IQCP Layout

IQCP INDIVIDUALIZED
QUALITY CONTROL
PLAN
Developing an IQCP
A Step-by-Step Guide
U.S. Department of Health and Human Services

INSTRUCTIONS – IQCP WORKBOOK FILLABLE FORMS
This step-by-step instructional guide walks readers through the process
of developing an IQCP that can be sustained and modified, as needed. It
demonstrates how laboratories can perform a risk assessment to evaluate
and record their current quality activities using the IQCP Risk Assessment
worksheet, create a Quality Control Plan from the risk assessment
IQCP INDIVIDUALIZED
QUALITY CONTROL
PLAN
information, and establish a Quality Assessment for the test system being
evaluated for an IQCP.
Developing an iQCp
a Step-by-Step guiDe
INSTRUCTIONS FOR FILLING OUT THE DOCUMENT
You may, but you are not required to, use these worksheets to complete the
steps of performing an IQCP. As you work through this workbook, you may U.S. Department of Health and Human Services
enter the information for each IQCP directly onto the worksheets that follow
for the Risk Assessment, Quality Control Plan and Quality Assessment; the
cells will not expand to accommodate your information. The number of boxes for each form is fixed and
will not change, and the amount you can type into each box is limited. Once complete, you may save the
document or print a hard copy, as needed.
To save the document

Follow the instructions provided for your computer’s operating system to SAVE the file in the location of
your choice.
To print the document

Follow the instructions provided for your computer’s operating system to PRINT the complete file or select
the specific page number(s) to print.
IQCP Workbook:
For additional IQCP resources and the “Developing an IQCP; A Step-By-Step Guide”, you may access and
download free of charge by visiting the CDC’s website at:
http://wwwn.cdc.gov/clia/Resources/IQCP/
Or visit the CMS website at:

https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Individualized_Quality_Control_Plan_
IQCP.html
INTRODUCTION
OVERVIEW
The Clinical Laboratory Improvement Amendments
of 1988 (CLIA) regulations require a laboratory to
have quality control (QC) procedures to monitor
the accuracy and precision of the complete testing
process. A QC option is now available that provides
you the opportunity to tailor an individualized
quality control plan (IQCP) for your unique testing
environment and your patients. The IQCP option offers
your laboratory flexibility for meeting regulatory QC
requirements appropriate for the testing you perform
and when you add a new test.
IQCP is an all-inclusive approach to assuring quality. It

includes many practices that your laboratory already
uses to ensure quality testing beyond requiring
that a certain number of QC materials be tested at
a designated frequency. IQCP can be applied to all
nonwaived testing performed, including existing
and new test systems. All CLIA specialties and
subspecialites except Pathology are eligible for IQCP.
Adoption of an IQCP will not necessarily reduce your QC testing practices. It will allow you to develop
customized QC for your laboratory specific to specimens you test, your test system, reagents, environment,
and testing personnel.
Prior to going through this workbook, you may find it beneficial to review CLIA brochures #11, 12, and 13
developed by The Centers for Medicare & Medicaid Services (CMS) for a general overview of IQCP.
http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/CLIA_Brochures.html
PURPOSE
This workbook is designed to assist in developing an IQCP for one or more test systems. Using an example
scenario, the workbook will guide you through a step-by-step process to develop an IQCP that can be
sustained and modified, as needed, over time. You will evaluate your current quality activities and develop
an IQCP worksheet which, when completed, can serve as your IQCP document. The approach outlined in this
workbook is not mandatory or the only format for documentation, but is one example that can be used. You
are free to develop your own format that meets the needs of your laboratory.
At the completion of this workbook you will have performed a Risk Assessment,
created a Quality Control Plan, and conducted a Quality Assessment for the test system
being evaluated for an IQCP.
1
TABLE OF CONTENTS
Introduction............................................................................................................................................................................... 1
Overview................................................................................................................................................................................ 1
Purpose................................................................................................................................................................................... 1
Why do an IQCP?...................................................................................................................................................................... 4
What are the three steps of the IQCP?.............................................................................................................................. 5
What are we already doing?................................................................................................................................................. 6
Step 1: Risk Assessment 7

How do I get started?......................................................................................................................................................... 8
What is happening in my laboratory?.......................................................................................................................... 9

Assessing Specimen Risks..............................................................................................................................................11
Assessing Test System Risks...........................................................................................................................................15
Assessing Reagent Risks.................................................................................................................................................19
Assessing Environment Risks........................................................................................................................................23
Assessing Testing Personnel Risks...............................................................................................................................27
Step 2: Quality Control Plan 35

What is a Quality Control Plan (QCP)?........................................................................................................................35
What is included in a QCP?............................................................................................................................................35
Developing your QCP......................................................................................................................................................36
Happy Day Physicians Group QCP Example............................................................................................................37
Optional QCP Worksheet................................................................................................................................................40
Tips to remember..............................................................................................................................................................41
Step 3: Quality Assessment 42

What is Quality Assessment (QA)?...............................................................................................................................42
Documents to Consider for QA....................................................................................................................................44
Does your QA do the following?..................................................................................................................................45
Happy Day Physicians Group QA Example...............................................................................................................45
Optional QA Worksheet..................................................................................................................................................48
continued on next page...
2
TABLE OF CONTENTS (CONTINUED...)
Let’s review..........................................................................................................................................................................49
APPENDIX 52
APPENDIX A - Risk Assessment Worksheet..............................................................................................................52
APPENDIX B - QCP Worksheet.......................................................................................................................................57
APPENDIX C - QA Worksheet.........................................................................................................................................58
APPENDIX D - Additional Risk Assessment Questions.........................................................................................59
APPENDIX E - QA Activities............................................................................................................................................61
APPENDIX F - Glossary / Definitions...........................................................................................................................62
DISCLAIMER:
This workbook is not a legal document. The official CLIA program provisions are
contained in the relevant law, regulations, and rulings. For more information, you may
access the regulations on the internet at http://www.cdc.gov/clia/.
3
WHY DO AN IQCP?
An IQCP offers flexibility in achieving QC compliance and allows you to:
99Customize a QC Plan for each nonwaived test in its unique environment

99Optimize the use of electronic/integrated controls
99Adapt testing practices for advances in technology
99Incorporate other sources of quality information into the QC Plan
99Strengthen partnerships with manufacturers
99Formalize the risk management data already maintained within the laboratory
99Provide equivalent quality testing to meet the CLIA QC regulations
The IQCP approach is voluntary. If you do not choose to adopt an IQCP, your laboratory must test two
levels of external controls on each test system for each day of testing and follow all specialty/subspecialty
requirements in the CLIA regulations for nonwaived tests.
4
WHAT ARE THE 3 STEPS OF THE IQCP?
The IQCP process includes: Risk Assessment, Quality
Control Plan (QCP), and Quality Assessment (QA). An
IQCP must address the potential failures and errors
identified in the entire testing process: preanalytic,
analytic and postanalytic phases of testing.
1. RISK ASSESSMENT
A Risk Assessment identifies and evaluates
potential failures and sources of errors in your
testing process. It must include, at a minimum, an
evaluation of the following five components:
• Specimen
• Test system
• Reagent
• Environment
• Testing personnel
2. QUALITY CONTROL PLAN (QCP)

A Quality Control Plan is a written document describing the practices and procedures performed by
your laboratory to reduce the chance of possible failures and errors in your test processes. The QCP must
ensure that the accuracy and reliability of test results, for a specific process, are appropriate for patient
care. Practices, procedures, and resources that you incorporate in your QCP may include, but are not
limited to:
• Electronic controls
• Internal controls
• Proficiency testing (PT)
• Calibration
• Maintenance
• Training and competency assessment
3. QUALITY ASSESSMENT (QA)

Quality Assessment is the continuous process of monitoring the effectiveness of the QCP. Practices,
processes, and resources to consider for monitoring effectiveness of a QCP may include, but are not
limited to:
• QC reviews
• PT performance reviews
• Chart reviews
• Specimen rejection logs
• Turnaround time reports
• Complaint reports
5
WHAT ARE WE ALREADY DOING?
Gather and review information already available to your
laboratory about the testing process, such as manufacturer’s
information, data you obtained through verification or
establishment of performance specifications, historical QC and
PT data, as applicable.
The steps listed below will help you determine if your current
quality procedures are adequate or if additional or different
activities are needed to reduce potential failures and errors.
1. Review the preanalytic, analytic, and postanalytic phases of the testing process.
2. Break down each phase into steps, so that potential failures and errors can be identified.
3. Analyze the information gathered to see if control activities can be put into place to reduce the
identified potential failures and errors.
6
Step 1: Risk Assessment
A risk assessment is the process of identifying and
evaluating the potential failures and errors that could
occur during the preanalytical (before testing), analytical
(testing), and postanalytical (after testing) phases of
testing.
At a minimum, evaluate the following five components of

the testing process for potential failures and errors:
• specimen
• test system
• reagent
• environment
• testing personnel
Some risks could fit under more than one of the five
risk assessment components. When conducting the risk
assessment, identify the risks under the component that is
most appropriate for your laboratory.
For example, an inadequate specimen volume (i.e. 0.5 ml of whole blood might be collected instead
of 1.0 ml as specified by the manufacturer’s instructions) could fall under more than one risk assessment
component:
1. Specimen- manufacturer’s instructions specify a minimum of 1.0 ml whole blood for the test
system, or
2. Test System- wrong specimen volume would result in the reporting of wrong result or test system
procedural error, or
3. Reagent- incorrect specimen volume would result in the test kit reagents performing improperly
and producing incorrect test results.
Pre- Post-
Analytical
Analytical Analytical
Specimen * Test System * Reagents * Environment * Testing Personnel
7
STEP 1: RISK ASSESSMENT
HOW DO I GET STARTED?
To begin your risk assessment, review and assess all manufacturers’ information and other applicable
resources including, but not limited to:
99Laboratory procedures/standard operating procedures (SOPs)

99Manufacturer’s instructions/package inserts
99Instrument and troubleshooting manuals
99Manufacturer’s alerts and bulletins
99Calibration data
99Data obtained through verification or establishment of
performance specifications
99FDA alerts
99Historical QC data, including data from a previously conducted
equivalent quality control study
99Instrument correlation data
99PT results and data
99Records of complaints and corrected reports
99Regulatory and accreditation requirements
99Scientific publications
99Test process flow charts or maps
99Testing personnel training and competency records
• Pay special attention to the following package insert sections: intended use, patient preparation,
limitations, environmental requirements, QC frequency, specimen requirements, reagent storage,
maintenance, calibration, interfering substances.
• If you have questions concerning the manufacturer’s instructions or need additional information, contact
the manufacturer directly.
• In laboratories with multiple, identical test systems (same make and manufacturer), a single risk
assessment may be performed. However, differences in testing personnel and environments where the
test systems are used must be taken into consideration. Due to these differences, you should determine
if you need to perform a risk assessment for each individual location and/or device.
8
WHAT IS HAPPENING IN MY LABORATORY?
The following is an example scenario for you to refer to throughout this workbook. The example is based on
a fictitious laboratory and test system. It contains information about the laboratory, test system, and other
pertinent information the laboratory has or can acquire in order to develop and implement an IQCP.
Scenario
Dr. Martin is the laboratory director for the Happy Day Physicians Group. She is considering
implementing an IQCP for her laboratory. To determine if IQCP is a good option for Happy Day
Physicians Group’s laboratory to meet CLIA QC requirements, Dr. Martin has asked her laboratory
supervisor, Kim, to take the lead in performing a risk assessment.
Kim decided to evaluate the test for magnesium performed on the Acme Chemotrific System-
Magnesium because the manufacturer’s instructions recommended performing external QC less
frequently than required by CLIA. She gathered supporting data to review what her laboratory is
currently doing to reduce potential sources of error.
Supporting Data
99 Test system is FDA cleared and moderate complexity under CLIA
99 Laboratory follows the CLIA regulatory requirements for QC - two control materials of different
concentration each day of patient testing
99 Acme Chemotrific System-Magnesium package insert includes:

• Specimen collection time and collection tube requirements
• Limitations of the test
• Criteria for acceptable results
• Use of an internal control process that performs internal QC on every reagent disc
• Recommendations for performing external controls at least every 30 days; when there is a
significant change in laboratory conditions; training or retraining of personnel is indicated; or
when test results do not match patient symptoms or clinical findings
99 Two years of successful PT performance reports
99 Test performance specification verification studies demonstrating the test system’s accuracy and
stability
99 Specimen - Review of specimen receipt logs for the past two years demonstrates gaps in
documentation when requesting re-collection of specimens.
9
99 Instrument maintenance (Test System)-

• Review of instrument maintenance logs show no problems with test system’s instrument
mechanics for the past two years
• Review of patient test results and two levels of external QC results for the past two years
demonstrates no problems with the test system. QC outliers were resolved with corrrective
actions.
• Review of troubleshooting logs demonstrate no indication of problems with the test system or
patient results reporting for the past two years
99 Reagent- Review of lot-to-lot reagent logs demonstrates no problems or indications of problems

for past six months
99 Environment:
• Room temperature logs- Review of temperature logs demonstrates no problems with
temperature for past year
• Refrigerator and freezer temperature log- Review demonstrates minimal outlier temperature
points with investigation and appropriate corrective action for the past year
99 Testing personnel training and competency – Review of personnel training records for the past
two years demonstrates no personnel turnover.
*NOTE REGARDING SUPPORTING DATA: Support your risk assessment with available data that include, but
are not limited to, test performance specifications, manufacturer’s package inserts, PT performance data, QC
logs/data, specimen receipt and rejection logs, to determine a QC plan that will reduce potential sources of
error.
Now let’s review your supporting data
Gather the supporting data for your laboratory and record your findings below.
10
ASSESSING THE SPECIMEN RISKS
“Let’s talk about the specimen…” Review the manufacturer’s

instructions, technical bulletins, your policies and procedures, patient
instructions, and any other documents associated with the specimen. As
you review these documents, stop and think about when and where in the
testing process a potential error associated with the specimen may occur.
Specimen Scenario
Let’s take a closer look at how Happy Day Physicians Group identified sources of error for the
risk assessment component, specimen.
Kim reviewed the specimen receipt logs for the past two years and noted
that, according to the laboratory’s policy, not all personnel had properly
documented requests for re-collection of specimens. Additionally, Kim
noted some specimens remained unprocessed for more than 60 minutes
without being properly stored.
A review of the refrigerator and freezer logs for the past year showed a
few recorded temperatures outside of the acceptable range; however,
they had been investigated and appropriate corrective actions were
taken.
Kim identified the possible sources of error and recorded her findings in the Risk Assessment
Worksheet.
Instructions needed to follow the Happy Day Physicians Group Risk Assessment Worksheets:
For each risk assessment component, Kim has gathered and reviewed the data sources and used the
information to consider “What could go wrong?” during the entire testing process to complete the Happy
Day Physicians Group Risk Assessment Worksheets:
In column 2, Kim recorded the identified possible sources of error, and considered how these errors could
be reduced.
In column 3, Kim indicated “yes” or “no” if there were actions the laboratory could take to reduce the sources
of error.
In column 4, Kim recorded the actions the laboratory staff could implement to reduce the identified errors.
Note: To complete the risk assessment worksheet, consider your testing process in its entirety; from the
time the order is placed, through collection, processing, analysis, and reporting (preanalytic, analytic and
postanalytic processes). One of many possible examples to document your risk assessment follows. The
information provided in this example should not be considered all-inclusive of potential risks, QC and QA
procedures, and CLIA requirements that may apply for your laboratory.
11
Happy Day Physicians Group Risk Assessment Worksheet
1 2 3 4
What are our possible sources of

Can our identified
error? How can we reduce the identified
sources of error be
sources of error?
reduced?
What can go wrong?
Risk Assessment
Components
Indicate how to reduce possible
Gather information, from the Yes/No error sources.
manufacturer’s instructions and Not Applicable • Internal controls
other resources, on how we should (N/A) • Actions taken by laboratory
be performing the testing process. • Safeguards in the test system or
laboratory practices
Documentation of specimen Retrain testing personnel on

re-collection. re-collection policy.
Manufacturer’s instructions: Train testing personnel to verify

• Use lithium heparin tubes use of proper specimen collection
Yes
for whole blood or plasma tubes.
specimens
• Use no additive or serum
separator tubes for serum
specimens
SPECIMEN
Testing time frame/stability of
specimen.
Train testing personnel to verify and
Manufacturer’s instructions: document:
• Whole blood - run within 60 • Collection time and time of
Yes receipt in laboratory
minutes of collection
• Store serum or plasma in • Proper storage and
capped tubes at 2°C to 8°C for processing of specimen
48 hours or at -10°C for up to 5
weeks
12
General Specimen Questions to Consider in Your Laboratory
Think about your laboratory and your entire testing process as it

relates to the specimen.
Do you see a potential risk of an error in test results if: Answer
The manufacturer’s instructions for specimen requirements including, but not limited to,
Yes No
specimen tube or container type, patient preparation, or specimen storage are not followed?
The current version of the manufacturer’s instructions is not used? Yes No
The specimen is improperly labeled? Yes No
The specimen isn’t accurately identified throughout the testing process? Yes No
Criteria for specimen rejection are not established and followed? Yes No
Note: For the purposes of this example, not all questions to consider have been
identified or included above. Additional example questions can be found in
Appendix D.
In the spaces below, record questions to consider for your laboratory that relate to
incorrect test results associated with the specimen risk assessment component.
Record Your Specimen Risk Assessment Questions/Findings
13
Steps to complete your laboratory’s risk assessment worksheets:
After reviewing the example worksheet for each component, take your identified sources of error from the
“Risk Assessment Questions/ Findings” for each component section, and follow the process taken by Kim
to complete your laboratory’s risk assessment worksheet.
Risk Assessment Worksheet

Laboratory Name____________________________ Test System Name
1 2 3 4
What are our possible sources of error?
Can our identified
How can we reduce the identified
sources of error be
What can go wrong? sources of error?
reduced?
Risk Assessment Indicate how to reduce possible error

Components Gather information, from the sources.
Yes/No
manufacturer’s instructions and other • Internal controls
Not Applicable (N/A)
resources, on how we should be • Actions taken by laboratory
performing the testing process. • Safeguards in the test system or
SPECIMEN
14
ASSESSING THE TEST SYSTEM RISKS
“Let’s talk about the test system…” Review the manufacturer’s

instructions, technical bulletins, your policies and procedures,
and any other documents associated with the test system. As you
review these documents, stop and think about when and where
in the testing process a potential error associated with the test
system may occur.
Test System Scenario:
risk assessment component, test system.
Kim reviewed external QC log sheets for the last two

years. Although she identified a couple of outliers,
corrective actions were performed and QC results
following the corrective actions were acceptable. Her
review suggests that the test system is stable. She also
noted the test system performs an internal control with
each reagent disc; however, an unacceptable internal
control does not prevent a patient result from being
reported. The manufacturer has built in safeguards
to help reduce the likelihood of test system errors,
including the detection of sampling errors.
Kim completed the Risk Assessment Worksheet for the test system using the instructions given on
page 12.
15
1 2 3 4
What are our possible sources of error? Can our identified

How can we reduce the identified sources
sources of error be
of error?
What can go wrong? reduced?
Risk
Assessment
Components
Indicate how to reduce possible error
Gather information, from the Yes/No sources.
manufacturer’s instructions and other Not Applicable • Internal controls
resources, on how we should be (N/A) • Actions taken by laboratory
Assure testing personnel review each QC

QC Results:
result upon completion of the test run.
Manufacturer’s instructions - test system Yes
Document QC results in QC log. Report
does not prevent patient results from
patient results only when QC is acceptable.
being reported when QC is unacceptable.
TEST SYSTEM
The test system will not perform the test if

Specimen volume. N/A the specimen volume does not meet the
minimum volume requirement.
16
General Test System Questions to Consider in Your Laboratory
Think about your laboratory and your entire testing process as it relates
to the test system.
Do you see a potential risk of producing incorrect test results if: Answer
Maintenance procedures are not consistent with the manufacturer’s instructions? Yes No
The test is performed outside of its intended use as described in the manufacturer’s
Yes No
instructions?
The limitations to the test system are ignored. For example, do lipemia or medications interfere
Yes No
with the test systems performance?
Built-in monitors do not exist for the test system, e.g. the ability to detect inadequate specimen
Yes No
volume?
The laboratory information system (LIS) isn’t transmitting results or other information
Yes No
accurately?
The test system doesn’t have a means to ensure positive patient identification, such as a
Yes No
functioning bar code reader?
There is no mechanism, such as an operator lockout, to ensure only trained personnel use the
Yes No
test system?
Appendix D.
incorrect test results associated with the test system risk assessment component.
Record Your Test System Risk Assessment Questions/Findings
17
Instructions needed to complete this worksheet can be found on page 15.

1 2 3 4

Can our identified
sources of error be
What can go wrong? of error?
reduced?
Risk
Assessment
Components
TEST SYSTEM
18
ASSESSING REAGENT RISKS
“Let’s talk about the reagent…” Review the manufacturer’s

instructions, technical bulletins, your policies and procedures,
and any other documents associated with the reagent. As you
review these documents, stop and think about when and where
in the testing process a potential error associated with the
reagent may occur.
Reagent Scenario
risk assessment component, reagent.
Kim reviewed the lot-to-lot reagent logs for the past six months
and found no indications of problems. She noticed that some
testing personnel took out multiple packs of reagent discs and
left them on the work bench for several days at a time. Kim
has received several complaints from testing personnel about
the warmer laboratory conditions during the early afternoon
hours, which could affect the stability of the reagent discs.
She reviewed the room temperature logs and found no issues
with the daily room temperatures recorded in the past year, as
part of the daily morning maintenance. Kim recorded this as a
possible source of error in the risk assessment worksheet.
Kim completed the Risk Assessment Worksheet for the reagent using the instructions given on page
12.
19
1 2 3 4
Can our
identified How can we reduce the identified sources
sources of error of error?
What can go wrong?
be reduced?
Components Gather information, from the Yes/No sources.
Monitor storage conditions of discs daily
for refrigerated storage (2°-8°C).
Reagent storage - prevent reagent
Monitor room temperature (20° - 25°C)
degradation during storage and use.
each day of testing.
Yes
Manufacturer’s instructions - do not allow
Document date and time on reagent discs
discs to remain at room temperature
when removed from refrigerator.
longer than 48 hours prior to use.
Do not use reagent discs that are at room
temperature beyond 48 hours.
Reagent expiration date - the test system’s

QC does not detect the use of expired
Train testing personnel to check reagent
reagents prior to testing.
Yes expiration dates prior to using them for
testing.
Manufacturer’s instructions - do not use
discs after expiration date.
REAGENT
Testing the external normal and abnormal

controls.
Manufacturer’s instructions:
• Test and document external normal
and abnormal controls:
ºº Every 30 days
Train testing personnel to perform
ºº At change of reagent disc lot
Yes external QC procedures, as described in
number
the manufacturer’s instructions.
ºº Whenever laboratory conditions
have changed significantly
ºº When training or retraining of
personnel is indicated
ºº Whenever test results do not
match patient symptoms or clinical
findings
20
General Reagent Questions to Consider in Your Laboratory
Think about your laboratory and your entire testing process as it

relates to the reagents.
Storage requirements for reagents are not followed? Yes No
Integrity of reagents are not checked when received? (e.g. some manufacturers ship reagents
Yes No
on dry ice or icepacks to maintain required temperatures.)
There is a delay in storing reagents upon receipt? Yes No
Reagents are shipped to the laboratory at a time when staff are not available to ensure proper
Yes No
storage (e.g. a weekend or holiday)?
Reagents with different lot numbers are mixed? (Consider if the test system has a mechanism to
Yes No
identify reagent lot numbers or if the laboratory will need to track them manually.)
Manufacturer’s instructions for reagent preparation are not followed?
Yes No
(e.g. reconstitution of reagents or bringing to room temperature)
The specified type of water required by the test system is not used? Yes No
Appendix D.
incorrect test results associated with the reagent risk assessment component.
Record Your Reagent Risk Assessment Questions/Findings
21
1 2 3 4
What are our possible sources of error? Can our
identified How can we reduce the identified sources
What can go wrong? sources of error of error?
be reduced?
REAGENT
22
ASSESSING ENVIRONMENT RISKS
“Let’s talk about the environment…” Review the

manufacturer’s instructions, technical bulletins, your policies
and procedures, and any other documents associated with the
environment. As you review these documents, stop and think
about when and where in the testing process a potential error
associated with the environment may occur.
Environment Scenario
risk assessment component, environment.
Kim has received several complaints from testing

personnel about the warmer laboratory conditions
during the early afternoon hours. She reviewed the room
temperature logs and found that room temperatures
recorded each morning for the past year were within the
acceptable range.
Kim had also noticed that the Acme Chemotrific

System-Magnesium was located directly under the air
conditioning vent. She was concerned that the location of
the test system could lead to fluctuations in temperature
that could affect test results.
Kim recorded her findings in the Risk Assessment

Worksheet using the instructions given on page 12.
23
1 2 3 4
Can our
What are our possible sources of error? identified
sources of
sources of error?
What can go wrong? error be
reduced?
Risk Assessment
Components
Room temperature:
Record room temperature daily in the
Manufacturer’s instructions - operate Yes morning and afternoon, and adjust as
test system at temperatures between needed to maintain 20o - 25oC.
20°C and 25°C.
ENVIRONMENT
Proper ventilation of instrument:

Move test system to a location away
Manufacturer’s instructions - do not Yes from air conditioning vents to meet
locate test system in front of room air manufacturer’s requirements.
in-take and out-take flow vents.
24
General Environment Questions to Consider in Your Laboratory
Think about your laboratory and the testing process as it relates to the
environment.
The manufacturer’s instructions for space and the testing environment are not followed? Yes No
The manufacturer’s ventilation and airflow requirements are not adhered to? Yes No
There is insufficient lighting and space for workflow and the test system? Yes No
The manufacturer’s instructions for maintaining the appropriate temperature and humidity for
Yes No
the test system are not followed?
Workspace is not free of clutter, dust, or debris? Yes No
Appendix D.
In the spaces below, record questions to consider for your laboratory that relate
to incorrect test results associated with the environment risk assessment
component.
Record Your Environment Risk Assessment Questions/Findings
25

1 2 3 4
Can our
identified
sources of
What can go wrong? sources of error?
error be
reduced?
Risk Assessment
Components Indicate how to reduce possible error
ENVIRONMENT
26
ASSESSING TESTING PERSONNEL RISKS
“Let’s talk about testing personnel…” Review the

manufacturer’s instructions, technical bulletins, your policies and
procedures, and any other documents associated with testing
personnel. As you review these documents, stop and think about
when and where in the testing process a potential error associated
with testing personnel may occur.
Testing Personnel Scenario

risk assessment component, testing personnel.
Kim reviewed the personnel training records for the past

two years. There were no personnel changes during that
time. Kim recognized that some testing personnel had not
been properly trained on the test system, but had signed
off on and reported results. A review of the laboratory
competency assessment revealed that the assessment did
not include all elements required by CLIA.
Kim also noted that the laboratory policy did not prohibit
verbal reporting of test results before entry into the
laboratory information system (LIS). Concerned that this
practice could potentially be an additional source of error
related to testing personnel, she recorded her findings in the Risk Assessment Worksheet.
Kim completed the Risk Assessment Worksheet for the test personnel using the instructions given on
page 12.
27
1 2 3 4
What are our possible sources of error? Can our identified

sources of error be
of error?
What can go wrong? reduced?
Risk
Assessment
Components Indicate how to reduce possible error
Train testing personnel on specimen

requirements, and proper performance
Improperly trained personnel. Yes
of test according to manufacturer
instructions.
Evaluate competency assessment policy

and procedures, rewrite to include all CLIA
required elements.
Perform and document competency

Competency assessment does not include
TESTING Yes assessment for all testing personnel.
all CLIA required elements.
PERSONNEL
Competency assessments required for
new employees at least every six months,
and annually thereafter, or when test
methodology and test system changes.
Update policy to require testing personnel

Verbal reporting of test results prior to LIS
Yes do not verbally release results until they
entry.
are entered into the LIS.
28
General Testing Personnel Questions to Consider in Your Laboratory
Think about your laboratory and the testing process as it relates to

testing personnel.
Do you see a potential risk of an error in test results if: Answer
Laboratory personnel do not have a formal certification or license if required by the state? Yes No
The laboratory does not have adequate personnel to perform patient testing in a safe and
Yes No
timely manner?
There is no documentation of CLIA-required competency assessment for all laboratory person-
Yes No
nel?
Laboratory personnel are not trained on specimen requirements (collection and type) required
Yes No
for the test system?
Laboratory personnel are not trained to follow the manufacturer’s instructions in their entirety? Yes No
Laboratory personnel make transcription errors when reporting results, either written or when
Yes No
using an LIS?
Appendix D.
In the spaces below, record questions to consider for your laboratory that relate
to incorrect test results associated with the testing personnel risk assessment
component.
Record Your Testing Personnel Risk Assessment Questions/Findings
29

1 2 3 4
What are our possible sources of error? Can our

identified sources How can we reduce the identified
What can go wrong? of error be sources of error?
reduced?
Risk
Assessment Indicate how to reduce possible error
TESTING
PERSONNEL
30
Completed EXAMPLE
The example below shows the complete Risk Assessment containing the merged information from all five
components for Happy Day Physicians Group’s Acme Chemotrific System-Magnesium test system.
Happy Day Physicians Group Risk Assessment Worksheet Acme Chemotrific System-Magnesium
(Showing all 5 components)
1 2 3 4
Can our
identified sources How can we reduce the identified
of error be sources of error?
What can go wrong?
reduced?
Risk
Assessment Indicate how to reduce possible error
Documentation of specimen Retrain testing personnel on
re-collection. re-collection policy.
Manufacturer’s instructions: Train testing personnel to verify use of

• Use lithium heparin tubes for Yes proper specimen collection tubes.
whole blood or plasma specimens
• Use no additive or serum
separator tubes for serum
specimens
SPECIMEN
Testing time frame/stability of
specimen. Train testing personnel to verify and
document:
Manufacturer’s instructions: • Collection time and time of receipt
• Whole blood - run within 60 Yes in laboratory
minutes of collection
• Proper storage and processing
• Store serum or plasma in capped
tubes at 2°C to 8°C for 48 hours or of specimen
at -10°C for up to 5 weeks
31
1 2 3 4
Assure testing personnel review each QC
QC Results: result upon completion of the test run.
Manufacturer’s instructions - test system Yes Document QC results in QC log.

does not prevent patient results from Report patient results only when QC is
being reported when QC is unacceptable. acceptable.
TEST SYSTEM
The test system will not perform the test if

Specimen volume. N/A the specimen volume does not meet the
minimum volume requirement.
Monitor storage conditions of discs daily

for refrigerated storage (2°-8°C).
Reagent storage - prevent reagent
Monitor room temperature (20° - 25°C)
degradation during storage and use.
each day of testing.
Yes
Manufacturer’s instructions - do not allow
discs to remain at room temperature
when removed from refrigerator.
longer than 48 hours prior to use.
Do not use reagent discs that are at room
temperature beyond 48 hours.
Reagent expiration date - the test system’s

QC does not detect the use of expired
Train testing personnel to check reagent
reagents prior to testing.
Yes expiration dates prior to using them for
testing.
Manufacturer’s instructions - do not use
REAGENT discs after expiration date.
Testing the external normal and abnormal

controls.
Manufacturer’s instructions:
• Test and document external normal
and abnormal controls:
ºº Every 30 days
Train testing personnel to perform
ºº At change of reagent disc lot
Yes external QC procedures, as described in
number
the manufacturer’s instructions.
ºº Whenever laboratory conditions
have changed significantly
ºº When training or retraining of
ºº Whenever test results do not
match patient symptoms or clinical
findings
32
1 2 3 4
Room temperature:
Record room temperature daily in the
Manufacturer’s instructions - operate Yes morning and afternoon, and adjust as
test system at temperatures between needed to maintain 20o - 25oC.
20°C and 25°C.
ENVIRONMENT
Proper ventilation of instrument:
Move test system to a location away
Manufacturer’s instructions - do not Yes from air conditioning vents to meet
locate test system in front of room air manufacturer’s requirements.
in-take and out-take flow vents.
Train testing personnel on specimen

requirements, and proper performance
Improperly trained personnel. Yes
of test according to manufacturer
instructions.
Evaluate competency assessment policy

and procedures, rewrite to include all CLIA
required elements.
Perform and document competency

Competency assessment does not include
Yes assessment for all testing personnel.
all CLIA required elements.
TESTING
PERSONNEL Competency assessments required for
new employees at least every six months,
and annually thereafter, or when test
methodology and test system changes.
Update policy to require testing personnel

Verbal reporting of test results prior to LIS
Yes do not verbally release results until they
entry.
are entered into the LIS.
33
LET’S REVIEW…
So far, the workbook has guided you through Specimen

the steps of performing a risk assessment. Test
System
Before you move to the next step, you
should:
Reagent
99 Review your Risk Assessment and make
sure it includes all three phases of the Environment
testing process (preanalytic, analytic and
Testing
postanalytic). l
Personne
99 Ensure that your Risk Assessment
includes the five components (specimen,
test system, reagent, environment and,
testing personnel).
99 Determine if your current practices are sufficient to detect the sources of error
or failure in your test system.
99 Determine whether your identified risks need to be monitored or controlled

regularly in the testing process.
34
Step 2: Quality Control Plan
WHAT IS A QUALITY CONTROL PLAN?
A Quality Control Plan (QCP) describes practices,

procedures and resources needed by your laboratory to
ensure the quality of a testing process. The QCP includes
measures to assure the accuracy and reliability of test
results, and that the quality of testing is adequate for
patient care.
The QCP must provide for immediate detection of

errors that occur due to test system failure, adverse
environmental conditions, and operator performance. It
must also monitor, over time, the accuracy and precision
of test performance that may be influenced by changes
in the specimen, test system, reagent, environment, or
variance in operator performance.
Create a plan that includes activities to reduce the

likelihood of failures and errors identified from your risk
assessment. Consider the amount of QC necessary based
on the frequency and volume of patient testing.
NOTE: Laboratories cannot establish QC procedures that are less stringent than those specified by the
manufacturer of the test system.
WHAT IS INCLUDED IN A QCP?
At a minimum, your QCP must include the number, type, and frequency of testing control materials, as well
as criteria for acceptable quality control.
If indicated by the risk assessment, your QCP

may also incorporate the use of:
• Electronic controls
• Equipment maintenance
• Personnel training and competency
assessment
• Equipment calibration
• Other specified quality control activities
35
STEP 2: QUALITY CONTROL PLAN
DEVELOPING YOUR QCP
The development and implementation of QCPs may be delegated (in writing) to a qualified individual.
However, the laboratory director has the ultimate responsibility for the proper development and
implementation of a QCP. There must be documented evidence that the laboratory director has approved,
signed and dated the QCP. The laboratory director must consider the laboratory’s clinical and legal
responsibility for providing accurate and reliable patient results prior to implementing a QCP.
Quality Control Plan Scenario:

Kim, the laboratory supervisor for the Happy Day Physicians Group,
reviewed the findings from the risk assessment and is ready to develop
her new QCP.
Kim found several opportunities to improve the QCP, in order to reduce

the risk of failures and errors. Kim identified instances where testing
personnel had not verified sample acceptability or followed proper
storage recommendations, and she noted fluctuations in room temperature that had not been
addressed. Additionally, internal QC was not being documented as acceptable for each patient test
performed prior to reporting patient results.
Putting it all together

Kim used the information she reviewed to consider “What could go
wrong?” during the entire testing process. Using the Happy Day Physicians
Group Risk Assessment Worksheet:
99 Kim reviewed the potential failures and errors that were entered
in column 2 of the Happy Day Physicians Group risk assessment
worksheet.
99 She determined that the activities that were identified in column 4

of the risk assessment worksheet will adequately detect and reduce the identified potential sources
of failure and error.
99 Kim reviewed the QC activities in column 4. She noted some of the QC activities could be performed
immediately to resolve potential errors in the future. For example, moving the test system to a better
location in the laboratory immediately resolved airflow and temperature fluctuations. (You may also
encounter similar QC activities that can immediately resolve the potential for errors in your own
laboratory.) Kim decided all other QC activities would be incorporated into her QCP, which will be
monitored on an ongoing basis.
36
HAPPY DAY PHYSICIANS GROUP QUALITY CONTROL PLAN
After reviewing the Acme Chemotrific System-Magnesium risk assessment worksheet, Kim used the
information that she gathered to develop the following QCP for Happy Day Physicians Group. The examples
below show how you can use the information that you obtain from the risk assessment to create a QCP.
These examples are not meant to be all inclusive of all possible QC procedures that may apply to your
laboratory.
3
1 2
Criteria for Acceptability
Type of Quality Control Frequency
(Range of Acceptable Values)
Record room temperature 20oC – 25oC (Room)
Temperature Checks
daily, in the morning and 2oC – 8oC (Refrigerator)
Room
afternoon. Record refrigerator -10oC – -20oC (Freezer)
Refrigerator
and freezer each day of
Freezer A
patient testing. Recorded on temperature log sheets
Refer to Specimen Rejection Policy and record

Verify specimen collection tubes for
With each specimen all improperly collected tubes on specimen
acceptability upon receipt in the laboratory.
rejection log sheet.
If the time lapse for specimen collection and

receipt is greater than 60 minutes, aliquot and
Verify specimen collection time and time
With each specimen store according to manufacturer’s instructions
received by the laboratory.
(2oC – 8oC for 48 hrs or freeze at -10° C up to 5
weeks).
Performed with each reagent Must be documented as acceptable on quality

Internal Quality Control
disc. control log sheet prior to reporting results.
Assay normal and abnormal

quality control every 30 days
or the first day of patient
testing each month.
In addition to the above,
external quality control will be Acceptable range printed in the
External Quality Control
ran when: manufacturer’s package insert.
Normal value
• laboratory conditions
Abnormal value
have changed Results must be recorded on quality control
significantly log sheet prior to reporting results.
• training or retraining of
• test results do not match
patient symptoms or
clinical findings

when removed from refrigerator. Do not use
Reagent Disc Storage With each reagent disc
reagent discs that are at room temperature
beyond 48 hours.
37
3
1 2
With each new testing Successful demonstration of test

Training personnel and when performance.
indicated. Document training activities.
Six months and one year All testing personnel must successfully
Competency Assessment after initial training, annually meet all six CLIA elements for competency
thereafter. assessment.
There are many options for documenting your QCP. See the example of how Kim documented her Acme
Chemotrific-Magnesium QCP using a different format.
HAPPY DAY PHYSICIANS GROUP QUALITY CONTROL PLAN

NOTE: The example provided below does not represent a complete QCP. It is NOT meant to represent every
QC procedure that you may need to implement in your laboratory.
1. Document temperatures for the refrigerator and freezer each day of patient testing. Document the room
temperature, morning and afternoon, each day of patient testing. The acceptable criteria for temperature ranges
must be included in the temperature logs.
2. Verify specimen collection tubes for acceptability upon receipt in the laboratory. Document improperly collected
specimens following established Specimen Rejection Policy.
3. Verify specimen collection and receipt times on the test order forms prior to loading the sample on the disc.
Specimens that are not tested within 60 minutes of collection must be separated into plasma or serum and store
in capped sample tubes at 20C to 80C for 48 hours or store at -100C in a freezer without a self-defrost cycle for up
to five weeks. Train testing personnel regarding specimen collection and storage.
4. Test and document reagent stability by running external normal and abnormal controls per manufacturer’s
instructions for the following: every 30 days, at change of reagent disc lot number, whenever laboratory
conditions have changed significantly, when training or retraining of personnel is indicated, and when test
results do not match patient symptoms or clinical findings.
5. Verify and document Internal QC as “acceptable” for each patient test performed before patient results are
reported.
6. Document the date and time when reagent discs are removed from the refrigerator. Do not use reagent discs
that have been at room temperature beyond 48 hours.
7. Verify that training of testing personnel, upon hire and when indicated, documents successful demonstration of
competency as indicated by laboratory policy and regulations. CLIA Regulation 493.1451 (b)(8)i-vi and (9)
After reviewing how Kim completed the QCP worksheet above for Happy Day Physicians Group, develop a
QCP worksheet for your laboratory.
38
General Quality Control Questions to Consider for Your Laboratory’s QCP
Think about your laboratory and your QC process.
Do the QC activities identified in your Risk Assessment: Answer
Provide for immediate detection of errors for each phase of the testing process (i.e. before,
Yes No
during, and after testing) for the test?
Specify the number, type, and frequency of testing QC material(s)? Yes No
Contain criteria to determine acceptable QC results? Yes No
Require the laboratory perform QC as specified by the manufacturer’s instructions, but not less
Yes No
than the manufacturer’s instructions?
Indicate that your Laboratory Director has reviewed, signed and dated the QCP document? Yes No
39
Take your identified sources of error and follow the steps taken by Kim to complete your laboratory’s QCP
worksheet below.
QUALITY CONTROL PLAN WORKSHEET

3
1 2
Laboratory Director Signature____________________________ Date
40
LET’S REVIEW
TIPS TO REMEMBER:
A complete QCP must:
99 Provide for immediate detection of

errors for each phase of the testing
process (i.e. before, during, and after
testing) for the test.
99 Specify the number, type, and

frequency of testing QC material(s).
99 Contain criteria to determine

acceptable QC results.
99 Require the laboratory perform QC as specified by the manufacturer’s

instructions, but not less than the manufacturer’s instructions.
99 Indicate that your Laboratory Director reviewed, signed, and dated the QCP
document.
If your QCP does not address all five items listed above, you do not have a QCP.
Go back and investigate what is missing.
41
Step 3: Quality Assessment
WHAT IS QUALITY ASSESSMENT?
Quality Assessment (QA) can be described as a multi-part
activity.
Monitor and Assess

The laboratory must establish and follow written policies
and procedures to monitor and assess, and when
indicated, correct problems identified. The monitoring
should include, but is not limited to, the following risk
assessment components: specimen, test system, reagents,
environment, and testing personnel.
Corrective Action
The QA must also include a review of the effectiveness of
corrective actions taken to resolve problems identified.
The laboratory must update the risk assessment and
modify the QCP, as necessary based on the information
obtained from the QA.
QA vs. QC
Now that we have defined QA and before we begin to discuss QA activities, let’s take a look at the differences
between QC and QA activities.
Below is an example that explains the difference between a QC activity and a QA activity.
Example of a QC activity:
99 Recording the room temperature on a log sheet
99 Documenting controls on log sheets
99 Documenting personnel training
Example of a QA activity:
99 Reviewing the room temperature log sheet for problems and evidence of corrective actions
99 Reviewing control documents for out of range values and corrective actions taken
99 Reviewing personnel training records for completion of required trainings and competency
assessments
42
STEP 3: QUALITY ASSESSMENT
Without Quality Assessment (QA), you don’t have a complete IQCP
Once QA has been incorporated into your IQCP, the three parts of the IQCP may be viewed as a continuous
cycle of improvement, as depicted above.
Quality Assessment Monitoring and Review

Quality Assessment (QA) is used to determine if the quality activities you have put in place are working
according to your QCP.
The laboratory personnel must establish a review system for the ongoing monitoring of the effectiveness
of their QCP. The monitoring should include, but is not limited to, the following components: specimen, test
system, reagent, environment, and testing personnel. Reevaluate the QCP when changes occur in any of the
above components.
How frequently will you monitor your QCP?

Your QA plan should include a schedule for evaluating your QCP to ensure it continues to provide accurate
and reliable test results. If necessary, you must update any portion of the risk assessment with new
information and modify the QCP as needed.
43
DOCUMENTS TO CONSIDER FOR QUALITY ASSESSMENT MONITORING
AND REVIEW MAY INCLUDE, BUT ARE NOT LIMITED TO:
• QC data sheets review • Turnaround time reports

• Delta check logs • Temperature logs
• PT records (scores, testing failures, trends) • Records of preventive measures, corrective
• Complaint reports actions, & follow-up
• Patient results review • Personnel competency records
• Specimen recollection logs • Maintenance logs
• Specimen rejection or quantity not sufficient logs • Training logs
• Panic value call logs • FDA alerts
Quality Assessment helps you:

99 Make sure that your QCP is working as expected
99 Monitor errors and QC failures
99 Identify errors and failures so you can take the appropriate corrective action
99 Investigate the cause of the error and reassess your risk assessment, if indicated
99 Evaluate whether any changes need to be made in the QCP
Corrective Actions
When the laboratory discovers a testing process failure,
the laboratory must conduct an investigation to identify
the cause of the failure and its impact on patient care.
The investigation must include documentation of all
corrections, corresponding corrective action(s) for all
patient results affected by the testing process failure, and
evaluation of the effectiveness of the corrective action(s)
taken. The laboratory must implement the correction(s) and
corresponding corrective action(s) necessary to resolve
the failure and reduce the risk of recurrence in the future. If
necessary, the laboratory must update the risk assessment
with the new information and modify the QCP, as needed.
Always review your QCP to ensure that your customized plan is working and modify the plan if it is not
adequately detecting or preventing errors. A plan that may have seemed appropriate, based upon the
available evidence when it was established may turn out to be insufficient to address all possible errors
upon the next evaluation.
44
DOES YOUR QA DO THE FOLLOWING?
99 Outline the QA practices for your laboratory?

99 Monitor continuously for effectiveness?
99 Revise policies and procedures necessary to prevent recurrence of problems?
99 Discuss QA reviews with appropriate staff?
99 Document all QA activities?
Remember - QA is used to determine if the quality activities you have put in place are working.
QA Scenario:
The quality assessment activities below are currently implemented at Happy Day Physicians Group for the
Acme Chemotrific System-Magnesium assay.
Happy Day Physicians Group QA
1. Review all temperature logs monthly for room, refrigerator, and freezer to ensure temperatures
were monitored according to the QCP, and appropriate corrective action(s) were taken for any
temperatures that were out of range.
2. Review Specimen Receipt Log weekly for any unacceptable conditions, i.e. rejected samples, to
ensure appropriate action(s) were taken. If the number of unacceptable specimens or occurrences
exceeds a threshold established by the laboratory, conduct training, or another activity and
monitor the effectiveness of the corrective action.
3. Review manufacturer’s instructions with each new lot/shipment of reagent discs or software
change. Ensure changes are incorporated into the standard operating procedures as well as
monitor any quality control problems found regarding lot-to-lot variability.
4. Review Internal QC Logs monthly to ensure appropriate corrective action(s) were taken for any
unacceptable values.
5. Update policy and procedures to outline steps for verbal reporting of patient test results.
6. Update policy and procedures for competency assessment and review personnel records/
documentations to ensure competency assessments meet the CLIA required elements.
7. Review scheduled maintenance records/documentation for completeness for the test system(s)
per laboratory policies and procedures.
Laboratory Director Signature Dr. Martin

Date mm/dd/yyyy
45
QA Scenario:
Let’s take a closer look at how Happy Day Physicians

Group identified new QA monitors.
As a result of her QA reviews, Kim discovered testing

personnel had been performing an external control run
and not including controls on patient specimen runs. The
laboratory’s standard operating procedure (SOP) indicated
controls should be run at the same time as patient specimens.
Kim identified additional QC activities to reduce this risk of
error and included them in the laboratory’s updated QCP.
Kim also added a monthly supervisory review of the

instrument print-outs to ensure that controls are
simultaneously run with patient specimens. She will initiate
periodic remedial training for all testing personnel, annually
assess personnel performance, and review competency
assessments based on compliance with the updated policy.
Additionally, Kim will review the instrument print-outs
to ensure controls are properly tested as indicated in the
laboratory’s SOP, and there are no indications of errors. If
abnormalities are identified during the review, Kim will
document them and develop a corrective action plan to
address the errors. Going forward, Dr. Martin, the laboratory
director, will now review and sign all QC logs quarterly.
The new QA activities Kim identified in the scenario above are now listed in the Happy Day Physician Group’s
QA worksheet below. You may use this worksheet as an example of how to document your QA activities or
you can develop your own.
46
Note: The information provided in this worksheet should not be considered all-inclusive of processes and
CLIA requirements that may apply to your laboratory.
HAPPY DAY PHYSICIANS GROUP QA WORKSHEET
ASSESSMENT OF QA
QA ACTIVITY ACTIVITY
CORRECTIVE ACTION (WHEN
(TO MONITOR) FREQUENCY (Was there variation from
INDICATED)
established policy and
procedures?)
Remedial training of testing

Supervisor reviews and personnel
signs instrument print-outs Monthly Yes
and QC logs Reassess testing personnel
performance
Rewrite competency
Annually after first year of
Competency Assessment No assessment training program
employment
to ensure it is up to date.
Laboratory Director reviews

Quarterly No N/A
and signs QC logs
In the blank spaces below, record your current QA activities and/or those activities that could reduce
potential errors in testing.
Record Your Quality Assessment Activities/Findings
47
OPTIONAL QA WORKSHEET
Take your identified sources of error from the “Record Your Quality Assessment Questions/Findings”
section, and follow the steps taken by Kim to complete your laboratory’s QA worksheet below.
ASSESSMENT OF QA
QA ACTIVITY ACTIVITY
CORRECTIVE ACTION (WHEN
(TO MONITOR) FREQUENCY (Was there variation from
INDICATED)
established policy and
procedures?)
48
LET’S REVIEW
Now that you have seen all parts of an IQCP and sample scenarios, you are ready to apply
this process to your laboratory’s test systems for which you choose to implement the IQCP
process.
Important Points
Keep these points in mind when
developing an IQCP:
99 The IQCP is unique to your

laboratory and is customized for
your laboratory’s specific testing
considerations.
99 The risk assessment must include

the entire testing process and
address all five components:
specimen, test system, reagents,
environment and testing
personnel.
99 The risk assessment should

be updated to include all risk
identified in your QA, as some risk
originally identified may no longer
apply.
99 The QCP should include the number, type and frequency of testing control materials.
99 The IQCP should include all activities performed to reduce your risk of failures and errors.
99 The entire testing process continually evolves and the IQCP will need to be reviewed
periodically to identify new sources of errors or failures.
99 The QCP must be reviewed, approved, and signed by the Laboratory Director.
49
CONGRATULATIONS!!!
You have completed a Risk Assessment,
created a Quality Control Plan
and performed a Quality Assessment
for the test system being evaluated for an IQCP!!
50
For more information please visit the websites listed below:
CDC CLIA Website

http://wwwn.cdc.gov/clia/default.aspx
CDC IQCP Workbook and Resources

http://wwwn.cdc.gov/CLIA/Resources/IQCP/
CMS CLIA Website

http://www.cms.gov/CLIA/
CLIA Federal Regulations

http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/CLIA_Regulations_
and_Federal_Register_Documents.html
CLIA Brochures
http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/CLIA_Brochures.html
Additional questions may be directed to the electronic mailbox

IQCP@cms.hhs.gov
51
PRINT WORKSHEET
APPENDIX A
RISK ASSESSMENT WORKSHEET
Laboratory Name ____________________________ Test System Name
1 2 3 4
Can our
How can we reduce the identified sources of
sources of
error?
RISK reduced?
ASSESSMENT Indicate how to reduce possible error
COMPONENTS Yes/No
sources.
Gather information, from the manufacturer’s Not
instructions and other resources, on how we Applicable
• Actions taken by laboratory
should be performing the testing process. (N/A)
• Safeguards in the test system or
SPECIMEN
52
APPENDIX A (CONTINUED...)
1 2 3 4
Can our
sources of
error?
RISK reduced?
COMPONENTS Yes/No
sources.
TEST SYSTEM
53
1 2 3 4
Can our
sources of
error?
RISK reduced?
COMPONENTS Yes/No
sources.
REAGENT
54
1 2 3 4
Can our
sources of
error?
RISK reduced?
COMPONENTS Yes/No
sources.
ENVIRONMENT
55
PRINT WORKSHEET
APPENDIX A
1 2 3 4
Can our
sources of
error?
RISK reduced?
COMPONENTS Yes/No
sources.
TESTING
PERSONNEL
56
PRINT WORKSHEET
APPENDIX B
QUALITY CONTROL PLAN WORKSHEET
3
1 2
57
PRINT WORKSHEET
APPENDIX C
QUALITY ASSESSMENT WORKSHEET
ASSESSMENT OF QA ACTIVITY
(Was there variation from CORRECTIVE ACTION (WHEN
QA ACTIVITY TO MONITOR Frequency
established policy and INDICATED)
procedures?)
58
APPENDIX D
ADDITIONAL RISK ASSESSMENT QUESTIONS
The following questions are a mixture of requirements under the CLIA regulations and recommended good
laboratory practices. These questions are provided to help guide you as you consider the types of issues that
contribute to your laboratory’s potential risk of incorrect test results. The questions listed are not intended
to be all-inclusive but are intended to stimulate your thinking when considering potential risks that could
lead to incorrect test results in your laboratory setting.
Note: Good laboratory practices may be representative of laboratory practices that are more stringent than
CLIA regulations.
Specimen
1. Are specimens collected in the correct container, with proper preservatives?
2. Are the manufacturer’s instructions followed for proper centrifugation (time and speed) to ensure proper
and adequate separation of cells from serum or plasma?
3. Are written procedures followed for managing unacceptable specimens?
4. Are the manufacturer’s instructions followed for proper specimen collection and use of specimen
collection containers?
5. Are there written procedures for specimen referral to other laboratories?
Test System
1. Does the laboratory have an established range for an acceptable calibration that includes a minimum
(or zero), midpoint, and a maximum value near the upper limit of the range that verifies the laboratory’s
reportable range?
2. Is the laboratory able to detect mechanical or electronic errors on this test system?
3. Does the laboratory define and document mechanisms to detect test system optical, pipette, or barcode
reader errors?
4. Does the laboratory perform system controls and function checks according to the manufacturer’s
instructions, to include checks for:
• Built-in procedural and electronic controls (internal controls)?
• External or internal liquid quality control (assayed vs. unassayed)?
• Temperature monitors and systems?
5. Does the laboratory utilize hardware/software that is current and appropriate for the needs of the
facility?
6. Is an evaluation of instrument and reagent stability performed following relocation of instruments?
7. Does the laboratory have established corrective action policies and procedures, to include corrective
action for out of range controls and calibrations?
8. Does the laboratory document corrective actions taken, to include resolutions, and review and share
with testing personnel?
9. Does the laboratory have an adequate manual or electronic system(s) in place to accurately and reliably
transmit patient results in a timely manner from data entry point to final report destination?
10. Are final results reviewed by a laboratory supervisor within 24 hours?
11. Does the laboratory have a Laboratory Information System (LIS)? If so, are there procedures to monitor
the accuracy and completeness of the information being transmitted to the LIS?
59
APPENDIX D (CONTINUED...)
12. Does the laboratory have multiple locations? If so, has a risk assessment been performed for each test
system (method) at each location for which an IQCP will be established?
13. Are procedures written according to the manufacturer’s instructions for this test?
14. Are commercial tests performed following the manufacturer’s instructions and within the laboratory’s
stated performance specifications?
15. Does the laboratory perform and document calibration procedures following the manufacturer’s
recommendations and using calibration material appropriate for the test systems (per manufacturer’s
recommendation)?
16. Does the system recognize when external QC and calibrations are expired and prevent users from
reporting results if these are due to be performed?
Reagent
1. Are expiration dates clearly identified and in agreement with manufacturer’s recommendations (properly
labeled)?
2. Are all reagents, controls, and calibrators used within the manufacturer’s designated expiration date?
3. Are all reagents removed from storage and disposed of when they have reached their expiration date?
4. Are lot numbers recorded in a log (when new lots are received and when beginning use of different lot
numbers)?
5. Is there a procedure for evaluating new lot numbers before beginning use for patient testing?
Environment
1. Does the laboratory have ventilation adequate for conducting all phases of laboratory testing?
2. Do the manufacturer’s instructions specify requirements for ventilation and airflow?
3. Do the manufacturer’s instructions specify the type of water required for this testing process?
4. Does the laboratory have adequate space to perform testing, prevent cross contamination, and/or
injury?
5. Is lighting adequate to perform visual interpretation of test results, where required?
6. Are surge protectors used to prevent fluctuations of the power source in testing areas?
7. Is the testing area kept clean and clear of clutter and debris that could interfere with the testing process
or disrupt airflow?
Testing Personnel
1. Do all personnel who collect specimens and perform testing follow the manufacturer’s instructions?
2. Do all testing personnel perform QC and PT?
3. Do all laboratory personnel meet the appropriate educational and training requirements specified by
CLIA?
4. Do laboratory personnel have a formal certification or license, if required by their state?
5. Does the laboratory have adequate personnel to perform testing in a safe and timely manner?
6. Does the laboratory have an ongoing and documented competency assessment program that includes
the six elements required by CLIA for all personnel categories?
60
APPENDIX E
QUALITY ASSESSMENT (QA) ACTIVITIES
Below you will find a list of QA activities to help you reduce the occurrence or enhance the detection of
potential failures and errors.
• Review all reports, manufacturer’s instructions, and procedure manuals to monitor:

ºº Accuracy and clarity of results reporting
ºº Appropriateness of specimen, specimen collection, specimen handling and transportation
ºº Assay accuracy and precision
ºº Turnaround time
ºº Compliance with policy and procedures
• Ensure there is a written procedure or manufacturer’s instructions for each assay performed and that
they are all readily accessible to testing personnel. Written procedures should include all information
required by CLIA.
• Keep a log of known errors and sources of errors encountered over time for:
ºº Specimen collection
ºº Temperatures variations
ºº Reagent and QC performance
ºº Personnel errors
• Ensure all personnel meet the minimum qualifications necessary for performing testing.
• Ensure that there is a formal training period for all new personnel and refresher training for existing
personnel.
• Ensure that there are procedures in place to document:
ºº Corrective actions taken
ºº Record reviews
ºº Data entry errors
ºº Laboratory investigations of failures and errors, to include actions taken to prevent future
occurrences
ºº Personnel training and competency assessment
ºº Complaints received and actions taken to resolve
• Monitor QC results for shifts and trends.
• Ensure that all personnel participate in performing proficiency testing (PT).
• Monitor and document laboratory conditions that could adversely affect patient testing.
61
APPENDIX F
GLOSSARY
Glossary Term Definition

A part of the total testing process involving workflows related to preparation and processing of
patient specimens, analysis of specimens, and interpretation of test results.
Analytic Phase
CLIA §493.1251-493.1283
A process of testing and adjusting an instrument or test system to establish a correlation between
the measurement response and the concentration or amount of the substance that is being
Calibration
measured by the test procedure. CLIA §493.2
The ability of personnel to apply their skill, knowledge, and experience to perform their laboratory
Competency duties correctly. CMS CLIA Brochure #10
A process to monitor and assess laboratory personnel performance to ensure that they are fulfilling
Competency their duties as required by federal regulation.
Assessment CMS CLIA Brochure #10 CLIA §493.1413(b)(8) or §493.1451(b)(8)
Actions taken to remedy a situation, remove an error, adjust a condition, or prevent recurrence of a
Corrective action problem. Interpretive Guidelines §493.1239(a)(b)(c), §493.1299(a)(b)(c)
An internal part of the (analyzer) test system that monitors the electrical or electronic components
of the test system.
“Good Laboratory Practices for Waived Testing Sites” Morbidity and Mortality Weekly Report
Electronic Controls
(MMWR), Recommendations and Reports; November 11, 2005, vol 54(RR13);1-25.
http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5413a1.htm
Conditions that may affect test system performance. These include, but are not limited to,
Environmental
temperature, airflow, light intensity, humidity, and altitude.
Conditions
Materials that have a similar matrix to patient specimens, are treated in the same manner as patient
specimens, and go through all analytic phases of testing. External controls check the operating
characteristics of a test system, including instrument stability and calibration.
External Controls “Good Laboratory Practices for Waived Testing Sites” Morbidity and Mortality Weekly Report
A framework for customizing a quality control (QC) program for your test systems and your
laboratory’s unique environment. By performing the steps in an IQCP, you will examine the potential
Individualized Quality sources of error in your preanalytic, analytic and postanalytic phases of testing, as well as establish
Control Plan (IQCP) the appropriate QC and quality practices which reduce the likelihood of errors occurring in your
laboratory. CMS CLIA Brochure #13
Internal or procedural controls may only monitor a portion of the test system’s analytic components,
for example, a color change that indicates when a patient’s specimen or reagent is added correctly.
Internal Controls
62
APPENDIX F (CONTINUED...)

Written product information usually supplied by the manufacturer with each test kit or test system
containing instructions and critical details for performing the test. All of the instructions in the
product insert from “intended use” to “limitations of the procedure” must be followed.
Manufacturer’s
Instructions
Post-analytic is a part of the total testing process occurring after analysis. It includes but is not
limited to data entry; follow-up plan; and reporting results to the healthcare provider.
Post-Analytic Phase
CLIA §493.1291- 493.1299
Pre-analytic is a part of the total testing process referring to all steps taken prior to the actual testing
of a patient specimen from the test request to the actual testing of the specimen.
Pre-Analytic Phase
CLIA Interpretive Guidelines at §493.1240.
Proficiency testing or PT is the testing of unknown samples sent to a laboratory by a CMS approved
Proficiency Test (PT) PT program. CMS CLIA Brochure #8
An ongoing review process that encompasses all facets of the laboratory’s technical and non-
technical functions and all locations/sites where testing is performed. The laboratory must establish
and follow written policies and procedures to monitor and assess, and when indicated correct
Quality Assessment
problems identified. The QA must also include a review of the effectiveness of corrective actions
(QA)
taken to resolve problems identified.
CLIA Interpretive Guidelines at §493.1239, §493.1249, §493.1289, §493.1299
The procedures used to detect and correct errors that occur because of test system failure, adverse
environmental conditions and variance in operator performance, as well as the monitoring of the
Quality Control (QC)
accuracy and precision of the test performance over time. CMS CLIA Brochure #12
A laboratory’s standard operating procedure that describes the practices, resources, and procedures
to control the quality of a particular test process.
Quality Control Plan
(QCP) S&C: 13-54-CLIA Individualized Quality Control Plan (IQCP):
A New Quality Control (QC) Option Attachment 1: INDIVIDUALIZED QUALITY CONTROL PLAN
Risk assessment is the identification and evaluation of potential failures and sources of errors in
a testing process. Risk assessments for IQCP must include, at a minimum, an evaluation of the
following five components (Specimen, Test system, Reagent, Environment, and Testing Personnel).
Risk Assessment (RA)
S&C: 13-54-CLIA Individualized Quality Control Plan (IQCP):
A New Quality Control (QC) Option Attachment 1: INDIVIDUALIZED QUALITY CONTROL PLAN
CMS CLIA Brochure #13
The instructions and all the instrumentation, equipment, reagents, and supplies needed to perform
Test System an assay or examination and generate test results. CLIA §493.2
63
APPENDIX F (CONTINUED...)
Includes the pre-analytic, analytic, and post-analytic phases of testing. This process includes
Testing Process everything that occurs from the time the physician initiates the test request to the time the test
result is entered in the patient’s medical record. CLIA §493.2
The process of the laboratory verifying the manufacturer’s analytical claims of a test or test system.
The verification of method performance should provide evidence that the accuracy, precision,
and reportable range of the procedure are adequate to meet the clients’ needs, as determined by
Verification
the laboratory director and clinical consultant. This process must be completed prior to reporting
patient results. CLIA §493.1253(b)(1)
64
For questions, please e-mail: IQCP@cms.hhs.gov
For additional information go to:

http://wwwn.cdc.gov/CLIA/Resources/IQCP/
To request a hardcopy of the IQCP Workbook, please e-mail:

iqcpworkbook@cdc.gov

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IQCP is an all-inclusive approach to assuring quality. It

What are the three steps of the IQCP?.............................................................................................................................. 5

What are we already doing?................................................................................................................................................. 6

Step 1: Risk Assessment 7

What is happening in my laboratory?.......................................................................................................................... 9

Assessing Test System Risks...........................................................................................................................................15

Assessing Reagent Risks.................................................................................................................................................19

Assessing Environment Risks........................................................................................................................................23

Assessing Testing Personnel Risks...............................................................................................................................27

Step 2: Quality Control Plan 35

What is included in a QCP?............................................................................................................................................35

Developing your QCP......................................................................................................................................................36

Happy Day Physicians Group QCP Example............................................................................................................37

Optional QCP Worksheet................................................................................................................................................40

Step 3: Quality Assessment 42

Documents to Consider for QA....................................................................................................................................44

Does your QA do the following?..................................................................................................................................45

Happy Day Physicians Group QA Example...............................................................................................................45

APPENDIX B - QCP Worksheet.......................................................................................................................................57

APPENDIX D - Additional Risk Assessment Questions.........................................................................................59

APPENDIX F - Glossary / Definitions...........................................................................................................................62

99Customize a QC Plan for each nonwaived test in its unique environment

2. QUALITY CONTROL PLAN (QCP)

3. QUALITY ASSESSMENT (QA)

At a minimum, evaluate the following five components of

Specimen * Test System * Reagents * Environment * Testing Personnel

99Laboratory procedures/standard operating procedures (SOPs)

99 Test system is FDA cleared and moderate complexity under CLIA

99 Acme Chemotrific System-Magnesium package insert includes:

99 Two years of successful PT performance reports

99 Instrument maintenance (Test System)-

99 Reagent- Review of lot-to-lot reagent logs demonstrates no problems or indications of problems

Now let’s review your supporting data

“Let’s talk about the specimen…” Review the manufacturer’s

What are our possible sources of

Documentation of specimen Retrain testing personnel on

Manufacturer’s instructions: Train testing personnel to verify

Think about your laboratory and your entire testing process as it

Do you see a potential risk of an error in test results if: Answer

The current version of the manufacturer’s instructions is not used? Yes No

The specimen is improperly labeled? Yes No

Record Your Specimen Risk Assessment Questions/Findings

Risk Assessment Worksheet

Risk Assessment Indicate how to reduce possible error

“Let’s talk about the test system…” Review the manufacturer’s

Test System Scenario:

Kim reviewed external QC log sheets for the last two

What are our possible sources of error? Can our identified

Assure testing personnel review each QC

The test system will not perform the test if

Record Your Test System Risk Assessment Questions/Findings

Risk Assessment Worksheet

What are our possible sources of error?

“Let’s talk about the reagent…” Review the manufacturer’s

Reagent expiration date - the test system’s