Competency Requirements for Waived/Non-waived Testing

Cynthia,

Speaking only about compliance and not best practices, we use TJC waived testing chapter standards for our waived testing. There is no requirement to observe for annual competency assessment.

Do you mean a physical audit of the testing site or do you mean auditing the paperwork or documentation for competency assessments for annual CLIA requirement on testing personnel?

There is no regulatory required specific competency steps for waived testing.  Regulatory essentially states that what the Medical Director deems acceptable training and is written in policy is acceptable for them,  I would strongly recommend including the manufacturer recommended training steps be incorporated into this.

For our glucometer system we use a annually required eLearning course that includes a powerpoint, quiz and attestation page.  After the eLearning we require an annual observed "skill-check" with a glucometer SuperUser.  The skill-check ensures that someone with experience with the glucometer reviews the system with them and answers any potential questions while the user performs a QC or patient test.

These glucometer SuperUsers can be anyone the manager of the dept deems would be good in this role.  The vast majority of them are not lab employees but staff on the floors. 

Non-waived competency requirements are specifically defined by regulatory CAP / JHACO.

Hi Peggy,

Thank you for your reply. We have CAP and TJC. I meant the documentation for competency assessment for annual CLIA requirement on testing personnel. 

Most CLIA competency regulations require 6 elements: (1) Direct observation of sample testing including specimen handling and processing, (2) Monitoring of records and reporting of test results, (3) Review of QC records, maintenance logs, and proficiency testing, (4) Direct observation of instrument maintenance, (5) assessment of test performance through blind study, and (6) assessment of problem solving skills. I'm not sure if these regulatory requirements are only for nonwaived testing for our POC devices since we also have iSTAT (moderate complexity) which also only has the online quiz.

Hi Jeremy,

Thank you for your reply. Do you have a document/sign-off in your eLearning the Superusers can log into and state they have reviewed the operator's "skill-check"?

Hi Cynthia,

For glucose we no longer use direct observation. We have a PowerPoint with quiz and procedure review in our electronic learning systems that all operators need to do annually. Then they have to do 2 levels of QC. In Telcor, we are able to automatically recertify them once they complete both of these requirements. For other waived testing, we do still have direct observation, either by POCT at skills fairs, or by superusers or educators on the units. For non-waived testing, there is a PowerPoint/quiz that the operator completes, then there is a checklist with the 6 elements that has to be completed by a technical consultant who we designate--either POCT or a unit educator with the requisite qualifications. That checklist is "completed" in the electronic learning system, and then the operator is recertified automatically in Telcor. We don't do an annual audit of operators. Since we have so many, we're basically always checking operator lists for expired competency. We do go over the list for completeness when our CAP window opens, but it changes every week with people coming and going. In our system we have nearly 10,000 operators, with about 1800 of them being non-waived.

Hi Kathleen,

Thank you for your response. I noticed for our Accucheks, it seems to update automatically in Cobas IT but does not translate over to Telcor so I will have to manually recertify the operators in Telcor after they complete their quiz and 2 levels of QC. Is this automated recertification something you set up through Telcor or your local IT?

Check with Telcor. We have an automated operator sync between cobas IT 1000 and Telcor, and we recertify in Telcor. The information then goes back to cobas and then to the devices. Then, through Telcor we have eLearning, where the learning system completes a file which is picked up by Telcor. Automating those processes has made a huge difference in how our POC team spends their time. 

Thank you for the information!

Cynthia,

We use a program that documents the Super User and user observation within the POC middleware.  No paperwork is generated.

The last step of the eLearning is the attestation which the user agrees that they know the correct process to perform this testing and are aware of who to go to if they need help/support.

This not true for the non-waived that does have a signed skill-check paper worksheet.

Thank you Jeremy.

This is extremely helpful with our Accucheck and iSTAT competency.

For those who do paperless non-waived testing certification, is there a way to see what that looks like?  I currently have the staff sign a form when they do their competency.  Then, I have to keep track of all that paperwork!  I am looking for a more seamless method.  We have Healthstream, so I am guessing I can set something up in that. 

Much appreciate any advice. :)

All of my competency for waived tests are built in Net Learning. Annual competency can be completed using the net learning module as kind of an auto-recertification. Operator must score 100% because there are no filler questions only what the operator must know to do accurate testing.

Hospital is Joint Commission

Laboratory is CAP.

Has anyone successfully built an online competency module for non-waived testing?  We are being challenged to do so.  We have a good start on the waived modules for both training and competency but I am at a loss regarding how to cover all 6 elements of non-waived competency without paper. 

Thanks in advance for any information this super group can offer!

Sonya Evans, MT(ASCP)

Point of Care Coordinator

Prisma Health Greenville Memorial Hospital

Greenville, SC

sonya.evans@prismahealth.org

864-455-4494

We have our operators complete an online module in our learning system for each POCT they perform.  The module itself is pretty basic, it only consists of 3 tasks. 

1. They have to read the procedure (a link to the procedure or the procedure itself) is attached to the task.  Mark that as complete


2. They have to acknowledge that they are contacting a super user for observation and return demonstration.


3. Mod complex - The super user shows the operator pictures of a critical result, an instrument error and they explain what they would do with each of those.  Then then watch the operator perform a QC and a fake patient (using QC as the sample).  They have cards with the acceptable ranges for the fake patient and as long as both of those pass they mark the operator "Approved" in our learning system.


4. Waived - they just watch them do a fake patient

We get an email report the next day for any operator that has been completed the day before and we verify the mod complex results in QML.  We put a note on the result as competency so we can pull it up by a filter if we need to and then we update the operators access for 6 months or a year depending on their time.

We sort of combine the requirements between the procedure, fake pt, QC sample and pics.

We have COMPASS by MediaLab. It is pretty amazing!

www.medialab.com/poct-compass-laboratories