Daniel J. Vreeman, PT, DPT, MScAssociate Research Professor, Indiana University School of Medicine

Associate Director for Terminology Services, Regenstrief Institute, Inc

@djvreeman

2015

LOINC: Introduction and Use for Interoperability

FDA/CDC/NLM Workshop on Promoting Semantic Interoperability of Laboratory Data

Session Overview

1. LOINC today

2. Linking an IVD test/device to a list of LOINC codes is a great idea

3. Challenging opportunities

photo via Vernio77

LOINC is a universal code system for tests, measurements, and observations.

LOINC makes health data more fluid and understandable to different computer systems.

photo via puuikibeach

WE DO MEASUREMENTS

A non-profit research organization in Indianapolis, USA

Overall steward and owner of LOINC

Develops and licenses LOINC to promote widespread global adoption

Financial SupportMany sources over the 20+ years of LOINC AHCPR, ASPE, CDC, CHCF, CMS, Hartford Foundation, IN CTSA, Regenstrief Foundation*, Regenstrief Institute, NCRR, NIBIB*, NLM*, LOINC User Community* *active now

Today, the U.S. National Library of Medicine (NLM) accounts for about 2/3 of our funding.

Development ApproachWorldwide distribution at no cost

New terms requested by end-users

Welcome all comers

Committees are volunteers

Development ApproachWorldwide distribution at no cost

New terms requested by end-users

Welcome all comers

Committees are volunteers

Development ApproachWorldwide distribution at no cost

New terms requested by end-users

Welcome all comers

Committees are volunteers

Its free, but invaluable

LOINC fits well with other data standards

Collaboration with other SDOs see http://loinc.org/collaboration

photo via Temari 09

The LOINC DistributionLOINC Table, Accessory Files, and Tools and Resources for Implementers

loinc.org/downloads

LOINC Codes Over Time by Release

laboratory terms only

0

10,000

20,000

30,000

40,000

50,000

60,000

70,000

80,000

90,000

4/24

/199

5 | 1.

0

5/24

/199

5 | 1.

0a

6/23

/199

5 | 1.

0b

6/28

/199

5 | 1.

0c

7/14

/199

5 | 1.

0d

9/15

/199

5 | 1.

0e

12/2

1/19

95 | 1

.0f

4/28

/199

6 | 1.

0g

8/29

/199

6 | 1.

0h(2

)

12/3

/199

6 | 1.

0h(3

)

1/8/

1999

7 | 1.

0i

10/9

/199

7 | 1.

0j-a

5/1/

1998

| 1.0

k

2/12

/199

9 | 1.

0l

7/23

/199

9 | 1.

0m

8/6/

1999

| 1.0

ma

2/4/

2000

| 1.0

n

6/13

/200

0 | 1.

00

1/1/

2001

| 2.0

0

1/31

/200

1 | 2.

01

7/1/

2001

| 2.0

3

1/1/

2002

| 2.0

4

2/1/

2002

| 2.0

5

2/19

/200

2 | 2.

06

8/1/

2002

| 2.0

7

9/1/

2002

| 2.0

8

5/1/

2003

| 2.0

9

10/1

/200

3 | 2.

10

1/1/

2004

| 2.1

1

2/1/

2004

| 2.1

2

12/1

/200

4 | 2.

13

12/1

/200

4 | 2.

14

6/1/

2005

| 2.1

5

12/1

/200

5 | 2.

16

6/1/

2006

| 2.1

7

12/2

1/20

06|2

.19

6/21

/200

7|2.

21

12/0

3/20

07|2

.22

7/10

/200

8|2.

24

1/10

/200

9|2.

26

07/0

6/20

09|2

.27

12/3

0/20

09|2

.29

2/26

/201

0|2.

30

6/15

/201

0|2.

32

12/2

9/20

10|2

.34

06/3

0/20

11|2

.36

12/3

0/20

11|2

.38

6/30

/201

2|2.

40

12/3

0/20

12|2

.42

06/2

9/20

13|2

.44

12/2

6/20

13|2

.46

06/2

6/20

14|2

.48

12/2

2/20

14|2

.50

06/2

9/20

15|2

.52

LOINC Codes

Only Lab LOINC Codes

Accessory FilesLOINC Panels and Forms File

An export of key panels, survey instruments, and forms in a detailed data structure.

LOINC Multiaxial Hierarchy File Hierarchical organization of LOINC terms based on their axes. Lab terms are organized first by Component, then by System.

LOINC Document Ontology File Special file for the detailed naming conventions for clinical document titles (e.g. Discharge Summary, Progress Note, etc).

Tools for Implementers

photo via Robert S Donovan

search.loinc.org

forum.loinc.org

RELMAThe Gold Standard LOINC mapping tool

Browse LOINC content

Map local terms to LOINC import/export translate local words to LOINC-speak manual/automated mapping

Search in translated languages (and English)

LOINC in action today

40,000+ registered users in 169 countries

loinc.org registered users

0

5,000

10,000

15,000

20,000

25,000

30,000

35,000

40,000

6/1/08

12/1/

086/1

/09

12/1/

096/1

/10

12/1/

106/1

/11

12/1/

116/1

/12

12/1/

126/1

/13

12/1/

136/1

/14

12/1/

146/1

/15

loinc.org registered users

0

5,000

10,000

15,000

20,000

25,000

30,000

35,000

40,000

6/1/08

12/1/

086/1

/09

12/1/

096/1

/10

12/1/

106/1

/11

12/1/

116/1

/12

12/1/

126/1

/13

12/1/

136/1

/14

12/1/

146/1

/15

6,000 new users per year

LOINC Translators

22 organizations. Currently translations into 18 variants of 12 languages

Australia

Austria

Belgium

Brazil

Canada

Cyprus

Estonia

Finland

France

Germany

Iceland

India

Malaysia

Mexico

Mongolia

The Netherlands

New Zealand

Philippines

Portugal

Qatar

Rwanda

Saudi Arabia

Slovakia

Slovenia

Spain

Thailand

Turkey

United States

Adopted as National Standard

Large ImplementationsSIGA Sade project

7+ Provincial systems in Canada

8+ Regional Health Information Exchanges in Spain

ePSOS

Assistance publique - Hpitaux de Paris

Hong Kong Hospital Authority

Philippine Health Insurance Corporation

InFSE Project in 5 regions in Italy (LOINC Italia)

Many more...

Upstream StandardizationA long-term goal starting to bear fruit

photo via Fishking_1

ivdconnectivity.org

Having a predefined list of appropriate LOINC codes for each IVD device is a fantastic idea

photo via didmyself

No one needs all 76,000+ LOINC codes.

For laboratories, mapping to LOINC can be complex and resource intensive.

We love working with IVD vendors.

IVD manufacturers represent the best source of information about the tests they produce.

New LOINC codes requested by IVD vendors are the most efficient ones to process.

Accelerating the goal of interoperable lab data will have huge downstream benefits.

Challenging opportunities

photo via bombeador

New initiatives will likely require new funding.

New initiatives will likely require new funding.

Processing submissions is the bulk of our work.

New term creation process:

Balance responsiveness to submitters with needs of end-users who dont want constant change.

Throughput is throttled by available resources.

A consistent format for presenting the clinically-reported measures for a test in a package insert would be marvelous.

A consistent format for presenting the clinically-reported measures for a test in a package insert would be marvelous.True, even if LOINC codes arent in the package insert.

CYP2D6 gene and CYP2C19 gene mutation analysis

Analyte Specimen Type Example result Units Answer list Expected range

CYP2D6 gene allele 1 Blood, tissue *1A *1A *2A

*1B

*1C CYP2D6 gene allele 2 Blood, tissue *1A *1A

*2A

*1B

*1C CYP2D6 gene drug metabolism analysis

Blood, tissue Extensive metabolizer

Ultra rapid metabolizer Extensive metabolizer Intermediate metabolizer Poor metabolizer Inconclusive

CYP2C19 gene allele 1 Blood, tissue *1 *1 *2 *3

CYP2C19 gene allele 2 Blood, tissue *2 *1 *2 *3

CYP2D6 gene drug metabolism analysis

Blood, tissue Intermediate metabolizer

Ultra rapid metabolizer Extensive metabolizer Intermediate metabolizer Poor metabolizer Inconclusive

CYP2D6 gene and CYP2C19 gene mutation analysis

Analyte Specimen Type Example result Units Answer list Expected range

CYP2D6 gene allele 1 Blood, tissue *1A *1A *2A

*1B

*1C CYP2D6 gene allele 2 Blood, tissue *1A *1A

*2A

*1B

*1C CYP2D6 gene drug metabolism analysis

Blood, tissue Extensive metabolizer

Ultra rapid metabolizer Extensive metabolizer Intermediate metabolizer Poor metabolizer Inconclusive

CYP2C19 gene allele 1 Blood, tissue *1 *1 *2 *3

CYP2C19 gene allele 2 Blood, tissue *2 *1 *2 *3

CYP2D6 gene drug metabolism analysis

Blood, tissue Intermediate metabolizer

Ultra rapid metabolizer Extensive metabolizer Intermediate metabolizer Poor metabolizer Inconclusive

One row per discrete, reported variable

Cell Free DNA screening of maternal blood for fetal aneuploidy

Analyte Specimen Type Example result Units Answer list Expected range

Prenatal noninvasive cell-free DNA testing for fetal trisomy 21 & 18 & 13

Maternal plasma cell-free DNA

No aneuploidy detected

No aneuploidy detected

Aneuploidy suspected

Aneuploidy detected

Chromsome 21 Maternal plasma cell-free DNA

Consistent with diploid chromosome 21

Consistent with diploid chromosome 21

Borderline result suggestive of trisomy 21

Consistent with trisomy 21

Chromosome 18 Maternal plasma cell-free DNA

Consistent with diploid chromosome 18

Consistent with diploid chromosome 18 Borderline result suggestive of trisomy 18 Consistent with trisomy 18

Chromosome 13 Maternal plasma cell-free DNA

Consistent with diploid chromosome 13

Consistent with diploid chromosome 13 Borderline result suggestive of trisomy 13 Consistent with trisomy 13

Sex chromosome Maternal plasma cell-free DNA

Not requested Female fetus Male fetus Not requested

Fetal number ^Fetus 1 {#}

Gestational age at testing ^Fetus 15.4 wk

^Fetus

Maternal weight ^Patient 125 [lb_av]

Standardization is not always just a matter of codification but rather of conceptualization.

Not all juice is worth the squeeze.Pareto principle > Long Tail in standards.

Ignore challenge tests for now.photo via elwillo

Some fruit is lower than others.

Dont need everything all at once.

photo via iancarroll

The Race is On!

Happy LOINCing!photo via ryarwood