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OO CR192-853 - Pre-Adopt ARV Segments in LOI/LRI

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Submitted by: Patrick E. Loyd Revision date: <<Revision Date>>
Submitted date: 17-Nov-2016 Change request ID: OO CR-385
Standard/IG: v2.10 Standard Artifact ID, Name: <<Artifact ID, Name>>

Issue

Proposal Summary For HL7 LOI and LRI IGs Pre-adopt V2.9 ARV segments to lab order and lab result messaging at PID. HL7 Orders and Observations V2.10 Change Request Pre-adopt addition of optional ARV segments at OBR and OBX as to the following: • OMG^O19 – just so it is generally available as well. • OML^O21 - to support LOI IG. • ORU^R01 – to support LRI IG • OUL^O22 – for future lab support NOTE – if there’s an issue with adding ARV because there’s nothing that says one can or cannot use it on clinical information besides a PV1, then add CON for ORC, OBR and OBX instead as that is explicitly allowed. Same use of CON-9 would be made as proposed for ARV-4. KC Question – does it make sense to add to OCR? Don’t think so, but let me know. Rationale: HL7 V2.9 includes ARV Access Restriction segments at PID for Chapters 4 and 7 Messages. Per HL7 V2.9 Chapter 3, this supports “communication of requested/required types of access restrictions from system to system at the person/patient level”. The ARV segment is also used to provide access restrictions at the encounter level in most Chapter 3 ADT messages, which conveys clinical information that may be considered sensitive and require heightened confidentiality protections under organizational, jurisdictional, and patient privacy policies as stipulated in healthcare consumer privacy consent directives. This proposal would provide similar access restrictions to a patient’s sensitive laboratory order and observation information. ARV-4 Access Restriction Reason (CWE) currently supports use of the HL7 Privacy and Security Healthcare Classification System [HCS] codes or “Privacy Tags”. A set of Privacy Tags represents the access restrictions in a patient’s privacy consent directive or those included in an organizational or jurisdictional privacy policy. These could be include singularly in the permitted repeats of ARV-4 or be included in one iteration. We recommend including the set in one iteration of an ARV-4. Sets of Privacy Tags, which convey a privacy policy or patient consent directive, constitute a “Security Label”. As specified in the HCS, HL7 Security Labels using the HCS Privacy Tag vocabulary are currently supported by the HL7 Data Segmentation for Privacy CDA IG [DS4P IG], the HL7 Data Provenance IG, and by FHIR at Meta and within the FHIR Consent Directive and Contract Resources. The HL7 DS4P CDA IG specifications at the header level are an optional Meaningful Use 3 standard. HL7 V2.8.2 Chapter 3 ARV Access Restrictions segment The ARV segment is used to communicate the requested/required type of access restrictions from system to system, at both the person/patient and the encounter/visit level. […] The ARV segment is optional and is sent after the PID/PD1 segments to describe access restrictions associated with the person/patient. The ARV segment is optional and is sent after the PV1/PV2 segments to describe access restrictions associated with that specific encounter. ARV-4 Access Restriction Reason (CWE) 02146 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)> ^ <Second Alternate Identifier (ST)> ^ <Second Alternate Text (ST)> ^ <Name of Second Alternate Coding System (ID)> ^ <Second Alternate Coding System Version ID (ST)> ^ <Coding System OID (ST)> ^ <Value Set OID (ST)> ^ <Value Set Version ID (DTM)> ^ <Alternate Coding System OID (ST)> ^ <Alternate Value Set OID (ST)> ^ <Alternate Value Set Version ID (DTM)> ^ <Second Alternate Coding System OID (ST)> ^ <Second Alternate Value Set OID (ST)> ^ <Second Alternate Value Set Version ID (DTM)> Definition: This field is used to convey the reason for the restricted access. Repeat of the Access Restriction Reason is allowed to accommodate communication of multiple reasons for an access restriction. Refer to User-defined Table 0719 – Access Restriction Reason Code in Chapter 2C, Code Tables, for suggested values. Below is an example for the use of the ARV Segment on a patient’s encounter in a 42 CFR Part 2 facility that may be disclosed in accordance with a Michigan Behavioral Health Consent Directive, the DCH-3927 “Consent to Share Behavioral Health Information for Care Coordination Purposes”. ARV-4 contains the applicable HL7 HCS Privacy Tags. ARV|1|A|DCH-3927^DCH-3927 Behavioral Health Opt-in|R^restricted confidentiality^2.16.840.1.113883.5.25~ETH^ substance abuse information sensitivity^2.16.840.1.113883.11.20428~PSY^ psychiatry information sensitivity^2.16.840.1.113883.11.20428~MHC^Michigan Mental Health Code^2.16.840.1.113883.1.11.20426~42CFRPart2^42 CFR Part 2^2.16.840.1.113883.1.11.20426~TREAT^treatment purpose of use^2.16.840.1.113883.1.1120448~HPAYMT^healthcare payment purpose of use^2.16.840.1.113883.1.1120448~HOPERAT^healthcare operations purpose of use^2.16.840.1.113883.1.1120448~PERSISTLABEL^persist security label^2.16.840.1.113883.1.11.20445~PRIVMARK^privacy mark^2.16.840.1.113883.1.11.20445~NORDSCLCD^no redisclosure without consent directive^2.16.840.1.113883.1.11.20446|This information is protected by 38 U.S.C. 7332, which prohibits further disclosure unless further disclosure is expressly permitted by written authorization of the person to whom it pertains or as otherwise permitted by 38 U.S.C. 7332|20160824002637.193-0400^ 20170824002637.193-0400



HL7 V2.9 Chapter 4 OMG – general clinical order message (event O19) The function of this message is to initiate the transmission of information about a general clinical order that uses the OBR segment. OMG messages can originate also with a placer, filler, or an interested third party. The trigger event for this message is any change to a general clinical order. Such changes include submission of new orders, cancellations, updates, patient and non-patient-specific orders, etc. This trigger includes segments identified as being for 'previous results.' These segments allow the sending system to include demographic and/or result information from previous result reports when they are related to the current order. For example: • Diagnostic laboratories referring tests to another lab for either confirmation of results (HIV, etc.) or due to not being equipped to do the tests (genetic testing, etc.). • Diagnostic laboratories sending test results to Knowledge Bases for the automated generation of diagnostic comments for inclusion into the lab report. The CTD segment in this trigger is used to transmit temporary patient contact details specific to this order. When one wants to convey with the detailed order message a supporting document, such as a CDA, one can transmit that document using the OBX associated with the ORC/OBR(s) using OBX-11 = "O" Order Detail Description Only, using either OBX-2 = "ED" or "RP". OMG^O19^OMG_O19: General Clinical Order Message Segments Description Status Chapter MSH Message Header 2 [{SFT}] Software 2 [ UAC ] User Authentication Credential 2 [{NTE}] Notes and Comments (for Header) 2 [ --- PATIENT begin

   PID	Patient Identification		3
  [PD1]	Additional Demographics		3
 [{PRT}]	Participation (for Patient)		7
 [{NTE}]	Notes and Comments (for Patient ID) 		2
 [{NK1}]	Next of Kin/Associated Parties		3

[{ARV}] Access Restrictions 3

 [ 	--- PATIENT_VISIT begin		
     PV1	Patient Visit		3
   [ PV2 ]	Patient Visit- Additional Info		3
   [{PRT}]	Participation (for Patient Visit)		7
  [{ARV}]	Access Restrictions		3 
 ]	--- PATIENT_VISIT end		
 [{	--- INSURANCE begin		
     IN1	Insurance		6
   [ IN2 ]	Insurance Additional Information		6
   [ IN3 ]	Insurance Additional Information, Certification		6
 }]	--- INSURANCE end		
 [ GT1 ]	Guarantor		6
 [{AL1}]	Allergy Information		3

] --- PATIENT end { --- ORDER begin

   ORC	Common Order		4
   [{NTE}]	Notes and Comments (for Order)		2
   [{PRT}]	Participation (for Common Order)		7
 [{	--- TIMING begin		
     TQ1	Timing/Quantity		4
   [{TQ2}]	Timing/Quantity Order Sequence		4
 }]	--- TIMING end		
   OBR	Observation		4
 [{NTE}]	Notes and Comments (for Detail)  		2
 [{PRT}]	Participation (for Order)		7
 [ CTD ]	Contact Data		11
 [{DG1}]	Diagnosis		6 
 [{	--- OBSERVATION begin		
     OBX	Observation/Result		7
   [{PRT}]	Participation (for Observation)		7
   [{NTE}]	Notes and Comments (for Results) 		2
 [{ARV}]	Access Restrictions		3 
 }]	--- OBSERVATION end		
 [{	--- SPECIMEN begin		
     SPM	Specimen		7
   [{NTE}]	Notes and Comments (for Specimen)		2
  [{	--- SPECIMEN_OBSERVATION begin		
   OBX	Observation/Result		7
   [{PRT}]	Participation (for Specimen Observation)		7
  [{ARV}]	Access Restrictions		3 
  }]	--- SPECIMEN_OBSERVATION end		
   [{	--- CONTAINER begin		
       SAC	Specimen Container		13
     [{NTE}]	Notes and Comments		2
     [{	--- CONTAINER_OBSERVATION begin		
       OBX	Observation/Result		7
     [{PRT}]	Participation (for Container Observation)		7
     }]	--- CONTAINER_OBSERVATION end		
   }]	--- CONTAINER end		
 }]	--- SPECIMEN end		
    [SGH]	Segment Group Header		2
 [{	--- PRIOR_RESULT begin		
   [ 	--- PATIENT_PRIOR begin		
       PID	Patient Identification  – previous result		3
     [PD1]	Additional Demographics – previous result		3
     [{ARV}]	Access Restrictions		3
     [{PRT}]	Participation (for Patient Prior)		7
   ]	--- PATIENT_PRIOR end		
   [ 	--- PATIENT_VISIT_PRIOR begin		
       PV1	Patient Visit           – previous result		3
     [ PV2 ]	Patient Visit Add. Info – previous result		3
     [{PRT}]	Participation (for Patient Visit Prior)		7
   [{ARV}]	Access Restrictions		3 
   ]	--- PATIENT_VISIT_PRIOR end		
   [{AL1}]	Allergy Information     - previous result		3
   { 	--- ORDER_PRIOR begin		
     ORC	Common Order            - previous result		4
    [{PRT}]	Participation		7
       OBR	Order Detail            - previous result		4
     [{	--- TIMING_PRIOR begin		
         TQ1	Timing/Quantity		4
       [{TQ2}]	Timing/Quantity Order Sequence		4
     }]	--- TIMING_PRIOR end		
     [{NTE}]	Notes and Comments      - previous result		2
     [{PRT}]	Participation (for Order Prior)  - previous result		7
     [ CTD ]	Contact Data            - previous result		10
     { 	--- OBSERVATION_PRIOR begin		
         OBX	Observation/Result      - previous result		7
       [{PRT}]	Participation (for Oservation Prior)		7
       [{NTE}]	Notes and Comments      - previous result		2
     }	--- OBSERVATION_PRIOR end		
   [{ARV}]	Access Restrictions		3 
   }	--- ORDER_PRIOR end		
 }]	--- PRIOR_RESULT end		
   [SGT]	Segment Group Trailer		2
 [{FT1}]	Financial Transaction		6
 [{CTI}]	Clinical Trial Identification		7
 [ BLG ]	Billing Segment		4

[{ARV}] Access Restrictions 3 } --- ORDER end

OML – laboratory order message (event O21) The following message structure may be used for the communication of laboratory and other order messages and must be used for lab automation messages where it is required that the Specimen/Container information is within the ORC/OBR segment group. The trigger event for this message is any change to a laboratory order. Such changes include submission of new orders, cancellations, updates, etc. OML messages can originate also with a placer, filler, or an interested third party. Note: The additional patient information, which is sent after the OBR with the current order (the segments PID, PD1, PV1, PV2, etc, indicated below with words "previous result"), could have been transferred with the previous result because the patient demographics related to the previous result can differ from the demographics related to the current order. The current intent is to only allow references to the same patient as in the header PID. The SAC segments included in the message allow the transfer of, e.g., a laboratory order with multiple containers and multiple test orders related to each container, or laboratory orders with test order requiring multiple containers. Refer to Chapter 13, "Laboratory Automation" for examples of usage, particularly to clarify the use of two references to SAC segments in this one message. The CTD segment in this trigger is used to transmit temporary patient contact details specific to this order. The IPC segment in this trigger is used to transmit imaging process identifiers for obsrevations that will result in DICOM information objects (e.g., slide images). Note that the IPC-1 Accession Identifier is the identifier assigned by the Order Filler for associating the DICOM results with other laboratory information and processes; it may or may not be the same as the SPM-30 Accession ID or the SAC-2 Accession Identifier. In relationship to triggers O21, O33, O35, and O39 this message/trigger (O21) should be used where an order with multiple samples and optionally multiple containers per order item are to be communicated, but not against a complete specimen shipment (O39) When one wants to convey with the detailed order message a supporting document, such as a CDA, one can transmit that document using the OBX associated with the ORC/OBR(s) using OBX-11 = "O" Order Detail Description Only, using either OBX-2 = "ED" or "RP".

OML^O21^OML_O21: Laboratory Order Message Segments Description Status Chapter MSH Message Header 2 [{SFT}] Software 2 [ UAC ] User Authentication Credential 2 [{NTE}] Notes and Comments (for Header) 2 [ --- PATIENT begin

   PID	Patient Identification		3
 [PD1]	Additional Demographics		3
 [{PRT}]	Participation (for Patient)		7
 [{NTE}]	Notes and Comments (for Patient ID) 		2
 [{NK1}]	Next of Kin/Associated Parties		3

[{ARV}] Access Restrictions 3

 [ 	--- PATIENT_VISIT begin		
     PV1	Patient Visit		3
   [ PV2 ]	Patient Visit- Additional Info		3
   [{PRT}]	Participation (for Patient Visit)		7
  [{ARV}]	Access Restrictions		3 
 ]	--- PATIENT_VISIT end		
 [{	--- INSURANCE begin		
     IN1	Insurance		6
   [ IN2 ]	Insurance Additional Information		6
   [ IN3 ]	Insurance Additional Information, Certification		6
 }]	--- INSURANCE end		
 [ GT1 ]	Guarantor		6
 [{AL1}]	Allergy Information		3

] --- PATIENT end { --- ORDER begin

   ORC	Common Order		4
 [{NTE}]	Notes and Comments (for Order)		2
 [{PRT}]	Participation (for Common Order)		7
 [{	--- TIMING begin		
     TQ1	Timing/Quantity		4
   [{TQ2}]	Timing/Quantity Order Sequence		4
 }]	--- TIMING end		
 [ 	--- OBSERVATION_REQUEST begin		
     OBR	Observation Request		4
   [ TCD ]	Test Code Details		13
   [{NTE}]	Notes and Comments (for Detail)  		2
   [{PRT}]	Participation (for Observation Request)		7
   [ CTD ]	Contact Data		11
   [{DG1}]	Diagnosis		6
   [{	--- OBSERVATION begin		
       OBX	Observation/Result		7
     [{PRT}]	Participation (for OBX)		7
     [ TCD ]	Test Code Detail		13
     [{NTE}]	Notes and Comments (for Results) 		2
   [{ARV}]	Access Restrictions		3 
   }]	--- OBSERVATION end		
   [{	--- SPECIMEN begin		
       SPM	Specimen		7
     [{NTE}]	Notes and Comments (for Specimen)		2
   [{	--- SPECIMEN_OBSERVATION begin		
       OBX	Observation/Result related to specimen		7
     [{PRT}]	Participation (for Specimen Observation)		7
   [{ARV}]	Access Restrictions		3 
   }]	--- SPECIMEN_OBSERVATION end		
     [{	--- CONTAINER begin		
         SAC	Specimen Container		13
       [{NTE]]	Notest and Comments (for Specimen Container)		2
       [{	--- CONTAINER_OBSERVATION begin		
         OBX	Observation/Result related to container		7
       [{PRT}]	Participation (for Container Observation)		7
       }]	--- CONTAINER_OBSERVATION end		
     }]	--- CONTAINER end		
   }]	--- SPECIMEN end		
   [IPC]	Imaging Procedure Control		4
    [SGH]	Segment Group Header		2
   [{	--- PRIOR_RESULT begin		
     [ 	--- PATIENT_PRIOR begin		
         PID	Patient Identification  – previous result		3
        [PD1]	Additional Demographics – previous result		3
       [{PRT}]	Participation (for Patient Prior)		7
       [{ARV}]	Access Restrictions		3
     ]	--- PATIENT_PRIOR end		
     [ 	--- PATIENT_VISIT_PRIOR begin		
         PV1	Patient Visit           – previous result		3
       [ PV2 ]	Patient Visit Add. Info – previous result		3
       [{PRT}]	Participation (for Patient Visit Prior)		7
     [{ARV}]	Access Restrictions		3
     ]	--- PATIENT_VISIT_PRIOR end		
     [{AL1}]	Allergy Information     - previous result		3
     { 	--- ORDER_PRIOR begin		
       ORC	Common Order            - previous result		4
     [{PRT}]	Participation		7
       OBR	Order Detail            - previous result		4
     [{NTE}]	Notes and Comments      - previous result		2
     [{PRT}]	Participation (for Order Prior)		7
       [{	--- TIMING_PRIOR begin		
           TQ1	Timing/Quantity		4
         [{TQ2}]	Timing/Quantity Order Sequence		4
       }]	--- TIMING_PRIOR end		
       { 	--- OBSERVATION_PRIOR begin		
           OBX	Observation/Result      - previous result		7
         [{PRT}]	Participation (for Observation Prior)		7
         [{NTE}]	Notes and Comments      - previous result		2
       }	--- OBSERVATION_PRIOR end		
     [{ARV}]	Access Restrictions		3 
     }	--- ORDER_PRIOR end		
   }]	--- PRIOR_RESULT end		
    [SGT]	Segment Group Trailer		2
 ]	--- OBSERVATION_REQUEST end		
 [{FT1}]	Financial Transaction		6
 [{CTI}]	Clinical Trial Identification		7
 [ BLG ]	Billing Segment                  		4

[{ARV}] Access Restrictions 3 } --- ORDER end

ORU – Unsolicited Observation Message (Event R01) The ORU message is for transmitting observational results, including lab, clinical or other observations, to other systems.. The OUL message is designed to accommodate the laboratory processes of laboratory automation systems. With the segment (OBX) defined in this chapter, and the OBR defined in Chapter 4, one can construct almost any clinical report as a multi-level hierarchy, with the PID segment defined in Chapter 3 at the upper level, an order record (OBR) at the next level with one or more observation records (OBX), followed by the specimen information (SPM) and one or more observations (OBX) directly associated with the specimen. One result segment (OBX) is transmitted for each component of a diagnostic report, such as an EKG or obstetrical ultrasound or electrolyte battery. The CTD segment in this trigger is used to transmit temporary patient contact details specific to this order. ORU^R01^ORU_R01: Observation Message Segments Description Status Chapter MSH Message Header 2 [{ SFT }] Software Segment 2 [UAC] User Authentication Credential 2 { --- PATIENT_RESULT begin

 [	--- PATIENT begin		
    PID	Patient Identification		3
    [PD1]	Additional Demographics		3
    [{PRT}]

Participation (for Patient) 7

    [{NTE}]	Notes and Comments		2
    [{NK1}]	Next of Kin/Associated Parties		3
    [{ARV}]	Access Restrictions		3
    [{	--- PATIENT_OBSERVATION begin		
      OBX

Observation (for Patient ID) 7

      [{PRT}]

Participation (Observation Participation) 7

    }]	--- PATIENT_OBSERVATION end		
    [	--- VISIT begin		
      PV1	Patient Visit		3
      [PV2]	Patient Visit - Additional Info		3
      [{PRT}]

Participation (for Patient Visit) 7

    [{ARV}]	Access Restrictions		3
    ]	--- VISIT end		
  ]	--- PATIENT end		
  {	--- ORDER_OBSERVATION begin		
     [	--- COMMON_ORDER begin		
     ORC	Order common		4
     [{PRT}]

Participation (for Observation) 7

       [	--- ORDER DOCUMENT begin		
        OBX	Observation containing Document		7
        [{PRT}]	Participation		7
        TXA	Transcription Document Header		9
       ]	--- ORDER DOCUMENT end		
     [{ARV}]	Access Restrictions 		3
     ]	--- COMMON ORDER end		
     OBR

Observations Request 7

     {[NTE]}	Notes and comments		2
     [{PRT}]

Participation (for Observation) 7

     [{	--- TIMING_QTY begin		
        TQ1	Timing/Quantity		4
        [{TQ2}]	Timing/Quantity Order Sequence		4
     }]	--- TIMING_QTY end		
     [CTD]	Contact Data		11
     [{	--- OBSERVATION begin		
       OBX

Observation related to OBR 7

       [{PRT}]

Participation (Observation Participation) 7

       {[NTE]}	Notes and comments		2
     [{ARV}]	Access Restrictions		3 
     }]	--- OBSERVATION end		
     [{FT1}]	Financial Transaction		6
     {[CTI]}

Clinical Trial Identification 7

     [{	--- SPECIMEN begin		
       SPM

Specimen

       [{	--- SPECIMEN_OBSERVATION begin		
         OBX

Observation (for Patient ID) 7

         [{PRT}]

Participation (Observation Participation) 7

      [{ARV}]	Access Restrictions		3 
       }]	--- SPECIMEN_OBSERVATION end		
     }]	--- SPECIMEN end		
   [{ARV}]	Access Restrictions		3 
  }   	--- ORDER_OBSERVATION end		

} --- PATIENT_RESULT end [DSC] Continuation Pointer 2

OUL – Unsolicited Order Oriented Observation Message (Event R24) This message was designed to accommodate multi-specimen oriented testing. It should be applicable to, e.g., laboratory automation systems requiring container. Generally this construct allows transfer of multiple results, each one related to none, one or more specific containers with one or more specimens from a patient. (Example: Creatinine Clearance result with detailed information about the urine and serum specimens and their containers.) In addition to the patient results themselves it permits the communication of the following kinds of information: Analysis results of a non patient related sample (e.g., environmental) – patient related segments (e.g., PID, PD1, PV1, PV2) are optional. Analysis results to a particular container with QC sample and the lot and manufacturer information about this sample (SAC-INV segments). Basic identification data (lot, manufacturer, etc.) of the reagents and other substances involved in the generation of analysis results (TCD-SID segments). Refer to Chapter 13 Laboratory Automation for additional examples of usage of SAC. OUL^R24^OUL_R24: Observation Message Segments Description Status Chapter MSH Message Header 2 [{ SFT }] Software Segment 2 [UAC] User Authentication Credential 2

[NTE]	Notes and Comments		2
[	--- PATIENT begin		
  PID	Patient Identification		3
  [PD1]	Additional Demographics		3
  [{PRT}]

Participation (for Patient) 7

  [{ARV}]	Access Restrictions		3
  [{NTE}]	Notes and Comments (for Patient ID)		2
  [{	--- PATIENT_OBSERVATION begin		
  OBX

Observation (for Patient ID) 7

  [{PRT}]

Participation (for Observation) 7

  }]	--- PATIENT_OBSERVATION end		
[	--- VISIT begin		
  PV1	Patient Visit		3
  [PV2]	Patient Visit – Additional Information		3
  [{PRT}]

Participation (for Patient Visit) 7

 [{ARV}]	Access Restrictions		3 
]	--- VISIT end		
]	--- PATIENT end		
[{NK1}]	Next of Kin		3
{	--- ORDER begin		
  OBR

Observation Order 7

  [{PRT}]

Participation (for observation) 7

  [	--- COMMON_ORDER begin		
  ORC	Common Order		4
  [{PRT}]

Participation (for common order) 7

  [	--- ORDER_DOCUMENT begin		
   OBX	Observation containing Document		7
   [{PRT}]	Participation		7
   TXA	Transcription Document Header		9
   [{ARV}]	Access Restrictions 		3
   ]	--- ORDER_DOCUMENT end		
     [{ARV}]	Access Restrictions 		3
  ]	--- COMMON_ORDER end		
  [{NTE}]	Notes and Comments (for Detail)		2
  [{PRT}]

Deprecated as of V2.8 Deprecated 7

  [{	--- TIMING_QTY begin		
    TQ1	Timing/Quantity		4
    [{TQ2}]	Timing/Quantity Order Sequence		4
  }]	--- TIMING_QTY end		
  [{	--- SPECIMEN begin		
    SPM

Specimen information 7

      [{	--- SPECIMEN_OBSERVATION begin		
        OBX

Observation (for Specimen) 7

        [{PRT}]

Participation (for Observation) 7

      [{ARV}]	Access Restrictions		3 
      }]	--- SPECIMEN_OBSERVATION end		
    [{	--- CONTAINER begin		
      SAC	Container information		13
        [INV]	Detailed Substance information (e.g., id, lot, manufacturer, ... of QC specimen)		13
    }]	--- CONTAINER end		
  }]	--- SPECIMEN end		
  [{	--- RESULT begin		
    OBX

Observation Result 7

    [{PRT}]

Participation 7

    [TCD]	Test Code Detail		13
    [{SID}]	Substance Identifier (e.g., reagents used for testing)	B	13
    [{INV}]	Inventory Detail (Detailed substance data e.g., reagents used for testing)		13
    [{NTE}]	Notes and Comments		2
  [{ARV}] 	Access Restrictions		3
  }]	--- RESULT end		
  [{CTI}]

Clinical Trial Identification 7

}	--- ORDER end		

[DSC] Continuation Pointer 2

Recommendation

Rationale

Discussion

OOWG 11/17/2016> From today's call - re reviewed where things were. Patrick was speaking to the proposal and had not been looped in to the ARV change. We considered an evote for timing but ended up with the following:

We have a motion on the table to approve the CR as presented (from OO point of view) We agreed to post on the wiki and start a wiki based discussion (which could have been the discussion period leading up to an evote.) Since people needed to the 23rd to review, a one week evote would put us to the 30th, so we agreed to take up the question on the Dec 1 call Need to email v2 Publishing with their v2 Management Group hat on to clarify who should contribute/ review. Their next call is 3 ET on the 29th PSS has been approved by TSC with the request for the clarifications changes would have to be made to the IG to pre-adopt the CR, Bob Yencha seemed to think that was do-able.

On Thu, Nov 17, 2016 at 1:35 PM, Buitendijk,Hans <Hans.Buitendijk@cerner.com> wrote: With further notes that the proposal is switching to ARV rather than CON, which is owned by Chapter 3, which is PA, but always confused how much may be FM.

So we have two clarifications then:

· Ownership of now ARV

· Adjustment of the language to reflect that CG V2 Lite apparently was never official.


The second I had applied, but not the first. Per OO call today, what’s left to be done and how much needs to be done before we go to ballot, or is just considered an administrative clarification?

Thank you!

Recommended Action Items

Resolution

8-Feb-2018 - Riki to work with Patrick, since she is working on a different approach for use of the ARV segment