What Does it Mean for You?

What Does it Mean for You?
SCACM Audio conference 4/28/15 PACE #: IQCP - Individualized Quality Control Plan What Does it Mean for You? Susan E. Sharp, Ph.D., ABMM, FAAM Director, Airport Way Regional Laboratory Director, Regional Microbiology and Molecular Infectious Diseases Laboratories Kaiser Permanente Department of Pathology Portland, OR 97230

Susan E. Sharp, Ph.D. (no disclosures)
Objectives Understand the history behind CMS’s IQCP Detail the new CMS requirements for IQCP Develop an IQCP plan for microbiology systems in your laboratory 1

CMS: QC Milestones Quality Systems Regulations 2003 CLIA ‘67 CLIA ‘88
Equivalent QC “EQC” 2004 1 In 1967 the Clinical Laboratory Improvement Act (CLIA-67) set guidelines that regulated laboratories that did Medicare billing and/or engaged in interstate commerce (primarily large independent laboratories). s Individualized QC plan “IQCP” 2013 “QC for the Future” 2005 CLSI EP-23 2011

Equivalent QC “EQC” 2004 1 s CLIA ’88 (with the FINAL regulations published in 1992) set forth new regulations for personnel standards, specimen management, quality control, quality assurance, and proficiency testing (PT) for ALL entities performing laboratory testing. CLIA ’88 mandated that testing must follow manufacturers requirements. Now… after this, the CDC & CMS had many meetings to try to find better ways to do QC, but these meetings met with limited success. Individualized QC plan “IQCP” 2013 “QC for the Future” 2005 CLSI EP-23 2011

Equivalent QC “EQC” 2004 1 CMS published their Quality Systems Regulations in 2003 which updated all QC requirements. At this time, instead of changing regulations for new, emerging technology, CMS allowed “equivalent QC testing” to be performed. Default QC testing, according to CLIA, was to perform 2 levels of external QC on each day of testing. s Individualized QC plan “IQCP” 2013 “QC for the Future” 2005 CLSI EP-23 2011

Equivalent QC “EQC” 2004 1 Equivalent QC or ‘EQC’ was developed in 2004 by CMS as a voluntary alternative to the default QC. This Option included both external QC and internal QC monitors in the total QC testing process. EQC was meant to minimize the frequency of external QC that was required to control laboratory test systems, to help save costs & resources for laboratories, and acknowledge technological advances. s Individualized QC plan “IQCP” 2013 “QC for the Future” 2005 CLSI EP-23 2011

Equivalent QC “EQC” 2004 1 However, there were concerns expressed by industry, laboratories, and other experts about the EQC plan. Many laboratories had adopted EQC successfully & had no quality issues; but it was felt by some that there was little flexibility in EQC that it was limited in scope. So, in 2005, CMS reached out to CLSI to facilitate the development of an scientific, objective consensus QC guideline. In 2005, a meeting called “QC for the Future” was held and sponsored by accrediting organizations, industry, professional organizations & governmental agencies. OUTCOME: Stakeholders expressed concerns that manufacturers did not provide laboratories sufficient information regarding QC and that a ‘One-size-fits-all’ QC would not work with new technologies coming into the field. s Individualized QC plan “IQCP” 2013 “QC for the Future” 2005 CLSI EP-23 2011

Equivalent QC “EQC” 2004 1 Thus, CMS asked the CLSI to develop an QC evaluation protocol document: = the “EP23—Laboratory Quality Control Based on Risk Management”. This document was published by CLSI in October of 2011. s Individualized QC plan “IQCP” 2013 “QC for the Future” 2005 CLSI EP-23 2011

Equivalent QC “EQC” 2004 1 CMS incorporated the key concepts of the EP-23 into the CLIA Interpretive Guidance as QC policy = This resulted in the mandate of the Individualized Quality Control Plan – IQCP. s Individualized QC plan “IQCP” 2013 “QC for the Future” 2005 CLSI EP-23 2011

Mandatory vs. Voluntary
IQCP is “voluntary” for laboratories Current CLIA control “default” regulations continue to be in effect: Pos & Neg QC each test day for qualitative tests 2 levels of QC each test day for quantitative tests EQC (based on using internal controls; weekly QC; shipment/lot QC; etc.) will be discontinued and will no longer be an acceptable QC option under CLIA in January 2016 The laboratory must choose to: follow CLIA default QC regulations, OR develop an IQCP 1

CMS IQCP Consists of 3 components: III. Quality Assessment (QA)
I. Risk Assessment (RA) A. Collect data Note the areas where errors or failures could occur in the entire workflow path (pre analytical, analytical, post-analytical) B. Assess the frequency of occurrence of the error and the potential harm (impact) if an error would occur II. Quality Control Plan (QCP) > Defines the control mechanisms in place for detecting, controlling or preventing errors > Defines resulting QC and acceptability criteria III. Quality Assessment (QA) > Designed to ensure (and to monitor) the effectiveness of the QCP 1

I. Risk Assessment *Risk Assessment Components (as defined by CMS)
Identify the RISKs (sources of potential failures and errors) associated with the test system* *Risk Assessment Components (as defined by CMS) specimen test system reagent environment testing personnel Evaluate the frequency (occurrence) of those failures/errors Evaluate the impact (potential harm) due to those failures/errors The resulting “Risk Assessment” is then used to develop the Quality Control Plan (QCP) = How you will control for these risks 1

I. Risk Assessment *Risk Assessment Components (as defined by CMS)
I. Risk Assessment *Risk Assessment Components (as defined by CMS) Specimen Patient preparation, collection, labeling, storage preservation, stability, transportation, processing, acceptability, referral Test System Inadequate sampling, clot detection, detecting interfering substances, calibration issues, mechanical/electronic failure, optics, pipettors, bar code readers, function checks, built-in controls, external controls, temperature monitors/controllers, software/hardware, transmission of data to LIS, result reporting Reagent Shipping/receiving, storage, expiration dates, preparation Environment Temperature, airflow/ventilation, light intensity, humidity, altitude, dust, water, utilities, space Testing Personnel Training, competency, education, experience, staffing 1

II. Quality Control Plan (QCP)
A document/process/plan that describes the practices, resources, and procedures used to control the quality of a test system. Control all phases of testing specimen collection…performance…result reporting Must monitor the accuracy and precision of test performance Include the number, type, and frequency of QC Define criteria for acceptability of QC 1

III. Quality Assessment
The laboratory must establish a review system for the on-going monitoring of the effectiveness of their QCP. The monitoring should include all 5 Risk Assessment Components (part of our RA): specimens, test system, reagents, environment, testing personnel When the laboratory discovers a testing process failure or error it must: conduct and document an investigation to identify the cause of the failure/error, determine its impact or harm, and make appropriate modifications to their QCP to control for this failure. 1

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

IQCP – An Example Commercial Antimicrobial Susceptibility Testing (AST) 1

IQCP – Commercial AST I. Risk assessment (RA) of the System
II. Quality Control Plan (QCP) for the System III. Quality Assessment (QA) for the System 1

Conduct a risk assessment
Collect Information + B. Conduct a risk assessment -Manufacturer instructions -Manufacturer performance data -Literature published on assay -Accreditation/Regulatory requirements -Individual laboratory data available > verification testing data > historical QC data 1

A – Collect information
Risk Assessment A – Collect information Manufacturer instructions Look specifically at the ‘Limitations’ section to identify possible risks. Note manufacturer recommended QC (IQCP may not include QC that is less than that recommended by the manufacturer). Include a copy of your manufacturer’s instructions 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. Include copy in your IQCP materials. Literature published on assay Look for any risks/concerns associated with this system that have been identified in the literature. Include copies of pertinent articles in your IQCP materials. Accreditation/Regulatory requirements Ensure that your IQCP will be in compliance with any accreditation or regulatory requirements. Include copies of these requirements in your IQCP materials. Individual laboratory data available Review your verification (initial and any subsequent studies) and historical QC data to help define your IQCP. Include these data in your IQCP materials, or identify where this data can be found in the laboratory.  1

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

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

CLSI EP-23 document: Risk Matrix
Severity of harm (Impact) Probability of harm (Frequency) Negligible Minor Serious Critical Catastrophic Frequent U Probable A Occasional Remote Improbable 1 A = Acceptable risk U = Unacceptable risk

Risk Evaluation Frequency Impact Unlikely (1/2-3 yrs)
Occasional (1/mo-yr) Frequent (1/wk) Impact Negligible (temporary discomfort) Minor (temporary injury; not requiring medical intervention) Critical (permanent impairment requiring medical intervention) 1 All risks need to have control measures in place.

Collect Information + B. Conduct a risk assessment Identify where along the testing process risk or errors might occur. Determine the frequency of occurrence of the error and the potential harm if an error would occur. This risk assessment must include pre-analytical, analytical, and post-analytical areas of laboratory testing. Risk assessment must include the 5 Risk Assessment Components (CMS): 1. Specimen 2. Testing Personnel 3. Reagent 4. Environment 5. Test System 1  FISHBONE DIAGRAM

Identify Potential Hazards Incorrect Test Results
1 Specimen; Organism RISK ASSESSMENT: Identification of Potential Failures - Commercial AST System Specimen (1A) -Patient identification -Collection/container/ volume -Transport -Storage Organism (1B) -Clinically relevant -Colony age -Media type -Pure isolate -Inoculum suspension 2 Testing Personnel 4 Environment Factors -Temperature/ Airflow/ Humidity/ Ventilation -Utilities -Space -Noise/Vibrations Operator Function -Training -Competency Assessment -Proficiency Testing -Staffing Identify Potential Hazards Incorrect Test Results Instrument -Electrical -Jam -Software/ Antibiotic Reporting Rules QC Organism -Storage/ Preparation Reported Results -Transmission of results to Hospital Information Systems -Review of released results -Clinician feedback Reagent Integrity -Shipping / storage -Expirations date -Preparation/Use QC organism -Failure -Error 6 Test Results 3 Reagents 5 Test System Pre-analytical Analytical Post-analytical

IQCP – Commercial AST I. Risk assessment (RA) of the AST System
II. Quality Control Plan (QCP) for the AST System III. Quality Assurance (QA) for the AST System 1

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

IQCP – Commercial AST Identify Measures to Control/Reduce Risk
II. Quality Control Plan (QCP) for the AST System Identify Measures to Control/Reduce Risk Build tables to include all of the risks identified in your risk assessment. Determine the “Probability of occurrence” (frequency) and the “Severity of harm” (impact) for each risk identified. Indicate the measures you have in place to mitigate/ reduce/control these risks/errors. Include where to find these measures in your procedures, reports, logs, etc. 1

1 Specimen; Organism RISK ASSESSMENT: Identification of Potential Failures - Commercial AST System Specimen (1A) -Patient identification -Collection/container/ volume -Transport -Storage Organism (1B) -Clinically relevant -Colony age -Media type -Pure isolate -Inoculum suspension 2 Testing Personnel 4 Environment Factors -Temperature/ Airflow/ Humidity/ Ventilation -Utilities -Space -Noise/Vibrations Operator Function -Training -Competency Assessment -Proficiency Testing -Staffing Identify Potential Hazards Incorrect Test Results Instrument -Electrical -Jam -Software/ Antibiotic Reporting Rules QC Organism -Storage/ Preparation Reported Results -Transmission of results to Hospital Information Systems -Review of released results -Clinician feedback Reagent Integrity -Shipping / storage -Expiration date -Preparation/Use QC organism -Failure -Error 6 Test Results 3 Reagents 5 Test System Pre-analytical Analytical Post-analytical

Harm from Potential Error: Measures to control risk
Commercial AST System 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 SOP.xxxx Collection/ Container/ Volume Collection and container criteria defined per source; acceptability defined; competency assessment performed Transport Transport criteria defined per source; acceptability defined; competency assessment performed Storage Storage criteria defined per source; acceptability defined; competency assessment performed 1

Commercial AST System Organism Frequency of Occurrence Severity of Harm Measures to control risk Relevant SOP Clinically relevant Occasional Minor-Critical Selection criteria defined in training; competency assessment performed SOP.xxxx Colony Age Media type Selection criteria defined in training; competency assessment performed Pure isolate Inoculum suspension Preparation criteria defined in training; competency assessment performed 1

1 Specimen; Organism RISK ASSESSMENT: Identification of Potential Failures - Commercial AST System Specimen (1A) -Patient identification -Collection/container/ volume -Transport -Storage Organism (1B) -Clinically relevant -Colony age -Media type -Pure isolate -Inoculum suspension 2 Testing Personnel 4 Environment Factors -Temperature/ Airflow/ Humidity/ Ventilation -Utilities -Space -Noise/Vibrations Operator Function -Training -Competency Assessment -Proficiency Testing -Staffing Identify Potential Hazards Incorrect Test Results Instrument -Electrical -Jam -Software/ Antibiotic Reporting Rules QC Organism -Storage/ Preparation Reported Results -Transmission of results to Hospital Information Systems -Review of released results -Clinician feedback Regent Integrity -Shipping / storage -Expiration date -Preparation/Use QC organism -Failure -Error 6 Test Results 3 Reagents 5 Test System Pre-analytical Analytical Post-analytical

Commercial AST System 2 Operator Frequency of Occurrence Severity Harm Measures to control risk Relevant SOP Training Occasional Minor-Critical All testing personnel have had appropriate training SOP.xxxx Competency Assessment All personnel have appropriate CA performed Proficiency Testing Negligible-Minor All PT failures addressed with corrective action Staffing Adequate staffing to support test menu and turn-around-times on all shifts 1

Commercial AST System 3 Reagents Frequency of Occurrence Severity Harm Measures to control risk Relevant SOP Shipping / Storage Occasional Minor – Critical Reagents are shipped and stored according to manufacturer’s instructions. SOP.xxxx Expiration dates Unlikely Reagents are used within expiration dates. Preparation / Use Critical All reagents are prepared/used according to manufacturer’s instructions. QC organism storage / preparation Results for all QC organisms are within acceptable limits. 1

Harm from Potential Error: Commercial AST System
4 Environment Frequency of Occurrence Severity of Harm Measures to control risk Relevant SOP Temperature / Airflow / Humidity / Ventilation Unlikely Negligible – Minor Appropriate environmental conditions are maintained in the laboratory SOP.xxxx Utilities Appropriate utilities are employed in the laboratory to serve the instrumentation Space Appropriate space is available in the laboratory to serve the instrumentation Noise / Vibration Appropriate parameters are in place to serve the instrumentation 1

Commercial AST System 5 Test System Frequency of Occurrence Severity of Harm Measures to control risk Relevant SOP Electrical / Jam Occasional Negligible – Minor AST Instrument Maintenance log; appropriate utilities are employed in the laboratory to serve the instrumentation SOP.xxxx Software / Antibiotic result reporting Unlikely Minor – Critical All testing personnel have had appropriate training on software and appropriate result reporting QC organism failure / error All testing personnel have had appropriate training to detect failures/error; AST QC log 1

1 Specimen; Organism RISK ASSESSMENT: Identification of Potential Failures - Commercial AST System Specimen (1A) -Patient identification -Collection/container/ volume -Transport -Storage Organism (1B) -Clinically relevant -Colony age -Media type -Pure isolate -Inoculum suspension 2 Testing Personnel 4 Environment Factors -Temperature/ Airflow/ Humidity/ Ventilation -Utilities -Space -Noise/Vibrations Operator Function -Training -Competency Assessment -Proficiency Testing -Staffing Identify Potential Hazards Incorrect Test Results Instrument -Electrical -Jam -Software/ Antibiotic Reporting Rules QC Organism -Storage/ Preparation Reported Results -Transmission of results to Hospital Information System -Review of released results -Clinician feedback Reagent Integrity -Shipping / storage -Expiration date -Preparation/Use QC organism -Failure -Error 6 Test Results 3 Reagents 5 Test System Pre-analytical Analytical Post-analytical

Commercial AST System 6 Test Results Frequency of Occurrence Severity of Harm Measures to control risk Relevant SOP Transmission of results to HIS Unlikely Negligible – Minor Periodic review of released results to HIS. SOP.xxxx Review of released results Occasional – Frequent Review of all (or pertinent) released results according to SOP. Appropriate investigation for all reporting errors. Clinician feedback Occasional Minor – Critical Appropriate investigation for all clinician feedback, issues, complaints. 1

IQCP – Commercial AST I. Risk assessment (RA) of the System
- Fishbone Diagram II. Quality Control Plan (QCP) for the System - QCP Tables III. Quality Assessment (QA) for the System 1

III. Quality Assessment (QA):
Develop a “Post-Implementation Monitoring Process” that will allow you to know when a process is in need of review/revision. These may include the periodic review and monitoring of the following (not limited to these): Specimen collection/transportation, etc. protocols Staff training Competency assessment Proficiency testing Quality Control/Instrument function results Unexpected Errors Laboratory error investigation/remediation Complaint investigation/remediation 1 Pre-analytical Analytical Post-analytical

III. Quality Assessment (QA): Post-implementation monitoring process
All instrument or QC organism failures will be brought to the attention of the supervisor or designee immediately for investigation (see SOP.xxxx). Documented review of QC will be performed by supervisor or designee weekly and by supervisor monthly to see that QC is accurately performed and documented (see SOP.xxxx). Remediation of PT failures is addressed timely (see SOP.xxxx). Reporting errors are investigated timely (see SOP.xxxx). Complaint investigations are carried out timely in a timely manner (see SOP.xxxx). For all QC/PT failures, laboratory reporting errors, complaints, etc., a reassessment of risk will be performed and adjustments made to the QCP as necessary. The reason for failure will be identified and addressed in a new/updated risk assessment answering the following: Has a new hazard been identified? Does this hazard change the frequency of occurrence for errors/risks? Does this hazard change the severity of harm (impact)? Additional control measures will be implemented if necessary as determined by the new risk assessment. 1

IQCP: Commercial AST (example)
Based on our: Risk Assessment Quality Control Program Overall Laboratory Quality Assessment program The QCP for our Commercial AST System will consist of following the instructions in SOP.xxxx and recording results on QC-FORM.xxxx QC will consist of: Testing of ATCC QC organism(s) (specify organisms) per each lot & shipment on each type of AST panel before or concurrently with placing these materials into service. Thereafter, weekly (or a time frame supported by your QCP and data) testing with ATCC QC organism(s) (specify organisms) on each type of AST panel. Testing ATCC QC organism(s) (specify organisms) on each type of AST panel after each major system maintenance or software upgrade before or concurrently with placing the instrument back into service. QC Acceptability Criteria is defined in SOP.xxxx 1

Questions? CMS: ASM: (Clin Micro Portal  Lab Management)
ASM: (Clin Micro Portal  Lab Management) CMS information IQCP Templates and examples from an ASM-CAP-CLSI collaborative effort (coming soon) 1

IQCP-Individualized Quality Control Plan What Does it Mean for You
IQCP-Individualized Quality Control Plan What Does it Mean for You? SCACM Audioconference April 28, 2015 This audioconference is supported through an educational grant from BioFire Diagnostics

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