Patient-centered approach to Health IT Safety
Recommendations of Adoption Certification Workgroup
Here’s the text of a draft recommendation to be presented and discussed at the Health IT Policy Committee on April 21, 2010.
Meeting materials on ONC site
DRAFT DOCUMENT –
SUBJECT TO HEALTH IT POLICY COMMITTEE REVIEW AND APPROVAL –
PDF VERSION
April 21, 2010
Dear Dr. Blumenthal:
The HIT Policy Committee (Committee) gave the following broad charge to the Adoption-Certification Workgroup:
Broad Charge to the Workgroup: To make recommendations to the HIT Policy Committee on issues related to the certification and adoption of a certified EHR for every American by 2014, including issues related to workforce, training, etc.
This letter provides recommendations to the Department of Health and Human Services (HHS) on the topic of patient safety.
BACKGROUND AND DISCUSSION
On February 25, 2010, the Adoption-Certification Workgroup (Workgroup) held a hearing on the topic of patient safety related to the use of electronic health records. A summary of the hearing is attached. After the hearing was held, the Workgroup conducted several public phone conference calls during which possible approaches to this vitally important topic were discussed. Preliminary findings were discussed with the HIT Policy Committee during its meeting on March 19, 2010. Based upon the feedback that we received during these meetings and from the public, we are making the following patient safety recommendations, based upon the following goal:
Establish a patient-centered approach to HIT safety that is consistent with the National Coordinator’s vision of a learning health and healthcare system. To achieve this goal, a culture of improvement needs to be created by each healthcare entity.
HIT POLICY COMMITTEE RECOMMENDATIONS AND COMMENTS: NATIONAL OVERSIGHT PROCESS AND INFORMATION SYSTEMS
In order to create the conditions that enhance the ability to prevent unsafe conditions that could lead to injuries, information is needed on hazards and “near-misses.”
In order to create the conditions that enhance the ability to prevent unsafe conditions that could lead to injuries, information is needed on hazards and “near-misses.”
Recommendation 1.0 – A national, transparent oversight process and information system is proposed, similar to a Patient Safety Organization (PSO), with the following components:
Confidential reporting with liability protection (e.g.,. whistle-blower protection, confidential disclosure of adverse events)
Ability to investigate serious incidents
Provision of standardized data reporting formats that facilitate analysis and evaluation
Receive reports from patients, clinicians, vendors, and healthcare organizations
A reporting process to cover multiple factors including usability, processes, and training
Receive reports about all health information technology (HIT) systems
Receive reports from all Software Sources (e.g., vendors, self-developed, and open source)
Ability to disseminate information about reported hazards
While this recommendation appears to be necessary, it might not represent a complete response to all HIT patient safety concerns. Additional research is needed.
Recommendation 1.1 - We recommend that the Office of the National Coordinator (ONC) commission a formal study to thoroughly evaluate HIT patient safety concerns, and to recommend additional actions and strategies to address those concerns.
FACILITATE AND ENCOURAGE REPORTING
We learned that most unsafe conditions are not the result of a single software error. Instead, multiple factors are involved, including challenges with usability, processes, and interoperability. Healthcare organizations and clinicians represent a primary source of information about unsafe conditions. In order to encourage healthcare organizations and clinicians to report unsafe conditions, we make the following recommendations.
Recommendation 2.0 – Stage 2 of Meaningful Use should include a requirement that EPs and hospitals report HIT-related patient safety issues to an organization authorized by ONC to receive HIT-related safety reports (“HIT safety organization”). Copies of those reports should be sent to any vendors that might be involved.
Recommendation 2.1 – Certification criteria for EHRs should include functionality that makes it easier for clinician-users to immediately report any problems/concerns with information that appears on screens (a “feedback button”) to appropriate staff who can either make modifications themselves or escalate the problem to those who can. This feedback button could also be used by clinician-users to request corrections to data.
Recommendation 2.2 – The Regional Extension Centers should provide HIT-related patient safety reporting training.
VENDOR PATIENT SAFETY ALERTS
The certification process can be used to ensure that vendors provide safety alerts to their customers, and it can also be used to improve patient safety.
Recommendation 3.0 – We recommend that the Stage 2 EHR certification criteria should include requirements that vendors maintain records on all patient safety concerns reported by their customers, and that vendors have established processes to promptly provide all impacted customers with safety alerts.
PATIENT ENGAGEMENT
Patient Engagement plays a major role in identifying errors and preventing problems. For example, in ambulatory settings, in nearly every encounter when it is possible for patients to observe and discuss information as it is entered during the health care encounter, potential errors can be avoided. Through a personal health record (PHR) or patient portal, patients obtain the ability to review some of the data in their EHR, and, as a result, PHRs and/or patient portals should continue to be encouraged. Access by family members to inpatient medication lists should also be encouraged (assuming appropriate authorization from the patient). Mechanisms that make it easier for patients to report inaccurate or questionable data need to be encouraged as ―best practices.‖ Examples include (a) the use of a ―feedback button‖ that makes it easy for a patient to communicate with and receive feedback about system problems, and (b) a secure communication link, perhaps through a PHR, that permits patients to link back to the provider to report data corrections and omissions.
IMPLEMENTATION, EDUCATION, AND TRAINING
The implementation, education, and training processes can impact patient safety conditions. Training programs should include information about the value of reporting patient safety incidents and unsafe conditions in the context of broader educational efforts to create and continuously enhance cultures of patient safety.
INTEROPERABILITY
Interoperability problems are a significant source of patient safety concerns. As a result, ONC’s interoperability efforts continue to be extremely important
Recommendation 4.0 – The HIT Standards Committee should consider the concept of “traceability” of interface transactions. “Traceability” refers to the ability to trace and analyze the source of problems. The HIT Standards Committee is asked to consider techniques like requiring the use of audit trails or “logs” of interface transactions.
BEST SAFETY PRACTICES
Recommendation 5.0 - We recommend that ONC work with the Regional Extension Centers (RECs) and with organizations such as the American Medical Informatics Association (AMIA) to create a set of best safety practices for selecting, installing, using, and maintaining HIT, and disseminate those best practices to providers. Tools, such as Geisinger/Jim Walker’s Hazard Evaluation tool and Dave Classen’s flight simulator should be explored as possible resources for providers.
ACCREDITATION
Accreditation organizations such as The Joint Commission can play an important role in assuring HIT patient safety.
Recommendation 6.0 – ONC should discuss HIT patient safety concepts with these organizations to determine, for example, if they are examining whether large institutions have a patient safety review committee, and whether processes are in place that encourage reporting of problems.
TIMING OF STAGE 2 AND STAGE 3
The time period between the publication of certification criteria and the beginning of the eligibility period is a safety concern for both of the next two stages. Any software changes or updates must be carefully tested by each healthcare organization that receives those updates.
Recommendation 7.0 – We recommend that, for each stage, certification criteria should be finalized at least 18 months prior to the beginning of the eligibility period.
With this proposed schedule, a vendor could have 12 months to develop, test, certify, and distribute their software, and then customers could have 6 months to test, train and implement changes prior to the beginning of the eligibility period. For example, this schedule would require that Stage 2 certification criteria be finalized by April 1, 2011, which would allow vendors to complete their programming, testing, certification, and distribution work by April 1, 2012, and existing customers to train, test and implement by October 1, 2012. For vendors with a large number of customers, the six month window is probably difficult, and an even longer period might be requested. In this example, in order to finalize the certification criteria for Stage 2 by April 1, 2011, the initial publication needs to occur by December 31, 2010.
FOOD AND DRUG ADMINISTRATION
A number of concerns were expressed about the potential for increased Food and Drug Administration (FDA) regulation of EHR systems. These concerns include:
a. The FDA focuses on problems caused by individual ―devices.‖ As a result, it does not seem to cover situations where problems occur even though the software is operating correctly. This is only one example of a situation that arises because HIT is embedded in a sociotechnical system that includes a complex mix of people, technology, work processes, and factors outside the organization that influence it.
b. The FDA reporting system focuses on serious injuries and death caused by individual devices. That reporting process might not cover many unsafe conditions and hazards, such as incompatible work-processes in which no actual injuries occur, that might be another result of sociotechnical factors beyond the technology.
c. The FDA’s Quality Systems Regulation (QSR) process is inconsistent with the incremental nature of HIT development, and, as a result, could harm innovation and increase vendor and product costs. By hampering and slowing the ability of vendors to continuously improve systems, thus making them safer, such a process could actually work against the safety efforts we are proposing.
d. The increased costs of FDA class II regulation could become a barrier to entry for small vendors.
While we have concerns, we have also seen that the FDA has valuable experience that could help the ONC accomplish its goals. Two possible ways that the ONC and the FDA could collaborate are:
1. Collaborate on certification criteria that improve patient safety.
2. Focus on selected HIT areas that are creating safety risks for EHR implementations. For example, retail pharmacies create safety problems because they do not process electronic order cancellations, which can result in over-medication of patients. Additionally, most retail pharmacies are not providing compliance data. The FDA could be a valuable ally to address this type of patient safety issue with non-certified software systems that connect to the EMR.
Recommendation 8.0 – We recommend that the ONC work with the FDA and representatives of patient, clinician, vendor, and healthcare organizations to determine the role that the FDA should play to improve the safe use of Certified EHR Technology.
FINAL OBSERVATION
The workgroup did not hear any testimony that indicated that EHR systems and CPOE systems should not be implemented. We detected, however, frustration that these systems are not reaching their full potential. We also clearly heard concerns that these systems need to be properly and safely implemented. In the public comments, we were also reminded of the 1999 Institute of Medicine report, which indicated that over 90,000 lives could be saved each year through computerized ordering. As a result, we believe that the biggest risk to patient safety would be to either avoid or delay the proper implementation of EHR and CPOE systems.
Recommendation 9.0 – We recommend that ONC continue its efforts to encourage implementation of EHR systems.
Sincerely yours,
Paul Egerman and Marc Probst
Co-Chairs
Adoption Certification Workgroup
