Minutes: Laboratory Automation SIG
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Minutes: Laboratory Automation SIG
Dates: May 23-25, 2000
Attendees: Charles D. Hawker, PhD Co-Chair Andrzej J. Knafel, PhD Co-Chair Sadamu Takasaka Suzanne Nagami Manish Narang Phillip A. Taggart Jeffrey S. Perry
1) Introduction
For the benefit of first time attendees at a Lab Automation SIG meeting C. Hawker briefly reviewed the history of this SIG and its relation to the NCCLS AUTO3 Subcommittee on Automation Communications. HL7 and NCCLS have signed a verbal agreement that will allow NCCLS to reprint HL7 Chapter 13 (when approved) as part of a larger automation standard without a royalty payment. Chapter 13 was drafted by a group of individuals who are members of both the Lab Auto SIG and the NCCLS AUTO3 Subcommittee. The NCCLS AUTO3 standard also includes sections on subjects such as system architecture, lower level protocols, relationships between various standards with applicability in the lab automation domain, and implementation considerations. Chapter 13 is in the HL7 version 2.4 membership ballot just concluded, and we received comments from only one member which we will address at this meeting.
2) Discussion of expansion of scope of Lab Automation SIG
C. Hawker introduced Jeffrey Perry, Vice President of the Connectivity Industry Consortium (CIC). The CIC, whose need emerged from a meeting held in conjunction with the 1999 AACC meeting and which has 32 organizational members, was formed in November, 1999 in order to develop communication and connectivity standards for laboratory testing performed at bedside (often referred to as point of care testing) or in patient homes. CIC has raised $650,000 from its members thus far. Among its 32 members CIC includes major users of this technology such as the Mayo Clinic, Kaiser Permanente, UC – Davis, UCSF - Stanford, Penn State - Geisinger, Mt. Sinai Medical Center, Profil GmbH, and Johns Hopkins, and major vendors such as Agilent Technologies, Bayer, Instrumentation Laboratory, Medical Automation Systems, Radiometer Medical A/S, Roche Diagnostics, SCC Soft Computer, Sunquest Information Systems, and Life Scan. Since CIC is not an ANSI- approved standards organization, it is CIC’s desire to link with one or more such groups in order that the standard that is developed can be published by an ANSI- Minutes Lab Automation SIG, May, 2000 2
approved standards organization.
After preliminary review of the HL7 messages related to lab automation and lab instruments in Chapter 13 the CIC concluded that these messages might meet 80- 90% of the perceived needs for messages for point of care testing. After further discussion, the members of the Lab Automation SIG present agreed that expansion of our scope and mission to include point of care testing was logical and appropriate. It was further thought that the current relationship between HL7 and NCCLS would be a good model for the point of care standard, since the latter would require not only the messages, etc. developed within the expanded SIG for point of care, but also would require an implementation and connectivity standard with lower level protocols, architectural issues, etc., as Lab Automation did within the NCCLS document. Thus, an expanded HL7 Chapter 13 with messages for both point of care and lab automation could be reproduced in a new NCCLS standard for point of care in addition to the already drafted standard on lab automation communications.
3) Timeline and actions related to expansion of Lab Auto SIG’s scope
1. Revise charter and mission statement for the ARB by this meeting’s end.
2. Also submit the revised charter and mission to the CIC BoD by June 2, 2000.
3. Teleconference between CIC Technical Coordinating Committee and LabAuto SIG on May 31, 2000 at 2pm EDT. Participants: A. Knafel, M. Narang, C. Hawker, J. Perry + CIC.
4. (Potential) joint meeting of the CIC and Lab Auto SIG on July 27th at AACC in San Francisco.
5. Assuming the satisfactory review of the revised mission statement and charter by the ARB, this request for expansion of our scope will be presented by C. Hawker and A. Knafel at the September TSC meeting.
6. CIC will distribute within the Lab Auto SIG ([email protected]) the draft of the messaging standard proposal at the very latest 1 week before the HL7 meeting in September, 2000.
7. Part of the HL7-LabAuto SIG meeting in September (~1day – probably Monday) will be dedicated to POCT aspects: Co-chair nominations (to be determined). Organizational issues related to HL7, NCCLS, and CIC. Technical discussion – review of the CIC draft standard for POCT. Minutes Lab Automation SIG, May, 2000 3
8. Target date for the “ballot-ready” messaging standard draft would be the end of 2000.
4) Revision/update of mission statement and charter
The template provided by HL7 was used. The mission statement and charter were revised to include the point of care expansion of scope. A copy is attached to these minutes.
5) Discussion of Version 3 and RIM mapping issues (materials handling, etc.)
The Lab Auto SIG spent much of one day identifying questions about containers, carriers, trays, and similar objects (materials) related to using version 3 and the Reference Information Model that could be posed to Orders And Observations in a joint meeting. The following summarizes the questions that were developed by the SIG and the answers obtained from those participating in the joint meeting with O&O.
1. Container, carrier, location are classes (roles) of Material, but there is no relation described among them. Example: A carrier can hold a maximum of 5 sample containers (aggregation relation) and this carrier can be at a specific multidimensional position at a specific location. How to express in the USAM that a sample container 12345678 is at position 2 of carrier 2002 at position 4 in a tray at location X?
We need to add attributes to the material role carrier/tray (=location?) or an interpretation of existing attributes: - position numbers for holding the nested class (e.g., Material_relationship.position_nmb)
O&O Response the approach is OK
2. Why are the attributes of a container limited (do not cover the attributes of the SAC segment from Ch. 13)?
O&O Response check and extend if necessary – send an email to O&O list server for clarifications.
3. The Device (equipment) has specific attributes, e.g., describing current state according to the device’s state-machine. We need to add e.g., “state_of_device” as an attribute.
O&O Response see above; check if the attributes exist (material.status) and Minutes Lab Automation SIG, May, 2000 4
add if necessary.
4. How to issue commands from one device to another device, e.g., initialize (nil) or pipet_from (specimen_container)?
O&O Response command will be a service request using specific service code.
5. How to include an observation (e.g., a specimen is hemolytic or lipemic) as a characteristic of a specimen container, which will then determine further processing of this container? O&O Response use a relation between the specimen, the container and the observation (sub-class of a service). Observation can be unsolicited, i.e., w/o test orders.
6. Ref. point 8.1.1: How is the Material ID used for the specimen?
SERVICE 1. Mapping of time stamps used in lab automation to the time stamps used in services.
O&O Response Lab Auto SIG can work on this for the September meeting.
OTHERS 1. The chapter 13 defines additional characteristics of test orders (TCD segment), observations (SID) or testing process configuration (TCC). How we can include these characteristics into the RIM?
O&O Response use the service (DEFinition as mood).
6) Discussion and resolution of Chapter 13 Version 2.4 ballot comments
a) Comments from Frank Oemig: Lab Auto SIG Minutes, May, 2000 5
ID # Section Vote Type Existing Wording Proposed Wording Comments SIG Disposition 13.2.1 A Mi message type ESU^U01 ESU^U01^ESU_U01 SIG Agreed 13.2.2 A Mi message type ESR^U02 ESR^U02^ESR_U02 SIG Agreed 13.2.3 A Mi message type SSU^U03 SSU^U03^SSU_U03 SIG Agreed 13.2.4 A Mi message type SSR^U04 SSR^U04^SSR_U04 SIG Agreed 13.2.5 A Mi message type INU^U05 INU^U05^INU_U05 SIG Agreed 13.2.6 A Mi message type INR^U06 INR^U06^INR_U06 SIG Agreed 13.2.7 A Mi message type EAC^U07 EAC^U07^EAC_U07 SIG Agreed 13.2.8 A Mi message type EAR^U08 EAR^U08^EAR_U08 SIG Agreed 13.2.9 A Mi message type EAN^U09 EAN^U09^EAN_U09 SIG Agreed 13.2.10 A Mi message type TCM^U10^TCM_U10 SIG Agreed TCM^U10 13.2.11 A Mi message type TCR^U11 TCR^U11^TCR_U11 SIG Agreed 13.2.12 A Mi message type LSU^U12 LSU^U12^LSU_U12 SIG Agreed 13.2.13 A Mi message type LSR^U13 LSR^U13^LSR_U13 SIG Agreed 13.2.13 A Mj Divide table for SIG Agreed message definition for answer into a separate table 13.3.1.2 N Mj EQU-2 Event date/time This section should SIG Disagreed: (TS) 01322 be deleted The “event” in Definition: This field is completely. When chapter 13 is a the date/time that the Event Timestamps “happening” within event (e.g., state are needed an the equipment, transition, issuing of EVN Segment e.g., reagent command, finishing of should be included inventory reaches command execution) in the message. a threshold level or occurred container moved into a pipetting position. Using of the EVN segment is not necessary, confusing and produces unnecessary overhead. 13.3.2.2 N Mj Definition: This field Definition: This field There is no HL7 SIG Agreed: specifies the type of specifies the type of table 368 defined, We changed it to interaction. If the interaction. either it should be User defined table interaction is performed a user defined with suggested as the result of a table without value set. previous command, suggested values, then the interaction type or the second as specified in HL7 sentence and the Table 0368 - Remote table reference control command should have to be deleted be used.
13.3.2.3 N Mj Definition: This field Definition: This field There is no HL7 SIG Agreed: transfers the state of the transfers the state of table defined. We changed it to interaction. If the the interaction. If the Since different User defined table interaction is performed interaction is encoded values with suggested as the result of a performed as the can be used value set. previous command, result of a previous (LECIS, user then the interaction command, then the defined or state should be one of interaction state equipment specific) the Command should be one of the a user defined Responses (Refer to Command table seems to be HL7 Table 0387 – Responses If the unsuitable as well. Command response). If interaction is not Therefore the best the interaction is not performed as a result is to leave the performed as a result of of a command (e.g., datatype CE and Minutes Lab Automation SIG, May, 2000 6
ID # Section Vote Type Existing Wording Proposed Wording Comments SIG Disposition a command (e.g., periodically time delete the table periodically time triggered automatic reference triggered automatic maintenance) then completely. maintenance) then this this state is state is interaction interaction specific, specific, and should and should refer to refer to either the LECIS either the LECIS state state transitions for transitions for interactions or a user or interactions or a user equipment specific or equipment specific table. table.
13.3.3.6 N Mj SAC-6 Specimen Section 2.8.6 WITHDRAWN by source (CM) 00249 reads: F. Oemig: As The CM data type discussed between is maintained M. Shafarman, F. strictly for Oemig, and A. backward Knafel, this field is compatibility and used consistently may not be used among segments for the definition of in chapters 4, 7, & new fields. 13, and there is Therefore, the seven only one components of this specification of this field have to be split field (0249). up to seven individual fields. 13.3.3.15 N Mi SAC-15 Location (CE) SAC-15 Location The CE data type SIG Disagreed: 01342 (ST) 01342 should be used for The Components:
13.3.3.25 N Mi Definition: This field There is no SIG Agreed: identifies the type of the definition what kind Explanation added. Minutes Lab Automation SIG, May, 2000 7
ID # Section Vote Type Existing Wording Proposed Wording Comments SIG Disposition separator that is being of separator is to used be identified. There is an ambiguity with the term separator used for HL7 field, component and subcomponent separator. 13.3.3.27 N Mj Definition: This field Definition: This field If a table is to be SIG Agreed: identifies any additives identifies any extended with user Changed introduced to the additives introduced specific values it specimen before or at to the specimen can’t be a HL7 the time of collection. It before or at the time table but must be a is a repetitive field. of collection. It is a user defined table Refer to HL7 Table repetitive field. Refer 0371 – Additive for valid to User defined values. The table’s Table 0371 – Additive values are taken from for suggested values. NCCLS AUTO4. The The table’s values are value set can be taken from NCCLS extended with user AUTO4. The value specific values. set can be extended with user specific values.
13.3.3.28 N Mj Definition: This field Definition: This field If a table is to be SIG Agreed: identifies the specimen identifies the extended with user Changed component, e.g., specimen component, specific values it supernatant, sediment, e.g., supernatant, can’t be a HL7 etc. Refer to HL7 Table sediment, etc. Refer table but must be a 0372 – Specimen to User defined table user defined table component for valid 0372 – Specimen values. This table’s component for values are taken from suggested values. NCCLS AUTO4. The This table’s values value set can be are taken from extended with user NCCLS AUTO4. The specific values. value set can be extended with user specific values.
13.3.3.30 N Mj Definition: This field Definition: This field If a table is to be SIG Agreed: identifies the specimen identifies the extended with user Changed collection treatment. specimen collection specific values it Refer to HL7 Table treatment. Refer to can’t be a HL7 0373 – Treatment for user defined table table but must be a valid values. This 0373 – Treatment for user defined table table’s values are taken suggested values. from NCCLS AUTO4. This table’s values The value set can be are taken from extended with user NCCLS AUTO4. The specific values. value set can be extended with user specific values.
13.3.3.31 A S Definition: This field Definition: This field Since HL7 SIG Disagreed: identifies the specimen identifies the encourages the The laboratory temperature in degrees specimen use of SI units the standards Celsius [°C] at the time temperature in Kelvin temperature should worldwide use of the transaction [K] at the time of the either be given in Celsius for specified in the EQU transaction specified Kelvin, or an own temperature units. segment. in the EQU segment. field for the unit of temperature should be given. 13.3.3.40 N Mj Definition: This field Definition: This field If a table is to be SIG Agreed: Minutes Lab Automation SIG, May, 2000 8
ID # Section Vote Type Existing Wording Proposed Wording Comments SIG Disposition describes the specimen describes the extended with user Changed contaminant identifier specimen specific values it that is associated with contaminant identifier can’t be a HL7 the specimen. Refer to that is associated with table but must be a HL7 Table 0374 – the specimen. Refer user defined table System induced to User defined contaminants for valid Table 0374 – System values. This table’s induced values are taken from contaminants for NCCLS AUTO4. The suggested values. value set can be This table’s values extended with user are taken from specific values. NCCLS AUTO4. The value set can be extended with user specific values.
13.3.3.42 N Mj Definition: This field Definition: This field If a table is to be SIG Agreed: describes the artificial describes the artificial extended with user Changed blood identifier that is blood identifier that is specific values it associated with the associated with the can’t be a HL7 specimen. Refer to HL7 specimen. Refer to table but must be a Table 0375 – Artificial User defined Table user defined table blood for valid values. 0375 – Artificial blood This table’s values are for suggested values. taken from NCCLS This table’s values AUTO4. The value set are taken from can be extended with NCCLS AUTO4. The user specific values. value set can be extended with user specific values.
13.3.3.43 N Mj Definition: This field Definition: This field If a table is to be SIG Agreed: describes any special describes any special extended with user Changed handling considerations handling specific values it that are associated with considerations that can’t be a HL7 the specimen. (E.g. are associated with table but must be a centrifugation). Refer to the specimen. (E.g. user defined table HL7 Table 0376 – centrifugation). Refer Special handling to User defined table considerations for valid 0376 – Special values. This table’s handling values are taken from considerations for NCCLS AUTO4. The suggested values. value set can be This table’s values extended with user are taken from specific values. NCCLS AUTO4. The value set can be extended with user specific values.
13.3.3.44 N Mj Definition: This field Definition: This field If a table is to be SIG Agreed: describes other describes other extended with user Changed environmental factors environmental factors specific that are associated with that are associated values it can’t be a the specimen, e.g., with the specimen, HL7 table but must atmospheric exposure. e.g., atmospheric be a Refer to HL7 Table exposure. Refer to user defined table 0377 – Other user define d table environmental factors 0377 – Other for valid values. This environmental factors table’s values are taken for suggested values. from NCCLS AUTO4. This table’s values The value set can be are taken from extended with user NCCLS AUTO4. The specific values. value set can be extended with user specific values. Minutes Lab Automation SIG, May, 2000 9
ID # Section Vote Type Existing Wording Proposed Wording Comments SIG Disposition
13.3.5.3 N T ECD-3 Response ECD-3 Response Data type mixture SIG Agreed: required (ID) 01392 required (ID) 01392 Changed Components:
After reviewing ballot comments, the SIG made a few minor changes to Chapter 13. The SIG also reviewed and addressed leftover minor issues from the previous meeting. c) Technical Corrections to Other Chapters
The SIG noted that Specimen Source (7.3.1.15) must be corrected to be consistent with Specimen Source (4.4.3.15) which is correct. The Lab Auto SIG did not look for this error elsewhere. A. Knafel will notify the committee responsible for Chapter 7.
7) Follow-up items and assignments
Refer to item 3 above for specific follow up items and schedule related to expanding the Lab Auto SIG to include non-automated and point-of-care testing in the SIG’s area of interest, and to formally link with the Connectivity Industry Consortium (CIC).
C. Hawker will forward the revised mission statement and charter to Mead Walker of the Architecture Review Board. C. Hawker will participate in an ARB conference call in the second half of June. C. Hawker and A. Knafel will present the proposed expansion of the Lab Auto SIG (and name change to Laboratory, Point of Care, and Automated Testing SIG) to the Technical Steering Committee in September.
In preparation for the September meeting, several SIG members agreed to start work on mapping our existing messages to the current RIM. M. Narang will map ESU, ESR, EAC, EAR, and EAN. A. Knafel will map SSU and SSR. S. Takasaka will map INU, INR, TCU, TCR, LSU, and LSR.
8) Schedule for HL7 in St. Louis September 11-15.
Both sections of the Lab Auto SIG (automation and point-of-care) will meet Monday all day to discuss organizational issues and review draft additions to version 2.4 Chapter 13 from the point-of-care group. Tuesday will be reserved for an anticipated, improved version 3 tutorial. Wednesday a.m. and p.m., Thursday a.m. and p.m., and Friday a.m. will be scheduled for separate meetings of the automation and point-of- care sections of the Lab Auto SIG or an additional joint meeting if required.
Agenda items will include review of the draft version 2.x extensions of Chapter 13 for point-of-care testing provided by the CIC and work on version 3 for both the existing Chapter 13 and the additions from the point-of-care section. Minutes Lab Automation SIG, May, 2000 11
Minutes prepared by Charles Hawker