain testing person in question on criteria for pass/fail determination fo
QC results.
3. Retrain testing person in question on proper handling and correct usage of
QC material and test reagents. Give particular emphasis on documentation o
correct expiration and review of QC results.
4. Written corrective action required.
Yes
Were any patients tested while reagents were expired, not recorded, or out of
control?
No further action required
No
1. Client status not affected.
2. State that no clients were tested in the
corrective action report.
3. Send to lab director for review and
signature
Yes
1. Any patient testing done must be considered invalid.
2. Pull all client charts for those tested with expired of out-of-control QC. Co
form RLF-73.
3. Recall and retest clients
4. Alternatively, medical director should compare test results to clinical statu
Retest any clients whose test results are inconsistent with clinical status.
5. Document the process and send to lab director for review and signature.
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 Assessment Manual for Rapid HIV Testing
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Effective Date: November 14, 2008
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Page 25 of 26
Quality Control Troubleshooting Flow Sheet
Page 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?
Yes
The instrument is functioning as
expected.
1. Document results of optic check,
calibration check, etc. on test records.
2. Proceed to testing controls
No
The instrument is NOT functioning as
expected.
1. Document results of optic check,
calibration check, etc on test records.
2. Do not test controls yet.
3. Check expiration date of optic check or
calibration strip.
Not expired
Expired
Yes
Clean instrument &
repeat testing.
Did the instrument function
check yield expected results
on retest?
Bad News!
1. Order new supplies
at once.
2. Do not use this
instrument until new
shipment is received.
3. Start at the
beginning when new
supplies received
No
Proceed to
TESTING CONTROL
REAGENTS
(continued on next page)
Bad News!
1. Document results of optic check, calibration check, etc. on test records
2. Document what was done to try to correct the problem.
3. Call technical support
4. DO NOT USE THIS INSTRUMENT UNTIL THE PROBLEM IS
CORRECTED.
5. Complete a corrective action report and contact your technical consultant or
laboratory director
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Effective Date: November 14, 2008
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Quality Control Troubleshooting Flow Sheet
Page 2
1. Start on Page 2 once the Instrument Function check is successful
2. Start on Page 2 if no instrument function checks are required.
1. Document results of controls on the QC log
2. Compare actual results to expected values
3. Make a determination of PASS/FAIL on the QC log
4. Do the results for BOTH controls fall within the
expected range?
Testing Control Reagents
1. Test high (abnormal) controls
2. Test low (normal) controls
How many controls were out of range?
YES
NO
Two
One
1. Re-test the control using the SAME vial
of control and the SAME lot number of test
kit (e.g, 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 (e.g, same cuvettes, cassettes, etc.
2. Document results
Does the repeat test fall within the
expected range?
Does the repeat test fall within the expected
range?
Yes
Problem may be
pipetting error.
Review your
technique. Record
corrective action in
QC log.
QC is ACCEPTABLE.
OK to start testing
No
No
Yes
Retest using a NEW LOT
NUMBER of CONTROL
REAGENT.
Retest using a NEW LOT
NUMBER of TEST Kit or
REAGENT
Does the repeat test fall
within the expected
range?
Does the repeat test fall
within the expected range?
Yes
No
No
EQUIPMENT FAILURE!
1. Contact technical support for repairs.
2. DO NOT USE this instrument for clinical
testing.
3. Document corrective action in QC log
4. Notify lab director immediately.
Yes
Initial test kits
or reagents may
be bad. Discard
them. Retest.
Initial controls are
bad. Discard them.