HL-7 Medical Record/Health Information Management



Attendees:

Tuesday Morning: Joint meeting between Medical Records/Health Information and Structured Documents. Wayne Tracy, Bob Dolin, Michelle Dougherty, Rhonda Sato, Mike Cassidy, Vassil Peytchev, Sandy Boyer, Calvin Beebe, Shekhar Sharma, Pai Jung Huang, Janet Washington.

Tuesday Afternoon: (Discussion on HIPAA privacy issues) Wayne Tracy, Michelle Dougherty, Rhonda Sato, Dean Ibaraki.

Wednesday Morning: Joint meeting between Medical Records/Information Management and the Structured Documents. Wayne Tracy, Bob Dolin, Michelle Dougherty, Rhonda Sato, Calvin Beebe, Andrew Woyak.

Wednesday Afternoon: Wayne Tracy, Michelle Dougherty, Rhonda Sato, Robin Zimmerman, Joann Larson, Jean Spohn, Suzanne Nagami.

Highlights:

• Analyzed and discussed the merged MDM/CDA Hierarchical descriptions presented by Bob Dolin in a joint meeting between MR/IM and Structured Documents. (Tuesday morning and Wednesday morning).

• Reviewed HIPAA privacy rules and discussed items which will need to be or potentially will need to be addressed. (Tuesday afternoon)

• Reviewed submitted proposal to clarify MDM usage. This proposal was previously proposed and approved by the Orders and Observations TC on Monday, May 7, 2001 and was presented and approved by the MR/IM TC.

• Ballots and Results:

• Voted unanimously to use the VISIO graphic tool (will be modified to an enhanced version) as the way to analyze and vote on the content of the R-MIM.

• Voted unanimously to accept a proposal to clarify MDM usage as approved by the Orders and Observations TC on Monday, May 7, 2001 and is presented for approval by the MR/IM TC.

• The group discussed and took a ballot to agree in principal with the modifications to add full ordering context to the existing MDM messages.

• Deprecation Issues:

• (CDA) Move the “signature time” from interval to point in the following– originator, patient, provider.

• Move “transcriptionist” to a singular rather than multiple.

• Outstanding/Future Issues:

• Vocabulary for the term “provider.”

• Address handling of documents originated by a patient (pre-admission questionnaire or patient amendment).

• Multiple providers in the heading for legal authenticator for the document as a whole.

• TX19 – Document Availability Status: Discussion related to whether an “unavailable” document is defined as “new” in version 3. Concerned that this definition/vocabulary is a poor word to describe a document’s availability status rather than the “newness” of a document.

• Address in the future a shortfall in which a use case where collaborative (multi-authored) documents are not deterministically treated.

• Need ability to track the actual assigned legal authenticator who is assigned separate from the actual authenticator. Need to add a refinement that doesn’t exist in the current CDA chapter.

• Nested OBX’s: It was discussed to allow Structured Documents to have OBX’s associated with a header to allow nesting. MR/IM will want to be involved in the future, but will allow structured documents to create the mechanism. Discussed need to use multi-media in a document.

• Discussed the originator in the act-context in the R-MIM. At this time will not include additional messaging for the originator in the act-context. This should be addressed in the future.

• A formal ballot will need to be taken in follow up with the discussion and vote-in-principle- on modifications to full ordering context to the existing MDM messages.

• Further discussion needed -- the group discussed obtaining use cases for a note for OBX and what it means in the document.

Tuesday Morning:

Joint meeting between Medical Records/Information Management and Structured Documents.

Wayne reviewed issues related to a confidentiality hierarchy to apply to an entire document rather than components of a document. Applying the 3 level hierarchy used by Structured Documents that would lend itself well to the medical records component. Wayne has worked with Bob from the Structured Documents TC to apply the 3 level hierarchy to medical records.

Bob from Structured Documents presented the VISIO used to describe the MDM/CDA R-MIM. He delivered a presentation to help the joint TC to understand the merged MDM/CDA R-MIM and hierarchical description to get the committee to a level where we will be comfortable balloting by the end of the day Wednesday.

• Bob reviewed TXA Mapping. There was discussion related to whom the role was scoped by.

• Maintaining of unique document names will be included in Clinical LOINC, but it will be an open table and allow additional document names to be added. Clinical LOINC will include unique names for documents and will be the keeper of the document names. Advantage over 1.02 architecture where we had to maintain table 270.

Open Issue for Data Types to be resolved prior to ballot:

• Discussion related to the TMR and assigning one time stamp versus an interval of time. When there is capability to record an interval, however, only one time will be applied, it is ambiguous whether the time recorded should be at the start or at the stop. The group concurred that if it is ambiguous that we will have to supply the final HMD with the assumption of which one it will be when the structure supports two times. One company present (Softmed) has addressed this and reports the end time when the TMR can be reported in intervals. After discussion it was decided that this be consider this an open issue for Data Types. MR/IM TC recommends that there be a single data type.

• Currently birth date time and origination are the only times that are defined as points. Would like to remove interval times for the following and move to a point – authenticator, legal authenticator.

• Deprecation Issue (CDA) – The following will move from interval to a point – originator, patient, provider. In the e-mail announcing the deprecation, will ask for real case studies. If there is a use for interval, then will keep as interval rather than moving to a point. If there are no real life examples will deprecate it and move to a point.

Vocabulary Issue: Need to work on a vocabulary issue for “provider” term used in the header. Separate from that responsible/primary provider concept that are in use in specialized use settings (teaching hospitals, OR’s).

Future Enhancement: Need further evaluation on how to address patient amendments/patient entries in the medical record under this model. Currently, only providers are “participant” which is constrained to formal members of organization. There is a potential need to expand to patient, parent, or legally responsible party. For example, this could be for the implementation of a pre-admission questionnaire or a patient amendment.

Tuesday Afternoon:

Medical Record/Information Management TC: Discussion focused on HIPAA privacy mandates.

In version 2.4 the Orders and Observation TC began to put consent information.

HIPAA Privacy Issues:

• Consent for treatment, payment, and healthcare operation (as mandated by HIPAA) as well as other healthcare consents related to specific medical treatment. Need ability to report status of a consent (i.e. one has been obtained) and a second message is the communication of the content of the consent (what did they consent to, who signed, etc.), and third the potential to electronically obtain a consent (message to send and message to return when signed). Also consider the ability to track patient’s advanced directives (i.e. living will, durable power of attorney, etc.).

• Need to build messaging related to a consent including the signatures and restrictions in time and purpose.

• Under HIPAA, the patient has the ability to request limited access to their health information that may include excluding specific providers from access to their records/information. Will need ability to allow for limitations in access and restrict their uses (restriction in purpose of uses and restriction in time for use of information).

• Outlined four classes of potential users of the medical record:

1) Formal association with patients – i.e. attending, admitting, consulting physicians.

2) Direct care providers involved in care delivery, but having no established formal relationship to a patient; healthcare providers not documenting in the chart who have a temporal need to access your record or know your information – appropriate access should only be for the short period of time; (e.g. the nursed assigned to the patients current care location).

3) Indirect care providers with broad patient responsibility (no direct care or temporary limitation but a functional need to access information). Need access to a broad number of patient records. Example, hospital hematologist, staff epidemiologist.

4) Administrative (versus clinical) functions which require access to records/information. Example, chart financial auditors.

• Discussed not actually prohibiting a provider from accessing records to prevent unnecessary steps for obtaining access in emergency situations that may compromise patient care. Would recommend using audit trails, timely review, and follow up with staff who inappropriately access records.

The following HIPAA requirements will need to be discussed in the future to determine if there are messaging requirements.

• Authorization for Release of Information with required elements and ability to tracking release of information.

• Minimum necessary – ability to limit access/disclosure of information to only the minimum data necessary.

• Amendments made by patients to their records

• De-identification of Information

• Notice of Health Information Practices

• Reporting of Complaints – don’t expect that there will be any messaging requirements although it is expected that there will be applications similar to incident reporting developed.

DHHS in the comments to introduce the final privacy rule, indicated that they will write guidelines to assist in further clarifying information requirements.

AHIMA produced practice briefs (practice guidelines) for HIM professionals in addressing HIPAA related issues particularly related to privacy. The practice briefs are available on AHIMA’s website to both members and non-members at , click on “Ready Resources” and then “Practice Briefs.”

The HIPAA regulations can be accessed and downloaded on the Administrative Simplification website at:

Wednesday Morning:

Joint meeting between Medical Records/Information Management and Structured Documents.

Bob Dolin will be revising the graphic display of the merged MDM/CDA hierarchical description based on discussion from this meeting. Group continued to review the VISIO of R-MIM and analyzed/discussed content.

|Ballot: |

|Voted to use the VISIO graphic tool (will be modified to an enhanced version) as the way to analyze and vote on the content of the |

|R-MIM. |

|Ballot Results: Unanimous – 6 in favor, 0 opposed, 0 abstentions |

Clarification requested/discussed: Primary activity provider – is the provider that has primary responsibility for the services that took place. Discussed whether provider can be misconstrued to mean the organization rather than a person, however, this was clarified as the “responsible individual healthcare provider” as defined by the role.

Open Action Item: Need ability to track the actual assigned legal authenticator who is assigned separate from the actual authenticator. Need to add a refinement that doesn’t exist in the current CDA chapter.

Discussed whether it was necessary to scope the identifier to the health care institution. It was decided that it was necessary to scope to the healthcare institution because of limitations in the OID reference table. There are two ways to bind the identifier to the reference table 1) communicate/messages via a HL7 reference table or 2) define the scope for identifier, authenticator, legal authenticator, originator, provider, transcriptionist.

Discussed TX19 – Document Availability Status: Discussion related to whether an Unavailable document is defined as “new” in version 3. Concerned that this definition/vocabulary is a poor word to describe a document’s availability status rather than the “newness” of a document. (Open Issue)

TX23 - Distributed copies field has been represented in version 3 as intended recipient and is fully covered.

Signature codes: Will add a value to the RIM – three values = required, intended, or obtained.

Intended Recipient = no signature code (not applicable)

Intended Authenticator = there is an intention to have a value of signature required,

intended or obtained

Intended Legal Authenticator = signature code can be required or obtained.

Deprecation Issues:

Plan to announce deprecation issues via the Web/List-Serve and request comments on the change. Feedback from the web/list-serve should show cases in which this is required or planned to be used.

• Move “transcriptionist” to a singular rather than multiple.

Open, Outstanding, or Future Issues:

• Multiple providers in the heading for legal authenticator for the document as a whole.

• TX19 – Document Availability Status: Discussion related to whether an Unavailable document is defined as “new” in version 3. Concerned that this definition/vocabulary is a poor word to describe a document’s availability status rather than the “newness” of a document.

• Address (in the future) the use case where collaborative (multi-authored) documents are not now deterministically treated.

• Nested OBX’s: It was discussed to allow Structured Documents to have OBX’s associated with a header to allow nesting. MR/IM will want to be involved in the future, but will allow structured documents to create the mechanism. Discussed need to use multi-media in a document.

• Discussed the originator in the act-context in the R-MIM. At this time will not include additional messaging for the originator in the act-context. This should be addressed in the future.

• Note: Compound documents mandated by HCFA (i.e. Minimum Data Set) require document to be authenticated by all authors and that the specific sections of the document be linked back to the author/authenticated.

Wednesday Afternoon:

Joint meeting between Medical Records/Information Management

Proposal 1:

Reviewed submitted proposal to clarify MDM usage. This proposal was previously proposed and approved by the Orders and Observations TC on Monday, May 7, 2001 and is presented for approval by the MR/IM TC.

The proposal is included here:

Clarify MDM vs. ORU Usage

Short Description:

Add language to chapters 7 and 9 clarifying when the MDM message should be used rather than the ORU.

Justification:

Continuation of a portion of a proposal originally submitted by Kaiser Permanente to the Fall 2000 Working Group meeting in St. Louis. The MDM Subcommittee has reviewed and modified the proposal again in Orlando’s January Working Group meeting. The current proposal supports the general consensus that Chapters 7 and 9 should be clarified to reduce the current ambiguity regarding the ORU and the MDM.

Original Problem Statement:

There is considerable difficulty in interpreting the HL7 Standard when implementing transcription messages. For example, if the reader is looking for direction on what message to use for a transcribed lab pathology report the standard is ambiguous. After reading the Document Management (MDM) messages as described in section 9.4 of chapter 9, it would appear that the MDM message is appropriate, although lab pathology is not a suggested value in user-defined table 0270 Document Type as used in TXA-2 Document Type. Section 7.1 of chapter 7 speaks broadly and vaguely about structured reports. The reader is not referred elsewhere, such as chapter 9, for transcribed reports. Indeed, the presence of a Transcriptionist field in the OBR segment, specifically OBR-35 suggests that the ORU is a valid mechanism for transmitting transcription reports.

We believe that HL7 should clearly and unambiguously designate which message is to be used for transcription; there should not be 2 applicable to the same function.

Solution:

7.2 - Purpose

This chapter describes the transaction set required for sending structured patient-oriented clinical data from one computer system to another. A common use of these transaction sets will be to transmit observations and results of diagnostic studies from the producing system (e.g., clinical laboratory system, EKG system) (the filler), to the ordering system (e.g., HIS order entry, physician’s office system) (the placer). However, the transaction set is not limited to such transactions. Observations can be sent from producing systems to archival medical record clinical information systems (not necessarily the order placer) and from such medical record systems to other systems that were not part of the ordering loop, e.g., an office practice system of the referring physician for inpatient test results ordered by an inpatient surgeon. This chapter also provides mechanisms for registering clinical trials and methods for linking orders and results to clinical trials and for reporting experiences with drugs and devices.

These transaction sets permit the transmission of any kind of clinical observations including (but not limited to) clinical laboratory results, the results of imaging studies (excluding the image), EKG pulmonary function studies, measures of patient status and condition, vital signs, intake and output, severity and/or frequency of symptoms, drug allergies, problem lists, diagnostic lists, physician and nursing history, physicals, progress notes, operative notes and so on.

These transaction sets permit the transmission of clinical observations including (but not limited to) clinical laboratory results, measures of patient status and condition, vital signs, intake and output, severity and/or frequency of symptoms.

If the observation being reported meets one or more of the following criteria, then the content would qualify as a medical document management message (MDM) rather than an observation message (ORU). The reader is referred to the MDM message type in Chapter 9.

• Documents/reports where the whole requires a signature or authentication as part of the message.

• Documents/reports that require succession management to reflect the evolution of both document addenda and replacement documents. Succession management is described in Chapter 9.

• Documents/reports where the Sender wants to indicate the availability of the report for use in patient care using the availability status present in the TXA segment, as described in Chapter 9.

Additional considerations that may affect the appropriateness of using an MDM message:

• Documents/reports where the content as a whole requires special confidentiality protection using the confidentiality status present in the TXA segment, as described in Chapter 9.

• Documents/reports where document storage status is useful for archival and purging purposes using the storage status present in the TXA segment, as described in Chapter 9.

Using these criteria, the following examples of documents/reports would typically qualify as medical document management (MDM) messages:

• History and Physical

• Consultation reports

• Discharge summaries

• Surgical/anatomic pathology reports

• Diagnostic imaging reports

• Cardio-diagnostic reports

• Operative reports

Usage Notes:

• Transcription is not a defining quality for the selection of an MDM or ORU message. In an MDM message, the document/report is typically dictated or transcribed, but not always. Machine-generated or automated output is an example of a document/report that is appropriate to the MDM but is not transcribed.

9.2 - Purpose

This chapter currently supports document management. In the future, it is intended also to support the data exchange needs of applications supporting other medical record functions, including chart location and tracking, deficiency analysis, consents, and release of information. The main purpose of the medical record is to produce an accurate, legal, and legible document that serves as a comprehensive account of healthcare services provided to a patient.

Documents/reports supported in this chapter will meet the criteria as described in Chapter 7 (section 7.2 - Purpose).

(The following material should be removed from the chapter.)

This chapter defines the transactions at the seventh level, i.e., the abstract messages. Various schemes may be used to generate the actual characters that comprise the messages according to the communications environment. The HL7 Encoding Rules will be used where there is not a complete Presentation Layer. This is described in Chapter 1, “Relationship to Other Protocols.” The examples in this chapter were constructed using the HL7 Encoding Rules.

After review and discussion the MR/IM technical committee voted:

|Ballot: |

|Approve proposal to clarify MDM usage as approved by the Orders and Observations TC on Monday, May 7, 2001 and is presented for |

|approval by the MR/IM TC. |

|Ballot Results: Unanimous – 6 in favor, 0 opposed, 0 abstentions (1 attendee not present for vote) |

Proposal 2:

The group discussed and took a ballot to agree in principal with the modifications to add full ordering context to the existing MDM messages. In the interim will schedule phone conferences to review use cases to assure placer and order repetition logic is appropriate. 1) For the placer order number fields. 2) Review use cases and potentially add note segments associated with the order information.

|Ballot: |

|The group discussed and took a ballot to agree in principal with the modifications to add full ordering context to the existing MDM|

|messages. |

|Ballot Results: Unanimous – 6 in favor, 0 opposed, 0 abstentions (1 attendee not present for vote) |

Additional discussion for future consideration: The group discussed obtaining use cases for a note for OBX and what it means in the document. Use case discussed was using a note to point to a scanned document. This was considered non-persuasive.

Agenda for the HL-7 Medical Record/Information Management Technical Committee Meeting in Salt Lake City, UT, October 2 and 3, 2001

Agenda Items:

Tuesday AM:

• Joint meeting with Structured Documents for ballot package review of the version 3 MDM message

Tuesday PM:

• Joint meeting with Scheduling and Logistics to continue to advance version 2 and 3 modeling efforts on chart tracking. MR/IM TC will act as the.

Wednesday AM:

• Joint meeting with Structured Documents for ballot package review of the version 3 MDM message.

Wednesday PM:

• Formal ballot on the modifications to add full ordering context to the existing MDM messages.

• Consents and continued discussion of HIPAA issues.

Minutes approved and submitted by: Minutes Taken by:

Wayne R. Tracy, M.S. Michelle Dougherty

MR/IM Technical Committee Cochair Member of the MR/IM TC

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