Cadia Rehabilitation Renaissance, DAB CR6085 (2022)

DECISION

Cadia Rehabilitation Renaissance (Cadia or Petitioner) challenges the determination by the Centers for Medicare & Medicaid Services (CMS) that it was not in substantial compliance with Medicare program participation requirements.  Petitioner also challenges CMS’s imposition of a $17,705 per-instance civil money penalty (CMP) as unreasonable.  As explained herein, I conclude that Petitioner did not substantially comply with the Medicare participation requirement at 42 C.F.R. § 483.25(b)(1) and find the CMP amount imposed by CMS reasonable.  

I.    Background

Cadia is a skilled nursing facility (SNF) located in Millsboro, Delaware that participates in the Medicare program.  CMS Exhibit (Ex.) 1 at 1.  Surveyors from the Delaware Department of Health and Social Services’ Division of Long Term Care Residents Protection (DDHS or state agency) completed an annual recertification survey at Petitioner’s facility on September 5, 2017.  Id.  DDHS found the facility was not in substantial compliance with 10 Medicare program requirements: 

42 C.F.R. § 483.10(f)(1)-(3) (Tag F242);

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42 C.F.R. § 483.10(e)(3) (Tag F246);
42 C.F.R. §§ 483.20(d); 483.21(b)(1) (Tag F279);
42 C.F.R. §§ 483.10(c)(2)(i), (ii), (iv), (v), (3); 483.21(b)(2) (Tag F280);
42 C.F.R. § 483.21(b)(3)(ii) (Tag F282);
42 C.F.R. § 483.24(a)(2) (Tag F312);
42 C.F.R. § 483.25(b)(1) (Tag F314);
42 C.F.R. § 483.25(e)(1)-(3) (Tag F315);
42 C.F.R. § 483.65(a)(1), (2) (Tag F406); and
42 C.F.R. § 483.80(a)(1), (2), (4)(e), (f) (Tag F441). 

Id.  Tag F314 was cited at scope and severity level “G,” Tag F279 was cited at level “E,” and the remaining eight deficiencies were cited at level “D.”  Id. 

On October 3, 2017, relying on the state agency’s findings, CMS notified Cadia it found the facility to be out of substantial compliance.  CMS Ex. 21 at 1-2.  CMS advised Petitioner that based on its noncompliance with 42 C.F.R. § 483.25(b)(1) (Tag F314),CMS modified its deficiency tags to conform to the reorganized regulations on June 30, 2017, but the tag changes did not become effective until November 28, 2017, after the survey at issue here took place.  Ctrs. for Medicare & Medicaid Servs., Center for Clinical Standards and Quality/Survey & Certification Group, Revisions to State Operations Manual (SOM) Appendix PP for Phase 2, F-Tag Revisions, and Related Issues, available at https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/Downloads/Survey-and-Cert-Letter-17-36.pdf (eff. Nov. 28, 2017).  Following the survey, the tag relating to accidents and supervision was relocated to Tag F686.  This change in tag identifier did not substantively change the language of the tag, which conforms to the regulatory requirement for which Petitioner received a notice of deficiency and per-instance CMP.  For the sake of simplicity, I refer to Tag F314. CMS would impose a per-instance CMP of $17,705.  Id. at 2.  DDHS conducted a revisit survey on November 21, 2017 and subsequently notified Petitioner it had returned to substantial compliance with CMS’s conditions of participation on that date.  CMS Ex. 31. 

Petitioner timely sought hearing before an Administrative Law Judge (ALJ) in the Civil Remedies Division to challenge CMS’s determination of noncompliance with program requirements and the imposition of the $17,705 per-instance CMP.  I was designated to hear and decide this case and issued an Acknowledgment and Pre-hearing Order (Pre-hearing order) that established a briefing schedule and directed the parties to file pre-hearing submissions that included written direct testimony for all proposed witnesses, proposed exhibits, and pre-hearing briefs. 

CMS filed a pre-hearing brief (CMS Br.) and 31 proposed exhibits (CMS Exs. 1-31).  Petitioner filed a pre-hearing brief (P. Br.) and six exhibits (P. Exs. 1-6).  Petitioner subsequently filed a seventh exhibit (P. Ex. 7) to correct the record.  Petitioner also filed four audio files of the state independent informal dispute resolution (IIDR) hearing in this

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matter and a transcript of that proceeding as attachments to its brief.Petitioner advised me at the hearing that it did not submit the audio and written transcripts of the IIDR hearing as proposed exhibits but instead attached them to its brief for the purpose of cross-examination.  Tr. at 6-7.  DAB E-File Dkt. No. C-18-285, Doc. Nos. 14-18a. 

CMS identified one witness in its exchange, Karen Linderborn, MS, RN, GCNS-BC.  Petitioner identified three witnesses in its exchange:  (1) Kimberly Webb, RN; (2) Holly Smith-Kunde, PTA; and (3) Wendy Smollock, APRN, CWS.  Both parties requested to cross-examine the opposing party’s witnesses. 

II.   Hearing and Admission of Exhibits

On December 6, 2018, I held a videoconference hearing to allow for the cross-examination of witnesses.  At the outset of the hearing, absent objection from either party, I entered CMS Exhibits 1 through 31 and Petitioner’s Exhibits 1 through 7 into the record.  Hearing Transcript (Tr.) at 7.  Following the hearing, the parties filed post-hearing briefs (CMS Closing Br. and P. Closing Br.). 

III.  Issues

The issues presented are:

1. Whether Petitioner was in substantial compliance with the Medicare participation requirement obligations imposed by 42 C.F.R. § 483.25(b)(1) (Tag F314);
2. If Petitioner was not in substantial compliance with 42 C.F.R. § 483.25(b)(1), whether the remedies imposed are reasonable. 

IV.   Jurisdiction

I have jurisdiction to hear and decide this case.  42 U.S.C. §§ 1320a-7a(c)(2), 1395i-3(h)(2)(B)(ii); 42 C.F.R. §§ 488.408(g), 488.434(a)(2)(viii), 498.3(b)(13). 

V.    Discussion

A.  Applicable Legal Authority

The Social Security Act (Act) sets forth requirements for a SNF’s participation in the Medicare program and authorizes the Secretary of Health and Human Services to promulgate regulations implementing those statutory provisions.  42 U.S.C. § 1395i-3.  These implementing regulations are found at 42 C.F.R. Parts 483 and 488.

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To participate in the Medicare program, a SNF must maintain substantial compliance with program participation requirements.  To be in substantial compliance, a SNF’s deficiencies may “pose no greater risk to resident health or safety than the potential for causing minimal harm.”  42 C.F.R. § 488.301.  A deficiency is a violation of a participation requirement established by 42 U.S.C. § 1395i-3(b)-(d), or the Secretary’s regulations at 42 C.F.R. pt. 483, subpt. B.  Id.  “Noncompliance” means “any deficiency that causes a facility to not be in substantial compliance.”  Id. 

The Secretary contracts with state agencies to conduct periodic surveys to determine whether SNFs are in substantial compliance with the participation requirements.  42 U.S.C. § 1395aa(a); 42 C.F.R. § 488.10.  The Act also authorizes the Secretary to impose enforcement remedies against SNFs that are not in substantial compliance with program participation requirements.  42 U.S.C. § 1395i-3(h)(2).  The Secretary’s regulations specify the enforcement remedies that CMS may impose if a facility is not in substantial compliance.  42 C.F.R. § 488.406. 

Among other enforcement remedies, CMS may opt to impose a per-instance CMP for a SNF’s noncompliance.  42 C.F.R. § 488.430(a).  CMS may select a per-instance CMP ranging from $2,097 to $20,965 for each instance of noncompliance.CMS increased the CMP amounts to account for inflation in compliance with the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015, Pub. L. No. 114-74, § 704, 129 Stat. 584, 599 (2015).  See 81 Fed. Reg. 61,538 (Sept. 6, 2016).  The inflation-adjusted amounts apply to CMPs assessed after August 1, 2016, for deficiencies occurring on or after November 2, 2015.  Id.  As the CMPs in this case were assessed after August 1, 2016, the increased CMP amounts apply in this case.  42 C.F.R. § 488.438(a)(2); 45 C.F.R. § 102.3.  When CMS elects to impose a CMP, it sets the CMP amount based on, among other factors, the “seriousness” of the noncompliance.  42 C.F.R. §§ 488.404(a), (b), 488.438(f).  Seriousness is a function of the scope of a facility’s noncompliance (whether it is “isolated,” constitutes a “pattern,” or is “widespread”) and severity (whether it has created a “potential for” harm, resulted in “[a]ctual harm,” or placed residents in “immediate jeopardy”).  42 C.F.R. § 488.404(b). 

If CMS imposes a CMP based on a determination of noncompliance, the facility may request a hearing before an ALJ to determine whether there was a basis for the deficiency findings that led to the imposition of the remedy and whether the CMP imposed was reasonable.  42 U.S.C. §§ 1320a-7a(c)(2), 1395i-3(h)(2)(B)(ii); 42 C.F.R. §§ 488.408(g), 488.434(a)(2)(viii), 498.3(b)(13).  However, the facility may not appeal CMS’s choice of remedies.  42 C.F.R. § 488.408(g)(2). 

CMS has the burden to come forward with evidence sufficient to make a prima facie showing that Petitioner is out of substantial compliance with participation requirements to establish a basis to impose an enforcement remedy.  See, e.g., Evergreene Nursing Care Ctr., DAB No. 2069 at 7 (2007).  If CMS makes this prima facie showing, then Petitioner bears the ultimate burden of persuasion as to whether it substantially complied.

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In other words, Petitioner must show by a preponderance of the evidence of record that it was in substantial compliance with participation requirements.  Id.  Petitioner has both the burden of coming forward and the burden of persuasion as to any affirmative defense.  Id.; Batavia Nursing & Convalescent Inn, DAB No. 1911 (2004), aff’d, Batavia Nursing & Convalescent Ctr. v. Thompson, 129 F. App’x 181 (6th Cir. 2005).

B.  Petitioner was not in substantial compliance with 42 C.F.R. § 483.25(b)(1) (Tag F314) because Petitioner’s staff did not take necessary precautions to protect Resident 228 from developing preventable pressure ulcers or take all necessary precautions to promote healing, prevent infection, and prevent new sores from developing after the resident developed pressure ulcers.  

1.  Relevant Facts

Resident 228, a 90-year-old woman at the time of the incident, was readmitted to Petitioner’s facility on June 13, 2017 following a hospital stay.  CMS Ex. 3 at 1.  Her diagnoses upon readmission included weakness, unspecified dementia without behavioral disturbance, a pressure ulcer on her right heel, unspecified abnormalities of gait and mobility, age-related cognitive decline, Type 2 diabetes mellitus, hypertension, and osteoarthritis.  Id.  Facility staff conducted a skin assessment at the time of readmission which showed Resident 228’s had “intact” skin and “pink blanchable” heels.  Id. at 3.  Resident 228 exhibited edema in both ankles but otherwise had no obvious problems with her overall skin condition or any reddened areas.  Id.

Resident 228 had risk factors for developing pressure ulcers including dementia, cognitive impairment, diabetes, decreased mobility, edema, and incontinence.  CMS Ex. 3 at 1; CMS Ex. 7 at 26; CMS Ex. 20 at 6, 9; CMS Ex. 26 at 4, 6.  Her physician issued an order on June 13, 2017 advising facility staff to offload her heels every shift and turn or reposition her every 2 hours or as needed.  CMS Ex. 14 at 3.  On June 19, 2017, Cadia established a care plan to address Resident 228’s potential for pressure ulcers related to decreased mobility with the stated goal of keeping her free from skin breakdown at pressure points over the next 90 days.  CMS Ex. 7 at 32.  The facility identified the following interventions to meet that goal:  pressure-reducing mattress; pressure risk assessment on admission; preventative skin measures as ordered; skin checks every two hours and as needed; turning and repositioning every two hours and as needed; and a weekly skin check as ordered.  Id.  A Care Area Assessment (CAA) performed by the facility on June 26, 2017 confirmed Resident 228 was at risk for development of pressure ulcers.  CMS Ex. 13 at 11.

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Consistent with Resident 228’s care plan, Cadia’s staff completed skin assessments and weekly skin checks.  Braden ScaleThe Braden scale is a widely used diagnostic tool to assess the risk of pressure sores.  The final score ranges from 6 to 23.  A score of 18 or less indicates the subject is at risk to develop pressure sores.  A lower score suggests a higher risk of pressure ulcer development.  Agency for Healthcare Research & Quality, Preventing Pressure Ulcers in Hospitals § 7 at 3D, available at https://www.ahrq.gov/patient-safety/settings/hospital/resource/pressureulcer/tool/pu7b.html (last rev. Oct. 2014). skin risk assessments completed during the first month of admission indicated Resident 228 was at low risk for developing a pressure ulcer.  CMS Ex. 9 at 5-8, 10-11, 14-15; CMS Ex. 13 at 4-9.  Weekly skin checks conducted by facility staff members on June 15, June 21, June 27, July 4, July 11, July 18, July 25, and August 1, 2017 showed Resident 228 had no skin issues and exhibited clean, dry, and intact skin.  CMS Ex. 9 at 1, 7, 9, 14; CMS Ex. 13 at 1, 8; P. Ex. 3.  From June 13 through August 2, 2017, facility staff documented their efforts to check Resident 228’s skin every two hours and turn and reposition her every two hours.  CMS Ex. 11 at 7-8, 12; P. Ex. 2 at 5-9, 14-18.  Staff encouraged Resident 228 to offload pressure from her heels by using pillows but noted she refused to do so and would push out pillows from under her heels.  CMS Ex. 4 at 9-10; CMS Ex. 11 at 1-4; CMS Ex. 18 at 5, 11; CMS Ex. 20 ¶¶ 29; P. Ex. 2 at 2-4, 11-13.  When asked by the surveyor what she would do in that circumstance, one nurse aide replied she documented the resident’s refusal of the pillows but did not offer an alternative intervention.  CMS Ex. 18 at 5; CMS Ex. 20 ¶¶ 29. 

On July 21, 2017, while a staff member assisted her to sit in a chair, Resident 228 slid off the edge of the chair onto the floor.  CMS Ex. 8 at 12.  Progress notes from the next day reflect Resident 228 exhibited no injuries or signs of pain or discomfort.  Id. at 13.The same day, at the recommendation of a psychiatrist, the resident’s primary physician ordered facility staff to discontinue her dementia medication.  CMS Ex. 8 at 12; CMS Ex. 18 at 2. 

A week after her fall, Resident 228 complained of hip, knee, and ankle pain and required additional staff assistance for increased difficulty in standing.  CMS Ex. 8 at 15-16.  Facility staff noted the resident became verbally aggressive and difficult to redirect.  Id.  The results of a July 30, 2017 Physical Therapy (PT) evaluation showed Resident 228 had pain in her right ankle with swelling and strength deficits in both legs.  P. Ex. 1 at 3.  The evaluation also noted that Resident 228’s current mobility level had significantly declined from her previous level of function at the end of her course of therapy.  Id.  The physical therapist also noted that although Resident 228’s skin was intact, Resident 228 was at risk for decreased skin integrity due to her physical impairments and associated deficits.  Id. 

On August 2, 2017, physical therapist Jill Burger observed a dry blood blister on Resident 228’s right heel.  CMS Ex. 12 at 10.  PT Burger notified nursing staff of the blood blister’s presence at 7:42 a.m. on August 2, 2017.  CMS Ex. 8 at 19.  That same

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day, LPN Jermel Vanderhorst generated an incident report to document the development of a partially fluid-filled “purple discoloration” on Resident 228’s right heel.  CMS Ex. 17.  The evaluation stemming from the report described this as an “unavoidable pressure area.”  Id.

On August 3, 2017, wound care specialist Nurse Practitioner Patricia Schell assessed Resident 228 and diagnosed her to have an unstageable“Unstageable” refers to full-thickness skin and tissue loss where the extent of damage cannot be assessed because of obscuration by dead tissue referred to as slough or eschar.  If the dead tissue were removed, a Stage 3 or 4 pressure injury would be revealed.  Nat’l Pressure Ulcer Advisory Panel, NPUAP Pressure Injury Stages at 1, available at https://cdn.ymaws.com/npiap.com/resource/resmgr/online_store/npiap_pressure_injury_stages.pdf (last visited May 2, 2022). pressure ulcer on her right heel measuring 2.5 by 3.0 centimeters secondary to a suspected deep tissue injury.  CMS Ex. 5 at 1; see also CMS Ex. 8 at 20.  NP Schell observed Resident 228’s pressure wound was “[d]eemed unavoidable due to patient overall decline” and cited the resident’s use of a wheelchair as a contributing factor.  Id.  The nurse practitioner recommended offloading the resident’s right heel, repositioning her every two hours and as needed, daily cleansing of the wound, application of skin prep twice a day, monitoring for infection development, use of heel boots, and avoidance of shoes except for therapy.  CMS Ex. 5 at 1.  By August 10, 2017, Resident 228’s right heel wound grew to 3.0 x 4.0 cm.  Id. at 3. 

On August 3, 2017, Adult Nurse Practitioner Marion RyanIt is unclear whether ANP Ryan had the authority to issue orders without a physician’s approval or if she had conferred with an unidentified physician who approved the order beforehand.  The distinction is ultimately irrelevant, as the facility entered her instructions into Resident 228’s electronic case record as a “Physician Order.”  CMS Ex. 6 at 1.  Facility staff members were therefore obliged to follow it as a physician’s order, regardless of its ultimate source. ordered interventions to treat Resident 228’s right heel pressure ulcer, namely use of a right heel boot while in bed, skin prep to both heels twice a day, and no shoes except during therapy.  CMS Ex. 6 at 1; CMS Ex. 14 at 8-9.  Petitioner established a new care plan for Resident 228 that same day with the goal of preventing any signs and symptoms of infection in the resident’s right heel pressure ulcer for 90 days.  CMS Ex. 7 at 39.  The care plan required staff to apply the following interventions:  Braden risk assessment on admission, quarterly, and as needed; use of a heel boot on the resident’s right foot; measurement of pressure sores during weekly wound rounds and notification to the resident’s physician of worsening status; monitoring the pressure wound site for signs and symptoms of complications; use of a pressure-relieving device in the resident’s bed and chair; skin checks every two hours; skin treatments as ordered; turning and repositioning of the resident every two hours and as needed; and weekly skin checks on shower days.  Id. 

Consistent with the updated care plan, Cadia’s staff documented their efforts to encourage Resident 228 to offload her heels.  CMS Ex. 4 at 8-9, 16; CMS Ex. 11 at 3-6,

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14, 16; P. Ex. 2 at 11.  Staff also documented Resident 228’s use a heel boot on her right foot while in bed.  CMS Ex. 11 at 17.  Petitioner’s staff documented administration of skin prep to both of Resident 228’s heels twice a day, continued skin checks, and turning or repositioning of the resident every two hours.  CMS Ex. 4 at 7, 11-12, 14, 20, 21, 34; CMS Ex. 10 at 13; CMS Ex. 11 at 8-14; P. Ex. 2 at 14, 17.State agency surveyor Karen Linderborn, R.N. testified that on two different days, she observed Petitioner’s staff fail to perform skin checks or reposition Resident 228 every two hours, despite documentation to the contrary in the resident’s medical record.  CMS Ex. 4 at 20-21, 34; CMS Ex. 20 ¶ 46.  And on August 28 and 30, 2017, Surveyor Linderborn observed Resident 228 sitting in her wheelchair in the dining room for several hours, during which time facility staff did not check her skin or reposition her.  Id.

On August 10, 2017, a week after the facility updated Resident 228’s care plan to address the pressure ulcer on her right foot, LPN Deidra Wagner conducted a Braden Scale skin assessment and concluded Resident 228 was at high risk for developing a pressure ulcer.  CMS Ex. 9 at 3-4.  LPN Wagner recommended interventions for the resident that were largely present in her existing care plan, including use of a pressure-relieving device in her chair and bed, a turning/repositioning program, and other preventative or protective skin care.  Id. at 4. 

On August 17, 2017, ANP Ryan ordered use of heel boots on both of Resident 228’s feet while she was in bed, as well as use of a pressure-relieving air mattress.  CMS Ex. 6 at 2; CMS Ex. 14 at 9.  But on August 22, 26, and 27, facility staff documented Resident 228 was discovered wearing only one heel boot.  CMS Ex. 10 at 11; Tr. at 113.  Staff failed to document on which foot Resident 228 wore the heel boot.  Id. 

On August 21 and 24, 2017, PT Burger documented treating a pressure ulcer on Resident 228’s left heel even though her prior treatment notes indicated discovery and treatment of a right heel blood blister.  CMS Ex. 12 at 18, 20, 24-26; CMS Ex. 20 ¶ 42.  At Surveyor Linderborn’s behest, the physical therapist subsequently corrected the documentation error.  CMS Ex. 12 at 25-26; CMS Ex. 20 ¶ 42.  But on August 31, 2017, Surveyor Linderborn observed NP Schell treat a pressure ulcer on Resident 228’s left heel and fail to assess and treat the pressure ulcer on Resident 228’s right heel.NP Schell appears to have inadvertently discovered the pressure ulcer on Resident 228’s left heel, though it is possible PT Burger had not mistakenly documented the pressure ulcer on Resident 228’s right heel as a left heel pressure wound, as Surveyor Linderborn thought.  Confused documentation by Petitioner’s staff makes it impossible to determine when Resident 228 developed a pressure wound on her left heel, or when staff members noticed it.  But the state surveyors opted not to include the apparent failure to identify or treat Resident 228’s left heel pressure ulcer in the Statement of Deficiencies, and CMS did not base its penalty imposition on the presence or treatment of Resident 228’s left heel ulcer.  Therefore, beyond reinforcing the facility’s poor efforts at documentation which underly the deficiency before me, the prevention and treatment of the left heel pressure ulcer are not at issue in this case.  CMS Ex. 5 at 11-12; CMS Ex. 20 ¶¶ 43-44.  The wound nurse did not assess or treat the existing pressure ulcer

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on the resident’s right heel.  CMS Ex. 5 at 11-12.  The next day, NP Schell corrected her treatment notes and indicated she had assessed an unstageable pressure ulcer on Resident 228’s left heel and not her right heel on August 31, 2017.  Id. at 14.  NP Schell then assessed the resident’s unstageable right heel pressure wound and noted it measured 2.5 x 4.2 cm with 100% of the wound area covered in deep-purple ecchymosis (discoloration caused by leakage of blood beneath the skin).  Id. at 15.  

2.  Analysis

There is no dispute that Resident 228 entered Petitioner’s facility on June 3, 2017 free of pressure ulcers.  Given the resident’s age and other risk factors, Cadia appropriately recognized she was at risk to develop them.  The facility therefore developed a care plan that sought to keep Resident 228 free from skin breakdown over the next 90 days.  CMS Ex. 7 at 32.  But by August 2, 2017, Resident 228 developed an unstageable pressure ulcer on her right heel.  CMS Ex. 5 at 1; CMS Ex. 12 at 10; CMS Ex. 17.  The question before me is whether the development of this pressure ulcer while Resident 228 was in Cadia’s care amounts to a deficiency within the meaning of the Act and the applicable regulations.  

Under 42 U.S.C. § 1395i-3(b) and the “quality of care” regulation, “[b]ased on the comprehensive assessment of a resident, the facility must ensure that residents receive treatment and care in accordance with professional standards of practice, the comprehensive person-centered care plan, and the resident's choices . . . .”  42 C.F.R. § 483.25.  The regulation provides that: 

Based on the comprehensive assessment of a resident, the facility must ensure that–

(i)     A resident receives care, consistent with professional standards of practice, to prevent pressure ulcers and does not develop pressure ulcers unless the individual’s clinical condition demonstrates that they were unavoidable; and

(ii)     A resident with pressure ulcers receives necessary treatment and services, consistent with professional standards of practice, to promote healing, prevent infection and prevent new ulcers from developing. 

42 C.F.R. § 483.25(b)(1). 

This requirement does not impose strict liability on a facility whenever a resident develops pressure sores.  Instead, in assessing the facility’s compliance with this requirement, the relevant question is:  did the facility “take all necessary precautions” to promote healing, prevent infection, and prevent new sores from developing?  If so, the

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fact that a resident develops sores does not demonstrate a deficiency.  But if the evidence establishes that the facility fell short of taking all necessary precautions, it has failed to meet the demands of the regulation.  Senior Rehab. & Skilled Nursing Ctr., DAB No. 2300 at 13-14 (2010), aff’d, Senior Rehab. & Skilled Nursing Ctr. v. Health & Human Servs., 405 F. App’x 820 (5th Cir. 2010); Koester Pavilion, DAB No. 1750 at 32 (2000). 

To be in substantial compliance, a SNF must ensure that “a resident who enters the facility without pressure sores does not develop pressure sores unless the individual’s clinical condition demonstrates that they were unavoidable.”  The Harborage, DAB No. 2905 at 1-2 (2018).  A prima facie case of noncompliance exists when the evidence establishes that a nursing home resident with no pressure sores on admission develops a pressure sore in the facility; the burden then shifts to the facility to establish development of a pressure sore was clinically unavoidable.  Koester Pavilion, DAB No. 1750 at 34 (2000).

Here, CMS asserts Cadia failed to ensure Resident 228 did not develop an avoidable pressure ulcer because it did not take necessary preventative measures.  First, CMS contends the facility failed to complete a Braden scale pressure ulcer risk assessment after Resident 228’s fall on July 21, 2017.  CMS Br. at 10; CMS Closing Br. at 12-13; Tr. 43-44.  CMS explains that professional standards of practice required Petitioner to complete such an assessment after any change in the resident’s condition, including a fall.   CMS Br. at 10; CMS Closing Br. at 12-13; CMS Ex. 24 at 16; CMS Ex. 27.  CMS also contends Petitioner failed to ensure Resident 228’s heels were adequately offloaded, specifying the facility should have modified offloading interventions for Resident 228 when it became clear she would not tolerate use of a pillow to elevate her heel, and that in any event its own policy prescribed use of a heel boot in the presence of a deep tissue injury, an intervention the facility did not provide until after Resident 228 developed a pressure ulcer.  CMS Br. at 10-12; CMS Closing Br. at 13-14.  Finally, CMS contends that Petitioner failed to perform skin checks or reposition Resident 228 every two hours, measures mandated in the resident’s care plan.  CMS Br. at 12-14; CMS Closing Br. at 13-14.

Petitioner responds that the development of a pressure ulcer on Resident 228’s right heel was unavoidable given her clinical condition.  P. Br. at 8.  Petitioner argues that after Resident 228’s fall, the facility met its obligation to re-assess her for the risk of pressure sore development, including evaluation of her functional mobility by physical therapy staff, implementation of a revised care plan, and ultrasound evaluation to assess the resident’s edema.  P. Br. at 10; P. Closing Br. at 4.  Petitioner argues it was not required to perform a Braden Scale risk assessment after Resident 228’s fall because it had already assessed the resident’s risk factors and implemented effective interventions prior to the development of her right heel pressure ulcer.  P. Closing Br. at 5; P. Ex. 6 ¶¶ 12-14.  The facility claims Resident 228 was generally compliant with offloading her heels and only occasionally refused the use of pillows to offload her heels, especially in the days leading

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up to the discovery of the right heel pressure ulcer.  P. Br. at 7.  In sum, Petitioner argues that it implemented interventions consistent with the resident’s care plan, her physician’s orders, and recognized standards of practice, and that there were no objective signs these measures were not adequate to prevent her pressure ulcers.  P. Br. at 11-13; P. Closing Br. at 2-3; Tr. at 22-24. 

I am unpersuaded by Cadia’s claim that Resident 228’s right heel pressure ulcer was clinically unavoidable.  “Clinically unavoidable” in this context “means not just unsurprising given the clinical condition of the resident, but incapable of prevention despite appropriate measures taken in light of the clinical risks.”  Harmony Court, DAB No. 1968 at 11 (2005), aff’d, Harmony Court v. Leavitt, 188 F. App’x 438 (6th Cir. 2006).  “A facility cannot meet its burden of proof on the issue of whether a pressure sore is unavoidable merely by establishing that the resident’s clinical condition heightens the risk that pressure sores will develop.”  Id. (quoting Ivy Woods Health Care & Rehab. Ctr., DAB No. 1933 at 9 (2004), aff’d, Ivy Woods Health Care & Rehab. Ctr. v. Thompson, 156 F. App’x 775 (6th Cir. 2005)); see also Edgemont Healthcare, DAB No. 2202 at 7-8 (2008). 

In the first place, I note that the parties agree that Resident 228 required re-evaluation after her fall on July 21, 2017 but disagree as to the adequacy of Petitioner’s response.  I agree with CMS that Petitioner should have conducted a Braden assessment following Resident 228’s fall on July 21, 2017.  CMS Ex. 8 at 12.  After that fall, Resident 228 went from being able to ambulate with a walker to experiencing difficulty standing and requiring two people to assist with mobility.  CMS Ex. 8 at 1, 2, 7, 10, 12-14; CMS Ex. 12 at 8.  Such a reduction in mobility signaled the possibility of an increased risk for the development of pressure sores since the resident would inevitably spend more time in bed or in a wheelchair.  Yet PT Burger did not evaluate Resident 228 until July 30, 2017, over a week after her fall. Even if PT Burger’s evaluation was sufficient to assess Resident 228’s risk for pressure ulcers after her fall, the facility cannot explain why it took nine days to conduct such an assessment.  Whatever the appropriate evaluation to perform, the lengthy delay to which Petitioner subjected Resident 228 in assessing her change in condition reflects a failure to take all necessary measures to prevent the development of a pressure ulcer within the meaning of the regulations.  Bradford Cty. Manor, DAB No. 2181 at 17 (2008) (holding a 12-day delay in implementing measures to prevent pressure ulcers was sufficient to establish noncompliance).  P. Ex. 1.  When she did so, the physical therapist took note of Resident 228’s right ankle swelling and concluded she was at risk for decreased skin integrity – in other words, at greater risk to develop a pressure ulcer.  P. Ex. 1 at 1, 3.  But even then, Petitioner did not conduct a Braden scale assessment until August 10, 2017, well after Resident 228 developed an unstageable pressure ulcer on her right heel.  CMS Ex. 14 at 9.  By waiting nine days after Resident 228’s fall to evaluate her change in condition and an additional 11 days to conduct a formal Braden scale assessment, Petitioner failed to furnish all necessary care to prevent the development of a pressure

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ulcer, as required by the regulations.  See Woodland Village Nursing Ctr., DAB No. 2172 at 13 (2008). 

I find persuasive CMS’s argument that Petitioner did not take adequate measures to prevent the development of pressure ulcers by ensuring Resident 228 was offered alternative interventions to the use of pillows to elevate her heels at night.  Petitioner claims that Resident 228 was in fact generally compliant in offloading her heels through the use of pillows and prior to the identification of a pressure ulcer on August 2, 2017, only refused to use them on seven occasions.  P. Br. at 6-7; P. Ex. 2 at 2, 12.  Petitioner’s attempt to blame the resident for her disinclination to use pillows is without merit because Petitioner failed to provide alternate means to allow Resident 228 to offload pressure on her heels, and instead simply documented her refusals.  As CMS argues, Petitioner failed to document contemporaneous efforts to provide Resident 228 alternative means that she could tolerate to offload her heels on at least seven occasions before she developed a pressure ulcer.  CMS Closing Br. at 13-14.  I cannot say, based on these facts, that Petitioner took all necessary steps to prevent the development of pressure ulcers or to promote their healing.  See Gooding Rehab. & Living Ctr., DAB No. 2239 at 14-15 (2009). 

I also conclude that after Resident 228 developed pressure ulcers, Petitioner did not take all necessary measures to treat her in order to promote healing of those ulcers, as required under 42 C.F.R. § 483.25(b)(1)(ii).  Specifically, the record establishes that the interventions identified to address Resident 228’s pressure ulcers –  skin checks, repositioning, use of an air mattress, and bilateral heel boots – were not consistently provided or appropriately documented.  Petitioner did not even consistently identify the correct heel on which Resident 228’s pressure ulcer developed.  On August 21 and 24, 2017, PT Burger documented treatment of a blood blister on Resident 228’s left heel.  CMS Ex. 12 at 18, 20.  On August 31, 2017, Surveyor Linderborn observed NP Schell treat a pressure ulcer on Resident 228’s left heel but incorrectly document treating the resident’s right heel.  CMS Ex. 20 at ¶ 35; CMS Ex. 18 at 4.  Later that day, Surveyor Linderborn observed that Resident 228 had pressure ulcers on both heels, but her treatment notes only documented a right heel pressure ulcer; Resident 228’s right heel was not treated that day at all.Resident 228’s right heel pressure ulcer continued to grow as a result of the facility’s lack of proper treatment.  CMS Ex. 5 at 15.  When the pressure ulcer was discovered on August 3, 2017, the wound measured 2.5 x 3.0 cm, with 75% dark purple and 25% a blister filled with clear liquid.  Id. at 1.  By August 31, 2017, the wound measured 2.5 x 4.2 cm and 100% of the wound area exhibited deep-purple ecchymosis (discoloration resulting from underlying bleeding).  Id. at 15.  CMS Ex. 20 at ¶ 44; CMS Ex. 18 at 4-5.  PT Burger conceded that she had identified the wrong heel (left) in Resident 228’s treatment notes, an error she subsequently “corrected,” though it appears that revision was also erroneous, as Resident 228 developed pressure ulcers on both heels.  CMS Ex. 20 at ¶ 45; CMS Ex. 18 at 5; CMS Ex. 12 at 25-26.  This failure to accurately identify and properly document the presence of pressure ulcers on Resident 228’s heels tends to corroborate Surveyor

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Linderborn’s observation that Petitioner’s staff did not consistently provide necessary treatment to promote healing of Resident 228’s right heel pressure ulcer.

It is also undisputed that Petitioner failed to timely implement the use of heel boots for Resident 228 and even after doing so, failed to adequately document the use of that intervention.  Cadia’s guidelines for treating pressure ulcers instructed staff to use a HeelMedix heel protector for deep tissue injuries.  CMS Ex. 23 at 1.  Resident 228 fell on July 21, 2017, CMS Ex. 8 at 12, but facility staff did not identify a “blood blister” and “purple discoloration” on Resident 228’s right heel until August 2, 2017.  CMS Ex. 12 at 10; CMS Ex. 17.  ANP Ryan did not issue an order for use of a right heel boot for Resident 228 until August 3, 2017.  CMS Ex. 6 at 1.  She did not prescribe bilateral heel boots or the use of a pressure-relieving air mattress until August 17, 2017, a week after a Braden scale assessment revealed Resident 228 to be at high risk for development of a pressure ulcer.  CMS Ex. 6 at 2; CMS Ex. 9 at 3-4; CMS Ex. 14 at 9.  Even then, as Surveyor Linderborn observed, Petitioner’s staff did not actually implement the use of bilateral heel boots on August 22, 26, or 27, 2017.  On those dates, Petitioner’s staff documented that Resident 228 wore only one boot and did not indicate on which foot the boot was applied.  CMS Ex. 20 at ¶ 45; CMS Ex. 8 at 22; CMS Ex. 10 at 11; CMS Ex. 18 at 4; Tr. at 113. 

Finally, Surveyor Linderborn’s observations during her survey visits at the facility tend to support a finding that Petitioner did not consistently provide repositioning and skin checks.  Surveyor Linderborn testified that she observed Resident 228 sitting in her wheelchair in the same position in the facility’s dining room for four hours on August 28, 2017 and again for five hours on August 31, 2017.  CMS Ex. 20 at ¶ 46.  Meanwhile, Petitioner’s corresponding documentation indicated the resident was repositioned and subjected to skin checks every two hours at those times.  CMS Ex. 4 at 20-21, 34. 

Petitioner contends Surveyor Linderborn’s observations are inconsistent with her sworn testimony, noting the surveyor testified she observed Resident 228 sitting in one position for five hours in the facility dining room but also claiming to have observed a wound nurse treat Resident 228’s pressure ulcer in the resident’s bedroom during the same timeframe.  P. Br. at 17-18; compare CMS Ex. 20 at ¶ 46, with CMS Ex. 20 at ¶ 44. 

There are indeed slight inconsistencies in the surveyor’s testimony, but these errors do not irretrievably tarnish her credibility, as Petitioner claims.  It is possible Surveyor Linderborn observed Resident 228 unattended for significant periods of time on two separate days and that she was able to witness at least one pressure ulcer treatment in the resident’s bedroom on one of those two days.  The former claim is not entirely undermined by the latter.  As such, I find no basis to discredit Surveyor Linderborn’s testimony.

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In any case, as I previously discussed, the record as a whole points to larger inconsistencies in documentation by Petitioner that evidence a failure to provide necessary treatment to Resident 228 to promote healing of her right heel pressure ulcer.  Even if I were to reject the surveyor’s testimony as to the periods of time she claims to have observed Resident 228 unattended and deprived of repositioning, there remains ample evidence of poor documentation and a failure to take all necessary measures to either prevent the development of pressure ulcers or to promote their healing.  

In sum, Petitioner recognized Resident 228’s risk for pressure ulcers when she was admitted and implemented a care plan to prevent their development.  But Petitioner failed to comply with the resident’s care plan and did not furnish all necessary treatment and services to prevent the development of a pressure ulcer.  Gooding Rehab. & Living Ctr., DAB No. 2239 at 15.  Less than two months after being admitted, Resident 228 fell and developed an injury on her right heel.  Petitioner failed to timely assess the injury and made critical documentation errors that allowed for that injury to develop into a pressure ulcer and for a second pressure ulcer to develop as well.  Once Resident 228 developed a pressure ulcer, Petitioner failed to provide necessary treatment to promote its healing.  I therefore conclude Petitioner was not in substantial compliance with 42 C.F.R. § 483.25(b)(1). 

C.  The $17,705 per-instance CMP selected by CMS is a reasonable enforcement remedy for Petitioner’s noncompliance with 42 C.F.R. § 483.25(b)(1). 

Where a facility is not in substantial compliance with program requirements, CMS has the authority to impose one or more of the enforcement remedies listed in 42 C.F.R. § 488.406, including a CMP.  In determining whether the per-instance CMP amount imposed against Petitioner here is reasonable, I apply the factors listed in 42 C.F.R. § 488.438(f).  42 C.F.R. § 488.438(e)(3).  These factors include:  (1) the facility’s history of noncompliance; (2) the facility’s financial condition; (3) the factors specified in 42 C.F.R. § 488.404;These factors are:  (1) the scope and severity of the deficiency; (2) the relationship of the deficiency to other deficiencies resulting in noncompliance; and (3) the facility’s prior history of noncompliance in general and specifically with reference to the cited deficiencies.  42 C.F.R. § 488.404. and (4) the facility’s degree of culpability, which includes neglect, indifference, or disregard for resident care, comfort, or safety.  42 C.F.R. § 488.438(f).  The absence of culpability is not a mitigating factor.  Unless a facility contends that a particular regulatory factor does not support the CMP amount that CMS proposed, I must sustain it.  Coquina Ctr., DAB No. 1860 at 32 (2002).

Here, CMS imposed a per-instance CMP of $17,705, falling in higher end of the range for this type of penalty at the time of its imposition ($2,097 to $20,965).  42 C.F.R. § 488.408(e)(1)(iv).  With respect to the factors set forth at 42 C.F.R. § 488.438(f), Petitioner does not claim that its financial condition affects its ability to pay the CMP.

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CMS asserts that Cadia’s history of noncompliance supports the CMP amount.  CMS Br. at 18.  CMS has proffered evidence of Petitioner’s history of noncompliance, namely deficiencies cited in 2014 through 2017.  CMS Ex. 22.  Most notably, Petitioner was cited for a deficiency involving actual harm to a resident discovered at survey in March 2017 survey, only six months before the survey conducted here.Petitioner’s appeal of the March 6, 2017 survey findings and CMP was dismissed by another ALJ in the Civil Remedies Division pursuant to 42 C.F.R. § 498.70(c)(2).  Id. at 1.  The remainder of Cadia’s prior deficiencies revealed lower to moderate levels of noncompliance.  Id. at 1-2.  However, given that Petitioner was cited with two deficiencies causing actual harm within six months, I find a higher CMP amount reasonable. 

CMS also argues that the seriousness of the deficiency and the facility’s culpability support the CMP amount.  CMS Br. at 18.  Petitioner claims the CMP is not reasonable because the CMP imposed in this case “is nearly as high as CMS could impose.”  P. Br. at 19.  Petitioner argues that it is unreasonable to impose such a high CMP because the development of Resident 228’s left heel pressure ulcer demonstrates her right heel pressure ulcer was unavoidable.  Id.  I take this assertion to be a claim that the facility’s level of culpability is low. 

I reject Petitioner’s claim.  As I have explained, Petitioner did not establish that Resident 228’s right heel pressure ulcer was clinically unavoidable.  Following a fall that resulted in bruising and reduced mobility, both factors that would increase the risk for pressure ulcers, Petitioner failed to reassess Resident 228’s risk for developing pressure ulcers for over a week.  When the facility finally did recognize the resident was at risk to develop pressure ulcers, it implemented some additional interventions but then either failed to properly document relevant findings or failed to provide alternative interventions to prevent the development of a pressure ulcer.  After Resident 228 developed a pressure ulcer on her right heel, the facility failed to provide necessary treatment and services to promote healing of that ulcer.  The facility did not conduct timely skin assessments or implement important treatment protocols such as bilateral heel boots and a pressure-relieving mattress.  Petitioner’s staff also incorrectly documented treatment of the wound and on at least one occasion, failed to treat the right heel pressure wound at all.  As a result, the right heel pressure ulcer continued to worsen.  In short, Petitioner’s noncompliance caused Resident 228 actual harm.  I find Petitioner highly culpable. 

Finally, I have considered the serious nature of the facility’s noncompliance in this case.  Cadia was aware that Resident 228 was at risk for pressure ulcers.  Both the care plan and physician ordered offloading of the resident’s heels.  But when Resident 228 refused to offload her heels with pillows, Petitioner did not attempt other accepted measures to offload her heels to prevent development of a pressure ulcer.  Following a fall and decline in mobility, Petitioner failed to timely reassess Resident 228’s risk for developing

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pressure ulcers.  After Resident 228 developed an avoidable right heel pressure ulcer, Petitioner’s staff failed to consistently implement appropriate measures to prevent further development of pressure ulcers, made documentation errors regarding treatment of the pressure ulcer, and even failed to treat the resident’s right heel pressure ulcer on one occasion.  Petitioner’s inconsistent treatment of Resident 228 placed her at increased risk to develop pressure ulcers.  In consideration of all the relevant factors, I conclude the imposition of a $17,705 per-instance CMP to be reasonable.  

VI.   Conclusion

For the foregoing reasons, I conclude that Petitioner was not in substantial compliance with 42 C.F.R. § 483.25(b)(1) (cited as Tag F314).  I further conclude the $17,705 per-instance CMP imposed by CMS for noncompliance with 42 C.F.R. § 483.25(b)(1) to be reasonable.