Transcript Laboratory Pilots/Deployment November 13, 2012 Participants Coordination of Effort • • • • • Production/Deployment Project Participants • Validation Suite • Vocabulary Group • Implementation Guide Updates • • LRI/LOI/eDOS Workgroups • Support Team • • • Allscripts (EHR) Athenahealth (EHR) Cerner (EHR/LIS/HIE) OPTUMInsight (HIE/EHR) RML.

Laboratory Pilots/Deployment
November 13, 2012
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Participants
Coordination of Effort
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Production/Deployment Project Participants
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Validation Suite
•
Vocabulary Group
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Implementation Guide Updates •
•
LRI/LOI/eDOS Workgroups
•
Support Team
•
•
•
Allscripts (EHR)
Athenahealth (EHR)
Cerner (EHR/LIS/HIE)
OPTUMInsight (HIE/EHR)
RML (LIS)
LabCorp (LIS)
Halfpenny Technologies (Integrator)
ARUP (LIS)
Epic (EHR)
2
Agenda
Updates on Laboratory Activity
1. eDos pilot status update
2. LOI Issues for comment
3. Cancel Testing
4. MU Stage 2
5. EHR Certification 2014
a)
b)
LRI “Test Report”
LRI Mapping of CLIA required information
6. Next Steps
3
eDOS Workgroup
Pilots – Updates
Patrick Loyd
LRI/LOI Regulatory Issues
Workgroup
Review of outstanding issues from LOI IG
– Confirmation of oral request for testing
– Facility information
– Additional Clinical Information
– Specimen type and SNOMED-CT
– Prior Results in profile supporting Prior Results Segment
Update on Add-on testing
Update on Cancel
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Confirmation of oral request for testing
The use of ORC-1/ORC-16 (with possible support in ORC-15/ORC-30) for
a non-executable follow-up to a verbal order (any need to review as long
as this is supported?)
MS:I don’t have the standards with me to know exactly what
ORC1 and 16 are, but see we did recommend 15 and 30 on
our spreadsheet. Also probably need an explanation of what
you mean by “non-executable follow-up”. That said, we are
most interested in the EHR supporting the business process
of capturing verbal orders and obtaining provider
authentication. We are content to let the technical IT experts
guide us on the best way to implement this in the HL7
standards.
Recommendation: support ORC.1/ORC.16/ORC.15 and where
necessary/appropriate ORC.30
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ORC Segment Elements
Segment
.Element
Description
Data
Type
ORC-1
Order Control
ID
ORC-15
Order Effective Date/Time
TS
ORC-16
Order Control Code Reason
CE
ORC-30
Enterer Authorization Mode
CWE
Usage Cardinality Value Set
R
[1..1]
HL70119
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Facility information
The use of ORC 21-23 (facility information) – is this just in support of
Public Health? The labs indicate that they would not use these fields, but
rely on the same information that is part of the client contract. (do we need
to push this or include it in the “Public Health” profile?)
MS: No, this is not related to public health at all and does not need to be in
the profile. We included those fields (assuming name and address of
facility) as the required information for compliance COULD be
transmitted in those fields rather than the others for the ordering
provider. For some clients, the information may be identical and either
set would be considered compliant. We are not trying to suggest that
one set should be used over the other and would expect the provider
information to be the most commonly used. We were only attempting to
acknowledge that the facility information could also be used to meet the
CLIA requirement.
Recommendation: Agree with recommendation to leave ORC 21-23
optional
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ORC Segment Elements
Segment
.Element
Description
Data
Type
Usage Cardinality Value Set
ORC-21
Ordering Facility
XON
O
ORC-22
Ordering Facility Address
XAD
O
ORC-23
Ordering Facility Phone Number
XTN
O
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Additional Clinical Information
Use of OBR-13 for relevant clinical information. Currently, this is used in HL7 2.7 and
beyond for fasting time (a change that was made at the request of ACLA and the CDC). I
questioned the appropriateness of support for both OBR-13 and ask at order (AOE)
questions. In general, labs currently request the information in AOE and we will be
instructing them to move to support for OBR-13 for this one purpose. What do you
think?
MS: After hearing the issues around OBR-13 and AOE questions previously, it did seem that AOR was
the best way to address the need today. Unfortunately, it is a generic option and I don’t believe
certification will assure an AOR will specifically collect LMP for Pap smear orders (correct me if I
am wrong). Certification will only verify that the AOR functionality works, is that right? Otherwise, I
don’t feel strongly about use of OBR-13 (which is also generic), especially given the precedent for
its now specific use to document fasting status. Ideally, the long term solution would be an actual
HL7 field specifically for last menstrual period that is expressly tied to the Pap smear test order
code. This solution will also allow for collection of more robust data to support queries for public
health, research and clinical decision support tools. But we’re a bit away from having that level of
test specific prompting in the IGs. Also want to note that for Pap smears, the requirement is for
LMP AND indication of whether the patient had a previous abnormal report, treatment, or
biopsy. Prompting for this prior history detail is essential to ensuring the quality of the cytology
testing for women’s health
Recommendation: use AOE for LMP, ok with OBR.13 for very specific sets of information (defined list
of specific codes) and appropriately documented in the LOI IG
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ORC Segment Elements
Segment
.Element
OBR-13
Description
Data
Type
Relevant Clinical Information – to CWE.
be used for times in associated
CRE
table (e.g. fasting time)
Usage Cardinality Value Set
RE
[0..1]
Created
Table
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Specimen type and SNOMED-CT
Use of SNOMED-CT for SPM-4 (question raised about coverage and use in identifying tube
type (e.g. additive) . There is an active conversation about constraining this element to
SNOMED-CT only and eliminating the use of the HL7 defined table (it appears that the
table it will be deprecated in future version of HL7). This restarted the conversation to
required SPM-5 thru SPM-10. Concern is with the ability of the office staff to appropriately
select entries for these fields and the ability of the labs to consume and utilize these
elements. One possibility is to have the vocabulary workgroup define an appropriate set of
selections for each field and make the lists generally available to EHR vendors. (what do
you think?)
MS: I hope we are not taking a step backward. I may not hold a popular opinion at CDC and while I
strongly support moving toward capturing the full SPM 4-10, I do not believe we are ready to ask for
providers to enter this highly granular structured information in the EHR. Even education will not be
adequate. They will need tools that are simple to use and which prompt for the details in a
standardized method. Such tools have yet to be innovated.
MS: I like the sound of your suggestion and having the vocabulary workgroup define selections
(assuming you mean for each SPM field), but we need to be sure it doesn’t create a conflict with
what has been developed by Riki’s group for this purpose. I am also unclear on the implications of
the problem with only using SPM-4 at the moment, which is current and common practice for most
labs. I probably need to see the current HL7 table for SPM-4. We would need to understand the
pros/cons of leaving the current HL7 table for SPM-4 in place until a complete restructuring is
available for release vs. removing the table now and creating some type of transitional set of tables,
which I think is the nature of your question.
Recommendation:SPM-4 as R and SPM 5-10 O with Public Health profile constraining SPM 5-10 as RE
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SPM Segment Elements
SegmentElement
Description
ELINCS
Usage
LOI IG
Crosswalk
Public Hlth
SPM-4
Specimen Type
R
R
R
SPM-5
Specimen Type Modifier
X
O
RE
SPM-6
Specimen Type Additives
X
O
RE
SPM-7
Specimen Collection Method
O
O
RE
SPM-8
Specimen Source Site
O
RE/O
RE
SPM-9
Specimen Source Site Modifier O
O
RE
SPM-10
Specimen Collection Site
O
RE
X
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Prior Test Results
The conversation regarding prior test results is still
ongoing. Currently, several members of the LOI IG
Workgroup believe that:
The OBX after the OBR should be reserved for ask at order questions
and any prior results should ether not be sent or, if sent, should be in
the currently unsupported (Optional) Prior Result Segment(s)
Suggest we clarify that when a “prior observation/result” is sent as part
of the ask at order question, it should have the date and time of the
testing that created the observation/result
Sugges that we only use the Prior Result Segment(s) when the original
HL7 R01 transaction OBX is being sent to the lab as part of the
order.
Recommendation:
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Cancel Testing
Proposed LOI and LRI IG Implications of Cancel scenarios below
Until specimen is received in laboratory ,
– provider may cancel test [LOI cancel transaction]
– Laboratory may cancel test if unable to obtain acceptable specimen (e.g.
patient did not show , unable to draw) [what is the correct transaction? LOI
status, LRI or LRI cancel]
Once laboratory has received requisition and specimen
– Provider may request cancel [LOI cancel transaction?]
– Laboratory may cancel if unable to perform test (e.g. unacceptable
specimen) [LOI status or LRI cancel]
Once any result has been reported to provider
– Provider may not request cancel
– Laboratory may not cancel once any report has been issued to the provider
(preliminary, partial, final, …). If there is a problem with completing the
testing (e.g. reflex, final, …) the appropriate comment is sent and provider is
called [LRI only]
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42 CFR Part 495 MU Stage 2 Final Rule
Stage 2 Core Criteria for Eligible Providers
(7)(i) Objective. Incorporate clinical lab test results into Certified EHR Technology as structured data.
(ii) Measure. Subject to paragraph (c) of this section, more than 55 percent of all clinical lab tests results
ordered by the EP during the EHR reporting period whose results are either in a positive/negative
affirmation or numerical format are incorporated in Certified EHR Technology as structured data.
Stage 2 Core Criteria for Eligible Hospitals or CAH
(6)(i) Objective. Incorporate clinical lab test results into Certified EHR Technology as structured data.
(ii) Measure. More than 55 percent of all clinical lab tests results ordered by authorized providers of the
eligible hospital or CAH for patients admitted to its inpatient or emergency department (POS 21 or 23)
during the EHR reporting period whose results are either in a positive/negative affirmation or numerical
format are incorporated in Certified EHR Technology as structured data.
Stage 2 Menu Set Criteria for Eligible Hospitals or CAH
(6)(i) Objective. Provide structured electronic lab results to ambulatory providers.
(ii) Measure. Hospital labs send structured electronic clinical lab results to the ordering provider for more
than 20 percent of electronic lab orders received.
11/7/2015
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Criteria for EHR Technology 2014
§ 170.102 Definitions.
Common MU Data Set means the following data expressed, where indicated, according to the specified standard(s):
…
(11) Laboratory test(s) – at a minimum, the version of the standard specified in § 170.207(c)(2).
(12) Laboratory value(s)/result(s).
…
§ 170.205 Content exchange standards and implementation specifications for exchanging electronic health
information.
(j) Electronic incorporation and transmission of lab results. Standard. HL7 Version 2.5.1 Implementation Guide:
S&I Framework Lab Results Interface, (incorporated by reference in § 170.299).
§ 170.207 Vocabulary standards for representing electronic health information.
(c) Laboratory tests.
(1) Standard. Logical Observation Identifiers Names and Codes (LOINC®) version 2.27, when such codes were
received within an electronic transaction from a laboratory (incorporated by reference in § 170.299).
(2) Standard. Logical Observation Identifiers Names and Codes (LOINC®) Database version 2.40, a universal code
system for identifying laboratory and clinical observations produced by the Regenstrief Institute, Inc. (incorporated by
reference in § 170.299).
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Certification Criteria for EHR Technology 2014
Criteria for EHR Technology 2014
§ 170.299 Incorporation by reference.
(f) Health Level Seven, 3300 Washtenaw Avenue, Suite 227, Ann Arbor, MI 48104; Telephone
(734) 677–7777 or http://www.hl7.org/
(10) HL7 Version 2.5.1 Implementation Guide: S&I Framework Lab Results Interface, Release
1 - US Realm [HL7 Version 2.5.1: ORU^R01] Draft Standard for Trial Use, July 2012, IBR
approved for § 170.205.
(l) Regenstrief Institute, Inc., LOINC® c/o Medical Informatics The Regenstrief Institute, Inc 410
West 10th Street, Suite 2000 Indianapolis, IN 46202-3012; Telephone (317) http://loinc.org/.
Logical Observation Identifiers Names and Codes (LOINC®) version 2.27, June 15, 2009, IBR
approved for § 170.207.
(2) Logical Observation Identifiers Names and Codes (LOINC®) Database version 2.40,
Released June 2012, IBR approved for § 170.207.
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Certification Criteria for EHR Technology 2014
Criteria for EHR Technology 2014
170.314(b)(5) Incorporate laboratory tests and values/results.
(i) Receive results.
(A) Ambulatory setting only.
(1) Electronically receive and incorporate clinical laboratory tests and
values/results in accordance with the standard specified in § 170.205(j) and, at a
minimum, the version of the standard specified in § 170.207(c)(2).
(2) Electronically display the tests and values/results received in human
readable format.
(B) Inpatient setting only. Electronically receive clinical laboratory tests and
values/results in a structured format and electronically display such tests and
values/results in human readable format.
(ii) Electronically display all the information for a test report specified at 42 CFR
493.1291(c)(1) through (7).
(iii) Electronically attribute, associate, or link a laboratory test and value/result with a
laboratory order or patient record.
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Certification Criteria for EHR Technology 2014
Criteria for EHR Technology 2014
§ 170.314 2014 Edition electronic health record certification
criteria.
(6) Inpatient setting only – transmission of electronic laboratory tests and
values/results to ambulatory providers. EHR technology must be able to
electronically create laboratory test reports for electronic transmission in
accordance with the standard specified in § 170.205(j) and with laboratory
tests expressed in accordance with, at a minimum, the version of the standard
specified in § 170.207(c)(2).
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Description of Laboratory Test Report for EHR Certification
(see attached document for final form)
When testing compliance with the 2014 Edition electronic health record certification criterion, adopted at 45 CFR
§170.314(b)(5), EHR technology is required at §170.314(b)(5)(ii) to display the data elements that include, as a
minimum, the information specified in §170.314(b)(5)(ii) [42 CFR 493.1291(c)(1)-(7)].
For the purposes of paragraph 170.314(b)(5)(ii), a laboratory “test report” is meant to comprise all of the data
elements specified at 42 CFR 493.1291(c)(1)-(7). Such data is meant to be concurrently displayed in their entirety by
the EHR technology under test and the content must be presented in a human readable format.
When all of the required data elements cannot be concurrently displayed in their entirety (for example, due to
complexity or IT limitations), additional electronic display screens are permitted. When multi-page electronic display
screens are utilized, they should follow these characteristics:
•
Identify individual electronic display screens unambiguously as part of the same report and as belonging to the
specific patient
•
Indicate on each electronic display screen the continuation of the report on additional display screens
•
Provide additional information with ideally no more than two motions for electronic displays, e.g., hover, click,
scroll, pan, zoom
Other presentations of laboratory information may be present in the EHR technology such as a flow sheet or summary
reports.
Health Information Technology: Standards, Implementation Specifications, and Certification Criteria for
Electronic Health Record Technology, 2014 Edition [45 CFR 170.314(b)]
Clinical Laboratory Improvement Amendments of 1988 [42 CFR 493.1291]
Human readable format means a format that enables a human to read and easily comprehend the information
presented to him or her regardless of the method of presentation. [45 CFR 170.102]
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Required Elements (1 of 3)
Description of CLIA required elements for EHR Technology Certification
When testing compliance with the 2014 Edition electronic health record certification criterion, adopted at
45 CFR §170.314(b)(5), EHR technology is required at §170.314(b)(5)(ii) to display the data
elements that include, as a minimum, the information specified in §170.314(b)(5)(ii) [42 CFR
493.1291(c)(1)-(7)].
For the purposes of paragraph 170.314(b)(5)(ii), the data elements specified at 42 CFR 493.1291(c)(1)(7) should be:
1. 42 CFR 493.1291(c)(1) “For positive patient identification, either the patient's name and identification
number, or a unique patient identifier and identification number.”
– Patient name that includes when available the patient’s legal name consisting of a first name,
middle name or initials, and the last name [PID-5]
– Unique patient Identification number assigned by the facility (may be used when the patient
name is not available) and the unique identification number for the order [PID-3] which may
contain either numbers or letters or both
– If the laboratory test and value/result have been successfully and unambiguously linked, to a
patient record as required by §170.314(b)(5)(iii), then the patient name, unique patient
identifier and identification number displayed may be from the EHR patient record.
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Required Elements (2 of 3)
2.
3.
4.
5.
42 CFR 493.1291(c)(2) “The name and address of the laboratory location where the test was
performed.”
– The actual name of the laboratory as indicated on the CLIA certificate [OBX-23]
– The actual physical location of the laboratory facility or location within the facility (including
room, suite, floor as applicable) where testing is performed, as indicated on the CLIA
certificate [OBX-24].
42 CFR 493.1291(c)(3) “The test report date.”
– The date (e.g. mm/dd/yyyy) the test report/status change was finalized by the laboratory
[OBR-22].
42 CFR 493.1291(c)(4) “The test performed.”
– The specific name of the test/analyte that is assigned by the laboratory [OBX-3]. A coded
value received from the laboratory may be translated in the EHR to an equivalent test
description prior to display.
42 CFR 493.1291(c)(5) “Specimen source, when appropriate.”
– The type of specimen submitted for testing and/or the collection site/method of collection as
applicable [SPM-4]. The coded values received from the laboratory may be translated in the
EHR to an equivalent description prior to display.
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Required Elements (3 of 3)
6.
7.
42 CFR 493.1291(c)(6) “The test result and, if applicable, the units of measurement or interpretation,
or both.”
– The corresponding test result, and interpretation (where available) for the requested analyte/test in
numeric or text format [OBX-5].
– Where available, the corresponding units of measure for the requested analyte/test identified and
used by the laboratory [OBX-6]
– Where available, the laboratory's interpretation communicated by defined text/symbols indicating test
results that do not fall within the established reference/normal range [OBX-8]. The coded values
received from the laboratory may be translated in the EHR to an equivalent description prior to display.
– The laboratory's additional, miscellaneous notes, comments, interpretations regarding the
test/analyte/report [NTE-3].
42 CFR 493.1291(c)(7) “Any information regarding the condition and disposition of specimens that do
not meet the laboratory's criteria for acceptability.”
– When available, the laboratory's defined comment(s) denoting specimen suitability or not for testing
[any of OBX-5/NTE-3/SPM-21]. The coded values received from the laboratory may be translated in
the EHR to an equivalent description prior to display.
– When available, the laboratory's comment(s) denoting the condition of the specimen (hemolysis,
lipemia, icterus, clotted, etc.) [any of OBX-5/NTE-3/SPM-24]. The coded values received from the
laboratory may be translated in the EHR to an equivalent description prior to display.
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Best Practice Elements (1 of 2)
While the following data elements do not have specific certification criteria for display as part of the test
report, best practice requires each to be included in the test report when the data element is available.
1.
2.
3.
4.
Date of Birth or Age
– Date of Birth (or Age) should be displayed in either date/time format or in numeric with units (e.g.
15 years) [PID-7]
Gender
– Administrative Gender should be displayed as either the coded value (e.g. M, F, …) or an
appropriate translation (e.g. Female, Male,…) [PID-8]
Laboratory Director
– The name of the Laboratory Director as recorded on the CLIA certificate [OBX-25].
Test report time
– The time (e.g. hh/mm) the test report/status change was finalized by the laboratory [OBR-22].
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Best Practice Elements (2 of 2)
5.
6.
7.
Specimen Date/Time or Collection Date/Time
– The date (e.g. mm/dd/yyyy) and time (e.g. hh/mm) when the specimen to be tested was
obtained from the patient [OBR-7]
Reference Range
– The “reference intervals” or “normal” values that are determined by the laboratory and
correspond to the particular test/analyte result [OBX-7]
Result/Report Status
– The laboratory's status of the test result/report (preliminary, partial, final, corrected, etc.)
[OBX-11/OBR-25]. The coded values received from the laboratory may be translated in the
EHR to an equivalent description prior to display.
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Next Steps / Questions
•
Next Steps
• Convert any pilot efforts to production code for standard release and support
•
Schedule
• Calls for coordination every other week at same time next call 11/27 at 2pm Eastern
• Continue participation in LOI
•
For questions, please feel free to contact
• Bob Dieterle: [email protected]
• Patrick Loyd: [email protected]
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“Parking Lot Issues”
• Standardization of methodology or normalization of results and
normal ranges
– E.g. PSA normal is 0-4 for both methodologies
– 8 methods for hgb what is variability for normal ranges
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