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.

CLIA 05/29/2012 6

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

CLIA 05/29/2012 7

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

CLIA 05/29/2012 8

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.

CLIA 05/29/2012 9

“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%)

CLIA 05/29/2012 11

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

CLIA 05/29/2012 12

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.

CLIA 05/29/2012 13

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

CLIA 05/29/2012 14

What Competency IS NOT Training Performance Review: It is a portion of a

performance review Proficiency Testing Peer Review by Testing Personnel

CLIA 05/29/2012 15

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)

CLIA 05/29/2012 19

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

CLIA 05/29/2012 20

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

CLIA 05/29/2012 21

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

CLIA 05/29/2012 22

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

CLIA 05/29/2012 23

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.

CLIA 05/29/2012 24

Six Elements / Competency At a minimum, all 6 elements are

required; but a lab add more elements

CLIA 05/29/2012 25

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

CLIA 05/29/2012 28

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

31

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

05/29/2012

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

CLIA 05/29/2012 33

Contacts

Sandra.Pearson@cms.hhs.gov 214-767-4414

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