The National Quality Forum (NQF) has issued a request for public comment about their update on Serious Reportable Events (SREs). Every hospital-based outpatient wound center (HOPD) and “mobile” wound care practitioner needs to read this carefully. I hope all of you will comment before the deadline of July 1, 2025. Here’s the link to comment.
The New Policy Specifically Applies to Wound Care Clinics, Mobile Clinics, and Office-Based Specialty Care
The goals of the NQF as an organization are laudable, but it’s policies around pressure ulcers/injuries have always been misguided. Their updated policy is beyond misguided. The 2025 SRE list has been expanded so that it is “applicable to all healthcare settings.” As you can see on page 2, wound care clinics, mobile clinics, and office-based specialty care are specifically called out as healthcare settings for SRE reporting
Serious Reportable Events Defined
The problem goes all the way back to the 2011 Serious Reportable Events in Healthcare. The criteria to be listed as an SRE were that an event was, “unambiguous, largely if not entirely preventable, serious… and indicative of a problem in a healthcare setting’s safety systems…” At the time, any stage 3, 4 or unstageable pressure ulcer “acquired after admission to a healthcare facility” was included in the 2011 NQF list of “Care Management Events,” just in front of “artificial insemination with the wrong sperm.” To be fair, I can’t argue with anything else on the list which includes surgery on the wrong patient/wrong procedure/wrong site, harm from contaminated drugs/devices, harm from device malfunction, delivery of radiotherapy to the wrong patient/body region, administering the wrong breathing gas, fires from healthcare equipment, and sexual abuse of a patient. However, none of the other events on the NQF lest could ever result from natural physiological processes. That’s not true for pressure ulcers/injuries which certainly can be medically unpreventable due to uncontrollable physiological factors which have yet to be clearly defined.
The updated 2025 language is “Patient Harm Associated with a Stage 3 Pressure Injury, Stage 4 Pressure Injury, or Deep Tissue Injury Acquired After Admission.” It further states that, “this event focuses on occurrences that are noted to be likely avoidable and require major intervention.” “Largely preventable” is defined as an event that is “likely avoidable by any means currently available within the generally accepted performance standards of care and triggers further investigation into causative factors.” “Harm” includes emotional harm or something that impairs a patients’ ability to perform activities of daily living.
Wound Centers and Mobile Practitioners Should Report Outpatient Pressure Ulcers/Injuries To…?
Perhaps the majority of pressure ulcers/injuries develop at home and are cared for in the outpatient setting – at least among Medicare beneficiaries. That’s why “mobile” wound care is the fastest growing segment of wound care. If I understand the NQF document, a Stage 3 Pressure Injury, Stage 4 Pressure Injury, or Deep Tissue Injury developing AT HOME in a patient being seen by a mobile practitioner or at an outpatient wound clinic, could be serious reportable event (SRE), unless it is possible to determine that it was NOT avoidable “by any means currently available within the generally accepted performance standards of care,” and has no impact on the patient’s emotional health or ability to perform activities of daily living. I will also ignore the difficulty of deciding what the term “acquired after admission” means in an outpatient living at home. The document states the following: “While all SREs are serious and should never occur, those denoted with regardless of outcome send a signal that there are no circumstances under which the occurrence of this event should go unreported.” The document implies that the mobile practitioner or wound clinic staff could be held at fault for these events. Since the NQF does not receive or collect reports of SREs, I assume that wound care practitioners would be required to notify the State Department of Health of pressure ulcers forming at home, and that wound clinics would use the hospital’s established process for adverse event reporting (making the hospital potentially liable for pressure ulcers that occur at home). At least, that’s what it sounds like from reading the document.
Don’t Forget, in 2016, the NPIAP Changed the Definition of a Stage 3 Pressure Ulcer
Remember that in 2016, the definition of a stage 2 was changed by the (then) National Pressure Ulcer Advisory Panel (NPUAP) to include only partial thickness lesions (e.g., a ruptured blister). Suddenly that made even the most superficial skin lesion a Stage 3. Also, an ulcer that has any amount of slough or granulation tissue is a Stage 3. Thus, even minor lesions related to friction and shear are now Stage 3 pressure ulcers/injuries. Let’s hope that the superficial ulcers which since 2016 have the ominous classification of a “Stage 3 pressure injury” won’t be classified as an NQF SRE as long as they don’t impact the patient’s emotional well-being or affect activities of daily life. (The fact that relatively superficial lesions now have other big regulatory implications is also a story for another day.)
Summary of the NQF 2025 Serious Reportable Events List
- Applicable healthcare settings have been expanded to all ambulatory settings. The healthcare settings that may be required to report Stage 3 Pressure Injury, Stage 4 Pressure Injury, or Deep Tissue Injury as Serious Reportable Events (SREs) include Wound Care Clinics, Mobile clinics, and Office-Based specialty Care.
- The wording of the document not only states that “all SREs are serious and should never occur,” but that “there are no circumstances under which the occurrence of this event should go unreported.”
- The crux of the issue may lie in the definitions of “likely avoidable,” “patient harm,” and what “after admission” means in an outpatient living at home.
- Other issues:
- Since 2016, Stage 3 pressure injuries include even superficial ulcers and lesions with any amount of slough or granulation tissue. The implications of this arbitrary re-definition by the NPIAP have not been on the radar of wound care practitioners working outside of SNFs and nursing homes –but maybe now that it impacts office-based care and wound clinics, the implications of this change should be discussed.
- Hemodynamic instability is a major factor contributing to the formation of severe pressure injuries/ulcers, and which likely determines whether pressure injuries/ulcers are medically unpreventable. Medical unpreventability is thus impossible to determine among patients who do not routinely get their blood pressure taken.
- Here’s the link to comment and the deadline is July 1: [NQF] 2025 Serious Reportable Events Public Comment Period Survey.
–Caroline
Dr. Fife is a world renowned wound care physician dedicated to improving patient outcomes through quality driven care. Please visit my blog at CarolineFifeMD.com and my Youtube channel at https://www.youtube.com/c/carolinefifemd/videos
The opinions, comments, and content expressed or implied in my statements are solely my own and do not necessarily reflect the position or views of Intellicure or any of the boards on which I serve.
