Minutes: Laboratory, Automated, and Point of Care Testing SIG

Minutes: Laboratory, Automated, and Point of Care Testing SIG (LAPOCT SIG)

Dates: May 7-11, 2001

Attendees: Charles D. Hawker, PhD Co-Chair, LAPOCT SIG Andrzej J. Knafel, PhD Co-Chair, LAPOCT SIG Michael Aryev Jeffrey DuBois, PhD Louis Dunka, PhD Tammy Dugan Charles Fisher Louis Gordon Suzanne E. Nagami Manish Narang Jeffrey S. Perry Paul Schluter Allan Soerensen Sadamu Takasaka Robert Uleski Wayne Tracy (guest from Orders & Observations) Mike Henderson (guest from Control Query) Austin Kreisler (guest from Orders & Observations)

Additional attendees from Community Based Healthcare SIG, Monday afternoon: Bobby Barker John Firl Dan Nowicki Melvin Reynolds

Additional attendees from Blood Bank SIG, Monday afternoon: Miklos Csore Becky Farr Gaby Jewell Patti Larson Ken McCaslin Claudette Murch Suzanne E. Nagami

Issues Discussed

1. Charles Hawker and Andrzej Knafel opened the session by welcoming attendees and reviewing the general agenda for the week.

1 Minutes LAPOCT SIG, May 7-11, 2001

2. Louis Dunka, Vice Chair of the NCCLS Subcommittee on Point of Care Testing reviewed the current status of that project. The subcommittee has approved a draft document that will, after approval by the NCCLS Area Committee on Automation, be issued on CDs for a 60-day public comment period. It is expected that the CDs will be released in the second week of May.

3. Andrzej Knafel reviewed the action items from the January, 2001 Orlando meeting to determine the status of each and their readiness for further action.

4. Jeffrey Perry reviewed the status of the three proposed new trigger events requested for Point of Care applications for version 2.5 and the request that is being made of HL7 for an Authoritative Statement granting permission to use these trigger events before they are balloted for version 2.5. A conference call was held on April 20 with Orders & Observations T.C., which resolved some concerns. Next, we must obtain approval from each of the following committees in sequence: O&O on Monday, May 7, TSC on Monday evening, May 7, and Board of Directors on Tuesday, May 8.

5. Wayne Tracy, as a Co-Chair of O&O, presented a concern about the proposed Authoritative Use Statement. Wayne’s concern was that the expression “results without orders” appeared to refer to tests being performed without legal orders from authorized providers such as physicians or nurse practitioners. It was explained that the term orders in the context of the proposed Authoritative Statement referred only to orders transferring on the interface between the Observation Reviewer and the Observation Recipient. Separate from anything to do with this proposal, each institution has its own rules in place to record or chart the existence of the authorized orders that led to the results that are being transferred across the interface.

6. Louis Gordon and members of the Community Based Health Services SIG presented the emerging concept of Telehealth systems, which are systems that may be installed in locations such as a home, a hospice-respite care facility, or a workplace, where a patient may be monitored for a period of time by him or herself or by an untrained relative or associate, along with periodic monitoring by skilled providers through the tele-connection. These systems may have diagnostic elements such as a blood pressure cuff, stethoscope, scale, and blood glucose monitor, plus a video camera and/or telephone modem. The need of the Community Based Health Services SIG was to collaborate with the LAPOCT SIG to begin developing the modeling and compatibility with the RIM and with the work already initiated on Version 3 by the LAPOCT SIG. The LAPOCT SIG agreed that it was appropriate to undertake this effort and it was agreed that this could be initiated at the September HL7 meeting. Representatives of IEEE who normally attend HL7 (e.g., Todd Cooper), will also be invited, since IEEE has already completed some modeling in this area. In the meantime, the Community Based Health Services SIG agreed to develop more use cases as examples of these systems and settings.

7. As of this ongoing meeting, Charles Hawker and Andrzej Knafel have served two years as the Co-Chairs of the LAPOCT SIG. Therefore we should have an election of Co-Chairs to serve the next two years. Charles Hawker indicated he will not continue to serve, having completed his role in the coordination of NCCLS standards with HL7. Those present at the meeting nominated Andrzej Knafel, Manish Narang, Jeff Perry, and Bob Uleski as new Co-Chairs. The election will be in October 2001.

8. Members of the Blood Bank SIG presented a need to have expiration dates for blood bank specimens and to clarify other issues involving Specimen Source. There are also other HL7 groups (LAPOCT SIG and Orders-Micro) with issues concerning Specimen Source. None of these existing groups is taking leadership relative to addressing these issues. This concern will be expressed to Orders & Observations in order to have that TC facilitate a subgroup to address the issues. The following individuals have agreed to serve on this committee although none was willing to chair this group:

Charles Hawker Gaby Jewell Patti Larson Ken McCaslin Claudette Murch Suzanne Nagami

Subsequent to this session, Scott Robertson agreed to chair this group.

9. Summary of actions on Monday from outside the LAPOCT SIG meeting:

a. The Orders and Observations TC, in a joint session with LAPOCT SIG, approved the reservation of 4 new trigger events, R30-R33, for publication and use in the implementation guide for how to use HL7 v2.4 in point-of-care (POC) connectivity applications. O&O also approved 4 motions that defined these proposed triggers and the conditions of their use in POC applications. The LAPOCT SIG will undertake to develop the complete proposals for these new trigger events and submit them to O&O for approval and inclusion in the next v2 ballot cycle. The details of these motions and the approved proposal from the LAPOCT SIG can be found in the O&O minutes.

b. The Technical Steering Committee approved the drafting of an authoritative statement to be sent from the HL7 Board of Directors to NCCLS based on the above actions and motions from O&O, and subject to the limitations outlined by O&O. Hans Buitendijk drafted this letter. It was reviewed and edited by Charles Hawker and Jeff Perry and printed for Board review on Tuesday evening.

10. Mike Henderson, a Co-Chair of the Control Query TC, lead a discussion of the steps that the LAPOCT SIG should follow to submit (and get approval for) a proposed new query that was requested by Sadamu Takasaka on behalf of the

Japanese users of HL7. Conformance statements must be prepared in order to present the proposal to Orders & Observations TC.

11. The Japanese request for new query messages was discussed. Sadamu Takasaka agreed to complete the proposal with the conformance statements and submit them to the LAPOCT SIG list by July 2001. After review by the LAPOCT SIG they will be submitted to the O&O home page of version 2.x proposals by August 2001.

12. Manish Narang presented for discussion a list of Host Query issues (action item from the January 2001 meeting).

a) Do we support only the ASTM approach to query, which allows specification of all, a range, or a specific ID? [No longer an issue.]

b) If we are more flexible by allowing query of multiple disparate IDs, should the responding system respond to all at the same time or only respond one at a time as programming is available? [In the response we will specify if the response is a complete response.]

c) What is the timeout for a response? [Timeouts will be specified as follows: Initial Timeout, Periodic Timeout, Completion Timeout, and Timeout Type - either periodic (provides a response to the query by every timeout event) or one-time only.]

d) How do we communicate to the responding system if a query is pending and the responding system is single threaded? [We don’t need to know the type of systems with which we are dealing, e.g., is sync or async communications required?]

e) Do we support a query to the instrument or only the LIS? [Both.]

f) When are timers required? [Optional – default behavior may be specified.]

g) Does HL7 specify requirements with respect to contention? [No, this an application issue. Here we only deal with message flows.]

h) What happens if the implementation is both point-to-point and single threaded? Does this mean that if both sides try to transmit a query and or result, they have to be in lock step? So, in this case, should queries wait for a response before sending up results or should results have priority and so queries should be deferred? [This will be dealt with as an application issue outside the scope of what we will be defining.]

i) If the query timer expires, do we assume the message was lost, do we resend the query, or do we first send an abort and then re-query? [Add a comment to

state that there is no default behavior specified as part of the standard, and that this will be negotiated on a site-by-site basis.]

j) Does the query/response need to be synchronous (i.e., should the query party wait for a response)? [No it doesn’t; but we don’t specify.]

k) When does the timer expire (there maybe a disagreement between parties as to when the timer starts and hence expires)? [We recommend the use of absolute time and a clock sync scheme.]

l) Does the other party reply to a query if the query is badly formatted, has insufficient information, or failed? [Yes, but a reject.]

m) How does a query get aborted prior to the timeout? [We need to look into this, perhaps in chapter 5, or we should come up with an ST action item.]

n) If we allow querying by a list of IDs, then the responses should be independent (but need to realize that the low-level implementation may preclude an efficient implementation). [Same as earlier, the responses can be independent or lumped; however this can only be implemented if we allow the fields in the query to be repeatable. Some in the group have suggested that we have a separate message that doesn’t allow repeatability in the query field.]

o) What happens if a query is required when a lot of orders are being downloaded and we are dealing with a point-to-point single thread implementation? [We are not going to specify the behavior here; we may create an application note stating this.]

13.Summary of action on Tuesday from outside LAPOCT SIG meeting: the HL7 Board of Directors approved the letter to NCCLS containing the Authoritative Statement requested for POC applications.

14.Austin Kreisler joined the LAPOCT SIG to explain some of the rules for mapping to the RIM for version 3 and to answer questions.

15.Charles Hawker presented the draft of a story describing a typical patient-testing scenario. The SIG members added the relevant messages and triggers to fit the story. The story was presented to the joint session with Orders & Observation and is attached to these minutes.

16.Provided definitions for tray, carrier, container, and specimen to Vocabulary.

17.Developed RMIM CMETs for Specimen, Placer Order, and Order Options.

18.Action Items, Agenda For October Plenary Meeting

a. By August, Jeffrey Perry and Andrzej Knafel will complete the revisions to the proposed new message triggers (R30, R31, R32, R33) requested for Point of Care, so that they are in a format that can be submitted for the version 2.5 ballot.

b. Monday, Quarter 3, work on remaining version 2 issues.

c. Monday, Quarter 4, 30 minutes only joint with Orders to review the version 2 Point of Care triggers and related messages referenced above.

d. Tuesday morning – election of SIG Co Chairs, work on remaining version 2 issues.

e. Tuesday, Quarter 3 – joint with Community Based Health Services and IEEE (we host) on Telemedicine proposal.

f. Tuesday, Quarter 4 – work on version 3.

g. Wednesday, all day – work on version 3.

h. Thursday all day – joint with Orders (they host) on version 3 laboratory issues.

i. Friday, Quarters 1 & 2 – version 3.

Minutes prepared by Charles Hawker and Andrzej Knafel