Competency/Training and CLIA Anne Chenoweth, MBA, MT(ASCP)CM, CQA(ASQ) May 2015

Agenda Background CLIA regulations – Training and Competency www.aabb.org

Background 1995: AABB granted deemed status by CMS for CLIA BBTS Standards equal to or more stringent than CLIA condition level requirements AABB assessment takes the place of routine government inspections mandated by CLIA Deemed status granted for up to 6 years 2014 AABB granted deemed status for BB/TS, IRL, MT and Cellular Therapy Standards for 6 years www.aabb.org

When AABB  CLIA Assessment Tool CLIA Verification Form Inclusion of assessor questions Inclusion of CLIA regulation CLIA Verification Form Specific questions related to CLIA regulations Lead assessor packet and website www.aabb.org

AABB CLIA Verification Form Use when AABB is the CLIA provider Included in Lead Assessor packet Lead is responsible for completion based on feedback from team members www.aabb.org

AABB Standards Medical Director (on CLIA certificate) Review of new or revised procedures Meets CLIA requirements found in CFR www.aabb.org

Competency 2. Monitoring the recording and reporting of test results; 42 CFR 493.1235, 42 CFR 493.1451(b)(8)(9) 1. Direct observations of routine patient test performance, including patient preparation, if applicable, specimen handling, processing and testing; 2. Monitoring the recording and reporting of test results; 3. Review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records; 4. Direct observations of performance of instrument maintenance and function checks; 5. Assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples; and 6. Assessment of problem solving skills. www.aabb.org

Regulated Analytes ABO Rh Antibody Transfusion Antibody Non Transfusion (prenatal) Antibody Identification Compatibility Testing www.aabb.org

Element 1 Direct observations of routine patient test performance, including patient preparation, if applicable, specimen handling, processing and testing; www.aabb.org

Element 2 Monitoring the recording and reporting of test results; www.aabb.org

Element 3 Review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records; www.aabb.org

Element 4 Direct observations of performance of instrument maintenance and function checks; www.aabb.org

Element 5 Assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples; and www.aabb.org

Element 6 Assessment of problem solving skills. www.aabb.org

Training and Competency www.aabb.org

Semi Annual www.aabb.org

Frequency At least semiannually during the first year the individual tests patient specimens At least annually thereafter unless test methodology or instrumentation changes Prior to reporting patient test results, the individual's performance must be re-evaluated to include the use of the new test methodology or instrumentation www.aabb.org

Who Is Responsible for Performing Competency Assessment? Technical Consultant – moderate complexity testing Can be performed by other personnel meeting TC qualifications Technical Supervisor – high complexity testing Can be delegated, in writing, to a General Supervisor meeting qualifications as GS for high complexity testing “Peer testing personnel who do not meet the regulatory qualifications of a TC, TS, or GS cannot be designated to perform competency assessments.” ~CMS www.aabb.org

Qualifications Technical Consultant Bachelor’s degree in chemical, physical or biological science or medical technology AND Have at least 2 years of laboratory training or experience, or both, in non-waived testing General Supervisor Qualify as testing personnel under 42CFR493.1489(b)2 AND Have at least 2 years of laboratory training or experience, or both, in high complexity testing www.aabb.org

Step 1 Define the tests These are NOT tests: Unit confirmation ABO Rh Ab Screen/ID Crossmatch DAT Antigen typing FMH screen Prenatal titer These are NOT tests: Unit confirmation Prenatal workup Cord blood workup Transfusion reaction investigation www.aabb.org

Define methodology(ies) Tube Manual gel Automation Echo ProVue Step 2 Define methodology(ies) Tube Manual gel Automation Echo ProVue www.aabb.org

Step 3 Identify equipment Exclude equipment not related to testing Cell washer Incubator Centrifuge Provue Echo Exclude equipment not related to testing Refrigerator Freezer Plasma Thawer Platelet Incubator www.aabb.org

And That Includes the Supervisor!! Just Remember… Those who assess competency must also have their competency assessed IF they perform critical tasks! And That Includes the Supervisor!! www.aabb.org

Have You Defined What Tasks Are Critical? Sample collection Sample evaluation Component preparation Thawing FFP Making aliquots Washing red cells Irradiating products Issue of blood products Others? www.aabb.org

What To Assess Deviation reporting Customer complaints Staff complaints High risk activities Low frequency activities You decide! www.aabb.org

Document What was assessed Who was assessed Method of assessment Who performed assessment When Competent Y/N www.aabb.org

Design a form www.aabb.org

Example Competency Statements (employee sign/date)___________ certify that I am fully trained and competent to perform the roles listed above (assessor sign/date)___________ attest that the staff member listed above is fully trained and competent to perform the roles listed above www.aabb.org

Questions? www.aabb.org