anyone have hospital POC inspected/accredited by CLIA?
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Does anyone have experience using CLIA/state inspectors as their accreditation/inspection for hospital POC labs? I've been told our hospital wants to do this, maybe because it's cheaper. We have been CAP forever with all lab services under the same CLIA, but they want to split up the POC on a separate CLIA certificate and have CLIA inspect POC sites rather than CAP. Main lab will stay CAP. Pros/cons? Hospital is JC accredited. Thanks everyone.
Cathy Owens
Lab POCT Supervisor
Roanoke Memorial Hospital
caowens@carilionclinic.org
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Cathy,
Our hospital is only accredited by JCAHO, not CAP. Our main lab, Home Health, and Point of Care testing done at the bedside in our hospital is only accredited by Joint Commission. Home Health has a separate CLIA certificate and the hospital testing is done under the main lab's CLIA. However, we have some outlying clinics each with their own CLIA, of course. Initially these clinics were accredited by JCAHO, per our choice, so they were included in our Lab and Hospital inspections. Since then the hospital chose to no longer have those clinics accredited by JCAHO, so now they are only under CLIA regulations. So far, we have had no CLIA inspections. My understanding is the CLIA inspections are random unless some sort of complaint has been filed. A CLIA inspection can also be done as a followup to another accrediting inspections, which has happened at our hospital also. Not sure if this is what you are asking.
Hi Cathy,
I have 8 hospital-owned clinic labs that I oversee which are all under CLIA. Our hospital is both JCAHO and CAP. I guess CLIA is a little more lenient in some areas since I am used to CAP regulations. I think CLIA is a more cost-effective way to go, although we have considered changing to COLA. Since I am the only person in a POC role here, I guess one of the cons is having to learn a whole new set of regulations and being the only one to make sure all of the sites are compliant. From my understanding, COLA provides a contact that will help you stay in compliance all throughout the year rather than having to make sure everything is done on your own a few months prior to inspection. Inspections are every two years (but can be random although we've never had that situation). All of the inspections I have been through have been conducted in the same general fashion in that the inspector calls about a week prior to tell me the day and time they will arrive. This is a pro, in my opinion, when compared to CAP's unannounced inspection. Another difference is that there is only one inspector rather than a team, which could be a good or a bad thing. The inspector that has been assigned to my clinics the last two times happens to be very condescending and unappeasable no matter how hard you try to prove compliance. The one CLIA inspection I had with another inspector was tough but fair. Hope this helps!
My previous responsibilities before( 2001-2013) involved CAP, TJC, COLA and CLIA inspected hospital laboratories and clinics.
So I dealt with all of them. The strictest inspector was CLIA but after the first inspection, I know what she was going to look for next time.
I learned a lot about regulations from our CLIA inspector. CLIA always check to make sure your users have the correct credentials.
Clinics usually don’t get inspected because they are mostly waived tests.
But if you have one that has moderately complex certificate, monitor them really closely.
CLIA do not have Standards written out like TJC, CAP or COLA. So I prepared my clients and our hospitals
based on the standards for each agency and even add the CLIA regs to make sure I have everything covered.
All the standards are based on CLIA regs. Each agency just want to make sure that we are CLIA compliant
and these agencies interpret them a little different from each other.
CLIA and COLA fees are less expensive than TJC or CAP . TJC is less expensive that CAP.
Go to each agency standards to make sure what is required is being done by the users.
I monitor each place at least once or twice a month.
Competency monitoring is a biggie for all of them. Documentation is a must.
Don’t take the inspectors comment personally. Just fix whatever deficiency you got.
Usually they will tell you all kinds of things that they want you to do or have .
But at the end, they usually only give you a few recommendations and hardly any citation
unless you really did not have the documentation to comply with the standards.
I think the answer depends largely whether you are talking about waived-only or moderately complex testing. If it is waived-only, I say go for it. Waived-only testing does not get regular inspections by BOL/CLIA entities, but they can always show up for a random (I have never had that happen). But remember, if your facility is JC-accredited, they always have the right to look at your waived testing practices, so you still have to meet them.
For moderately complex, I have had all of them State BOL (in PA - they do CLIA's work), JC and CAP. As long as it's my choice, I would never, ever leave CAP. JC were fair, but they had way too much time allocated to inspecting very small lab-POC areas and essentially left no stone unturned. The worst was the BOL. I found them to be extremely out of touch with modern technology and what could be accomplished with regard to things like remote monitoring of operations/devices, as well as all aspects of an electronic medical record. They inspected like they were in a lab circa 1975, where an outpatient walks in with a paper script, tests are done and a paper report is issued. No allowances for how modern health care technology and HIM changes all that. One inspector actually confused QC with PT - no lie. It was extremely frustrating. We got all areas that we could under CAP, along with our core lab, and haven't looked back since.