Specification - Extended

HL7 CDA® R2 Implementation Guide: Quality Reporting Document Architecture I (QRDA I) Release 1, STU Release 5.2 - US Realm

Document Description

extended per TSC approval Jira TSC-68, errata by CTO

Existing Wording

Ten instances in the IG contain the following for effectiveTime. 8 begin with "SHALL contain ... effectiveTime" and 2 begin with "MAY contain ... effectiveTime." 8. SHALL contain exactly one [1..1] effectiveTime (CONF:4444-13611). Note: QDM Attribute: Relevant Period, Relevant dateTime a. This effectiveTime SHOULD contain zero or one [0..1] @value (CONF:4444-29742). Note: QDM Attribute: Relevant Period - the time the intervention is performed when the intervention occurs at a single point in time b. This effectiveTime SHOULD contain zero or one [0..1] low (CONF:4444-13612). Note: QDM Attribute: Relevant Period - startTime - the time the intervention begins when it occurs over a time interval c. This effectiveTime MAY contain zero or one [0..1] high (CONF:4444-13613). Note: QDM Attribute: Relevant Period - stopTime - the time the intervention ends when it occurs over a time interval d. This effectiveTime SHALL contain either a low or a @value but not both (CONF:4444-29743). Note: QDM Attributes Relevant dateTime and Relevant Period are mutually exclusive. These conformance statements mean that: **Is allowed** **Is allowed** **NOT allowed** **Is allowed** Guidance for use of nullFlavor: Section 3.3 of Vol 1: "In many cases, the C-CDA standard will stipulate that a piece of information is required (e.g., via a SHALL conformance verb). However, in most of these cases, the standard provides an “out”, allowing the sender to indicate that the information isn’t known." Again Section 3.3: "Any SHALL, SHOULD or MAY conformance statement may use nullFlavor, unless the nullFlavor is explicitly disallowed (e.g., through another conformance statement which includes a SHALL conformance for a vocabulary binding to the @code attribute, or through an explicit SHALL NOT allow use of nullFlavor conformance)." Section 4.1.5 of Vol 1: "The keyword "SHALL" allows the use of nullFlavor unless the requirement is on an attribute or the use of nullFlavor is explicitly precluded."

Proposed Wording

As the conformance statements are written, a nullFlavor is allowed for QDM attribute Relevant period (effectiveTime/low/@nullFlavor) but not for QDM dateTime since 8.d. in the existing wording states that "effectiveTime SHALL contain either a low or a @value but not both." It seems as though the intent of 8.d. was to require one of dateTime (@value) or Period (/low), but not allow both. Was the intent also to disallow the use of nullFlavor only when QDM dateTime is in use by requiring effectiveTime/@value? Allowance of nullFlavor should be consistent within this conformance statement. It could be consistently allowed by changing 8.d. to read "This effectiveTime SHALL contain either a low or a @value but not both, or the effectiveTime SHALL contain a @nullFlavor". Or it could be consistently disallowed by adding conformance statement that effectiveTime/low (and possibly also /high) "SHALL NOT contain a @nullFlavor." The use of nullFlavor can be important when data is not available in an EHR. However, most of the instances of the existing conformance statements are on "...Performed" templates, for which a time can be expected.