West Caldwell Care Center, DAB No. 3210 (2025)

FINAL DECISION ON REVIEW OF ADMINISTRATIVE LAW JUDGE DECISION

West Caldwell Care Center (Petitioner), a skilled nursing facility, appealed the decision of an administrative law judge (ALJ) upholding on summary judgment a determination by the Centers for Medicare & Medicaid Services (CMS) to impose a civil money penalty (penalty) against Petitioner for noncompliance with Medicare participation requirements regarding the prevention of pressure sores.  West Caldwell Care Center, DAB CR5237 (2019) (ALJ Decision).  The ALJ found, based on undisputed facts, that Petitioner was not in substantial compliance with 42 C.F.R. § 483.25(b)(1) and concluded that the penalty imposed by CMS in the amount of $1,720 per day from February 23, 2018, through March 23, 2018, was reasonable.  Based on our de novo review of the record, we affirm the ALJ’s decision to grant summary judgment in favor of CMS; however, we modify the ALJ’s decision concerning the duration of Petitioner’s noncompliance and conclude that Petitioner remained out of substantial compliance with section 483.25(b)(1) for 34 days – from February 23, 2018, through March 28, 2018.

Legal Background

To participate in the Medicare program, a skilled nursing facility must be in “substantial compliance” with the requirements in 42 C.F.R. Part 483, Subpart B (§§ 483.1 - 483.95).  42 C.F.R. §§ 483.1(b), 488.400.1  A skilled nursing facility is not in “substantial compliance” when it has a “deficiency” – that is, a failure to meet a participation requirement – that creates the potential for more than minimal harm to one or more residents.  42 C.F.R. § 488.301 (defining “substantial compliance” and “deficiency”).  The term “noncompliance,” as used in the applicable regulations, is synonymous with lack of substantial compliance.  Id. (defining “noncompliance”).  The participation requirements relevant to this appeal provide as follows:

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Quality of care is a fundamental principle that applies to all treatment and care provided to facility residents.  Based 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, including but not limited to the following:

***

(b) Skin integrity —

(1) Pressure ulcers.  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)(i)-(ii).

Compliance with Medicare participation requirements is verified through onsite surveys performed by state health agencies.  Id. §§ 488.10, 488.11(a).  A state agency reports any “deficiency” it finds in a statement of deficiencies.  Id. § 488.325(f)(1).2  A statement of deficiencies also indicates the survey agency’s assessment of the “seriousness” of any cited deficiency.  Id. § 488.404(a).  Seriousness is a function of the scope of noncompliance (whether a deficiency is “isolated,” constitutes a “pattern,” or is “widespread”) and severity (whether a deficiency has created a “potential for” only “minimal harm” or a potential for “more than minimal harm,” resulted in “[a]ctual harm,” or placed residents in “immediate jeopardy”).  Id. § 488.404(b).

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CMS may impose one or more remedies against a skilled nursing facility that is out of substantial compliance.  Id. §§ 488.400, 488.402(b)-(c), 488.406.  The remedies that CMS may impose for noncompliance include civil money penalties.  Id. §§ 488.406, 488.430.  A per-day penalty may be imposed for “the number of days a facility is not in substantial compliance with one or more participation requirements.”  Id. § 488.430(a).  When CMS assessed the penalty here, it had authority to impose a penalty (adjusted for inflation) in the range of $105 to $6,289 per day for deficiencies that either caused actual harm or have the potential for more than minimal harm (but do not constitute immediate jeopardy).  Id. § 488.438(a)(1)(ii); 45 C.F.R. § 102.3 (penalty adjustment table) (Feb. 3, 2017).3  In selecting the penalty amount, CMS considers the facility’s history of noncompliance, financial condition, degree of culpability, and the factors specified in section 488.404 (mainly, the seriousness of the noncompliance).  42 C.F.R. § 488.438(f).

A skilled nursing facility may challenge a determination of noncompliance that led to the imposition of a remedy by requesting an ALJ hearing and appealing any unfavorable ALJ decision to the Board.  42 C.F.R. §§ 488.408(g)(1), 498.3(b)(13), 498.5(b)-(c).  In cases where a skilled nursing facility appeals a CMS determination that led to a penalty, the scope of review is limited to considering whether a basis for imposing the penalty exists and whether the amount of the penalty is reasonable.  See id. §§ 488.438(e), (f).

Case Background

On February 23, 2018, the New Jersey Department of Health (state agency) completed a survey of Petitioner’s facility and found deficiencies involving several Medicare participation requirements, including noncompliance concerning the prevention of pressure sores under 42 C.F.R. § 483.25(b)(1) (Tag F686).  CMS Ex. 2, at 10-16.  The surveyors assessed the Tag F686 deficiency at the “G” level of seriousness.  Id. at 10.4

The surveyors found that Petitioner assessed Resident 21 (R21) at the time of admission to be at risk for developing pressure sores due to decreased mobility, use of anticoagulants, and incontinence.  Id. at 12.  The surveyors found that despite this risk, Petitioner failed to carry out interventions in R21’s care plan “to apply skin barrier cream and apply peri-guard” and failed to perform weekly skin assessments as required by a

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physician’s order.  Id.  The surveyors noted that after months of failing to implement these interventions, R21 developed an “unstageable” pressure sore on her sacrum.  Id. at 12-16.5  An “unstageable” pressure sore, the surveyors explained, is one “defined as full thickness tissue loss in which the base of the ulcer is covered by slough, a yellow, tan, gray, green or brown and/or eschar/black in the wound bed,” and that “[t]his injury results from intense and/or prolonged pressure and shear forces at the bone-muscle interface that developed over time.”  Id. at 13-14 (quoting the National Pressure Ulcer Advisory Panel (NPUAP)).

CMS concurred with the state agency’s findings regarding Tag F686 and, by letter dated June 13, 2018, imposed enforcement remedies against Petitioner, including a civil money penalty, based on Petitioner’s noncompliance with 42 C.F.R. § 483.25(b)(1).  CMS Ex. 1, at 1-2, 8-9.6  CMS determined that Petitioner corrected this deficiency and achieved substantial compliance on March 29, 2018.  Id. at 1, 8.  CMS imposed a penalty of $1,720 per day for the duration of Petitioner’s noncompliance, which CMS determined ran from February 23, 2018, to March 28, 2018.  Id. at 1-2, 8-9.7  The letter also notified Petitioner of its appeal rights.  Id. at 4-6, 11-13.

ALJ Proceedings and Decision

Petitioner filed a request for hearing, challenging the noncompliance finding, the imposition of the penalty, and the penalty amount.  Request for Hearing (RFH) at 2.  CMS filed a pre-hearing brief and motion for summary judgment, including 18 exhibits (CMS Exs. 1-18).  CMS argued that the undisputed facts show Petitioner failed to provide R21 with the necessary care and services to prevent the development of a pressure sore in violation of section 483.25(b)(1) and that the penalty imposed ($1,720 per day for 34 days) was reasonable.  Petitioner filed a pre-hearing brief and opposition to summary judgment, including nine exhibits (P. Exs. 1-9).  Petitioner argued that there are disputed material facts concerning its implementation of R21’s care plan, that the pressure sore was unavoidable, and that the penalty amount is unreasonable.  CMS filed a

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reply brief in further support of its motion for summary judgment.  Neither party raised any evidentiary objections.8

The ALJ found no material facts in dispute and granted summary judgment in favor of CMS.  ALJ Decision at 1.  The ALJ found the undisputed material facts “plainly establish” that Petitioner was not in substantial compliance with 42 C.F.R. § 483.25(b)(1) because Petitioner:  (i) failed to conduct weekly skin assessments as ordered by R21’s treating physician; (ii) failed to comply with R21’s care plan by not applying skin barrier cream and PeriGuard as a preventive measure; and (iii) failed to update R21’s care plan for nearly a month after she developed a pressure sore.  Id. at 2.  The ALJ further concluded that the penalty imposed by CMS of $1,720 per day was reasonable for the duration of Petitioner’s noncompliance.  Id. at 1, 8-9.9

Standard of Review

We review whether summary judgment is appropriate de novo.  Southpark Meadows Nursing & Rehab. Ctr., DAB No. 2703, at 5 (2016).  “Summary judgment is appropriate when the record shows there is no genuine issue as to any material fact, and the moving party is entitled to judgment as a matter of law.”  Id. (internal quotation marks omitted).  “To defeat an adequately supported summary judgment motion, the non-moving party may not rely on the denials in its pleadings or briefs, but must furnish evidence of a dispute concerning a material fact – a fact that, if proven, would affect the outcome of the case under governing law.”  Senior Rehab. & Skilled Nursing Ctr., DAB No. 2300, at 3 (2010), aff’d, 405 F. App’x 820 (5th Cir. 2010).  “A party must do more than show that there is some metaphysical doubt as to the material facts.  Where the record taken as a whole could not lead a rational trier of fact to find for the nonmoving party, there is no genuine issue for trial.’”  The Harborage, DAB No. 2905, at 5 (2018) (internal quotation marks and ellipses omitted).10

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“In examining the evidence to determine the appropriateness of summary judgment, we view the evidence in the light most favorable to the non-moving party and draw all reasonable inferences in that party’s favor.”  Heritage House of Marshall Health & Rehab., DAB No. 3035, at 8 (2021).  Drawing factual inferences in the light most favorable to the non-moving party does not require that we draw unreasonable inferences or accept the non-moving party’s legal conclusions.  See Brightview Care Ctr., DAB No. 2132, at 10 (2007); Cedar Lake Nursing Home, DAB No. 2344, at 7 (2010).  When deciding summary judgment, it is inappropriate for the tribunal to make credibility determinations or weigh competing evidence.  See Heritage House at 9.

Analysis

In its Request for Review (RR), Petitioner asserts that the ALJ erred in granting summary judgment for CMS and concluding that the facility was not in substantial compliance with 42 C.F.R. § 483.25(b)(1).  RR at 8-9.  Petitioner contends that there are disputed facts regarding the facility’s preventive care, the use of skin checks and wound assessments, and its treatment of the actual wound.  Id. at 9-12.  Petitioner further contends that the ALJ erred in concluding that the penalty amount is reasonable.  Id. at 12-13.  Petitioner asks the Board to reverse the ALJ Decision and remand the case for a “full hearing,” which, according to Petitioner, will show that (i) the pressure sore was unavoidable, and (ii) the penalty was unreasonable.  Id. at 13.

Based on our de novo review, we conclude that the ALJ did not err in granting summary judgment for CMS.  The undisputed material facts establish that Petitioner was not in substantial compliance with section 483.25(b)(1) because R21 developed an unstageable pressure sore when Petitioner failed to apply skin barrier cream and PeriGuard as a preventive measure required by R21’s care plan and failed to conduct weekly skin assessments as ordered by R21’s treating physician.11  We further conclude that the per-day penalty imposed by CMS in the amount of $1,720 for the duration of Petitioner’s noncompliance (February 23, 2018, through March 28, 2018) was reasonable.

I. The undisputed material facts establish that Petitioner was not in substantial compliance with 42 C.F.R. § 483.25(b)(1) (F686).

The regulations governing the prevention and treatment of pressure sores are part of the quality of care requirements at 42 C.F.R. § 483.25.  This regulation’s overarching requirement is that “the facility must ensure that residents receive treatment and care in accordance with professional standards of practice, the comprehensive person-centered

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care plan, and the resident’s choices . . . .”  42 C.F.R. § 483.25.  The specific subsection of 483.25 governing the prevention and treatment of pressure sores was previously designated under 42 C.F.R. § 483.25(c).  In 2016, this subsection was redesignated and revised at 42 C.F.R. § 483.25(b)(1).  While the specific language was modified to clarify that care must be consistent with professional standards of practice, CMS made clear in response to public comments that the fundamental intent and purpose of the regulation had not changed:

Any resident at any time who does not have a pressure ulcer, even if the resident had one upon admission and it has resolved, must receive care and services to prevent the formation of pressure ulcers unless the resident’s clinical condition demonstrates that the development of pressure ulcers was unavoidable.  Similarly, any resident who has a pressure ulcer, no matter when or why it developed, must receive care and services to promote healing, prevent infection, and prevent new ulcers from developing.

81 Fed. Reg. at 68,746, 68,749-50 (describing skin integrity regulation as revised and redesignated at section 483.25(b)(1)).12

Section 483.25(b)(1) requires that the facility “ensure” that each “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.”  42 C.F.R. § 483.25(b)(1)(i).  If a resident has a pressure sore, then the facility must “ensure” that the resident “receives necessary treatment and services, consistent with professional standards of practice, to promote healing, prevent infection and prevent new ulcers from developing.”  Id. § 483.25(b)(1)(ii).  This case primarily involves Petitioner’s noncompliance with section 483.25(b)(1)(i) concerning the prevention of pressure sores.

The Board has long held “that the language of section 483.25 requires skilled nursing facilities to furnish the care and services set forth in a resident’s care plan, to implement doctors’ orders, to monitor and document the resident’s condition, and to follow its own policies.”  Life Care Ctr. of Bardstown, DAB No. 2479, at 22 (2012), aff’d, 535 F. App’x 468 (6th Cir. 2013).  Regarding pressure sores specifically, “the failure of a facility to follow its own plan of care to prevent pressure sores from developing . . . is evidence of noncompliance with section [483.25(b)(1)].”  The Harborage at 6.  “[A] facility must provide all necessary care and services to prevent the development of pressure sores, rather than just provide prompt treatment after they develop, particularly where the residents involved were known to have a high risk of developing sores.”  Koester Pavilion, DAB No. 1750, at 33 (2000).  Thus, a facility’s failure to provide such care and

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services in accordance with a physician’s order or the resident’s comprehensive care plan can establish noncompliance with section 483.25(b)(1).  See, e.g., The Harborage at 8 (failure to provide all pressure sore prevention interventions required by resident’s care plan); Senior Rehab., DAB No. 2300, at 19 (failure to prevent and treat pressure sores in accordance with resident care plan and facility policies); Columbus Nursing & Rehab. Ctr., DAB No. 2273, at 6-7 (2009) (failure to follow physician orders regarding treatment of pressure sores); Clermont Nursing & Convalescent Ctr., DAB No. 1923, at 13 (2004) (failure to follow physician order to prevent pressure sores).

A. R21 developed an unstageable pressure sore when Petitioner failed to provide the care required by R21’s care plan.

R21 was admitted to Petitioner’s facility on February 15, 2017, with diagnoses including right hip dislocation, anxiety disorder, hypertension, chronic atrial fibrillation, and muscle weakness.  CMS Ex. 10, at 11.  Petitioner’s staff assessed R21 to be at risk for skin integrity impairment (i.e., pressures sores) due to decreased mobility and use of a right knee immobilizer.  Id.  On February 16, 2017, Petitioner developed a care plan for R21 to prevent the development of pressure sores.  Id.  The care plan specified the treatment goal for R21 as “no new skin integrity impairment,” and directed interventions by staff including to “apply barrier cream as ordered.”  Id.

On March 7, 2017, Petitioner revised R21’s care plan.  CMS Ex. 10, at 12.  The revised care plan noted that R21 “presents with potential for skin integrity impairment” due to decreased mobility, use of anticoagulants, and incontinence.  Id.  The stated treatment goal in the revised plan remained “no skin integrity impairment.”  Id.  The revised plan directed staff to apply skin barrier cream and PeriGuard, among other interventions.  Id.  PeriGuard is the brand name of a zinc oxide-based ointment commonly used to treat skin irritations associated with incontinence.  CMS Ex. 3, at 6 (¶ 21, n.3); CMS Ex. 11.  The application of skin barrier cream and PeriGuard are listed as separate measures in the care plan.  CMS Ex. 10, at 12.  The revised care plan was continued on a quarterly basis, with no changes to the prescribed interventions, until the time of the survey.  Id. at 12-13 (noting changes to care plan on February 16, 2018).

On January 18, 2018, Petitioner’s staff discovered that R21 had developed an “unstageable” pressure sore on her sacrum.  CMS Ex. 10, at 1; CMS Ex. 13; CMS Ex. 3, at 7 (¶ 25).  The facility’s weekly wound documentation indicated that the wound originated at the facility and was a type of “pressure” sore.  CMS Ex. 10, at 1.  A follow-up notation on February 1, 2018, indicates that the pressure sore continued to be “unstageable” with slough and epithelial tissue, and measured 2.0 cm long and 1.5 cm wide almost two weeks after the wound was first discovered by staff.  Id.

The ALJ found no genuine dispute of material fact concerning Petitioner’s failure to provide the interventions required by R21’s care plan for the prevention of pressure sores.

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ALJ Decision at 4 (“[T]he record is devoid of treatment records showing that the staff regularly applied barrier cream and Peri-guard to the resident’s skin.”).  The ALJ further concluded that this omission is “sufficient to establish noncompliance” with section 483.25(b)(1).  Id.  As explained below, we find no error in the ALJ’s conclusion.

The application of skin barrier cream and PeriGuard are “common interventions” to minimize the skin’s exposure to moisture and prevent pressure sores from developing.  CMS Ex. 3, at 6 (¶ 22); see also CMS Ex. 6, at 10; CMS Ex. 8, at 19.  The facility’s nurse care logs for January 2018 and treatment administration records do not indicate that Petitioner’s staff applied barrier cream or PeriGuard to R21’s sacral area at any time before staff documented the open wound on her sacrum.  See CMS Ex. 10; CMS Ex. 3, at 8 (¶ 30).  At the time of the survey, the licensed practical nurse (LPN) assigned to care for R21 told the surveyor that skin ointment was not provided to R21 until January 18, 2018, when treatment for the wound was ordered.  CMS Ex. 3, at 8 (¶ 31); CMS Ex. 4, at 4.  The facility’s Director of Nursing (DON) also acknowledged during the survey that the facility did not order barrier cream and PeriGuard for R21 per the instructions in her care plan.  CMS Ex. 3, at 9 (¶ 32).

Petitioner argues there are genuine disputes of material fact regarding its implementation of R21’s care plan based on the written declaration of Petitioner’s assistant director of nursing (ADON).  RR at 9 (citing P. Ex. 4).  The ADON provided a declaration acknowledging that R21 was at risk for “skin impairment” and had multiple interventions in her care plan to “prevent skin breakdown or injury,” including “skin barrier cream or Periguard.”  P. Ex. 4, at 2 (¶¶ 12-13) (emphasis added).  Contrary to the ADON’s conclusory assertion, R21’s care plan required the application of both skin barrier cream and PeriGuard.  CMS Ex. 10, at 12; see also ALJ Decision at 7 (“Petitioner consistently confuses the requirement that its staff apply a barrier cream to [R21] with the additional requirement that it apply Peri-guard to the resident.  These are two separate medications and one is not a substitute for the other.”).  Notably, the ADON did not assert that these medications were the same or that one medication could be substituted for the other.

The ADON also did not raise a genuine dispute of material fact by declaring that skin integrity issues secondary to incontinence “were being prevented with Periguard cream,” which is standard nursing practice, and that certified nursing assistants “routinely utilize barrier cream per the facility’s incontinence care protocol.”  P. Ex. 4, at 2 (¶ 14).  Nowhere in the ADON’s declaration did she assert that Petitioner’s staff regularly applied skin barrier cream and PeriGuard to R21’s sacral area to prevent pressure sores as R21’s care plan required.  Nor did the ADON point to any documentation to refute the surveyor’s finding that there are no facility records showing that Petitioner’s staff applied barrier cream or PeriGuard to R21’s sacral area before staff discovered the open wound on her sacrum on January 18, 2018.  Further, in response to the LPN’s statement to the surveyor that skin ointment was not provided to R21 before January 18, 2018, the ADON wrote that the LPN’s statement “makes sense” because there was no “wound treatment”

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before January 18, 2018.  P. Ex. 4, at 4 (¶ 31).  However, as the ALJ noted, skin barrier cream and PeriGuard were prescribed as preventive medications in R21’s care plan, not as wound treatment.  ALJ Decision at 6 n.2.

The Board has previously affirmed, in the context of summary judgment, “the importance of contemporaneous clinical documentation” in assessing a facility’s compliance with quality-of-care regulations.  See, e.g., The Harborage at 15.  Here, the ADON’s assertions would require the ALJ (or the Board) to surmise that facility staff implemented R21’s plan of care, not based on nursing records or other clinical documentation, but on conclusory assertions about the facility’s usual practices.  “We cannot find a dispute of material fact requiring reversal of summary judgment based on conjecture.”  Harborage at 12.  As the ALJ explained, merely asserting that barrier cream was “routinely” provided to residents “is a bald assertion that does not even address the question of whether barrier cream and Peri-guard were applied to the specific resident whose care is at issue here.”  ALJ Decision at 6.  Such general and conclusory assertions about the facility’s standard practices and routines do not, without more, generate a genuine dispute of material fact about the lack of preventive care received by R21 based on this record.  See Rehab at River’s Edge, DAB No. 3163, at 17-18 (2024) (rejecting, in the summary judgment context, inferences based on conclusory witness opinions and speculation).  We find no error in the ALJ’s determination that the undisputed material facts establish that Petitioner’s staff did not apply skin barrier cream and PeriGuard as required by R21’s care plan to prevent the development of pressure sores.  ALJ Decision at 2, 4.

B. R21 developed a pressure sore when Petitioner failed to provide the care required by R21’s physician’s order.

In addition to the interventions in R21’s care plan, R21’s physician ordered that she receive a weekly “skin assessment” every Monday on the “7-3 shift,” effective April 28, 2017.  CMS Ex. 10, at 7.  R21’s treatment administration record likewise identified weekly skin assessments as “routine treatment” to be conducted every Monday beginning in April 2017.  Id. at 3.  The surveyor noted that such skin assessments must be performed by a registered nurse (RN) in accordance with state law because it is a task that requires skilled professional nursing judgment and cannot be delegated to a staff member who is not an RN.  CMS Ex. 3, at 10-11 (¶ 40); see also N.J. Admin. Code § 13:37-6.5(b) (2016) (“A registered professional nurse shall not delegate the physical . . . assessment of the patient, which requires professional nursing judgment, intervention, referral, or modification of care.”).

The record shows that on January 8, 2018, and January 15, 2018, the weekly skin assessments for R21 were signed by an LPN (identified by his initials “KH”) and were not signed (or counter-signed) by the charge nurse or any other RN.  CMS Ex. 2, at 15 (“There was no documented evidence of a weekly skin assessment by an RN nor was there a co-signature by an RN.”); CMS Ex. 3, at 11 (¶ 41, n.4); CMS Ex. 10, at 3.  On

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January 22, 2018, the facility’s DON and its Administrator issued a written warning to the charge nurse, noting that R21 was found with an “unstageable wound” on January 18, 2018, and that the charge nurse “failed to notify [the] DON of [the] wound.”  CMS Ex. 13.  The warning states:  “Residents should be assessed by the charge nurse on a regular basis.”  Id.  The “corrective action” section of the warning further states:  “Charge nurse to assume responsibility for residents in her care and periodically evaluate their body assessments.”  Id.13

The ALJ concluded, based on the undisputed facts, that Petitioner “failed to conduct weekly skin assessments” of R21 to protect against the development of pressure sores as “ordered by the resident’s treating physician.”  ALJ Decision at 2.  The ALJ noted that “although [R21’s] clinical records are initialed to indicate that skin assessments were performed by a licensed practical nurse (LPN), the record is devoid of evidence showing that a registered nurse performed weekly skin assessments on [R21].”  Id. at 3.  The ALJ explained that delegation of the duty to perform skin assessments to an LPN violates New Jersey law, which requires that an RN perform such physical assessments.  Id. at 3 (citing N.J. Admin. Code § 13:37-6.5 (2016)).  The ALJ thus concluded:  “There is nothing in the record showing that skin assessments were performed weekly by a registered nurse as is required by New Jersey law.  Rather, the record shows only that an LPN made assessments.”  Id. at 4.  The ALJ found this shortcoming sufficient to establish noncompliance with section 483.25(b)(1).  Id.

Petitioner concedes that an RN was to perform “skin assessments.”  RR at 10 (“The ALJ accurately found that skin assessments are to be performed by a registered nurse.”).  Moreover, Petitioner does not dispute that R21 did not receive weekly “skin assessments” by an RN before R21 developed an open wound in January 2018.  According to Petitioner, “skin assessments” were only to be performed on R21 if the resident developed a wound.  Id. (“There was no order for ‘skin assessments’ to be performed on [R21] prior to the occurrence of a wound.”).  Petitioner contends that it complied with R21’s “treatment plan” because R21 received weekly “skin checks” by other staff, such as an LPN.  Id.  According to Petitioner, “CMS (and the ALJ) confused routine skin checks with wound assessments.”  Id. at 11 (“The issue of skin checks versus wound assessments was confused in the record.”).

There was no issue of “skin checks versus wound assessments” and neither CMS nor the ALJ confused those things; rather, Petitioner is confusing the issues by conflating “skin assessments” and “wound assessments.”  See P. Ex. 5, at 3 (¶ 16) (“Our facility has a separate detailed skin assessment form that is used by registered nurses for skin assessments.  (P. Exh. 2.)”); see also P. Ex. 6, at 5 (¶ 31) (“It is our procedure that if any

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skin abnormality is identified, then an RN is called and will perform an assessment and complete a wound sheet.  (See P. Exh. 2.)”).  The wound assessment forms that Petitioner’s Administrator and its Director of Nursing point to are the “weekly wound documentation” sheets that an RN completed after R21 developed an unstageable pressure sore.  P. Ex. 2.  This evidence has no bearing on the issue of whether an RN performed the weekly “skin assessments” required by R21’s physician’s order beginning on April 28, 2017 – before R21 developed a pressure sore.

According to Petitioner, R21’s treatment plan “required just a weekly skin check” and asserts, without evidence, that such “skin checks” need not be performed by an RN.  RR at 10 (citing P. Ex. 5; P. Ex. 6).  Petitioner does not explain how a “skin check” differs from a “skin assessment,” apart from acknowledging that “skin assessments” must be performed by RNs, while asserting that “skin checks” do not.  RR at 10.  This purported distinction, however, generates no genuine issue of material fact because the physician’s order at issue plainly required weekly “skin assessments” – a type of physical assessment.  Neither Petitioner’s Administrator (P. Ex. 5) nor its Director of Nursing (P. Ex. 6) offered testimony that the “skin assessments” required by R21’s physician order need not be performed by an RN.  Nor did Petitioner explain how any required physical assessment of a resident could be lawfully delegated to an LPN or conducted without an RN.

We do not suggest that LPNs or other staff should not or cannot examine residents or assist in resident care, but “skin checks” by non-RN staff cannot substitute for the weekly “skin assessments” required by R21’s physician’s order.  See, e.g., The Harborage at 7-8 (sustaining summary judgment against facility because record did not support finding that the facility “provided all of the pressure sore prevention interventions required” by resident’s care plan (underlining omitted, italics added)).  Thus, evidence of other interventions undertaken by Petitioner’s staff, such as routine “skin checks” by LPNs, even if assumed to be true for purposes of summary judgment, does not negate Petitioner’s failure to provide the services required by R21’s physician’s order.  See Emerald Oaks, DAB No. 1800, at 29 (2001) (concerning specific instances of noncompliant care, “[i]t is not an adequate response to assert that many other things were done for the resident at other times”).

Here, there is no documented evidence of weekly skin assessments by an RN (or even skin assessments counter-signed by an RN) before staff discovered R21’s pressure sore on January 18, 2018.  We find no error in the ALJ’s conclusion that R21 did not receive weekly skin assessments by an RN as required by R21’s physician’s order for the prevention of pressure sores and that CMS is entitled to summary judgment based on that noncompliance.  See Senior Rehab., DAB No. 2300, at 17-18 (sustaining summary judgment against facility for noncompliance with quality-of-care regulation because undisputed material facts established staff were not conducting skin assessments in accordance with resident’s care plan); see also Columbus Nursing, DAB No. 2273, at 7

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(affirming ALJ’s conclusion that facility was not in substantial compliance with quality-of-care regulation where facility failed to follow physician orders).

C. R21’s pressure sore cannot be considered “unavoidable” where the facility failed to implement interventions in R21’s care plan and physician’s order.

Petitioner further argues that R21’s pressure sore was “unavoidable,” asserting that “[p]roper care was rendered as evidenced by the resident not having any skin integrity issues from admission until the presentation of trauma-related skin impairment.”  RR at 4 (citing P. Ex. 4, at 4 (¶ 27)).  Petitioner claims, pointing to an unsworn report by Gail Elkouby, RN, that R21’s pressure sore was the unavoidable result of “friction and shearing” due to R21’s “comorbidities and increasing physical agitation.”  RR at 7, 9 (citing P. Ex. 7).  The ALJ properly rejected this argument as a matter of law because Petitioner cannot avail itself of such a defense given its failure to provide the preventive care prescribed to R21.  ALJ Decision at 8 (“The defense of unavoidability is never available to a facility that fails to undertake requisite preventive measures to protect a resident against developing a pressure sore.” (citing Clermont Nursing & Convalescent Ctr., DAB No. 1923, at 8, 10-11 (2004)).

Section 483.25(b)(1)(i) requires that a facility “ensure” that 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.”  The Board has long held that “[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.”  Ivy Woods Health Care & Rehab. Ctr., DAB No. 1933, at 9 (2004).  Rather, the facility must show that the pressure sore was not just unsurprising, but “incapable of prevention despite appropriate measures taken in light of the clinical risks.”  Id.; see also Edgemont Healthcare, DAB No. 2202, at 8 (2008); Harmony Court, DAB No. 1968, at 11 (2005).  “The language of the regulation clearly calls for facilities to take necessary actions in the face of high-risk conditions in order to prevent new sores.”  Ivy Woods at 9.  Thus, a facility cannot claim unavoidability unless it first shows that it furnished all necessary services to prevent new sores from developing.  See Gooding Rehab. & Living Ctr., DAB No. 2239, at 15 (2009).

As we have already determined, Petitioner did not furnish all necessary services to prevent the development of pressure sores.  The facility’s own clinical records establish that its staff failed to apply skin barrier cream and PeriGuard as prescribed in R21’s care plan, and RNs did not properly or consistently assess R21’s skin in accordance with R21’s physician’s order.  These failures to provide necessary and appropriate care to prevent the development of pressure sores are, by themselves, sufficient to establish Petitioner’s noncompliance with section 483.25(b)(1)(i).  And, because Petitioner did not

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provide the care and treatment required by R21’s care plan and physician’s order, Petitioner cannot, as a matter of law, claim that R21’s pressure sore was unavoidable.  See The Harborage at 8 (rejecting facility’s contention that pressure sores were unavoidable because evidence did not support finding that the facility provided “all of the pressure sore prevention interventions” required by resident’s plan of care).  For all these reasons, we conclude that a rational trier of fact, viewing the record in the light most favorable to Petitioner and drawing all reasonable inferences in its favor, could not find that Petitioner was in substantial compliance with section 483.25(b)(1)(i).

D. We vacate the ALJ’s noncompliance finding based on Petitioner’s alleged failure to update R21’s care plan.

Before the Board, Petitioner argues that “[f]ailing to update the plan of care expeditiously does not establish a violation of 42 C.F.R. 483.25(b), where the actual care rendered was changed immediately.”  RR at 12.  While the ALJ found that Petitioner was noncompliant with section 483.25(b)(1) because Petitioner allegedly failed to update R21’s care plan after she developed a pressure sore, we cannot uphold that part of the ALJ Decision.  ALJ Decision at 2, 4.  The state agency identified this alleged deficiency as a violation of 42 C.F.R. § 483.21(b)(2) (Tag F657 - Care Plan Timing and Revision).  CMS Ex. 2, at 4-7.  Importantly, CMS imposed no remedy against Petitioner for an alleged violation of 42 C.F.R. § 483.21(b)(2) (Tag F657).  CMS Ex. 1.14  Moreover, during the ALJ proceedings, CMS did not allege that Petitioner failed to comply with section 483.25(b)(1) (Tag F686) because it did not immediately update R21’s care plan after discovering the pressure sore.  Absent such notice, we cannot sustain that aspect of the ALJ Decision.  Cf. Golden Living Ctr. - Superior, DAB No. 2768, at 8 n.4 (2017) (holding that due process requirements were satisfied when CMS’s summary judgment motion notified the facility of the evidence and allegations supporting noncompliance determinations and petitioner had an opportunity to respond).  Because Petitioner was not provided adequate notice and a meaningful opportunity to respond to these allegations before the ALJ, and because section 483.25(b)(1) does not specifically require a facility to update a resident’s care plan upon discovering a pressure sore, we vacate that aspect of the ALJ Decision.

II. Petitioner remained out of substantial compliance from February 23, 2018, through March 28, 2018.

Following its receipt of the statement of deficiencies, Petitioner outlined the measures it would take to achieve substantial compliance in a plan of correction.  See RFH at 2; CMS Ex. 16 (plan of correction).  Petitioner designated March 28, 2018, as the “completion date” for all corrective measures, including the corrective measures relevant to Tag F686.  CMS Ex. 16, at 10.  Consistent with the “completion date” in Petitioner’s plan of

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correction, CMS concluded that Petitioner remained out of substantial compliance for 34 days – from February 23, 2018, through March 28, 2018.  CMS Ex. 1, at 1 (concluding after a revisit survey that Petitioner achieved substantial compliance on March 29, 2018).

Despite this uncontroverted evidence, the ALJ wrote that CMS determined Petitioner’s noncompliance “began on February 23, 2018, the date of the survey of Petitioner’s facility, and ended on March 23, 2018, the date when Petitioner represented that it had remedied the noncompliance . . . .”  ALJ Decision at 8.  The ALJ further noted that Petitioner never argued that it attained compliance on a date earlier than March 23.  Id.  In fact, Petitioner did not argue that it achieved substantial compliance on a date earlier than March 28.  RFH at 2 (“The plan of correction was completed by March 28, 2018.”). The ALJ’s repeated reference to “March 23” appears to be a typographical error and thus is harmless.  See, e.g., Greenbrier Nursing & Rehab. Ctr., DAB No. 2335, at 1 & n.1 (2010) (affirming ALJ decision while noting that, “based on the totality of the ALJ Decision and the record,” the ALJ’s misstatement of the date a facility’s noncompliance ended was “clearly a typographical error”), aff’d, 686 F.3d 521 (8th Cir. 2012).

The Board has long held that “the facility bears the burden of showing that it returned to substantial compliance on a date earlier than that determined by CMS and has rejected the idea that CMS must establish a lack of substantial compliance during each day in which a remedy remains in effect.”  Owensboro Place & Rehab. Ctr., DAB No. 2397, at 12 (2011).  CMS determined that Petitioner’s noncompliance continued for 34 days – from February 23, 2018, through March 28, 2018 – and that this period of noncompliance resulted in a total penalty of $58,480.  CMS Ex. 1, at 1-2.  Petitioner, for its part, acknowledges that CMS imposed a penalty of “$1,720 per day for 34 days totaling $58,480.00 . . . .”  RR at 7.  Apart from Petitioner’s contention that it was never out of substantial compliance – a contention we reject for the reasons stated above – Petitioner presented no evidence and made no argument that it returned to substantial compliance before March 28.  Accordingly, we conclude that Petitioner remained noncompliant from February 23, 2018, through March 28, 2018.

III. The per-day penalty amount imposed by CMS is reasonable.

The ALJ (or the Board) determines de novo whether a civil money penalty is reasonable based on the facts and evidence in the record concerning the factors specified under section 488.438.  See 42 C.F.R. § 488.438(e), (f); Green Oaks Health & Rehab. Ctr., DAB No. 2567, at 16 (2014) (collecting cases).  Those factors are:  (i) the facility’s history of noncompliance; (ii) the facility’s financial condition; (iii) the factors specified in 42 C.F.R. § 488.404; and (iv) the facility’s degree of culpability, including but not limited to, neglect, indifference, or disregard for resident care, comfort or safety.  42 C.F.R. § 488.438(f).  The Board has long held “that the [penalty] amount selected by CMS is presumptively reasonable based on those factors, and that the burden is on the [facility] to demonstrate, through argument and the submission of evidence addressing

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the regulatory factors, that a reduction . . . is necessary to make the [penalty] amount reasonable.”  Good Shepherd Home for the Aged, Inc., DAB No. 2858, at 23 (2018) (internal quotation marks omitted).

“Whether a [penalty] amount is reasonable is a legal, not a factual, issue.”  Crawford Healthcare & Rehab., DAB No. 2738, at 19 (2016).  To overcome a summary judgment motion as to the reasonableness of a penalty, the facility “must proffer evidence sufficient to create a genuine dispute about facts affecting our assessment of the relevant regulatory factors.”  Id.  For the reasons explained below, we find that Petitioner has not identified a genuine dispute of material fact relating to any of the regulatory factors that would affect our assessment or justify a reduction in the per-day penalty amount.

Here, CMS imposed a $1,720 per day penalty for 34 days of noncompliance based on the deficiency cited under Tag F686.  CMS Ex. 1, at 1-2.15  The ALJ correctly noted that the penalty amount is “only slightly more” than one-fourth of the maximum per-day penalty that CMS could have imposed for this level of noncompliance.  ALJ Decision at 8; see also 42 C.F.R. § 488.438(a)(1)(ii); 45 C.F.R. § 102.3 (Feb. 3, 2017) (authorizing penalty up to $6,289 per day for non-immediate jeopardy level noncompliance).16

The ALJ described the per day penalty amount as “modest” and found the “seriousness of Petitioner’s noncompliance and its rather lengthy history” of noncompliance “amply justify” the penalty amount.  ALJ Decision at 9.  We find no error in the ALJ’s assessment that Petitioner’s failure to provide necessary care to R21 to prevent the development of a pressure sore was serious and, at the very least, “put the resident at risk for injury or harm.”  Id.  We also find no error in the ALJ’s conclusion that Petitioner had a “history of significant noncompliance” further justifying the penalty amount.  Id. at 10.  CMS presented uncontroverted evidence that the facility had been found noncompliant with Medicare participation requirements in surveys dating back to 2004 and, in 2015, CMS imposed a $7,550 per instance penalty for an “L” level deficiency (immediate jeopardy).  See CMS Ex. 18, at 2, 6.

Regarding the facility’s financial condition, the relevant inquiry is “whether the facility can show that it lacks ‘adequate assets to pay the CMP without having to go out of business or compromise resident health and safety.’”  Oceanside Nursing & Rehab. Ctr., DAB No. 2382, at 23 (2011) (quoting Gilman Care Ctr., DAB No. 2357, at 7 (2010)); see also Western Care Mgmt. Corp., DAB No. 1921, at 91 (2004).  While Petitioner provided a declaration from its administrator stating that the total accrued penalty is

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“absolutely devastating” and “takes away” from the facility’s ability to provide “above quality care,” Petitioner offered no record of its financial condition.  P. Ex. 5, at 3 (¶ 21); ALJ Decision at 10 (“The record is devoid of any facts concerning Petitioner’s profits, its monthly expenses versus revenue, its assets, and its liabilities.”).  Petitioner’s administrator also did not aver that the facility lacked assets to the extent that paying the penalty would put the facility out of business or cause a reduction of quality of care to the point of compromising resident health or safety.  We find no error in the ALJ’s conclusion that absent evidence of Petitioner’s “actual financial condition,” the administrator’s “unsupported and anecdotal claims” could not support a finding that Petitioner’s financial condition warranted a reduction in the penalty amount.  ALJ Decision at 10.

Before the Board, Petitioner does not challenge the per-day penalty amount based on the applicable regulatory factors but argues that the total accrued penalty of $58,480 is unreasonable because R21’s pressure sore was small (1 cm x 1.5 cm) and improved over time with treatment.  RR at 12 (arguing that the wound improved to 1 cm x 0.5 cm by the time of the survey).  These arguments provide no legal or factual basis to reduce the penalty amount.  First, the issue here is not the total accrued penalty – which is a function of the duration of noncompliance – but the reasonableness of the per-day penalty amount.  In reviewing the reasonableness of a penalty, “we look at the per day amount, not at the total amount of the [penalty].”  Crawford at 20 (quoting Century Care of Crystal Coast, DAB No. 2076, at 26 (2007), aff’d, 281 F. App’x 180 (4th Cir. 2008)).  “Stating that the total [penalty] amount is not reasonable does not raise a clear dispute about the reasonableness of the per-day [penalty] amounts.”  Id. (internal quotation marks omitted).

Second, the facility’s implementation of necessary medical treatment after failing to prevent the pressure sore in the first place, while necessary to return to substantial compliance, is not a relevant factor in assessing the reasonableness of the penalty amount.  See Brian Ctr. Health & Rehab./Goldsboro, DAB No. 2336, at 13 (2010); see also Crawford at 20 (rejecting argument that a facility’s culpability may be lessened by its implementation of certain remedial measures, when other necessary measures were not timely implemented by the facility); Cedar Lake at 13 (stating, when considering facility’s culpability, that a “facility’s having taken steps to correct its deficiencies . . . is not responsive to its culpability for having the deficiencies in the first instance”).  “Although a facility’s prompt institution of corrective measures is certainly desirable, the Secretary of Health and Human Services has not made doing so a basis for reducing a CMP amount.”  Brian Ctr. at 13 (citing 42 C.F.R. § 488.438(f)).

Finally, Petitioner argues that the penalty is unreasonable because staff were told at the end of the survey that they were doing a “good job,” and Petitioner did not receive the statement of deficiencies until March 26, 2018.  RR at 4-5, 7-8.  Thus, Petitioner contends it had no notice of any deficiency for 31 of the 34 days it was found to be out of substantial compliance.  Id. at 5, 8.  This argument fails to raise any dispute of material

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fact regarding the relevant regulatory factors.  “The suggestion by [a facility] that only if it knows in advance that a penalty will be imposed does it have sufficient notice that it should take steps to correct a deficiency is disingenuous.”  Fairfax Nursing Home, Inc., DAB No. 1794, at 18 (2001), aff’d, 300 F.3d 835 (7th Cir. 2002), cert. denied, 537 U.S. 1111 (2003).  This is because facilities are required to comply with Medicare participation requirements regardless of when deficiencies are discovered by the state agency.  See Vibra Hosp. of Charleston - TCU, DAB No. 3094, at 24-25 (2023); see also Owensboro at 11 (explaining that facilities “cannot expect to always have advance notice” that a penalty will be assessed and, in any event, are “required to take corrective action, regardless of the level of noncompliance”).  Here, Petitioner certainly knew R21 had developed a pressure sore and that certain interventions in R21’s care plan had not been implemented, as Petitioner’s staff had reported to the surveyors.

In short, Petitioner has not identified a genuine dispute of material fact relating to any of the regulatory factors that would affect our assessment of those factors or justify a reduction in the per-day penalty amount.  Accordingly, we conclude that the $1,720 per-day penalty imposed by CMS is reasonable.

Conclusion

We affirm the ALJ’s determination that Petitioner was not in substantial compliance with 42 C.F.R. § 483.25(b)(1)(i) and further conclude that the penalty imposed in the amount of $1,720 per day for the duration of Petitioner’s noncompliance (February 23, 2018, through March 28, 2018) is reasonable.