Transcript IQCP - Illinois Society for Microbiology |Microbiology

IQCP
Example #1
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1
Individualized Quality Control Plan
(IQCP)
Commercial Antimicrobial
Susceptibility Testing (AST)
Systems
(Vendor and System)
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IQCP includes the following and each will be
addressed separately:
• Risk assessment (RA) of the AST System
• Quality Control Plan (QCP) for the AST
System
• Quality Assessment (QA) for the AST System
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Risk Assessment
Consists of two parts:
• Collect Information/Data:
• Identify areas where errors or
failures could occur in the entire
testing process (pre-analytical,
analytical, and post-analytical)
• Conduct a Risk Assessment:
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Risk Assessment
Collection of information:
• Manufacturer instructions
• Manufacturer performance data
• Literature published on assay
• Accreditation/regulatory requirements
• Available laboratory data
 Verification / validation testing data
 Historical QC data
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Risk Assessment
Collecting Information/Data
Manufacturer instructions:
• Look specifically at ‘Limitations’ section to
identify possible risks.
• Note manufacturer’s recommended QC (QC
defined in your IQCP may not be less
stringent than that recommended by the
manufacturer)
• Include a copy of your manufacturer’s
package insert (PI) in your IQCP materials.
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Risk Assessment
Collecting Information/Data
Manufacturer performance data:
• Look for any risks associated with this
system that have been identified in the
manufacturer’s performance data.
• Also review any manufacturer alerts or
bulletins for associated risks. Include copy
of alert, bulletin, etc. in your IQCP
materials.
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Risk Assessment
Collecting Information/Data
Literature published on assay:
• Look for any risks associated with this system that
have been identified in literature.
• Be sure to consider version of system reported in
literature as related to version of system/software used
in your laboratory.
• Include copies of pertinent articles in your IQCP
materials.
Accreditation/Regulatory requirements:
• Ensure that your IQCP is in compliance with
accreditation or regulatory requirements.
• Include copies of these requirements in your IQCP
materials.
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Risk Assessment
Collect Information/Data
In-house laboratory data:
• Review your initial verification studies (and
any subsequent studies)
• Review historical QC data to help define
your IQCP.
• Include these data in your IQCP materials,
or identify where data can be found in lab.
• Include previously reported patient test
errors, etc. may also be pertinent if
available. See following page for additional
details on historical QC data review.
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Example Summary of
Historical In-house QC data
Example summary may include:
•
QC data for the past [XX] months (1/1/XX 12/31/XX) were reviewed. Testing was performed
as outlined in the QC section of SOP.xxxx (name
of policy/procedure).
•
When testing CLSI or manufacturer
recommended QC strains using the same
procedures as for testing patient’s isolates, our
data showed:
• # or % occurrence of random QC errors which
corrected upon repeat testing, and
• # or % occurrence of potential system QC
errors that required corrective action beyond
simple repeat testing. (Make a table listing
these errors and corrective action in a
separate table.)
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Example Summary of
Historical In-house QC data
•
•
When performing/reviewing manufacturer
or laboratory defined instrument records
and functions checks, our data showed
that there were # or % out-of-control
observations.
For all reviews, include time span of review
ex 1/2013 – 12/2014
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Risk Assessment
Conduct a Risk Assessment MUST include 5 CMS (Centers for Medicare
and Medicaid Services) risk assessment
components (may add others):
1) Specimen (also include organism for
AST)
2) Testing Personnel
3) Reagents
4) Environment
5) Test System
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Risk Assessment (cont’d)
•
Identify where, along the testing process,
risk of errors might occur.
•
Determine the frequency of occurrence of
the error and the possible severity of harm
if an error would occur.
•
This risk assessment must include preanalytical, analytical, and post-analytical
areas of the testing process.
(See Fishbone diagram example next page)
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1
Specimen
Specimen (1A)
-Patient identification
-Collection/container/
volume
-Transport
-Storage
Specimen (1B)
-Clinically relevant
-Colony age
-Media type
-Pure isolate
-Inoculum suspension
RISK ASSESSMENT: Identification of
Potential Failures
for Commercial AST System
2
Testing Personnel
Operator Function
-Training
-Competency Assessment
-Proficiency Testing
-Staffing
Identify Potential
Hazards
Reagent Integrity
-Shipping / storage
-Expirations date
-Preparation/Use
4
Environment
Factors
-Temperature/ Humidity
Airflow/ Ventilation
-Utilities / Space
-Noise/Vibrations
Instrument
-Electrical
-Jam
-Software
QC Organism
-Storage/
Preparation
QC organism
Failure/error
3
Reagents
5
Test System
Incorrect Test
Results
Reported Results
-Transmission of results to
Hospital Information Systems
-Review of released results
-Clinician feedback
Pre-analytical
Analytical
Post-analytical
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Risk Assessment
•
•
•
•
Identify measures to control and/or reduce
risk.
Build tables to include all risks identified in
your fishbone diagram (formats other than
fishbone diagrams may be used).
Determine “Frequency of occurrence” and
“Possible severity of harm” for each risk
identified.
Indicate measures you have in place to
mitigate or reduce these risks/errors
(including where to find these measures in
your procedures, reports, logs, etc.).
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Risk Assessment
Frequency of occurrence of an error
(how often might this error occur?)
Frequency of Occurrence
• Unlikely (1 every 2-3 years)
• Occasional (1 per year)
• Probable (1 per month)
• Frequent (1 per week)
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Risk Assessment
Possible “Severity of harm” due to this error
(if this error occurs, what is the possible
severity of harm as a result?)
Severity of Harm
• Negligible (temporary discomfort)
• Minor (temporary injury; not requiring medical
intervention)
• Serious (impairment requiring medical
intervention)
• Critical (permanent impairment requiring
medical intervention)
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Risk Assessment - Specimen
1A
Specimen
Frequency Severity
of
of
Occurrence Harm
Patient
Occasional
identification
Collection/
Container/
Volume
Occasional
Measures to control
risk
Minor- Patient identification
Critical criteria defined;
acceptability defined;
competency
assessment performed
Minor- Collection/ container
Critical criteria defined per
source; acceptability
defined; competency
assessment performed
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Relevant
SOP
SOP
SOP
SOP
SOP
SOP
SOP
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Risk Assessment - Specimen
1A
Frequency Severity
Specimen
of
of
Occurrence
Harm
Transport
Occasional
MinorCritical
Storage
Occasional
MinorCritical
Measures to control
risk
Relevant
SOP
Transport criteria
defined per source;
acceptability defined;
competency
assessment performed
Storage criteria defined
per source;
acceptability defined;
competency
assessment performed
SOP
SOP
SOP
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SOP
SOP
SOP
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Risk Assessment - Specimen
1B
Organism
Measures to control
risk
Relevant
SOP
MinorCritical
Selection criteria defined
in training; competency
assessment performed
SOP
SOP
SOP
Colony Age OccasionalFrequent
MinorCritical
SOP
SOP
Media type Occasional
MinorCritical
Selection criteria defined
in training; competency
assessment performed
Selection criteria defined
in training; competency
assessment performed
Clinically
relevant
Frequency Severity
of
of
Occurrence Harm
Occasional
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SOP
SOP
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Risk Assessment - Specimen
1B
Organism
Frequency Severity
of
of
Occurrence
Harm
Pure isolate OccasionalFrequent
MinorCritical
Inoculum
Occasional
suspension
preparation
MinorCritical
Measures to control
risk
Relevant
SOP
Selection criteria
defined in training;
competency
assessment performed
Preparation criteria
defined in training;
competency
assessment performed
SOP.xxxx
SOP.xxxx
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SOP.xxxx
SOP.xxxx
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Risk Assessment – Testing Personnel
2
Testing
Personnel
Training
Frequency Severity
of
of
Occurrence Harm
Measures to control
risk
Occasional
MinorCritical
All testing personnel
have had appropriate
training
Competency Occasional
Assessment
MinorCritical
All personnel have
appropriate CA
performed
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Relevant
SOP
SOP.xxxx
(training
documenta
tion, etc.)
SOP.xxxx
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Risk Assessment – Testing Personnel
2
Frequency Severity
Testing
of
of
Personnel Occurrence
Harm
Measures to control
risk
Proficiency Occasional
Testing
Negligible All PT failures
-Minor
addressed with
corrective action
Staffing
MinorCritical
Occasional
Relevant
SOP
SOP.xxxx
Adequate staffing to
SOP.xxxx
support test menu and
turn-around-times on all
shifts
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Risk Assessment – Reagents
3
Reagents
Frequency Severity
of
of
Occurrence
Harm
Occasional
Minor –
Critical
Expiration Unlikely
dates
Preparation Occasional
/Use
Minor –
Critical
Critical
Receiving
/Storage
Measures to control
risk
Relevant
SOP
Reagents are shipped
and stored according to
manufacturer’s
instructions.
Reagents are used
within expiration dates.
All reagents are
prepared/used
according to
manufacturer’s
instructions.
SOP.xx
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SOP.xx
SOP.xx
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Risk Assessment – Reagents
3
Reagents
Frequency Severity
of
of
Occurrence
Harm
Measures to control
risk
Relevant
SOP
QC
Occasional
organism
storage/
preparation
Minor –
Critical
Results for all QC
organisms are within
acceptable limits.
Storage and
preparation of QC
strains are defined.
SOP.xxxx
SOP.xxxx
QC
Occasional
organism
failure/error
Negligible AST QC log and
–
corrective action logs
Minor
SOP.xxxx
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Risk Assessment – Environment
4
Frequency Severity
Environment
of
of
Occurrence Harm
Temperature/ Unlikely
Airflow
Humidity/
Ventilation
Utilities
Unlikely
Measures to control Relevant
risk
SOP
Negligible Appropriate
SOP.xxxx
– Minor
environmental
conditions are
maintained in the
laboratory
Negligible Appropriate utilities
SOP.xxxx
– Minor
are employed in the
laboratory to serve the
instrumentation
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Risk Assessment – Environment
4
Frequency Severity Measures to control Relevant
Environment
of
of
risk
SOP
Occurrenc
Harm
e
Space
Unlikely
Negligible Appropriate space is
SOP.xxxx
– Minor
available in the
laboratory to serve the
instrumentation
Noise
/Vibration
Unlikely
Negligible Appropriate
– Minor
parameters are in
place to serve the
instrumentation
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SOP.xxxx
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Risk Assessment – Test System
5
Frequency Severity
Test
of
of
System Occurrence
Harm
Measures to control risk
Relevant
SOP
Electrical Occasional
Negligible AST Instrument Maintenance SOP.xx
– Minor
log; appropriate utilities are
SOP.xx
employed in laboratory to
serve instrumentation
Jam
Negligible Training and procedures &/or SOP.xx
– Minor
instrument operation manual SOP.xx
is provided to resolve jams
and evaluate test results
after resolution.
Occasional
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Risk Assessment – Test System
5
Test System
Software
Frequency Severity Measures to control Relevant
of
of
risk
SOP
Occurrenc
Harm
e
Occasional Minor –
All testing personnel
SOP.xxxx
Critical
have had appropriate
training
Transmission Unlikely
of data to LIS
Minor –
Critical
Measures are in place SOP.xxxx
to verify appropriate
transmission of data.
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Risk Assessment – Test System
5
Test System
Frequency Severity
of
of
Occurrence Harm
Transmission Unlikely
of results to
Hospital
Information
Systems (HIS)
Review of
Occasionalreleased
frequent
results
Measures to control Relevant
risk
SOP
Negligible Periodic review of
– Minor
released results to
HIS.
SOP.xxxx
Negligible Review of all (or
– Minor
pertinent) released
results according to
SOP. Appropriate
investigation for all
reporting errors.
SOP.xxxx
SOP.xxxx
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Quality Control Plan (QCP)
QCP must also include:
• Number of QC,
• Type of QC,
• Frequency of QC testing (supported by
data)
• Criteria for QC acceptability
• May be no less than manufacturer’s
instructions
• May include electronic QC, procedural QC,
training, competency assessment, other
QC activities
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Example - QCP Summary
QC for Commercial AST will consist of:
• Testing of ATCC QC organism(s) (specify
organisms) per each lot & shipment on each type
of AST card before or concurrently with placing
these materials into service.
• Thereafter, weekly (or a time frame supported by
your QCP) testing with ATCC QC organism(s)
(specify organisms) on each type of AST card.
• Testing ATCC QC organism(s) (specify
organisms) on each type of AST card 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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Example - QCP Summary
•
May want to include a chart the details
what
 ATCC QC strains are used for Gram positive




panel (eg Vitek panel, MicroScan panel)
ATCC QC strains are used for Gram negative
panel
Frequency (eg once each week)
Testing to be done on each type of AST after
major system maintenance or software upgrade
before or concurrently with placing instrument
back in service
Testing appropriate QC Strains for new
antimicrobial agents added to a panel in addition
to performing verification studies
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Director Signature
Include a signed statement by your laboratory
director indicating that the IQCP/QCP has
been reviewed and is acceptable. For
example:
This IQCP/QCP has been reviewed and is
approved by the laboratory director (as
named on the CLIA license).
_____________
_________
(Laboratory Director signature)
(date)
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Quality Assessment (QA)
Develop a continual “Post-Implementation Monitoring
Process” that will allow you to know when a process is in
need of review/revision.
 QA must include the review and monitoring of the
following:
 Specimen
 Testing Personnel
 Reagents
 Environment
 Test System
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Example - Quality Assessment
Staff training in specimen requirements, test
organism selection/preparation
See SOP.xxxx, SOP.xxxx
Competency assessment
See SOP.xxxx
Proficiency Testing
See SOP.xxxx
Quality Control/Instrument Function
See SOP.xxxx, SOP.xxxx
Unexpected Errors
See SOP.xxxx
Pre-analytical
Analytical
Post-analyticall
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Example - Quality Assessment (cont)
Laboratory error investigation/remediation
See SOP.xxxx
Complaint investigation/remediation
See SOP.xxxx
Pre-analytical
Analytical
Post-analytical
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Example - Monitoring of the PostImplementation Process may include:
•
•
•
•
•
Instrument or QC organism failures are
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 ensure QC is accurately
performed and documented (see SOP.xxxx).
PT (proficiency testing) failures are addressed
as soon as possible (see SOP.xxxx).
Reporting errors are addressed as soon as
possible (see SOP.xxxx).
Complaint investigations are carried out in a
timely manner (see SOP.xxxx).
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Monitoring of the Post-Implementation
Process may include: (cont’d)
•
For all QC failures, PT failures, laboratory
reporting errors, complaints, etc., reassessment of
risk will be performed and adjustments made to
the QCP as necessary.
•
Reason for failure will be identified and addressed
in a new/updated risk assessment answering
following:
Has a new hazard been identified?
Does this hazard change the frequency of
risk?
Does this hazard change the severity of harm?
•
Additional control measures will be implemented if
necessary as determined by new risk assessment.
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EXAMPLE # 2
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Individualized Quality Control Plan
(IQCP)
Commercially Prepared Exempt
Culture Media
(Vendors)
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IQCP includes the following and each will be
addressed separately:
• Risk assessment (RA) of Exempt Culture
Media as defined in CLSI M22 – Table 1B
• Quality Control Plan (QCP) for Exempt
Culture Media as defined in CLSI M22 –
Table 1B
• Quality Assessment (QA) for Exempt Culture
Media as defined in CLSI M22 – Table 1B
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Risk Assessment
Consists of two parts:
• Collecting of Information/Data:
 Identify areas where errors or failures
could occur in the entire testing process
(pre-analytical, analytical, and postanalytical)
• Conducting a Risk Assessment:
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Risk Assessment
Collection of information:
• Manufacturer instructions
• Manufacturer performance data
• Literature published on assay
• Accreditation/regulatory requirements
• Available laboratory data
 Verification / validation testing data
 Historical QC data
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Risk Assessment
Collecting Information/Data
Manufacturer instructions:
• Look specifically at ‘Limitations’ section to
identify possible risks.
• Note manufacturer’s recommended QC (QC
defined in your IQCP may not be less
stringent than that recommended by the
manufacturer)
• Include a copy of your manufacturer’s
package insert (PI) in your IQCP materials.
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45
Risk Assessment
Collecting Information/Data
Manufacturer performance data:
• Look for any risks associated with this
system that have been identified in the
manufacturer’s performance data.
• Also review any manufacturer alerts or
bulletins for associated risks. Include copy
of alert, bulletin, etc. in your IQCP
materials.
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46
Risk Assessment
Collecting Information/Data
Literature published on assay:
• Look for any risks associated with this system that
have been identified in literature.
• Be sure to consider version of system reported in
literature as related to version of system/software used
in your laboratory.
• Include copies of pertinent articles in your IQCP
materials.
Accreditation/Regulatory requirements:
• Ensure that your IQCP is in compliance with
accreditation or regulatory requirements.
• Include copies of these requirements in your IQCP
materials.
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Risk Assessment
Collect Information/Data
In-house laboratory data:
• Review your initial verification studies (and
any subsequent studies)
• Review historical QC data to help define
your IQCP.
• Include these data in your IQCP materials,
or identify where data can be found in lab.
• Include previously reported patient test
errors, etc. may also be pertinent if
available. See following page for additional
details on historical QC data review.
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Example Summary of
Historical In-house QC data
Example summary may include:
• QC data for the past [XX] months (1/1/XX 12/31/XX) were reviewed
• Visual inspection records of exempt media
as listed in NCCLS / CLSI M22 document
were reviewed
• Testing was performed as outlined in the
QC section of SOP.xxxx.
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Summary of Historical In-house
QC data
•
Reference used is NCCLS M22-A3 – “Quality
Control for Commercially Prepared Microbiological
Culture Media; Approved Standard – Third Edition
Table 1 - College of American Pathologists
Extrapolated Failure Rates (EFR) of Media
from 3 surveys (1984, 1988 and 2001)
 Exempt media has EFR <=0.5%, quality
control is not required unless used for
fastidious organisms
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Summary of Historical In-house
QC data
•
QC reviewed were for exempt media as
defined in NCCLS M22-A3-Table 1A for:




•
Blood culture media
Bacteriology culture media
Mycology culture media
Mycobacteriology culture media
Documentation reviewed were:
 Visual inspection (in accordance with
CMS/CLIA and CAP) records
 Vendor QC/Performance statements in
accordance with NCCLS M22-A3
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Vendor – QC CLSI M22 Statements
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References and data
•
•
•
Vendor statements – NCCLS M22-A3
CAP checklist questions – your lab
documentation for these questions
NCCLS M22-A3 document – Table 1A for
exempt media
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Vendor – QC CLSI M22 Statements
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Vendor – CLSI M22 Statements
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Media – CAP Checklist Questions
MIC.21220 Media Visual Inspection
I
•
The laboratory has documentation that
each shipment of purchased media is
examined for breakage, contamination,
appearance, and evidence of freezing or
overheating.
•
Reference: CLSI M22-A3
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Media – CAP Checklist Questions
MIC.21420 Media Visual Examination
II
•
All media are in visibly satisfactory
condition (with expiration date, plates
smooth, adequately hydrated,
uncontaminated, appropriate color and
thickness, tubed media not dried or loose
from sides).
•
Reference: CLSI M22-A3
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NCCLS – M22- A3 – Table 1B
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NCCLS – M22- A3 – Table 1B
•
Exempt categories for Media included in
CAP Surveys (1984, 1988, 2001)
•
Results of the survey of the quality
assurance for commercially prepared
microbiology media.
•
Use NCCLS – M22-A3- Table 1B as a
reference
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Risk Assessment
Conduct a Risk Assessment MUST include 5 CMS risk assessment
components (may add others):
1) Specimen
2) Testing Personnel
3) Reagents 4) Environment
5) Test System
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60
Risk Assessment (cont’d)
•
Identify where, along the testing process,
risk of errors might occur.
•
Determine the frequency of occurrence of
the error and the possible severity of harm
if an error would occur.
•
This risk assessment must include preanalytical, analytical, and post-analytical
areas of the testing process.
(See Fishbone diagram example next page)
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61
1
Specimen
Specimen (1A)
-Patient identification
-Collection/container/
volume
-Transport
-Storage
Specimen (1B)
-Clinically relevant
-Colony age
-Media type
-Pure isolate
-Inoculum suspension
RISK ASSESSMENT: Identification of
Potential Failures for
Commercially Prepared Exempt Culture Media
2
Testing Personnel
Operator Function
-Training
-Competency Assessment
-Proficiency Testing
-Staffing
4
Environment
Factors
-Temperature/ Humidity
Airflow/ Ventilation
-Utilities / Space
-Noise/Vibrations
Identify Potential
Hazards
Incorrect Test
Results
Reported Results
-Transmission of results to
Hospital Information Systems
-Review of released results
-Clinician feedback
Commercially Prepared
Exempt Culture Media
-Shipping / storage
-Expirations date
-Visual inspection
-Vendor QC/performance statements
3
Reagents
5
Test System
Pre-analytical
Analytical
Post-analytical
62
Risk Assessment
•
•
•
•
Identify measures to control and/or reduce
risk.
Build tables to include all risks identified in
your fishbone diagram (formats other than
fishbone diagrams may be used).
Determine “Frequency of occurrence” and
“Possible severity of harm” for each risk
identified.
Indicate measures you have in place to
mitigate or reduce these risks/errors
(including where to find these measures in
your procedures, reports, logs, etc.).
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63
Risk Assessment
Frequency of occurrence of an error
(how often might this error occur?)
Frequency of Occurrence
• Unlikely (1 every 2-3 years)
• Occasional (1 per year)
• Probable (1 per month)
• Frequent (1 per week)
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Risk Assessment
Possible “Severity of harm” due to this error
(if this error occurs, what is the possible
severity of harm as a result?)
Severity of Harm
• Negligible (temporary discomfort)
• Minor (temporary injury; not requiring medical
intervention)
• Serious (impairment requiring medical
intervention)
• Critical (permanent impairment requiring
medical intervention)
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Risk Assessment - Specimen
1A
Specimen
Frequency Severity
of
of
Occurrence Harm
Patient
Occasional
identification
Collection/
Container/
Volume
Occasional
Measures to control
risk
Minor- Patient identification
Critical criteria defined;
acceptability defined;
competency
assessment performed
Minor- Collection/ container
Critical criteria defined per
source; acceptability
defined; competency
assessment performed
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Relevant
SOP
SOP
SOP
SOP
SOP
SOP
SOP
66
Risk Assessment - Specimen
1A
Frequency Severity
Specimen
of
of
Occurrence
Harm
Transport
Occasional
MinorCritical
Storage
Occasional
MinorCritical
Measures to control
risk
Relevant
SOP
Transport criteria
defined per source;
acceptability defined;
competency
assessment performed
Storage criteria defined
per source;
acceptability defined;
competency
assessment performed
SOP
SOP
SOP
A partnership of the Advocate and Aurora Health Care System
SOP
SOP
SOP
67
Risk Assessment - Specimen
1B
Organism
Measures to control
risk
Relevant
SOP
MinorCritical
Selection criteria defined
in training; competency
assessment performed
SOP
SOP
SOP
Colony Age OccasionalFrequent
MinorCritical
SOP
SOP
Media type Occasional
MinorCritical
Selection criteria defined
in training; competency
assessment performed
Selection criteria defined
in training; competency
assessment performed
Clinically
relevant
Frequency Severity
of
of
Occurrence Harm
Occasional
A partnership of the Advocate and Aurora Health Care System
SOP
SOP
68
Risk Assessment - Specimen
1B
Organism
Frequency Severity
of
of
Occurrence
Harm
Pure isolate OccasionalFrequent
MinorCritical
Inoculum
Occasional
suspension
preparation
MinorCritical
Measures to control
risk
Relevant
SOP
Selection criteria
defined in training;
competency
assessment performed
Preparation criteria
defined in training;
competency
assessment performed
SOP.xxxx
SOP.xxxx
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SOP.xxxx
SOP.xxxx
69
Risk Assessment – Testing Personnel
2
Testing
Personnel
Training
Frequency Severity
of
of
Occurrence Harm
Measures to control
risk
Occasional
MinorCritical
All testing personnel
have had appropriate
training
Competency Occasional
Assessment
MinorCritical
All personnel have
appropriate CA
performed
A partnership of the Advocate and Aurora Health Care System
Relevant
SOP
SOP.xxxx
(training
documenta
tion, etc.)
SOP.xxxx
70
Risk Assessment – Testing Personnel
2
Frequency Severity
Testing
of
of
Personnel Occurrence
Harm
Measures to control
risk
Proficiency Occasional
Testing
Negligible All PT failures
-Minor
addressed with
corrective action
Staffing
MinorCritical
Occasional
Relevant
SOP
SOP.xxxx
Adequate staffing to
SOP.xxxx
support test menu and
turn-around-times on all
shifts
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71
Risk Assessment – Reagents
3
Reagents
Frequency Severity
of
of
Occurrence
Harm
Occasional
Minor –
Critical
Expiration Unlikely
dates
Preparation Occasional
/Use
Minor –
Critical
Critical
Receiving
/Storage
Measures to control
risk
Relevant
SOP
Reagents are shipped
and stored according to
manufacturer’s
instructions.
Reagents are used
within expiration dates.
All reagents are
prepared/used
according to
manufacturer’s
instructions.
SOP.xx
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SOP.xx
SOP.xx
72
Risk Assessment – Reagents
3 Reagents
Frequency Severity
of
of
Occurrence
Harm
Visual
inspection
Occasional
Vendor QC/ Occasional
Performance
statements
Minor –
Critical
Measures to control
risk
Relevant
SOP
Results for all visual
inspections are within
acceptable limits.
SOP.xxxx
SOP.xxxx
Negligible Certificate of media
–
conformance can be
Minor
referenced on vendor
website
SOP.xxxx
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73
Risk Assessment – Environment
4
Frequency Severity
Environment
of
of
Occurrence Harm
Temperature/ Unlikely
Airflow
Humidity/
Ventilation
Utilities
Unlikely
Measures to control Relevant
risk
SOP
Negligible Appropriate
SOP.xxxx
– Minor
environmental
conditions are
maintained in the
laboratory
Negligible Appropriate utilities
SOP.xxxx
– Minor
are employed in the
laboratory to serve the
instrumentation
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Risk Assessment – Environment
4
Frequency Severity Measures to control Relevant
Environment
of
of
risk
SOP
Occurrenc
Harm
e
Space
Unlikely
Negligible Appropriate space is
SOP.xxxx
– Minor
available in the
laboratory to serve the
instrumentation
Noise
/Vibration
Unlikely
Negligible Appropriate
– Minor
parameters are in
place to serve the
instrumentation
A partnership of the Advocate and Aurora Health Care System
SOP.xxxx
75
Risk Assessment – Test System
5
Test System
Frequency Severity
of
of
Occurrence Harm
Transmission Unlikely
of results to
Hospital
Information
Systems (HIS)
Review of
Occasionalreleased
frequent
results
Measures to control Relevant
risk
SOP
Negligible Periodic review of
– Minor
released results to
HIS.
SOP.xxxx
Negligible Review of all (or
– Minor
pertinent) released
results according to
SOP. Appropriate
investigation for all
reporting errors.
SOP.xxxx
SOP.xxxx
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Quality Control Plan (QCP)
QCP must also include:
• Number of QC,
• Type of QC,
• Frequency of QC testing (supported by
data)
• Criteria for QC acceptability
• May be no less than manufacturer’s
instructions
• May include electronic QC, procedural QC,
training, competency assessment, other
QC activities
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77
Example - QCP Summary
•
May want to include a chart or listing of
specific exempt media used for:
 Blood culture media (vendor, may want to
list bottle types)
 Bacteriology culture media (vendor, blood
agar, MacConkey, CNA, etc)
 Mycology culture media (vendor, type of
media)
 Mycobacteriology culture media (vendor,
type of media)
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78
Director Signature
Include a signed statement by your laboratory
director indicating that the IQCP/QCP has
been reviewed and is acceptable. For
example:
This IQCP/QCP has been reviewed and is
approved by the laboratory director (as
named on the CLIA license).
_____________
_________
(Laboratory Director signature)
(date)
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79
Quality Assessment (QA)
Develop a continual “Post-Implementation Monitoring
Process” that will allow you to know when a process is in
need of review/revision.
 QA must include the review and monitoring of the
following:
 Specimen
 Testing Personnel
 Reagents
 Environment
 Test System
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80
Quality Assessment (QA)
Develop a continual “Post-Implementation Monitoring
Process” that will allow you to know when a process is in
need of review/revision.
 QA must include the review and monitoring of the
following:
 Specimen
 Testing Personnel
 Reagents
 Environment
 Test System
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81
Example - Quality Assessment
Staff training in specimen requirements, test
organism selection/preparation
See SOP.xxxx, SOP.xxxx
Competency assessment
See SOP.xxxx
Proficiency Testing
See SOP.xxxx
Quality Control/Instrument Function
See SOP.xxxx, SOP.xxxx
Unexpected Errors
See SOP.xxxx
Pre-analytical
Analytical
Post-analyticall
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82
Example - Quality Assessment (cont)
Laboratory error investigation/remediation
See SOP.xxxx
Complaint investigation/remediation
See SOP.xxxx
Pre-analytical
Analytical
Post-analytical
A partnership of the Advocate and Aurora Health Care System
83
Example -Monitoring of the PostImplementation Process may include:
•
•
•
•
Documented review of media visual inspection
records will be performed by supervisor or
designee weekly and by supervisor monthly to
ensure media visual inspection records are
accurately performed and documented (see
SOP.xxxx).
PT (proficiency testing) failures are addressed
as soon as possible (see SOP.xxxx).
Reporting errors are addressed as soon as
possible (see SOP.xxxx).
Complaint investigations are carried out in a
timely manner (see SOP.xxxx).
A partnership of the Advocate and Aurora Health Care System
84
Monitoring of the Post-Implementation
Process may include: (cont’d)
•
For all QC failures, PT failures, laboratory
reporting errors, complaints, etc., reassessment of
risk will be performed and adjustments made to
the QCP as necessary.
•
Reason for failure will be identified and addressed
in a new/updated risk assessment answering
following:
Has a new hazard been identified?
Does this hazard change the frequency of
risk?
Does this hazard change the severity of harm?
•
Additional control measures will be implemented if
necessary as determined by new risk assessment.
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85
EXAMPLE # 3
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86
Individualized Quality Control Plan
(IQCP)
Commercial Microbial Identification
Systems
Vitek 2 Identification Cards
bioMerieux
A partnership of the Advocate and Aurora Health Care System
IQCP includes the following and each will be
addressed separately:
• Risk assessment (RA) of Vitek Identification
for Bacteria (GN, GP, NH, ANC)
• Quality Control Plan (QCP) for Vitek
Identification for Bacteria
• Quality Assessment (QA) for Vitek
Identification for Bacteria
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88
Risk Assessment
Consists of two parts:
• Collect Information/Data:
• Identify areas where errors or
failures could occur in the entire
testing process (pre-analytical,
analytical, and post-analytical)
• Conduct a Risk Assessment:
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89
Risk Assessment
Collection of information:
• Manufacturer instructions
• Manufacturer performance data
• Literature published on assay
• Accreditation/regulatory requirements
• Available laboratory data
 Verification / validation testing data
 Historical QC data
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90
Risk Assessment
Collecting Information/Data
Manufacturer instructions:
• Look specifically at ‘Limitations’ section to
identify possible risks.
• Note manufacturer’s recommended QC (QC
defined in your IQCP may not be less
stringent than that recommended by the
manufacturer)
• Include a copy of your manufacturer’s
package insert (PI) in your IQCP materials.
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91
Risk Assessment
Collecting Information/Data
Manufacturer performance data:
• Look for any risks associated with this
system that have been identified in the
manufacturer’s performance data.
• Also review any manufacturer alerts or
bulletins for associated risks. Include copy
of alert, bulletin, etc. in your IQCP
materials.
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Risk Assessment
Collecting Information/Data
Literature published on assay:
• Look for any risks associated with this system that
have been identified in literature.
• Be sure to consider version of system reported in
literature as related to version of system/software used
in your laboratory.
• Include copies of pertinent articles in your IQCP
materials.
Accreditation/Regulatory requirements:
• Ensure that your IQCP is in compliance with
accreditation or regulatory requirements.
• Include copies of these requirements in your IQCP
materials.
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93
Risk Assessment
Collect Information/Data
In-house laboratory data:
• Review your initial verification studies (and
any subsequent studies)
• Review historical QC data to help define
your IQCP.
• Include these data in your IQCP materials,
or identify where data can be found in lab.
• Include previously reported patient test
errors, etc. may also be pertinent if
available. See following page for additional
details on historical QC data review.
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94
Summary of Historical In-house
QC data
•
Reference used CLSI M50-A– “Quality Control for
Commercial Microbial Identification Systems;
Approved Guideline”
Streamline QC
•
Question to ask – are all Vitek ID cards setup,
incubation and reading similar enough to be
included all in one IQCP? Even Yeast Card? If not
separate in to different IQCPs.
•
Do IQCP for those ID systems that you are
already doing Streamline QC
A partnership of the Advocate and Aurora Health Care System
95
CLSI M50 – Streamline QC
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96
References and Data Review
Review of:
• In-house verification / validation data
• Comprehensive MIS QC(CLIA 42 CFR
493.1256(e)(1) historical review as
described in CLSI M50 (6.2.1.2.b.i)
• Streamline QC data
• Vendor /manufacturer:
 Package insert
 Recommended QC organisms
 Recommended QC organisms for streamline
QC
A partnership of the Advocate and Aurora Health Care System
97
Risk Assessment (cont’d)
•
Identify where, along the testing process,
risk of errors might occur.
•
Determine the frequency of occurrence of
the error and the possible severity of harm
if an error would occur.
•
This risk assessment must include preanalytical, analytical, and post-analytical
areas of the testing process.
(See Fishbone diagram example next page)
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98
Risk Assessment
Conduct a Risk Assessment MUST include 5 CMS risk assessment
components (may add others):
1) Specimen
2) Testing Personnel
3) Reagents
4) Environment
5) Test System
A partnership of the Advocate and Aurora Health Care System
99
1
Specimen
Specimen (1A)
-Patient identification
-Collection/container/
volume
-Transport
-Storage
Specimen (1B)
-Clinically relevant
-Colony age
-Media type
-Pure isolate
-Inoculum suspension
RISK ASSESSMENT:
Identification of Potential Failures for
Commercial Microbial Identification Systems –
Vitek 2 Identification Cards
2
Testing Personnel
Factors
-Temperature/ Humidity
Airflow/ Ventilation
-Utilities / Space
-Noise/Vibrations
Operator Function
-Training
-Competency Assessment
-Proficiency Testing
-Staffing
Identify Potential
Hazards
Vitek ID Cards
-Shipping / storage
-Expirations date
-Use
4
Environment
Instrument
-Electrical
-Jam
-Software
QC Organism
-Storage
-Preparation
QC organism
Failure/error
3
Reagents
5
Test System
Incorrect Test
Results
Reported Results
-Transmission of results to
Hospital Information Systems
-Review of released results
-Clinician feedback
Pre-analytical
Analytical
Post-analytical
100
Risk Assessment
•
•
•
•
Identify measures to control and/or reduce
risk.
Build tables to include all risks identified in
your fishbone diagram (formats other than
fishbone diagrams may be used).
Determine “Frequency of occurrence” and
“Possible severity of harm” for each risk
identified.
Indicate measures you have in place to
mitigate or reduce these risks/errors
(including where to find these measures in
your procedures, reports, logs, etc.).
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101
Risk Assessment
Frequency of occurrence of an error
(how often might this error occur?)
Frequency of Occurrence
• Unlikely (1 every 2-3 years)
• Occasional (1 per year)
• Probable (1 per month)
• Frequent (1 per week)
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Risk Assessment
Possible “Severity of harm” due to this error
(if this error occurs, what is the possible
severity of harm as a result?)
Severity of Harm
• Negligible (temporary discomfort)
• Minor (temporary injury; not requiring medical
intervention)
• Serious (impairment requiring medical
intervention)
• Critical (permanent impairment requiring
medical intervention)
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Risk Assessment - Specimen
1A
Specimen
Frequency Severity
of
of
Occurrence Harm
Patient
Occasional
identification
Collection/
Container/
Volume
Occasional
Measures to control
risk
Minor- Patient identification
Critical criteria defined;
acceptability defined;
competency
assessment performed
Minor- Collection/ container
Critical criteria defined per
source; acceptability
defined; competency
assessment performed
A partnership of the Advocate and Aurora Health Care System
Relevant
SOP
SOP
SOP
SOP
SOP
SOP
SOP
104
Risk Assessment - Specimen
1A
Frequency Severity
Specimen
of
of
Occurrence
Harm
Transport
Occasional
MinorCritical
Storage
Occasional
MinorCritical
Measures to control
risk
Relevant
SOP
Transport criteria
defined per source;
acceptability defined;
competency
assessment performed
Storage criteria defined
per source;
acceptability defined;
competency
assessment performed
SOP
SOP
SOP
A partnership of the Advocate and Aurora Health Care System
SOP
SOP
SOP
105
Risk Assessment - Specimen
1B
Organism
Measures to control
risk
Relevant
SOP
MinorCritical
Selection criteria defined
in training; competency
assessment performed
SOP
SOP
Colony Age OccasionalFrequent
MinorCritical
SOP
SOP
Media type Occasional
MinorCritical
Selection criteria defined
in training; competency
assessment performed
Selection criteria defined
in training; competency
assessment performed
Clinically
relevant
Frequency Severity
of
of
Occurrence Harm
Occasional
A partnership of the Advocate and Aurora Health Care System
SOP
SOP
106
Risk Assessment - Specimen
1B
Organism
Frequency Severity
of
of
Occurrence
Harm
Pure isolate OccasionalFrequent
MinorCritical
Inoculum
Occasional
suspension
preparation
MinorCritical
Measures to control
risk
Relevant
SOP
Selection criteria
defined in training;
competency
assessment performed
Preparation criteria
defined in training;
competency
assessment performed
SOP.xxxx
SOP.xxxx
A partnership of the Advocate and Aurora Health Care System
SOP.xxxx
SOP.xxxx
107
Risk Assessment – Testing
Personnel
2
Testing
Personnel
Training
Frequency Severity
of
of
Occurrence Harm
Measures to control
risk
Occasional
MinorCritical
All testing personnel
have had appropriate
training
Competency Occasional
Assessment
MinorCritical
All personnel have
appropriate CA
performed
A partnership of the Advocate and Aurora Health Care System
Relevant
SOP
SOP.xxxx
(training
documenta
tion, etc.)
SOP.xxxx
108
Risk Assessment – Testing
Personnel
2
Frequency Severity
Testing
of
of
Personnel Occurrence
Harm
Measures to control
risk
Proficiency Occasional
Testing
Negligible All PT failures
-Minor
addressed with
corrective action
Staffing
MinorCritical
Occasional
Relevant
SOP
SOP.xxxx
Adequate staffing to
SOP.xxxx
support test menu and
turn-around-times on all
shifts
A partnership of the Advocate and Aurora Health Care System
109
Risk Assessment – Reagents
3
Frequency Severity
Reagents
of
of
Vitek ID Occurrence Harm
Cards
Receiving
/Storage
Occasional
Minor –
Critical
Expiration
dates
Use
Unlikely
Minor –
Critical
Critical
Occasional
Measures to control
risk
Cards are shipped and
stored according to
manufacturer’s
instructions.
Cards are used within
expiration dates.
Cards are used
according to
manufacturer’s
instructions.
A partnership of the Advocate and Aurora Health Care System
Relevant
SOP
SOP.xx
SOP.xx
SOP.xx
110
Risk Assessment – Reagents
3
Frequency Severity
Measures to control
Reagents
of
of
risk
QC
Occurrence
Harm
Organisms
Storage
Occasional Minor –
QC organisms are
Critical
stored according to
established guidelines
Preparation Occasional
Negligible QC organisms are
–
prepared according to
Minor
established guidelines
A partnership of the Advocate and Aurora Health Care System
Relevant
SOP
SOP.xxxx
SOP.xxxx
SOP.xxxx
111
Risk Assessment – Environment
4
Frequency Severity
Environment
of
of
Occurrence Harm
Temperature/ Unlikely
Airflow
Humidity/
Ventilation
Utilities
Unlikely
Measures to control Relevant
risk
SOP
Negligible Appropriate
SOP.xxxx
– Minor
environmental
conditions are
maintained in the
laboratory
Negligible Appropriate utilities
SOP.xxxx
– Minor
are employed in the
laboratory to serve the
instrumentation
A partnership of the Advocate and Aurora Health Care System
112
Risk Assessment – Environment
4
Frequency Severity Measures to control Relevant
Environment
of
of
risk
SOP
Occurrenc
Harm
e
Space
Unlikely
Negligible Appropriate space is
SOP.xxxx
– Minor
available in the
laboratory to serve the
instrumentation
Noise
/Vibration
Unlikely
Negligible Appropriate
– Minor
parameters are in
place to serve the
instrumentation
A partnership of the Advocate and Aurora Health Care System
SOP.xxxx
113
Risk Assessment – Test System
5
Test System
Frequency Severity
of
of
Occurrence Harm
Transmission Unlikely
of results to
Hospital
Information
Systems (HIS)
Review of
Occasionalreleased
frequent
results
Measures to control Relevant
risk
SOP
Negligible Periodic review of
– Minor
released results to
HIS.
SOP.xxxx
Negligible Review of all (or
– Minor
pertinent) released
results according to
SOP. Appropriate
investigation for all
reporting errors.
SOP.xxxx
SOP.xxxx
A partnership of the Advocate and Aurora Health Care System
114
Risk Assessment – Test System
5
Test System
Frequency Severity Measures to control Relevant
of
of
risk
SOP
Occurrence Harm
QC organism Unlikely
Negligible QC organisms are
SOP.xxxx
failure / error
prepared according to
established guidelines
A partnership of the Advocate and Aurora Health Care System
115
Quality Control Plan (QCP)
QCP must also include:
• Number of QC,
• Type of QC,
• Frequency of QC testing (supported by
data)
• Criteria for QC acceptability
• May be no less than manufacturer’s
instructions
• May include electronic QC, procedural QC,
training, competency assessment, other
QC activities
A partnership of the Advocate and Aurora Health Care System
116
QCP Summary
•
May want to include a chart for streamline
QC listing:
 Specific QC organisms used for each
Vitek ID card
 Frequency of testing
 Expected QC results
A partnership of the Advocate and Aurora Health Care System
117
Director Signature
Include a signed statement by your laboratory
director indicating that the IQCP/QCP has
been reviewed and is acceptable. For
example:
This IQCP/QCP has been reviewed and is
approved by the laboratory director (as
named on the CLIA license).
_____________
_________
(Laboratory Director signature)
(date)
A partnership of the Advocate and Aurora Health Care System
118
Quality Assessment (QA)
Develop a continual “Post-Implementation Monitoring
Process” that will allow you to know when a process is in
need of review/revision.
 QA must include the review and monitoring of the
following:
 Specimen
 Testing Personnel
 Reagents
 Environment
 Test System
A partnership of the Advocate and Aurora Health Care System
119
Example - Quality Assessment
Staff training in specimen requirements, test
organism selection/preparation
See SOP.xxxx, SOP.xxxx
Competency assessment
See SOP.xxxx
Proficiency Testing
See SOP.xxxx
Quality Control/Instrument Function
See SOP.xxxx, SOP.xxxx
Unexpected Errors
See SOP.xxxx
Pre-analytical
Analytical
Post-analyticall
A partnership of the Advocate and Aurora Health Care System
120
Example - Quality Assessment (cont)
Laboratory error investigation/remediation
See SOP.xxxx
Complaint investigation/remediation
See SOP.xxxx
Pre-analytical
Analytical
Post-analytical
A partnership of the Advocate and Aurora Health Care System
121
Monitoring of the PostImplementation Process may include:
•
•
•
•
Documented review of Vitek ID QC records
will be performed by supervisor or designee
weekly and by supervisor monthly to ensure
QC are accurately performed and
documented (see SOP.xxxx).
PT (proficiency testing) failures are addressed
as soon as possible (see SOP.xxxx).
Reporting errors are addressed as soon as
possible (see SOP.xxxx).
Complaint investigations are carried out in a
timely manner (see SOP.xxxx).
A partnership of the Advocate and Aurora Health Care System
122
Monitoring of the Post-Implementation
Process may include: (cont’d)
•
For all QC failures, PT failures, laboratory
reporting errors, complaints, etc., reassessment of
risk will be performed and adjustments made to
the QCP as necessary.
•
Reason for failure will be identified and addressed
in a new/updated risk assessment answering
following:
Has a new hazard been identified?
Does this hazard change the frequency of
risk?
Does this hazard change the severity of harm?
•
Additional control measures will be implemented if
necessary as determined by new risk assessment.
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123
EXAMPLE #4
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124
Individualized Quality Control Plan
(IQCP)
Gradient Strip MIC Testing
bioMerieux
A partnership of the Advocate and Aurora Health Care System
IQCP includes the following and each will be
addressed separately:
• Risk assessment (RA) of Gradient
Susceptibility Test System
• Quality Control Plan (QCP) for Gradient
Susceptibility Test System
• Quality Assessment (QA) for Gradient
Susceptibility Test System
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Risk Assessment
Consists of two parts:
• Collect Information/Data:
• Identify areas where errors or
failures could occur in the entire
testing process (pre-analytical,
analytical, and post-analytical)
• Conduct a Risk Assessment:
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127
Risk Assessment
Collection of information:
• Manufacturer instructions
• Manufacturer performance data
• Literature published on assay
• Accreditation/regulatory requirements
• Available laboratory data
 Verification / validation testing data
 Historical QC data
A partnership of the Advocate and Aurora Health Care System
128
Risk Assessment
Collecting Information/Data
Manufacturer instructions:
• Look specifically at ‘Limitations’ section to
identify possible risks.
• Note manufacturer’s recommended QC (QC
defined in your IQCP may not be less
stringent than that recommended by the
manufacturer)
• Include a copy of your manufacturer’s
package insert (PI) in your IQCP materials.
A partnership of the Advocate and Aurora Health Care System
129
Risk Assessment
Collecting Information/Data
Manufacturer performance data:
• Look for any risks associated with this
system that have been identified in the
manufacturer’s performance data.
• Also review any manufacturer alerts or
bulletins for associated risks. Include copy
of alert, bulletin, etc. in your IQCP
materials.
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Risk Assessment
Collecting Information/Data
Literature published on assay:
• Look for any risks associated with this system that
have been identified in literature.
• Be sure to consider version of system reported in
literature as related to version of system/software used
in your laboratory.
• Include copies of pertinent articles in your IQCP
materials.
Accreditation/Regulatory requirements:
• Ensure that your IQCP is in compliance with
accreditation or regulatory requirements.
• Include copies of these requirements in your IQCP
materials.
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Risk Assessment
Collect Information/Data
In-house laboratory data:
• Review your initial verification studies (and
any subsequent studies)
• Review historical QC data to help define
your IQCP.
• Include these data in your IQCP materials,
or identify where data can be found in lab.
• Include previously reported patient test
errors, etc. may also be pertinent if
available. See following page for additional
details on historical QC data review.
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Summary of Historical In-house
QC data
•
Reference used CLSI M100– “Performance
Standards for Antimicrobial Susceptibility
Testing;Twenty-Fifth Informational Supplement”
•
Gradient testing – media used:
Plain Mueller Hinton Agar
Blood Mueller Hinton Agar for Streptococcus
pneumoniae
Brucella Agar for anaerobes
Haemophilus Test Medium for Haemophilus
influenzae
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Summary of Historical In-house
QC data
•
QC organisms used and schedule for
subculturing (refer to chart)
 Monthly from CryoBEADS
 Weekly from loop
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Risk Assessment (cont’d)
•
Identify where, along the testing process,
risk of errors might occur.
•
Determine the frequency of occurrence of
the error and the possible severity of harm
if an error would occur.
•
This risk assessment must include preanalytical, analytical, and post-analytical
areas of the testing process.
(See Fishbone diagram example next page)
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Risk Assessment
Conduct a Risk Assessment MUST include 5 CMS risk assessment
components (may add others):
1) Specimen
2) Testing Personnel
3) Reagents
4) Environment
5) Test System
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1
Specimen
Specimen (1A)
-Patient identification
-Collection/container/
volume
-Transport
-Storage
Specimen (1B)
-Clinically relevant
-Colony age
-Media type
-Pure isolate
-Inoculum suspension
RISK ASSESSMENT:
Identification of Potential Failures for
Gradient Strip MIC Testing
2
Testing Personnel
Operator Function
-Training
-Competency Assessment
-Proficiency Testing
-Staffing
Identify Potential
Hazards
Gradient Strip MIC
-Shipping / storage
-Expirations date
-Use
3
Reagents
4
Environment
Factors
-Temperature/ Humidity
Airflow/ Ventilation
-Utilities / Space
-Noise/Vibrations
Incorrect Test
Results
QC Organism
-Storage
-Preparation
-Monthly
-Weekly
Media Used
-Plain MH
Reported Results
-Blood MH
-Transmission of results to
-Brucella Agar
Hospital Information Systems
-Haemophilus
-Review of released results
Test Medium
-Clinician feedback
-AST reporting rules
QC organism
Pre-analytical
Failure/error
5
Test System
Analytical
Post-analytical
137
Risk Assessment
•
•
•
•
Identify measures to control and/or reduce
risk.
Build tables to include all risks identified in
your fishbone diagram (formats other than
fishbone diagrams may be used).
Determine “Frequency of occurrence” and
“Possible severity of harm” for each risk
identified.
Indicate measures you have in place to
mitigate or reduce these risks/errors
(including where to find these measures in
your procedures, reports, logs, etc.).
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Risk Assessment
Frequency of occurrence of an error
(how often might this error occur?)
Frequency of Occurrence
• Unlikely (1 every 2-3 years)
• Occasional (1 per year)
• Probable (1 per month)
• Frequent (1 per week)
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Risk Assessment
Possible “Severity of harm” due to this error
(if this error occurs, what is the possible
severity of harm as a result?)
Severity of Harm
• Negligible (temporary discomfort)
• Minor (temporary injury; not requiring medical
intervention)
• Serious (impairment requiring medical
intervention)
• Critical (permanent impairment requiring
medical intervention)
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Risk Assessment - Specimen
1A
Specimen
Frequency Severity
of
of
Occurrence Harm
Patient
Occasional
identification
Collection/
Container/
Volume
Occasional
Measures to control
risk
Minor- Patient identification
Critical criteria defined;
acceptability defined;
competency
assessment performed
Minor- Collection/ container
Critical criteria defined per
source; acceptability
defined; competency
assessment performed
A partnership of the Advocate and Aurora Health Care System
Relevant
SOP
SOP
SOP
SOP
SOP
SOP
SOP
141
Risk Assessment - Specimen
1A
Frequency Severity
Specimen
of
of
Occurrence
Harm
Transport
Occasional
MinorCritical
Storage
Occasional
MinorCritical
Measures to control
risk
Relevant
SOP
Transport criteria
defined per source;
acceptability defined;
competency
assessment performed
Storage criteria defined
per source;
acceptability defined;
competency
assessment performed
SOP
SOP
SOP
A partnership of the Advocate and Aurora Health Care System
SOP
SOP
SOP
142
Risk Assessment - Specimen
1B
Organism
Measures to control
risk
Relevant
SOP
MinorCritical
Selection criteria defined
in training; competency
assessment performed
SOP
SOP
SOP
Colony Age OccasionalFrequent
MinorCritical
SOP
SOP
Media type Occasional
MinorCritical
Selection criteria defined
in training; competency
assessment performed
Selection criteria defined
in training; competency
assessment performed
Clinically
relevant
Frequency Severity
of
of
Occurrence Harm
Occasional
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SOP
SOP
143
Risk Assessment - Specimen
1B
Organism
Frequency Severity
of
of
Occurrence
Harm
Pure isolate OccasionalFrequent
MinorCritical
Inoculum
Occasional
suspension
preparation
MinorCritical
Measures to control
risk
Relevant
SOP
Selection criteria
defined in training;
competency
assessment performed
Preparation criteria
defined in training;
competency
assessment performed
SOP.xxxx
SOP.xxxx
A partnership of the Advocate and Aurora Health Care System
SOP.xxxx
SOP.xxxx
144
Risk Assessment – Testing Personnel
2
Testing
Personnel
Training
Frequency Severity
of
of
Occurrence Harm
Measures to control
risk
Occasional
MinorCritical
All testing personnel
have had appropriate
training
Competency Occasional
Assessment
MinorCritical
All personnel have
appropriate CA
performed
A partnership of the Advocate and Aurora Health Care System
Relevant
SOP
SOP.xxxx
(training
documenta
tion, etc.)
SOP.xxxx
145
Risk Assessment – Testing Personnel
2
Frequency Severity
Testing
of
of
Personnel Occurrence
Harm
Measures to control
risk
Proficiency Occasional
Testing
Negligible All PT failures
-Minor
addressed with
corrective action
Staffing
MinorCritical
Occasional
Relevant
SOP
SOP.xxxx
Adequate staffing to
SOP.xxxx
support test menu and
turn-around-times on all
shifts
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Risk Assessment – Reagents
3
Frequency Severity
Reagents
of
of
Gradient Occurrence Harm
Strip MIC
Receiving
/Storage
Occasional
Minor –
Critical
Expiration
dates
Use
Unlikely
Minor –
Critical
Critical
Occasional
Measures to control
risk
Cards are shipped and
stored according to
manufacturer’s
instructions.
Cards are used within
expiration dates.
Cards are used
according to
manufacturer’s
instructions.
A partnership of the Advocate and Aurora Health Care System
Relevant
SOP
SOP.xx
SOP.xx
SOP.xx
147
Risk Assessment – Reagents
3
Frequency Severity
Reagents
of
of
QC
Occurrence
Harm
Organisms
Storage
Occasional
Minor –
Critical
Measures to control
risk
Relevant
SOP
QC organisms are
stored according to
established guidelines
SOP.xxxx
SOP.xxxx
Subcultured Occasional
monthly
Negligible QC organisms are
–
prepared according to
Minor
established guidelines
SOP.xxxx
Subcultured
weekly from
loop
Minor
SOP.xxx
Established guidelines
E. faecalis ATCC 51299
E. coli ATCC 35218
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Risk Assessment – Environment
4
Frequency Severity
Environment
of
of
Occurrence Harm
Temperature/ Unlikely
Airflow
Humidity/
Ventilation
Utilities
Unlikely
Measures to control Relevant
risk
SOP
Negligible Appropriate
SOP.xxxx
– Minor
environmental
conditions are
maintained in the
laboratory
Negligible Appropriate utilities
SOP.xxxx
– Minor
are employed in the
laboratory to serve the
instrumentation
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Risk Assessment – Environment
4
Environment
Frequency Severity Measures to control Relevant
of
of
risk
SOP
Occurrence Harm
Space
Unlikely
Negligible Appropriate space is
– Minor
available in the
laboratory to serve
the instrumentation
SOP.xxxx
Noise
/Vibration
Unlikely
Negligible Appropriate
– Minor
parameters are in
place to serve the
instrumentation
SOP.xxxx
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Risk Assessment – Test System
5
Test System
Frequency Severity
of
of
Occurrence Harm
Transmission Unlikely
of results to
Hospital
Information
Systems (HIS)
Review of
Occasionalreleased
frequent
results
Measures to control Relevant
risk
SOP
Negligible Periodic review of
– Minor
released results to
HIS.
SOP.xxxx
Negligible Review of all (or
– Minor
pertinent) released
results according to
SOP. Appropriate
investigation for all
reporting errors.
SOP.xxxx
SOP.xxxx
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Quality Control Plan (QCP)
QCP must also include:
• Number of QC,
• Type of QC,
• Frequency of QC testing (supported by
data)
• Criteria for QC acceptability
• May be no less than manufacturer’s
instructions
• May include electronic QC, procedural QC,
training, competency assessment, other
QC activities
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152
QCP Summary
•
May want to include a chart for various
media used for gradient MIC testing and
corresponding QC organisms:
 Specific QC organisms used for each
gradient MIC testing media
 Frequency of subculturing QC
organisms
 Frequency of testing media and QC
 Expected QC results
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153
Director Signature
Include a signed statement by your laboratory
director indicating that the IQCP/QCP has
been reviewed and is acceptable. For
example:
This IQCP/QCP has been reviewed and is
approved by the laboratory director (as
named on the CLIA license).
_____________
_________
(Laboratory Director signature)
(date)
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Quality Assessment (QA)
Develop a continual “Post-Implementation Monitoring
Process” that will allow you to know when a process is in
need of review/revision.
 QA must include the review and monitoring of the
following:
 Specimen
 Testing Personnel
 Reagents
 Environment
 Test System
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155
Example - Quality Assessment
Staff training in specimen requirements, test
organism selection/preparation
See SOP.xxxx, SOP.xxxx
Competency assessment
See SOP.xxxx
Proficiency Testing
See SOP.xxxx
Quality Control/Instrument Function
See SOP.xxxx, SOP.xxxx
Unexpected Errors
See SOP.xxxx
Pre-analytical
Analytical
Post-analyticall
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Example - Quality Assessment (cont)
Laboratory error investigation/remediation
See SOP.xxxx
Complaint investigation/remediation
See SOP.xxxx
Pre-analytical
Analytical
Post-analytical
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Monitoring of the PostImplementation Process may include:
•
•
•
•
Documented review of gradient MIC QC
records will be performed by supervisor or
designee weekly and by supervisor monthly to
ensure QC are accurately performed and
documented (see SOP.xxxx).
PT (proficiency testing) failures are addressed
as soon as possible (see SOP.xxxx).
Reporting errors are addressed as soon as
possible (see SOP.xxxx).
Complaint investigations are carried out in a
timely manner (see SOP.xxxx).
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Monitoring of the Post-Implementation
Process may include: (cont’d)
•
For all QC failures, PT failures, laboratory
reporting errors, complaints, etc., reassessment of
risk will be performed and adjustments made to
the QCP as necessary.
•
Reason for failure will be identified and addressed
in a new/updated risk assessment answering
following:
Has a new hazard been identified?
Does this hazard change the frequency of
risk?
Does this hazard change the severity of harm?
•
Additional control measures will be implemented if
necessary as determined by new risk assessment.
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EXAMPLE #5
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Individualized Quality Control Plan
(IQCP)
Kirby Bauer Disk Diffusion Testing
Vendor
A partnership of the Advocate and Aurora Health Care System
IQCP includes the following and each will be
addressed separately:
• Risk assessment (RA) of Kirby Bauer Disk
Diffusion Testing
• Quality Control Plan (QCP) for Kirby Bauer Disk
Diffusion Testing
• Quality Assessment (QA) for Kirby Bauer Disk
Diffusion Testing
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Risk Assessment
Consists of two parts:
• Collect Information/Data:
• Identify areas where errors or
failures could occur in the entire
testing process (pre-analytical,
analytical, and post-analytical)
• Conduct a Risk Assessment:
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163
Risk Assessment
Collection of information:
• Manufacturer instructions
• Manufacturer performance data
• Literature published on assay
• Accreditation/regulatory requirements
• Available laboratory data
 Verification / validation testing data
 Historical QC data
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Risk Assessment
Collecting Information/Data
Manufacturer instructions:
• Look specifically at ‘Limitations’ section to
identify possible risks.
• Note manufacturer’s recommended QC (QC
defined in your IQCP may not be less
stringent than that recommended by the
manufacturer)
• Include a copy of your manufacturer’s
package insert (PI) in your IQCP materials.
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Risk Assessment
Collecting Information/Data
Manufacturer performance data:
• Look for any risks associated with this
system that have been identified in the
manufacturer’s performance data.
• Also review any manufacturer alerts or
bulletins for associated risks. Include copy
of alert, bulletin, etc. in your IQCP
materials.
A partnership of the Advocate and Aurora Health Care System
166
Risk Assessment
Collecting Information/Data
Literature published on assay:
• Look for any risks associated with this system that
have been identified in literature.
• Be sure to consider version of system reported in
literature as related to version of system/software used
in your laboratory.
• Include copies of pertinent articles in your IQCP
materials.
Accreditation/Regulatory requirements:
• Ensure that your IQCP is in compliance with
accreditation or regulatory requirements.
• Include copies of these requirements in your IQCP
materials.
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167
Risk Assessment
Collect Information/Data
In-house laboratory data:
• Review your initial verification studies (and
any subsequent studies)
• Review historical QC data to help define
your IQCP.
• Include these data in your IQCP materials,
or identify where data can be found in lab.
• Include previously reported patient test
errors, etc. may also be pertinent if
available. See following page for additional
details on historical QC data review.
A partnership of the Advocate and Aurora Health Care System
168
Summary of Historical In-house
QC data
•
Reference used CLSI M100– “Performance
Standards for Antimicrobial Susceptibility
Testing;Twenty-Fifth Informational Supplement”
•
Kirby Bauer Disk Diffusion – media used:
Plain Mueller Hinton Agar
Blood Mueller Hinton Agar for Streptococcus
pneumoniae
A partnership of the Advocate and Aurora Health Care System
169
Summary of Historical In-house
QC data
•
QC organisms used and schedule for
subculturing (refer to chart)
 Monthly from CryoBEADS
 Weekly from loop
A partnership of the Advocate and Aurora Health Care System
170
Risk Assessment (cont’d)
•
Identify where, along the testing process,
risk of errors might occur.
•
Determine the frequency of occurrence of
the error and the possible severity of harm
if an error would occur.
•
This risk assessment must include preanalytical, analytical, and post-analytical
areas of the testing process.
(See Fishbone diagram example next page)
A partnership of the Advocate and Aurora Health Care System
171
Risk Assessment
Conduct a Risk Assessment MUST include 5 CMS risk assessment
components (may add others):
1) Specimen
2) Testing Personnel
3) Reagents
4) Environment
5) Test System
A partnership of the Advocate and Aurora Health Care System
172
1
Specimen
Specimen (1A)
-Patient identification
-Collection/container/
volume
-Transport
-Storage
Specimen (1B)
-Clinically relevant
-Colony age
-Media type
-Pure isolate
-Inoculum suspension
RISK ASSESSMENT:
Identification of Potential Failures for
Kirby Bauer Disk Diffusion Testing
2
Testing Personnel
Operator Function
-Training
-Competency Assessment
-Proficiency Testing
-Staffing
Identify Potential
Hazards
KB Disk Diffusion
-Shipping / storage
-Expirations date
-Use
Factors
-Temperature/ Humidity
Airflow/ Ventilation
-Utilities / Space
-Noise/Vibrations
Incorrect Test
Results
QC Organism
-Storage
-Preparation
-Monthly
-Weekly
Media Used
-Plain MH
Reported Results
-Blood MH
-Transmission of results to
Hospital Information Systems
-Review of released results
-Clinician feedback
-AST reporting rules
QC organism
Failure/error
3
Reagents
4
Environment
5
Test System
Pre-analytical
Analytical
Post-analytical
173
Risk Assessment
•
•
•
•
Identify measures to control and/or reduce
risk.
Build tables to include all risks identified in
your fishbone diagram (formats other than
fishbone diagrams may be used).
Determine “Frequency of occurrence” and
“Possible severity of harm” for each risk
identified.
Indicate measures you have in place to
mitigate or reduce these risks/errors
(including where to find these measures in
your procedures, reports, logs, etc.).
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Risk Assessment
Frequency of occurrence of an error
(how often might this error occur?)
Frequency of Occurrence
• Unlikely (1 every 2-3 years)
• Occasional (1 per year)
• Probable (1 per month)
• Frequent (1 per week)
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Risk Assessment
Possible “Severity of harm” due to this error
(if this error occurs, what is the possible
severity of harm as a result?)
Severity of Harm
• Negligible (temporary discomfort)
• Minor (temporary injury; not requiring medical
intervention)
• Serious (impairment requiring medical
intervention)
• Critical (permanent impairment requiring
medical intervention)
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Risk Assessment - Specimen
1A
Specimen
Frequency Severity
of
of
Occurrence Harm
Patient
Occasional
identification
Collection/
Container/
Volume
Occasional
Measures to control
risk
Minor- Patient identification
Critical criteria defined;
acceptability defined;
competency
assessment performed
Minor- Collection/ container
Critical criteria defined per
source; acceptability
defined; competency
assessment performed
A partnership of the Advocate and Aurora Health Care System
Relevant
SOP
SOP
SOP
SOP
SOP
SOP
SOP
177
Risk Assessment - Specimen
1A
Frequency Severity
Specimen
of
of
Occurrence
Harm
Transport
Occasional
MinorCritical
Storage
Occasional
MinorCritical
Measures to control
risk
Relevant
SOP
Transport criteria
defined per source;
acceptability defined;
competency
assessment performed
Storage criteria defined
per source;
acceptability defined;
competency
assessment performed
SOP
SOP
SOP
A partnership of the Advocate and Aurora Health Care System
SOP
SOP
SOP
178
Risk Assessment - Specimen
1B
Organism
Measures to control
risk
Relevant
SOP
MinorCritical
Selection criteria defined
in training; competency
assessment performed
SOP
SOP
SOP
Colony Age OccasionalFrequent
MinorCritical
SOP
SOP
Media type Occasional
MinorCritical
Selection criteria defined
in training; competency
assessment performed
Selection criteria defined
in training; competency
assessment performed
Clinically
relevant
Frequency Severity
of
of
Occurrence Harm
Occasional
A partnership of the Advocate and Aurora Health Care System
SOP
SOP
179
Risk Assessment - Specimen
1B
Organism
Frequency Severity
of
of
Occurrence
Harm
Pure isolate OccasionalFrequent
MinorCritical
Inoculum
Occasional
suspension
preparation
MinorCritical
Measures to control
risk
Relevant
SOP
Selection criteria
defined in training;
competency
assessment performed
Preparation criteria
defined in training;
competency
assessment performed
SOP.xxxx
SOP.xxxx
A partnership of the Advocate and Aurora Health Care System
SOP.xxxx
SOP.xxxx
180
Risk Assessment – Testing Personnel
2
Testing
Personnel
Training
Frequency Severity
of
of
Occurrence Harm
Measures to control
risk
Occasional
MinorCritical
All testing personnel
have had appropriate
training
Competency Occasional
Assessment
MinorCritical
All personnel have
appropriate CA
performed
A partnership of the Advocate and Aurora Health Care System
Relevant
SOP
SOP.xxxx
(training
documenta
tion, etc.)
SOP.xxxx
181
Risk Assessment – Testing Personnel
2
Frequency Severity
Testing
of
of
Personnel Occurrence
Harm
Measures to control
risk
Proficiency Occasional
Testing
Negligible All PT failures
-Minor
addressed with
corrective action
Staffing
MinorCritical
Occasional
Relevant
SOP
SOP.xxxx
Adequate staffing to
SOP.xxxx
support test menu and
turn-around-times on all
shifts
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Risk Assessment – Reagents
3
Frequency Severity
Reagents
of
of
KB Disk Occurrence Harm
Diffusion
Measures to control
risk
Relevant
SOP
Receiving
/Storage
Media and
Disks
Occasional
Minor –
Critical
Shipped and stored
according to
manufacturer’s
instructions.
SOP.xx
Media and
Disks
Expiration
dates
Unlikely
Minor –
Critical
Used within expiration
dates.
SOP.xx
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183
Risk Assessment – Reagents
3
Frequency Severity
Reagents
of
of
QC
Occurrence
Harm
Organisms
Storage
Occasional
Minor –
Critical
Measures to control
risk
Relevant
SOP
QC organisms are
stored according to
established guidelines
SOP.xxxx
SOP.xxxx
Subcultured Occasional
monthly
Negligible QC organisms are
–
prepared according to
Minor
established guidelines
SOP.xxxx
Subcultured
weekly from
loop
Minor
Established guidelines SOP.xxx
E. faecalis ATCC 51299
E. coli ATCC 35218
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184
Risk Assessment – Environment
4
Frequency Severity
Environment
of
of
Occurrence Harm
Temperature/ Unlikely
Airflow
Humidity/
Ventilation
Utilities
Unlikely
Measures to control Relevant
risk
SOP
Negligible Appropriate
SOP.xxxx
– Minor
environmental
conditions are
maintained in the
laboratory
Negligible Appropriate utilities
SOP.xxxx
– Minor
are employed in the
laboratory to serve the
instrumentation
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185
Risk Assessment – Environment
4
Frequency Severity Measures to control Relevant
Environment
of
of
risk
SOP
Occurrenc
Harm
e
Space
Unlikely
Negligible Appropriate space is
SOP.xxxx
– Minor
available in the
laboratory to serve the
instrumentation
Noise
/Vibration
Unlikely
Negligible Appropriate
– Minor
parameters are in
place to serve the
instrumentation
A partnership of the Advocate and Aurora Health Care System
SOP.xxxx
186
Risk Assessment – Test System
5
Test System
Frequency Severity
of
of
Occurrence Harm
Transmission Unlikely
of results to
Hospital
Information
Systems (HIS)
Review of
Occasionalreleased
frequent
results
Measures to control Relevant
risk
SOP
Negligible Periodic review of
– Minor
released results to
HIS.
SOP.xxxx
Negligible Review of all (or
– Minor
pertinent) released
results according to
SOP. Appropriate
investigation for all
reporting errors.
SOP.xxxx
SOP.xxxx
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187
Quality Control Plan (QCP)
QCP must also include:
• Number of QC,
• Type of QC,
• Frequency of QC testing (supported by
data)
• Criteria for QC acceptability
• May be no less than manufacturer’s
instructions
• May include electronic QC, procedural QC,
training, competency assessment, other
QC activities
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QCP Summary
•
May want to include a chart for various
media used for KB Disk Diffusion testing
and corresponding QC organisms:
 Specific QC organisms used for each
drug testing, gram negative, gram
positive, D Test - testing media
 Frequency of subculturing QC
organisms
 Frequency of testing media and QC
 Expected QC results
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Director Signature
Include a signed statement by your laboratory
director indicating that the IQCP/QCP has
been reviewed and is acceptable. For
example:
This IQCP/QCP has been reviewed and is
approved by the laboratory director (as
named on the CLIA license).
_____________
_________
(Laboratory Director signature)
(date)
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Quality Assessment (QA)
Develop a continual “Post-Implementation Monitoring
Process” that will allow you to know when a process is in
need of review/revision.
 QA must include the review and monitoring of the
following:
 Specimen
 Testing Personnel
 Reagents
 Environment
 Test System
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III. Quality Assessment (QA)
Staff training
• See SOP.xxxx
Competency assessment
• See SOP.xxxx
Proficiency Testing
• See SOP.xxxx
Laboratory error investigation/remediation
• See SOP.xxxx
Complaint investigation/remediation
• See SOP.xxxx
A partnership of the Advocate and Aurora Health Care System
Pre-analytical
Analytical
Post-analytical
Monitoring of the PostImplementation Process may include:
•
•
•
•
Documented review of KB media and
antibiotic disk diffusion disks QC records will
be performed by supervisor or designee
weekly and by supervisor monthly to ensure
QC are accurately performed and
documented (see SOP.xxxx).
PT (proficiency testing) failures are addressed
as soon as possible (see SOP.xxxx).
Reporting errors are addressed as soon as
possible (see SOP.xxxx).
Complaint investigations are carried out in a
timely manner (see SOP.xxxx).
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Monitoring of the Post-Implementation
Process may include: (cont’d)
•
For all QC failures, PT failures, laboratory
reporting errors, complaints, etc., reassessment of
risk will be performed and adjustments made to
the QCP as necessary.
•
Reason for failure will be identified and addressed
in a new/updated risk assessment answering
following:
Has a new hazard been identified?
Does this hazard change the frequency of
risk?
Does this hazard change the severity of harm?
•
Additional control measures will be implemented if
necessary as determined by new risk assessment.
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