Today s Featured Speaker

Transcription

1 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

2 Sandy Pearson, MBA, MT(ASCP) CMS / Dallas Regional Office 05/29/2012 2

3 Objectives Overview of regulations regarding personnel competency Discussion on What is Competency Discussion on What Competency is NOT 05/29/2012 3

4 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 05/29/2012 4

5 POCT and does not have a category for POCT. looks at test complexity levels Very defined Personnel requirements for LD Minimum Personnel requirements for TP 05/29/2012 5

6 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. 05/29/2012 6

7 Non-waived Testing; to include POCT Includes moderate and high complexity tests Must follow: All manufacturer s instructions and Applicable requirements AO requirements State requirements (ex. Maryland, New York) When in doubt, always follow the most stringent requirements 05/29/2012 7

8 Non-waived Testing - QC Must perform the appropriate quality control as defined by the manufacturer, 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 Interpretive Guidelines 05/29/2012 8

9 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. 05/29/2012 9

10 POCT Deficiencies and AO s strive to ensure consistency when citing deficiencies during surveys AO s meet minimum requirements 2010 data collected from AO s and regarding most frequently cited POCT deficiencies. 05/29/

11 Top Five POCT Deficiencies Not following manufacturer s instructions (25%) Procedures and Policies (16%) Documentation/records (15%) Competency assessment/training (14%) QC data (10%) 05/29/

12 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 05/29/

13 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 D6068; 42 CFR D6173) All competency activities must be documented. 05/29/

14 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 05/29/

15 What Competency IS NOT Training Performance Review: It is a portion of a performance review Proficiency Testing Peer Review by Testing Personnel 05/29/

16 Competency Overview Policy & Procedure Manuals: training; competency (based on test procedure/methods) Hire/Job: Job description; review job GOAL: Hire the best person for the job to get the best patient test results Accurate / Reliable Patient Testing Competent TP; able to perform tests Training: length & depth Review Competency Assessment ; signs off on TP prior to patient testing; must document 05/29/

17 Competency Responsibilities Ultimate Responsibility LD Clinical Laboratory Oversight Delegation of Responsibilities in writing Review Competency Assessment and signs off on TP prior to patient testing; must document TC/TS Personnel Competency Assessment Performs Assessment; provides documentation TP Competent produce accurate /reliable test results 05/29/

18 LD Responsibilities: Moderate 42 CFR (e)(10): Employ qualified personnel (D6028) 42 CFR (e)(11): Education & Training (D6029) 42 CFR (e)(12): P/P for competency (D6030) 42 CFR (e)(14): Based on review of competency assessment, document what TP can perform (D6032) 05/29/

19 LD Responsibilities: High 42 CFR (e)(11): Employ qualified personnel (D6101) 42 CFR (e)(12): Education & Training (D6102) 42 CFR (e)(13): P/P for competency (D6103) 42 CFR (e)(15): Based on review of competency assessment, document what TP can perform (D6107) 05/29/

20 LD Responsibilities (High) Not only assess competency on TP, but Assess competency on (42 CFR 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 05/29/

21 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 05/29/

22 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 05/29/

23 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 05/29/

24 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. 05/29/

25 Six Elements / Competency At a minimum, all 6 elements are required; but a lab add more elements 05/29/

26 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 05/29/

27 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. 05/29/

28 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 05/29/

29 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 05/29/

30 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 05/29/

31 Guidance / Problems to Avoid 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/

32 Questions?? THANK YOU!!!! 05/29/

33 Resources: Website Includes State Agency & CMS RO contacts Interpretive Guidelines Regulations 05/29/

34 Contacts /29/