HEMOCHRON 100 ACT-LR Competency Physical Observation Suggestion

19 followers
0 Likes

Does anyone have a suggestion for doing Direct Observations on Hemochron 100? In general how do you go about completing #1 of the 6 required elements:  The six required 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. Do you actually go watch them run a patient sample from start to finish or do you have them do an explanation of how they collect the specimen and process it. How do you watch them run a sample and how do you document that for CAP inspectors? 

13 Replies

I have a section for their direct observation on their annual competency form, but also separate logs for delegated competency assessors to observe multiple staff on one sheet. Unfortunately, I have very few assessors and will likely soon have none with the CLIA 2025 update.

I've notified management that I will have to schedule time in the OR and other floors/depts next year to accomplish this. Seems like an impossible task for one POCC.

Hi Marisha,
 
We sometimes do meter to meter on a patient to make sure they have both results within 12% like when we do meter to meter comparison studies but my primary way is using a QC sample and having the ref range to show they used proper handling and technique. I emailed you a copy of the form we use.

@Jason
That's the problem; QC doesn't satisfy the direct observation requirement for moderate complexity training. If you read the quoted bold text, its VERY specific. And TJC is now citing everyone for it. Fun to watch the new posts as we all get inspected...

Having been to many inspection and Inspector - I believe “DIRECT OBSERVATION” means Direct observation.

Sincerely,
Alma
“Far and away the best prize that life offers is the CHANCE to work hard at work worth doing” – Theodore Roosevelt

Alma Calzado-Knudson, MBA, CLS, MT (ASCPi & AMT)
Manager, Lab Quality and Point of Care Testing
Student Education Coordinator
[cid:image001.png@01DC1683.EECE3310]
[cid:image002.png@01DC1683.EECE3310]1531 Esplanade Chico CA 95926
•530-332-7360 (Main Lab) l 530-332-7362 (Direct) l 254-722-5388 (Mobile) / [cid:image003.png@01DC1683.EECE3310] 530-893-6809
• alma.calzadoknudson@enloe.org
“Together you and I will Each Accomplish More as we WORK towards achieving a common goal – Patient Safety and Satisfaction”

Basically, you gotta observe everyone yourself doing actual patient testing unless you can find some qualified designees your medical director can delegate. But unless you have a lot of staff that have chemistry degrees or were pre-med... very few clinical staff have the necessary chem and bio hours to qualify. And even then, they will probably be as over-worked as you and unable to complete any direct patient testing observations. 

CLIA 2025 made an impossible situation more impossible. It's just that not everyone in the field knows it yet. TJC sure is working on that.

Hi Ken,

Yes. I am directly watching them mix and run the QC or one of my technical consultants do. It's not just having them run it and going off a log. The ref range I was saying is just to help gauge that they mixed it appropriately. If they fail it I remediate and have them repeat and show them how they are mixing wrong. This way they know how to properly run a PT sample since they are the same technique. Unless what you are saying is even watching them directly with QC is still not accepted. Our current technical consultants are grandfathered in before the Dec 28 cutoff. I haven't found anyone that meets the criteria to replace ones that have transferred or left the org. So far no inspector has said anything and I explain watching them run the sample. I was just inspected in May with no deficiencies and they looked at several of my sign offs and the form. I would be interested to know if the direct observation of QC doesn't count. I definitely don't want to get cited in the future and would happily change processes to comply. We are CAP certified.

QC is not acceptable because it is not a patient.
CAP inspected... I'm not sure if their inspectors are citing this like TJC inspectors are.
But TJC is.

Yes. CAP certified. We've had one of three methods since I started here in 2020; patient meter to meter, QC, or CAP survey sample. I am currently reviewing the PT section of the CAP check list and talking with the coordinator (I'm just the lead) to shre this with her while we are talking. Thanks for all the input. I really do appreciate it. One of our other hospitals is coming due in Dec for inspection and I am hleping her get all her forms and policies and procedures ready and reviewed (kind of like doing a practice run as me coming in as the inspector).

That's how I used to do it. 
Until several inspections ago. That inspection turned my whole POCT program upside down. 
The direct patient observation requirement alone makes POCT so incredibly difficult. I had to completely re-do all of my competency assessment materials and how I worked with clinical educators. Maintenance and function checks are also direct observation, btw.

and you can't complete a records review of your performing staff during a skills fair. I try to do those throughout the year with other weekly and monthly tasks. 

Moderate complexity assessment is no joke.

Thanks Ken. I am reviewing the CAP requirements and evidence of compliance and talking with the coordinator now to see if we need to adjust how we document. I use QC as a method to watch them mix and handle cartridges, sampling of the cuvette, running the meter, etc. but the TC's have to watch them during cases on patients since they are behind a red line. I rely on them to watch their staff during cases. My TC's are also supervisors/educators so they are involved in all cases. I do need to start planning ahead with the new criteria for TC since I can't replace them if they leave and this discussion has definitely helped thinking ahead on what we will need to do.

We use a QC test as a blind sample (blind to the test operator) and use the acceptable range as a pass/fail.  As long as you have a test procedure (or section of a larger procedure) stating how you blind the samples and how you grade the results as a pass/fail, it should pass an inspection.  

With the recent CLIA change and the impossible situations where these types of tests are taking place (Amnisure at L&D - no one wants an extra body in the exam room, Heparin Assay/iSTAT testing/ACT testing in the CVOR and Cath Lab - no space for QA staff, Flight situations (no space for QA staff in the Helicopter/Plane, etc..) it is not reasonable for an accrediting agency to want/need Direct Observations on actual patient tests.  

To avoid an inspector pushing back on whatever process you choose, I would recommend reaching out to your accreditation agency by email and getting a pre-clearance response in writing as a go-ahead on your process.

CAP inspected.  I go up watch them run a patient for their direct observation.  While QC is good to watch for cuvette handling, watching patient testing also catches the preanalytical parts such as timing from heparin bolus to draw, correct amount of waste drawn, instrument counting down prior to draw, scanning patient label, etc.  My RN that grandfathered in as a TC just informed me last week she was leaving.  Have to admit, it made me want to cry.

Reply
Subgroup Membership is required to post Replies
Join POCT Listserv now
Marisha CIchon
3 months ago
13
Replies
0
Likes
19
Followers
526
Views
Liked By:
Suggested Posts
TopicRepliesLikesViewsParticipantsLast Reply
POC ammonia test
Jake Fray
2 days ago
00161
Jake Fray
2 days ago
Glucose Meter Strip Validations
Adelina Wright
2 days ago
40318
Jeremy MacDonald
2 days ago
FOB - moving away from POC
Brian Castle
3 days ago
100488
Jeremy MacDonald
2 days ago