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This scope gathers the assertion including in the 2016 cycle for Conformity Assessment Testing

402 Assertions in Scope

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Id scheme
Assertion id
DEC-Vol1DEC-Vol1-001Each actor implementing this Patient Care Device (PCD) profile shall be grouped with the IT Infrastructure Consistent Time profile Time Client Actor for the purpose of consistent time-stamping of messages and data
DEC-Vol2DEC-Vol2-001The Communicate PCD Data [PCD-01] transaction references the following chapters from the HL7 Version 2.6 standard: Chapter 7 Observation Reporting
DEC-Vol2DEC-Vol2-002The Communicate PCD Data [PCD-01] transaction references the IEEE 11073-10201 Domain Information Model standard
DEC-Vol2DEC-Vol2-003The Communicate PCD Data [PCD-01] transaction references the IEEE 11073-10101a Nomenclature standard
DEC-Vol2DEC-Vol2-004The static definition for the PCD-01 Communicate PCD Data message is defined in the unnamed table in this section of the doument
DEC-Vol2DEC-Vol2-005The PCD-01 message structure differs from the basic HL7 version 2.6 by allowing for the appearance of PRT segments, a segment new in HL7 version 2.7, in certain locations.
DEC-Vol2DEC-Vol2-006The period for periodic reporting shall be several times a minute for high acuity reports and maximum interval of once every 24 hours, with a typical interval of 1 minute.
DEC-Vol2DEC-Vol2-007Upon receipt of a PCD-01 message the DOC actor validates the message and shall respond with an acccept acknowledgement message as defined in Appendix G.11 Acknowledgement Modes.
DEC-Vol2DEC-Vol2-008For PCD-01 messages MSH-9 Message Type shall contain ORU^R01^ORU_R01.
DEC-Vol2DEC-Vol2-009Device to Enterprise Communications PCD-01 Communicate PCD Data message (also used for observations in response to a PCD-02 PCD Data Query) shall contain in MSH-21 Message Profile Identifier the value
DEC-Vol2DEC-Vol2-010For PCD-01 messages the ORC segment use is X, i.e. not sent.
DEC-Vol2DEC-Vol2-011Pulse Oximetry Integration (POI) device observations shall include an observation of oxygen saturation of blood gas as a percentage numeric data type. Given the variety of available device designs (dedicated function SPO2 monitor or modular component to a physiologic monitor), the variety of sensor capabilities, and that the observation identification can include the sense point body part, i.e. left/right arm, etc. there is no single observation definition for all devices and all use cases. Any communicated SPO2 observation shall appear in RTMMS. A non-exclusive example is 150456^MDC_PULS_OXIM_SAT_O2^MDC.
ITI10ITI10-001The Patient Identifier Cross-reference Manager shall notify a Patient Identifier Cross-reference Consumer when there is a change in a set of cross-referenced patient identifiers for any of the patient identifiers belonging to Patient Identifier Domains of interest to the consumer.
ITI10ITI10-003The information provided by the Patient Identifier Cross-reference Manager to Patient Identifier Cross-reference Consumers shall only contain a list of cross-referenced identifiers for the domains of interest as configured with the Patient Identifier Cross-reference Manager in two or more of the domains managed by the Patient Identifier Cross-reference Manager.
ITI10ITI10-008The Patient Identifier Cross-reference Manager configuration is expected to have configuration indicating which Consumers are interested in receiving the PIX Update Notification transactions. This configuration information shall include identification of the identity consumer systems interested in receiving notifications and, for each of those systems, a list of the patient identifier domains of interest.
ITI10ITI10-011Each ITI-10 message shall be acknowledged by the HL7 ACK message sent by the receiver of ADT message to its sender. Acknowledgement shall respect ITI TF-2x C.2.3.
ITI10ITI10-014The Patient Identifier Cross-reference Manager Actor shall provide only those attributes within the PID segment that are required by the HL7 standard: PID-3-Patient Identifier List and PID-5-Patient Name.
ITI10ITI10-015The Patient Identifier Cross-reference Manager Actor shall use the field PID-3 Patient Identifier List to convey the Patient IDs uniquely identifying the patient within each Patient Identification Domain for which a Patient ID exists for the specified patient. Each resulting ID returned in PID-3 shall include a fully qualified Assigning Authority component. In other words, the Assigning Authority component returned shall include ALL subcomponents (namespace ID, Universal ID, and Universal ID type).
ITI10ITI10-016To eliminate the issue of multiple name values between Patient Identifier Domains, the Patient Identifier Cross-reference Manager Actor shall return a single space character in field PID-5-Patient Name.
ITI10ITI10-017A single PID segment is sent in which one repetition of PID-3-Patient Identifier List is populated for each of the identifiers in the notification. If the Patient Identifier Cross-reference Manager Actor chooses to send multiple identifiers associated with the same domain, it shall return these identifiers grouped in successive repetitions within the PID-3-Patient Identifier List.