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Competency Assessment in the Transfusion Service.


goodchild

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I haven't seen much discussion relating to competency assessment on these forums. I find this odd because it is such an albatross at our institution. (This post is focused on USA regs, I can't even imagine what others might have to put up with.)

 

Are there any facilities out there that have a successful competency assessment plan that meets the CLIA requirements? (i.e. Assess the six applicable elements of competency, with EVERY test system, for EACH associate, EVERY year)

 

How are you documenting your competency assessment activities? Are you including copies of result entry/review, copies of worksheets, profiency results, direct observation checklists, copies of problem solving quizzes/scores?

 

Are you including transfusion service activities that aren't testing into your competency assessment plan? (i.e. receipt/logging in blood products, issuing blood products, component processing, etc.)

 

How do you handle competency assessment with part timers, zero hour/PRN associates, weekenders, and overnighters?

 

How are you delegating competency assessment activities among your staff?

 

We have a plan that I'm pretty happy with but there's a lot of contention with the specifics. I'm hoping to hear from other institutions and have a better understanding how the community as a whole handles this process. My previous experience was with military blood banks and we had a very rigorous training and competency assessment program, which I have been told was unnecessarily rigorous simply because it was military.

 

I'm also curious if anyone is willing to share any of your assessment plans/checklists/documentation. I need to blank out one of our template cover sheets and maybe include an example of our excel sheet tracking tool.

 

Thanks !

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If your goal is to meet CLIA rules, they only apply to patient lab tests. That means they don't apply to things like thawing plasma.  You may want your own competency assessments for that but you don't have to do it according to CLIA.  If you test horse blood, those don't fall under CLIA either. I'll be happy to see if someone posts a reasonable and useful answer.  I could use improvement to our system.

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We are just now revising our competency to comply with the CLIA (6 elements) and NYS Dept of Health (added a 7th element). It is a BEAST...the competency will now be many pages long and will require an average of 4 hours time with each tech (I have a total of 22 techs that rotate through the Blood Bank). Trying to wrap my head around how in the world I will get my other work done. :)

Yes, goodchild, I am including all of the methods that you describe above: direct observation, tests, verbal scenarios, review of computer entry, etc. Yes, I will also be including "tasks" in our competency, such as issuing blood. We will do the same competency for all Blood Bankers, including per diems. I won't be delegating, NYS is pretty strict about the part that it has to be a supervisor.

I just went to a CLIA presentation, which cleared up a few things for me. Now we just have to start it.

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I'm getting some flak here that our competency assessment plan includes too much. I agree that it is an intimidating project, especially if you have 22 people to assess competency with like Terri. I did try to make our plan as minimal and as user friendly as possible. I was hoping to see the level of details of other institutions' competency assessment plan. With more perspective I could gain some insight in how I could reorganize things further and trim the plan down a bit or feel justified that I did the best I could do.

 

I only mentioned the CLIA requirement because they are very direct with what they are looking for. I've also come across hospitals who don't have a plan that would meet the minimum requirements. They are under the impression you can competency assess one test or process a year with the 6-elements and call that your annual competency assessment plan.

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I am really glad this post started. We have been working on this issue since we were inspected by CAP in July. I have an extensive new employee training system, an annual computer review called "HealthStream" that includes a blood bank module for lab and RNs, CAP and United Blood Services competencie articles on line, CAP proficiency samples used as competencies, and of course the usual review of all QC and work done on bench with cards and computer enteries but  we need to add more direct observations I guess.

As I understand it, as far as CMs is concerned, this 6 point review is for every "test" we do every year.

(i.e. ABO/Rh, DAT, FHB, ABSC, XM, ABID, etcCOMPETENC-BB YEARLY ASSESSMENT.docx

I have attached a template that was sent to us from our CAP inspectors. Any ideas would help.

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Just returned from AABB where this was discussed in length.  CLIA is putting lots of pressure on TJC, CAP and AABB to comply with their guidelines so if you are to be inspected anytime this year, expect this to garner much focus. Yes, the requirement is every test, every tech, every year.  And if you are a BB, then your processes (i.e. issuing blood, thawing plasma, emergency release, etc.) also need competency assessment per AABB.

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I am having trouble finding just who is qualified to assess competency.  It looks like CLIA requires a bachelor's degree and 2 years experience, but Joint Commission says Associate's and 2 years experience.  Can anyone help me out here and point me in the right direction?  Do state qualifications rule over federal? (I am in Florida). Thanks.

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I agree that this is a very daunting task and I don't know where I'm going to find the time to do the direct observation on all tests for everyone, especially with a new computer system validation and launch coming up soon. I have a few techs on the evening shift who have Florida blood bank supervisor's licenses, so I am going to see if I can delegate some of those tasks to them, after I do the direct observation on them.  I have competency files on all of my techs and whenever I just so happen to observe them doing anything, I write it down in their files. That saves me a little time.  I have made a customized course (quiz) on the CAP website, which assesses their knowledge of our policies and procedures.  I have the AABB publication that has observation checklists and competency assessments, so I will use them as a starting point. 

 

I really don't understand what intermediate worksheets are. If someone could clarify, I would appreciate it.

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The reason why I am asking about who qualifies is that I work per diem at another facility (different corporation) and they are having techs with associate degrees assessing competency in blood bank.  I am not sure this is right, but I need documentation.  Neither one qualifies as a supervisor in the state of Florida. 

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I am having trouble finding just who is qualified to assess competency.  It looks like CLIA requires a bachelor's degree and 2 years experience, but Joint Commission says Associate's and 2 years experience.  Can anyone help me out here and point me in the right direction?  Do state qualifications rule over federal? (I am in Florida). Thanks.

 

There's some useful information found on CLIA Brochure 10.

 

Basically you need to be qualified to be a general supervisor which can be found at: 42 CFR 493.1461.

Briefly, individuals who have associates degrees in med lab technology and two years of experience can perform competency assessment (there is a broader definition to include additional exceptions to these minimum requirements in the CFR). You also need state license if your state requires licensure.

Edited by goodchild
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I really don't understand what intermediate worksheets are. If someone could clarify, I would appreciate it.

 

I hope I can explain this best (our interpretation) with a few examples of what we have considered required documentation under element 3 for our competency assessment plan.

 

  • For antigen typings, we record the results/interpretation concurrently on a paper log for both units and patients. We consider this the intermediate result/worksheet because we use this worksheet to record the interpretation into the LIS (we use Meditech).
  • For antibody titers we keep a copy of the titering worksheet.
  • For aliquoting units we keep a copy of the sterile connection log.
  • For issuing units we keep a copy of the completed requisition form.
  • For issuing tissue products we keep a copy of the completed requisition form.

And so on.

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How are you documenting your competency assessment activities? Are you including copies of result entry/review, copies of worksheets, profiency results, direct observation checklists, copies of problem solving quizzes/scores?

 

 

 

 Yes, you should include copies of the quizzes with pass/fail documentation for each tech. If you do your quizzes on line, I would think a single copy to show what you are using would be sufficient as long as the scores are documented for the individuals. I document which specific proficiency surveys the individual has participated in, but not the actual results. I will pull out the actual survey results if the inspector wants to see that. If there is a specific case where the tech demonstrated good problem solving skills, I will document what/when/how so the original record can be accessed if necessary. The direct observation checklist is included in each persons 'packet'. The checklist includes tests, which need the 6 elements documented, and tasks which can be checked off in a way your lab considers appropriate but does not have to include all 6 elements. The checklist gets longer, not shorter....heavy sigh.......and still a work in progress.

 

I did just pass a CAP inspection and they did pay a lot of attention to competencies here. I had to retrain a tech because of problems with work quality and they combed through that file in detail. I almost tossed some of the multiples of worksheets I used in the retraining process because the file was very thick, but that is what the inspector was most interested in and satisfied with, so I'm glad I left it all. I had documentation of all the discussions that led up to retraining, documentation of progress, paper tools to help the tech improve her work (including those she had used/filled in), documentation of testing she had performed under my direct supervision with her signature and mine, etc etc etc.

Edited by AMcCord
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I must be blind.  I'm looking through my CAP checklist and I'm not seeing anything that talks about personnel competencies.  Can someone share the checklist item number? 

 

thanks,

 

You can find it under Lab General checklist. GEN.55500.

 

**REVISED** 07/29/2013

GEN.55500 Competency Assessment Phase II

The competency of each person to perform his/her assigned duties is assessed.

NOTE: Prior to starting patient testing and prior to reporting patient results for new methods or

instruments, each individual must have training and be evaluated for proper test performance as

required in GEN.55450. Thereafter, during the first year of an individual's duties, competency must

be assessed at least semiannually for nonwaived testing. After an individual has performed his/her

duties for one year, competency must be assessed annually for all duties. Retraining and

reassessment of employee competency must occur when problems are identified with employee

performance.

For nonwaived test systems, competency assessment using all six elements described below must

be assessed for each individual on each test system during annual and semi-annual assessments,

unless an element is not applicable to the test system. For waived test systems, the laboratory may

select which elements to assess for each test system at least annually.

Elements of competency assessment include but are not limited to:

1. Direct observations of routine patient test performance, including, as applicable, patient

identification and preparation; and specimen collection, handling, processing and testing

2. Monitoring the recording and reporting of test results, including, as applicable, reporting

critical results

3. Review of intermediate test results or worksheets, quality control records, proficiency

testing results, and preventive maintenance records

4. Direct observation 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. Evaluation of problem-solving skills

The laboratory must identify the test systems that an employee uses to generate patient test results.

Competency must be evaluated and documented for all testing personnel for each test system. A

TEST SYSTEM is the process that includes pre-analytic, analytic, and post-analytic steps used to

produce a test result or set of results. A test system may be manual, automated, multi-channel or

single use and can include reagents, components, equipment or instruments required to produce

results. A test system may encompass multiple identical analyzers or devices. Different test systems

may be used for the same analyte. In many situations, tests performed on the same analyzer may

be considered one test system; however, if there are any tests with unique aspects, problems or

procedures within the same testing platform (e.g. pretreatment of samples prior to analysis),

competency must be assessed as a separate test system to ensure staff are performing those

aspects correctly.

Many of the elements of competency assessment are performed during routine review of an employee

throughout the year. Documentation of these elements, including adherence to laboratory policies

and procedures, observation of test performance, results reporting, instrument maintenance, review

of worksheets, recording QC, performance of PT, and demonstration of taking appropriate corrective

actions are examples of daily activities that can be used to demonstrate competency. If elements

of competency are assessed by routine review, the competency procedure must outline how this

routine review is used to evaluate competency. Competency assessment during routine review

may be documented by a checklist.

The laboratory director must ensure that the individuals performing competency assessments are

qualified through education and experience to meet the defined regulatory requirements associated

with the complexity of the testing.

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  • 4 weeks later...

I agree that this is a very daunting task and I don't know where I'm going to find the time to do the direct observation on all tests for everyone, especially with a new computer system validation and launch coming up soon. I have a few techs on the evening shift who have Florida blood bank supervisor's licenses, so I am going to see if I can delegate some of those tasks to them, after I do the direct observation on them.  I have competency files on all of my techs and whenever I just so happen to observe them doing anything, I write it down in their files. That saves me a little time.  I have made a customized course (quiz) on the CAP website, which assesses their knowledge of our policies and procedures.  I have the AABB publication that has observation checklists and competency assessments, so I will use them as a starting point. 

 

I really don't understand what intermediate worksheets are. If someone could clarify, I would appreciate it.

I'm curious about the customized course you made on the CAP website - can you elaborate?  Thanks!

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CAP offers competency assessment courses on all areas of the lab. You also have the option of putting your own competency assessment courses online on the CAP website - they can be shared so other customers can use them or they can be private for your institution only. The nice part is that you can assign the custom courses to whoever you choose by email, just as you can the CAP courses. The courses are graded automatically. If the test taker fails to 'pass' (you choose what a passing score is), the course can be automatically reassigned. The course is stored by the website so you can use it over and over, assign it to new employees as they come on board, edit to cover different things, etc.

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For #6: Evaluation of problem solving skills.

I decided not to do a written exam, because if the tech answered incorrectly I would have to show re-training, re-competency, etc. I handled this element by putting a "scenario-based question" for each test/task on my competency. While I am directly observing them and tubes are incubating, etc, I have the discussion with them (for example for the antibody screen "What would you do if you had a patient last week with a 4+ reaction on an antibody screen, result was an Anti-K, and now they are back in the ER this week with a negative antibody screen? What steps would you take to troubleshoot this?"). What's nice about this is you get to have a good conversation with the tech and go over all of the possibilities and they ask other good questions. If they answer "I have no idea", you can ask "so what do you do when you have no idea"; hopefully they answer "refer to the policy, ask my lead tech, call the supervisor, etc" and can still show good judgment. I will change the scenarios every year.

See attached for a good article about tips for competency in the Blood Bank.

Competency assessment in the transfusion service, MLO article Oct 2013.doc

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For #6: Evaluation of problem solving skills.

I decided not to do a written exam, because if the tech answered incorrectly I would have to show re-training, re-competency, etc. I handled this element by putting a "scenario-based question" for each test/task on my competency. While I am directly observing them and tubes are incubating, etc, I have the discussion with them (for example for the antibody screen "What would you do if you had a patient last week with a 4+ reaction on an antibody screen, result was an Anti-K, and now they are back in the ER this week with a negative antibody screen? What steps would you take to troubleshoot this?"). What's nice about this is you get to have a good conversation with the tech and go over all of the possibilities and they ask other good questions. If they answer "I have no idea", you can ask "so what do you do when you have no idea"; hopefully they answer "refer to the policy, ask my lead tech, call the supervisor, etc" and can still show good judgment. I will change the scenarios every year.

See attached for a good article about tips for competency in the Blood Bank.

Excellent article with a lot of valuable and useful info.   

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  • 4 months later...

My recent AABB assessor also stressed the need to include pre- and post-analytic elements to your competency program.

Mine apparently was good enough, so I'm back to the drawing board.  The above-quoted CAP guideline is more inclusive "A

TEST SYSTEM is the process that includes pre-analytic, analytic, and post-analytic steps used to

produce a test result or set of results. This is where you would include review of patient labels and reporting issues.

She said to be sure to include not just the analytic testing in the competency.

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This is the electronic tool that I use to track completion. This will give an idea of the "TEST SYSTEMs" that we have decided to evaluate annually for competency. Once an assessment is complete I drop the date in the proper cell and it calculates the completion percent automatically based on how I've set up the spreadsheet.

 

Each cell represents either a completed direct observation checklist, result entry review worksheet, reviewed copy of QC/results worksheet, blind sample testing worksheet, or graded problem solving exam.

 

I have a form document with all of the information from the spreadsheet in a condensed version for the associate/lead technologist to sign when all competency assessment events are complete.

 

Copy of cy2014 competency assessment completion.xlsx

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