May 19

QRPH May 19 Face-to-Face Meeting Minutes

Attendees:

• Floyd Eisenberg (Siemens) - Co-chair
• Jason Colquitt (Greenway Medical Systems) - Co-chair
• Harry Solomon (GE)
• Landen Bain (CDISC)
• Brian Bush (GE)
• Patty Craig (Joint Commission / HIMSS)
• Mick Halley (University Bank)
• Joanne Larson (Kaiser)
• Mary Lewis (RSNA)
• Judy Logan (HL7, OHSU)
• Jan Orton (Intermountain Healthcare)
• Gary Walker
• Damon Wittenberg (Greenway Medical Systems)

1. Review Agenda and Overview of Efforts:
   1. Clinical Research Profile
   2. Value Set White Paper
2. Clinical Research Profile
   1. Merged with Drug Safety Profile to manage the clinical research associated reporting of adverse events (CCD to CDASH component), but not the post-market surveillance of medication reactions or severe medication reactions. The latter requires Individual Case Safety Report (ICSR)-3 which is expected to be through balloting at HL7, ISO and CEN in December 2009. Mapping of ICSR to CCD (necessary for success of an implementation profile) will not occur until version 3.
   2. Reason for deferring post-market surveillance: With XFORMs, vocabulary is bound to the schema; FDA has implemented SPL in XFORMS but vocabulary is the challenge. Clinicians want to use the vocabulary that supports their workflow. A terminology service may be needed to provide the mapping from local vocabulary to a standard vocabulary. It is also challenging to harmonize the vocabulary to service multiple stakeholders and multi-purpose the data elements. Triggers for AE, may have a broad category and add human intervention; sensitivity is high, and specificity is low - err on the side of false positives; Re-training the workforce will enable more specificity. Roadmap is identified for future - participation of NCI/HL7 to slowly bring AE into a standard language known to HL7, a longer-term effort.
   3. ICSR has 2 flavors:
      1. International conference of Harmonization E2B; does not cover vaccines, devices or food; does not include combination products (e.g. drug/device, drug/biologic) – only supports use of MEDRA; extends use of MEDRA to code surgical, disease conditions; discussion using to code lab; MEDRA has incorporated some of the lab code test names; AE
      2. HL7 ICSR – developed as a broader use case – next release (v3) is what FDA is trying to get international consensus; HL7 includes food, devices and medications, and vaccines
      3. HL7 GIN – covers other adverse events – patient safety incidents like falls, processes – initial notification of incident; after this, would use Root cause and Underlying factors Message (RUM) – not yet developed;
      4. In the US, the Agency for Healthcare Research and Quality (AHRQ) is currently under contract doing analysis and creating a data set for patient safety HAI, ICSR, and GIN and other types of reporting into one large set. AHRQ, CDC, and FDA working to come up with common dataset data elements; Data requirements for these common elements are incomplete.
      5. Harmonization under ISO, HL7, CEN – scope strictly AE reporting; under way, but is currently incomplete.
      6. HL7 Workgroup RCRIM – ICSR-3
      7. BRIDG Biomedical Research Domain Grid - harmonization of Clinical research standards from HL7 RCRIM, CDISC, AE domain, Study data tabulation model - CDISC, HL7 ICSR, ICH E2B; need to determine if this needs to include animal information; considering device content
      8. ICSR-1 normative standard - drug/devices (HL7)
      9. ICSR-2 - possible interim; DSTU; developed for all products (includes food and device); vocabulary agnostic
      10. ICSR-3 - pick up the changes/gaps identified from ISO not currently in current DSTU. All requirements are available for ICSR-3, but the process of modeling is not complete
      11. CADSR: cancer data standards repository from NCI - some of the common data elements are more or less complex than the attributes they need to be bound to RMIMs
      12. CDC - V2 vaccine AE; not adopted by others including FDA
      13. MedDRA has a cost impact; it is proprietary with licensing fees
      14. SNOMED for clinical observations and lab
3. Value Set White Paper
   1. Modification of name to:
   2. Updates from suggestions thus far incorporated in the current document. Review by the group is encouraged for editing and wordsmithing.
   3. Research Use Case is still required. Content from the Quality, Research and Public Health Case Management white paper attempt in 2007 may fit the needs for the use case. Jason Colquitt and Landen Bain to review.
   4. Gastroenterology Measures (2) reviewed. Developed by a Joint Task Force of the American College of Gastroenterology (ACG) and the American Society of Gastroenterological Endoscopy (ASGE) as part of clinical outcome research initiatives.
      1. Adequacy of colonoscopy preparation – COL5
         1. There is no standard CDA constraint for a procedure report generically, nor for a colonoscopy report specifically. Without a common template a specific source for information (structured or otherwise) is not clear. Cardiac catheterization and Stress testing have DICOM templates; Diagnostic Imaging has an informative ballot in HL7 for a procedure report. None is available for GI procedures.
         2. Required elements for a Colonoscopy report are defined by CORAD. There is no specific coding scheme for these elements (e.g., LOINC, SNOMED) and no electronic format standard.
      2. Average duration of colonoscopies that do not include biopsies or polypectomies of 6 minutes or more - COL8
         1. Similar procedure report issues as “adequacy of colonoscopy preparation” above.
         2. This measure requires an aggregate report as a continuous variable. There is a defined population as with the other gastroenterology measure, but there is no specific numerator. The time of each procedure (start and end times defined) is documented and averaged over the total number of procedures. The measure does not fit directly into the XML from the Collaborative for Performance Measure Integration with EHRS. Similarly, the second Joint Commission measure (OP3) identifies the median time from admission to discharge from the Emergency Department for AMI patients transferred to another facility for a cardiac procedure.
   5. The committee agreed a single gastroenterology measure is sufficient and necessary to highlight the requirements of some existing specialty measures for specifications with EHR usage. The second (mean time of > 6 minutes) was chosen.
4. Drug Research Profile – Met with PCC 1:00 – 1:30 PM to discuss the “home” for this profile. It was agreed this profile will be managed in the QRPH Domain.
   1. ODM CDASH CDISC expert sought to assist with the Drug Research Profile work this week.
5. Joint Commission Measures
   1. Value sets shown for some of the indicators (Evaluation Management codes, Diagnosis codes, RxNorm for medications <requires some additional coding from RxNorm>, Fibrinolytic agents and ContraIndications require more effort)
   2. Location for information – agreed that CCD allergies and intolerances should be used. Similarly, a discharge summary is available in CCD format and includes medication reconciliation to represent the required information for prescription at discharge. The selection will need to describe the benefits of a single location preference in contrast to the multiple possible sources highlighted in the current measure specification for chart abstraction.