Page Comparison

Clinical interoperability

Test results performed on one platform can be SAFELY commingled with test results for the same type of test performed on a different platform.

COULD WE SAY “AGGREGAGED” INSTEAD OF “COMMINGLED”? CAN WE SAY “Tests results performed on one platform can be aggregated with test results of the same type performed on a different platform while assuring the clinical meaning is the same .”

Sam McCash: I prefer the term “trended”, i.e. safely trended because all results are comparable due to a standardization or institutional comparison studies.

Andrea: With trended, it implies graphical representation. Is this any representation of lab data? With trended it also implies the scale of the data is the same (to be on the same graph scale). Do we need to include these aspects in the definition? For example, results may have the same LOINC, but reported in different units of scale mg/dL vs. mg/L. Perhaps include trended with preprocessing of result values to ensure on same scale (whether conversion from C to F or by 10, 100 as example)?

SHIELD

Systemic Harmonization and Interoperability Enhancement for Laboratory Data

Calibration

“Calibration means a process of testing and adjusting an instrument or test system to establish a correlation between the measurement response and the concentration or amount of the substance that is being measured by the test procedure.”

CLIA definition: https://www.ecfr.gov/cgi-bin/text-idx?SID=1248e3189da5e5f936e55315402bc38b&node=pt42.5.493&rgn=div5#se42.5.493_12 = Calibration means a process of testing and adjusting an instrument or test system to establish a correlation between the measurement response and the concentration or amount of the substance that is being measured by the test procedure.

“§493.1253   Standard: Establishment and verification of performance specifications.

Determination of calibration and control procedures. The laboratory must determine the test system's calibration procedures and control procedures based upon the performance specifications verified or established under paragraph (b)(1) or (b)(2) of this section.”

“§493.1255   Standard: Calibration and calibration verification procedures.

Calibration and calibration verification procedures are required to substantiate the continued accuracy of the test system throughout the laboratory's reportable range of test results for the test system”

Sam McCash (SM): An important question that needs to be answered for each test is “to what is the test/platform calibrated to?”, which can be thought of as TRACEABILITY, which I see below. Ultimately this is one way to aggregate test results.

provenance

traceability

‘property of the result of a measurement or the property of the result of a measurement or the value of a standard whereby it can be related to value of a standard whereby it can be related to stated references, usually national or international stated references, usually national or international standards, through an unbroken chain of standards, through an unbroken chain of comparisons all having stated uncertainties’ comparisons all having stated uncertainties’ VIM 1993 - From a presentation on the CDC website https://www.cdc.gov/cliac/docs/addenda/cliac0903/I_Traceability.pdf

Semantic Interoperability

Shaun: A common definition/interpretation of the data exchanged in a message

SM: I think of semantic interoperability as the ability for computer systems to communicate the meaning of the data elements unambiguously. Like the definition of a word in human language, codes also have definitions.

Andrea: See clinical interoperability definition and points above. In addition to clinical interop, I’d add human and computer usability of the data. Each knows the meaning for the term, including context. For example, “ear” can be a specimen type (sent to AP) or specimen source (sent to Micro for culture). The SNOMED CT code from the specimen type vs body structure hierarchy provides the appropriate context for the term so it’s semantically interoperable by both humans and computers (and messaged in the appropriate field for senders/receivers, etc.)

Syntactic Interoperability

transmission of data from point A (sender) to point B (receiver)

SM: I think of syntactic interoperability as the ability to structure data elements together to convey information. Like how humans word a sentence, HL7 structures data elements in a message so they can be organized correctly within a database.

performed test

compare Auto 17 definitions, CLIA definitions, ONC USCDI definitions, etc.

SM: I imagine “performed test' is specific to the result of the actual test run, and to what is reported out. This can be different from what is ordered (less specific) and also different from a preliminary result (i.e. preliminary result cell count by automative methods versus the final manual count).

Andrea: Using SM definition, would IVD vendor “performed test” be the glucose on a specimen (without any time or challenge aspects)? Would it be the test “performed” and “reported” in the LIS (e.g fasting glucose, 1 hr glucose)? Is the test both the order and result or the result and its value only?

What synonyms would folks use? Reported result?

ordered test (aka order or CLIA Test request)

See CLIA requirements for test request/order: https://www.ecfr.gov/cgi-bin/text-idx?SID=1248e3189da5e5f936e55315402bc38b&node=pt42.5.493&rgn=div5#se42.5.493_12

SM: Can be thought of what the healthcare provider selected to order. This is based on what the provider sees in the name of the test order and any attached definitions. I believe this is more pertinent for provider understanding what they are ordering and for meaningful use.

Andrea: Concur, SM. However, what providers order/document is often more generic/named differently than the performing lab’s order. Providers have a different notion of orders than the laboratory community (i.e. the details and what is built in their CPOE and what they see in the EHR)

result value

The value associated with a test result. It may be quantitative (number), semi-quantitative (think urine dipstick), qualitative (pos, neg, detected, not detected), organisms (MRSA), short answer (B Pos), narrative (text blob, think pathology and genomics reports, interpretations)

analyte

“Analyte means a substance or constituent for which the laboratory conducts testing.”

CLIA definition

Kit (Test Kit)

“Kit means all components of a test that are packaged together.”

CLIA definition: https://www.ecfr.gov/cgi-bin/text-idx?SID=1248e3189da5e5f936e55315402bc38b&node=pt42.5.493&rgn=div5#se42.5.493_12

SM: Keep in mind a test result can come from a testing platform (aka test system) that uses multiple kits. This is more problematic in LDTs.

Andrea: totally agree SM. I think of kits as more point of care like a rapid flu, COVID, etc kit. However, FDA and others, in LIVD, etc. a kit may include reagent cartridges, cubes/bottles of reagents, etc which each may have their own UDI. May need to name these as consumable devices or defer to the CLIA definition of test system instead.

Test System

“Test system means the instructions and all of the instrumentation, equipment, reagents, and supplies needed to perform an assay or examination and generate test results.”

CLIA definition: https://www.ecfr.gov/cgi-bin/text-idx?SID=1248e3189da5e5f936e55315402bc38b&node=pt42.5.493&rgn=div5#se42.5.493_12

Performing lab

Laboratory performing testing. Origin of data. Source of Truth.

SM: The performing lab is lab where the test is performed. The performing lab should have all the studies on that test in terms of precision, accuracy, and comparison studies per government regulations. It is required that performing lab information be on the lab report. I do not know what the regulation is for each test result, but it would be useful to have that information in the HL7 message to properly aggregate data.

Andrea: Concur, SM. Performing lab would have IVD test info (package inserts, instrument platform), LDT details, AOEs, UDIs, etc. This is not all being collected, stored, shared/messaged currently. Will be part of SHIELD work and others to make these data more complete.

Clinical Laboratory Improvement Amendments (CLIA)

CLIA means the Clinical Laboratory Improvement Amendments of 1988

https://www.ecfr.gov/cgi-bin/text-idx?SID=1248e3189da5e5f936e55315402bc38b&node=pt42.5.493&rgn=div5#se42.5.493_12

Total Testing Process

End to end workflow from test ordering by clinician to specimen collection, laboratory analysis of specimen and reporting of results. Comprises the Pre-Analytical (processes before specimen receipt in lab), Analytical (in lab processes), and Post-Analytical (after results released by performing lab including clinical decision making) Phases of testing.

See CLIA specifications for Pre-Analytical, Analytical and Post-Analytical Phases of testing.

Laboratory Report of Record

See §493.1291   Standard: Test report. https://www.ecfr.gov/cgi-bin/text-idx?SID=1248e3189da5e5f936e55315402bc38b&node=pt42.5.493&rgn=div5#se42.5.493_12

UDI

Unique Device Identification/Identifier

in the USA : FDA - UDI

in EU : Europe - UDI

In US only required for COVID reporting. LISs don’t have capability to collect, store/map, or transmit UDIs. Realize folks want this data so may need to discuss required functionality for information systems and how best to ensure it is available so info is not blocked from reaching surveillance, RWD destinations as a result.

Laboratory Middleware

Software providing the interface between the lab test instrumentation and the LIS.

SM: Software providing the interface between the lab test instrumentation and the LIS. Middleware can also perform operations on the values coming across applying rules and logic before sending the values to the LIS, such as holding results for technologist review, adding adding an interpretation, or ordering a reflex test.

Andrea: Concur, SM. Middleware can provide (almost) any functionality missing from the LIS. If LIS had complete functionality, middleware wouldn’t be necessary. Some LIS vendors do not provide interface functionality with instruments and thus middleware is needed.

Laboratory Information System (LIS)/Laboratory Information Management System (LIMS)

SM: Traditionally, the LIS is the information system that sits between the clinical lab and the EMR. It is the system that does the final organizing of data from instruments and technologists before it sends it to the hospital system. With the integration of the LIS into the EMR, it can still be thought of the module that the lab interacts with.

Andrea: I’ll add for LISs, there are typically two scenarios: 1. The LIS and EHR vendor are the same with a shared database. The LIS is a module that provides lab functionality and used by laboratory professionals and pathologists not providers/other health professionals like the rest of the EHR. It is often managed by a clinical informatics team or a lab/pathology informatics team. PH reporting such as ELR is after results are verified and occurs in another module of the EHR. Interfaces are not used to “share” data between modules and thus these vendors indicate CAP/CLIA interface checks do not apply. With the shared database, the same order and result term is also shared amongst the LIS-EHR-PH applications. When the LIS is added on to the established EHR, often the lab terms are not updated to performing lab terms in favor of already built EHR terms. 2. The LIS is a different vendor from the EHR vendor. Interfaces are used to transmit orders and results between information systems. The LIS builds reflects performing lab’s order and result terms. EHR order and result terms often reflect provider preferences and are often different than the LIS. CLIA/CAP interface checks apply.