Pacific Gardens Nursing and Rehabilitation Center, DAB CR6082 (2022)

DECISION

I enter summary judgment in favor of the Centers for Medicare & Medicaid Services (CMS) and against Petitioner, Pacific Gardens Nursing and Rehabilitation Center, a skilled nursing facility.  I sustain remedies consisting of a civil money penalty of $1,345 for each day of a period that began on July 27, 2021 and extended through August 5, 2021.1

I.  Background

CMS moved for summary judgment, and Petitioner opposed the motion.  With its motion, CMS filed 16 exhibits, identified as CMS Ex. 1-CMS Ex. 16.  Petitioner filed 16 exhibits in opposition to the motion, identified as P. Ex. 1-P. Ex. 16.  Petitioner objected to my receiving some of CMS’s exhibits into evidence.  Petitioner’s Objections to CMS’ Proposed Exhibits.

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I do not receive the parties’ exhibits into evidence, and I find it unnecessary to rule on Petitioner’s objections.  I rely only on material facts that are not disputed in issuing summary judgment.  I cite to some of the parties’ exhibits in this decision, but only to illustrate facts that are not in dispute or to explain why certain facts are irrelevant. 

II.  Issues, Findings of Fact and Conclusions of Law

1. Issues

The issues are whether Petitioner failed to comply substantially with Medicare participation requirements and whether CMS’s remedy determination is reasonable. 

2. Findings of Fact and Conclusions of Law

In issuing summary judgment, I must base my decision only on material facts that are undisputed.  I must draw all reasonable inferences that are favorable to the party opposing the motion in addressing the facts that are before me.  However, the facts that the parties offer must be relevant.  Irrelevant facts are no impediment to my issuing summary judgment. 

CMS alleges that Petitioner failed to comply substantially with the requirements of 42 C.F.R. § 483.25.  This regulation requires a facility to ensure that each of its residents receives treatment and care that accord with professional standards of practice, based on the facility’s comprehensive assessment of that resident’s condition and needs, the resident’s comprehensive plan of care, and the resident’s personal choices. 

CMS alleges that Petitioner failed to comply with the regulation’s requirements in providing care to two of its residents, identified as Residents 1 and 3.  CMS contends that Petitioner failed to provide wound care to each of these residents consistent with professional practice standards and the resident’s plan of care. 

The undisputed facts establish CMS’s noncompliance allegations. 

The undisputed facts are that Resident 1 had a surgical wound on her left knee.  This wound was serious.  She was noted on admission to Petitioner’s facility on October 1, 2020, to be suffering from an infection and an inflammatory reaction.  CMS Ex. 3 at 1-2.  The wound was of such severity that the resident was awaiting a surgical wound revision.  CMS Ex. 3 at 8, 11. 

A physician ordered Petitioner’s staff to clean, treat, and re-bandage the wound twice per day:  once during each day shift and once during each night shift.  CMS Ex. 3 at 11. 

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On December 2, 2020, Resident 1 was found to be infected with Covid-19.  CMS Ex. 3 at 2.  Petitioner’s staff moved the resident to an area designated for residents who were infected with the virus.  CMS Ex. 16 at 5 ¶ 13.  Staff failed to carry out the physician’s order after the resident’s move.  During a four-day period that began on December 3 and continuing through December 6, 2020, Petitioner’s staff failed to provide Resident 1 with wound care during the day shift.  CMS Ex. 16 at 5 ¶ 14.

During that period, Petitioner’s staff did not execute records documenting that wound care was provided.  Petitioner’s treatment administration record fails to show any wound care treatments on the dates and shifts in question.  CMS Ex. 3 at 15; CMS Ex. 16 at 3-4 ¶ 9.2   Petitioner did not produce any other records that showed that the care was provided, nor has it come forward with the testimony of any witness averring that the care was provided.  The only reasonable inference that I can draw from the absence of care records and the absence of affirmative evidence showing that care was provided to Resident 1 is that Petitioner’s staff failed to provide the care that had been ordered for the resident.

It is undisputed that Resident 3 had venous ulcers on his legs.  CMS Ex. 4 at 7-8, 11.  These ulcers were open sores caused by circulation difficulty.  CMS Ex. 9 at 1. 

A physician ordered that Resident 3’s ulcers be cleaned, treated, and re-bandaged once during each day and night shift (twice per day).  CMS Ex. 4 at 7-8.  The prescribed treatment included cleaning and drying the resident’s wounds, applying antibiotic ointment, and wrapping the ulcers.  CMS Ex. 4 at 7-8, 31.

Resident 3 was diagnosed with Covid-19 on November 27, 2020.  CMS Ex. 4 at 2.  Petitioner’s staff moved the resident to the part of Petitioner’s facility that was designated for infected residents.  CMS Ex. 16 at 6-7 ¶ 22.  Staff began failing to treat the resident’s ulcers after he had been moved.  CMS Ex. 16 at 6 ¶ 21.

There are no treatment records establishing that the resident received the ordered wound care during the day shifts on December 1, 3-7, 2020 or during the night shifts on December 4 and 7, 2020.  CMS Ex. 4 at 7.  Petitioner has not produced any evidence, either documentary or testimony, to show that wound care was performed on these dates and shifts.  I can only infer from the absence of records or testimony showing that the resident received wound care that the resident did not receive it as directed.

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There exists no record showing that Petitioner’s staff assessed the status of Resident 3’s venous ulcers during the first week of December 2020.  Petitioner’s policy was that its staff perform a weekly head to toe skin inspection on each resident and for each identified wound to receive a comprehensive wound assessment.  CMS Ex. 7 at 1-2.  I infer from Petitioner’s failure to document a wound assessment for Resident 3 that the assessment was not performed.  Petitioner has not offered documentation to show that the assessment was performed.

As I have stated, there are no facts to show that Residents 1 and 3 received the care that was ordered by their physicians.  That absence of treatment records leads inexorably to the inference that the ordered care wasn’t provided.  Absence of evidence of assessment likewise leads to the inference that no assessment was performed.  Petitioner has offered nothing that would rebut that inference.3

Petitioner plainly violated the regulation’s requirement that each resident receive care in accordance with his or her plan of care and professional practice standards.  The failures by Petitioner’s staff to treat Resident 1 and 3’s wounds were obvious failures to comply with physicians’ orders.  This contravenes professional practice standards governing the care that nurses must give to the patients under their care.  CMS Ex. 16 at 7-8 ¶ 25.  The failure to assess Resident 3’s wounds violated Petitioner’s policy.

Regulations define substantial compliance to mean a level of compliance such that any identified deficiencies pose no greater risk to a resident or residents than the potential for causing only minimal harm.  42 C.F.R. § 488.301.  The only reasonable inference that I can draw from the undisputed facts is that Petitioner’s failure to provide prescribed care posed a potential for more than minimal harm to Residents 1 and 3.  Likewise, the failure to perform a weekly assessment of Resident 3’s venous ulcers posed a potential for more than minimal harm to this resident.

The significance and the potential for harm to these residents that their wounds posed, whether they worsened or not, is manifest in the fact that both residents’ physicians ordered twice-daily wound care.  It would be unreasonable to infer that these residents’ wounds were not significant and did not pose a potential for harm to the residents, given the physicians’ orders for twice-daily care.  The obvious inference also is that failure to follow the physicians’ orders created a risk of more than minimal harm; that the wounds would worsen if left untreated.

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The failure to assess Resident 3’s ulcers also created a risk of more than minimal harm for this resident.  Petitioner’s own policy, calling for weekly wound inspections and assessments, makes the risk of untreated and unassessed wounds evident.

Both Resident 1 and 3’s wounds worsened during the period that included Petitioner’s staff’s failure to provide care as ordered by the residents’ physicians.  CMS Ex. 3 at 43‑45; CMS Ex. 4 at 14-16.  I could infer from these facts that the failure to provide prescribed care to the residents and, in the case of Resident 3, to assess his wounds, contributed to the wounds’ deterioration.  I find it unnecessary to do so.

Actual harm is not a necessary element to finding that Petitioner’s noncompliance was substantial.  Noncompliance means only the potential for causing more than minimal harm.  42 C.F.R. § 488.301; State Operations Manual (CMS Pub. 100-07), Ch. 7 § 7400.3.1 (effective Nov. 16, 2018).4   I have found that potential existed in Petitioner’s failure to provide prescribed care to Residents 1 and 3 and in the failure to assess Resident 3’s wounds.  That is enough to find that Petitioner was deficient and to authorize CMS to impose remedies.

I also find Petitioner’s arguments to be without merit. 

Petitioner admits that the evidence does not support that it provided wound care to Residents 1 and 3, as ordered by the residents’ physicians.  Petitioner’s Updated Opposition to Motion for Summary Judgment and Pre-hearing Brief (Petitioner’s brief) at 6.  It asserts that it complied with participation requirements, notwithstanding this admitted failure to provide care.  Id.

As its primary defense, Petitioner argues that the residents’ wounds were chronic and either failing to heal or recurring and, therefore, there is no basis to conclude that Petitioner’s failure to provide care, as ordered, contributed to the deteriorating status of the wounds.  Petitioner’s brief at 6-7.  To support this assertion, Petitioner offers a detailed summary of the status of the residents’ wounds.  Petitioner’s Updated Separate Statement of Undisputed Facts in Support of Opposition to CMS’ Motion for Summary Judgment; Petitioner’s brief at 7-12.

In effect, Petitioner argues that it should be excused from its dereliction because treating the residents’ wounds as ordered wouldn’t have benefitted the residents.  It asserts that CMS has a burden to show that the wounds worsened due to failures to provide care and that the undisputed facts do not lead only to this conclusion.  Petitioner’s brief at 6-7.

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These arguments have no basis in law.  As I have explained, a finding of noncompliance does not require a finding of actual harm.  A deficiency that has the potential for causing more than minimal harm is all that is needed to find noncompliance.  42 C.F.R. § 488.301.  The existence of a potential for more than minimal harm in this case is the only reasonable conclusion that I may draw from the undisputed facts.  Physicians would not have ordered wound care for Residents 1 and 3 had they concluded that such care was unnecessary or would be futile.  Resident 1, for example, suffered from a chronic and non-healing wound that put her at risk for infection and other complications.  At a minimum, wound treatment was necessary to protect the resident from wound deterioration pending additional surgery to revise her wound.

Petitioner seems to claim that the failure by its staff to assess Resident 1’s wound was harmless error because the assessment process was of no benefit.  Petitioner’s brief at 8‑9.  In effect, Petitioner contends that the assessments did not have a meaningful relationship to the care that its staff actually provided:

It is equally worth noting that the wound care assessments in question ask only that a nurse check a radial button indicating whether a wound’s condition is “worsening”, “improving” or “unchanged.”  There are no other notes or assessments included that describe the specific reasons a nurse might check one box over another.  These assessments are entirely subjective and do not require a nurse to explain their reasoning.

Id.  (internal citation omitted).  In other words, Petitioner seems to be making the startling argument there was no harm in its staff failing to assess a resident’s wounds because the assessments themselves were of little value.  Alternatively, Petitioner says that if staff concludes in an assessment that a resident’s wound is worsening, that assessment means very little because it is “entirely subjective.”  Id. at 8.

These arguments are belied by Petitioner’s own policy that required its staff to perform weekly head to toe skin checks and assessments of each of its residents.  CMS Ex. 7 at 1‑2.  Implicit in that policy is the conclusion that performing these evaluations was a necessary and valuable element of resident care.  Otherwise, requiring them would have been pointless window dressing.

Indeed, if the actual assessments that Petitioner’s staff were performing were as superficial, subjective, and as worthless as Petitioner contends, those assessments would have been a wholesale violation of Petitioner’s skin assessment policy.  That policy explicitly requires the staff to perform comprehensive and highly detailed weekly evaluations of each resident’s skin condition.  CMS Ex. 7 at 1.

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Petitioner also asserts that CMS assumes “without evidence” that skin assessments were required to be done weekly.  Petitioner’s brief at 10.  But CMS isn’t assuming anything.  The undisputed facts are that Petitioner mandated its staff to perform comprehensive skin assessments weekly.  That is exactly what Petitioner’s policy demands.

Petitioner further asserts that its medication administration record and nursing notes show that even if its staff did not perform a skin assessment for Resident 3, the staff was nevertheless applying medication to the resident’s wounds and the resident was “regularly observed and assessed” as part of his care.  Petitioner’s brief at 10.

This argument is flawed for two reasons.  First, the undisputed facts establish that Resident 3 did not receive the care ordered by his physician.  Petitioner admits that its staff failed to provide the resident with wound care on the physician-ordered schedule.  Second, Petitioner’s skin assessment policy calls for something far more comprehensive as a weekly skin evaluation than ad hoc observations made when dressings were changed.

Finally, Petitioner argues that CMS mischaracterizes Petitioner’s skin care policy.  It asserts that the policy does not call for documenting weekly skin assessments and therefore, CMS misstates Petitioner’s duty of care.  Petitioner’s brief at 11.  According to Petitioner, the policy requires only “routine” assessments and that does not mean, necessarily, that assessments had to be performed weekly.  Id.

That is a gross mischaracterization by Petitioner of its own policy.  Notwithstanding Petitioner’s contentions, the policy explicitly requires:

A weekly comprehensive “head to toe” assessment conducted by licensed nurse on all patients.

CMS Ex. 7 at 1 (emphasis added).

Petitioner argues that it is entitled to challenge the scope and severity of CMS’s noncompliance findings.  Petitioner’s brief at 12-13.  This argument is incorrect.

CMS found that the noncompliance harmed Residents 1 and 3.  However, that finding is not a necessary element of my decision nor does Petitioner have a right to challenge it.

I have explained why a finding of actual harm is not a prerequisite to finding noncompliance.  All that is needed to find noncompliance is for the undisputed facts to demonstrate that a facility’s deficiency or deficiencies potentially caused residents to sustain harm.  Thus, a meaningful possibility that harm may result from deficient care suffices to establish substantial noncompliance, even without facts showing that residents sustained harm.  The potential for harm to residents is evident in the undisputed facts of this case.

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The regulations governing hearings in cases involving nursing facility noncompliance make it clear that, generally, a facility may not challenge the scope and severity of a noncompliance finding.  42 C.F.R. § 498.3(b)(14).  The exceptions to this general rule allow a skilled nursing facility to challenge a finding of immediate jeopardy level noncompliance or a finding of substandard care, but in the latter instance, only where the finding of substandard care results in the facility’s loss of authority to conduct a NATCEP. 

There was a finding of substandard care in this case and Petitioner did lose its authority to conduct a NATCEP.  However - and importantly - the remedy that CMS imposed against Petitioner, civil money penalties of $1,345 per day for a period of ten days for a total of $13,450, caused Petitioner to lose its authority to conduct a NATCEP, whether there was a finding of substandard care or not.  In 2021, when CMS made its remedy determination, a facility lost its authority to conduct a NATCEP in any circumstance where it is assessed civil money penalties totaling $11,160 or more.  42 C.F.R. § 483.151(b)(2)(iv); 45 C.F.R. § 102.3 (2020); CMS Ex. 11 at 2, 4.  As I explain below, the penalties that CMS determined to impose in this case are justified without considering the issue of harm or whether care was substandard.  Consequently, Petitioner has no right to challenge the scope and severity of CMS’s deficiency findings. 

I find to be reasonable the remedies that CMS determined to impose.  I note that Petitioner hasn’t challenged the duration of the penalty.  It has not argued that it corrected its noncompliance earlier than CMS determined to be the case.  Therefore, the only issue before me is the amount of the civil money penalty, in this case, $1,345 per day.  

The penalty amount falls within the lower range of daily civil money penalties that CMS may impose, the range that is reserved for noncompliance that is substantial but that does not put residents at immediate jeopardy.  42 C.F.R. § 488.438(a)(i)(ii); 45 C.F.R. § 102.3 (2020). 

In deciding whether the penalty amount is reasonable I must look at factors described at 42 C.F.R. §§ 488.438(f)(1)-(4) and 488.404 (incorporated by reference into 42 C.F.R. § 488.438(f)(3)).  These factors include the seriousness of a facility’s noncompliance, its compliance history, and its culpability.  A facility may also argue that its financial condition should mitigate the penalty amount. 

The penalty amount that CMS determined to impose is quite low.  It is approximately one-fifth of the maximum daily penalty that may be imposed for noncompliance that is not at the immediate jeopardy level.  See 45 C.F.R. § 102.3.5   I find that this low penalty

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amount is amply justified by the seriousness of Petitioner’s noncompliance.  These two residents were sick and vulnerable and wholly dependent on Petitioner’s staff for their physician-ordered care.  The residents had no recourse if the staff failed to discharge their duties.  Whether or not the dereliction of care caused the residents’ wounds to worsen, it put those residents at risk that the wounds would worsen and left those residents helpless but to accept that risk.

Petitioner argues that it had a good compliance history prior to it being found to be noncompliant and that it was not culpable for the noncompliance.  Petitioner’s brief at 15-16.  As I have stated, the seriousness of the noncompliance in this case is more than enough to justify the low penalty amount that CMS determined to impose.

Petitioner has not offered evidence showing that it lacks the wherewithal to pay the penalties that CMS imposed.

1. Additionally, Petitioner loses its authority to conduct a nurse aide training and competency evaluation program (NATCEP).  42 C.F.R. § 498.3(b)(14).
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2. Resident 1 averred to a surveyor that she had not been provided with ordered wound care.  CMS Ex. 16 at 5 ¶ 15.  This assertion is hearsay.  However, it is corroborated by the absence of any treatment record showing that the care was provided and by the failure of Petitioner to produce testimony asserting that the resident received wound care per the physician’s order.
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3. Moreover, the failure to document care, even had it been performed, violated professional practice standards and, consequently, the requirements of 42 C.F.R. § 483.25.  It is a widely recognized standard of nursing care that nursing staff carefully document the care that they provide.  CMS Ex. 12 at 2; CMS Ex. 16 at 7 ¶ 24.  Petitioner’s own policies reiterate that standard of care.  CMS Ex. 8 at 2.
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4. CMS manuals can be found online at https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Internet-Only-Manuals-IOMs (last visited May 18, 2022).
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5. The version of the regulation in effect on November 4, 2021, when CMS made its remedy determination, provided for a maximum non-immediate jeopardy level penalty amount of $6,695 per day.  85 Fed. Reg. 2870 (Jan. 17, 2020).
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