MICHIGAN HEALTH INFORMATION NETWORK SHARED SERVICES
SUBMIT NEWBORN SCREENING - CRITICAL CONGENITAL HEART DEFECTS
(CCHD) (PULSE – OXIMETRY) USE CASE AGREEMENT
Approve Date: 05/20/14
Effective Date:
Change Control
Version
Number
1
2
3
Revision
Date
10/11/13
2/18/14
03/06/14
4
05/01/14
5
Author(s)
Section(s)
Doty
Scott
Doty/Zimbelman
2,3,4,5, 10
5.2
4, 8.4
06/03/14
MOAC Use
Case Working
Group
Fontaine
6
07/08/14
Fontaine
Approve
Date,
intro, 8.4
footnote
7
10/28/14
Mannino
9.1.3
10.1
Summary
Approve
Date
Effective
Date
Initial Draft
Title and updates
General edits- updates/
Additional Permissible Use/
file name
Remove Specialized
Registry language. Add
HIPAA language.
Added the implementation
guide and changed wording
Added approve date from
MOAC UC WG May
meeting minutes. Changed
PO definition. Added
SSSOA to footnote.
Changed ‘may’ to ‘shall’
This Use Case Agreement (“Use Case”) is one of several Use Cases and is effective and binding
upon the undersigned Participating Organization (“Participating Organization”), and subject to
the Qualified Data Sharing Organization Agreement /Virtual Qualified Data Sharing
Organization Agreement/Consumer Qualified Data Sharing Agreement/Sponsored Shared
Organization Agreement/State Sponsored Sharing Organization Agreement (the “Agreement”)
between the Participating Organization and the Michigan Health Information Network Shared
Services (“HIN”), as of the last date in the signature block hereto. HIN and Participating
Organization are referred to herein collectively as “Parties” and individually as a “Party.”
1.
GOAL. HIN desires to assist participants of Participating Organization to meet
Meaningful Use requirements for a Specialized Registry by electronically communicating with a
public health agency1 on a Transactional Basis, as defined below.
2.
PURPOSE. The purpose of this Use Case is to set forth the requirements for
Participating Organization to use HIN to submit Newborn Screening for Critical Congenital
Heart Defects (CCHD) Data through the Michigan Department of Community Health Data Hub
(“MDCH”) to the Michigan Newborn Screening Registry (the “Platform”).
The Health Information Technology for Economic and Clinical Health Act (“HITECH Act”), created by the
American Recovery and Reinvestment Act of 2009, requires that eligible hospitals and eligible professionals be
“meaningful
EHR
users”
to
receive
incentive
funding.
See
generally
https://www.cms.gov/ehrincentiveprograms/30_Meaningful_Use.asp.
1
MiHIN Confidential
USE CASE DIAGRAM.2
3.
Newborn
CCHD
Message
Participating
Organization
Notice
Newborn
CCHD
Message
HIN
Notice
Newborn
CCHD
Message
Notice
MDCH
Data Hub
Newborn
CCHD
Message
Notice
Platform
participant
Source System
This use case is responsible for collecting the Newborn Screening for Critical Congenital Heart
Defects (CCHD) data as specified by the Platform. The Platform will issue an acknowledgment
or rejection notice back to the participant Source System if available.
The newborn screening mandate in Michigan Public Health code section 333.5431 requires
hospitals to screen the newborn babies for, among other things, critical congenital heart defects
(CCHD) and report the CCHD test results to MDCH.
Congenital heart defects are the most common of birth defects, affecting nine in 1,000 newborns.
The most severe type is called critical congenital heart disease, requires surgery or catheter
intervention in the first year of life. CCHD remains one of the most significant causes of infant
death in the United States. A simple non-invasive test called pulse oximetry helps detect CCHD
in newborns. Failure to detect CCHD early puts the baby at risk for death or other serious
complications within the first few days or weeks of life, often requiring emergency room care.
4.
DEFINITIONS.
4.1
Critical Congenital Heart Defects (CCHD) means a severe type of defect that
requires surgery or catheter intervention in the first year of life.
4.2
Message means a mechanism for exchanging Message Content, as defined
below, between Participants through HIN, including query, retrieve, and submit.
4.3
Message Content means information which is requested, received or sent by a
Participant through HIN, including PHI, de-identified data, pseudonymized data, metadata,
Digital Credentials and data schema.
4.5
Network Downtime means a Party is unable to transmit and receive data from
the Internet for any reason, including but not limited to the failure of network equipment or
software, scheduled or unscheduled maintenance, general Internet outages, and events of force
majeure.
2
The bidirectional communications reflected in the Use Case diagram include the transmission of
acknowledgements from the State of Michigan to HIN. HIN may, depending on the capabilities of a particular
Participating Organization, further pass on such acknowledgements to such organization. The transmission of error
messages from the Participating Organization to the Source System is optional.
MiHIN Confidential
4.6
Newborn Screening means screening for conditions such as newborn screening
tests to detect critical congenital heart disease (CCHD) in newborns. The newborn screening is
not limited to this test.
See the implementation guide for specific directions at
https://www.michiganhealthit.org/public-health/birth-defects-registry/.
4.7
Notice means a message transmission that is not Message Content and which
may include but not be limited to an acknowledgement of receipt or error response.
4.8
Transactional Basis means, on a per transaction basis, the transmission of
Message Content or a Notice within twenty (20) seconds of delivery or receipt of Message
Content or Notice from a sending or receiving party.
4.9
Source System means the computer system, typically and electronic health
record system, at the Participating Organization, that generates the Message Content or Notice.
5.
MESSAGE CONTENT. The Platform “Message Content”, as defined below,
submitted pursuant to this Use Case may be used as follows:
5.1
Primary Use. The Message Content and related Notices will be used for
reporting to the Platform consistent with the requirements set forth by Michigan statute and the
MDCH Administrative Rules3 (collectively, the “Platform Requirements”), as may be amended
from time to time, for reporting Electronic Reportable Conditions data.
5.2
Additional Permissible Use. The Parties may make additional use of the
Message Content, provided that such additional use is consistent with Applicable Laws and
Standards, as defined in Section 1.1 of the Data Sharing Agreement, including, without
limitation, the Platform Requirements, to the extent such requirements are applicable to a Party.
5.3
Additional Terms. The Parties may use the Platform Message Content
consistent with the terms herein and as otherwise permitted by the Data Sharing Agreement,
provided, however, that in no case shall Participating Organization share Message Content in a
manner inconsistent with this Use Case, as applicable. To the extent there is an express
conflict between the terms herein and the Data Sharing Agreements, the Data Sharing
Agreements, as applicable, shall prevail.
6.
FEES.
HIN shall not charge Participating Organization fees for the initial term of the Agreement for
submitting Platform Message Content into the Platform. This Use Case does not commit
Participating Organization to pay any future fees to HIN beyond the initial term of the
Agreement for submitting Platform Message Content into the Platform and if HIN implements a
fee schedule for this Use Case, Participating Organization may opt, in its sole discretion, to
withdraw from this Use Case in accordance with the terms of the Data Sharing Agreement.
3
See
Mich.
Admin.
Code
R.
R
333.5431
http://www.michigan.gov/documents/mdch/1987_PA_14_332815_7.pdf
MiHIN Confidential
et
seq.,
available
at
7.
SERVICE LEVEL. The Parties desire that the Message Content and Notice exchange
between Participating Organization, HIN and MDCH meet the service levels set forth below:
7.1
Timeliness of Exchange. The Parties desire that the Message Content and
Notice exchange occur on a Transactional Basis.
7.2
Network Downtime. Notwithstanding Sections 4.5, 4.8 and 7.1, if the Parties
experience a Network Downtime, Message Content and Notices queued during the Network
Downtime shall be retransmitted as soon as practicable.
8.
AUDITING.
8.1
Abilities to Audit. The Parties shall monitor and audit all access to and use of
its system related to this Use Case, for system administration, security, and other legitimate
purposes consistent with each Party’s standard operating procedures.
8.2
Audit Logs.
8.2.1 Participating Organization. Participating Organization shall, at a
minimum, log the following information: (i) date and time Message Content was accessed and
identity (e.g., unique identifier) of individual or system, as applicable, accessing the Message
Content to the extent such information is available to the Participating Organization; (ii) date and
time Message Content was transmitted through the Participating Organization Platform and
identity of individual or system, as applicable, transmitting the Message Content; (iii) date and
time a Notice was sent or received from or to HIN; (iv) the unique message identifier for the
Message Content accessed, sent, or received; (v) the Message Content accessed to the extent
such information is available to the Participating Organization; and (vi) any Notices, failures, or
network events.
8.2.2 HIN. With respect to its obligations as a business associate, if applicable,
HIN shall, at a minimum, log the following information: (i) date and time Message Content was
transmitted through the HIE Platform, and identity of individual or system, as applicable,
transmitting Message Content; (ii) destination of Message Content; (iii) name of Participating
Organization and/or participant accessing the HIE Platform; (iv) identity (e.g., unique identifier)
of individual or system, if applicable and available, accessing the Message Content; (v) the date
and time the access occurred; (vi) if technically possible, the Message Content accessed; (vii) if
technically possible, a description of Message Content accessed and, if necessary to comply with
Applicable Laws and Standards and, specific Message Content fields accessed; (vii) the source
IP address of the Message Content request; (viii) designation IP address of the Message Content
request; and (ix) any Notices, failures, or network events. Except as provided in the foregoing,
HIN shall not be obligated to maintain and shall not be responsible for, either maintaining records of
the content of any Message exchange between the Parties or inspecting the content of such Messages.
8.3
Production of Audit Logs. Upon a good faith written request by a Party, the
non-requesting Party shall produce the requested audit logs within five (5) days from the date of
the request to the requesting Party or a detailed written explanation of why the requested logs
cannot be produced.
MiHIN Confidential
8.4
Retention of Audit Logs. The Parties shall retain audit logs in accordance with
any and all requirements set forth in Applicable Laws and Standards4, including but not limited
to the requirements under the Health Insurance Portability and Accountability Act of 1996,
Public Law 104-191, and regulations at 45 CFR Part 160, Part 162, and Part 164, the Michigan
Public Health Code, MCL 333.1101 et seq., the Data Sharing Agreement, and as otherwise
necessary to comply with this Use Case.
9.
RESPONSIBILITIES OF THE PARTIES.
9.1
Participating Organization’s Responsibilities.
9.1.1 Participating Organization shall transmit to HIN the Message Content and
Notices on a Transactional Basis.
9.1.2 Participating Organization shall retransmit, or make provisions to have
retransmitted, Notices and/or Message Content to HIN, which (i) Participating Organization
failed to deliver to HIN, or (ii) HIN failed to deliver to MDCH, upon Participating Organization
receiving a failure delivery Notice from HIN so long as HIN does not send such failure delivery
notice after having first acknowledged and accepted with no errors the message from
Participating Organization.
9.1.3 Participating Organization shall, on a Transactional Basis, transmit any
Notices received from HIN to the Participating Organization participant that submitted the
Message Content, as necessary (e.g., transmitting an acknowledgment of submission received
from HIN), if such capabilities are supported by and enabled on Participating Organization’s
system as well as the Participating Organization participant’s systems. The specifications for the
Notices and/or Message Content are set forth for this Use Case on the HIN web site.
9.1.4 Participating Organization shall transmit data to HIN only from
Participating Organization participants that have been authenticated by MDCH.
9.1.5 Participating Organization shall validate the Message Content Header
(MSH) to ensure that the message is properly addressed with both sender and receiving facility
and application (MSH-3, MSH-4, MSH-5 and MSH-6) and that there is a valid HL7 version
(MSH12). Refer to Implementation Guide when published.
9.1.6 Participating Organization’s shall transmit data to HIN only from
organizations that have agreed to participate in this Use Case Agreement.
9.1.7 Notice of unauthorized receipt. In the event Participating Organization
sends or receives Message Content for which Participating Organization is not authorized to send
or receive, Participating Organization will immediately inform HIN, delete such Message
Content, and require its Participant Users to do so.
9.1.8 Participating Organizations shall work with HIN to schedule and
coordinate any changes to the production systems or networks involved in Message sending,
4
“Applicable Laws and Standards” is a defined term in the QDSOA, VQDSOA, CQDSOA, SSOA and SSSOA.
MiHIN Confidential
filtering, translating, or forwarding activities so as to ensure the reliability and availability of the
production environments.
9.2
HIN’s Responsibilities.
9.2.1 HIN shall transmit to MDCH all Message Content and Notices on a
Transactional Basis.
9.2.2 HIN shall transmit to Participating Organization all Notices on a
Transactional Basis.
9.2.3
HIN shall be responsible for protecting Message Content.
9.2.4 HIN shall work with Participating Organizations to schedule and
coordinate any changes to the production systems or networks involved in Message sending,
filtering, translating, forwarding or receiving activities so as to ensure the reliability and
availability of the production environments.
10.
OTHER TERMS.
10.1
Data Format, Validation and Transmission Specifications.
10.1.1 The Message Content submitted into the HIE Platform must meet the HL7
2.5.1 Specifications for the implementation guide called the Newborn Screening for Critical
Congenital
Heart
Disease
(CCHD)
Using
Pulse
Oximetry
found
at
https://www.michiganhealthit.org/wp-content/uploads/MDCH-Newborn-Screening-CCHD-IGv0_9_1.pdf (the “Platform Conforming Message”) set forth for this Use Case on the HIN web
site and all Message Content submitted to HIN shall meet these specifications.
10.1.2 Disclaimers.
(a)
Participating Organization shall bear sole responsibility for
ensuring that the Confirming Message meets the data integrity, format, security, and timeliness
standards prescribed by the MDCH as set forth in Sections 9.1 and 10.1 above.
[Signature Page Follows]
MiHIN Confidential
IN WITNESS WHEREOF, the undersigned have caused this Use Case to be accepted by
their duly authorized representatives effective on the date written below, whichever is later.
MICHIGAN HEALTH INFORMATION
NETWORK SHARED SERVICES
PARTICIPATING ORGANIZATION
Organization Name
By:
By:
Name:
Name:
Title:
Title:
Date:
Date:
MiHIN Confidential