Today’s Featured Speaker - Whitehat Communications...Today’s Featured Speaker Sandy Pearson,...
Transcript of Today’s Featured Speaker - Whitehat Communications...Today’s Featured Speaker Sandy Pearson,...
Today’s Featured Speaker Sandy Pearson, MBA, MT(ASCP): received her BS Degree
at the University of Wisconsin and her MBA from St. Edwards University, Austin , TX. She is an American Society for Clinical Pathology certified Medical Technologist. She has 30 + years of clinical laboratory experience in various health care settings: hospitals, research, Peace Corp Volunteer, Laboratory Surveyor for the State of Texas.
Sandy is currently a Laboratory Consultant/surveyor with the CMS Regional Office in Dallas, TX. She has been with CMS for 20 years.
05/29/2012 1
Sandy Pearson, MBA, MT(ASCP) CMS / Dallas Regional Office
CLIA 05/29/2012 2
Objectives Overview of regulations regarding
personnel competency Discussion on “What is Competency” Discussion on “What Competency is
NOT ”
CLIA 05/29/2012 3
TERMS POCT= Point of Care Testing
LD = Laboratory Director TC = Technical Consultant (moderate) TS = Technical Supervisor (high) TP = Testing Personnel AO = Accrediting Organization PP= Policy and Procedures CC = Clinical Consultant GS = General Supervisor
CLIA
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POCT and CLIA CLIA does not have a category for
“POCT”.
CLIA looks at test complexity levels Very defined Personnel requirements for
LD Minimum Personnel requirements for TP
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In General…… POCT programs often incorporate
different levels of test complexity. Non-waived testing has more stringent
requirements that will need to be incorporated. AO’s can have more specific/stringent
requirements than CLIA.
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Non-waived Testing; to include POCT Includes moderate and high complexity tests Must follow: All manufacturer’s instructions and Applicable CLIA requirements AO requirements State requirements (ex. Maryland, New York)
When in doubt, always follow the most stringent requirements
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Non-waived Testing - QC Must perform the appropriate quality control as
defined by the manufacturer, CLIA or the AO (whichever is the most stringent)
Minimum two levels of control each day of testing
EQC If use EQC, need to have plan on how you will re-assess
previously tested patients if problems arise Additional information on EQC can be found in the
CLIA Interpretive Guidelines
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Non-waived Testing
Proficiency Testing (PT)Required
Quality Assessment (QA)Required
Personnel qualifications and responsibilities for ALL personnel Hire the right person w/the right
qualifications for the right job.
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“POCT” Deficiencies CLIA and AO’s strive to ensure
consistency when citing deficiencies during surveys AO’s meet minimum CLIA requirements 2010 data collected from AO’s and CLIA
regarding most frequently cited “POCT” deficiencies.
CLIA 05/29/2012 10
Top Five “POCT” Deficiencies Not following manufacturer’s
instructions (25%)
Procedures and Policies (16%)
Documentation/records (15%)
Competency assessment/training (14%)
QC data (10%)
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Competency/Training Citations New staff not properly trained Competency to perform test is not
assessed at appropriate intervals Competency not assessed using
required elements Competency assessment confused
with training
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What is Competency? Assurance that all personnel have suitable &
sufficient skill, knowledge, & experience to perform their laboratory duties accurately and timely.
Also, assurance that TP are fulfilling their duties as required by regulation. (42 CFR 493.1425 D6068; 42 CFR 493.1495 D6173)
All competency activities must be documented.
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Rational for Personnel Competency Ensure accurate, reliable & timely testing
Studies indicate that more education & training produce higher quality results
A method to confirm effectiveness of training
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What Competency IS NOT Training Performance Review: It is a portion of a
performance review Proficiency Testing Peer Review by Testing Personnel
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CLIA Competency Overview
Accurate / Reliable Patient Testing
GOAL: Hire the best person for the job to get the best patient test results
Hire/Job: Job description; review job
Competent TP; able to perform tests
Policy & Procedure Manuals: training;
competency (based on test
procedure/methods)
CLIA
Training: length & depth
Review Competency Assessment ; signs off on TP prior to patient testing; must document
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CLIA Competency Responsibilities
LD
TC/TS TP
Clinical Laboratory Oversight
Personnel Competency Assessment
Competent – produce accurate /reliable test
results
CLIA
Delegation of Responsibilities in writing
Performs Assessment; provides documentation
Review Competency Assessment and signs off on TP prior to patient testing; must document
Ultimate Responsibility
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LD Responsibilities: Moderate 42 CFR 493.1407(e)(10): Employ qualified personnel
(D6028)
42 CFR 493.1407(e)(11): Education & Training (D6029)
42 CFR 493.1407(e)(12): P/P for competency (D6030)
42 CFR 493.1407(e)(14): Based on review of competency assessment, document what TP can perform (D6032)
CLIA 05/29/2012 18
LD Responsibilities: High 42 CFR 493.1445(e)(11): Employ qualified
personnel (D6101)
42 CFR 493.1445(e)(12): Education & Training (D6102)
42 CFR 493.1445(e)(13): P/P for competency (D6103)
42 CFR 493.1407(e)(15): Based on review of competency assessment, document what TP can perform (D6107)
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LD Responsibilities (High) Not only assess competency on TP, but Assess competency on (42 CFR 493.1235 – D5209):
General Supervisor (GS) Technical Consultant (TC) Technical Supervisor (TS) Clinical Consultant (CC) Documentation Required If the LD serves as all three, this assessment is not
needed
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D6028/D6101 Employ sufficient amount of personnel w/appropriate
education and experience and/or training to:
Provide Consultation
Properly supervise staff
Accurately perform tests
Report out test results
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D6029 / D6102 Prior to patient testing; staff must have
appropriate education and experience;
Receive the appropriate training for the type
and complexity of the services offered;
And demonstrate they can perform all testing
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D6030 / D6103 Write P/P to monitor TP in all phase of testing
(Pre/Analtyic/Post)
To assess competency to:
Process specimens,
Perform test procedures
Report test results
ID needs for remedial training/continuing education to improve skills
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D6032 / D6107 Specify in writing: Responsibilities & duties of each consultant
and each person engaged in patient testing (pre/analytic/post)
ID which tests each person can perform
When supervision is required;
When consultant or LD review is required.
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Six Elements / Competency At a minimum, all 6 elements are
required; but a lab add more elements
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Six Elements / Competency 1) Direct observations of routine patient
test performance, including patient prep, specimen handling, processing, testing
2) Monitoring the recording & reporting of test results
3) Review of intermediate test results or worksheets, QC records, PT results, and PM records
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Six Elements / Competency 4) Direct observations of performance of
instrument maintenance checks and functions checks;
5) Assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external PT samples;
6) Assessment of problem solving skill.
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Frequency of Competency Evaluations
Semiannually during the first year (new hires)
Thereafter; annually
Methodologies/instrument change; reevaluation of TP (prior to patient testing)
Can be done thought-out the entire year
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Guidance / Problems to Avoid Operator training prior to testing Competency assessments must demonstrate TP’s
proficiency Competency Assessments must be documented Person doing the competency assessment must
meet personnel regulations Competency records should match the actual
laboratory procedure being performed by staff
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Guidance / Problems to Avoid Can use QA/Post Analytic – confirming tests
ordered match reported & charted results Follow-up on QC corrective actions will
demonstrate problem solving ability Competency for clinical & technical consultants
based on their regulatory requirements Lab director serving as TC, CC, TS. &/or GS isn't
subject to competency requirements
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CLIA
Guidance / Problems to Avoid
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Personnel who perform pre & post analytic activities & who aren't listed in the regulations as required positions aren't subject to competency. But laboratory may want to do similar evaluations for
QA or if a problem has occurred
Competency evaluations must be done for Provider Performed Microscopy (PPM) individuals.
Pathologists serving as TS must be evaluated by LD
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CLIA
Questions??
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THANK YOU !!!!
Resources: CLIA Website http://www.cms.gov/CLIA Includes State Agency & CMS RO contacts Interpretive Guidelines – CLIA Regulations
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