What Do I Need to Do to Assess Personnel Competency? General overview of CLIA Identification of types of CLIA certificates, focusing on the certificate for provider - performed microscopy (PPM) Competency assessment, which includes the six procedures, must be performed for testing personnel for each test that the individual is approved by the laboratory director to perform. Competency Assessment in the Clinical Microbiology Laboratory. • Quality management includes personnel, processes, & procedures, as does competency. What is CLIA 1988? Competency Assessment Requirements •Documented competency assessment is required for the following named positions: •Technical Supervisor •General Supervisor •Technical Consultant •Clinical Consultant •The laboratory must have policies and procedures to assess competency based on the position responsibilities Lab personnel competency assessments, Corrective action and monitoring, and Procedure manual for pre-examination, examination and post examination. A federal government website managed and paid for by the U.S. Centers for Medicare & stream to the 2018 First Quarter CLIA Corner. Enjoy the videos and music you love, upload original content, and share it all with friends, family, and the world on YouTube. The technical consultants are responsible for assessing, performing, and documenting the training and competency of the testing staff of the ACHDLS. The results of the infrastructure assessment provided the basis for understanding the structure and processes of DPH laboratories. CMS has a wealth of information on its website, including contact information for CLIA state and regional offices, the interpretive guidelines, regulations, and brochures (including one on assessing personnel competencies). If the laboratory cannot list the six CLIA required criteria, refer back to the 2018 First Quarter CLIA Corner! 2016 LabHIT LRI EHR Test Methods for CLIA Compliance Megan Sawchuk. in order to improve competency assessments in the field. %���� ���� JFIF � � ��XICC_PROFILE HLino mntrRGB XYZ � 1 acspMSFT IEC sRGB �� �-HP cprt P 3desc � lwtpt � bkpt rXYZ gXYZ , bXYZ @ dmnd T pdmdd � �vued L �view � $lumi � meas $tech 0 rTRC. (from 2012 CMS brochure) The knowledge, skills, abilities, and behaviors needed to carry out a job (from Wright, 3rd ed.) WA 3,710 . Several CLIA-approved PT programs offer voluntary modules for PPM and participation in a clinical microscopy or PPM PT module will satisfy the bi-annual alternative performance assessment … CLIA requires that your laboratory assess the competency of point of care testing personnel who perform nonwaived testing. This brochure explains the requirements for assessing the competency for laboratory personnel. endobj Review the laboratory’s competency assessment forms to ensure they contain the six CLIA required criteria. (PDF), CLIA Brochure - CLIA Individualized Quality Control Plan Introduction (PDF), CLIA Brochure - CLIA IQCP, Considerations When Deciding to Develop an IQCP (PDF), CLIA Brochure - CLIA IQCP, What is an IQCP? CLIA covers “any facility which performs laboratory testing on specimens derived from humans for the purpose of providing information for the diagnosis, prevention, treatment of disease, of impairment of, or assessment of health.” (See the CMS website.) • Competency Brochure Published • Resources . It is a grouping of technical competencies for the main domains of expertise within the Agency. endstream – mirror the responsibilities of … 2 That brochure outlines the requirements for competency assessment, including those individuals who may assess the competency of … You choose where and when. Idaho Bureau of Laboratories Competency Assessment . %PDF-1.5 Fig.2 2 as an example of how this form can be used. 4 . Competency assessment in the clinical laboratory, as man-dated in U.S. law since 1988 as part of CLIA ’88, is published in the Federal Register as part of the Code of Federal Regula-tions (CFR). There are several assessment pitfalls that laboratory managers should look out for in their efforts to meet competency regulations and standards. Explore the categories below to find information on the various forms and templates available from SmartLabTools. Competency Testing assessment confirms that employees are doing the testing correctly. Depending on the number of people being assessed a competency based assessment tool will be indispensable. Direct observation of routine patient test performance, including patient preparation, if applicable, specimen handling, processing & testing 2. Medicaid Services. Assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency samples 6. People Transfer, the agency alternativeAccessing job seekers has never been easier, so why are you usinga recruitmen… a. The Centers for Medicare and Medicaid Services (CMS), the federal agency responsible for enforcing CLIA1 regula-tions, recently posted to its website a brochure titled “What Do I Need to Do to Assess Personnel Competency?”2 This document clarifies CMS’s current thinking regarding CLIA regulations related to competency assessment and SLT Templates  Temperature and Humidity. The POCT coordinator or evaluator may choose which evaluation types are to be included and should document all activities performed and evaluated. endobj In December 2012 CMS published CLIA Brochure 10, What Do I Need to Do to Assess Personnel Competency? • Competency for clinical & technical consultants & supervisors is based on their Competency Testing is defined as the application of the knowledge, skills and behaviors for performance. 10. http: //www.cms.gov. The problem with competency assessment… “It’s hard to see a problem clearly if you’ve already decided what to do about it.” Levitt and Dubner 3 . l Why does a given competency feature in one DOK and not in another? x���ok�0����TE���#I�-�@Gc�{:7��K�A�}O��8��Jg�|��9I�k8;�����п������`��U�g�N`�g��)J��t�g?�.G� ? Six elements of competency assessment are specifically listed in the regulations for both moderately complex and highly complex testing. All laboratory testing, under CLIA, is categorized as waived or nonwaived. • Who needs competency? If an employee is shared between 2 hospitals in the same system (different lab CLIA numbers) but the same instrument, same SOP, and same standardized competency is used at both sites, does the entire competency … The Lab Director responsibilities will be evaluated in detail at the time of survey. Effective applicationof knowledge and skill in the work setting (from a general reference) Staff Competency Assessment Berte and Warren, AACC 2014 3 Combined Definition of Competency 7 8 AB D C Training – A 4-Part Program* A. Posted: (3 months ago) An example of a competency assessment form for bacteriology is reprinted from Cumitech 39 and included in Fig. 4 0 obj must include assessment of actual test performance and interpretation of results. CLIA CLIA Competency Assessment • Competency is required for all technical, supervisory & testing personnel. What is competency and CLIA competency assessment? If the POCT is waived, performing competency assessment is good laboratory practice. 28 DOKs have been defined in the brochure - General Administration, Environment, Safety, etc. No, CMS requires competency of nonwaived testing to be assessed at the laboratory (CAP/CLIA number) where the testing is performed as there may be variations on how testing is performed at different sites. The Checklist … CLIA Competency Regulations •493.1235—Personnel Competency Assessment Policies— •As specified in the personnel requirements in Subpart M, the laboratory must establish & follow written policies & procedures to assess employee, & if applicable, consultant competency. FCIB delivers information on the latest developments in global commercial credit challenges. Competency assessment is used to ensure that the laboratory personnel are fulfilling their duties as required by federal regulation. SECTION 6: ASSESSMENT OF PROBLEM SOLVING SKILLS Please write in your answer to question number _____ from the attached Competency Questions list. 4/27/2016 . Laboratories may not share training and competency assessment documentation, even if laboratories are related and share the same instrumentation, LIS and procedures. CMS data base 1/2013 . In fact, the Competency Assessment Program offers its users tools that help meet CLIA requirements for all 6 elements of competency assessment, as well as help you manage the timing of your laboratory's assessments. CLIA and the CAP considers an employee new if he or she has not performed testing under the laboratory’s CLIA number. IQCP QA … The person doing the competency assessment does not need to be classified as a supervisor, but he or she must meet the CLIA requirements of a general supervisor for that specialty area. On December 21, 2012, the Centers for Medicare and Medicaid Services (CMS) published Survey & Certification letter: (S&C-13-07-CLIA) with Brochure #10 on Personnel Competency. (PDF). What do I need to do to assess personnel competency. 5 0 obj 2014 Continuing Compliance Master Series The Truth About Personnel Competency www.cap.org v. 1.0 Denise Driscoll, MS, MT(ASCP)SBB August 20, 2014 CLIA Brochure #10 . Six elements are necessary for all who perform non-waived testing, for all tests performed. CLIA Current Statistics--Enrollment Total Number of Laboratories 235,828 Total Non-Exempt 228,535 Compliance 19,235 Accredited 15,760 Waived 156,653 Provider Performed Microscopy 36,887 Exempt 7,293 NY 3.583 . <>>> Fig.1; 1; a partially completed form is included in Fig. <> A choice was made as to the most appropriate DOK for each competency. 2 0 obj Free Testosterone Calculators . stream New staff have CA … The Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations include federal standards applicable to all U.S. facilities or sites that test human specimens for health assessment or to diagnose, prevent, or treat disease. •Review supervisor competency requirements. If the POCT is waived, performing competency assessment is good laboratory practice. Signature: _____ Date: _____ Tiehen 65 Policy Manual Policy … Competency is the ability of personnel to apply their skill, knowledge, and experience to perform their laboratory duties correctly. 15 Renamed to Provider-performed microscopy (PPM) to include other practitioners, and to clarify tests that can be performed: •Added midlevel practitioners who are: •licensed by the state in which the laboratory is located, if required, •a nurse midwife, nurse practitioner, or physician assistant, and •under physician supervision unless independent practice is Presentations ( Click on an Image to Download PDF Powerpoint ) QC QA Review Forms. Fig.2 2 as an example of how this form can be used. In December 2012 CMS published CLIA Brochure 10, ... AABB indicated in a 2012 assessor’s workshop that, at a minimum, the assessor should expect to view documentation of competency assessment for the CLIA-regulated analytes: ABO, Rh, unexpected antibody detection, compatibility testing, and antibody identification. Evaluation of problem-solving skills Method of assessment key:Method of assessment key: DO: Direct Observation RR: results review WR: worksheet review W=waived NW=non waived or 12 3 4 5 6Method: • Competency is NOT the same as a performance evaluation/training. Clinical Laboratory Improvement Amendments (CLIA) How to Apply for a CLIA ... CLIA Brochure - Complaints, Do You Have a Concern About a Laboratory's ... (PDF) CLIA Brochure - Laboratory Director Responsibilities (PDF) CLIA Brochure - What Do I Need to Do to Assess Personnel Competency? The competency assessment records may be retained centrally within a healthcare system but must be available upon request. J.Gras Six SigmaTSIC 2010 jgras. <> Competency Assessment Tips • Competency records should match the laboratory’s actual procedures performed by its personnel. CLIA Non-Waived Laboratory Tests Competency Assessment Revised 03/01/2018 CLIA NON-WAIVED LABORATORY TESTS Personnel Competency Assessment Employee Name: _____ Title _____ Date _____ Next Assessment Due: _____ New Employee: Yes No Competency Assessment: Initial Semi-Annual Annual Guidelines Competency based on direct observations & record review … Fig.1; 1; a partially completed form is included in Fig. CLIA Competency Assessment. Competency assessment, which includes the six procedures, must be performed for testing personnel for each test that the individual is approved by the laboratory director to perform. Competency assessment in the transfusion service: tips and ... Posted: (5 days ago) If a supervisor performs testing, then his or her competency needs to be assessed. CLIA brochure no. Brochure - CLIA Individualized Quality Control Plan Introduction (IQCP) This brochure provides information on CLIA’s new quality control option called Individualized Quality … for alternative performance assessment by verifying the accuracy of their testing procedures at least twice per year. ]�{I;���WI����.��l��H��s4l�8n؈��Oa��Px�zc�Px}�S�ﷸP���ȣ6\��F!��BU�����}���V���a1kхʋ���Q]������=��Fjy�4 W�)��M *���E�* ��ީn�G����B�nO���P`lNF�>�P� �x0�,�-V�M�}>l����(������5mX�\e�L>�WD_uX�Y��J*��n���D}P�V� Enjoy the videos and music you love, upload original content, and share it all with friends, family, and the world on YouTube. Competency Assessment in the Clinical Microbiology Laboratory. Have competency assessment forms been updated to include the new testing? The reader is referred to Cumitech 39 for additional examples of competency assessment … GEN.55500 Competency Assessment •The competency of each person to perform his/her assigned duties is assessed •CLIA elements cited NOTE: The competency of each person to perform the duties assigned must be assessed following training before the person performs patient testing. • When observing test performance, use the procedure manual (PM) /package insert (PI) to ensure PM is current. •Define CLIA roles and appropriately assign responsibilities. •Outline the six CLIA-required components of Competency Assessment •Apply methods described to conduct and document meaningful competency assessments •Comply with COLA criteria that address Competency Assessments 2 . • Various related requirements are interspersed throughout the regulations. CLIA Compliance Manual contain links to websites referred to in the material. Introduction There is a new light. CLIA also addresses the following pieces of a management system: Confidentiality, Specimen identification, Complaint investigation, Communication breakdown, Lab personnel competency assessments, Corrective action and monitoring, and Procedure manual for pre-examination, examination and post examination. Data from the various methods for evaluating competency can be gathered over time and CLIA Brochure #10 What Do I Need to Do to Assess Personnel Competency? By clicking on the “Submit” button, I agree that: (1) the information I've provided will be used only by Abbott Point of Care and its contracted third parties to mail, telepho Top notch international credit education, available whenever you want them, 24/7. Competency assessment is used to ensure that the laboratory personnel are fulfilling their duties as required by federal regulation. Competency assessment, which includes the six procedures, must be performed for testing personnel for each test that the individual is approved by the laboratory director to perform. The CFR defines the requirements for initial training verification, initial competency assessment, and ongo- The reader is referred to Cumitech 39 for additional examples of competency assessment … CLIA. 4/27/2016 9 Example of Testing Performed in the facility • ABO • Rh • Antibody Transfusion • … CLIA Competency Assessment Key Requirement 493.1413(b)(8)(9) & 1451(b)(8)(9) Technical Consultant/Supervisor Responsibilities •Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently . All six CLIA evaluation types must be included in … If the POCT is non-waived or moderately complex, competency assessment must be performed and documented. <>/Font<>/ProcSet[/PDF/Text/ImageB/ImageC/ImageI] >>/MediaBox[ 0 0 720 540] /Contents 4 0 R/Group<>/Tabs/S/StructParents 0>> In 2014, CLIA introduced the Individualized Quality Control Plan (IQCP), and announced that laboratories would have a 2-year transition period, from January 1, 2014, to December 31, 2015, to transition away from EQC, and either perform the CLIA default for the frequency of QC or implement an IQCP … If the Clinical Consultant and the Lab Director are the same person, competency assessment is not required. Brochures to help explain the Clinical Laboratory Improvement Amendments (CLIA) regulation requirements are listed below in the Downloads Section. � Example B: Competency assessment. 1 0 obj 7500 Security Boulevard, Baltimore, MD 21244, Clinical Laboratory Improvement Amendments (CLIA), How to Apply for a CLIA Certificate, Including International Laboratories, State Agency & CLIA Operations Branch Contacts, Accreditation Organizations/Exempt States, Certification Boards for Laboratory Directors of High Complexity Testing, CLIA Regulations and Federal Register Documents, CLIA Related Hearing Decisions and Compliance Topics, CME Courses for Laboratory Directors of Moderate Complexity Laboratories, Individualized Quality Control Plan (IQCP), CLIA Brochure - How to Obtain a CLIA Certificate (PDF), CLIA Brochure - How to Obtain a CLIA Certificate of Waiver (PDF), CLIA Brochure - Complaints, Do You Have a Concern About a Laboratory's Operation? •Identify methods of delegating responsibilities. The POCT coordinator or evaluator may choose which evaluation types are to be included and should document all activities performed and evaluated. <> A Pre-inspection Checklist is also included in the Toolkit to facilitate internal assessments of laboratory processes. Templates Brief Descriptions. The CLIA regulations include a section on assessing the competency of staff. It is also good laboratory practice to periodically assess the competency of all POC testing personnel, even on waived testing. On December 21, 2012, the Centers for Medicare and Medicaid Services (CMS) published Survey & Certification letter: (S&C-13-07-CLIA) with Brochure #10 on Personnel Competency. CLIA does not have any requirement for assessing personnel competency on waived testing; however, CLIA requires that waived testing results are accurate to assist in making accurate patient diagnosis. CLIA Competency assessment is used to ensure that laboratory personnel are fulfilling their duties, as required by Federal regulations. The CLIA Toolkit is based on a statewide laboratory infrastructure assessment conducted November – December 2018. Operator training prior to testing is critical & required. CLIA. On December 21, 2012, the Centers for Medicare and Medicaid Services (CMS) published Survey & Certification letter: (S&C-13-07-CLIA) with Brochure #10 on Personnel Competency.It cites the six minimal regulatory requirements for assessment of competency for testing personnel: by CLIA Requirements of CAP Accreditation (GEN.55500) ChecklistBuilder & CourseBuilder 130+ Instrument-Specific Checklists Competency Assessment Courses Direct observations of routine patient test performance, including patient preparation, if applicable, specimen handling, processing and testing. Binder Covers, Spines, & Tabs. Use ChecklistBuilder to modify an existing • Acquire Documentation for Annual CLIA PPM Competency . Platform: _____ SOP: ... CLIA Required Procedures : 1. One reason why is that you’ll have a wealth of information that you can then analyse at a group level. �R�[�-ZM���y�Χ�����0���*$P��������H)�2΂�`��o��b3umD}`��+o�J`�*���Λ�H�(�/�@h�3@ŵ�Ջ��:/�ؼ����5U��~CPNП��t^J��#uh��&��$!|ϳ6X�b�w4����� ����)^�_�6/e��p�l�.���J+��]����a:n���L���D'�oR���PWzC�]�y��! If the POCT is non-waived or moderately complex, competency assessment must be performed and documented. The document called CLIA Contact List is correct but will not link due to the nature of how it was reproduced. endobj SC13-07.02_CLIA_Brochure_10_Competency_Assessment Joseph Noffsinger, MT (ASCP), MBA. endobj A competency assessment form needs to be used within the context of a competency assessment process.This is because the process doesn’t stop with the assessment. 5. 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