SHIELD Glossary

Analyte

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

CLIA definition

ANF

Analysis Normal Form, designed by the Solor Project, aims to provide a standardized encoded and machine processable representation of clinical statements that is intended to support data analysis safely and reliably. The solution is still mainly theoretical, but involves various attributes such as, ID, time, subject of record, author, subject of information, associated statement, topic, type, and circumstance.

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.

CAP

College of American Pathologists provides laboratory accreditation and proficiency testing services.

CAST

Causal Analysis based on System Theory (an MIT Model) is an approach to identify the questions that need to be asked during an accident investigation and determine why the accident occurred.

CDC

U.S. Centers for Disease Control and Prevention is the United States’ leading science-based, data-driven, service organization that protects the public’s health. It is a federal agency under HHS.

CDS

Clinical Decision Support provides clinicians staff and patients with knowledge and person specific information that is filtered and presented at appropriate times.

CIF

Clinical Input Form is the structure of how clinical information is put into the systems and separated, data entry and display.

CIMI

Clinical Information Modeling Initiative is a defining library of logical clinical information models using a common modeling formalism. Documentation of clinical statements.

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)?

Clinical Laboratory Improvement Amendments (CLIA)

CLIA means the Clinical Laboratory Improvement Amendments of 1988, ensures quality laboratory testing. There are currently 320,865 labs that are CLIA certified.

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

CMS

U.S. Centers for Medicare and Medicaid Services is a federal agency under HHS that provides insurance and medical services for the United States’ civilians who might not be able to afford care otherwise, including disabled peoples, low-income families, people 65 years old and older, pregnant women, and people who need long term care.

EHR

An Electronic Health Record is a digital version of a patient’s medical chart.

Equivalence

From Cambridge Dictionary: the fact of having the same amount, value, purpose, qualities

the state or fact of being equivalent, meaning (of a logical or mathematical relationship) reflexive, symmetrical, and transitive.

units are considered equivalent when

test are considered equivalent when

FDA

U.S. Food and Drug Administration is a federal agency under HHS that focuses on regulating food, drugs, medical devices, radiation-emitting products, vaccines, blood, biologics, animal and veterinary products, cosmetics, and tobacco products in the United States.

FHR

Fast Healthcare Interoperability Resources employs RESTful web services such as JSON and RDF data formats. Web services approach that makes it easier for systems to exchange specific data/information.

https://www.healthit.gov/faq/what-electronic-health-record-ehr

FMEA

The Failure Mode and Effects Analysis approach is used to identify all possible failures in a design, process, or service.

HHS

U.S. Department of Health and Human Services is the parent organization over twelve federal divisions, including CDC, CMS, FDA, NIH, and ONC. The mission of the U.S. Department of Health and Human Services (HHS) is to enhance the health and well-being of all Americans, by providing for effective health and human services and by fostering sound, sustained advances in the sciences underlying medicine, public health, and social services.

HIE

Health Information Exchange is a process/system that allows clinicians to access and securely share patient medical records electronically.

HL7

Health Level 7 refers to international standards for transfer of administrative and clinical data between software applications used by many different healthcare providers. LOINC codes are typically embedded in HL7 messages.

HRO

High Reliability Organizations operate in high-hazard domains during extend periods of time without failures. Example organizations would be a nuclear power plant or air traffic control systems.

IVD

In vitro diagnostics are tests conducted in laboratories (i.e., bio samples such as spit or blood). It detects diseases and other bodily disorders.

Note: There are differences in IVD products and calibration techniques which are not reflected in current electronic lab data.

Kit (Test Kit)

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

CLIA definition:

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.

KOMET

Knowledge Management Environment provides an example implementation of the TINKAR model. It shows how terminologies like SNOMED CT and LOINC could be represented and harmonized. Users can view and search concepts using the Komet browser, but this implementation is still in prototype form.

LIDR

Laboratory Information Data Repository is a concept promoted in the SHIELD Community Roadmap. Objectives include improving data quality in the LIDR, have IVD manufacturers assign codes using SHIELD’s direction, and then submitting the codes to the LIDR.

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

Laboratory Information System is a computer system that helps manage aspects of a medical laboratory.

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.

LIVD

LOINC-to-IVD specifications define IVD industry format for use by lab personnel or application, and focus on describing the same laboratory tests from the same vendor in the same manner across all labs.

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 Report of Record

See §493.1291   Standard: Test report.

LOINC

Logical Observation Identifiers Names and Codes is a database and universal standard for identifying medical laboratory observations. First developed in 1994, it was created and is maintained by the Regenstrief Institute, a US nonprofit medical research organization. LOINC was created in response to the demand for an electronic database for clinical care and management and is publicly available at no cost.

NLM

National Library of Medicine, a part of NIH, is the world’s largest biomedical library.

ONC

Office of the National Coordinator for Health Information Technology is an organization under HHS that leads Health IT efforts.

ordered test (aka order or CLIA Test request)

See CLIA requirements for test request/order:

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)

PASTF

Procedural, Assertional, Statement, Terminology, and Foundational layers are part of the Solor Project knowledge architecture.

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?

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.

PHA

Periodic Health Assessment is a screening tool used by U.S. armed forces to evaluate the individual medical readiness of Service members.

provenance

RCA

Root Cause Analysis is the process of discovering the root causes of problems in order to identify appropriate solutions.

repository

STILL TO ADD DEFINITION!!!!

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)

RWD

Real World Data is collected from several sources such as EHR’s, billing activities, etc.

RWE

Real World Evidence is data collected as part of a routine clinical care (i.e., EHR, registries, medical claims, pharmacy data, data from wearables, etc.).

RxNorm

RxNorm provides normalized names for clinical drugs and links names to many drug vocabularies that are used in pharmacy management. This system helps computers communicate drug related information efficiently.

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.)

SHIELD

Systemic Harmonization and Interoperability Enhancement for Laboratory Data

SNOMED

Systematized Nomenclature of Medicine systematically organized computer-processable collection of medical terms providing codes, terms, synonyms and definitions used in clinical documentation and reporting. SNOMED CT is the most comprehensive, multilingual clinical healthcare terminology in the world.

STAMP

MIT’s System-Theoretic Accident Model and Processes model is a systems approach to safety engineering that is founded on the concepts that accidents are part of a process and are control problems, which can be avoided by enforcing restraints and improving interactions.

STPA

System-Theoretic Process Analysis is a hazard and accident analysis technique built on the STAMP model. This technique helps to identify unsafe control actions and causal factors/control flaws.

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.

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:

Tinkar

The Terminology Knowledge Architecture (Tinkar) project, currently within HL7’s Vocabulary Working Group, begins the work to define a flexible self-describing standard logical model for format and distribution of terminology knowledge bases.

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.

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

UCA

An Unsafe Control Action is a control action that, in a particular context and

worst-case environment, will lead to a hazard.

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.

USCDI

ONC’s United States Core Data for Interoperability is a standardized set of health data classes and constituent data elements for nationwide, interoperable health information exchange.