Amnisure Compliance
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I'm a Point of Care Coordinator for a 500 bed hospital with an attached Mother/Baby Center. The hospital also supports a Women's Health Clinic across the parking lot which is connected with a pneumatic tube system. Currently, the RNs in the Mom/Baby Center perform moderate- complexity Amnisure testing in their 5 triage rooms. Results are recorded on a result form and sent to lab to be resulted in the EMR. The Women's Health Clinic also collects an occasional Amnisure specimen which is tubed to the hospital lab and tested by our lab staff. Here are my questions/ concerns:
1. Amnisure kits (including swab, test strip and reagent vial) are tubed from the hospital to the clinic. Clinic staff collect sample and send reagent vial containing sample and test strip back to lab to run the test. Is this acceptable? I'm concerned that the clinic would be considered a separate "site" and QC would be required at their site? Also, should we be monitoring the ambient temperature for the location they store these kits in at the clinic?
2. The Mom/Baby group does their own training and observations, however I have a very difficult time keeping track of their staff. They do not send me diplomas, completed observation forms, etc. though they claim their staff "did all the observations at their last skills day". Do any of you have any suggestions to improve compliance? My preference would be to remove Amnisure performance from Mom/Baby and rather have them collect and send to the lab. This option has not been well- received and the RNs claim triageing patients would be significantly slower waiting to get answers from lab.
3. During an observation of several Mom/Baby RNs, it was brought to my attention they do not use the calibrated timers I provided for them but rather look at the wall clock or their watch. They claim touching a timer while doing a pelvic/ cervical exam is not practical or sterile. Any ideas to resolve this? One RN suggested timers with a hole or loop of some sort to allow for a zip tie and ensure a calibrated timer is available in each triage room. Thoughts?
Anyone else struggle with this type of scenario?
Thank you!
1. Amnisure kits (including swab, test strip and reagent vial) are tubed from the hospital to the clinic. Clinic staff collect sample and send reagent vial containing sample and test strip back to lab to run the test. Is this acceptable? I'm concerned that the clinic would be considered a separate "site" and QC would be required at their site? Also, should we be monitoring the ambient temperature for the location they store these kits in at the clinic?
2. The Mom/Baby group does their own training and observations, however I have a very difficult time keeping track of their staff. They do not send me diplomas, completed observation forms, etc. though they claim their staff "did all the observations at their last skills day". Do any of you have any suggestions to improve compliance? My preference would be to remove Amnisure performance from Mom/Baby and rather have them collect and send to the lab. This option has not been well- received and the RNs claim triageing patients would be significantly slower waiting to get answers from lab.
3. During an observation of several Mom/Baby RNs, it was brought to my attention they do not use the calibrated timers I provided for them but rather look at the wall clock or their watch. They claim touching a timer while doing a pelvic/ cervical exam is not practical or sterile. Any ideas to resolve this? One RN suggested timers with a hole or loop of some sort to allow for a zip tie and ensure a calibrated timer is available in each triage room. Thoughts?
Anyone else struggle with this type of scenario?
Thank you!
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For your points:
1. I would think that since there is a tube system between locations that the buildings would be considered connected. It depends on what accreditation agency you use (we use CAP and have the same set up with buildings, they consider them connected). I would not worry about site QC. I would put in a temp monitor in the testing location.
2. The easiest way to test them that they have documentation of "all the observations at their last skills day" is to perform a mock inspection. Pick a day and use whatever inspection points from your accreditation agency and force them to come up with the documentation. If they can't (or if the documentation is sub-par), use that to pressure at the Director/Manager level to get more compliance from staff. Reiterate to the Director/Manager level that the CLIA license is under the Laboratory's Management/Direction. Use the threat of removing the test to get the compliance you need.
3. I would use magnetic back timers, Qiagen makes these. There is always some metal/magnetic surface in a patient room; I would also see if Qiagen could send you these for free (the price per test you are paying isn't cheap, you shouldn't have to pay extra for timers).
As for your questions:
1 - As long as they are under the same CLIA number, it would be considered the same site. We are CAP accredited so your rules may vary depending on your accreditation. Ambient temperature with a certified or NBS calibrated thermometer should be recorded daily in the department where they store the test kits. As for performing QC, my question is: who orders and stores the main stock? That will depend on where QC is performed. In our hospital, the main lab manages the orders and shipments and performs/monitors New Lot/new shipment QC. The departments are responsible for their 30 day QC on their current stock in their department. I go to the departments and provide them with QC and they perform and record the QC results so I can review monthly. This may be helpful information for your QC question. Also, do you have an IQCP to perform 30 day QC or do you perform QC daily? If your policy states the QC is performed daily, then it should definitely be performed in the unit and recorded on a QC form to be reviewed at least monthly.
2 - For moderate complex testing (according to CAP), the operators must meet the 6 elements of competency and competency must be performed initially, at 6 months, and annually thereafter. I do not believe that "did all the observations at their last skills day" is unacceptable and I would immediately request support from your lab director as well as your quality and patient safety directors to perform a department audit/overhaul to give them an opportunity to meet the proper requirements. Providing the CAP requirements (if you are CAP accredited) is a great way to educate the leadership team, if needed. Create a deadline (maybe 3 months) to give them an opportunity to provide you with diplomas, 3 months of temperature charts and QC documentation, and consider offering to do an inservice to get everyone in the department up to speed with the proper competency documentation. If you have someone in the department designated to perform competency training, you can give them your competency assessment documentation and request it to be sent to you when they complete training or competency so you have the documentation. Insist this documentation is required to be compliant and to be able to keep the testing in the department. If this cannot be done by your deadline, then you will have enough evidence to support removing it from the department. Just make sure you have plenty of email and/or written and signed documentation of this department audit/overhaul.
3 - I do not have any advice on the timers. I would just make sure to provide the department with the timers they need to be compliant. This will fulfill your obligation to provide them with the tools they need to do their job.
I hope this information was helpful.