West Cladwell Care Center, DAB CR5237 (2019)

DECISION

I grant summary judgment in favor of the Centers for Medicare & Medicaid Services (CMS), affirming its decision to impose civil money penalties against Petitioner, West Caldwell Care Center, a New Jersey skilled nursing facility, of $1,720 per day for each day of a period of noncompliance that began on February 23, 2018, and that continued through March 23 of that year.

I. Background

CMS moved for summary judgment and with its motion filed 18 exhibits that it identified as CMS Ex. 1-CMS Ex. 18.  Petitioner opposed the motion and filed nine exhibits, identified as P. Ex. 1-P. Ex. 9.  CMS filed a reply brief.

I do not receive the parties’ exhibits into evidence inasmuch as I grant summary judgment based on undisputed material facts.  However, I discuss some of the exhibits in this decision in order to illustrate undisputed facts or to explain why I find no fact dispute.

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II. Issues, Findings of Fact and Conclusions of Law

A. Issues

The issues in this case are:  whether Petitioner failed to comply with the requirements of 42 C.F.R. § 483.25(b)(1), a regulation that governs the care that a skilled nursing facility must provide to its residents in order to prevent the development of pressure sores; and whether CMS’s remedy determination is reasonable.

B. Findings of Fact and Conclusions of Law

In deciding a motion for summary judgment, I utilize the principles contained in Rule 56 of the Federal Rules of Civil Procedure.  In deciding whether to grant the motion, I consider only material facts that are not disputed by the parties.

The regulation at issue in this case mandates that a skilled nursing facility ensure that each of its residents receives the care necessary to prevent pressure sores that are avoidable.  42 C.F.R. § 483.25(b)(1).  Such care must be provided pursuant to each resident’s comprehensive plan of care.  Id.

The undisputed material facts plainly establish that Petitioner failed to provide care that had been prescribed for one of its residents in order to protect that resident against developing pressure sores:

• It failed to conduct weekly skin assessments of that resident (Resident # 21) as had been ordered by the resident’s treating physician;

• It failed to comply with its plan of care for Resident # 21 in that its staff did not apply barrier cream and a protective ointment, Peri-guard, to the resident’s skin; and

• It failed to update Resident # 21’s plan of care for nearly a month after the resident developed a pressure sore.

The inescapable conclusion that I draw from these undisputed facts is that Petitioner did not substantially comply with regulatory requirements governing the prevention of pressure sores.

The undisputed facts establish Resident # 21 to be a chronically ill and debilitated individual with multiple problems that put her at risk for developing pressure sores.  CMS Ex. 10 at 11.  Petitioner’s staff recognized the resident’s vulnerability.  CMS Ex. 9 at 12.  The staff developed a care plan that contained

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interventions intended to protect Resident # 21 against developing pressure sores.  On March 7, 2017, the staff prepared an updated plan that identified the resident as being at risk for “skin integrity impairment” (pressure sores).  CMS Ex. 10 at 12.  The plan listed a series of interventions that included applying a skin barrier cream and applying Peri-guard, a pressure sore preventive ointment, to the resident’s skin.  Id.  The staff recertified this care plan several times after its initial development and implementation.

The resident’s physician, aware of the resident’s vulnerability to developing pressure sores, issued an order to Petitioner’s staff that, commencing on April 28, 2017, the staff conduct weekly skin assessments.  CMS Ex. 10 at 7.  The resident’s treatment administration record incorporated this order as routine care to be provided to the resident.  Id. at 3.

However, there are no treatment records showing that Petitioner’s staff complied with the care plan’s directives to apply barrier cream and Peri-guard to the resident and with the physician’s order to conduct regular weekly skin assessments.  Resident # 21’s clinical record is devoid of entries showing that the staff applied barrier cream and Peri-guard to the resident’s skin.1  Furthermore, although the resident’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 Resident # 21.  Delegation to an LPN of the duty to perform skin assessments is a violation of New Jersey law, which requires that a registered nurse perform such assessments.  N.J. Admin. Code § 13:37-6.5 (2016).

Surveyors employed by the New Jersey State survey agency questioned the LPN responsible for providing care to Resident # 21 about administration of barrier cream and Peri-guard to the resident.  He stated that no skin ointment was applied to the resident prior to January 18, 2018.  CMS Ex. 3 at 8; CMS Ex. 4 at 4.  Petitioner’s director of nursing told the surveyors that Petitioner had failed to order barrier cream or Peri-guard for the resident.  CMS Ex. 3 at 9.

On January 18, 2018, Petitioner’s staff found that Resident # 21 had developed a pressure sore on her sacrum.  CMS Ex. 10 at 1.  The staff identified the wound as “unstageable,” meaning that they were unable to identify how deeply the wound had penetrated based on an initial visual inspection.  Petitioner’s staff began treating the resident’s sore with a medication, Santyl.  Id.  However, there is nothing in the record showing that the staff performed an assessment of the sore in

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order to determine its cause, nor is there anything showing whether the staff determined whether pre-development treatment was inadequate.  The staff did not revise the resident’s care plan in order to address the sore until February 16, 2018, three days after surveyors began examining the care that Petitioner’s staff had provided to Resident # 21.  CMS Ex. 2 at 6; CMS Ex. 3 at 11; CMS Ex. 10 at 13.

Petitioner contends that there is a factual dispute concerning whether Petitioner provided requisite care to Resident # 21.  Additionally, it asserts that the pressure sore that the resident acquired was unavoidable and from that assertion it seems to argue that it complied with regulatory requirements even if it failed to provide the resident with all of the care that had been ordered for her.

But, Petitioner’s assertions notwithstanding, I find no dispute as to the material facts that I have discussed above.  Nor do I find that Petitioner may hide behind the asserted unavoidability of the resident’s pressure sore as a defense to its noncompliance.

As I have stated, there exist no treatment records that show that Petitioner provided the care that had been ordered for Resident # 21.  To reiterate:  the record is devoid of treatment records showing that the staff regularly applied barrier cream and Peri-guard to the resident’s skin.  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.  The resident’s care plan wasn’t updated to reflect the presence of a pressure sore or to incorporate treatments for that sore until nearly a month after Petitioner’s staff identified the sore.  Any of these shortcomings would be sufficient to establish noncompliance with regulatory requirements.

For example, the failure to update the resident’s care plan is, in and of itself, a violation.  It is not possible for a facility to comply with the requirements of 42 C.F.R. § 483.25(b)(1) unless it has in place a comprehensive and written plan of care that sets forth precisely the care that a resident is to receive.  I would grant summary judgment in favor of CMS if the failure to revise the resident’s plan of care was the only fact establishing noncompliance because the failure to plan the resident’s care denotes a very serious violation of regulatory requirements.  The regulation governing prevention and treatment of pressure sores requires that all care be provided pursuant to a comprehensive care plan.  The absence of a plan is a fundamental regulatory violation.  It is not possible to provide well-reasoned and thorough care absent a plan which defines the resident’s problems and delineates the care that will be provided to address those problems.

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Petitioner offered no clinical records to refute what I have described.  Instead, it relies on declarations from Wanda Ayala, its assistant director of nursing (P. Ex. 4), and Susan Maak, its director of nursing (P. Ex. 6).

Petitioner offers Ms. Ayala’s declaration to dispute CMS’s assertion that Petitioner’s staff failed to apply barrier cream and Peri-guard to Resident # 21’s skin as was required by the resident’s plan of care.  In her declaration, Ms. Ayala avers that she held a number of positions in Petitioner’s facility.  She states that in her previous role as one of Petitioner’s nurse unit managers she “oversaw . . . [Resident 21’s] care.”  P. Ex. 4 at 2.  She asserts that the staff in Petitioner’s facility protected Resident # 21 against the development of a pressure sore by administering Peri-guard to the resident.  Id. at 2, 4-5.  She adds:

The certified nursing assistants (CNAs) routinely utilize barrier cream per the facility’s incontinence care protocol.

Id. at 2.

Ms. Ayala’s testimony raises no dispute as to a material fact in this case.  The fact allegation made by CMS is that Petitioner’s staff failed to administer a barrier cream and Peri-guard to Resident # 21 pursuant to the facility’s plan of care and the resident’s physician’s order.  That failure is evidenced by the total absence of any facility record showing that either of these medications were applied and by the admission of the LPN who provided care directly to the resident that he failed to apply these medications.  Saying without any explanation that the resident received Peri-guard and that barrier cream is “routinely” utilized doesn’t rebut this allegation.

Ms. Ayala did not assert that she personally supervised the administration of either barrier cream or Peri-guard to Resident # 21.  She did not explain how, in her supervisory role, she would know whether instructions in a plan of care were being carried out.  She did not state that she witnessed staff applying these medications.  She did not aver that staff told her that they were applying these medications to Resident # 21.  She did not identify a single facility record that corroborated her assertion that the staff routinely administered the medications to Resident # 21.  She did not directly rebut the admissions made by members of Petitioner’s staff to the New Jersey State Agency surveyors.

In short, Ms. Ayala’s contention is a naked assertion and nothing more.  It stands in stark contrast to the facts adduced by CMS:  the absence of any record showing that barrier cream and Peri-guard were administered to Resident # 21 prior to January 18, 2018; the admission by the LPN responsible for providing direct care to the resident that he’d failed to apply either barrier cream or Peri-guard prior to

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January 18; and the admission of the director of nursing that Petitioner had not ordered either medication for Resident # 21.

In deciding whether to grant a motion for summary judgment, I am required to accept as true facts offered by the party against which the motion is filed and I am required also to draw all reasonable inferences from such facts, including inferences that I might not draw after a full hearing on the record.  But, I am not required to accept as “fact” an unsubstantiated bald assertion that is unsupported by any evidence.

As a general rule a party opposing a motion for summary judgment must offer evidence of specific facts in order to establish a dispute as to the material facts of the case.  Matsushita Elec. Indus. Co. v. Zenith Radio Corp., 475 U.S. 574, 586 n.11 (1986).  A generalized denial or an unsubstantiated assertion is not enough to create a genuine fact dispute.  “[I]f the evidence is merely colorable or is not significantly probative summary judgment may be granted.”  Livingston Care Ctr.,108 F. App’x 350, at 354 (6th Cir. 2004) (quoting Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 249-50 (1986)).

Ms. Ayala’s assertion that barrier cream was routinely provided is an unsubstantiated assertion that does not rise to the level of a genuinely disputed material fact.  As I have discussed, it 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.2

Ms. Ayala also recites that a skin integrity observation was made of Resident # 21 on January 15, 2018.  P. Ex. 4 at 3.  Accepting this assertion as true, I find it does nothing to rebut CMS’s fact contention that prior to January 2018 Petitioner failed to ensure that a registered nurse performed weekly assessments consistent with the requirements of New Jersey State law.

Ms. Maak testified that she is Petitioner’s director of nursing.  P. Ex. 6.  In her declaration she asserts that:

• On January 8, 2018, a skin check of Resident # 21 revealed no abnormalities.  Id. at 3.

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• A nurse did weekly skin checks, which were coordinated with the resident’s shower day.  Such checks are documented on the resident’s treatment assessment record.  Id. at 4.

• Barrier cream is available to all nursing assistants without the need for an order and is applied routinely by them.  Id. at 5.

• Records of services provided by nursing assistants are kept only for 60 days and then routinely shredded.  That explains why there is no record of barrier cream being applied to Resident # 21.  Id. at 6.

These assertions raise no dispute as to the material facts of this case.  The assertion that a “nurse” did weekly skin checks does not show that a registered nurse performed skin assessments consistent with the requirements of law.  As CMS notes, the only record of skin checks consists of some initials made on a form, initials made by an LPN who was not authorized by New Jersey law to perform skin checks.  Ms. Maak’s assertion that a “nurse” performed skin checks does not raise any dispute concerning the failure by a registered nurse to perform those checks.

I accept as true Ms. Maak’s assertion that barrier cream is available to all nursing assistants.  That does not answer CMS’s assertion and supporting evidence showing that Peri-guard was not ordered for and provided to Resident # 21.

In its argument Petitioner consistently confuses the requirement that its staff apply a barrier cream to Resident # 21 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.  The fact that barrier cream may have been “available” to Petitioner’s staff says nothing about whether the staff obtained Peri-guard for Resident # 21 and applied it.  Furthermore, Petitioner has offered nothing to rebut the facts adduced by CMS showing that its staff neither ordered Peri-guard nor applied it to Resident # 21.

I also accept as true, if only for purposes of deciding this motion, Ms. Maak’s contention that Petitioner shreds records of services provided by its nursing assistants after 60 days.  That does not explain, however, why Petitioner had no records of services provided by nursing assistants in the 60 days immediately prior to the February 2018 survey of Petitioner’s facility.  Presumably, Petitioner had access to those records and could have produced them if they rebutted the surveyors’ noncompliance findings.

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Petitioner addresses at considerable length the issue of whether Resident # 21’s pressure sore was avoidable.  Petitioner argues that the sore was unavoidable – that it occurred despite Petitioner doing everything reasonable to prevent the development of a pressure sore – and from this, it asserts that it complied substantially with regulatory requirements.  Petitioner’s brief in opposition to CMS’s motion (Petitioner’s brief) at 4, 7, 10, 11-12.

However, the issue here isn’t whether Resident # 21 developed an avoidable sore.  Rather, the issue is whether Petitioner’s staff undertook all reasonable measures to protect the resident against developing a sore.  More specifically, at issue is whether the staff failed to comply with directives in the resident’s care plan; failed to carry out a physician’s order to perform weekly skin checks on the resident; and failed to revise the resident’s plan of care promptly after the resident developed a pressure sore.  As I have explained, the undisputed facts unequivocally establish that Petitioner failed to carry out all of these obligations.

Petitioner may not avail itself of the defense that the resident’s pressure sore was unavoidable given its failure to discharge its obligation to provide preventive care to Resident # 21.  That defense would apply only if Petitioner had undertaken all reasonable measures to protect the resident and if CMS nevertheless alleged noncompliance based solely on the resident’s developing a sore.  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.  See Clermont Nursing & Convalescent Ctr., DAB No. 1923 at 8, 10-11 (2004).

The remaining issue is whether the civil money penalties that CMS determined to impose are reasonable.  CMS determined that Petitioner was noncompliant during a period that 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 that the surveyors found.  Petitioner has not argued that it attained compliance at a date that is earlier than March 23, assuming that CMS’s noncompliance findings are correct.  Therefore, what I must decide is whether the daily penalty amount of $1,720 is reasonable.

The penalty amount falls within the range of daily penalty amounts that CMS may impose to remedy noncompliance that is substantial but that does not constitute immediate jeopardy for a facility’s residents.  42 C.F.R. § 488.438(a)(1)(ii); 45 C.F.R. § 102.3.  The penalty amount imposed by CMS is only slightly more than one-quarter the daily penalty amount that CMS may impose to remedy non-immediate jeopardy level noncompliance.

There are regulatory factors that must be considered in determining whether a civil money penalty amount is reasonable.  These factors include, among other things,

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the seriousness of a facility’s noncompliance, its compliance history, and its financial condition.  42 C.F.R. §§ 488.438(f)(1)-(4); 488.404 (incorporated by reference into 42 C.F.R. § 488.438(f)(3)).  I have considered all of the facts offered by the parties concerning the issue of penalty amount and I find that the undisputed facts establish the amount to be reasonable.3

I find that the penalty amount of $1,720 per day is reasonable given the undisputed facts of this case.  The seriousness of Petitioner’s noncompliance and its rather lengthy history of violations of regulatory requirements amply justify this penalty amount.  Indeed, the penalty amount is modest given that CMS had the authority to impose a much higher penalty amount for noncompliance at this level.  42 C.F.R. § 488.438(a)(1)(ii); 45 C.F.R. § 102.3.

There can be no question that Petitioner’s noncompliance in this case was serious.  It is not necessary that I decide whether Petitioner’s failure to provide preventive care to Resident # 21 caused her to develop a pressure sore or even whether the sore would have been unavoidable if Petitioner’s staff had done what they were supposed to do in providing care to the resident.  The undisputed facts establish that Petitioner failed to provide necessary care to Resident # 21.  That at the least put the resident at risk for injury or harm.

The undisputed fact that is most disturbing in this case – one that Petitioner effectively concedes – is Petitioner’s failure to revise Resident # 21’s care plan for about a month after a pressure sore was discovered on January 18, 2018.  See Petitioner’s brief at 9.  The discovery of that sore mandated that Petitioner thoroughly assess the care that it was providing to Resident # 21 and decide whether to change or implement new interventions for the resident, whether or not that sore was avoidable, and whether or not Petitioner had carried out its previous care instructions to the letter.  The discovery of the sore established that Petitioner’s concerns about the vulnerability of Resident # 21 to developing pressure sores had been realized.  That should have immediately set off alarms among Petitioner’s staff.

But, the staff did not conduct a thorough assessment of the resident’s condition and implement a new plan for nearly a month after the sore was discovered.  The staff began administering a new medication (Santyl) but without any

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comprehensive care plan in place.  Indeed, it was not until surveyors visited the facility in February 2018 that Petitioner’s staff developed a new care plan.  Petitioner seems to argue that, although it did not revise the resident’s care plan, it did something that was functionally the equivalent of that by identifying the resident’s pressure sore and applying Santyl to the wound.  But, doing that is not the functional equivalent of revising a care plan.  The purpose of a care plan is to memorialize a facility staff’s analysis of a resident’s problems and to establish a reasoned and structured approach to dealing with those problems.  The care plan provides a blueprint to facility’s staff about how to assist its residents.  In the absence of a plan the staff’s actions are, at best, ad hoc.  The facility is left without a metric by which to measure the success or lack thereof of the care that it provides to its residents, and the reasoning behind ordering or not ordering a specific treatment is lost.

Additionally, Petitioner manifests a history of significant noncompliance predating the findings that are at issue here.  CMS Ex. 18.  Petitioner was found to be noncompliant in surveys beginning in at least 2004 and on several occasions subsequently.  In 2015, CMS imposed a civil money penalty of $7,550 against Petitioner, evidently for an instance of noncompliance.  Id.

Petitioner argues, however, that the imposition of penalties against it would cause it to suffer an unacceptable financial hardship.  Charlene Harn, Petitioner’s administrator, testified that the total penalty amount (based on $1,720 per day x 34 days of noncompliance) of $58,480 is “absolutely devastating” to Petitioner’s operations and impairs the quality of care that Petitioner provides to its residents.  P. Ex. 5 at 3.  She contends that the penalties caused Petitioner to default on its payments to vendors and may cause suppliers to charge Petitioner a higher rate of interest for purchases made by Petitioner on credit.  Id. at 4.

I do not find Ms. Harn’s assertions to raise facts sufficient to call into question the reasonableness of the penalties that CMS determined to impose.  Her unadorned assertion aside, Petitioner has offered no evidence establishing its financial condition.  The record is devoid of any facts concerning Petitioner’s profits, its monthly expenses versus revenue, its assets, and its liabilities.  It is impossible for me to make a finding that Petitioner’s financial condition is affected adversely by the penalties imposed by CMS absent any evidence – aside from Ms. Harn’s unsupported and anecdotal claims – establishing Petitioner’s actual financial condition.

• 1.By contrast, the treatment record of at least one other resident establishes that the resident received Peri-guard pursuant to his/her plan of care. CMS Ex. 15.
• 2.Ms. Ayala attempts to explain the admission of the LPN that he failed to apply barrier cream and Peri-guard to Resident # 21 by asserting that “[t]his makes sense because prior to January 18, 2018 there was no wound treatment.”  P. Ex. 4 at 5.  However, these medications weren’t prescribed as “wound treatment” but as preventive medications.
• 3.I note that the time during which I allowed the parties to offer evidence in support of their contentions has elapsed. Even if I were to deny the motion for summary judgment, I would not allow either party to present additional evidence addressing any of the issues in this case. Thus, all of the evidence that the parties might possibly present is before me now.