quest diagnostics -- ask at order entry insight 20140707

Quality Lab-EHR Interoperability

Enabling Effective Patient Data Collection

Ask at Order Entry Insight into Ask at Order Entry (AOE) functionality using

international standards as directed by the U.S. Dept. of HHS

July 2014

By Ken McCaslin, FHL7 Freida Hall, FHL7 Virginia Sturmfels, MT (ASCP) Keith C. Drake, Ph.D.


Table of Contents

About the Authors 3

Overview 4

Organization/Target Audience 5

History of Events 5

The Goal of the AOE Standardization 6

AOE Concepts 6

AOE Structure 7

Ask at Order Entry – Why this is Necessary 9

Benefits from Standardized AOEs 10

Next Steps for Success 11

Information Technology/Electronic Health Record (EHR) 12

The Future Direction of AOEs 18

Appendix A - AOE 19

Appendix B - Acronyms 23

About the Authors

Virginia Sturmfels

Virginia is the Manager of Medical Regulatory Affairs at Quest Diagnostics and Co-Chair of S&I Framework’s Vocabulary Work Group. Virginia has been an active participant on the LRI and LOI Work Groups. She also participated in the ACLA HIT Committee’s work effort that produced the “HL7 Version 2 Implementation Guide: Laboratory Test Compendium Framework, Release 1 also known as the eDOS IG.1”

Freida Hall

Freida is the Manager of Healthcare Standards at Quest Diagnostics, Co-Chair of HL7’s Technical and Support Services Steering Division, Co-Chair of HL7’s Project Services Work Group, is a member of HL7’s Technical Steering Committee and past HL7 Board Secretary. She also is Co-Chair of S&I Framework’s eDOS IG Work Group. Freida is in the inaugural class (2010) of HL7 Fellows and has held several other roles in healthcare.

Ken McCaslin

Ken is the Director of Healthcare Standards at Quest Diagnostics, Co-Chair of HL7’s Electronic Services Work Group, Co-Chair of American Clinical Laboratory Association’s (ACLA) Health Information Technology (HIT) Committee and Chair HL7’s Technical Steering Committee and HL7 Board Member. He is Co-Chair of S&I Framework’s LRI and LOI IG Work Groups. Ken also is in the inaugural class (2010) of HL7 Fellows and has held several other roles in healthcare standards development. He participated in the ACLA HIT Committees work effort that produced the “HL7 Version 2 Implementation Guide: Laboratory Test Compendium Framework, Release 1” also known as the eDOS IG.

Keith C. Drake, Ph.D.

Keith is the managing Executive of the Quest Diagnostics Health IT Quality Solutions™ Program. The Program’s objective is to promote quality Lab-EHR interoperability by identifying and recognizing commercial electronic health record (EHR) systems meeting Quest Diagnostics high standard for result and order transactions, interface implementation and maintenance, and B2B business processes.

1 This guide can be found at http://www.hl7.org/implement/standards/product_brief.cfm?product_id=151 at Health Level Seven International (HL7). It is an American National Standards Institute (ANSI) Informative standard.

Overview

Upon receipt of a laboratory test, the laboratory may request additional information to accompany the order and collected sample. In some cases, no additional information is required; the test request is simply accompanied by the appropriate specimen. In other instances, additional information beyond patient name, age, and gender provide supplementary content necessary to fully report the ordered test. This supplemental information often is produced by additional test-specific questioning of the ordering provider. The result of these questions often is designated as Ask at Order Entry (AOE) information. AOE information should be provided as results attached to the Order Code that they impact. This additional data is used by the laboratory in conjunction with the test result to provide the physician with a patient-specific result.

This paper addresses AOEs based on the assumption of electronic ordering of laboratory tests. Therefore, its discussion is based on Health Level Seven International’s® (HL7®)2 Order Message structure, specifically version 2.5.1 to be consistent with the federal initiatives on Meaningful Use3 (MU). Laboratory Orders are specifically addressed in MU Stage 34 (MU3) and have a specific Implementation Guide (IG) called the Laboratory Order Interface IG (LOI IG5). There is a companion IG called the electronic Directory of Services IG (eDOS IG6) that provides the laboratory’s full test compendium to the Electronic Health Record (EHR) system using HL7’s Master File Updates.7 AOEs are provided in the eDOS IG including the laboratory’s local code, description (the question), and when available, the Logical Observation Identifiers Names and Codes (LOINC).

Work is under way in the health IT industry to create AOE standards to define how the AOE is identified, the data type the AOE values should support, and a potential list of ordinals that will be used to respond to the AOE request. In some cases, the data type directs the use of an HL7 table as identified in the underlying standard. In other cases, the data type is designed to have multiple inputs, and without an identified terminology, the test result may not be structured to provide seamless processing and reporting. These are the issues this paper addresses.

2Health Level Seven International ® (HL7®) is a healthcare standards body focused on the clinical and administrative data standards. This body has two message standards Version 2.x and Version 3.0. Additional HL7 information can be found at http://www.hl7.org .3Meaningful Use (MU) is an initiative from the Health and Human Services (HHS) under the auspices of the Office of the National Coordinator of Health Information Technology (ONC). The initiatives have been released in stages beginning with Stage 1 in 2010, Stage 2 in 2012 and Stage 3 is anticipated to be released in January 2014. The initiatives for each stage of MU are driven by participating members of the community. That work is posted and maintained on the Standards and Interoperability Framework Initiative (S&I Framework) wiki for all to view. That wiki can be found at http://wiki.siframework.org/ .4Meaningful Use Stage 3 Laboratory Orders can be referenced on the S&I Framework wiki at: http://wiki.siframework.org/Laboratory+Orders+Interface+Initiative 5The LOI IG can be found at: http://wiki.siframework.org/Laboratory+Orders+Interface+Initiative 6The eDOS IG is defined as “HL7 Version 2 Implementation Guide: Laboratory Test Compendium Framework, Release 1”can be found at: http://www.hl7.org/implement/standards/product_brief.cfm?product_id=151 7HL7 Master File Updates can be found in chapter 8 of version 2.x. In this case, eDOS IG is based on chapter 8 of HL7 version 2.5.1.

Work is under way in

the health IT industry to

create AOE standards.

Organization/Target Audience

The majority of this paper is assumed to be of interest to all audiences; however, information more technical in nature is included in the Information Technology/Electronic Health Record (EHR) section. The technical information is written for the EHR community and information technology (IT) professionals. It assumes a working knowledge of HL78 (specifically version 2.5.1 through 2.8.1), how the HL7 message is constructed, ANSI documentation processes, LOINC®9, and RELMA®. In most instances discussions about HL7 messages, segments, and fields will be limited.

History of Events

Several years ago, a group of healthcare standards pioneers in the laboratory industry gathered in Washington D.C., home of the American Clinical Laboratory Association (ACLA), to develop the first electronic delivery of a laboratory’s Directory of Services (DOS) using an existing standard, in this case HL7 version 2.6 known as eDOS IG. That first IG used HL7 Chapter 8 – Master Files to develop the messages necessary to send the DOS using existing connectivity already employed to support the delivery of laboratory orders and results. This breakthrough IG can be found at HL7 as an ANSI Standard titled “HL7 Version 2 Implementation Guide: Laboratory Test Compendium Framework, Release 1“ (http://www.hl7.org/implement/standards/product_brief.cfm?product_id=151)

In 2012, this guide was adopted by the Standards and Interoperability Framework Initiative (S&I Framework) to be part of the next stage of Meaningful Use under the eDOS IG Work Group.10 This Work Group, in collaboration with the Vocabulary Work Group11 has been standardizing the AOE process and broadening the eDOS IG to support the expanded standards being developed for the AOEs. Quest Diagnostics employees Freida Hall and Virginia Sturmfels are among the leadership of these two groups. The outcome of their work is an updated eDOS IG that will be known as “HL7 Version 2 Implementation Guide: Laboratory Test Compendium Framework, Release 2.“ Appendix A of this Implementation Guide is the initial work done by these two groups on the development of guidance for standard AOEs. This new document has been released as a Draft Standard for Trial Use (DSTU) with anticipation that further updates may be necessary after an initial pilot period. “Release 3” likely will start development in 2014 and should result in the Normative standard. In addition, the Release 2 document was aligned with its companion guides: the Laboratory Results Interface Implementation Guide (LRI IG) and the Laboratory Orders Interface IG (LOI IG).

8For more information about HL7 messages, segments and fields see the HL7 version 2.5.1 standard. It can be found at: http://www.hl7.org/implement/standards/product_brief.cfm?product_id=185 9LOINC® is a registered trademark of the Regenstrief Institute and can be found at http://www.regenstrief.org/ and the LOINC standard can be found at http://www.loinc.org/. It will require accepting the copyright notice and license agreement before entering the LOINC database.10The eDOS Work Group can be found at: http://wiki.siframework.org/LOI+-+eDOS 11The Vocabulary Work Group can be found at: http://wiki.siframework.org/LOI+-+Vocabulary+WG

The Goal of AOE Standardization

The goal of AOE standardization is a seamless gathering of AOE information from the ordering provider by the EHR, electronically transmitting the information in the HL7 Order Message, and uploading it into the patient record at the laboratory. The benefits of this process are: 1) the laboratory does not manually enter the AOE information into the LIS thereby saving costs and reducing errors, and 2) the test report sent back to the ordering provider automatically echoes the AOE information used to construct a patient-specific test value. These goals can only be reached if there is a reliable process that involves both the EHR and Laboratory Information Systems (LIS) using the same formats. Additionally, the ordering provider must use the same terminology as the laboratory, enabled by agreement on standards that can be supported.

AOE Concepts

AOE concepts can be categorized into two general categories: 1) Additional Information, and 2) State of other results. State of other results is very different from previous results. An example is an AOE that asks “Was the previous result abnormal?” This AOE question is not asking for the previous results, it is asking the clinician to define if the previous results were normal or abnormal. In this case, a normal answer for this question would be “No” and an abnormal answer would be “Yes”.

In the LOI IG, the user will find the HL7 message structure to support previous results. This message structure should be used when sending previous results. However, State of Other Results is an AOE often asked as a Yes/No response or in a similar fashion. Therefore, this remains as an AOE.

The other AOE type is the Additional Information. In this area we have two categories of: 1) Information about the specimen, and 2) Information necessary in providing laboratory results. Information about the specimen can define how it was collected, type of specimen, quantity of specimen, or timing of collection of specimen. This information may modify how the specimen is processed at the laboratory or alter a procedure.

With the information necessary in providing laboratory results, the AOEs may require the ordering provider to provide clinically significant information, such as patient race or ethnicity. The AOE may ask for clinical information such as Last Menstrual Period (LMP) in a date format or other required data in a structured format so that the information can be used for calculations and risk assessment.

AOE benefits:

1) the laboratory does

not manually enter the

AOE information into

the LIS thereby saving

costs and reducing

errors, and 2) the test

report automatically

echoes the AOE

information used to

construct a patient-

specific test value.

AOE Structure

There are several components to the AOE: The identifier, the description (also the question being asked), the format of the data (using data types12), and in some instances the accepted values for a given AOE as illustrated in the table below. Additional information on Data Type is provided in the Information Technology/Electronic Health Record (EHR) section.

Figure 1-1 – Example of AOE requirements table from S&I Framework13

Example LOINC AOE Questions

LOINC Code

LOINC Long Name

Alias Name Data Type

Usage Note

11778-8 Delivery date estimated

Estimated due date

DT

11884-4 Gestational age Estimated

NM Be sure to populate the units in OBX-6.

49051-6 Gestational age in weeks

Gestational age (weeks)


In some cases, there are answers to AOE questions provided by LOINC as outlined in this paper and illustrated in Figure 1-2 below.


LOINC Code

LOINC Long Name

Alias Name

Suggested HL7 Data Type OBX response Usage Note

Usage Note

32624-9 Race CWE PID-10 (Race) value is provided for demographic, not clinical use. An AOE must be provided for those tests where Race drives the interpretation of results. The value must be determined by the ordering provider and must be sent as an AOE OBX. Refer to LOINC for suggested answer list. More specific race values are available, but not limited to, those found in the CDCREC document if needed for AOE. (http://www.cdc.gov/nchs/data/dvs/Race_Ethnicity_CodeSet.pdf)

12For a discussion on data types; primitive and complex see: http://help.adobe.com/en_US/AS2LCR/Flash_10.0/help.html?content=00000029.html Also see chapter 2 of the HL7 Version 2.5.1.13Is called HL7 Version 2.5.1 Implementation Guide: S&I Framework Laboratory Test Compendium Framework, Release 2 US Realm and can be found at: http://www.hl7.org/implement/standards/prod-uct_brief.cfm?product_id=151 14Is called HL7 Version 2.5.1 Implementation Guide: S&I Framework Laboratory Test Compendium Framework, Release 2 US Realm and can be found at: http://www.hl7.org/implement/standards/prod-uct_brief.cfm?product_id=151

Figure 1-2 depicts the Ask on Order question “Race,” which may have an impact on the laboratory result value or reference range for certain laboratory tests. As explained in the S&I IG Usage Notes, if the patient’s race is not pertinent for the clinical test, it is reported along with other demographic data (date of birth, address, etc.) in the HL7 Message, and an AOE is not required. To view the LOINC suggested answer list for “Race,” one first needs to visit the LOINC.org® website.15 By entering 32624-9 to search for the LOINC code, its description and several other properties of the code are displayed. The LOINC suggested answer list can be viewed by clicking the hyperlinked code, which will display a second screen showing other attributes of the code and suggested answers as shown in Figure 1-3 below. In this example, the five values displayed in the LOINC answer list are the same as those developed by the Office of Management and Budget (OMB)16 and used in Meaningful Use to report demographics. They also are used by the Census Bureau and other federal agencies.

The Centers for Disease Control developed a list of more granular race codes, which may be used when a more specific value can be obtained or is required for electronic public health reporting purposes.17 The list of Race codes is hierarchal in nature, meaning granular codes can “roll up” to the five OMB values. The sequence number and answer ID ‘LL’ number shown in Figure 1-4 LOINC Race – expanded display are not the values messaged for Meaningful Use AOEs; instead use the top hierarchy of the CDC code list (R1, R2, etc.) or if necessary, a more granular value from the CDCREC table.

Figure 1-3 – LOINC Race

LOINC Code LOINC Long Name

1002-5 AMERICAN INDIAN OR ALASKA NATIVE

2028-9 ASIAN

2054-5 BLACK OR AFRICAN AMERICAN

2076-8 NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER

2106-3 WHITE

15 LOINC® is a registered trademark of the Regenstrief Institute and can be found at http://www.regenstrief.org/ and the LOINC standard can be found at http://www.loinc.org/. It will require accepting the copyright notice and license agreement before entering the LOINC database.16http://www.whitehouse.gov/omb/inforeg_statpolicy/#dr Data on Race and Ethnicity.17http://www.cdc.gov/nchs/data/dvs/Race_Ethnicity_CodeSet.pdf

Figure 1-4 LOINC Race – expanded display

Some of the AOEs will suggest LOINC values or other values suggested by the IG authors. Those values will reference the best place to find more information about the AOEs. The ultimate goal is to develop a precise process for defining AOEs, determine the appropriate data type based on HL7 Table 125, and (if possible) suggest consistent responses. These consistent responses provide for a reliable structured data process that is easily understood and, if necessary, capture additional information from the source for the standard data input. A standard data input eliminates the concerns of mistyping information and of multiple concepts for the same responses. It is recommended that (when possible) the available options be presented to the ordering provider so that they can easily select the appropriate response.

Ask at Order Entry – Why this is Necessary

Laboratory tests by themselves provide valuable diagnostic insight to a patient’s illness/wellness status. In some cases, the additional information provided by AOEs allows the laboratory to present the ordering provider with greater insight. Some computations based on AOE information can easily be found on the Internet, with the outcome determined by a simple calculator. The laboratory regularly provides calculated values based on AOEs, for thousands of patients daily, thereby reducing the opportunity for error and programmatically determining if the resulting calculation is within appropriate normal ranges. This automated approach also makes better use of the ordering provider’s valuable time.

In some cases, the AOEs provide the laboratory with valuable information about the specimen collection site and the source and process used to collect the patient’s specimen. The laboratory therefore is able to properly prepare the specimen for testing, using appropriate media or reagents. The additional AOE information may also assist the pathologist in providing an accurate assessment of the specimen.

AOEs provide the

laboratory with valuable

information about the

specimen collection

site and the source and

process used to collect

the patient’s specimen.

18Health Information Exchange among U.S. Non-federal Acute Care Hospitals: 2008-2013; Matthew Swain, MPH; Dustin Charles, MPH; Michael F. Furukawa, PhD; ONC Data Brief, No. 17, May 2014. 19Use and Characteristics of Electronic Health Record Systems Among Office-based Physician Practices: United States, 2001–2013; Chun-Ju Hsiao, Ph.D., and Esther Hing, M.P.H.; NCHS Data Brief, No. 143, January 2014.20http://www.healthit.gov/sites/default/files/acceleratinghieprinciples_strategy.pdf21Institute of Medicine report: Health IT and Patient Safety, Building Safer Systems for Better Care, http://www.iom.edu/Reports/2011/Health-IT-and-Patient-Safety-Building-Safer-Systems-for-Better-Care.aspx2245 CFR §170.314(b)(5) Incorporate Laboratory Tests and Values/Results

The inclusion of

patient specific

information obtained

from AOEs will provide

patients with customized

data regarding their

health status

Benefits from Standardized AOEs

The Department of Health and Human Services (HHS) has stated that the exchange of health information should be both interoperable and transmitted electronically across a myriad of information systems. These objectives enable the nation to realize a patient-centered, value-driven health care system. However, gaps and challenges remain for the widespread use of interoperable systems and Health Information Exchanges (HIEs) across providers, settings of care, consumers and patients, and payers. Health care providers and their vendors lack a business imperative to electronically share person-level health information across providers. In 2013, only 42% of hospital exchanged clinical care summaries electronically with providers outside the hospital and only 37% used electronic exchange to share medication histories with those providers.18 Moreover, in 2013, only 48% of office-based physician were using a basic EHR system.19 Similarly, consumers and patients are not actively engaged in accessing and using their personal health information and requesting that their providers do the same.20 However, the April 2014 U.S. Department of Health and Human Services rule requiring labs to directly provide patient direct access to their test reports, is expected to result in increased engagement

To accelerate health information exchange and interoperability, laboratories and EHR Vendors are under pressure from multiple federal agencies to standardize data and their exchange, due to findings by the Institute of Medicine (IOM). These findings indicate that appropriately implemented health information technology systems improves provider’s performance, improves communication with patients, and enhances patient safety.21 Specifically for laboratory results, the Meaningful Use Stage 2 incentive program administered by CMS and ONC requires EHR technology designed for an ambulatory setting to be capable of electronically receiving, incorporating, and displaying clinical laboratory tests and values/results in accordance with the HL7 Version 2.5.1 Implementation Guide: S&I Framework Lab Results Interface (LRI) and with laboratory tests represented in LOINC®.22 Using LOINC codes and other structured data enables decision support and provider alerts in EHR systems, as well as meeting Meaningful Use requirements.

As the healthcare community moves toward more personalized medicine, the inclusion of patient specific information obtained from AOEs will provide patients with customized data regarding their health status.

In The Quality of Health Care Delivered to Adults in the United States, the authors note:

“As a nation, we are transforming health care delivery into a system that is patient-centered and value-based. Existing Medicare and Medicaid programs and initiatives, as well as new programs authorized by the Patient Protection and Affordable Care Act (Affordable Care Act), focus on new service delivery and payment models that encourage and

facilitate greater coordination of care and improved quality. These new initiatives include Accountable Care Organizations (ACOs), bundled payments, health and medical homes, and reductions in payment for hospital readmissions. Critical to the success of these programs and the ultimate goal of a transformed health care system is real-time interoperable HIE among a variety of health care stakeholders (clinicians, laboratories, hospital, pharmacy, health plans, payers and patients) regardless of the application or application vendor. Greater access to person-level health information is integral to improving the quality, efficiency, and safety of health care delivery.”23

Next Steps for Success

CMS and ONC reported in their Principles and Strategy for Accelerating Health Information Exchange (HIE) published August 7, 201324, that stakeholders should advocate expansion of LOINC usage to accelerate health information exchange (excerpt below):

Laboratory Tests/Results Exchange

Commenters raised concern about barriers to using standardized electronic laboratory results including the cost of interfaces and the current trend towards creating preferred laboratories. Commenters suggested finalizing the Proposed Rule entitled “Clinical Laboratory Improvement Amendments (CLIA) Program and HIPAA Privacy Rule; Patients’ Access to Test Reports”25 to expand patients’ rights to access health records directly from laboratories, which has since been finalized. Commenters also advocated for further integration of Logical Observation Identifiers Names and Codes (LOINC®)26 into every possible program as the best method to increase interoperability and the electronic exchange of laboratory test results. To make progress in this area, commenters identified mapping other standards to LOINC® as a critical step in facilitating the adoption of LOINC® and suggested that HHS could provide such mapping as it has done in other areas. A few commenters recommended that CLIA regulations be revised to require laboratories to send results using LOINC®. Commenters also suggested that ONC ensure that laboratory-related certification criteria under the ONC HIT Certification Program (e.g., 45 CFR § 170.314(b)(5) and (6)), including the Laboratory Results Interface (LRI) specification, are consistent with 42 CFR 493.1291 and CLIA guidance. Once these certification criteria are consistent, some commenters suggested that

23McGlynn, E.A., S.M. Asch, J. Adams, J. Keesey, J. Hicks, A. DeCristofaro, and E.A. Kerr, “The Quality of Health Care Delivered to Adults in the United States.” New England Journal of Medicine 2003 348: 2635-45. See also, Rosenbaum, R., “Data Governance and Stewardship: Designing Data Stewardship Entities and Advancing Data Access,” Health Services Research 2010 45:5, Part II.24http://www.healthit.gov/sites/default/files/acceleratinghieprinciples_strategy.pdf2576 Fed. Reg. 56712 (Sept. 14, 2011)26LOINC® is a database of universal standards for identifying medical laboratory observations.

HHS consider offering a “safe harbor” or allow anyone who appropriately uses a laboratory system certified to the laboratory-related certification criteria to be deemed in compliance with CLIA regulations.

Information Technology/Electronic Health Record (EHR)

AOE Format

The format of the HL7 message requires that the owner of the identifier be included. This requirement is forced through the data type of the HL7 field, which in this case is the OBX segment position 3 (OBX-3). OBX-3 is known as the Observation Identifier which uses the CWE (Coded With Exceptions) data type. The CWE data type is a complex data type because it has multiple components. Depending on its version, the CWE data type it can have 11 or more components.27 For this discussion, we are interested only in the first six components, which are broken down as twin triplets. Essentially, the two components in each of the three sets are equivalent to one another: components 1 and 4 (the identifier) are the same; as are components 2 and 5 (description or question) and components 3 and 6 (source of identifier). Note that components 4 through 6 are noted in the data type as the alternative to components 1 through 3. This designation provides the ability to message local laboratory codes with a standard code specification such as LOINC.

Maternal Serum Screening – Hardcopy Requisition

The Maternal Serum Screening Profile has many complexities based on the trimester of the mother upon sample collection. The following example is based on a 2nd Trimester Screening Test named Quad Screen (Quest Diagnostics Order Code 30294).

To share a test that has more AOEs, the example also will share the additional AOEs needed for the 1st Trimester Screen HyperGly-hCG (Quest Diagnostics Order Code 16020) as noted on the example Quest Diagnostics hardcopy Requisition.28

27 See HL7 version 2.5.1 chapter 2 for details about the components of CWE28This information was taken from the Quest Diagnostics hardcopy requisition for Maternal Serum Screening (MSAFP) revision date 3/2013. It should be noted that this revision breaks out questions that need to be responded to by the ordering provider at Order time. For more information, the requisition can be found at: https://login6.smartworks.com/Assets/MET_32CE0969-7EFF-4CD9-A0D1-A80870D1DC05/QD20330-NW_Proof.pdf

Also provided on the requisition are the AOE questions:

Because maternal serum screening test results are influenced by certain patient characteristics, the following data must be provided with the specimen, in order to permit accurate interpretation of the results. The questions that are always asked are:29

Date of Birth Collection Date Maternal Weight Estimated Date of Delivery (EDD) How was the EDD determined: Ultrasound, Last Menstrual Period (LMP) or Physical Exam Mother’s Ethnic Origin: African American, Asian, Caucasian, Hispanic, and Other Number of Fetuses: One, two, or more When more how many:

Yes/No questions: Patient is an insulin-dependent diabetic prior to pregnancy This is a repeat specimen for this pregnancy Previous Pregnancy with Down Syndrome

Yes/No Questions requiring more information if Yes History of Neural tube defect – If yes explain Pregnancy is from a donor egg – Age of donor at time of egg retrieval:

Request for other relevant clinical information

29Refer to Appendix A for additional information on AOE/LOINC mapping

Through an initiative

within the S&I

Framework, there is an

effort to standardize the

LOINC codes for AOEs.

Additional questions for the first trimester are:

Ultrasound Date Ultrasonographer’s name: NTQR or FMF Ultrasonographer’s ID# Location ID# Reading Physician ID# Crown Rump Length (CRL) Nuchal translucency (NT) Nasal Bone: Present, Absent, Not Assessed If twin gestation, are the twins: Dichorionic, Monochorionic Twin B Crown Rump Length (CRL) Twin B Nuchal Translucency (NT) Twin B Nasal Bone: Present, Absent, Not Assessed

Construction of the Electronic Ask at Order Entry components

This construction takes on a slightly different process; instead of clicking boxes or filling in data above a blank line, the EHR must guide the ordering provider through the process. The EHR system provides navigation tools; i.e., answer drop-down choices, system auto population of the answers, etc.The collection date should be captured in the designated HL7 fields. The SPM segment field 17 is the Specimen Collection Date. Patient Date of Birth is messaged in the PID segment in field 7 Date/Time of Birth. These fields are critical because without the DOB and the collection date a test cannot be reported with the appropriate reference range. The remaining data on the hardcopy requisition are Ask at Order Entry questions. The best method for the data to be interchanged between an EHR and the performing laboratory are OBX segments trailing the OBR of the test in question.

The OBX segment contains the result field where the response to the AOE question will be placed. This is OBX-5, called Result Value. The structure of this field is derived from OBX-2, Value Type. Value Type is pulled from HL7 table 0125, which effectively defines the data types. This approach allows the response to be structured in a very deliberate way based on the selected data type. Historically, the Value Types used were typically Text Data (TX) or String Data (ST). This definition was used for cases including information that should have been formatted as date, timestamps, address, person, or other information. Through an initiative within the S&I Framework, there is an effort to standardize the LOINC codes for AOEs. In addition, this effort is attempting to structure further the AOEs by specifying the most appropriate data type for a given LOINC code in order for the content to be sent to the laboratory. As an example, Last Menstrual Period (LMP) would have a date data type to ensure a consistent structure for information transmission.


Example LOINC AOE Questions

LOINC Code

LOINC Long Name

Alias Name Data Type

Usage Note

11778-8 Delivery date estimated

Estimated due date

DT

11884-4 Gestational age Estimated


49051-6 Gestational age in weeks

Gestational age (weeks)


Delivery Date Estimated above in Figure 1-5, LOINC code 11778-8, must be sent as data type DT for Date. Data Types can be found prior to HL7 version 2.4 in chapter 2 and beginning in version 2.5 in chapter 2A. The DT data type is constructed in a unique fashion. The EHR will need to prompt for input of the data and then reformat it from what the user will be comfortable inputting to how electronically it will be sent. Refer to Figure 1-6 below.

Figure 1-6 – HL7 Component Table

SEQ LEN DT OPT TBL# COMPONENT NAME COMMENTS

8 Date

• Definition: Specifies the century and year with optional precision to month and day.

• Maximum Length: 8• As of v 2.3, the number of digits populated specifies the precision

using the format specification YYYY[MM[DD]]. Thus: - only the first four digits are used to specify a precision of “year” - the first six are used to specify a precision of “month” - the first eight are used to specify a precision of “day”

• Examples: - |19880704| - |199503|

• Prior to v 2.3, this data type was specified in the format YYYYMMDD. As of v 2.3 month and days are no longer required. By site-specific agreement, YYYYMMDD may be used where backward compatibility must be maintained. Taken from HL7 Version 2.5.1 Chapter 2A section 2.A.2131

30Is called HL7 Version 2.5.1 Implementation Guide: S&I Framework Laboratory Test Compendium Framework, Release 2 US Realm and can be found at: http://www.hl7.org/implement/standards/prod-uct_brief.cfm?product_id=151 31HL7 Version 2.5.1 is copyrighted. Quest Diagnostics is a Benefactor Member of HL7.

32The HL7 V3 Publishing Facilitators Guide is available only to HL7 members. It is embedded in ballot documents. In this case in the V3 September 2013 Ballot was used and can be found at: http://www.hl7.org/v3ballotarchive/v3ballot/html/welcome/environment/index.html and then the Guide is provided as a component of the ballot. The table of actors is found in Section D. Storybook Names as part of the Publishing Facilitators Guide near the end of the V3 ballot document, sub-section D.2 - D.5.33Quest Diagnostics Maternal Serum Quad Screen order code 30294 http://www.questdiagnostics.com/testcenter/TestDetail.action?ntc=30294

While the underlying standard suggests that Month and Day are optional, for this LOINC code it is required. Note that the format is Year, Month, and Day. In the United States, most users expect to enter dates in this format: Month/Day/Year.

For this paper, names and organizations are drawn from the HL7 V3 Publishing Facilitators guide.32 This guide provides a message that includes Ask at Order Entry (AOE) Observations, values that were created from lab testing and calculations based on input as AOEs, and the values from lab testing. Continuing the example of Maternal Serum Screening, Dr. Flem F. Flora ordered the Maternal Serum Alpha Feta-Protein Quad Screen for Eve E. Everywoman who is in her 2nd trimester of pregnancy. Eve E. Everywoman is an African-American with a calculated due date of March 20, 2015, is in her 16th week of pregnancy, and her current weight is 175 lbs. All of these data are observations by Dr. Flora, which she provided to her staff to add as AOEs to the lab order to be forwarded to Quest Diagnostics, the preferred lab for Eve’s medical insurance company. These different pieces of information, when inserted into the HL7 message, have several unique data types. However, this factor does not cause an issue of concern for Dr. Flora’s staff; the EHR prompts the user for the information and ensures the data is properly collected and reformatted in the HL7 message.

In the Directory of Service provided by Quest Diagnostics for the Quad Screen test 30294 there are several AOEs included as necessary when ordering this test. The EHR prompts for this information are shown in Figure 1-6, including how the information must be structured to meet the HL7 format. As noted previously, the Data Type(s) that determine the required format of the result is provided in the result record, which is the OBX-2. The value in this field determines the format for OBX-5, the component where the result is placed as outlined below in the table.

The Maternal Serum Quad Screen will be used as an example, Quest Diagnostics Order Code 30294.33 The complexity of the data being captured as results for the Ask at Order Entry questions creates the necessity of a variety of data types for the result.

Figure 1-6 – Maternal Serum Quad Screen

Result Entered by the staff

Sent in the HL7 message as an observation in OBX-5

OBX-2 Data Type(HL7 Data Type34)

LMP – Last Menstrual Period

10/4/2013 20131004 DT

EDD - Estimated delivery date

3/20/2013 20140320 DT

How EDD was calculated

LMP LMP ST

Number of fetuses

1 1 NM

First Pregnancy

Yes Y ID

Estimated Gestational Age

16 16 NM

Race* African/American

2058-6^ African/American^ CDCREC

CWE

Note: * The code for African/American 2058-6 is from the Vocabulary data set as noted in the footnote below.35

34HL7 Data types can be found in chapter 2a of the Version 2.x standards. In this case it is best to reference version 2.5.1 since this is the standard referenced by Meaningful Use. A copy of the standard can be found at: http://www.hl7.org/documentcenter/private/standards/V251/HL7-xml_v2.5.1_annotated.zip35The data set can be found at: http://www.cdc.gov/nchs/data/dvs/Race_Ethnicity_CodeSet.pdf

An example EHR screen for the Quad Screen might look like the following:

Figure 1-7 – EHR Screen Example

In many cases the EHR could provide drop down screens to allow the selection of the appropriate value.

The Future Direction of AOEs

Standardized AOEs, along with several other initiatives to standardize laboratory test ordering and resulting, will allow ordering providers to meet the federal initiatives of Meaningful Use. The standardization and consistent use of AOEs is being introduced in the eDOS IG release. There will continue to be discussion about the selection of standardized AOEs and the application of an applicable LOINC code.

Laboratory Community of Practice (LabCoP) has agreed to sponsor the standardization of AOEs in the future. Currently, the industry is anticipating decisions to be made by the LOINC Committee in 2014 to determine the process for LabCoP to interact with the Regenstrief Institute for the assignment of LOINC codes.


Appendix A — AOE

Because maternal serum screening test results are influenced by certain patient characteristics, the following data must be provided with the specimen in order to permit accurate interpretation of the results. The list of questions below includes appropriate LOINC codes used by Quest Diagnostics or other mapping instruction from the ONC S&I Framework eDOS AOE document.

• Date of Birth – send in PID-7 Patient Date of Birth• Collection Information

33882-2 Collection Time

49049-0 Collection time of Unspecified Specimen

SPM-17 (Specimen Collection Date/Time)(DR_1.1 [Range Start Date/Time])

19151-0 Specimen drawn [Date and time] of Serum or Plasma

SPM-17 (Specimen Collection Date/Time) (DR_1.1 [Range Start Date/Time])

• Maternal Weight – not specifically maternal

29463-7 Body weight NM MethodlessBe sure to populate the units in OBX-6.

3141-9 Body weight (measured) Patient weight (measured)


3142-7 Body weight (stated) Patient weight (stated)


• Estimated Date of Delivery (EDD) - How was the EDD determined:

� Ultrasound, Last Menstrual Period (LMP) or Physical Exam

11778-8 Delivery date Estimated Estimated due date

DT

34970-4 Ultrasound Date DT

8665-2 Date last menstrual period DT


• Mother’s Ethnic Origin: African American, Asian, Caucasian, Hispanic, Other

42784-9 Ethnic background Stated CWE PID-22 (Ethnic Group) value is provided for demographic, not clinical use. An AOE must be provided for those tests where Ethnic Group drives the interpretation of results. The value must be determined by the ordering provider and must be sent as an AOE OBX.More specific ethnicity values are available, but not limited to, those found in the CDCREC document if needed for AOE. (http://www.cdc.gov/nchs/data/dvs/Race_Ethnicity_CodeSet.pdf)

32624-9 Race CWE PID-10 (Race) value is provided for demographic, not clinical use. An AOE must be provided for those tests where Race drives the interpretation of results. The value must be determined by the ordering provider and must be sent as an AOE OBX.

More specific race values are available, but not limited to, those found in the CDCREC document if needed for AOE. (http://www.cdc.gov/nchs/data/dvs/Race_Ethnicity_CodeSet.pdf).

69490-1 Ethnicity OMB 1997 Ethnicity CWE Refer to LOINC for suggested answer list.

• Number of Fetuses: One, two, or more - When more how many:

11878-6 Number of Fetuses by US Number of Fetuses

NM ‘US’ is UltrasoundBe sure to populate the units in OBX-6.

42479-6 Fetal Narrative Study observation general, multiple fetuses US

ST


• Yes/No questions: - Patient is an insulin-dependent diabetic prior to pregnancy (**not pre-pregnancy)

44877-9 Insulin dependent diabetes mellitus [Presence]

Insulin dependent DM

CWE Y/N (HL7 Table 0136)

- This is a repeat specimen for this pregnancy - Previous Pregnancy with Down Syndrome

• Yes/No Questions requiring more information if Yes - History of Neural tube defect – If yes explain - Narrative of History of neural tube defect

53827-2 History of neural tube defect Qualitative

History of ONTD

CNE Y/N (HL7 Table 0136)

49053-2 History of neural tube defect Narrative

TX

• Pregnancy is from a donor egg – Age of donor at time of egg retrieval:

53948-6 Donated egg [Presence] Donor egg CWE Y/N (HL7 Table 0136)


Request for other relevant clinical information

Additional questions for the first trimester are:• Ultrasound Date

34970-4 Ultrasound Date DT

• Ultrasonographer’s name:

49088-8 Sonographer name XPN

• NTQR or FMF• Ultrasonographer’s ID#• Location ID#• Reading Physician ID#• Crown Rump Length (CRL)

11957-8 Fetal Crown Rump length US

Fetal Crown Rump length


• Nuchal translucency (NT)

12146-7 Fetal Nuchal fold thickness US

Nuchal translucency


• Nasal Bone: Present, Absent, Not Assessed• If twin gestation, are the twins: Dichorionic, Monochorionic• Twin B Crown Rump Length (CRL)• Twin B Nuchal Translucency (NT)• Twin B Nasal Bone: Present, Absent, Not Assessed


ACA Affordable Care Act

ACLA American Clinical Laboratory Association

ACO Accountable Care Organizations

ANSI American National Standards Institute

AOE Ask at Order Entry

CLIA Clinical Laboratory Improvement Amendments

CMS Centers for Medicare and Medicaid Services

CNE HL7 Data Type - Coded with no Exceptions

CRL Crown Rump Length

CWE HL7 Data Type – Coded with Exceptions

DOB Date of Birth

DOS Directory of Service

DR HL7 Data Type – Date/Time Range

DT HL7 Data Type -Date

EDD Estimated Date of Delivery

eDOS Electronic Directory of Service

EHR Electronic Health Record

FHL7 Fellow, Health Level Seven

FMF Fetal Medicine Foundation

HHS US Department of Health and Human Services

HIE Health Information Exchange

HIT Health Information Technology

HL7® Health Level Seven

IG Implementation Guide

IOM Institute of Medicine

LabCoP Lab Community of Practice

LMP Last Menstrual Period

LOI Laboratory Order Interface

LOINC® Logical Observation Identifiers Names and Codes

LRI Lab Result Interface

MT(ASCP) Medical Technologist (American Society for Clinical Pathology)

MU Meaningful Use

NT Nuchal translucency

NTQR Nuchal Translucency Quality Review

OBR HL7 Observation Request Segment

OBX HL7 Observation/Result Segment

OMB Office of Management and Budget

ONC Office of the National Coordinator (preferred abbreviation for ONCHIT - Office of the National Coordinator of Health Information Technology )

RELMA Regenstrief LOINC Mapping Assistant

S&I Standards and Interoperability (sponsored by the Office of National Coordinator)

SN HL7 Data Type – Structured Numeric

SPM HL7 Specimen Segment

US United States

Appendix B - Acronyms

quest diagnostics -- ask at order entry insight 20140707

Documents

co chair of hl7s technical

quest diagnostics health

cochair of si frameworks

hl7 version

hl7 fellows

international hl7

loi work groups

loi ig work groups