Submitted by mturchioe on
ANI's comment on USCDI draft v7: Adverse Events
The Alliance for Nursing Informatics (ANI) strongly supports the introduction of Adverse Events as a new USCDI data class. This addition represents a long-overdue formal acknowledgment of nursing's central role in patient safety surveillance. Registered nurses are the primary detectors, reporters, and documenters of adverse events across virtually all care settings, and the absence of a standardized, interoperable adverse event data class has long undermined cross-organizational patient safety data exchange. Standardizing both Adverse Event and Adverse Event Outcome will enable structured documentation to follow patients across care transitions, which is a critical gap in post-acute and transitional care settings where nursing leads handoff workflows. We advocate for vocabulary guidance that extends beyond the currently specified SNOMED CT to encompass nursing-sensitive adverse event categories, including patient falls, pressure injury staging events, and medication errors, and we encourage ONC to provide implementation guidance that supports embedded, point-of-care adverse event capture rather than reliance on siloed safety reporting systems.
Submitted by AQIPS on
V7 - data class: Adverse Events and Condition/Outcomes
Re: United States Core Data for Interoperability (USCDI) V.7 Concerning Adverse Event Data Elements Adverse Event Condition and Adverse Event Outcomes
Dear Dr. Keane,
The Alliance for Quality Improvement and Patient Safety (AQIPS) appreciates the opportunity to provide comments on V7 “Adverse Event” data elements, Adverse Event Condition and Adverse Event Outcome. As you know, the 21st Century Cures Act defines interoperability strictly around data generated in direct clinical areas, not data generated in private quality and patient safety reporting and investigation systems, including Patient Safety Organizations (PSOs). AQIPS is the national professional association for over 70 PSOs and their member hospitals and other healthcare providers. PSOs are private, market-based programs that assist health care providers in accelerating quality improvement and patient safety to ensure the welfare of patients. Federal, state and common law protect information concerning “adverse events” to allow healthcare providers to investigate adverse events and conduct self-critical analysis to solve quality and patient safety issues for the benefit of patients. The Patient Safety and Quality Improvement Act of 2005 specifically prohibits adverse event information from being placed in medical records (42 U.S.C. 299b-21(7)(a) and (b)). Adverse event information is not ePHI and is not contained in a designated record set (DRS) and, therefore, is not interoperable under the 21st Century Cures Act.
AQIPS stands by its previous comments for V.2 USCDI+ codes for adverse events Quality and V.7. USCDI Data elements and Codes for Adverse Events. As we stated in those comments, AI trigger tool is not mature enough to pull adverse events associated with clinical interventions and thus pulls all heath care complications and deaths, including those related to the patients underlying condition or other facts, that need to be evaluated in the PSES or patient safety event reporting and evaluation system to determine their cause and how to prevent them. Calling all complications and deaths “adverse events associated with clinical interventions” is false and misleading because not all complications and deaths result from clinical interventions. ONC’s USCDI codes will lead to an exaggerated, false and misleading number of “adverse events associated with clinical interventions” that can lead patients to avoid necessary medical care leading to seriously harm. Reviewing all complications and deaths in a PSES or adverse event reporting and evaluation system/risk management system to determine what complication and death is attributed to clinical interventions is burdensome and, according to Pascal Metrics, the company that created Tigger tool, will require 4 full time nurses for a 400 bed hospital as well as physicians to review the findings. Hospitals use Patient Safety Evaluation Systems,/patient safety event reporting systems to collect, track, analyze, and create solutions to prevent future patient safety events that are separate from medical records.
ONC’s record does not support creating USCDI data elements and USCDI codes for “adverse events associated with clinical interventions” for voluntary adverse event reporting to the FDA, AHRQ, or any other purpose. ONC appears to primarily rely on FDA’s use case for voluntary reporting of adverse events related to medication errors and pharmaceutical products. ONC’s own record does not support the adoption of USCDI codes for adverse events associated with clinical interventions, including for the voluntary reporting to FDA of adverse events related to FDA regulated pharmaceuticals. Indeed, ONC’s own working group discusses the need for quality assurance/risk management/patient safety activities to be conducted outside of the medical record and states that the “Use of Adverse Event to report drug adverse/side-effect data appears to be inappropriate.” See https://confluence.hl7.or/space/PC/pages/60017074/Adverse+event+topic. As we stated in previous comments to ASTR/ONC concerning USCDI Codes for adverse events, AQIPS supports reporting to FDA concerning adverse events related to pharmaceuticals and medical devices. Indeed, the Patient Safety Act provides a disclosure permission to report privileged and confidential Patient Safety Work Product to FDA (42 USC 299b-229(c)(2)(E)). Many PSOs and providers have used this permission to report adverse events associated with FDA regulated medical products when the adverse events were identified during a root cause analysis. This is information that FDA might not otherwise be provided under state peer review laws that are absent a disclosure permission.
The Adverse Event Work Group compiled clinical case studies concerning complications, medication errors, falls, near misses, medical device adverse events, clinical trial adverse events and hospital acquired adverse events. Many of the case studies simply list the potential causes that could be related to the underlying disease, the procedure or clinical intervention. These case studies had the benefit of extensive causal analysis and peer review, that are conducted within a Federally and state protected patient safety and quality event reporting system/patient safety evaluation system for learning purposes and Medical staff committees for clinical performance evaluation and disciplinary action. Such reporting and analysis are protected under State and Federal law. The case studies are disclosed in a deidentified/nonidentified form and therefore are not EHI. The case studies are not published in any patient’s medical record. In relevant case studies, the researcher/clinician documents that adverse event reports are created in systems outside of the EHR (see for example Use Case 2a). These event reporting and evaluation systems are not EHI or a DRS and therefore are not interoperable. In short, the evidentiary record created for providing a reasonable basis to create USCDI codes for “adverse events associated with clinical interventions” does not support the creation of the data class and elements.
ASTP’s evaluation of FDA’s use case concerning medication events states concerning maturity (criterion 2) that the “data element is captured, stored, or assessing multiple production EHRs or other HIT modules from more than one developer.” According to ONC’s record, an EHR developer offers hospitals a module that sits on top of the EHR and provides a med-watch form to be completed if a provider’s response to a clinical decision support question indicates that an adverse event could have occurred (see use case 13). The final rule implementing the 21st Century Cures Act clearly provides that modules and databases do not become part of the EHR by simply being connected to it. The module and/or databases must be EHI in a DRS to become interoperable. The module that has a provider complete a med-watch or patient safety and quality event report is part of the quality/risk management/Patient Safety Evaluation System is confidential under Federal state and common law and is not part of the DRS or EHR. Pulling adverse events from nonDRS violates the 21 Century Cures Act, including the HIPAA exemption, the Patient Safety Act, state law, common law and State and Federal Court orders. Additionally, Congress has not given authority to pull from private software that is not an EHR. The record is void of support or authority for AHRQ and/or FDA to collect adverse events associated with clinical interventions directly from private nonEHI/nonDRS sources.
Clinical trial adverse event information is required to be documented in the EHR. ASTR/ONC working groups recommendation that Clinical trial adverse events documented in the medical record could be pulled for reporting to FDA under the public health reporting under the 21st Cures Act. However, several of the use cases (use cases 15-17), appear to suggest that the USCDI codes pull information from the clinical trial adverse event report form that is not in the EHR, is not EHI and is not in a DRS. The clinical trial adverse event report form is not in the medical record, not in a DRS, and falls within the HIPAA exemption. Therefore, the USCDI+ codes cannot be adopted because this information, while required to be reported to FDA are not contained in a DRS as required by the 21st Century Cures Act.
Exemption For PSWP is non sequitur and does not apply. As previously stated patient safety and quality related event reports that are collected in a providers PSES and reported to PSOs are not in a designated record set (DRS) are not EHI and are not interoperable. Therefore, an exemption for datablocking for Patient safety work product does not make sense because, again, “patient safety event reports” are not in the medical record. Nonetheless, ASTR/ONC’s proposed exemption appears to limit the exemptions available to providers under the law. The 21st century Cures Act requires that the determination of whether an exemption applies must be made by a provider, who can rely on Federal, state, common law, court orders and other factors to determine whether an exemption applies.
Should you have any questions or require additional information, please contact Peggy Binzer at pbinzer@allianceforqualityimprovement.org.
Sincerely yours,
Peggy Binzer, J.D., CPSOW
Executive Director and General Counsel