V 2.8 HL7 Proposal Change Request ID: File Name: Description: Status: Sponsoring Person Sponsoring Business Unit Date Originated: HL7_ACLA_V2_ProposalOM1-31_20090728.doc Change cardinality for OM1-31 Observations Required to Interpret This Observation (00616). New Proposal Ken McCaslin American Clinical Laboratory Association (ACLA) 7/28/2009 Date HL7 approved: Backward Compatible: Yes Forward Compatible: Yes HL7 Status & Date 1 JUSTIFICATION DETAIL: The field in the OM1 segment position 31 Observations Required to Interpret This Observation is defined with cardinality of 1. In many cases this is acceptable however, for laboratories there are situations where there is a need for more than a single analyte information including something as simple as Creatinine Clearance which requires both a Urine Volume and the number of hours of the collection (typically 24 hours). There are more complex testing that requires many Observations to be provided by the Ordering Provider at the time they collect the specimen. Worse case examples include MSAFP and Pap Smears as outlined below: Maternal Serum Alpha Feta Protein: Require the following: Maternal Weight Estimated Date of Delivery How the Estimated Date of Delivery was calculated Mother’s Ethic Origin Number of Fetuses Insulin-Depend Diabetic (Y/N) History of Neural Tube Defects (Y/N) History of Down Syndrome (Y/N) Each of these items are use to do the calculation of the final result values and with any of these missing, the final observation cannot be provided. Therefore, this proposal requests that OM1-31 be a repeating field. Based on current known requirements there could be a limit of 20 repeats, however, as new tests are developed in the future it is unknown what the upper limit could need to be set at and therefore this proposal is to have unlimited repeats. 2 OPEN ISSUES: NA 3 CHANGE REQUEST IMPACT: Chapter 10 – Scheduling Section 8.8.8 – OM1 General Segment The Segment Chart Sub Section 8.8.8.31 OM1 -31 4 DOCUMENTATION CHANGES: 30 250 CWE O 31 250 CWE O 32 65536 TX O 33 250 CWE O 34 250 CWE O Y Y 0177 00615 Confidentiality Code 9999 00616 Observations Required to Interpret the Observation 00617 Interpretation of Observations 9999 00618 Contraindications to Observations 9999 00619 Reflex Tests/Observations OM1-31 Observations Required to Interpret This Observation (CWE) 00616 Components: <Identifier (ST)> ^ <Text (ST)> ^ <Name of Coding System (ID)> ^ <Alternate Identifier (ST)> ^ <Alternate Text (ST)> ^ <Name of Alternate Coding System (ID)> ^ <Coding System Version ID (ST)> ^ <Alternate Coding System Version ID (ST)> ^ <Original Text (ST)> Definition: This field contains the list of variables that the diagnostic service needs to interpret the results of an ordered study. The observations specified here should be sent to the diagnostic service as OBX segments along with the order (OBR) segment. Example for cervical pap smear: ...|2000.32^date last menstrual period^AS4~2000.33^menstrual state^AS4|... Example for arterial blood gas: ...|94700^inspired 02^AS4|... These examples use AS4 codes in code/text format to identify the variables. Separate multiple items by repeat delimiters. It appears there will not be any change other than in the Segment Chart in Section 8.8.8 since the sub section already describes the process for repeating this field consistent with the process followed for the Reflex Tests in OM1-34. the only missing item is Cardinality in the segment chart.