Laboratory Reporting Over Direct
Background & Implementation Guidance
June 19, 2012
Background
• States and other implementation geographies have plans to utilize
Direct for reporting of laboratory results to meet Meaningful Use
requirements, especially for underserved communities
• The laboratory industry was not moving to adopt Direct for reporting
laboratory results (in particular, the “report of record”)
• Concerns were expressed regarding the impact of Direct on
laboratory accreditation
• Specific issues raised:
– CLIA regulations and guidance
– Reliability of Direct for laboratory reporting
– Operational issues related to Direct
– Security of Direct
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What is CLIA?
• Congress passed the Clinical Laboratory Improvement Amendments
(CLIA) in 1988 establishing quality standards for all laboratory testing to
ensure the accuracy, reliability and timeliness of patient test results
regardless of where the test was performed.
• The Centers for Medicare & Medicaid Services (CMS) regulates all
laboratory testing (except research) performed on humans in the U.S.
through the Clinical Laboratory Improvement Amendments (CLIA). In
total, CLIA covers approximately 225,000 laboratory entities. The
Division of Laboratory Services, within the Survey and Certification
Group, under the Office of Clinical Standards and Quality (OCSQ) has
the responsibility for implementing the CLIA Program.
• Exempt states – New York, Washington
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Clinical Laboratory Demographics
Division of Laboratory Services -- June 2011
Enrollment
Laboratories Registered
Number of Labs
Number of POLs
225,746
114,461
CLIA Exempt States
Number of Labs
New York
3,336
Washington
3,466
Accreditation Organization
Number of Labs
COLA
6,623
College of American Pathologists
5,602
The Joint Commission
2,431
American Osteopathic Association
110
AABB
219
American Society for Histocompatibility and Immunogenetics
124
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Why is CLIA an issue?
• Sec. §493.1291 Standard: Test report
– The laboratory must have adequate manual or electronic systems in
place to ensure test results and other patient-specific data are
accurately and reliably sent from the point of data entry (whether
interfaced or entered manually) to final report destination, in a timely
manner.
– Test results must be released only to authorized persons and, if
applicable, the individual responsible for using the test results and the
laboratory that initially requested the test.
• Sec. §493.1299 Standard: Postanalytic systems assessment
– The laboratory must establish and follow written policies and procedures
for an ongoing mechanism to monitor, assess and, when indicated,
correct problems identified in the postanalytic systems specified in Sec.
493.1291.
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Direct – Laboratory Reporting Workgroup
• ONC formed a workgroup including labs, accrediting agencies,
and CLIA
– Chairs: Bob Dieterle, John Hall
– Members include: ONC, LabCorp, Quest, Methodist Hospital, Pathology
Inc., College of American Pathologists (CAP), CLIA
• Charge:
1.
Identify any regulatory and operational issues with Direct that prevent
or limit adoption by clinical laboratories for transmitting the “Report of
Record” to the Final Report Destination
2.
Identify mitigation strategies for each of the issues
3.
For regulatory issues, work with ONC and CMS/CLIA to ensure that,
where appropriate, guidance is issued to accrediting agencies to enable
the use of Direct for lab reporting
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Direct – Laboratory Reporting Workgroup
In Scope / Out of Scope
• In Scope
– Use of Direct messaging to deliver report images
• Comparison to FAX or remote teleprinter delivery today
– Use of Direct messaging to deliver laboratory information (test
orders and results) – specifically focused for Meaningful Use
Phase 1 on the structured data delivery of the “report of record”
• Comparison to current electronic interface approach today (for
example)
– HL7 MLLP over VPN
– HL7 via SOAP
• Out of Scope
– Any requirement that “raises the bar” when using Direct versus
the currently accepted equivalent electronic exchange method
– Interface certification/validation (e.g. visual verification) -- except
where the use of Direct creates new issues
– Reporting to patients
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Direct – Laboratory Reporting Workgroup
Effort Sequence and Timeline
•
•
•
•
Establish issues workgroup
Develop and agree on issues, if any
Review issues with ONC
ONC review of issues with CMS/CLIA
Phase 1
12 weeks
• Expand workgroup to address mitigation
• Develop “comprehensive” mitigation list
• Prioritize by specific metrics (time, cost,
impact)
• Review prioritized list with ONC and
create final list
• ONC review of mitigation approach with
CMS/CLIA
Phase 2
8-12 weeks
• Effort, Implement and Test
Pilot
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Direct – Laboratory Reporting Workgroup
Partial List of Definitions Used
Term
Authorized Person
Definition
Authorized person means an individual authorized
under State law to order tests and receive the report
of record
Agent
An individual or entity legally acting on behalf of the
authorized person to receive test results
Final Report Destination The authorized person or their designated agent
Report of Record
The Report of Record is the set of all preliminary,
partial, final and corrected reports delivered to the
Authorized Person or their Agent at the Final Report
Destination
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Laboratory Results Reporting Today
Phone
Letter mail
Courier Delivered
Laboratory
Fax
Lab report
Print Image
Physician
office
Remote Print
LIS or HIS system
HL7 over VPN or SOAP
EHR
HIE
All electronic methods provide some form of
positive or negative acknowledgement of receipt
Web Services
Terminal
or portal
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Electronic Laboratory Results Reporting via Direct
Multiple paths are possible depending on the specific implementation of Direct
Laboratory
HISP - A
SMTP /
MIME
SOAP/XD,
Other Edge
Protocols
Security Agent
E-Mail Server
HISP - B
Direct
(SMTP /
SMIME)
(Public
Internet)
Security Agent
E-Mail Server
SMTP/MIME,
SOAP/XD, Other
Edge Protocols
EHR
HL7 over VPN or
SOAP
Physician
office
LIS or HIS system
Web Services
HL7 over VPN or SOAP
HIE (Optional)
Terminal
or portal
Lab report
Print Image
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Direct – Laboratory Reporting Workgroup
Concerns with using Direct
• Timely and predictable acknowledgement of delivery success or failure
– Under CLIA, labs are responsible for delivering reports to the Final Report
Destination, and must know when report delivery has succeeded or failed
– Existing mechanisms for report delivery provide timely and predictable
acknowledgement of success and failures
• Direct Project’s Applicability Statement for Secure Health Transport
specification allows for acknowledgements of delivery success or
failure, but does not require them
– Security/Trust Agents (STAs), such as HISPs, that receive a Direct
Message MUST acknowledge successful receipt and trust verification of a
Message by sending a Message Disposition Notification (MDN) with a
processed disposition (i.e., a processed MDN)
– STAs / HISPs MAY issue other notifications under other conditions but are
not required to do so
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Lab Reporting Over Direct Subgroup
Subgroup of Direct Project’s Implementation Geographies Workgroup
formed to develop an implementation guide detailing how to implement
timely, predictable positive and negative acknowledgement of delivery
within a Direct context
•
Andre Hebert (Harris)
•
Lin Wan (OptumInsight)
•
Bob Dieterle (ONC)
•
•
Christine Phillips (Harris)
Paul Tuten (ONC, Direct Project
Implementation Geographies WG)
•
Greg Meyer (Cerner, Direct Project
Reference Implementation WG)
•
Roy Tharpe (Harris)
•
Seonho Kim (ApeniMED)
•
Vincent Lewis (GSI Health)
•
Joe Lamy (ONC)
•
John Hall (ONC, Direct Project)
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Implementation Guide for Destination
Delivery Notification in Direct
• Guide details how to implement timely, predictable
acknowledgement of positive or negative delivery within
a Direct context
• Requires HISPs to indicate successful or failed delivery
to destinations
• Guide details how to request destination delivery
notifications, what constitutes a delivery “success” or
“failed” notification, and the responsibilities of the
Sending and Receiving HISPs around these notifications
• Guide provides use cases that illustrate when and under
what circumstances “success” and “failed” notifications
could be sent
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Notification in a single HISP environment
(both parties using same HISP)
• In a single HISP environment, the HISP positively knows
when delivery to a destination (i.e., Receiver’s system or
inbox) has succeeded or failed
• Requirement: Must notify or indicate back to the
Sending system successful or failed delivery to the
destination
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Notification in a dual-HISP environment
(each party using a different HISP)
• The Sender and Receiver (e.g., lab and ordering
provider) may be using two different HISPs, a Sending
HISP and Receiving HISP
• The Sending HISP on its own cannot tell when delivery
to the destination (i.e., Receiver’s system or inbox) has
succeeded, so each of the HISPs – Receiving and
Sending – have certain requirements that must be met
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Notification requirements for Receiving
HISPs
1. Must provide destination delivery notification messages
upon request
2. Must notify Sending HISP upon successful delivery to a
destination by issuing a positive destination delivery
notification message (i.e., a “successful delivery”
message)
3. Must notify Sending HISP upon failure to deliver to a
destination by issuing a negative destination delivery
notification message (i.e., a “failed delivery” message)
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Notification requirements for Sending
HISPs
1.
Must request destination delivery notification messages from Receiving
HISP
2.
Must notify or indicate back to the Sending system of failure to deliver to
Receiving HISP
3.
Must notify or indicate back to the Sending system failed or successful
delivery to the destination based on any received positive or negative
destination delivery notification messages
4.
Must notify or indicate back to the Sending system failed delivery to the
destination if no processed MDN has been received from Receiving HISP
within a reasonable timeframe
5.
Must notify or indicate back to the Sending system failed delivery to the
destination if no destination delivery notification messages have been
received from Receiving HISP within a reasonable timeframe
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Destination Delivery Notification
Technical Details
•
Need for destination delivery notifications is indicated within the Message
Disposition Notification (MDN) request in the headers of the sent message
– MDN request is as specified in RFC 3798, Section 2.1
– MDN request contains a disposition notification options header per RFC 3798
Section 2.2
• Parameter named X-DIRECT-FINAL-DESTINATION-DELIVERY
• Importance set to optional to prevent failure notifications from mail user agents –
however, HISPs and Direct gateways MUST honor the request despite the setting of
optional
• Value set to true
•
Positive destination delivery notification (i.e., “success”)
– MDN disposition of dispatched
– MDN extension-field of X-DIRECT-FINAL-DESTINATION-DELIVERY
•
Negative destination delivery notification (i.e., “failure”)
– MDN with a disposition of failed
– Negative Delivery Status Notification (DSN)
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Lab Reporting Over Direct FAQ
1. What constitutes a “reasonable timeframe”?
A: In the context of lab reporting, a Sending HISP serving a lab
should wait for a destination delivery notification no longer than 1
hour before declaring the transmission a failure unless otherwise
specified within an SLA with the lab.
2. Beyond the Implementation Guide, are there any other
requirements that must be fulfilled in order to transmit lab
reports using Direct?
A: Yes. All STAs/HISPs must comply with Direct Project’s
Applicability Statement, and parties must continue to meet all their
responsibilities as applicable under HIPAA and CLIA and associated
guidance.
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Questions?
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