Glucose Monitoring in the Hospital Setting

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Would anyone have the CAP checklist item that pertains to home glucose monitoring in a hospital setting?  We are trying to decide whether we can make exception from a regulatory perspective, for example, if we created hospital policy and lab policy that allowed it.
 
Not sure if this is what we really want to do, but I want to be clear on the regulation.  I would greatly appreciate your help and insight.  Thanks!
 

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Interested to see what other members have to say.  We do not allow patients to do self testing in the hospital. I am assuming you mean with a meter brought to the hospital by the patient. I see nothing specific in the CAP checklist but it was a very brief look.  I would say that all CAP requirements would have to be met.  I did check FDA and found an article that says its ok by them for patients to self test.

We just addressed this topic and came to the same conclusion as Sherilyn.  we would have to meet the CAP requirements on the home meter.  I do think this will become a more common issue with the needleless systems seeing more use. 


There are no CAP checklist items on patients using their own glucometer in a hospital.  We have made an exception in our Policies/Procedures that allow patients to use their home glucometers, though since there is no CAP checklist item there is really no need for a policy.  Before any treatment, patients must be tested with the hospital glucometer system.

Question for Max,
If the patients have to be tested by hospital glucose monitor before treatment, what is the purpose of allowing self testing?

We do not allow self test. There is no QC or any device check for accuracy. They can self test at home, but at the hospital, it is our glucometer.

The CAP standards associated with supply temperature monitoring, QC requirements, training and competencies would all apply to use of self testing for treatment. We have a hospital system policy that speaks to not treating off of a non-hospital approved glucose meter where the result was obtained by a patient's home care meter. Sure, I suppose they could test themselves at any time but we would never treat them off of that result. I'm guessing if they were to provide a number from their meter and have to be poked again for a glucose value that could be treated off of...that would stop them from poking themselves.

We also still do not allow treatment from CGM systems, even though it was approved for use with the whole Covid thing. Again, we have a System Policy that speaks to it. Every few years the topic of home meter use and/or CGB gets brought up. We evaluate every time for needed changes. It just hasn't happened to make a change yet.

In response to Max's question on home meters being used at the hospital: 
All treatment we do to the patients while at the hospital must be properly documented. The home meter brought by the patient will have no record of QC done the day of testing that is recorded in the hospital records.  No guarantee that the meter was in good working condition when the test was performed. The result should not be entered in the patient's EMR because it is not the approved method for testing at the hospital.  A test result in the EMR should have the doctor's order, name of staff who performed the test,  methodology of the test used, result and the units of the test. .Should there be an adverse reaction to the patient due to the  treatment  based on the  results of glucose on home meter  used, the hospital is responsible for the patient while he/she is under the hospital care. There is a chance of a lawsuit if something happened to the patient and the hospital did not follow the CLIA regulations.  Remember that CLIA regs is over CAP. The home meter is  for home use only.  FDA specifies hospital or professional used meters and home meter is not approved for hospital use. 
WE do not allow home meter to be used for treating our patients. 

I suggest that you read the meter's IFU and see what the FDA says it's intended use is for, most home meters are not FDA cleared for use inside a hospital setting.  Regardless of what your site policy states, your site must still follow that instruments IFU.

Sherilyn,  I really cannot tell patients not to use their own glucometer while they are in the hospital if they wish (it is their own personal property).  However, any treatment decisions must be made by results from our hospital glucometer system.  If the patient asks why, our staff can use this as a teaching opportunity on correctly following manufacturers instructions (QC, open vial expiration dates, etc.)  

Pet,  we never treat off a patient's home glucometer and never enter that result into the EMR (due to all the reasons you listed).  Since that is the case, I don't see any CLIA/CAP/FDA regs applying to the hospital.

The big picture here is that patients who have their own glucometer supplies will be testing in hospitals, whether we like it or not.  If a hospital makes a policy that no treatment decision will be made from a patient's personal glucometer, won't that cover the hospital regulation-wise? 

Max: Patients can use their meter  while at the hospital if they want. We allow  them to test themselves. Some feel better using their meter.   But in no way will they be treated based on the result of the home meter.  Should they question the difference in results, then you would have to explain the detail of all quality testing we do on the hospital meters as compared to their home meter. I  can guarantee you, they probably do not QC them daily like we do. 

Pet,  well it looks like we are doing things the same.

If you  just want approval from CAP about writing a policy on allowing patients to use their meter while in the hospital, you might want to call CAP about this.  I doubt that they will recommend writing a  lab policy about this.  I don't think this is a lab policy.  This is more of a hospital  practice policy and the medical staff should be consulted on this. . 
 I think the  attending physician needs to talk to the patient about this practice.  The patient will be stuck more if they want to use their meter also. For what purpose?  

I agree with Pet, this is a hospital policy not CAP or TJC.  I have never heard of a patient using their home meter here.  Now I am curious and will ask the nursing floors. At any rate, I also ask, what is the pupose.

Pet and Sherilyn,  I am not sure what is meant by "what purpose"?  The patient can use their own glucometer (and have more "sticks") if they choose.  I certainly wouldn't choose that if I were a patient, but they can make that choice.

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