Entering on behalf of Mayo Clinic experts Beth Sievers APRN CNS MS and Brianna Skrukrud APRN CNP.

Thank you for providing Mayo Clinic an opportunity to comment on the Hospital Harm – Hospital-Acquired Pressure Injury eCQM.

We would like to respond to the question "How useful is this measure in assessing and improving the quality of care for patients?" Per the National Pressure Ulcer Advisory Panel (NPUAP) definition of a Deep Tissue Pressure Injury (DTPI), wounds may evolve rapidly to reveal the actual extent of the tissue injury, or may resolve without tissue loss (National Pressure Advisory Panel, April 2016. Accessed February 12, 2018 http://www.npuap.org/national-pressure-ulcer-advisory-panel-npuap-announces-a-change-in-terminology-from-pressure-ulcer-to-pressure-injury-and-updates-the-stages-of-pressure-injury/). The definition makes it clear that is not predictable if the skin will open or not once a DTPI is identified, regardless of the prevention interventions put in place. Therefore, DTPI should not be included in the measurement which reports worsening of pressure injury. In addition, a recent study was published stating "Based on these data, it is clear that MAP can guide the clinician when evaluating truncal wounds. The data suggest that MAP of less than 80 mm Hg can independently result in stalled or worsening wounds. In this study, the predictability of wounds stalling or deteriorating was observed to relate to MAP, regardless of topical treatment or standard-of-care interventions. In states of hypoperfusion (MAP<80 mm Hg), poor wound healing was observed." (Smollock, W, Montenegro, P, Czenis, A, He, Y. (2018) Hypoperfusion and Wound healing: another dimension of wound assessment. Advances in Skin and Wound Care,31, 72-77.) Based on this, worsening of wounds in the hospital does not equate to poor care/inadequate interventions/inadequate topical wound care of the patient. Therefore, worsening of wounds should not be included, or if a MAP<80 mm Hg was documented for a patient, those patients should be excluded.

In response to the question "Do you suggest any denominator exclusions for this measure, and why?", please see the above comments concerning why DTPI should not be included in the worsening pressure injury category. DTPI should not be included in the measure that looks at hospital acquired PI. Research has shown that it can take up to 5 days for a DTPI to appear on the skin after the injury occurred (Honaker, J., Brockopp, D., Moe, K. 2014. Suspected deep tissue injury profile: A pilot study. Advances in Skin and Wound Care, 27, 133-140.) Pressure injuries that reopen over scar tissue should be excluded for the following reasons:
• Exact healing time of full thickness wounds has not been established, however, according to wound healing physiology textbooks, even after closure and scar formation, the last of the many phases of wound healing continues beyond a year.
• Therefore, the “closed” stage 3 or 4 PI is not interchangeable with the term “healed”
• Full thickness wounds lose skin layers that do not regenerate, rather they fill in with collagen and other materials that form a scar. Scar tissue is weaker with only 80% of the tensile strength than uninjured skin and lacks elasticity (elastin) that facilitates the flexibility and resilience of healthy skin. In fact, at three weeks, the tensile strength of scar tissue is only 20%.

References:
• Kumar,V. et al (2012).). Robbins Basic Pathology 9th Edition St. Louis. Elsevier Saunders.
• Doughty, D. and Sparks B: Wound Healing Physiology In Bryant, R. Nix, D. Coeditors: Acute and Chronic Wounds: Current Management Concepts, 4th Edition. St. Louis, Mosby, January, 2012.
• Bates-Jensen BM et al; Characteristics of recurrent pressure ulcers in veterans with spinal cord injury J Spinal Cord Med. 2009;32(1):34-42.

In response to the question "Currently as specified, the measure uses 24 hours as the timeframe within which any pressure injuries that were present on arrival should be documented (in a structured field). Do you agree with this timeframe as a reasonable standard for reporting?", DTPI can take up to five days to open post injury (as noted in the above paragraph). The average time from injury to appearance is 2.41 days (Honaker, J., Brockopp, D., Moe, K. 2014. Suspected deep tissue injury profile: A pilot study. Advances in Skin and Wound Care, 27, 133-140.). Therefore, the injury may have occurred prior to admission, but it would not be visible until after the 24 hour time frame.