Articulate Presenter version 6 Pro,build10C:\Users\Jon\Documents\APHL CLIA Competency\Current files\Comp assess web files_SHL\Comp assessment for SHL Web3.pptx Comp assessment for SHL Web3 linkhttp://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/index.html linkhttp://wwwn.cdc.gov/clia/regs/subpart_m.aspx linkhttp://www.clsi.org linkhttp://www.shl.uiowa.edu filetraining checklist.pdf filepre_analytic_competency_assessment_form.pdf filetesting_personnel_competency_assessment_form_2.pdf filelaboratory personnel competency assessment.pdf filelab personnel competency assessment-tracking & evaluation.pdf filetraining_&_competency_checklist.pdfslide1.swfbgd2l2.swf Welcome to “Mission Possible: Understanding Competency Assessment.” Please use the “Course Information” tab at the top of the screen to learn more about this course.  notes/notesbig1.swf75notes/notessmall1.swf18710truefalsefalsedefaultdefault0-1 Welcome Mission Possible: Understanding Training & Competency Assessment © 2013 Association of Public Health Laboratories Content and instructional design provided by the State Hygienic Laboratory at The University of Iowa 30slide2.swfbgd2l2.swf That may be so, but it’s not really your supervisor’s decision. In 1988, Congress passed the Clinical Laboratory Improvements Amendment, which regulates all laboratory testing performed on clinical, or human, samples in the United States. Personnel training and competency assessment are both required by CLIA. The standards in the general system state that personnel competency assessment is a requirement for both moderate and high-complexity testing. The exact requirements can be found in the two references shown here. Although competency assessment is not required for waived testing, it’s a good laboratory practice for any facility where waived testing is performed. (See the “Links and Downloads” tab for more information.)  notes/notesbig2.swf261notes/notessmall2.swf68444truefalsefalsedefaultdefault0-1 Regulations I don’t really understand why my supervisor insists on competency assessment. I’ve been doing this job for a long time and I know what I’m doing. I hate being tested! Clinical Laboratory Improvements Act of 1988 (CLIA) requires: Personnel Training Competency Assessment Code of Federal Regulations: 42 CFR 493 Centers for Medicare & Medicaid Services State Operations Manual, Appendix C: Interpretive Guidelines for Laboratories and Laboratory Services. 30slide3.swfbgd2l2.swf For moderate-complexity testing, the CLIA Laboratory Director can designate a technical consultant to be responsible, and, for high-complexity testing, the responsibility can be delegated to a technical supervisor or a general supervisor. Ultimately, however, the CLIA Laboratory Director is responsible for ensuring that laboratory personnel are trained and competent prior to reporting patient test results, regardless of the complexity of testing. And, if the director does delegate this responsibility, it has to be done in writing.      notes/notesbig3.swf220notes/notessmall3.swf53230truefalsefalsedefaultdefault0-1 Who’s Responsible? OK. So who’s responsible for making sure we’re all trained and assessed? 30slide4.swfbgd2l2.swf The CLIA Laboratory Director must specify the duties and responsibilities of each person, including the personnel who are engaged in any phase of testing.      notes/notesbig4.swf137notes/notessmall4.swf22610truefalsefalsedefaultdefault1-1 Laboratory Director’s Duties Director 30slide5.swfbgd2l2.swf These duties and responsibilities of the CLIA Director are quite specific, and such tasks as identifying which examinations and procedures each individual is authorized to perform, must be set down in writing. Some of these procedures are shown here.    The Director must also specify whether supervision is required for specimen processing, test performance or results reporting.   And, the Director must also specify whether a review by the consultant or Director is required prior to reporting patient test results.      notes/notesbig5.swf324notes/notessmall5.swf60732truefalsefalsedefaultdefault1-1 Specifics of Lab Director’s Duties Director Instrument maintenance Reagent preparation Calibration Troubleshooting Authorization Supervision Specimen processing Test Performance Results reporting Consultant or Director Review Prior to reporting patient test results. 30slide6.swfbgd2l2.swf Yes, it is a big deal. Competency assessment is so important that the CLIA Laboratory Director's job is on the line. He or she is ultimately responsible for ensuring that laboratory personnel are trained and competent prior to reporting patient test results.   If you perform any non-waived testing in a clinical laboratory, competency assessment will be a part of your life.                              notes/notesbig6.swf578notes/notessmall6.swf80122truefalsefalsedefaultdefault1-1 Importance of Competency Assessment 6 I thought my supervisor was just trying to make my life miserable. I had no idea this competency assessment stuff was such a big deal. 30slide7.swfbgd2l2.swf The reasoning behind CLIA’s regulations is straightforward. notes/notesbig7.swf27notes/notessmall7.swf467truefalsefalsedefaultdefault1-1 CLIA Reasoning Ensure that laboratory staff are competent to perform test procedures. Ensure that laboratory staff report tests promptly, accurately and proficiently. Ensure that the satisfactory performance of test procedures remains constant. Makes sense. 30slide8.swfbgd2l2.swf Obviously, when personnel are newly employed by the laboratory or are moving to a different area in the laboratory, training is necessary.   Professionals with years of experience still need training in the policies, processes, and procedures for their new work environment. Even if a trainee has come from a lab that used the same equipment as their new place of employment - the new laboratory's work processes for that instrument, and the forms and computer systems, are likely to differ.       Staff who regularly perform testing must also be trained and assessed for competency to ensure a constant level of accuracy in laboratory results.              notes/notesbig8.swf510notes/notessmall8.swf86633truefalsefalsedefaultdefault1-1 New and Current Staff Laboratory Training Today 30slide9.swfbgd1l2.swf Whether competency assessment is done immediately after training or is conducted annually, the goal is to make certain the employee can perform the required tasks or tests. And, of course, by ensuring that staff are trained and competent, the CLIA Laboratory Director fulfills the responsibilities outlined in the CLIA regulations.   Not only must the Laboratory Director make sure staff are trained and their competency assessed, the Director is also responsible to ensure this competency remains consistent over time.              notes/notesbig9.swf396notes/notessmall9.swf68628truefalsefalsedefaultdefault1-1 Goals & Responsibility The Buck stops here! 30slide10.swfbgd1l2.swf CLIA regulations allow the Laboratory Director to delegate responsibility, in writing, to the appropriate staff.     But before anyone begins to perform any sort of training or competency, they have to know their responsibilities and understand exactly what they are expected to do. This includes everyone involved…the testing personnel being trained or assessed, and the technical consultant, technical supervisor or general supervisor to whom these responsibilities have been delegated. It's the CLIA Laboratory Director's responsibility to specify, in writing, each of these duties and responsibilities.              notes/notesbig10.swf376notes/notessmall10.swf69032truefalsefalsedefaultdefault1-1 Who Can Train & Assess Competency? Who Can Perform Training and Assess Competency? 30slide11.swfbgd1l2.swf The duties and responsibilities written by the CLIA Laboratory Director should include the actions identified here.notes/notesbig11.swf46notes/notessmall11.swf10412truefalsefalsedefaultdefault1-1 Written Directions Identifies which examinations and procedures each individual is authorized to perform and report, including instrument maintenance, reagent preparation, calibration, troubleshooting, etc. States whether supervision is required for specimen processing, test performance or results reporting Clarifies whether consultant or director review is required prior to reporting patient test results 30slide12.swfbgd1l1.swf Now let's see how much you learned in the first section. This course contains five self-evaluation tools called Knowledge Checks, which will give you the opportunity to find out what you know and will provide the correct answers when you select an incorrect choice. Knowledge Checks are not graded and no one is keeping score. If you prefer, you can skip any or all of the knowledge checks by using the navigation below the frame.  notes/notesbig12.swf144notes/notessmall12.swf41123truefalsefalsedefaultdefault0-1 Intro to Knowledge Checks 30 Knowledge Check 1: Competencynotes/notesbig13.swf22notes/notessmall13.swf225truefalsefalsedefaultdefault0-1300inplayerdata/swf/quizmaker_484/quiz.swf1falsedata/swf/quizmaker_484/quiz_content-1AdvanceAtWillnextnextpassedincompleteslide14.swfbgd2l2.swf No, training is not the same as competency. The two are related but they're very different.   Training is the process of providing and developing knowledge, skills and behaviors to meet established requirements for a particular test or procedure.   Competency, however, is the application of that knowledge, skill or behavior when performing the test or procedure for which you were trained.   So no matter how much training you receive, you can't be designated as competent until you demonstrate that you can use what you have learned, to properly perform a test or procedure, regardless of the level of complexity.  notes/notesbig14.swf324notes/notessmall14.swf69634truefalsefalsedefaultdefault0-1 Training vs. Competency OK, but when I receive training on a new procedure or instrument, isn’t that the same as competency? Training = Providing & developing knowledge, skills & behaviors Training = Competency Competency = Applying knowledge, skills & behaviors 30slide15.swfbgd2l2.swf Let's talk about training first. Now that you know the responsibilities of the CLIA Laboratory Director and the important role he or she plays in your facility's training and competency testing, and let me jump into the course and give you some pointers on the many factors that come together to make a good training program. Later, we'll look at competency.  notes/notesbig15.swf125notes/notessmall15.swf32519truefalsefalsedefaultdefault0-1 Training 30slide16.swfbgd2l1.swf To start with, there are three times when laboratories are required to provide and document training. When new employees are brought into the lab, they will have to be trained in the processes and procedures used in your facility. All employees will have to be trained when organizational or technological changes affect the work process. Examples would be when a test method is changed or a new instrument is introduced. And, finally, training must be performed and documented whenever a failure in lab processes is identified. This could be the result of something like unsuccessful proficiency testing, or an instance when someone has not been performing a procedure properly, such as a Gram stain. Also, if, during annual competency assessments, someone fails to meet the competency criteria, you’ll have to have a plan in place for some type of remedial training. notes/notesbig16.swf324notes/notessmall16.swf72147truefalsefalsedefaultdefault1-1 When to Train? When are laboratories required to perform and document training? 30slide17.swfbgd1l1.swf Now that we know when training is necessary, let’s look at the four-stages of the training process. The first stage is identifying all the tasks, processes and procedures in any given job, as well as all the policies in your laboratory that apply to these activities. Every procedure contains many related actions. For example, phlebotomy isn’t just a matter of drawing blood; there are other processes involved, like generating collection lists, prioritizing lab draws and properly identifying the patient. Once you’ve identified all of these items, it’s time to start writing your training plan. notes/notesbig17.swf205notes/notessmall17.swf49634truefalsefalsedefaultdefault1-1 1. Identify: Work processes Procedures Policies Stage 1- Identify 30slide18.swfbgd1l1.swf Your written training plan should identify and explain the training objectives, as well as the methods and materials you’ll use for training. Let’s take a closer look at these three topics: objectives, methods and materials. We can start with the training objectives.notes/notesbig18.swf65notes/notessmall18.swf20115truefalsefalsedefaultdefault1-1 1. Identify: Work processes Procedures Policies 2. Training Plan Objectives Methods Materials Stage 2- Plan 30slide19.swfbgd2l6.swf To write useful training objectives, you have to really think about your training goals. What, exactly, do you expect the trainee to be able to do after he’s trained in a specific area or task?   There are basically three areas, or domains, of learning, Cognitive, Affective and Psychomotor. When setting up your training program, goals should be established for each area.   The Cognitive area involves knowledge and the development of intellectual skills. Cognitive goals focus on our ability to understand, remember, apply and evaluate the information we are given.   The Affective domain includes the manner in which we deal with things emotionally; for example how we value and apply the lessons we’ve learned, the level of motivation we feel to perform the tasks correctly and the degree to which we can be objective in solving problems. Affective goals evaluate the actions we take as a result of these factors.   The Psychomotor area of learning focuses on physical movement, coordination, and use of the motor-skill areas. Psychomotor goals include developing the ability to perform precise actions in carrying out laboratory tasks and procedures.      notes/notesbig19.swf498notes/notessmall19.swf114467truefalsefalsedefaultdefault2-1 Objectives Cognitive Psychomotor Affective Example: …Recognize the steps required to calibrate the instrument Objectives: After completing training, staff will be able to… Example: …Take appropriate action when calibration fails. Example: …Demonstrate precision in pouring calibrators and loading the cassette onto the instrument What are your goals? 30slide20.swfbgd2l6.swf The written training policy should list the methods to be used for training in your laboratory. You’re not limited to just one method. You can provide training in many different formats, including those shown here. Keep in mind that people learn in different ways. Someone may learn better by directly observing the task being performed, others may improve their learning if they listen to the training material and still others may do better by performing the task themselves. To be most effective, training should address the trainee’s style of learning. notes/notesbig20.swf174notes/notessmall20.swf44529truefalsefalsedefaultdefault2-1 Methods Direct Observation Self-study Previously Tested Samples Lecture Webcast, video or e-learning 30slide21.swfbgd2l6.swf Next, you’ll have to determine the type of training materials you’ll use to carry out the various training methods, and identify these materials in your written plan. They might include things like procedure manuals, operator’s manuals, manufacturer’s instructions, lecture handouts, practice materials, laboratory forms and laboratory policies. Laboratory software, and access to webcasts or electronic training tools are also useful as training materials. When you write your training plan, just remember to include every type of training material you plan to use.notes/notesbig21.swf143notes/notessmall21.swf43431truefalsefalsedefaultdefault2-1 Materials 30slide22.swfbgd1l1.swf The third stage of training starts with identifying the persons who will conduct training in your laboratory. Trainers should be staff members who work with the same processes and procedures for which they’re providing training. They should be qualified to instruct others in the specific areas and should have patience as they train others. All trainers should show respect for the people they are training. The trainers should completely understand their responsibility in the training process and should be provided with instructions, as well as any materials they’ll need. That brings us to the other item you should consider. notes/notesbig22.swf168notes/notessmall22.swf47831truefalsefalsedefaultdefault1-1 1. Identify: Work processes Procedures Policies 2. Training Plan Objectives Methods Materials 3. Identify trainers Implement training Stage 3-Trainers 30slide23.swfbgd2l2.swf The training packet: While it’s not required, a training packet is useful to both the trainer and the trainee. A packet will be especially beneficial when the trainer has not had a lot of experience in conducting training. The trainer’s instructions can be stored in the packet, to assist them in preparing for and conducting the training. You should have a general idea of how long the training will take, whether days, weeks or months, and the packet should include the training schedule, with the days and times of specific activities. Instructions for the trainee should also be included in the packet, explaining the training expectations and also providing information on how the training will be conducted. You should always have a checklist to track the trainee’s progress and also a place to check off each task and test as it’s being performed and also a section where the trainer can document any comments during the direct observations of these tasks. CLIA surveyors will want to see this documentation of training as well as the trainer’s written observations. notes/notesbig23.swf396notes/notessmall23.swf95958truefalsefalsedefaultdefault2-1 Training Packet Training packets are a way to standardize the material presented in a training and the manner in which the material is presented. 30slide24.swfbgd1l1.swf As we said earlier, people learn in a variety of ways, so the trainer’s instructions should include techniques that can help to maximize the training experience. One way to do this is to follow a basic, four-step plan. First the trainer explains the theory behind the procedure or process and gives the reasons why each action is taken. Next, the trainer performs the task as the trainee looks on. The trainer again explains each action. The trainee is next asked to do exactly what the trainer just did and to state what he is doing and explain why. Finally, the trainer corrects any errors that were made by the trainee. If necessary, the steps can be repeated until the trainee fully understands and can perform the task. notes/notesbig24.swf307notes/notessmall24.swf61742truefalsefalsedefaultdefault2-1 Training: Different Strokes… 1 2 3 4 30slide25.swfbgd2l7.swf Now you’re ready to implement the training process. The training should always take place in an environment that encourages learning. But you don’t need a special training area. When possible, training should take place in the area where the work is usually performed. Once the training has been completed, you’ve arrived at the fourth and final stage of the training process.notes/notesbig25.swf135notes/notessmall25.swf31020truefalsefalsedefaultdefault1-1 1. Identify: Work processes Procedures Policies 2. Training Plan Objectives Methods Materials 3. Identify trainers Implement training Stage 3-Implement 30slide26.swfbgd1l1.swf Evaluating the training: You’ll have to decide how you will evaluate the training outcomes. There are actually two areas to be evaluated. First, you’ll want to check the effectiveness of the training. Is the trainee now able to understand and perform the task for which the training was provided? Secondly, you need to find out, from the trainee, how well the training process was received and what changes you may need to make.notes/notesbig26.swf135notes/notessmall26.swf32923truefalsefalsedefaultdefault1-1 1. Identify: Work processes Procedures Policies 2. Training Plan Objectives Methods Materials 3. Identify trainers Implement training 4. Evaluate training outcomes Stage 4-Evaluate Did the trainee learn the task or process? Do we need to make any changes in the training program? 30slide27.swfbgd2l6.swf Probably the simplest way to immediately check the effectiveness of training is to provide a quiz when the training is completed. You can do this with a written or an electronic quiz. However you decide to evaluate the training results, be sure to save copies as documentation for your laboratory records. notes/notesbig27.swf85notes/notessmall27.swf22117truefalsefalsedefaultdefault2-1 Measuring Effectiveness 30slide28.swfbgd2l6.swf In order to find out how your training is being received and whether or not it is meeting the needs of your staff, you should also offer the trainee an opportunity to provide you with feedback for the training. This will help you to assess your training plan and to make adjustments where necessary. notes/notesbig28.swf85notes/notessmall28.swf22114truefalsefalsedefaultdefault2-1 Feedback Things I liked about the training: Things I did not like: My suggestions 30 Knowledge Check 2: Competencynotes/notesbig29.swf22notes/notessmall29.swf225truefalsefalsedefaultdefault0-1300inplayerdata/swf/quizmaker_485/quiz.swf1falsedata/swf/quizmaker_485/quiz_content-1AdvanceAtWillnextnextpassedincompleteslide30.swfbgd1l1.swf That concludes the training section of this course. Once your staff has been trained in a process or procedure, you'll have to assess their competency in that area on a regular basis, according to the CLIA guidelines. Let's get started!  notes/notesbig30.swf131notes/notessmall30.swf24213truefalsefalsedefaultdefault0-1 Competency Intro 30slide31.swfbgd2l7.swf CLIA requires each laboratory to establish, and follow, written policies and procedures to monitor and assess each individual's competency. These procedures must also identify the need for remedial training or continuing education.   Competency assessment pertains to the entire laboratory staff, including consultants, supervisors and those who do not perform patient testing.      notes/notesbig31.swf236notes/notessmall31.swf45923truefalsefalsedefaultdefault0-1 Competency Assessment CLIA Rules Overview 30slide32.swfbgd2l7.swf There's a difference between the factors that are being evaluated in competency assessments and performance evaluations. Competency assessment judges the individual's ability and proficiency in performing and reporting laboratory tests and examinations.   Performance evaluation includes competency assessment, but goes beyond that to evaluate other behaviors and attributes that relate to the position and the job requirements. This includes such factors as your initiative, your attitude, your ability to follow time schedules and your relations with both internal staff and external clients. Your performance evaluation assesses these and other factors that relate to your work, beyond just your ability to competently perform testing.      notes/notesbig32.swf324notes/notessmall32.swf77142truefalsefalsedefaultdefault0-1 What’s the difference between competency assessment and my annual performance evaluation? Aren’t they the same? Competency Assessment Performance Evaluation Competency Assessment vs Performance Evaluation 30slide33.swfbgd1l1.swf Let’s start by looking at how often you’ll have to conduct competency assessments in order to meet CLIA regulations.notes/notesbig33.swf46notes/notessmall33.swf1047truefalsefalsedefaultdefault0-1 Setting up Your Competency Assessment Program How often? Setting up the Program 30slide34.swfbgd2l1.swf During a new employee’s first year, you must perform competency assessment two times. You don’t want to wait an entire year to discover that the person you trained didn’t understand something and has been performing a procedure incorrectly for a full year. After you’ve performed competency assessment for this employee twice during their first year, you will have to assess their competency annually, the same as for all employees. You must also conduct training and perform competency assessments to evaluate and monitor the staff competency any time you change a testing method or change or add instruments or your lab adds a new test, You don’t necessarily have to perform an entire competency evaluation if there have just been changes in a procedure or instrument. You just have to do the assessment for anything that pertains to the changes you’ve introduced in the laboratory. According to CLIA regulations, this competency assessment must be carried out prior to reporting out any patient results for the affected tests or procedures. notes/notesbig34.swf347notes/notessmall34.swf87056truefalsefalsedefaultdefault1-1 How Often? Perform competency assessment before the newly trained staff report any patient results for the affected tests or procedures. 30slide35.swfbgd1l1.swf There are five areas of competency assessment, shown here on the screen. The most complex of these is the direct observation of test performance, so we’ll start with that.notes/notesbig35.swf46notes/notessmall35.swf14313truefalsefalsedefaultdefault0-1 We don’t want to miss anything. What exactly should we include in our competency assessment plan? Direct Observation: Routine testing Instrument functions Monitor: Recording & Reporting Review: Results & Records Assess Sample Testing: Internally Analyzed Samples PT Samples Blind Samples Assess Cognitive Skills: Case Studies Questions Direct Observation: Routine testing Instrument functions Five Areas of Competency Assessment 30slide36.swfbgd2l1.swf According to the regulation, you must directly observe every staff member who performs non-waived testing.    Each person must be assessed for every non-waived instrument-test-system, analyzer, and test kit that they use. In addition, if someone has been assigned the responsibility of performing specific tasks, such as instrument maintenance or function checks, then part of that person's competency assessment must include direct observation as they perform each of these tasks.   The direct observation of manual testing includes procedures such as Gram stains, manual differentials, bleeding times, urine microscopic examinations, wet mounts and other direct-slide microscopy exams.   Finally, although CLIA regulations do not require competency assessments for waived-test systems, including these in your competency assessments is still a good laboratory practice.      notes/notesbig36.swf258notes/notessmall36.swf52648truefalsefalsedefaultdefault1-1 Direct Observation Each non-waived instrument test system, analyzer and test kit the individual is responsible to operate What should we include in direct observation? Direct observation of routine test performance Manual tests Waived-test systems Special tasks 30slide37.swfbgd1l1.swf CLIA requires the annual, direct observation of each staff member for a very good reason. Over time, it’s not uncommon for laboratory staff to adapt and adjust the procedures and tasks that they perform on a routine basis. Sometimes personnel think they know what they’re doing so they stop referring to the standard operating procedure and begin to create little shortcuts to testing procedures and even maintenance, perhaps thinking they are saving time or cutting costs by doing so. However, these practices can result in the elimination of certain steps or actually changing the procedure. By requiring direct observation, CLIA’s intention is to ensure that staff continue to follow the SOP for all their assigned tasks no matter how often or for how long they have been performing them. Otherwise, such invalidated changes to the standard operating procedures may lead to problems with patient test results. Without direct observations, these omissions will never be identified as a potential problem.notes/notesbig37.swf240notes/notessmall37.swf72556truefalsefalsedefaultdefault2-1 Why? 30slide38.swfbgd2l7.swf Competency assessment should focus on the high-risk steps in a laboratory procedure.   Also focus on the findings from unsatisfactory proficiency testing. If the laboratory received an unsatisfactory score on Gram stains, was it due to the staining procedure? If so competency could include direct observations of all personnel who perform Gram stains.   Finally, use deficiencies from the last survey as a focus for competency. If the laboratory received a deficiency for not performing quarterly maintenance on the coagulation analyzer, was it because staff didn't understand what maintenance was required and when?  notes/notesbig38.swf261notes/notessmall38.swf68438truefalsefalsedefaultdefault2-1 When it comes to direct observation, the focus of your competency assessment should be based on several important factors. High-risk steps Unsatisfactory Proficiency Testing Deficiencies from the last survey Focus 30slide39.swfbgd1l1.swf You don't have to devote one whole day to doing competency assessments. You can do these in different stages and may prefer to set up a schedule that’s in alignment with your written policy and which addresses one thing at a time, for instance instrument maintenance. For a week, or several consecutive days, you may be providing direct observation of every staff member who’s responsible to perform maintenance at the daily, weekly, or monthly level. Or you may prefer to observe and perform competency assessment for one staff member at a time, covering all aspects of the processes, procedures and responsibilities assigned to that person, again, according to your written policy. notes/notesbig39.swf193notes/notessmall39.swf56237truefalsefalsedefaultdefault2-1 It doesn’t have to be complicated. Scheduling 30slide40.swfbgd1l1.swf Direct observations should include the application of and adherence to, all components of the test method or the instrument procedure. This is a very detailed process. On the next slide you’ll see the many facets of direct observation. notes/notesbig40.swf141notes/notessmall40.swf25715truefalsefalsedefaultdefault2-1 Details are next! Direct observation of ALL components What to Observe 30 Direct Observationnotes/notesbig41.swf22notes/notessmall41.swf2255truefalsefalsedefaultdefault2-130data/swf/engage_437/engage.swffalse Knowledge Check 3: Competencynotes/notesbig42.swf22notes/notessmall42.swf225truefalsefalsedefaultdefault1-1300inplayerdata/swf/quizmaker_486/quiz.swf1falsedata/swf/quizmaker_486/quiz_content-1AdvanceAtWillnextnextpassedincompleteslide43.swfbgd1l1.swf When assessing competency, you must also monitor the recording of quality control results and the recording and reporting of patient testing results. Make sure all the results are recorded properly and with no transcription errors. notes/notesbig43.swf65notes/notessmall43.swf18214truefalsefalsedefaultdefault1-1 Got it! Direct Observation: Routine testing Instrument functions Monitor: Recording & Reporting Review: Results & Records Assess Sample Testing: Internally Analyzed Samples PT Samples Blind Samples Assess Cognitive Skills: Case Studies Questions Monitor 30slide44.swfbgd2l7.swf Ensure that any critical results are called and handled according to your laboratory’s policy or procedure. Is the person being observed properly recording all QC and patient test results? If a transcription error is observed, does the staff member make the correction according to lab policy?notes/notesbig44.swf116notes/notessmall44.swf23217truefalsefalsedefaultdefault2-1 Criticals/QC/Errors 30slide45.swfbgd1l1.swf All mistakes you identify must be documented and investigated to determine the cause. Any corrective action that is taken, such as education or retraining, should also be documented as part of the competency assessment record. notes/notesbig45.swf96notes/notessmall45.swf23214truefalsefalsedefaultdefault2-1 Lecture DOCUMENT! Document 30slide46.swfbgd1l1.swf It's important that the laboratory supervisor review the routine workflow testing records. The supervisor may find mistakes and issues that are related to a lack of competence.  notes/notesbig46.swf86notes/notessmall46.swf22011truefalsefalsedefaultdefault1-1 Thanks. I see we have to review things, too. Direct Observation: Routine testing Instrument functions Monitor: Recording & Reporting Review: Results & Records Assess Sample Testing: Internally Analyzed Samples PT Samples Blind Samples Assess Cognitive Skills: Case Studies Questions Review 30slide47.swfbgd1l1.swf Review the records over a broad enough timeframe to ensure there have been no transcription errors or deviations from laboratory policy or procedures. notes/notesbig47.swf65notes/notessmall47.swf1429truefalsefalsedefaultdefault2-1 Timeframe 30slide48.swfbgd1l1.swf When completing the review section of competency worksheets, the supervisor should document which specific records were reviewed and the timeframe in which this was done.   CLIA surveyors don’t want to see just a checkmark; they want to be able to see exactly how staff competency was determined.   The laboratory may choose to make copies, or electronically scan, the records that were used to determine competency. You should then attach copies to the competency form or competency checklist as part of your competency documentation.        notes/notesbig48.swf297notes/notessmall48.swf63230truefalsefalsedefaultdefault2-1 Photocopy Scan DETAILS DOCUMENTATION Documentation 30slide49.swfbgd1l1.swf As you routinely review laboratory data throughout the year, it will be useful for you to collect and document your review for easy reference when assessing competency. This includes your review of the quality control records, patient results, proficiency testing results and the preventive maintenance records for instruments in your laboratory.notes/notesbig49.swf91notes/notessmall49.swf28521truefalsefalsedefaultdefault2-1 Hint HINT! Quality Control Review Patient Results Review Proficiency Testing Review Preventive Maintenance Records Collect and Document Data as You Review It. 30slide50.swfbgd1l1.swf As part of competency assessment, your laboratory should also include the assessment of test performance by having staff analyze previously analyzed specimens, internal blind samples, or external proficiency testing samples. There are both advantages and disadvantages associated with some types of samples. notes/notesbig50.swf110notes/notessmall50.swf26519truefalsefalsedefaultdefault1-1 I’ll need more details on the types of samples. Direct Observation: Routine testing Instrument functions Monitor: Recording & Reporting Review: Results & Records Assess Sample Testing: Internally Analyzed Samples Blind Samples PT Samples Assess Cognitive Skills: Case Studies Questions Sample Testing 30slide51.swfbgd1l1.swf The major advantage of testing previously analyzed patient samples is the monetary savings, because the samples are already on-site.    The disadvantage is that competency will generally cover only the analytic phase of testing not the pre-analytic or the post-analytic phases.      notes/notesbig51.swf216notes/notessmall51.swf37216truefalsefalsedefaultdefault2-1 Previously Analyzed Previously analyzed patient samples 30slide52.swfbgd1l1.swf “Blind samples” are samples that are entered into the workflow without the employee’s knowledge. Blind samples look like and are indistinguishable from the other samples. One advantage of using blind samples is that they provide a reliable assessment of the routine performance. Blind samples can also identify problems that exist in any phase of the testing process. A disadvantage of using blind samples is the time and effort necessary to prepare the samples and insert them into the workload. Another issue is the possibility that the test results of the blind sample could somehow be reported as the result of an actual patient.notes/notesbig52.swf224notes/notessmall52.swf53535truefalsefalsedefaultdefault2-1 Blind Samples Blind samples 30slide53.swfbgd1l1.swf Like previously analyzed patient samples, previously analyzed Proficiency Testing samples are cost effective and you already have them on hand. There are two important points to remember about using previously analyzed PT samples. First, make sure that your lab’s PT results have been submitted to the proficiency testing program and that the PT Summary report has already been received by your facility, before you use the specimens for competency. Another important reminder is that you should never send PT samples to another lab, for ANY REASON, including using these samples as part of a competency program. notes/notesbig53.swf193notes/notessmall53.swf50435truefalsefalsedefaultdefault2-1 Proficiency Testing Samples Previously analyzed PT samples PT submitted and summary received NEVER share PT samples 30 Knowledge Check 4: Competencynotes/notesbig54.swf22notes/notessmall54.swf225truefalsefalsedefaultdefault1-1300inplayerdata/swf/quizmaker_487/quiz.swf1falsedata/swf/quizmaker_487/quiz_content-1AdvanceAtWillnextnextpassedincompleteslide55.swfbgd1l1.swf Finally, let’s look at some of the ways you can assess the cognitive skills of your staff. notes/notesbig55.swf27notes/notessmall55.swf656truefalsefalsedefaultdefault1-1 We’re down to the last one already? Direct Observation: Routine testing Instrument functions Monitor: Recording & Reporting Review: Results & Records Assess Sample Testing: Internally Analyzed Samples PT Samples Blind Samples Assess Cognitive Skills: Case Studies Various Types of Questions Problem-Solving Skills 30slide56.swfbgd1l1.swf You can assess cognitive skills by asking questions orally or in writing. Written records, of course, will serve as your documentation and are therefore generally preferred. This graphic shows some of the basic methods used to assess cognitive skills. On the following slides, we’ll look at each one in a little more detail. notes/notesbig56.swf116notes/notessmall56.swf27119truefalsefalsedefaultdefault2-1 Cognitive Skills Assessing Cognitive Skills 30slide57.swfbgd1l1.swf Case studies can be found in your own laboratory. Use real problems that have occurred in the past and write it up as a case study. Rather than using case studies once a year as an assessment tool, you could send case studies out periodically to your staff via email. Once each staff member replies with the solution to the problem, save the emails as documentation of assessment. This is one way to ensure that all staff are competent and consistent in solving the type of problem that arose in the case study. notes/notesbig57.swf177notes/notessmall57.swf41027truefalsefalsedefaultdefault2-1 Case Study Questions Case Study What would you do? 30slide58.swfbgd1l1.swf Theory questions assess the staff’s knowledge of background information related to a process or procedure. You could, for example, ask staff to explain the principle behind a specific testing method. notes/notesbig58.swf94notes/notessmall58.swf19113truefalsefalsedefaultdefault2-1 Theory Questions Theory Question 30slide59.swfbgd1l1.swf Technique questions assess your staff's knowledge and understanding of important steps in a procedure. For example, you might ask, when performing a Gram stain, why do we apply the reagents in this order?  notes/notesbig59.swf103notes/notessmall59.swf21412truefalsefalsedefaultdefault2-1 Technique Questions Technique Question 1 2 3 4 30slide60.swfbgd1l1.swf Interpretation questions are used to assess your staff's ability to arrive at the correct conclusion from a given set of information. For example, you could present staff with a patient diagnosis and a set of laboratory results on the patient and ask them to interpret the results. These results may or may not support the diagnosis and, if not, your staff's interpretation should note any inconsistency between the results and the diagnosis. Staff should also know how to handle such an inconsistency according to your laboratory's policy or procedure.  notes/notesbig60.swf192notes/notessmall60.swf48231truefalsefalsedefaultdefault2-1 Interpretation Questions Interpretation Question Diagnosis Lab results ≠ 30slide61.swfbgd1l1.swf Problem solving questions assess your staff’s ability to identify, reflect on and evaluate evidence to make decisions. These are known as critical thinking skills. People with good critical thinking skills are well informed and are able to consider all the implications of a decision and to make a broad, in-depth analysis before coming to a conclusion. You might describe a scenario where several stat tests arrive at the same time, from various areas of the hospital, including the emergency department, and ask how staff would prioritize them. Or you could use the example of an instrument or calibration problem and ask how to interpret the issue and correct the situation.notes/notesbig61.swf162notes/notessmall61.swf49239truefalsefalsedefaultdefault2-1 Problem-Solving Questions Problem-solving Question Critical-thinking Skills 30slide62.swfbgd1l1.swf Here's a big hint. You don't have to do everything at once. You can copy or scan examples of problem solving as they occur throughout the year and maintain the records in each individual's personnel file for later use. Also, keep emails that address problem solving and other issues so you can use them to assist you with competency assessments.  notes/notesbig62.swf153notes/notessmall62.swf33219truefalsefalsedefaultdefault2-1 Hint Hint! Ongoing records Save emails 30slide63.swfbgd1l1.swf Now that we’ve covered what must be included in competency assessment, you’re ready to set up your own program. Be sure to assess competency for each employee based only on the tasks for which they’re responsible. You should designate all the actions and practices you will observe for an employee and also indicate the date when each observation was completed. You can use checklists or other forms to organize the information for each assessment. Finally, be sure to save copies of any corrective actions you put into place or any problems that were observed and solved during the process. Next, we’ll look at documentation.notes/notesbig63.swf230notes/notessmall63.swf56034truefalsefalsedefaultdefault0-1 Make sure competencies are specific for the employee’s responsibilities. Designate what will be observed and when this was completed. Use checklists to organize information. Save copies of corrective actions or solved problems. Your Assessment Program 30slide64.swfbgd2l2.swf Each laboratory must have a way of documenting and tracking competency assessments. There must be documentation detailing who performed the competency assessment and when it was performed. The outcome of any written problem-solving questions must be included, as well as the details of your review of all records and reports that took place as a part of this employee's competency assessment.   See the “Links and Downloads” tab at the top of the frame for more information and examples of forms you can use.      notes/notesbig64.swf287notes/notessmall64.swf59928truefalsefalsedefaultdefault1-1 Documenting Competency Competency Assessment 30slide65.swfbgd2l2.swf The use of electronic record keeping is acceptable as a means of maintaining these records. Be sure that the system you are using is secure and that it maintains personnel's privacy and confidentiality.  notes/notesbig65.swf109notes/notessmall65.swf22012truefalsefalsedefaultdefault1-1 Electronic Documentation 30slide66.swfbgd2l2.swf Your plan should also include the steps you’ll take if someone fails to meet the criteria for competency. Corrective action must be taken for every task or area where the person was determined to be not competent, and the corrective action must be documented. Maybe your procedure isn't clear and you need to revise it. Or perhaps something in the testing process may need to be changed. Depending on the issue, corrective action may include retraining the employee. After retraining, you will have to re-assess the competency of this individual. Once the retraining and re-assessing have taken place, be sure to document all the steps in the process and also document that the corrective action was effective and that this employee is now deemed competent. Your laboratory’s plan should also include how you will monitor this individual in the future to prevent a recurrence of the problem. notes/notesbig66.swf324notes/notessmall66.swf74047truefalsefalsedefaultdefault1-1 Corrective Action Corrective Action Must be Taken and Documented Retrain Review procedure/process Re-assess for competency Future monitoring 30 Knowledge Check 5: Competencynotes/notesbig67.swf22notes/notessmall67.swf225truefalsefalsedefaultdefault0-1300inplayerdata/swf/quizmaker_488/quiz.swf1falsedata/swf/quizmaker_488/quiz_content-1AdvanceAtWillnextnextpassedincompleteslide68.swfbgd2l2.swf Keep in mind that your laboratory's training and competency assessment program helps to ensure the quality of your services. It's only when staff are properly trained and competent that consistent, high-quality results can be expected.  notes/notesbig68.swf131notes/notessmall68.swf26514truefalsefalsedefaultdefault0-1 The Final Word Training + Competency = Consistent Quality 30slide69.swfbgd1l1.swf There! We’ve done it. The final quiz is next. You can review any of the slides before attempting the quiz. Just use the navigation arrow or the side menu to move through the course. If you don’t pass the quiz the first time, you can try again right away or come back here, so you can review the areas you missed before retaking the quiz. notes/notesbig69.swf85notes/notessmall69.swf25918truefalsefalsedefaultdefault0-1 Mission Accomplished! Understanding Competency Assessment Mission Accomplished When you pass the final quiz with a score of 80 percent or greater, you can evaluate the course and obtain your certificate. 30 Training amp; Competency Assessment: Final Quiznotes/notesbig70.swf22notes/notessmall70.swf225truefalsefalsedefaultdefault0-1300inplayerdata/swf/quizmaker_491/quiz.swf1truedata/swf/quizmaker_491/quiz_content-1AfterPassedhttp://www.surveymonkey.com/s/5TPVKR8previouspassedincomplete