I just joined the site, and have some questions about competency assessments.  We have staff that rotate between two different campuses of the same hospital, but the labs have different CLIA numbers.  So we were recently informed that we have to demonstrate competency at each site where our staff works.  (Even though we use the same procedures, follow the same standard work, and have standardized things completely.)  So I am trying to put this into practice without overwhelming our staff, but I still want to make sure we are doing a thorough check.  We have a high percentage of new staff right now, so I don't want to half-a$$ it.

Question 1:  Competency must be assessed for every "test system," but what are the Blood Bank test systems you assess?  Do we need to assess competency for every method of testing we use every year?  Or would I be able to assess IAT as a test system and rotate yearly on what method we use?  I cannot seem to find any Blood Bank-specific listing of test systems that require annual competencies!  It seems pretty clear for other areas, but I am getting a bit stressed out trying to make sure we are fulfilling the requirements for CAP/AABB.  And I also don't want to overwhelm our staff with 17 yearly competencies.  

In my lab, we perform the following tests:

1. ABO/Rh - automated gel and tube testing
2. Antibody screens - automated gel, manual gel, and tube testing
3. DATs - manual gel and tube testing
4. Antibody titration - manual gel and tube testing
5. Antibody identification
6. Antigen typing
7. Elutions
8. Fetal bleed screens

Question 2:  How do you handle items that you want to do a competency assessment on that are not tests?  For example, we do quite a bit of component preparation, so we generally try to do an annual competency assessment and direct observation of our staff splitting a platelet into a pediatric dose.  I am familiar with the 6 elements of competency assessment (show below), but I struggle with how to apply these to processes.

"The following six (6) procedures are the minimal regulatory requirements for assessment of competency for all personnel performing laboratory testing:

1. Direct observations of routine patient test performance, including patient preparation, if applicable, specimen handling, processing and testing;
2. Monitoring the recording and reporting of test results;
3. Review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records;
4. Direct observations of performance of instrument maintenance and function checks;
5. Assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples; and
6. Assessment of problem solving skills."

 

Thank you in advance!  

Susan

Just HOW ridiculous is that?

In the UK, even UKAS, which appears to be an accreditation service set up to serve its own ends, rather than that of the laboratory or the patient, allows Biomedical Scientists and Laboratory Aides to "transfer" their competencies from one laboratory to another, if the tests are the same.

This ruling from CLIA seems to me set up to justify THEIR existence, rather than help either the laboratory or the patients, but will end up creating more and more (unjustified) work for all concerned, for no benefit - and they wonder why they get a bad reputation for making such stupid rulings.

You may assess tasks (those things that are not tests) as you choose. Only 'tests' require the 6 elements. Splitting a platelet unit would definitely be a task. If you use a tube welder for sterile docking when preparing platelet doses, the only elements you might not use would be #5, unless you choose to make a dummy unit for splitting and involve some kind of QC on the unit and #2 if you do no testing on the products. Simply observing the entire process would cover elements 1, 3 and 4. Problem solving skills could be addressed by asking 'what if' and 'what would you do if' questions while you are observing the process. Alternatively, the 'if' questions could be in the form of a written quiz.

My question would be, who informed you that competency had to be assessed at each site? If it was a CLIA inspector, can you request a review of that ruling based on what you've told us?

Different CLIA numbers, must do the competency at each site, despite everything being the same.  I sent this specific question to CAP after a webinar they ran.  It is silly and it seems our community and licensing agencies should be fighting to have this changed.  There are not many hospitals that are not part of a system and need to share staff.  Things need to keep up with our reality to make them feasible.

Yes, it was a CMS/CLIA regulation.  This is the Q and A session that I was forwarded that goes over the details:

If you have a tech that floats between 2 different hospital labs within the same health system do you need to perform competencies (6 mo. and annual) in both labs or just one and share documentation?

Per CMS, each CLIA laboratory must complete training and competency assessment for all employees at each facility. Laboratories may not share training and competency assessment documentation, even if laboratories are related and share the same instrumentation, LIS and procedures.

 

Must waived testing competency be repeated for all CLIA sites? Including CLIA waived?

Yes, a competency must be assessed at the site where the staff is responsible for testing. Each site must be separately assessed and waived is included (remembering all six elements are not mandated for waived testing).

 

Please clarify again competency documentations between sites that have different CLIA#, but are under the same system with the same test methods and instruments.

Yes, a competency must be assessed at the site where the staff is responsible for testing. Each site must be separately assessed and waived is included (remembering all six elements are not mandated for waived testing). All permutations at each site need to be taken into consideration as part of competency at that site.

 

 

Does the issue of not sharing competencies across hospitals within the same system, with different CLIA numbers also apply to Waived Testing?

Yes, competencies for both waived and non-waived testing must be performed and kept at each site (under each separate CLIA number).

 

 

If employees rotate between different CLIA numbers but are performing the same testing, does competency need to be assessed at each CLIA location?

Per CMS, each CLIA laboratory must complete training and competency assessment for all employees at each facility. Laboratories may not share training and competency assessment documentation, even if laboratories are related and share the same instrumentation, LIS and procedures.

 

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 need to be performed at both sites?

Per CMS, the entire competency assessment must be performed at each CLIA site.

 

Or is it permissible to provide a copy of the entire competency packet to the 2nd site for them to review and keep?

Per CMS, it is not acceptable to use a copy of a competency performed at a different CLIA site instead of performing training and competency assessment at the current CLIA site.

 

Or is it permissible to use perhaps some pieces (like the Direct Observation, evaluation of knowledge, PT or blind samples) and maybe just use record reviews from the 2nd site?

All six elements of competency assessment must be performed at each CLIA site the nonwaived laboratory testing is performed at.

Thanks for that SusieQ132, which just serves to confirm my thoughts that some accreditation organisations are their to massage their own egos, rather than to help either the laboratories or their clientele (those being patients or clinicians).

4 hours ago, AMcCord said:

You may assess tasks (those things that are not tests) as you choose. Only 'tests' require the 6 elements. Splitting a platelet unit would definitely be a task. If you use a tube welder for sterile docking when preparing platelet doses, the only elements you might not use would be #5, unless you choose to make a dummy unit for splitting and involve some kind of QC on the unit and #2 if you do no testing on the products. Simply observing the entire process would cover elements 1, 3 and 4. Problem solving skills could be addressed by asking 'what if' and 'what would you do if' questions while you are observing the process. Alternatively, the 'if' questions could be in the form of a written quiz.

Thank you for the input!   So I'm thinking that for anything that is not a test, we can put "N/A" for the other items that do not apply.  That makes more sense now. 

11 minutes ago, Malcolm Needs said:

Thanks for that SusieQ132, which just serves to confirm my thoughts that some accreditation organisations are their to massage their own egos, rather than to help either the laboratories or their clientele (those being patients or clinicians).

That's what I think, too!  It is a crazy task for our 40 staff members, so I really hope this goes okay.  It is daunting to look at right now!

Wow...what a pain in the______________! We are currently a stand alone but I will keep this in mind - things change. Thanks for the CMS info.

Does anyone have any information on assessing competence for electronic crossmatch? Are you using blinded samples? Just trying to wrap my head around the 6 elements...

 

I do not consider this a test but a task and would not use the 6 elements.  You should have some sort of documentation of yearly training IMO. 

So, in a tertiary transfusion service department, how much competency assessment needs to be done? If we group the tests into test systems, how many test systems would turn out to be necessary to do competency assessment on? For example, in the area of immunohematology where we do a lot of tests: antibody ID, DATs, EGA, DTT, ficin treatment, elution, ReSt adsorption, warm auto or allo adsorption, etc. Grouping these tests into a test system, does each staff still have to do ALL of these individually?

Does everyone need to perform unknowns even if the direct observation for the same set of tests have already been done? I mean, are unknowns supposed to be done for the same set of stuff?

19 hours ago, WisKnow said:

Does everyone need to perform unknowns even if the direct observation for the same set of tests have already been done? I mean, are unknowns supposed to be done for the same set of stuff?

Remember that you can combine the 6 elements into 1 competency exercise. You may observe the tech while they are performing testing on an unknown (2 elements covered) and ask questions related to the exercise for problem solving (another element). Have them document the unknown as they would a patient (4th element) and ask them to perform the appropriate QC for the tests they are using. Once you've reviewed any intermediate worksheets/other paperwork (5th element). They will use equipment while they work (6th element or at least part of it). Cover as much ground as possible with each observation.

Edited July 17, 20178 yr by AMcCord

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22 hours ago, WisKnow said:

So, in a tertiary transfusion service department, how much competency assessment needs to be done? If we group the tests into test systems, how many test systems would turn out to be necessary to do competency assessment on? For example, in the area of immunohematology where we do a lot of tests: antibody ID, DATs, EGA, DTT, ficin treatment, elution, ReSt adsorption, warm auto or allo adsorption, etc. Grouping these tests into a test system, does each staff still have to do ALL of these individually?

 

From what I have been told by accrediting agencies here, different tests can only be combined into one test system if there are no unique aspects in testing or in problem solving when something goes wrong.  I interpret that as meaning the antibody ID, DAT, and elution are all separate test systems because the testing method is very different.  Different treatments, however, I could see being grouped into 1 test system (EGA, DTT, ficin) if you can "sell" them as being similar enough.  Same goes for the adsorptions, in my opinion.  I would rotate which treatment and which type of adsorption you do each year, but group them each into a test system (RBC Treatments as 1 test system and Adsorptions as a separate test system).   If you group multiple tests into a test system, only one of the tests in that system need to have the 6 elements of competency assessed each year.  However, you have to watch what you group into a test system!

It seems crazy, but by the letter of the "law," we should be doing all 6 elements of competency for every test we perform if the procedure is not exactly the same.  (I have read that even if the amount of a reagent is different, it would be a different test system.  Crazy! )  In practice, this doesn't work for our site; we would spend more time assessing competency than doing real work!  We decided to live on the edge and combine a few things into test systems, even though they are pretty different test procedures. 

Edited July 17, 20178 yr by SusieQ132