Laboratory Accreditation Personnel-ly Speaking. Qualifications and Competency 2009. College of American Pathologists (CAP). All rights are reserved. Participants are permitted to duplicate the materials for educational use only within their own institution. These materials may not be used for commercial purposes or altered in any way. Personnel Qualifications What s New? What s New? Regulations have NOT changed GEN.54400 modified to be clearer; now specifically states that employers must indicate if personnel require supervision and/or review of work prior to reporting results CAP has released a new form that must be completed as part of a laboratory s application to document that the laboratory is in compliance with the CLIA personnel requirements and has copies of all the required information on employees in its files 3 All rights are reserved. 1
4 So, what s with this new form? It is a tool that ensures a laboratory has the appropriate records of the education, certification, training and, if required, state licensure, for the technical staff Electronic form can be downloaded at: http://www.cap.org/apps/docs/laboratory_accreditation/p ersonnel_evaluation_form.xls Instructions for completing the downloaded form are available at: http://www.cap.org/apps/docs/laboratory_accreditation/i nstructions_personnel_evaluation_roster.pdf 5 Where can I get more info? Frequently Asked Questions are available on the CAP Website at: www.cap.org, Accreditation and Laboratory Improvement, Resources for Laboratories, Frequently Asked Questions, Laboratory Personnel Evaluation For additional assistance, email accred@cap.org or call 800-323-4040, option 1 6 All rights are reserved. 2
Scenario #1 A laboratory just received their reapplication materials and they are reviewing the Personnel Roster. 7 Scenario #2 A small laboratory in New Orleans is attempting to fill out the Personnel Roster and ensure that their files are complete. Two employee homes were flooded by Hurricane Katrina. Neither can provide their diploma or transcripts. Both are MT(ASCP) certified. 8 Back to Basics: Definitions Certification represents a declaration of a particular individual s professional competence, typically demonstrated by passing a written exam Licensure is a permission granted by an agency of government to an individual to engage in a given profession or occupation, once an applicant has met qualifications standards 9 All rights are reserved. 3
Definitions Registration is similar to certification, and also denotes an individual s demonstration of competency by successfully completing a written and/or practical exam CRT = Certified Respiratory Therapist (entry level certification, consisting of a written examination)* RRT = Registered Respiratory Therapist (advanced level certification, consists of both written and practical examinations)* *Information obtained from the National Board of Respiratory Care 10 What are the Qualification Requirements for Personnel? Personnel Requirements vary depending on the complexity of testing performed There are 3 categories of testing complexity defined in the CLIA Regulations: Waived Complexity Moderate Complexity Subcategory: PPM High Complexity Where to find test classification? http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfclia/search.cfm 11 12 All rights are reserved. 4
13 What are the Minimum Requirements for Testing Personnel? Waived Tests CLIA does not define any specific personnel requirements. CAP requires waived testing personnel to meet facilitydefined requirements and have documented training and competency assessments. Moderate Complexity minimum requirement is high school diploma or equivalent and appropriate training/experience as outlined in 493.1423 High Complexity minimum requirement is an associate degree for anyone hired after April 24, 1995, except those staff qualified on or before 2/28/1992 (see 493.1491 for these grandfathering provisions). For staff hired prior to this date and performing high complexity testing prior to this date that do not qualify under 493.1491, refer to 493.1483 and 493.1489 for grandfathering provisions 14 Molecular Pathology Not a specialty covered under CLIA CAP has defined specific personnel requirements for the Director and person in charge of daily operations (equivalent to a Technical Supervisor) Section Director must be a pathologist, board-certified physician in a specialty other than pathology, or doctoral scientist in a biologic science, with specialized training and/or appropriate experience in molecular pathology Person in Charge must meet the qualifications for a director OR have CLSp(MB), BS, BA or MT(ASCP) with at least 4 years of experience (at least 1 of which is in molecular pathology methods) under a qualified director The Director can fill both roles See Molecular Pathology Checklist questions MOL.40000 and MOL.40100 15 All rights are reserved. 5
Molecular Microbiology Not a CLIA-defined Sub-specialty, but CAP has specific requirements For Molecular Microbiology laboratories performing non-fda cleared/approved tests, the person in charge must Qualify as a Director OR CLSp(MB), BS, BA or MT(ASCP) with at least 4 years of experience (at least 1 of which is in molecular microbiology methods) under a qualified director See Microbiology Checklist question MIC.64634 16 Scenario # 3 A 150 bed hospital has a full service laboratory that is open 24/7. A MLT works on the night shift and is frequently alone with one phlebotomist. 17 Scenario #4 As the supervisor of a clinical microbiology laboratory you have the opportunity to hire an additional bench technologist. An excellent applicant with an HEW certificate and nine years of laboratory experience applies. 18 All rights are reserved. 6
Laboratory Director CAP s requirements exceed those defined in CLIA Laboratory Director must be a licensed, board certified (or eligible) physician or doctoral-level scientist Laboratories with annual test volumes >500,000 must have a director qualified as a high complexity laboratory director 19 Clinical Consultant Applies to Moderate Complexity Labs Only required if director is not a physician or board-certified doctoral scientist Clinical Consultant must be a licensed MD, DO or DPM or Board-certified doctoral scientist See CLIA 493.1417 for more information on this role 20 Technical Consultant Applies to Moderate Complexity Labs Only required if director is not qualified as a high complexity laboratory director Technical Consultant must be qualified as a high complexity laboratory director See CLIA 493.1411 for more information on this role 21 All rights are reserved. 7
Technical Supervisors Required only for High Complexity Laboratories Technical Supervisor minimum requirements are a bachelor s degree and 4 years of experience in high complexity testing in the specialty, however a few specialties require a physician See 493.1449 for specific specialty requirements 22 General Supervisors Required only for High Complexity Laboratories General Supervisor minimum requirements are an associate s degree (or equivalent) in medical laboratory technology (or pulmonary function, for blood gas labs) and 2 years of laboratory (or blood gas analysis) training or experience, or both, in high complexity testing See 493.1461 for determination of equivalent education and grandfathering provisions 23 Scenario #5 A laboratory has a newly hired pathologist that has not passed his board examination. Can this pathologist perform reading and testing of surgical pathology? 24 All rights are reserved. 8
TLC.10100 Does the laboratory director satisfy the personnel requirements of the College of American Pathologists? NOTE: The qualifications required by CAP for the position of laboratory director depend on the testing performed in the laboratory.* For laboratories that perform high complexity testing (as defined under CLIA), or for laboratories performing only moderately complex and/or waived testing whose annual test volume exceeds 500,000, the qualifications for the director are similar to the requirements for directors of high complexity laboratories under CLIA, as follows. The director must: Be an M.D. or D.O. licensed to practice (if required) in the jurisdiction where the laboratory is located, and Be certified in anatomic or clinical pathology, or both, by the American Board of Pathology or American Osteopathic Board of Pathology, or possess qualifications equivalent to those required for certification 25 TLC.10100, cont. OR Be an M.D., D.O. or D.P.M. licensed to practice (if required) in the jurisdiction where the laboratory is located, and Have at least one year of laboratory training during residency, or at least two years of experience supervising high complexity testing OR Hold an earned doctoral degree in a chemical, physical, biological or clinical laboratory science from an accredited institution, and Be certified and continue to be certified by a board approved by HHS** (or, for non-u.s. laboratories, by an equivalent board) 26 Scenario #6 A new Flow Cytometry laboratory is opening. The staff consists of trained personnel with MT(ASCP) degrees but no one has one year of experience under a qualified director. Their director is a board certified pathologist with laboratory experience specifically in Flow Cytometry. 27 All rights are reserved. 9
FLO.40000 Does the person in charge of technical operations in flow cytometry have education equivalent to that of an MT(ASCP) and at least one year's experience in flow cytometry under a qualified director? 28 Training, Competency, Performance Reviews What s the difference? Copyright 2008College of American Pathologists (CAP). All rights are reserved. Participants are permitted to duplicate the materials for educational use only within their own institution. These materials may not be used for commercial purposes or altered in any way. Training Defined as training that occurred in the laboratory after hire (not college or internship training) and when a new test is introduced. Completed and signed off by the trainer before performing the test without supervision. Documented using a checklist, most commonly; listing each test or procedure. 30 All rights are reserved. 10
Training (continued) Include all procedures performed by the employee. Recommend including documentation of procedure reviews and direct observations. 31 Training (continued) Template A is an example for documenting training records and is included in the tool kit. 32 Performance Reviews Generally include: An overview of how well the employee performed his or her job functions. Some form of a grading scale. A connection to compensation based on merit. Facility-wide documents maintained by Human Resources. 33 All rights are reserved. 11
Performance Reviews (Continued) Performance reviews must be completed within the first six months of employment. Performance reviews must be completed annually after the initial six month evaluation. Performance reviews are not competency assessments. 34 Performance Reviews Example A Hire Date January 2008 First Performance Review July 2008 Second Performance Review July 2009 Annual Reviews thereafter July 2010 35 Performance Reviews Example B Hire Date January 2008 First Performance Review July 2008 Second Performance Review January 2009 Annual Reviews thereafter January 2010 36 All rights are reserved. 12
Performance Reviews (continued) Template B is an example of a performance review document and is included in the tool kit. 37 Competency What s required? GEN.55500 Has the competency of each person to perform his/her assigned duties been assessed? NOTE: The manual that describes training activities and evaluations must be specific for each job description. Those activities requiring judgment or interpretive skills must be included. The records must make it possible for the inspector to determine what skills were assessed and how those skills were measured. The competency of each person to perform the duties assigned must be assessed following training, and at least annually thereafter. During the first year of an individual's duties, competency must be assessed at least every six months. Retraining and reassessment of employee competency must occur when problems are identified with employee performance. Elements of competency assessment include but are not limited to: 39 All rights are reserved. 13
GEN.55500, cont. Direct observations of routine patient test performance, including, as applicable, patient identification and preparation; and specimen collection, handling, processing and testing Monitoring the recording and reporting of test results, including, as applicable, reporting critical results Review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records Direct observation of performance of instrument maintenance and function checks Assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples; and Evaluation of problem-solving skills It may not be necessary to assess all of the above elements for each individual on an annual basis. The Program Director should identify and incorporate the elements most pertinent to the testing being performed. 40 Competency Assessment Determines if the employee performs and documents laboratory tests and functions according to the laboratory s written procedures. Includes major methodologies and potential problem prone areas. Rotates tests for assessments from year to year. Performed within the first six months after training and again six months later for new employees. Performed annually once the first two assessments are completed. Ultimately, competency assessment content is the responsibility of the laboratory director. 41 Situation A Completes training First competency assessment (6 mos) Second assessment Annual assessments thereafter January 10, 2009 July 10, 2009 January 10, 2010 January 10, 2011, January 10, 2012 42 All rights are reserved. 14
Situation B Completes training First competency assessment (3 mos) Second assessment Annual assessments thereafter February 1, 2009 May 1, 2009 November 1, 2009 November 1, 2010, November 1, 2011 43 Competency Assessment (continued) The Six Elements of Competency Assessment Direct observations of routine patient test performance, including, as applicable, patient identification and preparation; and specimen collection, handling, processing and testing Monitoring the recording and reporting of test results, including, as applicable, reporting critical results Review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records Direct observation of performance of instrument maintenance and function checks Assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples; and Evaluation of problem-solving skills 44 Competency Assessment (continued) There may be additional means to assess competency other than the six elements listed in the previous slide. It may not be necessary to use all six elements to assess each individual annually. This is decided by the type of testing performed and the laboratory director. There is no requirement to utilize all six elements for each procedure or test assessed. A strong competency assessment program includes a mixture of all the elements. 45 All rights are reserved. 15
Competency Assessment (continued) Template C is an example template of a Competency Assessment Tool and is included in the tool kit. 46 Competency Assessment (continued) If an employee fails a portion of the competency assessment, there must be: A laboratory plan for retraining and reassessing the employee Documentation demonstrating that the employee was retrained, reassessed and passed the reassessment. 47 Competency Assessment (continued) Template D is an example template of a Competency Assessment Tool and is included in the tool kit. 48 All rights are reserved. 16
Scenario #7 You are inspecting a personnel file and find the competency records for 2009. The employee does point of care testing, specifically glucoses, occult bloods and ACT testing. The competency record shows that each test has been checked off with the employee listed as competent for quality control, maintenance, patient identification, test performance and reporting of results. It is dated and signed by the employee and supervisor. 49 Key Points related to Training, Performance Reviews and Competency Training refers to on the job training, and must include all procedures the employee will be performing. Performance Reviews and Competency Assessments are not the same and must be documented separately. A new employee is required to be assessed for competency at least each six months after training during the first year. A strong competency assessment program will include a mixture of all the elements. 50 Q&A Panel Earle S. Collum, MD, FCAP Denise Driscoll, MS, Linda Lewin, MT, ASCP Adrienne Malta, MBA, MT(ASCP)SBB MT(ASCP) 51 All rights are reserved. 17