IQCP Example #1.

IQCP Example #1

Individualized Quality Control Plan (IQCP)
Commercial Antimicrobial Susceptibility Testing (AST) Systems (Vendor and System)

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

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:

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

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.

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.

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.

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.

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.)

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

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

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 pre-analytical, analytical, and post-analytical areas of the testing process. (See Fishbone diagram example next page)

Identify Potential Hazards Incorrect Test Results
1 Specimen RISK ASSESSMENT: Identification of Potential Failures for Commercial AST System Specimen (1A) -Patient identification -Collection/container/ volume -Transport -Storage Specimen (1B) -Clinically relevant -Colony age -Media type -Pure isolate -Inoculum suspension 2 Testing Personnel 4 Environment Operator Function -Training -Competency Assessment -Proficiency Testing -Staffing Factors -Temperature/ Humidity Airflow/ Ventilation -Utilities / Space -Noise/Vibrations Identify Potential Hazards Incorrect Test Results Instrument -Electrical -Jam -Software 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 Pre-analytical Analytical Post-analytical 3 Reagents 5 Test System

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.).

Frequency of Occurrence
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)

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)

Risk Assessment - Specimen
Frequency of Occurrence Severity Harm Measures to control risk Relevant SOP Patient identification Occasional Minor-Critical Patient identification criteria defined; acceptability defined; competency assessment performed Collection/ Container/ Volume Collection/ container criteria defined per source; acceptability defined; competency assessment performed

Frequency of Occurrence Severity Harm Measures to control risk Relevant SOP Transport Occasional Minor-Critical Transport criteria defined per source; acceptability defined; competency assessment performed Storage Storage criteria defined per source; acceptability defined; competency assessment performed

1B Organism Frequency of Occurrence Severity Harm Measures to control risk Relevant SOP Clinically relevant Occasional Minor-Critical Selection criteria defined in training; competency assessment performed Colony Age Occasional-Frequent Media type Selection criteria defined in training; competency assessment performed

1B Organism Frequency of Occurrence Severity Harm Measures to control risk Relevant SOP Pure isolate Occasional-Frequent Minor-Critical Selection criteria defined in training; competency assessment performed SOP.xxxx Inoculum suspension preparation Occasional Preparation criteria defined in training; competency assessment performed

Risk Assessment – Testing Personnel
2 Testing Personnel Frequency of Occurrence Severity Harm Measures to control risk Relevant SOP Training Occasional Minor-Critical All testing personnel have had appropriate training SOP.xxxx (training documentation, etc.) Competency Assessment All personnel have appropriate CA performed SOP.xxxx

2 Testing Personnel Frequency of Occurrence Severity Harm Measures to control risk Relevant SOP Proficiency Testing Occasional Negligible-Minor All PT failures addressed with corrective action SOP.xxxx Staffing Minor-Critical Adequate staffing to support test menu and turn-around-times on all shifts

Risk Assessment – Reagents
3 Reagents Frequency of Occurrence Severity Harm Measures to control risk Relevant SOP Receiving /Storage Occasional Minor – Critical Reagents are shipped and stored according to manufacturer’s instructions. SOP.xx Expiration dates Unlikely Reagents are used within expiration dates. Preparation /Use Critical All reagents are prepared/used according to manufacturer’s instructions.

Frequency of Occurrence Severity Harm Measures to control risk Relevant SOP QC organism storage/ preparation Occasional Minor – Critical Results for all QC organisms are within acceptable limits. Storage and preparation of QC strains are defined. SOP.xxxx QC organism failure/error Negligible – Minor AST QC log and corrective action logs

Risk Assessment – Environment
Frequency of Occurrence Severity 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 Appropriate utilities are employed in the laboratory to serve the instrumentation

Frequency of Occurrence Severity Harm Measures to control risk Relevant SOP Space Unlikely Negligible – Minor Appropriate space is available in the laboratory to serve the instrumentation SOP.xxxx Noise /Vibration Appropriate parameters are in place to serve the instrumentation

Risk Assessment – Test System
5 Test System Frequency of Occurrence Severity Harm Measures to control risk Relevant SOP Electrical Occasional Negligible – Minor AST Instrument Maintenance log; appropriate utilities are employed in laboratory to serve instrumentation SOP.xx Jam Training and procedures &/or instrument operation manual is provided to resolve jams and evaluate test results after resolution.

5 Test System Frequency of Occurrence Severity Harm Measures to control risk Relevant SOP Software Occasional Minor – Critical All testing personnel have had appropriate training SOP.xxxx Transmission of data to LIS Unlikely Measures are in place to verify appropriate transmission of data.

5 Test System Frequency of Occurrence Severity Harm Measures to control risk Relevant SOP Transmission of results to Hospital Information Systems (HIS) Unlikely Negligible – Minor Periodic review of released results to HIS. SOP.xxxx Review of released results Occasional-frequent Review of all (or pertinent) released results according to SOP. Appropriate investigation for all reporting errors.

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

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

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

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)

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

Example - Quality Assessment
Staff training in specimen requirements, test organism selection/preparation See SOP.xxxx, SOP.xxxx Competency assessment See SOP.xxxx Proficiency Testing Quality Control/Instrument Function Unexpected Errors Pre-analytical Analytical Post-analyticall

Example - Quality Assessment (cont)
Laboratory error investigation/remediation See SOP.xxxx Complaint investigation/remediation Pre-analytical Analytical Post-analytical

Example - Monitoring of the Post-Implementation 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).

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.

EXAMPLE # 2

Commercially Prepared Exempt Culture Media (Vendors)

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

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 post-analytical) Conducting a Risk Assessment:

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.

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

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

Vendor – QC CLSI M22 Statements

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

Vendor – QC CLSI M22 Statements

Vendor – CLSI M22 Statements

Media – CAP Checklist Questions
MIC 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

Media – CAP Checklist Questions
MIC 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

NCCLS – M22- A3 – Table 1B

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

MUST include 5 CMS risk assessment components (may add others): 1) Specimen 2) Testing Personnel 3) Reagents - 4) Environment 5) Test System

1 Specimen RISK ASSESSMENT: Identification of Potential Failures for Commercially Prepared Exempt Culture Media Specimen (1A) -Patient identification -Collection/container/ volume -Transport -Storage Specimen (1B) -Clinically relevant -Colony age -Media type -Pure isolate -Inoculum suspension 2 Testing Personnel 4 Environment Operator Function -Training -Competency Assessment -Proficiency Testing -Staffing 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 Pre-analytical Analytical Post-analytical 3 Reagents 5 Test System

3 Reagents Frequency of Occurrence Severity Harm Measures to control risk Relevant SOP Receiving /Storage Occasional Minor – Critical Reagents are shipped and stored according to manufacturer’s instructions. SOP.xx Expiration dates Unlikely Reagents are used within expiration dates. Preparation /Use Critical All reagents are prepared/used according to manufacturer’s instructions.

Frequency of Occurrence Severity Harm Measures to control risk Relevant SOP Visual inspection Occasional Minor – Critical Results for all visual inspections are within acceptable limits. SOP.xxxx Vendor QC/ Performance statements Negligible – Minor Certificate of media conformance can be referenced on vendor website

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)

Example -Monitoring of the Post-Implementation 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).

EXAMPLE # 3

Commercial Microbial Identification Systems Vitek 2 Identification Cards bioMerieux

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

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

CLSI M50 – Streamline QC

References and Data Review
Review of: In-house verification / validation data Comprehensive MIS QC(CLIA 42 CFR (e)(1) historical review as described in CLSI M50 ( b.i) Streamline QC data Vendor /manufacturer: Package insert Recommended QC organisms Recommended QC organisms for streamline QC

MUST include 5 CMS risk assessment components (may add others): 1) Specimen 2) Testing Personnel 3) Reagents 4) Environment 5) Test System

1 Specimen RISK ASSESSMENT: Identification of Potential Failures for Commercial Microbial Identification Systems – Vitek 2 Identification Cards Specimen (1A) -Patient identification -Collection/container/ volume -Transport -Storage Specimen (1B) -Clinically relevant -Colony age -Media type -Pure isolate -Inoculum suspension 2 Testing Personnel 4 Environment Operator Function -Training -Competency Assessment -Proficiency Testing -Staffing Factors -Temperature/ Humidity Airflow/ Ventilation -Utilities / Space -Noise/Vibrations Identify Potential Hazards Incorrect Test Results Instrument -Electrical -Jam -Software QC Organism -Storage -Preparation Reported Results -Transmission of results to Hospital Information Systems -Review of released results -Clinician feedback Vitek ID Cards -Shipping / storage -Expirations date -Use QC organism Failure/error Pre-analytical Analytical Post-analytical 3 Reagents 5 Test System

3 Reagents Vitek ID Cards Frequency of Occurrence Severity Harm Measures to control risk Relevant SOP Receiving /Storage Occasional Minor – Critical Cards are shipped and stored according to manufacturer’s instructions. SOP.xx Expiration dates Unlikely Cards are used within expiration dates. Use Critical Cards are used according to manufacturer’s instructions.

3 Reagents QC Organisms Frequency of Occurrence Severity Harm Measures to control risk Relevant SOP Storage Occasional Minor – Critical QC organisms are stored according to established guidelines SOP.xxxx Preparation Negligible – Minor QC organisms are prepared according to established guidelines

5 Test System Frequency of Occurrence Severity Harm Measures to control risk Relevant SOP QC organism failure / error Unlikely Negligible QC organisms are prepared according to established guidelines SOP.xxxx

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

Monitoring of the Post-Implementation 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).

EXAMPLE #4

Gradient Strip MIC Testing bioMerieux

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

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

QC organisms used and schedule for subculturing (refer to chart) Monthly from CryoBEADS Weekly from loop

1 Specimen RISK ASSESSMENT: Identification of Potential Failures for Gradient Strip MIC Testing Specimen (1A) -Patient identification -Collection/container/ volume -Transport -Storage Specimen (1B) -Clinically relevant -Colony age -Media type -Pure isolate -Inoculum suspension 2 Testing Personnel 4 Environment Operator Function -Training -Competency Assessment -Proficiency Testing -Staffing Factors -Temperature/ Humidity Airflow/ Ventilation -Utilities / Space -Noise/Vibrations Identify Potential Hazards Incorrect Test Results Media Used -Plain MH -Blood MH -Brucella Agar -Haemophilus Test Medium QC Organism -Storage -Preparation -Monthly -Weekly Reported Results -Transmission of results to Hospital Information Systems -Review of released results -Clinician feedback -AST reporting rules Gradient Strip MIC -Shipping / storage -Expirations date -Use QC organism Failure/error Pre-analytical Analytical Post-analytical 3 Reagents 5 Test System

3 Reagents Gradient Strip MIC Frequency of Occurrence Severity Harm Measures to control risk Relevant SOP Receiving /Storage Occasional Minor – Critical Cards are shipped and stored according to manufacturer’s instructions. SOP.xx Expiration dates Unlikely Cards are used within expiration dates. Use Critical Cards are used according to manufacturer’s instructions.

3 Reagents QC Organisms Frequency of Occurrence Severity Harm Measures to control risk Relevant SOP Storage Occasional Minor – Critical QC organisms are stored according to established guidelines SOP.xxxx Subcultured monthly Negligible – Minor QC organisms are prepared according to established guidelines Subcultured weekly from loop Established guidelines E. faecalis ATCC 51299 E. coli ATCC 35218 SOP.xxx

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

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).

EXAMPLE #5

Kirby Bauer Disk Diffusion Testing Vendor

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

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

QC organisms used and schedule for subculturing (refer to chart) Monthly from CryoBEADS Weekly from loop

1 Specimen RISK ASSESSMENT: Identification of Potential Failures for Kirby Bauer Disk Diffusion Testing Specimen (1A) -Patient identification -Collection/container/ volume -Transport -Storage Specimen (1B) -Clinically relevant -Colony age -Media type -Pure isolate -Inoculum suspension 2 Testing Personnel 4 Environment Operator Function -Training -Competency Assessment -Proficiency Testing -Staffing Factors -Temperature/ Humidity Airflow/ Ventilation -Utilities / Space -Noise/Vibrations Identify Potential Hazards Incorrect Test Results Media Used -Plain MH -Blood MH QC Organism -Storage -Preparation -Monthly -Weekly Reported Results -Transmission of results to Hospital Information Systems -Review of released results -Clinician feedback -AST reporting rules KB Disk Diffusion -Shipping / storage -Expirations date -Use QC organism Failure/error Pre-analytical Analytical Post-analytical 3 Reagents 5 Test System

3 Reagents KB Disk Diffusion Frequency of Occurrence Severity Harm 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 Used within expiration dates.

3 Reagents QC Organisms Frequency of Occurrence Severity Harm Measures to control risk Relevant SOP Storage Occasional Minor – Critical QC organisms are stored according to established guidelines SOP.xxxx Subcultured monthly Negligible – Minor QC organisms are prepared according to established guidelines Subcultured weekly from loop Established guidelines E. faecalis ATCC 51299 E. coli ATCC 35218 SOP.xxx

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

III. Quality Assessment (QA)
Staff training See SOP.xxxx Competency assessment Proficiency Testing Laboratory error investigation/remediation Complaint investigation/remediation Pre-analytical Analytical Post-analytical

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).

IQCP Example #1.

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