Sent: Thursday, June 4, 2020
Alert - HHS has significantly increased laboratory reporting requirement for SARS-CoV-2
HHS/CDC released new reporting requirements for SARS-CoV-2 at this link:
https://www.hhs.gov/sites/default/files/covid-19-laboratory-data-reporting-guidance.pdf
This document:
· Significantly expands requirements for reporting of laboratory results,
· Wants each laboratory order to include 7 ask-at-order entry questions,
· Wants results to be reported to states/CDC within 24 hours of the result being released.
Challenges
· Some required data elements are not tracked in many if not all information systems (e.g., FDA Unique Device Identifier, the actual zip code of the ordering provider when they place an order since this can be done from anywhere).
· Not all of the data being requested will be in a single database (e.g., Employee testing data may be housed in an LIS and not transmitted to an EHR for privacy reasons mandated by law, patient zip codes may be in the EHR only, and employee zip codes are in a different database entirely).
· There is no mention of how laboratories should handle reference lab testing despite there being explicit instructions on prior communications from HHS regarding which reference laboratory reporting had to be duplicatively reported to the government and which did not.
· The significantly increased burden of data collection is being passed to our providers as well as to those healthcare workers responsible for getting this data together. Many of our healthcare workers are exhausted, some are on involuntary furloughs due to financial constraints created by the pandemic, and significant time has been required to meet testing needs amid shortages of swabs, reagents, and platforms.
· The document is enforcing use of a coding system which is significantly flawed with up to 19% of common tests being coded incorrectly. This data is not surprising given that, for SARS-CoV-2 molecular testing alone, there are no less than 50 different LOINC codes
https://loinc.org/sars-cov-2-and-covid-19/
There are 17 codes for antibody testing. None of them, that I can tell, support the use of a single LOINC code for an order or a result which is a combination of the recommended use of two gene targets. All of them are for single gene targets, and this creates a barrier because many lab systems only support the use of a single LOINC code per result.
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https://www.hhs.gov/sites/default/files/covid-19-laboratory-data-reporting-guidance.pdf
https://www.cdc.gov/csels/dls/sars-cov-2-livd-codes.html
IVD Connectivity Consortium
http://ivdconnectivity.org/livd/
