CAP TODAY Pathology/Laboratory Medicine/Laboratory Management
Contributed by Serge Jonnaert, president of the IVD Industry Connectivity Consortium, and Ed Heierman, PhD, CTO of the IVD Industry Connectivity Consortium.
In response to the rapidly evolving COVID-19 crisis, the Department of Health and Human Services (HHS) issued a laboratory data reporting guidance for COVID-19 testing on June 4, 2020 to assure the timely and quality data reporting to state and federal public health agencies of SARS-CoV-2 diagnostic test results, using LOINC and SNOMED-CT in electronic reporting systems. For the purpose of this article, we will focus only on how this requirement affects CLIA certified laboratories, excluding POC CLIA waived tests. While CLIA waived tests were placed under the same mandate, in most cases, there is by default no vehicle for automatic data collection, aggregation, and submission through an LIS or otherwise.
The resulting confusion and frustration was properly chronicled in the November 2020 CAP Today article “Checklist, CLIA line up on COVID reporting” by Anne Paxton. CAP also expressed concerns regarding the call for 18 ‘required’ data elements and more. The intent was right. Unfortunately, the needed infrastructure was not yet in place. While most of the 18 elements could be accommodated through related standards that were already well defined, mature, and published, the device identification to support tracking at the test kit level was not, and neither were the additional questions HHS wanted to get answered for each sample, e.g. Order Entry Question Codes (AOE), calculation input and documenting patient status that could affect result interpretation. These are not the traditional ask at order questions (even though they had to be labeled as such). Neither industry nor clinical laboratories were ready to implement all requirements, thereby avoiding the called for enforcement.
The IVD Industry Connectivity Consortium (IICC) and Regenstrief Institute are two of several organizations that have long touted the benefits of standardized coding of laboratory results and the resolution of related semantic and interoperability issues for the aggregation of big health data for improved real-time epidemiology, comprehensive and geo-specific population health data analysis, and the analysis of non-obvious multi-correlates that can lead to new discoveries. Little did we know that this need would become so acute with the COVID-19 pandemic.
Prior to the COVID-19 crisis, the FDA’s CDRH (Center for Devices and Radiological Health) had already launched the SHIELD Workgroup under the leadership of Michael Waters -who sadly enough passed away in September at the height of the pandemic- bringing together representatives of five agencies (FDA, CDC, NLM, ONC, and CMS) and related industry and standards development groups, including the IVD Industry Connectivity Consortium and Regenstrief Institute. Logically, the June 4, 2020 HHS requirement originated from the work already done by SHIELD. But much still needed to be done.
Many testing agencies had never been required to report data to public health agencies. To support the new COVID-19 pandemic reporting requirements, a SARS-CoV-2 LIVD reference file was created and maintained to allow health care facilities to identify the required harmonized codes. This SARS-CoV-2 LIVD file provided healthcare organizations LOINC mappings, SNOMED mappings (specimen and test result description), equipment identifiers, and test kit identifiers for SARS-CoV-2 diagnostic tests approved for Emergency Use Authorization (EUA) by the FDA for use in the United States. For now this excludes laboratory developed test (LDT) although we have to assume that they also used to report data. The file served as an important resource for the creation IVD test results coding that could improve semantic interoperability of test reporting.
Laboratories cannot reasonably be expected to meet the stated requirements without assuring that all upstream systems adopt the same standards and data structures. IVD, middleware and LIS vendors should make this their highest priority. Many of these systems have not been updated to collect and transmit the information required to support Real World Evidence (RWE) analysis of IVD test results, even though standards such as the LAW (IICC/IHE Laboratory Analytical Workflow published as CLSI AUTO16) and specifications such as LIVD (LOINC for IVD) were created to identify what is required to provide Real World Data (RWD).