HL7



Attendees:

|Name |E-mail Address |Sessions Attended |

|Wayne Tracy |wrtracy@ |Tues: Q1-Q4; Wed: Q1-Q4 |

|Michelle Dougherty |michelle.dougherty@ |Tues: Q1-Q4; Wed: Q1-Q4 |

|Bob Dolan |Robert.H.Dolan@ |Tues: Q1-Q2; |

|Nancy LeRoy |nancy.leroy@med. |Tues: Q1-Q4; Wed: Q1-Q4 |

|Calvin Beebe |cbeebe@mayo.edu |Tues: Q1-Q2; |

|Melanie Loucks |loucks@ |Tues: Q1-Q4; Wed: Q1-Q4 |

|Chandra Venkat |cvenkat@ |Tues: Q1, Q3; |

|Michael Welter |mike@ |Tues: Q1- Q2; |

|Tom DiCorcia |tdicorcia@ |Tues: Q1 |

|Andrea Sbona |asbona@ |Tues: Q1 |

|John Leslie |j.leslie@ |Tues: Q1 |

|Viet Nguyen |Viet.nguyen3@med. |Tues: Q1- Q2; |

|Karen Statzer |Karen.statzer@ |Tues: Q1- Q2; |

|Sarah Dahlhauser |sdahlhauser@ |Tues: Q3- Q4; Wed: Q1, Q2, Q4 |

|Scott Robertson |Scott.m.Robertson@ |Wed: Q1 |

Tuesday, September 9, 2003:

• Q1: Joint Meeting with Structured Documents for ballot reconciliation 3.0 2nd membership ballot.

• Q2: Discussed the status of the LOINC document codes and made recommendations on how they can be used from a medical records perspective. The LOINC meeting will be in Salt Lake City; Wayne, Viet (VA), and possibly Melanie Loucks will be attending the open meeting on September 29th.

• Q3 and Q4: Continued work on developing messaging standards for V2.6 consents, but decided to broaden the title of this type of documentation to include “medical/legal agreements” which includes consents, agreements, acknowledgements, release/approvals, requests/approvals, transfer of power legal agreements, and advanced directives. The committee defined medical/legal agreements, identified general behaviors of the broad type of documents, defined the various types of medical/legal agreements and identified examples for: Consent for therapeutic intervention, release of information/disclosure, administrative, acknowledgement/notification, clinical release/approval, requests/approval, legal transfer of power agreements, and advanced directives.

• We are asking the international community to look at the medical/legal agreements, categories/types and examples and identify similar documents used in countries outside of the US.

Wednesday, September 10, 2003:

• Vote: The MR/IM committee has decided the v3 medical record ballot should be a draft standard for trial use. The committee will start gathering feedback immediately and work to move the standard from draft to full within 18 months. Committee Vote: 6 – in favor, 0 opposed, 0 abstained.

• Q1: Continued work on medical/legal agreements by defining legal transfer of power agreements and advanced directives.

• Q2: Attended a joint meeting with structured documents and templates. Demonstration on ADL templates from Templates TC. See Structured Documents minutes for details.

• Q3 and Q4: Continuation of brainstorming session creating definitions and use case scenarios for various types of medical legal agreements.

• Call for samples: We would like multiple samples of each of the type of documents for our next meeting (a blank form and one completed for a patient with patient identifiers redacted): authorization/release of information, administrative documents, acknowledgements/notification; clinical release/approval; requests/approval, legal transfer of power agreements, and advanced directives.

Tuesday, September 9, 2003

Q1: V3.0 Medical Records Ballot Reconciliation

A joint meeting was held between MR/IM and Structured Documents to review the negative comments from the 2nd membership ballot for V3.0. There were 3 comments. All negative comments were resolved with the exception of one non-persuasive. Siemens withdrew their negative ballot upon the discussion that Wayne Tracy conducted with them before September’s Working Group meeting due to Siemens being unable to have a representative with the MR/IM technical committee. Below are the changes, which were voted in resolution to the negative comments. For more detailed information on the ballot results, negative comments, and responses refer to the file titled V3.0 medical records ballot (9-03).

1. Rename DMIM to Medical Records Clinical Documents

Reason: This area represents documents from MR/IM and SD.

2. Name change for Storyboard to Clinical Document Core Lifecycle

Reason: This led to the discussion that this area describes the birth and death of a document. Michelle Dougherty brought up the point that this does not fully represent the birth and death as it does not include purging, archiving or cancellation. A consensus was agreed upon to change the name.

3. Visio tool problem not displaying correct description on the link.

Reason: Bob Dolan clarified that if you disconnect and reconnect the link the problem is resolved.

4. A comment was asked to create a mapping from V2.4 to V3.0. MR/IM committee’s response this is

Non-persuasive for 2 reasons.

• MR/IM have gone to great lengths to ensure compatibility to V3.0.

• ARB/TC viewed this as out of scope

Q2: Discussion in the status of the LOINC V2.09 Documentation codes. Also, provide a recommendation to LOINC in how they are used from a medical records perspective.

Issue: Searching in the LOINC code database.

Wayne brought up the concern there needs to be clarification regarding the naming convention and that it should contain the behavior. He used the example of the word report versus document. He explained that some reports are not in Medical Records and are printed on the floor. In addition, he said that each patient has a cumulative summary and temporary reports. Concerns from other individuals regarding there is a risk of combinatorial explosion with the use of LOINC codes because they felt the descriptions were too vague.

Bob explained that LOINC’s approach is to serve as a generality and not to contain a list accommodating of every provider needs. A reasonable amount of LOINC codes was increasing the number to 1000. Bob further stated that LOINC does not have the intention of containing a large amount of document codes. His recommendation that LOINC must work in a hierarchical and reference terminology correctly so there is the ability to aggregate.

Conclusion: Wayne would like to see the methodology written in the LOINC manual to obtain consistency.

Q3 and Q4: Brainstorm session creating uses case scenarios for various types of Medical Legal Agreements. These Medical Legal Agreements will contain the following general behaviors in each category.

Definition of Medical/Legal Agreements

These documents are legal binding agreements that permit or require formal acknowledgment or acceptance by the patient or representative.

General Behaviors

• Patient eccentric

• Each document may contain signatures by the patient or representative for the approval, acceptance, acknowledgement, or validity

• There may be a need for additional approvals or acknowledgements

• Documents may be time sensitive and require organizational approval

• Each type of medical legal agreement may use a predefined template that contains specific text to address the agreement

• Title or purpose of each agreement would include one of the following terms:

Consent, Release, Authorization, Acknowledgment, or Requests

1. Therapeutic Intervention (procedural)

Definition: Medical Treatment or Procedure Consent (therapeutic intervention). Requires a description of procedure. Procedure includes: drug intervention, invasive procedure, participation in clinical trial, risks, complications, side effects, and outcomes/benefits. A consent may include: alternatives, convalescence, anticipated events if intervention is not done (if applicable (fed regs for VA), and signatures: patient (legal rep); provider; witness (not always required).

a. Drug i.e. psychotic, I.V. contrast

b. Invasive surgery – includes OR procedures (endoscopy) and

Non-OR procedures (lesion removal in physicians office)

c. Clinical Trails/Research

d. Non-Invasive transfusions i.e. blood products

e. Anesthesia

f. Immunization

g. General consent to treat (omnibus)

h. Refusal of therapeutic intervention

2. Release of Information/Disclosure

Definition: This document is utilized to provide authorization for information to be disclosed. The authorization describes info to be disclosed, limitations to use, patient specific, party(s) allowing disclosure, limited time period, purpose of use/disclosure, signed by patient/individual, may be witnessed or notarized if required. Authorizations are not typically signed by provider.

Similar types of documents related to release/disclosure of information includes: Request to Restrict Access, Request to Remain Anonymous, Authorization to disclose information, Disclosure to family and friends.

a. Information to be disclosed

3. Administrative

Definition: An administrative consent is a type of consent that does not directly impact the care of the patient. These type of consents contain a description of what is being consented to, in some cases, permits certain types of media to be used (i.e. photo, video), and are often used to mitigate financial or medical liability. Generally, the provider is not required to sign, it is preferable to have the patient sign, and is possible to have a witness sign.

a. Release of limb

b. Consent to photograph or videotape

c. Organ donation

d. Autopsy

e. Refusal of Treatment (AMA)

f. Transfer

4. Acknowledgement/Notification

Definition: An acknowledgment or notification is a type of document in which the patient is signing that they have received documentation or information from the facility. Acknowledgments are patient specific and include the patient signature. The documentation on the form is the notification from a care provider and the patient verifies/acknowledges that received information by their signature.

a. ABN

b. Receipt Bill of Rights

c. Notification of exposure (communicable diseases)

d. Notification of discharge (patient

e. Right of Advance Directives information

5. Clinical Release/Approval

Definition: A paper or electronic document, which is created by the patient to be signed by a clinician to request an exemption from complying with a law/regulation due to a medical condition. Also this may apply for the removal of a restriction once conditions have been met and approved by the clinician. We recommend that if a clinician signs the document that the organization retain the original and once compliance has been met return the document.

a. Release from seat-belt use

b. Obtain Handicap parking information

6. Request/Approval

Definition: This document is utilized when a patient or patient’s representative is requesting the entity to perform an action and each request requires the entity to respond. Generally these documents are non-clinical in nature due to the HIPAA regulation. (USA)

a. Request for MR amendment/response

b. Request for restriction (access, disclosure, directory info, anonymity)

c. Request for accounting of disclosures

d. Request for confidential communication (alternate address & phone number)

7. Legal Transfer of Power Agreements

Definition: These documents transfer decision-making authority from the patient to a third party. The

process for obtaining, scope and content of these documents are defined and/or controlled by prevailing

law. These documents may describe under what circumstances these powers are transferred and/or

revoked to a third part and any restrictions or limitations.

a. Power of Attorney

- General Power of Attorney (Typically over financial issues)

- Health Care Power of Attorney (The durable power of attorney for health care is the legal

document that names a patient's health care proxy. Once written, it should be signed, dated,

witnessed, notarized, copied, distributed, and incorporated into the patient's medical record.

-Limited or Special Power of Attorney (A power of attorney for a limited purpose)

- Revocations

8. Advance Directives

Definition: These documents describe the circumstances under which care services should be withheld. In order to be considered valid these documents are signed by the patient or their respresetaive and authenticated by a witness or notary and acknowledged by the providers staff.

Advanced care directives allow patients to make their own decisions regarding the care they would prefer to receive if they develop a terminal illness or contract a life-threatening injury. Advanced care directives are also used to designate someone the patient trusts to make decisions about medical care, if the patient becomes unable to make (or communicate) these decisions.

a. Organ donation

(This may be accomplished by completing an organ donation card and carrying it

in your wallet. A second card may be placed with important papers (such as a

living will, insurance papers, and so on.) Most hospitals or other major health care

centers have organ donor information available.)

b. Living Wills

A written, legal document that conveys the wishes of an individual in the

event he/she becomes terminally ill and incapable of communicating. A living will

may indicate specific care or treatment the person does or does not wish to have

implemented in the event of a terminal illness. This may include specific

procedures, care, or treatments such as the following:

- CPR, if cardiac or respiratory arrest occurs

- Artificial nutrition through intravenous or tube feedings

- Prolonged maintenance on a respirator, if unable to breathe adequately alone

- Blood cultures, spinal fluid evaluations, and other diagnostics tests

- Blood transfusions

9. International Categories – We have set aside a category for other types of medical legal agreements that are found in non-US healthcare settings. We ask for assistance from the international community in identifying additional types of documents. This category will be deleted if unnecessary.

Wednesday, September 10, 2003

Q1: Continuation of Brainstorm session creating definitions and use case scenarios for various types of Medical Legal Agreements. Refer above to the Medical Legal Agreement section.

A discussion was held for V3 to become standard. Wayne explained, there are two options: declare V3 to become standard or declare V3 as a draft standard for trial use. The ANSI requirement for a draft standard for trial use is that the version has a time frame that it cannot become standard less than 6 months and not more than 3 years. At that time the version must be declared it to be standard or be removed.

A discussion was held describing the benefits of declaring V3 a draft standard for trial use. First, it was felt that the medical records chapter in V3 in not totally completed. Next if there are early adopters they could provide feedback for areas in need of clarification or additions. Also, if we receive feedback requiring adding or withdrawing an attribute it can be done without performing a balloting cycle. Another advantage to the draft standard for trial use is the concern with unknown problems with the data types. The board commented that the website would provide an area for early adopters to provide their feedback.

A motion was made for V3 to become a draft standard for trial use and begin gathering feedback immediately. A time line was voted to move the draft to standard in 18 months from the September meeting.

Q2: Joint meeting with Structured Documents and Templates. Demonstration from Templates

committee on ADL templates. Refer to Structured Documents minutes

Q3 and Q4: Continuation of Brainstorm session creating definitions and use case scenarios for various types of Medical Legal Agreements. Refer above to the Medial Legal Agreement section.

Meeting Follow Up:

Hold a conference call Tuesday, November 4, 2003. Michelle will coordinate the call and provide the phone numbers and password once it has been confirmed. The agenda for the call is the following:

• Discuss the Medical Legal Agreements for any additions or modifications

• Obtain professional forms for each agreement (blank and anonymous)

• Assign each Medical Legal Agreements to a committee member

• Perform an analysis of the content in relation to the HL7 segments

• Discuss the Decision-making Practices document, Version 1 by the Process Improvement Committee

• A request was made to combine the information from the April and September Working Group Meeting minutes regarding the Medial Legal Agreements in one document. Michelle and Melanie will provide that document

Agenda for January Meeting:

1. Each committee member who has been assigned a Medial Legal Agreement will provide the following information:

• Provide an example that is currently being utilized

• Explain findings after performing an analysis of the content in relation to the HL7 segments

• Discuss any deficits such as data elements

• Create a model to validate the content and data relationships

• Build the message segments and begin drafting the field textual definitions

2. Review examples, compared contrasted, and identified data element gaps. (2 quarters) (compare and contrast is mapping data content to the message segments)

3. Model the 4 types of medical legal documents – consents, authorizations, notices, and acknowledgements. Meet with Bob Dolan for modeling in V3. Purpose of the modeling is to validate the logical content and structure and data relationships. (2 quarters)

4. Populate/construct the proposed segments, build message notations, and begin drafting the textual field definitions

5. Complete V2.6 scoping statements for May meeting

6. Complete Decision-making practices document for HL7.

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