Additional Information Specification 0005: Laboratory Results Attachmentadditional Information

CDAR1AIS0005R020V24AIM0005R010

Additional Information Specification 0005: Laboratory Results AttachmentAdditional Information Message 0005:
Laboratory Results Attachment

Release 2.0
Based on HL7 HL7 Version 2.4CDA Standard Release 1.0, Release 1.0
with supporting LOINC® Tables

NPRM CDA Draft #1
December 11July 15, 2003, 2001

© Copyright 2000, 2001, 2002, 2003
Health Level Seven, Inc.
Ann Arbor, MI

Table of Contents

1Introduction......

1.1LOINC Codes and Structure......

1.2Revision History......

1.3Privacy Concerns in Examples......

1.4HL7 Attachment-CDA Document Variants......

1.5Request for Information versus Request for Service......

1.6Specifying Laboratory Observations......

1.7Requirements for Sending Laboratory Results

2Use of the CDA for Laboratory Results......

2.1Human-Decision Variant, XML Body......

2.2Additional Requirements for the Computer-Decision Variant

3LOINC Codes......

3.1Laboratory Results Supporting Documentation......

3.1.2Requests for individual results......

3.1.3Requests for classes of laboratory test results......

3.1.4Requests for all laboratory tests set......

3.2Scope Modification Codes......

3.3Coding Example......

3.1.1Human-Decision Variant......

3.1.2Computer-Decision Variant......

4Value Tables for Specific Report Structures......

5Response Code Sets......

5.1iso+: Extended ISO Units Codes......

5.2HL70078: Abnormal Flags......

5.3HL70085: HL7 Observation results status......

5.4NPI: National Provider ID......

1Introduction...... 1

1.1LOINC Codes and Structure...... 2

1.2Revision History...... 2

1.3Request for Information versus Request for Service...... 2

1.4Specifying Laboratory Observations...... 3

Requirements for Sending Laboratory Results...... 3

2HL7 Laboratory Results Message...... 4

2.1Additional Information Message Variant...... Error! Bookmark not defined.

2.2Use of OBX-11, Observ Result Status...... 6

3LOINC Codes...... 6

3.1Laboratory Results Supporting Documentation...... 6

3.1.2Requests for individual results...... 8

3.1.3Requests for classes of laboratory test results...... 9

3.1.4Requests for all laboratory tests set...... 10

3.2Scope Modification Codes...... 10

3.3Coding Example...... 11

4Value Tables for Specific Report Structures...... 21

5Response Code Sets...... 21

5.1ans+: Extended ANSI Units Codes...... 21

5.2C4: CPT-4...... 30

5.3HL70070: Specimen Source Codes...... 30

5.4HL70085: HL7 Observation results status...... 33

5.5HL70103: Processing ID...... 33

5.6HL70163: Administrative Site...... 34

5.7HL70103: Processing ID...... Error! Bookmark not defined.

5.8I9C: ICD-9-CM...... Error! Bookmark not defined.

5.9iso+: Extended ISO Units Codes...... 35

5.10NPI: National Provider ID...... 35

Index of Tables

Table 1.1 Relationship of LOINC Codes, X12N Transactions, and HL7 ORU Message......

Table 3.1 – LOINC Report Subject Identifier Codes......

Table 3.3.1- First Battery......

Table 3.3.2 - Second Battery......

Table 5.5.1 - Status for an observation......

Table 1.1 Relationship of LOINC Codes, X12N Transactions, and HL7 ORU Message...... 2

Table 2.1 – HL7 ORU message segment...... Error! Bookmark not defined.

Table 2.2 – Describes the status of the information...... 6

Table 3.1 – LOINC Report Subject Identifier Codes...... 7

Table 3.3.1- OBR-4...... 11

Table 3.3.2 - Second OBR...... 12

Table 5.3.1 - Specimen Source Codes...... 31

Table 5.4.1 - Status for an observation contained in an OBX segment...... 33

Table 5.6.1 - Administrative Site...... 34

Table 3.1 is copyright,  1995-2001 2003 Regenstrief Institute and the LOINC Attachment Committee. All rights reserved.

Additional Information Specification 0005:
Laboratory Results AttachmentAdditional Information Message 0005
Laboratory Results Attachment
Release 2.0
Based on HL7 CDA Standard Release 1.0,
with supporting LOINC® Tables

HL7 Version 2.4 Standard, Release 1.0
with supporting LOINC® Tables

1 Introduction

This publication provides the LOINC[1] code values specific to the laboratory results attachment for the following applications.

• Certain codes will be used in transactions defined by the ASC X12N 277 Implementation Guide (004020X104) Health Care Claim Request for Additional Information and the ASC X12N 275 Implementation Guide (004020X107) Additional Information to Support a Health Care Claim or Encounter which are products of the insurance subcommittee, X12N, of Accredited Standards Committee X12.[2],[3]
• All of the codes may be used in HL7 Clinical Document Architecture (CDA) documents designed for inclusion in the BIN segment of the 275 transaction as described in Health Level Seven (HL7) Implementation Guide: Additional Information Message Implementation Guide[4]

All of the codes may be used in HL7 ORU messages designed for inclusion in the BIN segment of the 275 transaction as described in Health Level Seven (HL7) Implementation Guide for Additional Information to Support a Healthcare Claim or Encounter.[5]

The format of this document (Is this true?} and the methods used to arrive at its contents are prescribed in the HL7 Implementation Guide. Section 2 of this docuent defines the HL7 CDA variants used for laboratory results attachment data. Section 3 defines the LOINC codes used to request laboratory results attachment data and includes full examples of lab results in the human-decision and computer-decision variants.. Section 4 includes the value tables of LOINC codes specific to the data elements of a laboratory results attachment.

The format of this document and the methods used to arrive at its contents are prescribed in the HL7 Implementation Guide. Section 2 defines the HL7 message variant used for attachment data. Section 3 defines the LOINC codes used to request a laboratory results attachment data. Section 4 includes the value tables of LOINC codes specific to the data elements of a laboratory results attachment. Section 3 presents a fully coded example of a laboratory results attachment.

LOINC codes are copyright 1995-2001 2003 Regenstrief Institute and the LOINC® Committee. All rights reserved.

1.1 LOINC Codes and Structure

LOINC codes are used for several different purposes in the two X12 transactions and HL7 message that are used to request and provide laboratory results. The table below identifies four specific uses of LOINC codes and describes their use within the messages.

Table 1.1 Relationship of LOINC Codes, X12N Transactions, and HL7 ORU Message

1.2 Revision History

1.3 Privacy Concerns in Examples

The names of natural persons that appear in the examples of this book are intentionally fictional. Any resemblance to actual natural persons, living or deceased, is purely coincidental.

1.31.4 HL7 Attachment-CDA Document Variants

As described in the HL7 Implementation Guide, there are two variants of a CDA document when used as an attachment under HIPAA.

• The human-decision variant is used solely for information that will be rendered for a person to look at, in order to make a decision. HL7 provides a non-normative style sheet for this purpose.
• The computer-decision variant has the same content as the human-decision variant, but additional coded and structured information is included so that a computer could provide decision support based on the document. Attachments in the computer-decision variant can be rendered for human decisions using the same style sheet that HL7 provides for rendering documents formatted according to the human-decision variant.

1.41.5 Request for Information versus Request for Service

This attachment is a “send-what-you-have” attachment. It is asking for laboratory results that have been produced in the course of the care process. It is not asking for any additional data capture efforts. For example, if the request for data is all Hematology test results, it is not asking the provider to run any specific hematology test procedure, rather it is asking for the provider to send those that happen to have been during the time frame of the request.

1.51.6 Specifying Laboratory Observations

When a payer sends a request for supporting documentation, the payor does not have to enumerate every specific test result of interest. LOINC provides codes for large classes of laboratory test results (e.g., chemistry tests) as well as codes for individual test results such as serum potassium concentration. Either kind of code can be used as a subject identifier. As of July 2000, there were more than 22,400 LOINC codes identifying various kinds of lab observations. Whereas most laboratory LOINC codes identify very specific test measurements. The categories (sets) defined in the LOINC Report Subject have sufficient breadth to allow the payer to request a useful subset of laboratory tests with a single code.

The provider will respond to these LOINC class code with the set of individual test results contained within these codes that have been performed on the patient.

1.61.7 Requirements for Sending Laboratory Results

Laboratory results are transmitted using the HL7 CDA documentORU message. There are a variety of implementation models for the ORU message in sending lab results. In order to describe a workable set of requirements for the receiving systems, the ORU message variant for lab results in claims attachments imposes a specific set of implementation requirements that limit the information and format variations that may be sent as a claims attachment.

The requirements are:

• The patient must be identified.
• Observations must be fully contained in the transmitted CDA documenttransmitted in a single message, without reference to previous or subsequent messages.

Only the segments MSH, PID, OBR, and OBX may be used.

Values may only be sent which are correctly characterized by the Observ result status field, OBX-11.

If a specimen was taken, but results cannot be obtained, it is acceptable to send X in OBX-11 and the reason that results cannot be obtained in OBX-5. In this case the data type in OBX-2 must be ST or TX.

Other than an exception alternative described above, the data in OBX-5 must represent the information described by the LOINC code in OBX-3.

Any data that is sent as a OBX-5 in code must include, in its component 2, the textual interpretation of that code.

When an observation has a numeric value (rather than a coded or textual value) then an appropriate units of measure should be reported in the units field, OBX-6.

• Antimicrobial susceptibility studies are not covered at this time.

2 Use of the CDA for Laboratory Results

2.1 Human-Decision Variant, XML Body

When the provider sends a result using the CDA in the human-decision variant with an XML body, all laboratory results shall be presented in the following way:

• Each battery or other logical grouping shall be sent as a <section> element.
• Each such section shall contain a <caption> element identifying the battery.
• The <caption> element shall include the producer's name for the battery. For example, if an attachment is being prepared in response to a request for LOINC code 18720-3 (coagulation tests), and the local lab calls the battery that was ordered "pre operative coagulation studies," then the <caption> element should include the text "pre operative coagulation studies."
• Where the lab attachment is prepared in response to a 277 message from the payer, the <caption> elements for a section should contain a <caption_cd> element that echoes the LOINC code received in the 277.
• Each such section shall contain a <table> element. Each rows of this table except the header shall contain the individual observation.
• The columns of the table shall be labeled: Result Name, Result Value, Units, Normal Range, Abnormal Flag and Date/Time.
• A table cell in the Result Name column shall have text that identifies the observation in that row. The table cell may contain a <caption_cd> element with the LOINC code that identifies the observation.
• A table cell in the Result Value column shall have the result, which may be a numeric value, a code, a string, or text. If the result is a code, the cell should also include the textual interpretation of the code.
• When an observation has a numeric value (rather than a coded or textual value) then an appropriate units of measure should be reported in the Units column. Where units are not appropriate (for example, for a numerical ratio such as specific gravity) no value shall be used in this column.
• Where the laboratory reported a normal range for an observation the normal range shall be included in the Normal Range column.
• Where the laboratory determined that the reported value is abnormal the Abnormal Flag column shall contain a code drawn from table HL70078.
• The Date/Time columns shall include a text value that conveys the clinically relevant date and time for the observation.
• The data in the Result Value column must represent the information described by the CDA caption for the result. IIf a specimen was taken, but results cannot be obtained, it is acceptable to send X in the Status column and the reason that results cannot be obtained in a comment in the following row.
• Comments that apply to an individual row in the table may appear in a separate <tr> element following the <tr> element that defines a row of observations. Such comments may describe or explain a result but must not alter the meaning of the result.
• Comments that apply to an entire section may appear as CDA content (paragraphs, list, or tables) before or after the <table> element that conveys the results for the section. Such comments may describe or explain a result but must not alter the meaning of the result.

Note to reviewers: Perhaps the most unusual part of this proposal is not providing the equivalent to OBX-11, the observation status. Instead we propose to let them use a comment field to convey the information if the result specimen was obtained but no result was possible.

2.2 Additional Requirements for the Computer-Decision Variant

Except as described in this sections, the requirements for Human-Decision Variant shall also be followed for lab results reported using CDA documents in the computer-decision variant. The following requirements supplement or modify the above requirements.

• Each <caption> element shall contain a <caption_cd> element that includes the LOINC code for the caption of the section or individual observation. Example

<tr>

<th>urine color<caption_cd V="5778-6"/></th>

<td>STRAW</td<td/<td/<td/>

<td>

<local_markup descriptor="dt_ts">

1995-10-21T18:38</local_markup>

</td>

</tr>

• The entry in the Result Value column shall be encoded according to the specifications for the computer-decision variant in the Additional Information Message Implementation Guide. For numeric, string, or text data this is not different than the representation that would be used for the human-decision variant.
• Entries in the Units column shall be coded as described for the CE data type in the Additional Information Message Implementation Guide. For example

<tr>

<th>urine urobilinogen<caption_cd V="20405-7"/>

</th>

<td>0.2</td>

<td<coded_entry<coded_entry.value V="mg/dL" S="need.OID"/>

</coded_entry>

</td>

<td>0.2-1.0</td>

<td/>

<td>

<local_markup descriptor="dt_ts">1995-10-21T18:38</local_markup>

</td>

</tr>

Entries in the Units column shall be coded as described for the CE data type in the Additional Information Message Implementation Guide. For example

• Non-empty entries in the Abnormal Flag column must appear as the CE data type. For example:

<tr>

<th>monocytes count<caption_cd V="742-7"/</th>

<td>1.6</td>

<td<coded_entry>

<coded_entry.value V="10*3/mm3" S="need.OID"/>

</coded_entry>

</td>

<td>0.0-0.9</td>

<td<coded_entry<coded_entry.value V="H" S="need.OID"/>

</coded_entry>

</td>

<td>

<local_markup descriptor="dt_ts">1995-10-21T18:38</local_markup>

</td>

</tr>

• Entries in the Date/Time column shall be encoded as described for the TS data type in the HL7 Additional Information Specification Implementation Guide For example

<tr>

<th>monocytes count<caption_cd V="742-7"/</th>

<td>1.6</td>

<td<coded_entry>

<coded_entry.value V="10*3/mm3" S="need.OID"/>

</coded_entry>

</td>

<td>0.0-0.9</td>

<td<coded_entry<coded_entry.value V="H" S="need.OID"/>

</coded_entry>

</td>

<td>

<local_markup descriptor="dt_ts">1995-10-21T18:38</local_markup>

</td>

</tr>

HL7 Laboratory Results Message

All data elements for Textual Report Electronic Attachments are sent using the Laboratory Results Message Variant, described below. It is used to transmit textual and structured information.

1.7Use of OBX-11, Observ Result Status

In the provider’s information systems environment, HL7 messages are used to send preliminary, partial, updated, final, and corrected results, and to report that no result will be available for an order, because the specimen was unusable or for other reasons. The values available for this field are designed to support these use cases, and to reflect the status of a result at various points in its life cycle.

The use cases for sending supporting documentation do not support updating a result, once it has been sent the payer. The provider must use this data field to describe the status of the information at the time that it was extracted for transmission to the payer. Accordingly, the following values, which are a subset of HL7 Table 0085, may be used.

Table 2.2 – Describes the status of the information

23 LOINC Codes

2.13.1 Laboratory Results Supporting Documentation

Table 3.1 defines the LOINC code used to request a complete attachment data set specific to laboratory results. The use of this code in the 277 STC segment represents an explicit request for the complete set of data elements relevant to the laboratory results.

The provider is expected toshall return all data elements for which data is available. The minimum attachment data set equates to the required elements; those identified in the value table at Section 4 with a cardinality (Card) of {1,1} (element is required and has one and only one occurrence) or {1,n} (element is required and has one or more occurrences). Those data elements with a cardinality of {0,1} (if available has one and only one occurrence) or {0,n} (if available may have one or more occurrences) should shall be sent if available.

Table 3.1 lists the LOINC codes that represent the current major subclasses of laboratory results. The LOINC database includes a tree structure that links the LOINC term, “all laboratory studies” (LOINC 26436-6), to each of its major subclasses (see Table 3.1) and further links each of these subclassclasses to the LOINC codes for the individual laboratory test observations they contain. Any of the LOINC codes in this hierarchy are valid LOINC report subject codes for the 277-request for supporting documentation message. When a requestor asks for 26436-6 (all laboratory studies (set)), the organization answering that request will return all laboratory results related to a given claim that also satisfy the constraints imposed by the modifier codes submitted in the 277. When a requestor asks for a subclassclass of laboratory tests e.g., coagulation tests (set) (LOINC 18720-3) or chemistry tests (set) (LOINC 18719-5), the organization answering that request would return all coagulation tests or all chemistry tests respectively. When a requestor asks for a single LOINC code (e.g., 2974-1 blood sodium concentrate) the organization returns the test results for that sodium value only.