Heritage House of Marshall Health and Rehabilitation, DAB No. 3035 (2021)

FINAL DECISION ON REVIEW OF ADMINISTRATIVE LAW JUDGE DECISION

Heritage House of Marshall Health and Rehabilitation (Petitioner), a Texas 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), concluding that Petitioner was not in substantial compliance with the Medicare participation requirements governing the prevention and treatment of pressure sores and imposing a civil money penalty (CMP) for one day of noncompliance at the immediate jeopardy level, and one day of noncompliance below the immediate jeopardy level.  Heritage House of Marshall Health and Rehabilitation, DAB CR5179 (2018) (ALJ Decision).

For the reasons explained below, we find no genuine dispute of material fact and affirm the ALJ Decision in its entirety.

Legal Background

To participate in the Medicare program, a skilled nursing facility (hereafter "facility") must be in "substantial compliance" with the participation requirements in 42 C.F.R. Part 483, subpart B.  42 C.F.R. §§ 483.1, 488.400.1  The term "noncompliance," as used in the applicable regulations, is synonymous with lack of substantial compliance.  Id. § 488.301 (defining "noncompliance").  To be in substantial compliance, a facility must meet the Medicare participation requirements, including the "quality of care" requirements found at 42 C.F.R. § 483.25.  Among other requirements, a facility must ensure, based on the comprehensive assessment of a resident, that:

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(1)  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; and
(2)  A resident having pressure sores receives necessary treatment and services to promote healing, prevent infection and prevent new sores from developing.

Id. § 483.25(c).

Compliance with the Part 483 requirements is verified through onsite surveys performed by state health agencies.  Id. §§ 488.10(a), 488.11.  A state agency reports any "deficiency" ("failure to meet a participation requirement") it finds in a statement of deficiencies.  Id. §§ 488.301, 488.325(f)(1).  CMS may impose enforcement "remedies," including CMPs, when a facility is not in substantial compliance.  Id. §§ 488.400, 488.402(b), (c), 488.406.  A facility is not in "substantial compliance" when it has a "deficienc[y]" with the "potential for causing more than minimal harm" "to resident health or safety."  Id. § 488.301 (defining "substantial compliance").

When CMS elects to impose a CMP, it sets the amount based on, among other factors, the facility's history of noncompliance, and the "seriousness" of the facility's noncompliance.  Id. §§ 488.404(b), 488.438(f).  "Seriousness" is a function of the scope of noncompliance (whether it is "isolated," constitutes a "pattern," or is "widespread") and severity (whether it has created a "potential" for harm, resulted in "actual harm," or placed residents in "immediate jeopardy").  Id. § 488.404(b).  The most severe noncompliance is that which puts one or more residents in "immediate jeopardy."  See id. § 488.438(a) (authorizing the highest per-day CMPs for immediate-jeopardy-level noncompliance); Woodland Oaks Healthcare Facility, DAB No. 2355, at 2 (2010) (citing authorities).  "Immediate jeopardy" means "a situation in which the provider's noncompliance with one or more requirements of participation has caused, or is likely to cause, serious injury, harm, impairment, or death to a resident."  42 C.F.R. § 488.301.

For deficiencies at the immediate jeopardy level, CMS will impose a CMP amount within the "upper range" of $3,050 to $10,000 per day.  Id. § 488.438(a)(1)(i).  A CMP in the "lower range" of $50 to $3,000 per day will be imposed for deficiencies that do not place residents in "immediate jeopardy," but that either caused actual harm or created the potential for more than minimal harm.  Id. § 488.438(a)(1)(ii).  A per-day CMP may accrue until the facility achieves substantial compliance or its provider agreement is terminated.  Id. § 488.454(a).

A facility may appeal a CMS determination of noncompliance that led to the imposition of a CMP.  Id. §§ 488.408(g)(1), 498.3(b)(13).  In such a case, the scope of review is limited to considering whether a basis for imposing the CMP exists and whether the

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amount of the CMP is reasonable based on regulatory factors.  See id. § 488.438(e), (f); Capitol Hill Cmty. Rehab. & Specialty Care Ctr., DAB No. 1629, at 2-3 (1997).

Factual Background2

On April 4, 2016, a Texas state surveyor completed a health survey of Petitioner's facility.  ALJ Decision at 2 (citing CMS Exs. 1, 4; CMS Ex. 59, at 2).  The surveyor found that Petitioner was not in substantial compliance with 42 C.F.R. § 483.25(c), and concluded that the finding of noncompliance constituted immediate jeopardy to resident health and safety.  Id.

The surveyor based her determination, in part, on the care provided to Resident #6 (R6), a 75-year-old man who was admitted to the facility on August 20, 2015.  Id. at 9 (citing CMS Ex. 9, at 1; CMS Ex. 35, at 1).  R6 suffered from many "debilitating ailments," he was not able "to walk and required extensive assistance for bed mobility, transfers, and activities of daily living."  Id. (citing CMS Ex. 9, at 3, 4; CMS Ex. 10, at 1; Pet. Ex. 11, at 3, 4, 6; Pet. Ex. 22, at 6).  R6 could not reposition himself, his body alignment was poor, and he was incontinent of bowel and bladder.  Id. (citing Pet. Ex. 22, at 9; CMS Ex. 9, at 4).  On the date of admission, a nurse identified an area of "redness and 'mild irritation'" on R6's coccyx.  Id. (citing CMS Ex. 9, at 4; CMS Ex. 18, at 1; Pet. Ex. 3, at 1, 2; Pet. Ex. 9, at 30); see also Pet. Ex. 42, at 11; Pet. Prehearing Br. at 7).  On August 21, 2015, Petitioner's staff performed a Braden risk assessment, which indicated that R6 was at high risk for developing pressure sores.  CMS Ex. 10, at 1.

Between September 26 and October 26, 2015, Petitioner's staff documented that R6 developed five new pressure sores:  a stage II pressure sore on his right hip on September 26 (CMS Ex. 13, at 1-2); a stage II pressure sore on his upper right buttock on October 12 (CMS Ex. 11, at 8; CMS Ex. 14, at 1; CMS Ex. 18, at 11); a pressure sore between R6's buttocks on October 16 (determined to be a stage II pressure sore on October 20) (CMS Ex. 18, at 12; CMS Ex. 16, at 1); a stage II pressure sore on his left hip on October 20 (CMS Ex. 15, at 1); and a stage II pressure sore on his left ankle on October 26 (CMS Ex. 17, at 2).  ALJ Decision at 11, 12-13.

Petitioner's repositioning policy states that "for residents with pressure ulcers at stage I or above, a two-hour repositioning schedule is inadequate."  Id. at 8, 10 (citing CMS Ex. 52, at 4).  An interim care plan dated August 20, 2015, instructed staff to reposition R6 every two hours.  Id. at 10 (citing CMS Ex. 11, at 22).  A subsequent care plan dated September 2, 2015, did not include a specific repositioning program.  Id. at 10-11; CMS Ex. 11, at 1‑4.  On September 26, 2015, the facility amended R6's care plan to include

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turning and repositioning at least every two hours.  ALJ Decision at 11-12 (citing CMS Ex. 11, at 24).  Over the following month, the facility did not alter the care plan to increase the frequency of repositioning in response to the newly developed pressure sores.  Id. at 12-13.

The September 2 care plan did not specify a low air loss mattress for R6's use; he was instead given the facility's standard "pressure reduction mattress."  Id. at 11 (citing CMS Ex. 11, at 23; Pet. Ex. 2, at 1).  On October 15, 2015, a physician ordered a low air loss mattress.  Id. at 12 (citing Pet. Ex. 1, at 1; Pet. Ex. 6, at 9).  On October 16, 2015, a physical therapist noted that R6's mattress was not adequate and that he required a low air loss mattress to reduce body pressure when in bed.  Id. at 13 (citing Pet. Ex. 22, at 29).  A low air loss mattress was provided to R6 on October 21, 2015.  Id. (citing CMS Ex. 15, at 3; CMS Ex. 33; Pet. Ex. 1, at 5).

While some of the documented pressure sores improved, others deteriorated.  Id. (citing CMS Exs. 13, 14, 15).  Wound assessment reports show that the pressure sore on R6's left hip deteriorated to stage III by November 17, 2015, and was unstageable on December 28, due to slough/eschar.  Id. (citing CMS Ex. 15, at 10, 15).  Wound assessment reports also show that the pressure sore on R6's right hip deteriorated to stage III by November 24, and was infected on December 8, 2015, with "[m]alodorous or purulent drainage."  Id. at 13 n.6 (citing CMS Ex. 13, at 22); Id. at 13-14 (citing CMS Ex. 13, at 28).  The right hip pressure sore remained infected and was unstageable due to slough/eschar on December 15, and at stage IV on December 30.  Id. at 14 (citing CMS Ex. 13, at 31; CMS Ex. 20, at 8; Pet. Ex. 6, at 15; Pet. Ex. 9, at 10; CMS Ex. 13, at 35).  By January 13, 2016, the right hip pressure sore deteriorated further, and a CT scan taken on January 18 showed gangrene surrounding the greater trochanter of the right femur and osteomyelitis (infection in the bone) at the lateral aspect of the right greater trochanter.  Id. (citing CMS Ex. 13 at 41; Pet. Ex. 16, at 1).  R6 was referred to a surgeon, who ordered R6 go to the emergency room on January 26, 2016.  CMS Ex. 25.  R6 was admitted to the hospital for surgery "due to sepsis and wound infection to both hips and lower back[.]"  CMS Ex. 4, at 15; see also Pet. Ex. 9, at 1.3

The surveyor also found Petitioner not in substantial compliance based on the inability of Petitioner's nursing staff to ensure that low air loss mattresses provided to its residents, specifically Resident #5 (R5) and Resident #8 (R8), were properly inflated based on the resident's weight.  ALJ Decision at 16.  R5's physician ordered that the charge nurse "ensure proper inflation [every] shift."  Id. (citing CMS Ex. 38; Pet. Ex. 27, at 2).  Nurses told the surveyor that "they did not know how to properly set [R5]'s air mattress to the resident's weight even though both [nurses] had documented the settings had been

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checked by them."  CMS Ex. 59, at 8.  Regarding R8, a nurse acknowledged that "she checked the settings on the low air mattress for [R8] every shift however, she did not know if the settings were accurate."  Id.  The facility's Director of Nursing stated "that the facility did not have a manual or book on how to set or check low air mattress settings for accuracy."  Id.

Based on the survey results, CMS determined that Petitioner had violated the participation requirements at section 483.25(c).  By notice dated April 25, 2016, CMS imposed a $6,050 per-day CMP for twenty-eight days beginning March 8, 2016, and continuing through April 4, 2016, for a total amount of $169,400, and an ongoing $1,200 per-day CMP beginning April 5, 2016.  CMS Ex. 1, at 2.  CMS also notified Petitioner that its provider agreement had been terminated, and that payment would be denied for all new Medicare and Medicaid admissions.  Id. at 1, 3.

In a subsequent notice, dated June 17, 2016, CMS notified Petitioner that it had achieved substantial compliance with the participation requirements on April 6, 2016.  CMS Ex. 2, at 1.  CMS rescinded its determination to terminate Petitioner's provider agreement and the denial of payment for new admissions.  Id.  CMS also reduced the CMP amounts, imposing a per-day CMP of $6,050 for one day of noncompliance (April 4, 2016), and $1,200 for another day of noncompliance (April 5, 2016), for a total CMP amount of $7,250.  Id.

ALJ Proceedings and Decision

Petitioner appealed the April 25, 2016 determination by CMS concluding that Petitioner was not in substantial compliance with section 483.25(c).  Request for Hearing at 1.  Before the ALJ, each party submitted a prehearing brief, list of proposed witnesses and exhibits, and numbered exhibits (CMS Exs. 1-60; Pet. Exs. 1-44).  In its brief, Petitioner argued, among other things, that R6's pressures sores were "clinically unavoidable" (Pet. Prehearing Br. at 21), that R6 was placed on a turning and repositioning program known as "Think Pink" (id. at 7), that a physician was properly notified of each wound assessment of R6 (id. at 11, 21), and that the low air loss mattress settings are initially set by the manufacturer and there is no evidence the facility's beds were not functioning properly (id. at 21-23).

On January 9, 2017, CMS submitted a motion for summary judgment, arguing that the "[u]ndisputed material facts support CMS's finding of noncompliance with 42 C.F.R. § 483.25(c) (F-314) for the deficient care it provided to three residents with documented pressure ulcer concerns."  CMS Motion for Summary Judgment at 1.  CMS argued, among other things, that Petitioner failed to implement a turning/repositioning program in accordance with its own repositioning policy.  Id. at 4 (quoting facility policy providing that an every two  hour repositioning schedule is inadequate for residents with a Stage I or above pressure ulcer).  CMS argued that Petitioner had initiated an "every two hour"

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repositioning program and, even after R6 developed new pressure sores at Stage I and above, it did not change R6's repositioning plan to comply with its own policy.  Id.  CMS further argued that Petitioner's staff were "unable to demonstrate an ability to monitor, set or adjust the low air mattress provided for the treatment and prevention of pressure ulcers by its residents."  Id. at 9.  According to CMS, Petitioner's failure to ensure that its residents received necessary services to prevent and treat pressure ulcers demonstrated substantial noncompliance with section 483.25(c) and "placed its residents at serious risk of harm from deteriorating skin conditions and sepsis."  Id. at 10-12.  Petitioner did not file a response to CMS's motion for summary judgment.4

On September 5, 2018, the ALJ issued a decision granting summary judgment in favor of CMS.  The ALJ found that "CMS has come forward with evidence – primarily the facility's own documents – establishing facts that the facility was not in substantial compliance with section 483.25(c)."  ALJ Decision at 5.  The ALJ found that "Petitioner offers some unsupported and speculative assertions but presents no admissible evidence of specific facts showing that a dispute concerning a material fact exists."  Id. at 5-6.

The ALJ concluded:  "CMS is entitled to summary judgment because the undisputed evidence establishes that facility staff did not take necessary precautions to protect residents from developing preventable pressure sores; and, when residents developed pressure sores, staff did not take all necessary precautions to promote healing, prevent infection, and prevent new sores from developing."  Id. at 6 (emphasis removed).  Although the ALJ Decision mentions both quality of care requirements pertaining to pressure sores under 42 C.F.R. § 483.25(c), the ALJ Decision primarily focused on Petitioner's noncompliance with section 483.25(c)(2), which applies once a resident has pressure sores:

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 it did so, and the resident develops sores anyway, I could find no deficiency.  But if the evidence establishes that the facility fell short of taking all necessary precautions, it has violated the regulation.

Id.

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The ALJ did not find, for purposes of 42 C.F.R. § 483.25(c)(1), that R6 entered the facility without pressure sores or conclude that the facility was out of substantial compliance simply because R6 developed pressures sores.  Rather, the ALJ focused on Petitioner's inadequate response to R6's pressure sores based, in part, on its failure to follow its own policies and protocols.  ALJ Decision at 14 ("At a minimum, to comply with section 483.25(c), the facility must follow its own policies and protocols.").  The ALJ found that Petitioner's "policies emphasized that a two-hour repositioning program is inadequate for any resident suffering even one of R6's conditions – one who is bed/chair-bound or one who has a stage I or above pressure sore."  Id. at 15-16.  The ALJ explained that even if she accepted as true that R6 was placed on a repositioning program from the date of admission, she would still find that Petitioner violated "section 483.25(c) because the undisputed evidence establishes that [R6] was never repositioned more frequently than every two hours."  Id. at 15.

The ALJ also found that the facility was out of substantial compliance with section 483.25(c) because Petitioner's staff was "unable to monitor, set, or adjust residents' low air mattresses."  Id. at 16 (emphasis removed).  The ALJ noted that "no staff member was able to ensure that [resident] mattresses were, and remained, properly inflated."  Id.  The ALJ accepted as true that the initial mattress settings are calibrated by the manufacturer's representative (citing Pet. Prehearing Br. at 22 and Pet. Ex. 29), but found the record established that "the settings on one of these mattresses can deviate, and they must be checked regularly to [e]nsure that they remain at the appropriate setting, based on the resident's weight, so that resident derives maximum protection."  Id. (citing CMS Ex. 38, at 1).

Having found Petitioner out of substantial compliance, the ALJ next found no clear error in "CMS's determination that the facility's substantial noncompliance posed immediate jeopardy to resident health and safety."  Id. (emphasis removed).  The ALJ noted the evidence in this case illustrates how "a facility's failure to take all necessary precautions to promote healing, prevent infection, and prevent new sores from developing is likely to cause serious injury, harm, impairment, or death to a vulnerable resident, like R6."  Id. at 17.  The ALJ further concluded that CMS did not err in its determination as to the duration of noncompliance and immediate jeopardy, finding that Petitioner had "not met its burden of establishing that it alleviated the immediate jeopardy nor that it returned to substantial compliance any earlier than April 4 and 5."  Id. at 19.  Finally, applying the

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factors listed in 42 C.F.R. § 488.438(f), the ALJ sustained as reasonable the CMP amounts imposed by CMS.  Id. at 17-18.5

Standard of Review

We review de novo an ALJ's decision to grant summary judgment.  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.  See, e.g., Livingston Care Ctr., DAB No. 1871, at 5 (2003) (citing Celotex Corp. v. Catrett, 477 U.S. 317, 322-25 (1986)), aff'd, 388 F.3d 168, 172-73 (6th Cir. 2004).  "To defeat an adequately supported summary judgment motion, the nonmoving 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."'"  Mission Hosp. Reg'l Med. Ctr., DAB No. 2459, at 5 (2012) (quoting Matsushita Elec. Indus. Co. v. Zenith Radio, Ltd., 475 U.S. 574, 587 (1986)), aff'd, 819 F.3d 1112 (9th Cir. 2016).

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.  See Brightview Care Ctr., DAB No. 2132, at 2, 9 (2007); but see Cedar Lake Nursing Home, DAB No. 2344, at 7 (2010); Brightview at 10 (entry of summary judgment upheld where inferences and views of nonmoving party are not reasonable).  Thus, in deciding whether a facility has defeated an adequately supported motion for summary judgment – a motion that identifies facts of record sufficient to make out a prima facie case – we consider whether a rational trier of fact, viewing the entire record in the light most favorable to the facility, and drawing all reasonable inferences in its favor, could find its presentation sufficient to carry its burden of persuasion (to show substantial compliance).  Dumas Nursing & Rehab., L.P., DAB

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No. 2347, at 5 (2010) ("[I]t is appropriate [on summary judgment] for the tribunal to consider whether a rational trier of fact could regard the parties' presentations as sufficient to meet their evidentiary burdens under the relevant substantive law.").  Where the evaluation of credibility or weighing of competing evidence is required to decide whether the facility has demonstrated substantial compliance, however, summary judgment is not appropriate.  See, e.g., Kingsville Nursing & Rehab. Ctr., DAB No. 2234, at 8-9 (2009); Madison Health Care, Inc., DAB No. 1927, at 6 (2004).

Analysis

In its Request for Review (RR), Petitioner challenges the entry of summary judgment in favor of CMS.  Petitioner argues that genuine issues of material fact exist regarding its alleged noncompliance with 42 C.F.R. § 483.25(c), including facts relating to the care provided to R6, whether the pressure sores were medically unavoidable, and whether the facility's low air loss mattresses functioned properly.  RR at 27-29.  Petitioner also challenges the "propriety" of the surveyor's immediate jeopardy determination.  Id. at 29-31.  Petitioner further argues that summary judgment was inappropriate because the alleged noncompliance outlined in the ALJ Decision "can be synthesized to a 'reasonableness' test."  RR at 3.  In other words, Petitioner contends the question for the ALJ was whether the "facility provide[d] 'reasonable' care to prevent pressure ulcers, and 'reasonable' care for pressure ulcers that did develop."  Id.  According to Petitioner, "reasonableness" is a fact question that cannot be resolved by summary judgment.  Id.

Petitioner misstates the relevant legal standard, and its reliance on tort concepts such as "reasonable" care has no application here.  Cf. Springhill Senior Residence, DAB No. 2513, at 14 (2013) ("The issue here is not [the facility's] tort liability but its compliance with regulatory standards . . . ."); Libertywood Nursing Ctr., DAB No. 2433, at 14 (2011) (same), aff'd, 512 F. App'x 285 (4th Cir. 2013).6   The participation requirements concerning pressure sores are part of the quality of care standards at 42 C.F.R. § 483.25.  Section 483.25(c) requires facilities to ensure that:  (1) a resident who enters a facility without pressure sores does not develop pressure sores unless the resident's clinical condition shows they were unavoidable, and (2) a resident with pressure sores receives the necessary treatment and services to promote healing, prevent infection, and prevent new sores from developing.  "This section, the Board has held, imposes a duty on facilities to 'go beyond merely what seems reasonable, to, instead, always furnish what is necessary to prevent new sores unless clinically unavoidable, and to treat existing ones as

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needed.'"  Senior Rehab., DAB No. 2300, at 13 (quoting Koester Pavilion, DAB No. 1750, at 32 (2000) (emphasis added)).

Under the regulation, a facility must provide to each resident "the necessary care and services to attain or maintain the highest practicable physical, mental, and psychosocial well-being, in accordance with the comprehensive assessment and plan of care."  42 C.F.R. § 483.25; see also Social Security Act § 1819(b).  To this end, the Board has repeatedly held that the requirements under section 483.25 "obligate the [facility] 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 resident care policies."  Good Shepherd Home for the Aged, Inc. d/b/a The Good Shepherd Home, DAB No. 2858, at 12 (2018) (citing Life Care Ctr. of Bardstown, DAB No. 2479, at 22 (2012) (citing cases), aff'd, 535 F. App'x 468 (6th Cir. 2013)); Woodland Village Nursing Ctr., DAB No. 2053, at 9 (2006) (citing cases), aff'd, 239 F. App'x 80 (5th Cir. 2007).  The Board (and ALJ) may "rely on a facility policy as evidence of the provider's own judgment as to what must be done to attain or maintain its residents' highest practicable physical, mental and psychosocial well-being, as required by section 483.25."  Senior Rehab., DAB No. 2300, at 13 (quoting Sheridan Health Care Ctr., DAB No. 2178, at 15 (2008)).

For the reasons explained below, we conclude that a rational trier of fact, viewing the entire record in the light most favorable to Petitioner and drawing all reasonable inferences in its favor, could not find:  (i) that Petitioner was in substantial compliance with section 483.25(c)(2); or (ii) that the noncompliance did not pose immediate jeopardy to resident health and safety for at least one day.7

1.  The undisputed facts establish that Petitioner was not in substantial compliance with 42 C.F.R. § 483.25(c)(2).

A.  Petitioner failed to provide R6 with the care and services required by its own policies to prevent and treat pressure sores.

Petitioner presented no evidence that it ever complied with its own repositioning policy by turning and repositioning R6 more frequently than every two hours.  A facility's policies "may reflect [the] facility's own judgment about how best to achieve compliance [with the participation requirements] and hence failure to comply with its own policies can support a finding that the facility did not achieve compliance with the regulatory

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standard."  Bivins Mem'l Nursing Home, DAB No. 2771, at 9 (2017), appeal dismissed, No. 17-60292 (5th Cir. Aug. 15, 2017); see also Hanover Hill Health Care Ctr., DAB No. 2507, at 6 (2013) ("[T]he Board has long held that a facility's own policy may be sufficient evidence . . . of what the facility has determined is needed to meet the quality of care requirements in section 483.25."); Columbus Nursing & Rehab. Ctr., DAB No. 2273, at 7 (2009) (holding that staff's failure to follow facility's own wound care protocols violated section 483.25(c)); Sheridan Health at 32 (holding that facility's failure to follow its own meal‑monitoring policies "constituted a deficiency under section 483.25"); The Laurels at Forest Glenn, DAB No. 2182, at 6, 18 (2008) (finding facility's failure to follow own protocol for notification of low blood sugar levels was a failure to provide necessary care and services).

Petitioner does not address its lack of compliance with its own repositioning policy (CMS Ex. 52 at 3-5), but argues that its "staff did all that was within its power to prevent skin breakdown from the day [R6] was admitted to Heritage House," and that R6's comorbidities made the pressure sores unavoidable.  RR at 9, 28 ("[C]ontractures, diabetes, spinal stenosis, peripheral neuropathy, incontinence, hypothyroidism, and general circulatory problems rendered his skin breakdown clinically unavoidable." (emphasis removed)).  In this regard, Petitioner presented expert testimony of its regional nurse consultant who opined that R6's pressure sores were "clinically unavoidable" based on his comorbidities.  Pet. Ex. 42 at 11.  Even if we accepted as true that the pressure sores that R6 developed were clinically unavoidable, such a finding would not relieve Petitioner of its responsibility to "furnish all of the care and services necessary to promote healing, prevent infection, and prevent other pressure sores from developing," as required by section 483.25(c)(2).  See Senior Rehab., DAB No. 2300, at 17 (affirming summary judgment notwithstanding expert testimony that pressure sores were clinically unavoidable where undisputed evidence established facility did not provide services in accordance with resident care plan).

The quality of care requirements under section 483.25(c) impose two distinct obligations.  Under section 483.25(c)(1), a facility must ensure that a resident who enters a facility without pressure sores does not develop pressure sores, unless the resident's condition demonstrates they were unavoidable.  For a resident already having pressure sores, the regulations impose a different obligation:  the facility must ensure that a resident receives "necessary treatment and services to promote healing, prevent infection, and prevent new sores from developing."  Id. § 483.25(c)(2).  Section 483.25(c)(2) provides no exception for "clinically unavoidable" pressure sores.  Petitioner contends R6 had at least one pressure sore when he entered its facility, and the ALJ agreed.  RR at 11-12; ALJ Decision at 9 ("I agree that the reddened skin on R6's coccyx [at the time of admission] should have been identified as a stage I pressure sore.").  Given the existence of this pressure sore, Petitioner was required to ensure that R6 received all necessary treatment and services to promote healing, prevent infection, and prevent new sores from developing – requirements the ALJ concluded the facility failed to satisfy.  ALJ Decision

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at 10, 14-16.  Because we sustain that determination, Petitioner's argument that R6's pressure sores were "clinically unavoidable," even if accepted as true, provides no basis to reverse the summary judgment decision.  See Columbus Nursing, at 4-5.  In other words, even if Petitioner could not have avoided the development of sores, it had to care for them properly, and, as we explain, the facility did not even provide the care its policy called for.

Furthermore, a facility "cannot claim unavoidability unless it first shows that it furnished all necessary treatment and services."  Gooding Rehab. & Living Ctr., DAB No. 2239, at 15 (2009); see also Fireside Lodge Ret. Ctr., Inc., DAB No. 2794, at 12 (2017) ("The issue . . . is not whether the pressure sore could be expected to heal, but, rather, whether [the facility] staff was providing the necessary care and services to promote healing.").  As explained below, the undisputed evidence establishes that Petitioner did not ensure that R6 received all of the care and services "necessary" "to promote healing, prevent infection, and prevent new sores from developing" and, therefore, Petitioner's contention that R6's pressure sores were "clinically unavoidable" does not create a genuine issue of material fact.  See The Harborage, DAB No. 2905, at 8 (2018) (rejecting as a matter of law facility's contention that pressure sores were unavoidable because evidence did not support finding that the facility provided "all" required prevention interventions); see also Senior Rehab., DAB No. 2300, at 17.  The fact that a resident has medical conditions creating very high risk for pressure sores is not a license to stand by as they develop without doing what is possible and necessary to try to forestall their development.

At the time of R6's admission, Petitioner had a repositioning policy "to prevent skin breakdown, promote circulation and provide pressure relief."  CMS Ex. 52, at 3.  Petitioner's repositioning policy identified, among other things, the following interventions:

1.  A turning/repositioning program includes a continuous consistent program for changing the resident's position and realigning the body.  A program is defined as a specific approach that is organized, planned, documented, monitored and evaluated.

*   *   *

3.  Residents who are in bed should be on at least an every two hour (q2 hour) repositioning schedule.
4.  For residents with a Stage I or above pressure ulcer, an every two hour (q2 hour) repositioning schedule is inadequate.
5.  Residents who are in a chair should be on an every one hour (q1 hour) repositioning schedule.
6.  If ineffective, the turning and repositioning frequency will be increased.

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Id. at 4 (emphasis added).  Petitioner's policy also required that the following should be documented in the resident's medical record:

1.  The position in which the resident was placed.  This may be on a flow sheet.
2.  The name and title of the individual who gave the care.
3.  Any change in the resident's condition.

*   *   *

7.  The signature and title of the person recording the data.

Id. at 5.

R6's medical records show that on August 20 and 21, staff documented that his "coccyx area, buttock, and groin [were] pink with mild irritation."  Pet. Ex. 9, at 30; Pet. Ex. 3, at 1; CMS Ex. 18, at 1.  While staff did not specifically identify this as a Stage I pressure sore, Petitioner admits that the wound could be "considered a Stage I pressure area under the definitions set forth by the F314 interpretive guidelines and National Pressure Ulcer Council[.]"  RR at 11-12.8   The documentation further shows that on August 21, 2015, staff assessed R6 as being at high risk for developing pressure sores.  CMS Ex. 10, at 1.  Among other things, staff documented that R6 had "[v]ery [l]imited" mobility, "[o]ccasionally [m]oist" skin, and required "moderate to maximum assistance in moving."  Id.  Given the presence of a Stage I pressure sore on R6's coccyx at the time of admission, Petitioner's own policy required that R6 be turned and repositioned more frequently than every two hours.  See CMS Ex. 52, at 4 ("For residents with a Stage I or above pressure ulcer, an every two hour . . . repositioning schedule is inadequate").  Nonetheless, Petitioner's interim care plan dated August 20, 2015, instructed staff to reposition R6 every two hours.  CMS Ex. 11, at 22.  A subsequent care plan, dated September 2, 2015, did not document any repositioning program to address R6's skin breakdown.  Id. at 2.  R6's care plan was not updated again until September 26 – over a month after admission – and again instructed staff to only turn and reposition R6 "at least every two hours."  Id. at 24.

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R6 subsequently developed five new pressure sores at stage II or above between September 26, 2015, and January 26, 2016, the date that he was admitted to the hospital for sepsis.  CMS Exs. 11, 13-16, 18.  At least two of these sores deteriorated to the point that they became unstageable and infected.  Pet. Ex. 6, at 15; Pet. Ex. 9, at 10; CMS Ex. 15, at 10; CMS Ex. 13, at 28, 31; CMS Ex. 20, at 8.  By the time Petitioner was admitted to the hospital on January 26, 2016, he had "sepsis" and "infection[s]" on "both hips and [the] lower back[.]"  CMS Ex. 4, at 15.  Petitioner does not argue, and the record does not show, that Petitioner ever updated R6's care plan to increase the frequency of repositioning in accordance with its policy.  See CMS Ex. 11, at 24-72; CMS Ex. 52, at 4 ("If ineffective, the turning and repositioning frequency will be increased.").  Petitioner does not assert, and the evidence does not show, that R6 was ever placed on a turning and repositioning program more frequently than every two hours during the time he was in the facility's care.  Id.  Nor does Petitioner present any evidence that staff ever implemented an hourly turning and repositioning schedule for the time that R6 spent in a chair, even though staff encouraged R6 to "get out of bed daily to [his] wheelchair."  See CMS Ex. 13, at 5; CMS Ex. 18, at 10; CMS Ex. 52, at 4 ("Residents who are in a chair should be on an every one hour . . . repositioning schedule.").  The undisputed evidence shows Petitioner knew that a resident in R6's condition needed more frequent turning and repositioning to implement its own facility policy.  Petitioner does not point to any evidence that could support a reasonable determination by facility staff to nevertheless deviate from established policy under these circumstances.  In short, Petitioner remains silent regarding its failure to follow its own repositioning policies.

Instead, Petitioner renews its assertion that R6 was placed on the facility's undocumented "Think Pink" turning and repositioning program.  RR at 10.  Citing the testimony of SH, Petitioner's nurse consultant, Petitioner explains that under the Think Pink program, "nurse aides document turning/repositioning on a pink card, which is reviewed daily but is not recorded in the chart; these cards are not retained by the facility[.]"  Id. (citing Pet. Ex. 42, at 12-13).9  Petitioner argues that SH's testimony "demonstrates the existence of material, disputed fact issues" regarding turning and repositioning.  RR at 11.  Petitioner asserts that the ALJ "made a legally prohibited 'credibility determination' and summarily stated that she did not believe" SH's testimony.  Id. at 10.  Petitioner further asserts that the ALJ determined that SH "had no basis for knowing about the Think Pink program."  Id. at 10-11.

We reject Petitioner's arguments.  First, we find that Petitioner mischaracterizes the ALJ's findings.  The ALJ did not make a credibility determination, or find that SH had no basis for knowing about the Think Pink program generally.  Rather, the ALJ determined

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that SH's testimony regarding the Think Pink program as it relates to R6 was, on its face, "unsupported speculation," and that she "would decline to admit [SH's] testimony so lacking in foundation."  ALJ Decision at 15, 15 n.8.  We agree.  When asked whether R6 was "turned at least every two hours throughout his stay," SH stated:

I believe that he probably was.  He would meet the criteria to be on Think Pink.  In talking to different staff members, he was on that program.  Direct care staff knew what Think Pink w[as].  They all had the appropriate cards.  I have no reason not to believe that he was not provided turning and reposition[ing].

Pet. Ex. 42, at 12-13.  The ALJ acknowledged that she must "draw all reasonable inferences in the light most favorable to the non-moving party," but found that SH's testimony "does not create even 'metaphysical doubt' as to the material facts, much less raise the genuine dispute of material fact required to preclude summary judgment."  ALJ Decision at 15 (quoting W. Tex. LTC Partners, Inc., DAB No. 2652, at 15 (2015), aff'd, 843 F.3d 1043 (5th Cir. 2016)).  In our de novo review of this testimony, we agree that SH asserts no personal knowledge at all of R6's treatment and merely concludes with a triple negative denial of a reason to think the care was inadequate.  Even accepting as true that SH does not believe that R6 was not provided turning and repositioning at least every two hours, her testimony could not provide a trier of fact with a basis to find that the facility took the steps required by its own policies.  SH also vaguely alludes to hearing from "different staff members" that R6 was on the Think Pink program.  Pet. Ex. 42, at 13.  Although hearsay may be admissible in these administrative proceedings with sufficient indicia of reliability, no reasonable trier of fact could find indicia of reliability in hearsay neither attributed to specific sources nor asserting any specific content to the purported statements of these unidentified declarants.

Second, the ALJ correctly noted that SH "did not mention when [R6] might have been placed in the program nor what that would have meant in terms of repositioning him."  ALJ Decision at 15.  Even if we accept as true that R6 was placed in the Think Pink program, there is nothing in SH's testimony (or elsewhere in the evidentiary record) establishing:  (1) the frequency at which R6 was turned and repositioned under the program, or (2) whether the frequency of repositioning complied with the facility's own policies.  SH did not refute the fact that Petitioner failed to reposition R6 more often than every two hours as required by Petitioner's own policy.  In this regard, SH provided only "generalized and conclusory opinions" that fail to generate a genuine dispute of material fact.  See Senior Rehab., DAB No. 2300, at 15 n.11 (holding nurse's sworn statement that facility "properly cared for and met the needs of [the residents]" and "took reasonable measures" to treat and prevent pressure sores was insufficient to generate genuine issue of material fact).

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Third, we observe that a characteristic of the Think Pink program as described by SH – that it is undocumented – is in direct conflict with the facility's own repositioning policy, which provides that a repositioning program should be "documented" and "monitored."  CMS Ex. 52, at 4.  The ALJ noted, and we agree, that "Petitioner produced not one policy alluding to this program, not one card showing that staff documented changing a resident's position, much less any card or other reference to staff having repositioned R6 as part of a 'Think Pink' program."  ALJ Decision at 15.  Occasional nursing notes state that staff repositioned R6 every two hours.  See, e.g., CMS Ex. 18, at 10 ("Staff continues to attempt repositioning with pillow support at least every two hours[.]").  Again, an every two hour repositioning schedule is inadequate for residents such as R6 based on Petitioner's own policy.  Moreover, we affirm the ALJ's finding that these notes "fall[] far short of the level of documentation required by the facility policy, which directs staff to document in the resident's medical record, each position change, including the new position; the names and titles of the care-giver and the person recording the data; changes; problems; and observations."  ALJ Decision at 12 (citing CMS Ex. 52, at 5).

In addition, while staff began to document R6's turning and repositioning in his medication administration record on October 16, the documentation beginning on that date only states that staff repositioned R6 "frequently," and was marked by the treating nurse only once every eight hours, falling well short of the standards set forth in the facility's policies.  See Pet. Ex. 5.  Similarly, staff first documented in a departmental note dated October 6 that "[s]taff continues to turn and reposition" R6 at least every two hours, but these notes are inconsistent and infrequent and again fall short of the documentation standards outlined in the facility's policy.  See Pet. Ex. 9 at 21.

The Board has previously affirmed, in the context of summary judgment, the importance of a facility's contemporaneous documentation for satisfying the quality of care requirements.  See, e.g., The Harborage at 15 (citing Embassy Health Care Ctr., DAB No. 2327, at 6 (2010) (holding that section 483.25 imposes a duty on facilities to document a resident's condition)).  In The Harborage, the Board held that "[w]ithout contemporaneous documentation or testimony that supports inferences in Petitioner's favor, we are left to conjecture about the frequency of attempted repositioning . . . and what, if any, alternative measures were considered.  We cannot find a dispute of material fact requiring reversal of summary judgment based on conjecture."  Id. at 12.

The same rationale applies here.  Petitioner points to the existence of a "Think Pink" program, but the record is devoid of evidence documenting the parameters of that program as it applied to R6 or the facility's compliance with the program since the pink cards were not retained by Petitioner.  The mere existence of such a program, without more, does nothing to create a genuine dispute of material fact regarding the prevention and treatment of the myriad pressure sores R6 developed while a resident of the facility.  This is particularly true where, as here, the evidence unmistakably shows the facility had

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a repositioning policy that included documentation requirements, but staff did not adhere to those requirements as to R6.

It is further undisputed that R6 was not provided with a low air loss mattress until October 21, 2015.  Pet. Ex. 1, at 5.  A flow chart from the mattress manufacturer indicates that a low air loss mattress should be used when, among other situations, a stage II pressure sore is not "responding at assessment" after using a facility‑owned pressure redistribution mattress.  CMS Ex. 51, at 1.  The records from the facility show that by October 13, 2015, staff determined that the sore on R6's right hip "deteriorated" despite using the facility's standard pressure redistribution mattress.  CMS Ex. 13, at 7.  We accept as true for purposes of summary judgement Petitioner's evidence that the low air loss mattress needed to be ordered by a physician (Pet. Ex. 42, at 18), that R6's physician ordered the mattress on October 15 (Pet. Ex. 1, at 1; Pet. Ex. 6, at 9), and that Petitioner began renting R6's mattress on October 16 (Pet. Ex. 41).  Based on this account, however, no dispute of material fact exists that the facility failed to provide the low air loss mattress for R6 until six days after the physician's order.  Pet. Ex. 1, at 5.  And, once R6 was provided with the mattress, the nursing staff did not know how to ensure that the mattress was functioning properly, which we discuss more fully below as it applies to multiple residents.  See infra at Part 1.B.

In short, the undisputed evidence establishes that Petitioner failed to meet its obligations in preventing and treating R6's pressure sores in violation of section 483.25(c)(2).  Petitioner presented no evidence that it ever complied with its own repositioning policy by turning and repositioning R6 more frequently than every two hours.  Petitioner does not dispute that it failed to accurately and completely document R6's repositioning schedule in the manner required by its own policies, or that it delayed providing a low air loss mattress despite the worsening condition of at least one of R6's pressures sores.  We conclude based on this undisputed evidence that Petitioner failed to show that it furnished all "necessary treatment and services" to prevent and treat R6's pressure sores as required under section 483.25(c)(2).

B.  Petitioner's staff were unable to monitor, set, or adjust the low air loss mattresses provided to residents.

Low air loss mattresses were provided in the care of R5, R6, and R8.  Pet. Ex. 1, at 5; Pet. Ex. 27, at 2; CMS Ex. 38, at 1; CMS Ex. 4, at 19; CMS Ex. 15, at 3.  R5's physician ordered the charge nurse to "ensure proper inflation" settings every shift.  (Pet. Exs. 30, 31; CMS Ex. 38, at 1).  R5's nurses told the surveyor, however, that "they did not know how to properly set [the] air mattress to the resident's weight even though both had documented the settings had been checked by them."  CMS Ex. 59, at 8.  Similarly, R6's nurse stated that "she did not know how to make sure the settings were correct on [R6]'s low air mattress" (id. at 7), and R8's nurse stated that "she checked the settings on the low air mattress for [R8] every shift however, she did not know if the settings were

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accurate" (id. at 8).  Based on this uncontroverted evidence, the ALJ found that Petitioner's staff were "unable to monitor, set, or adjust residents' low air mattresses" in violation of section 483.25(c).  ALJ Decision at 16 (emphasis removed).

On appeal, Petitioner does not challenge this evidence, but argues that "there is absolutely no evidence" that the air pressure settings were incorrect.  See RR at 28, 29.  Petitioner's argument misses the mark.  Neither the surveyor, CMS, nor the ALJ based their deficiency findings on inaccurate air pressure settings or malfunctioning beds.  Rather, the deficiencies were based on the undisputed fact that the facility's nurses were unable to ensure that the low air loss mattresses were properly inflated in accordance with resident weight.  Evidence of a causal connection between the facility's inability to ensure correct air pressure settings and actual harm is unnecessary to establish noncompliance because "proof that a deficiency caused actual harm is not a prerequisite to finding a lack of substantial compliance."  North Las Vegas Care Ctr., DAB No. 2946, at 9 (2019).  "Under the nursing home enforcement regulations (in 42 C.F.R. Part 488, subpart F), a [facility] may be found out of substantial compliance (and thus subject to CMPs and other remedies) if the deficiency has the 'potential' to cause more than minimal harm to resident health or safety."  Id. (citing Libertyville Manor Rehab. & Healthcare Ctr., DAB No. 2849, at 17‑18 (2018); Oaks of Mid City Nursing and Rehab. Ctr., DAB No. 2375, at 16-17 (2011) (rejecting contention that CMS could not find the facility noncompliant with section 483.25 absent proof of a "causal link" between the regulatory violation and a "negative resident outcome")).

Petitioner's other arguments are equally unavailing.  Petitioner renews its assertion that the initial settings on the low air loss mattresses "are done by the manufacturer's representative."  RR at 28; Pet. Ex. 29 ("When a resident has an order for a Low Air Loss Mattress our provider['s] . . . representative places the mattress on the bed and adjusts the pump to the proper settings.").  However, this does not absolve the nursing staff of its duty to ensure that the mattresses continue to operate with the proper settings for the duration of a resident's use.  Regardless of who initially sets up the mattress, the nursing staff's admitted inability to subsequently check the settings to ensure proper functionality means staff did not know whether the mattress continued to function properly and meet the needs of the residents.

Petitioner further contends that low air loss mattress "settings" have no therapeutic benefit and pertain only to "patient comfort."  RR at 28; Pet. Ex. 42, at 18; Pet. Ex. 43, at 6.  Petitioner presented no evidence of which mattress "settings" are only necessary for patient comfort or that patient comfort is unimportant in the prevention and treatment of pressure sores.  In any event, there is no dispute that the mattress settings "have to be programmed into the equipment that accompanies the mattress in order for it to work."  Pet. Ex. 42, at 18.  Additionally, there is no dispute that the manufacturer's instruction manual requires that low air loss mattresses be adjusted according to resident weight.  Pet. Ex. 28, at 5 (providing that support surface pressure settings should be adjusted "to

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the [resident's] appropriate weight setting," and that "[i]t may be necessary to alter [the] weight setting to get optimal comfort").

Moreover, Petitioner was obligated to follow physician orders, regardless of what it believed about the therapeutic benefit of proper mattress settings.  A facility's failure to comply with a physician's order may, by itself, constitute a deficiency under section 483.25.  See Lakeridge Villa Health Care Ctr., DAB No. 1988, at 22-25 (2005), aff'd, 202 F. App'x 903 (6th Cir. 2006); Columbus Nursing at 7 (affirming ALJ's conclusion that facility was not in substantial compliance with section 483.25(c) where facility, among other things, failed to follow physician orders concerning the treatment of pressure sores).  Here, R5's physician ordered a low air loss mattress and directed that the charge nurse "ensure proper inflation [every] shift."  CMS Ex. 38, at 1; Pet. Ex. 27 at 2.  During the survey, Petitioner's nursing staff were unable to set R5's low air loss mattress according to the resident's weight and admitted that, although they checked the settings, they did not know if the settings were accurate.  CMS Ex. 4, at 2, 18-19.  As the ALJ concluded, the undisputed evidence established that the designated nurses were unable to fulfill the physician's order.  ALJ Decision at 16.  Failing to follow physician orders, in addition to being a potential deficiency in itself, demonstrates that the residents who were not provided with the care ordered by their physicians were not receiving all "necessary treatment and services to promote healing, prevent infection and prevent new sores from developing" as required by 42 C.F.R. § 483.25(c)(2).

C.  Other interventions implemented by Petitioner do not create a genuine issue of material fact.

Petitioner contends summary judgment is inappropriate because there is a genuine issue of material fact as to whether its staff took "reasonable steps" to prevent and treat pressure sores.  RR at 4 ("CMS (and the ALJ) claim that Petitioner's staff did not take reasonable steps to prevent and to treat pressure ulcers.").  Petitioner describes various efforts it undertook to help R6, including nutritional support, physical therapy, occupational therapy, restorative therapy (stretching/strengthening), wound care with debriding agents, and keeping his physician (or physician assistant) informed of his condition.  RR at 10-28.  Petitioner describes in detail its position that some of the wounds did heal (or improved) and suggested this demonstrated the quality of its care.  RR at 21-23, 28.  Petitioner did not dispute that some of R6's pressure sores did not heal, and deteriorated to the point that he was taken to the emergency room and admitted to the hospital for surgery "due to sepsis and wound infection to both hips and lower back[.]"  CMS Ex. 4, at 15; RR at 27.

As an initial matter, "reasonable" care is not the legal standard by which CMS (or the ALJ) evaluated the quality of care provided by Petitioner.  See supra at 9-10.  The issue here is one of substantial compliance with the quality of care requirements under 42 C.F.R. § 483.25(c)(2).  In terms of Petitioner's responsibility, it is simply not sufficient to

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provide some care and services, when other care and services required by the facility's own policy or a physician's order is not provided.  See, e.g., Senior Rehab., DAB No. 2300, at 19 (sustaining summary judgment against facility because undisputed facts established that the facility did not provide "all necessary precautions" called for under care plan and facility policies); 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 nutritional services, therapy, and wound care and debridement,10 even if assumed to be true for purposes of summary judgment, does not negate Petitioner's failure to provide the required repositioning or to promptly obtain and properly monitor a low air loss mattress.  Petitioner does not (and could not) argue that it was unnecessary to comply with its own policies or physician orders.  Indeed, the facility must provide all "necessary treatment and services to promote healing, prevent infection, and prevent new sores from developing"—not merely some services.  42 C.F.R. § 483.25(c)(2).  Accordingly, Petitioner's contentions about the other interventions it undertook to address R6's pressure sores cannot create a genuine issue of material fact that precludes summary judgment.

Petitioner further argues it was not cited in the statement of deficiencies for a clinical records violation or for failing to timely notify the physician.  RR at 8-9.  CMS is not obliged to cite every possible deficiency that its factual findings might support.  Not citing an additional deficiency does not mean unchallenged factual evidence supporting an uncited deficiency cannot be considered in connection with a cited deficiency.  Moreover, a statement of deficiencies is "a notice document, and is not designed to lay out every single detail in support of a finding that a violation has been committed."  Pac. Regency Arvin, DAB No. 1823, at 9 (2002), appeal dismissed, No. 02-71432 (9th Cir. Mar. 23, 2004).  Accordingly, a statement of deficiencies does not rigidly frame the scope of admissible evidence concerning a cited deficiency.  Id.  "CMS may defend a noncompliance determination based on facts, evidence, or reasoning not specified in the Statement of Deficiencies, provided, of course, that due process requirements – adequate notice and a meaningful opportunity to be heard – are satisfied."  Golden Living Ctr. – Superior, DAB No. 2768, at 8 n.4 (2017).  Petitioner does not contend it had inadequate

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notice of the facts CMS relied on to support its section 483.25(c) noncompliance determination or that it lacked a meaningful opportunity to be heard.

Based on the foregoing, we sustain the ALJ's determination on summary judgment that Petitioner failed to substantially comply with section 483.25(c)(2) because undisputed material facts establish that Petitioner did not take all necessary precautions to promote healing, prevent infection, and prevent new sores from developing.

2.  Petitioner presented no evidence that could lead a rational trier of fact to conclude that CMS's immediate jeopardy determination is clearly erroneous.11

When evaluating a determination of immediate jeopardy, the ALJ and Board must defer to CMS's assessment unless the facility demonstrates that it is clearly erroneous.  42 C.F.R. § 498.60(c)(2); Franklin Care Ctr., DAB No. 2869, at 9 (2018).  As the Board has explained, "a facility bears a heavy burden in challenging the assessment of immediate jeopardy, which, of necessity, includes an element of judgment."  Neighbors Rehab. Ctr., LLC, DAB No. 2859, at 18 (2018) (citing Meadowwood Nursing Ctr., DAB No. 2541, at 14 (2013); Britthaven of Havelock, DAB No. 2078, at 29 (2007), and cases cited therein), aff'd, 910 F.3d 919 (7th Cir. 2018).  Petitioner points to no evidence before the ALJ that could lead a rational trier of fact to conclude that it could meet that burden here.  See Dumas at 5 (on summary judgment, the tribunal "must view the evidence presented through the prism of the substantive evidentiary burden" (quoting Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 255 (1986)).

As established above, the uncontested evidence shows that Petitioner repeatedly violated its own turning and repositioning policies in its care of R6.  Petitioner, among other things, never put R6 on a repositioning schedule consistent with the facility's repositioning policy and delayed providing R6 with a low air loss mattress.  R6 developed at least five pressure sores while in Petitioner's care, some of which deteriorated to the point that he was hospitalized for infections and sepsis.  Petitioner

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does not challenge these factual underpinnings.  Petitioner has not argued that the pressure sores which occurred (and to which Petitioner recognizes R6's underlying conditions made him vulnerable) were not serious, and the hospitalization clearly shows that they were.  It is not necessary to find that the failures of care definitely caused the sores, but only that Petitioner's noncompliance "has caused, or is likely to cause, serious injury, harm, impairment, or death."  42 C.F.R. § 488.301 (defining "immediate jeopardy") (emphasis added).  We find nothing in Petitioner's evidence from which we could conclude that it was clearly erroneous for CMS to determine that the failures of care were likely to cause R6 serious harm, and indeed the undisputed facts make it likely those failures caused actual serious harm.

We reject Petitioner's argument that there is a genuine dispute of fact concerning the immediate jeopardy finding.  According to Petitioner, the surveyor "completed" an "investigation regarding pressure ulcers" on March 30, 2016, and found no "immediate jeopardy or harm . . . to any resident" at that time.  RR at 30 (emphasis removed); see also Pet. Ex. 26 (showing the surveyor's preliminary findings as of March 30, 2016).  Petitioner complains that on April 4, 2016, five days after the surveyor shared her preliminary findings, and without requesting additional documents or interviews, the surveyor declared noncompliance at the immediate jeopardy level.  RR at 30‑31.  Petitioner asserts that "nothing changed" at the facility between March 30 and April 4, 2016, and emphasizes that R6 – the resident at the center of the immediate jeopardy determination – had already been discharged for over two months.  Id. at 31; Pet. Ex. 44, at 2 ("This certainly begs the question of how, with no changes for any resident between 3/30/16 and 4/4/16, and the primary resident in question having been discharged for over two months, there could be an 'immediate threat of harm.'").  Petitioner further asserts that "there was no current, future, or 'prospective' harm identified by the surveyor for any specific resident at the time of the survey."  RR at 30.

Petitioner's argument mischaracterizes the timeline and the surveyor's findings.  The survey of Petitioner's facility began on March 29, 2016, and was not completed until April 4, 2016.  CMS Ex. 4, at 1.  The preliminary findings provided to Petitioner (Pet. Ex. 26) did not purport to contain the surveyor's final findings or a statement of deficiencies, but rather the "preliminary areas of potential noncompliance with federal and/or state requirements[.]"  Pet. Ex. 26, at 1.  The surveyor's preliminary findings made no determination about the level of any noncompliance.  When the preliminary findings were provided to Petitioner on March 30, 2016, the surveyor's investigation of Petitioner's facility was ongoing.  The surveyor did not make her immediate jeopardy determination until April 4, after conducting an "administrative review."  CMS Ex. 57, at 9.  We find no merit to Petitioner's argument that the finding of immediate jeopardy was somehow undermined because it was not declared before the surveyor completed her review.  The surveyor's March 30, 2016 preliminary findings do not generate any issue of material fact as to immediate jeopardy.

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Petitioner's assertion that the surveyor did not identify actual or potential harm to any resident is also inaccurate.  In making her immediate jeopardy determination, the surveyor cited to actual harm to R6, i.e., that R6 developed new pressure sores while in Petitioner's care and was hospitalized after his pressure sores became infected.  CMS Ex. 57, at 9, 10 (noting that R6 "had developed osteomyelitis and gangrene" due to pressure ulcers before he left the facility on January 26, 2016).  The surveyor documented in the statement of deficiencies how the deficient treatment of R6's pressure sores contributed to their worsening condition and led to the immediate jeopardy finding.  CMS Ex. 4, at 3-17.  Nothing more was required to establish CMS's immediate jeopardy determination and shift the burden to Petitioner to demonstrate that that finding was clearly erroneous.  See Barbourville Nursing Home, DAB No. 1962, at 11 (2005) ("CMS was not required to produce evidence other than the [statement of deficiencies] to support its determination of immediate jeopardy . . . ."), aff'd, 174 F. App'x 932 (6th Cir. 2006).  To avoid summary judgment on this issue, Petitioner had to present evidence that, viewed in the light most favorable to Petitioner together with all reasonable favorable inferences, could cause a rational trier of fact to see clear error in CMS's determination.  We find no such evidence in this record given the undisputed facts about R6's treatment discussed above.

With respect to the argument that R6 was no longer a resident of the facility at the time of the survey and when the immediate jeopardy determination was made, Petitioner "mistakenly focuses on whether a particular patient remained in danger rather than whether conditions that created immediate jeopardy for one or more patients were still present."  Nightingale Home Healthcare, Inc., DAB No. 2784, at 26 (2017).  Once a facility is "found to have placed residents in an immediate jeopardy situation," it "is presumed to continue to present immediate jeopardy unless the facility shows that the determination of continued immediate jeopardy is clearly erroneous."  The Bridge at Rockwood, DAB No. 2954, at 29 (2019).  Indeed, immediate jeopardy may be deemed to have been abated only when the facility has implemented necessary corrective measures so that there is no longer any likelihood of serious harm to residents from the deficient practices.  Countryside Rehab. & Health Ctr., DAB No. 2853, at 25-26 (2018), appeal dismissed, No. 18-11759 (11th Cir. Apr. 1, 2019); Covington Manor Nursing Home, DAB No. 2789, at 7 (2017); Glenoaks Nursing Ctr., DAB No. 2522, at 19 (2013); Florence Park Care Ctr., DAB No. 1931, at 30 (2004).

Although R6 left the facility more than two months before the survey, Petitioner presented no evidence that the systemic conditions that formed the basis of noncompliance – which ultimately led to R6's hospitalization – were abated before Petitioner implemented the corrective measures (i.e., plan of removal) required by the surveyor.  CMS Ex. 57, at 9 (noting that the surveyor needed a plan of removal in order to remove the immediate jeopardy finding).  It is undisputed Petitioner's plan of removal was not accepted or implemented until April 4, 2016.  CMS Ex. 4, at 2, 21 ("The facility's Plan of Removal was accepted on 04/04/2016 at 4:30 p.m."); ALJ Decision at

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19.  Petitioner presented no evidence that the conditions that posed immediate jeopardy to vulnerable residents like R6 were removed any earlier than April 4, 2016.

In short, Petitioner proffers no evidence that brings into dispute the factual findings on which the immediate jeopardy determination was based, much less any evidence on which a rational trier of fact could conclude that CMS's immediate jeopardy determination was clearly erroneous.  We therefore find no reason to disturb the ALJ's conclusion that CMS's immediate jeopardy determination is not clearly erroneous.  ALJ Decision at 17.

Conclusion

We conclude that CMS demonstrated Petitioner was not in substantial compliance with 42 C.F.R. § 483.25(c)(2) and there are no genuine disputes of material fact regarding Petitioner's lack of substantial compliance arising from its (i) failure to provide R6 with the care and services required by its own repositioning policy, and (ii) failure to provide and ensure that its staff were able to monitor, set, and adjust low air loss mattresses for its residents in accordance with physician orders.  We further conclude that Petitioner presented no evidence from which a rational trier of fact could find that CMS's immediate jeopardy determination is clearly erroneous.  And, we conclude that the reasonableness of the CMP amount is not at issue in this appeal.  Based on these conclusions, we affirm the ALJ's grant of summary judgment in favor of CMS.

1. On October 4, 2016, approximately six months after the compliance survey in this case, CMS issued a final rule that amended the Medicare requirements for long-term care facilities and redesignated some sections.  See Final Rule, Medicare and Medicaid Programs; Reform of Requirements for Long-Term Care Facilities, 81 Fed. Reg. 68,688, 68,688-89.  Our analysis and decision are based on the regulations in effect in April 2016, the month in which the state surveyor completed the survey providing the basis for CMS's determination of noncompliance.  See Carmel Convalescent Hosp., DAB No. 1584, at 2 n.2 (1996) (applying regulations in effect on the date of the survey and resurvey).
• back to note 1
2. The background information is drawn from the ALJ Decision and the record before the ALJ and is not intended to substitute for her findings.
• back to note 2
3. The ALJ notes "[t]he record is silent as to R6's ultimate fate."  ALJ Decision at 14.  According to Petitioner, R6 "never returned to Heritage House" after being admitted to the hospital for surgery on January 26, 2016.  Request for Review at 27; see also CMS Ex. 4, at 21 ("[R6] no longer resides in facility.").
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4. The ALJ's July 5, 2016 Acknowledgment and Initial Pre-Hearing Order (AIPHO) established a 30-day deadline for a party opposing a motion for summary judgment to file a response.  AIPHO at 4.  Accordingly, Petitioner had until February 8, 2017, to file its response in opposition to CMS's motion.  Petitioner never filed a response before the ALJ issued her September 5, 2018 decision.
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5. Petitioner's June 24, 2016 Request for Hearing challenged the initial $169,400 CMP and ongoing $1,200 per-day CMP as unreasonable.  Request for Hearing at 1.  Seven days before Petitioner filed its Request for Hearing, CMS amended the penalties to a $6,050 per-day CMP for one day of noncompliance at the immediate jeopardy level, and a $1,200 per‑day CMP for one day of noncompliance not at the immediate jeopardy level, for a total CMP amount of $7,250.  ALJ Decision at 3 (citing CMS Exs. 2, 3).  Petitioner never argued that the reduced CMP amount was unreasonable in any filing before the ALJ or the Board and, therefore, the issue has been waived.  See, e.g., The Harborage, DAB No. 2905, at 17 (2018) (affirming the ALJ's finding that petitioner waived its right to dispute the CMP amount because it never argued the amount was unreasonable based on the applicable regulatory factors).  Even if this issue were before the Board, we would find no error in the ALJ's conclusion that $7,250 was reasonable because the CMP amounts are within the applicable ranges and reasonable based on the regulatory factors.  See 42 C.F.R. § 488.438(a), (f); see also ALJ Decision at 17-18.
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6. We do not suggest that questions of reasonableness may never arise in skilled nursing facility cases.  For example, when a facility challenges the amount of a CMP, the ALJ (and the Board) will consider whether the CMP amount is reasonable based on specified regulatory factors.  See Capitol Hill Cmty., DAB No. 1629, at 2-3 (citing 42 C.F.R. § 488.438(e)(3)).  The CMP amount is not at issue in this appeal.  See supra at 8 n.5.
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7. The ALJ noted, and we agree, that "the evidence would likely support penalties of longer duration, [but] CMS simply did not impose them."  ALJ Decision at 3; see also CMS Ex. 2, at 1 (notifying Petitioner that it had achieved substantial compliance with the participation requirements on April 6, 2016); CMS Ex. 4, at 21, 23-24 (confirming that facility's plan of removal was sufficiently implemented to remove the immediate jeopardy at 4:30 p.m. on April 4, 2016).
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8. Petitioner is referring to the "definitions for the stages of pressure ulcers" in the CMS State Operations Manual (SOM), CMS's interpretive guidance for surveyors.  See State Operations Manual (CMS Pub. 100-07), Appendix PP, Guidance to Surveyors for Long-Term Care Facilities, Tag F314 (2016).  The SOM defined a "Stage I" pressure ulcer as an "observable, pressure-related alteration of intact skin, whose indicators as compared to an adjacent or opposite area on the body may include changes in one or more . . . parameters," including:  "[s]kin temperature," "[t]issue consistency," "[s]ensation," "and/or" "[a] defined area of persistent redness in lightly pigmented skin, whereas in darker skin tones, the ulcer may appear with persistent red, blue, or purple hues."  Id.
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9. As further explained below, this description of "Think Pink," if accurate, evidences another violation of Petitioner's repositioning policy, which requires the facility to document position changes in the resident's medical record.  See infra at 16 (discussing CMS Ex. 52, at 4); see also CMS Ex. 52, at 5 (documentation policy).
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10. Petitioner argues that wounds heal from the bottom up, so it is not unusual for the surface area of the wound to increase while the depth decreases, particularly after use of a debriding agent.  RR at 15; Pet. Ex. 42, at 8.  This fact, even if true, does not appear to contradict any conclusion reached by the ALJ, and Petitioner fails to explain how this information creates a genuine issue of material fact.  In one instance, the ALJ questioned the wound care nurse's assessment that a pressure sore had "improved" when it was at stage III and measured 3.0 cm (long) x 2.5 cm (wide) x 0.10 cm (deep).  ALJ Decision at 13 n.6 (citing CMS Ex. 13, at 22).  The ALJ pointed out that one week earlier the pressure sore had been assessed at stage II and measured 0.5 cm (long) x 0.6 cm (wide) x 0.01 cm (deep).  CMS Ex. 13, at 18.  Given Petitioner's assertion that wounds heal from the bottom up, the ALJ was correct to question the nurse's assessment that the wound had "improved," when both the surface area and depth of the wound increased from one week to the next.
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11. In its response brief, CMS asserts that the ALJ did "not have the authority to review CMS's immediate jeopardy determination."  CMS Response at 11 (emphasis removed).  Under the Part 498 regulations, a facility may appeal a finding of immediate jeopardy if a successful challenge would affect: "(i) [t]he range of civil money penalty amounts that CMS could collect"; or "(ii) [a] finding of substandard quality of care [as defined in 42 C.F.R. § 488.301] that results in the loss of approval . . . of its nurse aide training program."  42 C.F.R. § 498.3(b)(14); 38-40 Freneau Ave. Operating Co. LLC, d/b/a Atrium Post Acute Care of Matawan, DAB No. 3008, at 11-12 (2020).  Despite CMS's claims to the contrary, the first condition – that a successful challenge could affect the range of CMP amounts – is met in this case.  The regulations contemplate an upper ($3,050 ‑ $10,000) and lower ($50 - $3,000) penalty range for per-day CMPs, depending on the level of noncompliance.  42 C.F.R. § 488.438(a)(1); compare id. § 488.438(a)(2) (specifying a single range ($1,000 ‑ $10,000) for per-instance CMPs).  Here, CMS imposed, in part, a $6,050 per-day CMP for one day of noncompliance.  See CMS Ex. 2, at 1.  Accordingly, a successful challenge to the immediate jeopardy determination would affect the applicable per-day CMP range available to CMS.
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