No Ordering Provider- Need Creative Help

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Good Afternoon- 

We have a Diabetes Ed group that does community education at no cost. During the meetings they pass out OTC glucometers and then have the patient learn to use them etc. They are startingto be a resource for area physicians and they are asking if it is possible for them to run labs and have them documented in a chart. They are interested in running waived WB glucose, waived A1C, and waived UA. The issue is that they are under pharmacy and have no providers linked with their group and they would not have an ordering provider. Does anyone have any experience with this? Is this possible? I though maybe it could fall under a Health Fair Certificate, but A1Cs don't count. 

4 Replies

Kathleen I may be able to help txt me at 203-640-5370

Kathleen,
I work for a nationwide physician ordering service and can assist.  You can reach me at vridenour@cynergymro.com.

Hello Kathleen,
 The "traveling lab" would need a CLIA Certificate of Waiver (COW) (see Washington and New York State CMS sites to see if a certificate is necessary). A pharmacist can be the lab director for a COW site- they have the appropriate schooling and experience providing this service.
Items to think about:
1. Would you be providing this service for free or would billing be involved?
·         Free of charge wouldn't require your institutions billing and coding department to be involved.
·         Charging - Each test would have to appropriately coded for each test and an ABN signed in case insurance doesn't cover the test (i.e. - Medicare patient having an A1C performed greater than every 3 months.)
2. The local physicians should supply you with a requisition just like regular lab work - if they are requesting the service then the onus is on them to provide this to the patient or faxed you a central location in the home institution.
 3. Lab results to providers
·         Paper records could be a form in duplicate/triplicate - your institution keeping one and the other either mailed, scanned, or faxed to ordering provider and one for the patient if provided free of charge.
·         EMR - I think this would be an expensive endeavor for this type of service but there are middleware solutions that lab results can be manually or electronically uploaded (Telcor, RALS)
4. Maintain copies of the patient results in a central location within the home facility following any regulations for patient test result retention. 
5.  Test menu for Point of Care - 
  • Any glucometer FDA certified for use by medical personnel and multiple patients (The OTC are single use) Our organization used the Bayer One Touch Glucometer in our physician office labs.
  •  Urine dipsticks ( UA for Creatinine and Albumin Ratio - I would recommend the Clinitek Status + analyzer - Siemens) 
  • A1C test (We switched from A1C Now almost 3 years ago to a waived analyzer DCA Vantage Siemens).  If you would like to discuss the switch you can email me.
All the above analyzers or comprables could be transported fairly easy.
 I think this is a very noble and worthwhile endeavor. Diabetic patients that have this type of testing on a regular schedule have better outcomes.  (See ADA abd NKF for the most recent published works.
Good Luck

 

Kathleen
If you want to work with the local physicians, your state may require a Collaborative Practice Agreement.  Each state sets their specific requirements.  Here is a link to the CDC website that provides an overview - note the document is from 2012 so may not be up to date in regards to the state where this testing is going to take place:  https://www.cdc.gov/dhdsp/pubs/docs/translational_tools_pharmacists.pdf.  I would suggest checking with your state on the current regulations.

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Kathleen Hainsworth
over 4 years ago
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