Comments of the IEEE-USA Medical Technology Policy Committee (MTPC) On the 2014 Edition EHR Certification Criterion

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1 Comments of the IEEE-USA Medical Technology Policy Committee (MTPC) On the 2014 Edition EHR Certification Criterion (g)(4) Safety-Enhanced Design as proposed in: DEPARTMENT OF HEALTH AND HUMAN SERVICES (DHHS) Office of the Secretary 45 CFR Part 170 RIN 0991 AB82 Health Information Technology: Standards, Implementation Specifications and Certification Criteria for Electronic Health Record Technology, 2014 Edition; Revisions to the Permanent Certification Program for Health Information Technology AGENCY: Office of the National Coordinator for Health Information Technology (ONC), DHHS. ACTION: Proposed Rule Introduction On 7 March 2012, in Federal Register Vol. 77, No. 45, DHHS published proposed revisions to CFR Part 170 (Health Information Technology), with a call for comments by no later than 5 p.m. on 7 May Here, we focus our comments on revisions in the area of Safety-Enhanced Design (pp ). This section consists of three parts: Proposed Section (g)(4) Safety-Enhanced Design Consideration of additional certification criteria on Quality Systems Consideration of additional certification criteria on Patient Safety Events We focus on this section for a number of reasons, including: (1) Safety-Enhanced Design is a critical life-preserving component of health information technology (HIT). (2) Safety-Enhanced Design is a key element of closing the gap between optimal EHR technologies and many EHR technologies currently in use. (3) The 2014 Edition EHR Certification Criterion Revisions represent a significant and impactful step forward toward improving future HIT usefulness, effectiveness and safety. We hope to support and build on this important step forward. IEEE-USA, 2001 L Street, N.W., Suite 700, Washington, D.C USA Office: Fax: Web:

2 The comments below provide our response to the currently proposed rules on safety-enhanced design as stated in the 2014 Edition EHR Certification Criterion; and describe additional steps that are technically feasible to further address this issue. Comments Usability and Safety-Enhanced Design The usability of human-computer interaction (HCI) is a critically important aspect of the safety and reliability of electronic health record systems (EHR). If HCI is not carefully analyzed and designed it can cause such design induced errors as when: (1) Controlling computer functions requires excessive user attention that distract users (2) Information flow or presentation does not support appropriate user workflow (3) Feedback to the user is ambiguous about system state, or the state of a work product (4) Diverse sources of information must be integrated in an unplanned manner by the user. We agree with the report issued by the Institute of Medicine (IOM) on health IT and patient safety, recommending that: [t]he Secretary of HHS should specify the quality and risk management process requirements that health IT vendors must adopt with a particular focus on human factors, safety culture, and usability. [1] We also agree with ONC s statement that a significant step toward improving overall usability is to focus on the process of UCD [user-centered design] [2]; and that a gap exists between optimal usability and the usability offered by some current EHR technologies. [3] A source of this gap is a conventional EHR design process that focuses on the development of features and capabilities, often in isolation from their impact on the work of health care providers and the quality, efficiency and safety of that work. Certification criteria, such as the proposed rule , should further encourage a user-centered evidence-based approach, in which the impact on safety, quality and efficiency is a fundamental driver of the EHR design. 2.0 Use of Appropriate Standards in Certification We support ONC s proposed certification criterion that would entail EHR technology developers documenting that their UCD incorporates all of the data elements defined in the Customized Common Industry Format Template for EHR Usability Testing (NISTIR 7742), and the inclusion of that documentation in the publicly available testing results on which a certification is based. [4] We also support the use of a prioritized set of certification criteria and associated capabilities (i.e. use cases ), to which UCD would have to be applied. From a safety perspective, the eight proposed use cases (drug-drug interaction, drug-allergy interaction, medication list, medication allergy list, clinical decision support, medication administration record, electronic prescribing, and clinical information reconciliation) are a good starting point. While we agree with ONC that valid and reliable usability measurements exist [5], such as the EHR Usability Protocol (EUP) in NISTIR 7804 [6], we question ONC s position that it would be inappropriate at this juncture for ONC to seek to measure EHR technology in this way. [7] Usability is a quality of interactive software that can be objectively defined and evaluated. HCI standards to build usability into software are available for task analysis, user interface design and validation that critical or frequent tasks can be performed

3 under realistic conditions by intended users adopting standard evaluation protocols for EHR certification will benefit patients, EHR vendors and health care professionals--by addressing the issues in a systematic manner that increases safety for patients; increases predictability while providing tools for vendors; and increases efficiency for health care professionals--while reducing confusion, cost, liability, frustration, and reluctance to adopt EHR. Toward this end, we suggest additional standards below that should be considered for future adoption: ISO Standard 13407, User-centered Design (UCD)/NISTIR 7804 ISO defines a standard method of iterative design for building usability into an interactive system. It includes steps for the definition of the intended population of users, task analyses to identify functions that will add value to work performance, user interface design guidance and design evaluation. Since machine functions and user procedures must work together, task analysis is a strategic step where functions and complementary user procedures are developed. Task analysis for HCI was derived from remarkably successful experience with innovations in safety-critical systems, such as aerospace cockpits. A simplified version in NISTIR 7804 provides the information needed to adapt UCD for EHR managers to plan projects that will integrate UCD, identify skills of qualified staff, and monitor progress towards UCD objectives. 2.2 ISO Standard 25062, Common Industry Format for Summative Usability Tests (CCIF)/NISTIR 7742 ISO has been adapted to EHR in NISTIR The purpose in both is to provide a sort of Consumer Report on how well representative users were able to operate the EHR functions to perform the tasks the product is supposed to support during controlled, objective testing. If many of the test users cannot complete the tasks at all, the report allows non-technical customers to weed out candidate systems that are usability lemons. The standard requires the report to provide enough information for a customer to judge how well a product matches the customer s needs with: A) A description of the users who served in the test B) Any training users received C) Description of the test cases and test data D) The realistic test conditions Items A though D are commonly created during analysis and design, per UCD standard, and can be reused for the test. The test cases should represent the tasks that the product is supposed to add value to. For other labs to replicate the test, the standard also requires: E) The test protocols F) Test measures G) The procedures used for data analysis. The standard requires measures to cover effectiveness of task performance, efficiency of task performance, and user satisfaction. It does not set criteria levels for any measures.

4 4 Some EHR vendors have published objections that the scope of this type of testing would be unrealistic for an EHR that would be used in a wide variety of conditions [8]. The proposed rule for Safety-Enhanced Design mitigates this issue by defining an initial scope that is limited to eight specific activities for doctors to enter computerized orders, in which risk of patient harm is greatest from medication errors. These specifications provide boundaries for the scope of testing that mitigate the cost and practical issues for the size of the test. The experience from this limited scope is planned to provide the information needed to determine how the scope should be expanded incrementally. 2.3 Business Process Modeling Notation Standard (BPMN) BPMN is a standard of the Object Management Group, the largest standards organization for the software industry. The purpose of BPMN for EHR is to document and analyze health care workflow for improvement with information technology. Workflow modeling and analysis is widely recognized as a key step for health care improvement with information technology. The absence of any standard for workflow effectively prevents reuse of models or their reliable translation into software requirements. The BPMN standard was developed to address both of these problem areas. Importantly for safety, the BPMN standard has an explicit technique to represent exception handling to plan how the workflow will deal with error conditions. 3.0 Additional Requests for Comments In addition to the proposed safety-enhanced design certification criterion discussed above, ONC requested comment on two other safety-related criteria under consideration. 3.1 Recommendation for Quality Systems Management We agree with IOM that it would be useful to establish quality management principles and processes in health IT. [9] The purpose would be to document, analyze and improve best practices for developing EHR products that build in safety and usability. This recommendation is similar to establishing Capability Maturity Models (CMM) for EHR software development, with an emphasis on process improvement for safety and usability. As with CMM, we suggest the first step should be to document the current practice, and the eventual goal should be to develop the basis for certifying levels of capability for safe and usable interactive software. 3.2 Recommendation to Record Patient Safety Events The purpose of recording Patient Safety Events is to identify problem trends that are difficult to detect without aggregate data over many users. Currently, no convenient means for users to capture the conditions that led to an Event exists, and no standardization is in place to assemble and analyze data. We agree with ONC s proposal to require the initial steps: EHR products should have a feature that allows users to quickly and easily record the occurrence of an Event, back out of the condition, and capture a record of the data and conditions that led to it. The Event data should be easily uploaded to an eventual national patient safety database for trend analysis and solution development. 4.0 Two Additional Recommendations Below are two additional recommendations, not mentioned in the proposed rule, that we believe are worth consideration. 4.1 Recommendation for Information Architecture Analysis The purpose of an Information Architecture Measure is to determine how well the organization of information matches the needs of health care workflow. UCD does not currently consider the organization and flow of information across user tasks, or across users. Unmet coordination requirements increase error risks. For clinical care, UCD should be extended to specifically include the information architecture. Analytical

5 techniques should be developed to evaluate how well the information architecture meets the requirements of a specified appropriate workflow Recommendation for Patient Safety Risk Analysis The purpose of Patient Safety Risk Analysis is to understand the contributing factors to adverse events, and how the design of interactive systems can avoid or mitigate them. A method for Patient Safety Risk Analysis is given in section 5 of NISTIR The analysis model has four main components: (1) Use error root causes (2) Risk parameters (3) Evaluative indicators (4) Adverse events. The recommendation is to extend the task analysis of ISO standard to incorporate Patient Safety Risk Analysis. Finally, we note potential confusion as to whether or not summative testing is required, given first the requirement to document a UCD process that includes all of the data elements defined in NISTIR 7742, followed by the statement that it would be inappropriate at this time to measure EHR technology as described in NISTIR It is our interpretation that this means the vendors get to choose how to report, as long as the report includes all the content as described in CCIF/NISTIR IEEE-USA advances the public good and promotes the careers and public policy interests of more than 210,000 engineering, computing and technology professionals who are U.S. members of IEEE. IEEE-USA is part of IEEE, the world s largest technical professional society with 375,000 members in 160 countries. We appreciate the opportunity to comment on this important proposed rule and hope it is clear that while we recommend a number of additional opportunities to improve proposed (g)(4), we strongly support this first step to incorporate usability and UCD into safety-enhanced design of HIT, and seek to build on it. If you have questions, or for more information, please contact Deborah Rudolph, Manager, IEEE-USA Technology Policy Activities, at (202) ; or at Sincerely, James M. Howard IEEE-USA President JMH/dr:bc

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