What Does it Mean for You?

1
What Does it Mean for You?
SCACM Audio conference 4/28/15 PACE 362-011-15
IQCP -Individualized Quality Control Plan
Susan E. Sharp, Ph.D., ABMM, FAAMDirector,
Airport Way Regional LaboratoryDirector,
Regional Microbiology and Molecular Infectious
Diseases Laboratories Kaiser PermanenteDepartment
of PathologyPortland, OR 97230
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Susan E. Sharp, Ph.D.(no disclosures)

• Objectives
• Understand the history behind CMSs IQCP
• Detail the new CMS requirements for IQCP
• Develop an IQCP plan for microbiology systems in
  your laboratory

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CMS QC Milestones
Quality Systems Regulations 2003
CLIA 67
CLIA 88
QC)
Equivalent QC EQC 2004
s
Individualized QC plan IQCP 2013
QC for the Future 2005
CLSI EP-23 2011
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CMS QC Milestones
Quality Systems Regulations 2003
CLIA 67
CLIA 88
QC)
Equivalent QC EQC 2004
s
Individualized QC plan IQCP 2013
QC for the Future 2005
CLSI EP-23 2011
5
CMS QC Milestones
Quality Systems Regulations 2003
CLIA 67
CLIA 88
QC)
Equivalent QC EQC 2004
s
Individualized QC plan IQCP 2013
QC for the Future 2005
CLSI EP-23 2011
6
CMS QC Milestones
Quality Systems Regulations 2003
CLIA 67
CLIA 88
QC)
Equivalent QC EQC 2004
s
Individualized QC plan IQCP 2013
QC for the Future 2005
CLSI EP-23 2011
7
CMS QC Milestones
Quality Systems Regulations 2003
CLIA 67
CLIA 88
QC)
Equivalent QC EQC 2004
s
Individualized QC plan IQCP 2013
QC for the Future 2005
CLSI EP-23 2011
8
CMS QC Milestones
Quality Systems Regulations 2003
CLIA 67
CLIA 88
QC)
Equivalent QC EQC 2004
s
Individualized QC plan IQCP 2013
QC for the Future 2005
CLSI EP-23 2011
9
CMS QC Milestones
Quality Systems Regulations 2003
CLIA 67
CLIA 88
QC)
Equivalent QC EQC 2004
s
Individualized QC plan IQCP 2013
QC for the Future 2005
CLSI EP-23 2011
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Mandatory vs. Voluntary

• IQCP is voluntary for laboratories
• Current CLIA control default regulations
  continue to be in effect
• Pos Neg QC each test day for qualitative tests
• 2 levels of QC each test day for quantitative
  tests
• EQC (based on using internal controls weekly QC
  shipment/lot QC etc.) will be discontinued and
  will no longer be an acceptable QC option under
  CLIA in January 2016
• The laboratory must choose to
• follow CLIA default QC regulations, OR
• develop an IQCP

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CMS IQCP

• Consists of 3 components
• I. Risk Assessment (RA)
• A. Collect data
• Note the areas where errors or failures
  could occur in the entire workflow path
  (pre- analytical, analytical,
  post-analytical)
• B. Assess the frequency of occurrence of the
  error and the potential harm (impact) if
  an error would occur
• II. Quality Control Plan (QCP)
• gt Defines the control mechanisms in place for
  detecting, controlling or preventing
  errors
• gt Defines resulting QC and acceptability
  criteria
• III. Quality Assessment (QA)
• gt Designed to ensure (and to monitor) the
  effectiveness of the QCP

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I. Risk Assessment

• Identify the RISKs (sources of potential failures
  and errors) associated with the test system
• Risk Assessment Components (as defined by CMS)
• specimen
• test system
• reagent
• environment
• testing personnel
• Evaluate the frequency (occurrence) of those
  failures/errors
• Evaluate the impact (potential harm) due to those
  failures/errors
• The resulting Risk Assessment is then used to
  develop the Quality Control Plan (QCP) How you
  will control for these risks

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I. Risk Assessment
http//www.cms.gov/Regulations-and-Guidance/Legisl
ation/CLIA/Downloads/CLIAbrochure13.pdf

• Risk Assessment Components (as defined by CMS)
• Specimen
• Patient preparation, collection, labeling,
  storage preservation, stability, transportation,
  processing, acceptability, referral
• Test System
• Inadequate sampling, clot detection, detecting
  interfering substances, calibration issues,
  mechanical/electronic failure, optics, pipettors,
  bar code readers, function checks, built-in
  controls, external controls, temperature
  monitors/controllers, software/hardware,
  transmission of data to LIS, result reporting
• Reagent
• Shipping/receiving, storage, expiration dates,
  preparation
• Environment
• Temperature, airflow/ventilation, light
  intensity, humidity, altitude, dust, water,
  utilities, space
• Testing Personnel
• Training, competency, education, experience,
  staffing

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II. Quality Control Plan (QCP)

• A document/process/plan that describes the
  practices, resources, and procedures used to
  control the quality of a test system.
• Control all phases of testing
• specimen collectionperformanceresult reporting
• Must monitor the accuracy and precision of test
  performance
• Include the number, type, and frequency of QC
• Define criteria for acceptability of QC

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III. Quality Assessment

• The laboratory must establish a review system for
  the on-going monitoring of the effectiveness of
  their QCP.
• The monitoring should include all 5 Risk
  Assessment Components (part of our RA)
• specimens, test system, reagents, environment,
  testing personnel
• When the laboratory discovers a testing process
  failure or error it must
• conduct and document an investigation to identify
  the cause of the failure/error,
• determine its impact or harm, and
• make appropriate modifications to their QCP to
  control for this failure.

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Implementation of IQCP

• Until December 31, 2015 Laboratories may use
  CLIA QC regulations (QC each day of testing),
  EQC, or IQCP
• By January 1, 2016 Laboratories must follow CLIA
  QC regulations (QC each day of testing) or IQCP
  (no more EQC)
• All new and existing test systems must be in
  compliance
• NOTE Your IQCP must include testing of QC at
  least as stringent as recommended by the
  manufacturer.

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IQCP An Example

• Commercial Antimicrobial Susceptibility Testing
  (AST)

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IQCP Commercial AST

• I. Risk assessment (RA) of the System
• II. Quality Control Plan (QCP) for the System
• III. Quality Assessment (QA) for the System

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1. Risk Assessment

A. Collect Information
B. Conduct a risk assessment

-Manufacturer instructions -Manufacturer
performance data -Literature published on
assay -Accreditation/Regulatory
requirements -Individual laboratory data
available gt verification testing data gt
historical QC data
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• Risk Assessment
• A Collect information

Manufacturer instructions Look specifically at
the Limitations section to identify possible
risks. Note manufacturer recommended QC (IQCP
may not include QC that is less than that
recommended by the manufacturer). Include a copy
of your manufacturers instructions in your IQCP
materials.   Manufacturer performance data
Look for any risks associated with this system
that have been identified in the manufacturers
performance data. Include copy in your IQCP
materials.   Literature published on assay Look
for any risks/concerns associated with this
system that have been identified in the
literature. Include copies of pertinent articles
in your IQCP materials.   Accreditation/Regulato
ry requirements Ensure that your IQCP will be in
compliance with any accreditation or regulatory
requirements. Include copies of these
requirements in your IQCP materials.
  Individual laboratory data available Review
your verification (initial and any subsequent
studies) and historical QC data to help define
your IQCP. Include these data in your IQCP
materials, or identify where this data can be
found in the laboratory. ???
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Historical AST QC data - Summary

• QC data for the past XX months (1/1/XX -
  12/31/XX) was reviewed. Testing performed as
  outlined in QC section of the most current
  version of SOP.xxxx demonstrated
• When testing recommended QC strains using the
  same procedures as for testing patients isolates
• XX occurrence of random QC errors (corrected
  upon repeat testing)
• XX occurrence of potential system QC errors
  required corrective action beyond performance of
  a repeat test (list errors and corrective actions
  in a separate table)
• When performing manufacturer or laboratory
  defined instrument and equipment QC, there were
  XX out-of-control observations.

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1. Risk Assessment

A. Collect Information
B. Conduct a risk assessment

Identify where along the testing process risk or
errors might occur.   Determine the frequency
of occurrence of the error and the potential
severity of harm (impact) if an error would
occur.   This risk assessment must include
pre-analytical, analytical, and post-analytical
areas of laboratory testing. Risk assessment
must include the 5 Risk Assessment Components
(CMS) 1. Specimen 2. Testing Personnel 3.
Reagent 4. Environment 5. Test System
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CLSI EP-23 document Risk Matrix


Severity of harm (Impact) Severity of harm (Impact) Severity of harm (Impact) Severity of harm (Impact) Severity of harm (Impact) Severity of harm (Impact)
Probability of harm (Frequency) Negligible Minor Serious Critical Catastrophic
Frequent U U U U U
Probable A U U U U
Occasional A A A U U
Remote A A A U U
Improbable A A A A A
A Acceptable risk U Unacceptable risk
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Risk Evaluation

• Frequency
• Unlikely (1/2-3 yrs)
• Occasional (1/mo-yr)
• Frequent (1/wk)

• Impact
• Negligible (temporary discomfort)
• Minor (temporary injury not requiring medical
  intervention)
• Critical (permanent impairment requiring medical
  intervention)

All risks need to have control measures in place.
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1. Risk Assessment

A. Collect Information
B. Conduct a risk assessment

Identify where along the testing process risk or
errors might occur.   Determine the frequency
of occurrence of the error and the potential harm
if an error would occur.   This risk assessment
must include pre-analytical, analytical, and
post-analytical areas of laboratory testing.
Risk assessment must include the 5 Risk
Assessment Components (CMS) 1. Specimen 2.
Testing Personnel 3. Reagent 4. Environment 5.
Test System
? FISHBONE DIAGRAM
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1 Specimen Organism
RISK ASSESSMENT Identification of Potential
Failures - Commercial AST System
2 Testing Personnel
Specimen (1A) -Patient identification -Collection/
container/ volume -Transport -Storage Organism
(1B) -Clinically relevant -Colony age -Media type
-Pure isolate -Inoculum suspension
4 Environment
Factors -Temperature/ Airflow/ Humidity/
Ventilation -Utilities -Space -Noise/Vibrations
Operator Function -Training -Competency
Assessment -Proficiency Testing -Staffing
Incorrect Test Results
Identify Potential Hazards
Instrument -Electrical -Jam -Software/
Antibiotic Reporting Rules
QC Organism -Storage/ Preparation
Reported Results -Transmission of results to
Hospital Information Systems -Review of
released results -Clinician feedback
Reagent Integrity -Shipping / storage -Expirations
date -Preparation/Use
QC organism -Failure -Error
6 Test Results
3 Reagents
5 Test System
Pre-analytical Analytical Post-analytical
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IQCP Commercial AST

• I. Risk assessment (RA) of the AST System
• II. Quality Control Plan (QCP) for the AST
  System
• III. Quality Assurance (QA) for the AST System

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IQCP Commercial AST

• II. Quality Control Plan (QCP) for the AST System
• 1. Identify Measures to Control/Reduce Risk
• 2. Must also include
• - , type, and frequency of QC testing
• (supported by data)
• - criteria for QC acceptability
• - no less than manufacturers instructions
• - may include electronic QC, procedural QC,
  training, competency assessment, other QC
  activities

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IQCP Commercial AST

• II. Quality Control Plan (QCP) for the AST System
• Identify Measures to Control/Reduce Risk
• Build tables to include all of the risks
  identified in your risk assessment.
• Determine the Probability of occurrence
  (frequency) and the Severity of harm (impact)
  for each risk identified.
• Indicate the measures you have in place to
  mitigate/ reduce/control these risks/errors.
• Include where to find these measures in your
  procedures, reports, logs, etc.

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1 Specimen Organism
RISK ASSESSMENT Identification of Potential
Failures - Commercial AST System
2 Testing Personnel
Specimen (1A) -Patient identification -Collection/
container/ volume -Transport -Storage Organism
(1B) -Clinically relevant -Colony age -Media type
-Pure isolate -Inoculum suspension
4 Environment
Factors -Temperature/ Airflow/ Humidity/
Ventilation -Utilities -Space -Noise/Vibrations
Operator Function -Training -Competency
Assessment -Proficiency Testing -Staffing
Incorrect Test Results
Identify Potential Hazards
Instrument -Electrical -Jam -Software/
Antibiotic Reporting Rules
QC Organism -Storage/ Preparation
Reported Results -Transmission of results to
Hospital Information Systems -Review of
released results -Clinician feedback
Reagent Integrity -Shipping / storage -Expiration
date -Preparation/Use
QC organism -Failure -Error
6 Test Results
3 Reagents
5 Test System
Pre-analytical Analytical Post-analytical
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Harm from Potential Error Commercial
AST System
Specimen Frequency of Occurrence Severity of Harm Measures to control risk Relevant SOP
Patient identification Occasional Minor-Critical Patient identification criteria defined acceptability defined competency assessment performed SOP.xxxx SOP.xxxx SOP.xxxx
Collection/ Container/ Volume Occasional Minor-Critical Collection and container criteria defined per source acceptability defined competency assessment performed SOP.xxxx SOP.xxxx SOP.xxxx
Transport Occasional Minor-Critical Transport criteria defined per source acceptability defined competency assessment performed SOP.xxxx SOP.xxxx SOP.xxxx
Storage Occasional Minor-Critical Storage criteria defined per source acceptability defined competency assessment performed SOP.xxxx SOP.xxxx SOP.xxxx
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1 Specimen Organism
RISK ASSESSMENT Identification of Potential
Failures - Commercial AST System
2 Testing Personnel
Specimen (1A) -Patient identification -Collection/
container/ volume -Transport -Storage Organism
(1B) -Clinically relevant -Colony age -Media type
-Pure isolate -Inoculum suspension
4 Environment
Factors -Temperature/ Airflow/ Humidity/
Ventilation -Utilities -Space -Noise/Vibrations
Operator Function -Training -Competency
Assessment -Proficiency Testing -Staffing
Incorrect Test Results
Identify Potential Hazards
Instrument -Electrical -Jam -Software/
Antibiotic Reporting Rules
QC Organism -Storage/ Preparation
Reported Results -Transmission of results to
Hospital Information Systems -Review of
released results -Clinician feedback
Reagent Integrity -Shipping / storage -Expiration
date -Preparation/Use
QC organism -Failure -Error
6 Test Results
3 Reagents
5 Test System
Pre-analytical Analytical Post-analytical
33
Harm from Potential Error Commercial
AST System
Organism Frequency of Occurrence Severity of Harm Measures to control risk Relevant SOP
Clinically relevant Occasional Minor-Critical Selection criteria defined in training competency assessment performed SOP.xxxx SOP.xxxx
Colony Age Occasional Minor-Critical Selection criteria defined in training competency assessment performed SOP.xxxx SOP.xxxx
Media type Occasional Minor-Critical Selection criteria defined in training competency assessment performed SOP.xxxx SOP.xxxx
Pure isolate Occasional Minor-Critical Selection criteria defined in training competency assessment performed SOP.xxxx SOP.xxxx
Inoculum suspension Occasional Minor-Critical Preparation criteria defined in training competency assessment performed SOP.xxxx SOP.xxxx
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1 Specimen Organism
RISK ASSESSMENT Identification of Potential
Failures - Commercial AST System
2 Testing Personnel
Specimen (1A) -Patient identification -Collection/
container/ volume -Transport -Storage Organism
(1B) -Clinically relevant -Colony age -Media type
-Pure isolate -Inoculum suspension
4 Environment
Factors -Temperature/ Airflow/ Humidity/
Ventilation -Utilities -Space -Noise/Vibrations
Operator Function -Training -Competency
Assessment -Proficiency Testing -Staffing
Incorrect Test Results
Identify Potential Hazards
Instrument -Electrical -Jam -Software/
Antibiotic Reporting Rules
QC Organism -Storage/ Preparation
Reported Results -Transmission of results to
Hospital Information Systems -Review of
released results -Clinician feedback
Regent Integrity -Shipping / storage -Expiration
date -Preparation/Use
QC organism -Failure -Error
6 Test Results
3 Reagents
5 Test System
Pre-analytical Analytical Post-analytical
35
Harm from Potential Error Commercial
AST System
2 Operator Frequency of Occurrence Severity of Harm Measures to control risk Relevant SOP
Training Occasional Minor-Critical All testing personnel have had appropriate training SOP.xxxx
Competency Assessment Occasional Minor-Critical All personnel have appropriate CA performed SOP.xxxx
Proficiency Testing Occasional Negligible-Minor All PT failures addressed with corrective action SOP.xxxx
Staffing Occasional Minor-Critical Adequate staffing to support test menu and turn-around-times on all shifts SOP.xxxx
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1 Specimen Organism
RISK ASSESSMENT Identification of Potential
Failures - Commercial AST System
2 Testing Personnel
Specimen (1A) -Patient identification -Collection/
container/ volume -Transport -Storage Organism
(1B) -Clinically relevant -Colony age -Media type
-Pure isolate -Inoculum suspension
4 Environment
Factors -Temperature/ Airflow/ Humidity/
Ventilation -Utilities -Space -Noise/Vibrations
Operator Function -Training -Competency
Assessment -Proficiency Testing -Staffing
Incorrect Test Results
Identify Potential Hazards
Instrument -Electrical -Jam -Software/
Antibiotic Reporting Rules
QC Organism -Storage/ Preparation
Reported Results -Transmission of results to
Hospital Information Systems -Review of
released results -Clinician feedback
Reagent Integrity -Shipping / storage -Expiration
date -Preparation/Use
QC organism -Failure -Error
6 Test Results
3 Reagents
5 Test System
Pre-analytical Analytical Post-analytical
37
Harm from Potential Error Commercial
AST System
3 Reagents Frequency of Occurrence Severity of Harm Measures to control risk Relevant SOP
Shipping / Storage Occasional Minor Critical Reagents are shipped and stored according to manufacturers instructions. SOP.xxxx
Expiration dates Unlikely Minor Critical Reagents are used within expiration dates. SOP.xxxx
Preparation / Use Occasional Critical All reagents are prepared/used according to manufacturers instructions. SOP.xxxx
QC organism storage / preparation Occasional Minor Critical Results for all QC organisms are within acceptable limits. SOP.xxxx
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1 Specimen Organism
RISK ASSESSMENT Identification of Potential
Failures - Commercial AST System
2 Testing Personnel
Specimen (1A) -Patient identification -Collection/
container/ volume -Transport -Storage Organism
(1B) -Clinically relevant -Colony age -Media type
-Pure isolate -Inoculum suspension
4 Environment
Factors -Temperature/ Airflow/ Humidity/
Ventilation -Utilities -Space -Noise/Vibrations
Operator Function -Training -Competency
Assessment -Proficiency Testing -Staffing
Incorrect Test Results
Identify Potential Hazards
Instrument -Electrical -Jam -Software/
Antibiotic Reporting Rules
QC Organism -Storage/ Preparation
Reported Results -Transmission of results to
Hospital Information Systems -Review of
released results -Clinician feedback
Reagent Integrity -Shipping / storage -Expiration
date -Preparation/Use
QC organism -Failure -Error
6 Test Results
3 Reagents
5 Test System
Pre-analytical Analytical Post-analytical
39
Harm from Potential Error Commercial
AST System
4 Environment Frequency of Occurrence Severity of Harm Measures to control risk Relevant SOP
Temperature / Airflow / Humidity / Ventilation Unlikely Negligible Minor Appropriate environmental conditions are maintained in the laboratory SOP.xxxx
Utilities Unlikely Negligible Minor Appropriate utilities are employed in the laboratory to serve the instrumentation SOP.xxxx
Space Unlikely Negligible Minor Appropriate space is available in the laboratory to serve the instrumentation SOP.xxxx
Noise / Vibration Unlikely Negligible Minor Appropriate parameters are in place to serve the instrumentation SOP.xxxx
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1 Specimen Organism
RISK ASSESSMENT Identification of Potential
Failures - Commercial AST System
2 Testing Personnel
Specimen (1A) -Patient identification -Collection/
container/ volume -Transport -Storage Organism
(1B) -Clinically relevant -Colony age -Media type
-Pure isolate -Inoculum suspension
4 Environment
Factors -Temperature/ Airflow/ Humidity/
Ventilation -Utilities -Space -Noise/Vibrations
Operator Function -Training -Competency
Assessment -Proficiency Testing -Staffing
Incorrect Test Results
Identify Potential Hazards
Instrument -Electrical -Jam -Software/
Antibiotic Reporting Rules
QC Organism -Storage/ Preparation
Reported Results -Transmission of results to
Hospital Information Systems -Review of
released results -Clinician feedback
Reagent Integrity -Shipping / storage -Expiration
date -Preparation/Use
QC organism -Failure -Error
6 Test Results
3 Reagents
5 Test System
Pre-analytical Analytical Post-analytical
41
Harm from Potential Error Commercial
AST System
5 Test System Frequency of Occurrence Severity of Harm Measures to control risk Relevant SOP
Electrical / Jam Occasional Negligible Minor AST Instrument Maintenance log appropriate utilities are employed in the laboratory to serve the instrumentation SOP.xxxx SOP.xxxx
Software / Antibiotic result reporting Unlikely Minor Critical All testing personnel have had appropriate training on software and appropriate result reporting SOP.xxxx
QC organism failure / error Occasional Negligible Minor All testing personnel have had appropriate training to detect failures/error AST QC log SOP.xxxx
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1 Specimen Organism
RISK ASSESSMENT Identification of Potential
Failures - Commercial AST System
2 Testing Personnel
Specimen (1A) -Patient identification -Collection/
container/ volume -Transport -Storage Organism
(1B) -Clinically relevant -Colony age -Media type
-Pure isolate -Inoculum suspension
4 Environment
Factors -Temperature/ Airflow/ Humidity/
Ventilation -Utilities -Space -Noise/Vibrations
Operator Function -Training -Competency
Assessment -Proficiency Testing -Staffing
Incorrect Test Results
Identify Potential Hazards
Instrument -Electrical -Jam -Software/
Antibiotic Reporting Rules
QC Organism -Storage/ Preparation
Reported Results -Transmission of results to
Hospital Information System -Review of
released results -Clinician feedback
Reagent Integrity -Shipping / storage -Expiration
date -Preparation/Use
QC organism -Failure -Error
6 Test Results
3 Reagents
5 Test System
Pre-analytical Analytical Post-analytical
43
Harm from Potential Error Commercial
AST System
6 Test Results Frequency of Occurrence Severity of Harm Measures to control risk Relevant SOP
Transmission of results to HIS Unlikely Negligible Minor Periodic review of released results to HIS. SOP.xxxx
Review of released results Occasional Frequent Negligible Minor Review of all (or pertinent) released results according to SOP. Appropriate investigation for all reporting errors. SOP.xxxx SOP.xxxx
Clinician feedback Occasional Minor Critical Appropriate investigation for all clinician feedback, issues, complaints. SOP.xxxx
44
IQCP Commercial AST

• I. Risk assessment (RA) of the System
• - Fishbone Diagram
• II. Quality Control Plan (QCP) for the System
• - QCP Tables
• III. Quality Assessment (QA) for the System

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III. Quality Assessment (QA)
Develop a Post-Implementation Monitoring
Process that will allow you to know when a
process is in need of review/revision. These may
include the periodic review and monitoring of the
following (not limited to these)

• Specimen collection/transportation, etc.
  protocols
• Staff training
• Competency assessment
• Proficiency testing
• Quality Control/Instrument function results
• Unexpected Errors
• Laboratory error investigation/remediation
• Complaint investigation/remediation

Pre-analytical Analytical Post-analytical
46
III. Quality Assessment (QA)Post-implementation
monitoring process

• All instrument or QC organism failures will be
  brought to the attention of the supervisor or
  designee immediately for investigation (see
  SOP.xxxx).
• Documented review of QC will be performed by
  supervisor or designee weekly and by supervisor
  monthly to see that QC is accurately performed
  and documented (see SOP.xxxx).
• Remediation of PT failures is addressed timely
  (see SOP.xxxx).
• Reporting errors are investigated timely (see
  SOP.xxxx).
• Complaint investigations are carried out timely
  in a timely manner (see SOP.xxxx).
• For all QC/PT failures, laboratory reporting
  errors, complaints, etc., a reassessment of risk
  will be performed and adjustments made to the QCP
  as necessary. The reason for failure will be
  identified and addressed in a new/updated risk
  assessment answering the following
• Has a new hazard been identified?
• Does this hazard change the frequency of
  occurrence for errors/risks?
• Does this hazard change the severity of harm
  (impact)?
• Additional control measures will be implemented
  if necessary as determined by the new risk
  assessment.

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IQCP Commercial AST (example)

• Based on our
• Risk Assessment
• Quality Control Program
• Overall Laboratory Quality Assessment program
• The QCP for our Commercial AST System will
  consist of following the instructions in SOP.xxxx
  and recording results on QC-FORM.xxxx
• QC will consist of
• Testing of ATCC QC organism(s) (specify
  organisms) per each lot shipment on each type
  of AST panel before or concurrently with placing
  these materials into service.
• Thereafter, weekly (or a time frame supported by
  your QCP and data) testing with ATCC QC
  organism(s) (specify organisms) on each type of
  AST panel.
• Testing ATCC QC organism(s) (specify organisms)
  on each type of AST panel after each major system
  maintenance or software upgrade before or
  concurrently with placing the instrument back
  into service.
• QC Acceptability Criteria is defined in SOP.xxxx

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Questions?

• CMS
• IQCP_at_cms.hhs.gov
• ASM (Clin Micro Portal ? Lab Management)
• http//clinmicro.asm.org/index.php/lab-management/
  laboratory-management/445-iqcp-iqcp
• CMS information
• IQCP Templates and examples from an ASM-CAP-CLSI
  collaborative effort (coming soon)

49
IQCP-Individualized Quality Control PlanWhat
Does it Mean for You?SCACM Audioconference
April 28, 2015

• This audioconference is supported through an
  educational grant from BioFire Diagnostics