St. John of God Retirement and Care Center, DAB CR5290 (2019)

Department of Health and Human Services
Civil Remedies Division

Docket No. C-18-460
Decision No. CR5290


I sustain the determination of the Centers for Medicare & Medicaid Services (CMS) to impose remedies against Petitioner, St. John of God Retirement and Care Center, a skilled nursing facility, consisting of: a $10,000 per-instance civil money penalty; and, a denial of payment for new Medicare admissions for a period that began on November 14, 2017, and that ran through December 17, 2017.

I. Background

I held an in-person hearing in this case by video teleconference on January 11, 2019.  Prior to the hearing I received exhibits from CMS that it identified as CMS Ex. 1-CMS Ex. 22.  I received exhibits from Petitioner that it identified as P. Ex. 1, P. Ex. 2, P. Ex. 4-P. Ex. 6, and P. Ex. 8-P. Ex. 17.  I excluded exhibits from Petitioner that it identified as P. Ex. 3 and P. Ex. 7.

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II. Issues, Findings of Fact and Conclusions of Law

A. Issues

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

B. Findings of Fact and Conclusions of Law

CMS contends that Petitioner failed to comply substantially with 42 C.F.R. §§ 483.24 and 483.25, regulations that govern the quality of life, nursing care, and other services that a skilled nursing facility must provide to its residents.  CMS contends that Petitioner did not provide one of its residents, an individual identified as Resident 1, with the necessary care and services to “attain or maintain the highest practicable physical, mental, and psychosocial well-being” in accordance with that resident’s assessed needs and consistent with the applicable standards of nursing care and practice.  42 C.F.R. § 483.24; see 42 C.F.R. § 483.25.

CMS asserts that Resident 1 manifested a significant change in his clinical condition beginning at about one a.m. on March 17, 2017, when a licensed vocational nurse observed the resident to be breathing loudly.  CMS argues that, while the staff administered oxygen to the resident and gave him medication intended to ease his breathing (Albuterol), the staff failed to observe and document the resident’s vital signs and mentation, failed to perform any of the requisite assessments of the resident’s condition, and failed to consult with the resident’s physician.  These failures, CMS contends, violated professional nursing standards, Petitioner’s policy, and regulatory requirements.

The evidence overwhelmingly supports CMS’s assertions.  Petitioner’s staff failed to perform necessary assessments of Resident 1’s condition from one a.m. until about five a.m. on March 17, 2017, and failed to consult with the resident’s physician.  By five a.m., the resident’s condition had deteriorated markedly.  Paramedics transported him to a hospital where he expired several hours later.

Resident 1 was a severely debilitated individual whose medical conditions included dementia, the aftereffects of a stroke, and dysphagia (difficulty swallowing).  CMS Ex. 7.  Shortly prior to March 17 the resident had suffered an episode of sepsis and had been hospitalized in an acute care hospital.  CMS Ex. 15 at 1.  The resident was totally dependent on Petitioner’s staff for activities of daily living.  CMS Ex. 16 at 17-18, 25, 34.

At about one a.m. on March 17, a licensed vocational nurse, Raphael Morales, observed that the resident had “loud breathing.”  Mr. Morales noted that the resident’s oxygen saturation level was below normal at 90 percent.  CMS Ex. 9 at 1.  Mr. Morales elevated

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the head of the resident’s bed, presumably to ease his breathing, and administered supplementary oxygen to the resident at a flow rate of two liters per minute.  Id.  Mr. Morales advised the registered nurse who was on duty of his actions.  CMS Ex. 22 at 3 (¶ 7).

Neither the registered nurse nor Mr. Morales checked the resident’s vital signs.  There is no record of the resident’s pulse, his respiration, or his blood pressure.  Nor did the registered nurse or Mr. Morales assess the resident’s mental condition.  Furthermore, neither Mr. Morales nor anyone else on Petitioner’s staff attempted to consult with Resident 1’s treating physician about the resident’s breathing difficulties.

Resident 1 clearly manifested a significant change in his clinical condition at one a.m.  The resident’s loud breathing and his below-normal oxygen saturation level signified that he was in respiratory distress.  Mr. Morales admitted this in his testimony.  Hearing Transcript (Tr.) at 98-99.  Moreover, Mr. Morales’ actions when he first encountered the resident at one a.m. on the 17th of March – elevating the head of the resident’s bed and administering oxygen and Albuterol – are consistent with and corroborate his testimony that the resident’s condition had changed significantly.

What care should Petitioner’s staff have provided to Resident 1?  Nursing standards of care, Petitioner’s own policy, and regulatory requirements demand that Petitioner’s staff take the resident’s vital signs, assess the resident’s condition, and consult with the resident’s treating physician.  Petitioner’s staff took none of these actions.

The staff should have acted urgently to assess the cause of Resident 1’s respiratory distress.  The resident’s breathing distress and his low oxygen saturation level were markers of several possible life-threatening conditions.  This resident, with a history of swallowing difficulties (dysphagia), might have aspirated (inhaled) food or liquids, constricting his airway.  CMS Ex. 13 at 1-2; CMS Ex. 21 at 3-4 (¶ 8); CMS Ex. 22 at 3-4 (¶ 9).  As another possibility, the resident may have suffered a recurrence of sepsis, a condition that, if sufficiently severe, can cause breathing difficulty.  CMS Ex. 19 at 2.

Standards of nursing care mandate that when a resident – such as Resident 1 – manifests respiratory distress a nursing staff should obtain a full set of the resident’s vital signs.  That includes checking the resident’s rate of respiration, his pulse, his temperature, his level of consciousness, and his breathing sounds.  The staff also should determine the mental state of the resident.  All of these findings should be documented.  CMS Ex. 21 at 3-4 (¶ 8); Tr. at 68-69.  Collecting the aforesaid data is absolutely critical.  A nursing staff cannot assess a resident’s condition unless and until they obtain and document that resident’s vital signs.  CMS Ex. 21 at 4 (¶ 9).

Once vital signs are obtained a registered nurse must assess the resident’s condition based on those findings.  Assessment is as critical as obtaining vital signs.  It is the assessment

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that determines the possible cause of a resident’s distress.  The assessment is the essential prologue to treatment decisions.  The record in this case makes it obvious that Resident 1 had a life-threatening medical emergency early in the morning of March 17, 2017.  Had Petitioner’s staff assessed the resident based on a thorough examination of that resident, the staff might have recommended transfer of the resident to a hospital hours before he was eventually sent there.

It was equally important, both as a matter of nursing standards and of regulatory requirement, that Petitioner’s staff consult with the resident’s physician at the first available opportunity.  CMS Ex. 21 at 4-5 (¶ 10).  In a case such as this one the physician is uniquely empowered to decide on the appropriate treatment plan.  See 42 C.F.R. § 483.10(g)(14).

Petitioner’s policy mirrors nursing standards of care and regulatory requirements.  It maintains a policy governing assessment of a resident and a change in the resident’s condition.  CMS Ex. 12 at 4.  That policy explicitly lists respiratory congestion or shortness of breath as signs of a change in condition mandating assessment.  Id.  The policy therefore constitutes a reinforcing requirement that imposes on Petitioner’s staff the duty to assess any change in a resident’s clinical condition including respiratory distress.

These failures by Petitioner’s staff – to obtain Resident 1’s vital signs, to assess the resident’s condition, to attempt to establish a cause of the resident’s breathing difficulty, and to consult with the resident’s treating physician – plainly violated applicable nursing standards as well as Petitioner’s policy.  The evidence more than supports a finding that these omissions in turn violate the regulatory requirement that Petitioner provide care of a quality that enables its residents to attain the highest possible level of well-being.  42 C.F.R. § 483.24.

Petitioner’s noncompliance was egregious.  It was not until about 5:15 a.m. on March 17, 2017, that Petitioner’s staff finally took Resident 1’s vital signs.  All of his vital signs were abnormal.  CMS Ex. 1 at 4-5; CMS Ex. 9 at 2; CMS Ex. 22 at 3 (¶ 8).  The resident manifested an abnormally fast heart rate and abnormally fast breathing, among other things.  CMS Ex. 1 at 5; CMS Ex. 9 at 2.  An hour later the resident was transferred to a hospital where he soon expired.  I cannot conclude that the resident’s condition worsened because of Petitioner’s staff’s failure to assess his condition and consult with his treating physician.  But, I do conclude that the resident was at grave risk for harm due to the failures to measure vital signs and to assess and consult.  It is reasonable to infer that, but for these failures, the staff might have recognized dangerous signs sooner and might have obtained necessary care more quickly.  Whether that would have saved the resident is speculative.  But, it is not speculative to say that the staff’s neglectful care may have caused the resident to lose the opportunity to be saved.

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Petitioner raises several arguments to justify its staff’s conduct on March 17, 2017.  I find them to be without merit.  They are unsupported by the evidence of record, not relevant, or both.

First, Petitioner makes the remarkable argument that it is impossible to determine whether Resident 1 manifested a significant change in his condition on March 17 because there is no clinical evidence of vital signs showing a marked deviation from what Petitioner asserts was the resident’s “baseline” condition.  Petitioner’s Post-Hearing Brief at 4, 5-6.  This argument is self-serving, to say the least.  Petitioner seeks, in effect, to take advantage of its staff’s failure to measure the resident’s vital signs to assert that the resident showed no clinical evidence of a change in his condition.

Petitioner’s argument notwithstanding, the record is rife with evidence that the resident experienced a significant change in his condition.  Mr. Morales’ finding that the resident manifested “loud breathing,” his decisions to elevate the head of the resident’s bed and to administer oxygen and Albuterol to the resident, and his admission at the hearing that the resident had experienced a significant change are dispositive proof of a significant change.  Petitioner’s own policy defines Resident 1’s breathing difficulties as a change of condition.

Petitioner argues that its staff did not need to document Resident 1’s vital signs because doing so was not the practice at its facility.  Petitioner’s Post-Hearing Brief at 4.  It argues, apparently, that because its staff did not document residents’ vital signs as a general rule, its staff did not need to do so in this instance.

I’ll leave aside the question of whether failure to document vital signs as a general rule violates nursing standards of practice and regulatory requirements.  It is unnecessary that I address that question, because the overwhelming evidence establishes that it was critical that this resident’s vital signs be documented on March 17, 2017.  As I have discussed, there was an urgent need for Petitioner’s staff to assess Resident 1’s condition on March 17, an assessment that the staff could not possibly have performed without documenting the resident’s vital signs.  Indeed, Petitioner’s own policy for assessing a change in a resident’s condition requires the staff to identify the underlying problems that cause a change.  CMS Ex. 12 at 4-5.  That cannot be accomplished without establishing the signs that document the change.

Petitioner also suggests that the surveyors who determined initially that Petitioner was noncompliant erred because they allegedly failed to conduct an investigation of Resident 1’s baseline clinical condition and vital signs.  Petitioner’s Post-Hearing Brief at 4.  This argument fails for two reasons.  First, the surveyors’ performance is irrelevant at this stage of the case.  This is not a case about whether surveyors did their job well or poorly.  CMS predicates its case against Petitioner based on objective evidence, including the clinical records generated by Petitioner.  If that evidence establishes prima facie

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noncompliance by Petitioner (as it does here) then Petitioner must rebut it if it is to prevail.  What the surveyors did or did not accomplish is irrelevant because in the end, it is the objective clinical evidence that establishes what Petitioner and its staff did or did not do.

Second, Resident 1’s baseline clinical condition does not suggest that the resident manifested acute breathing difficulty prior to March 17.  There are no clinical records establishing that Resident 1 suffered from breathing difficulties prior to that date apart from a finding that the resident manifested mild wheezing.  See Tr. at 63, 88-89.  Indeed, the resident’s clinical record, while it describes numerous medical conditions and problems, says next to nothing about the resident having problems breathing.  CMS Ex. 7.  In addition to Admission Records that omitted any mention of a respiratory problem, the Order Summary Reports from the weeks before the events at issue, which contained Resident 1’s physician orders, neither listed respiratory diagnoses nor prescribed respiratory treatment of any kind.  CMS Ex. 11 at 1-6; CMS Ex. 7; P. Ex. 5.  Petitioner offered no treatment records or nursing notes that establish that the resident had a history of breathing problems.  There is no evidence that the resident’s physician ever ordered that the resident receive oxygen or Albuterol.  CMS Ex. 11; Tr. at 104.

Petitioner also contends that Mr. Morales took the resident’s vital signs several times between one a.m. and five a.m. on March 17, 2017.  Petitioner’s Post-Hearing Brief at 4-5.  Petitioner cites to nothing in the resident’s clinical record to support this contention and, in fact, nothing exists.  I do not find the assertion to be credible in the absence of any documentation of the resident’s vital signs.  Furthermore, even if Mr. Morales had taken the resident’s vital signs his failure to record them would have rendered his actions meaningless.  His observations – whatever they were – would be of no value unless they were recorded in a way that enabled a registered nurse to assess the resident’s condition and to consult with the resident’s treating physician.

Petitioner argues additionally that it is speculative to assume that the resident’s physician, had Petitioner’s staff consulted him, would have ordered that Resident 1 be transferred to a hospital on March 17.  According to Petitioner:

Even if there was a significant change at 1 a.m., it is highly improbable and speculative that the attending physician would have done anything different from what was in fact done at the time, instituting ordinary conservative measures to address these minor symptoms.

Petitioner’s Post-Hearing Brief at 6.  Petitioner predicates this argument on both an incorrect legal analysis and a false premise.

Hindsight is never an excuse for failing to perform a duty of care.  One cannot legitimately say that failure to provide care may be forgiven because the failure would

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not have made a difference to the resident.  The regulations impose a specific duty on a skilled nursing facility to consult with a resident’s physician about any significant change in that resident’s clinical condition.  That duty exists whether or not the resident ultimately benefits from the consultation.  Petitioner failed to perform that duty and that is a regulatory violation.

Moreover, there is nothing in this case’s record to support Petitioner’s argument that the resident’s breathing difficulty on March 17 was “minor.”  There is nothing in the record to suggest that the resident experienced only minor breathing problems.  The staff’s failure to assess the resident’s changed condition meant that the staff had no idea how severe it was and what might have caused it.  But, one thing is clear and that is that the change observed by Mr. Morales was sufficiently severe that he decided to provide oxygen and Albuterol to the resident.  That was more than enough to trigger Petitioner’s duty to assess the resident’s condition and consult with the resident’s treating physician.

There is no way of knowing what the resident’s physician might have ordered had the staff thoroughly assessed Resident 1 and consulted with the physician in a timely manner.  The failure by Petitioner’s staff to assess and consult deprived the resident of any opportunity to benefit from consultation.

There are two remedies at issue in this case, a $10,000 per-instance civil money penalty and denial of payment for new admissions for a period running from November 14 through December 17, 2017.  I find both of these remedies to be reasonable.  Evidence amply supports them.

As I have discussed, Petitioner’s noncompliance was egregious.  It constituted a wholesale failure by Petitioner’s staff to perform their duties to Resident 1.  Indeed, the record more than supports a finding that Petitioner’s staff lacked a basic understanding of their regulatory duties and Petitioner’s own policy.  The result was to leave Resident 1 essentially unprotected from a potentially life-threatening condition.

Regulations establish criteria for determining the amount of civil money penalties.  42 C.F.R. §§ 488.438(f)(1)-(4); 488.404 (incorporated by reference into 42 C.F.R. § 488.483(f)(3)).  These factors include the seriousness of a facility’s noncompliance and its culpability.  I find that Petitioner’s noncompliance was extremely serious.  It put the life of a resident at risk.  Petitioner manifests a high level of culpability for its noncompliance.  Neither Mr. Morales nor Petitioner’s other staff members understood their duties pursuant to nursing standards of care, Petitioner’s own policy, and applicable regulations.  That amounts to a basic failure by Petitioner to educate and train its staff as to their duties.

That egregious noncompliance in this case more than justifies both the penalty amount and the denial of payment.  A per-instance civil money penalty of $10,000 is, in fact,

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trivial compared to what CMS could have imposed.  It amounts to only about half of the maximum allowable amount for a per-instance penalty.  Moreover, CMS could have, had it elected to do so, imposed per-diem penalties for Petitioner’s noncompliance, noncompliance that extended for months after the March 17 incident involving Resident 1.  Had it done so, the total penalty amounts would have been many times what CMS determined to impose.

As for the denial of payment for new admissions, that is justified by the presence of noncompliance in this case.  CMS may impose a denial of payment for any substantial failure by a facility to comply with regulatory requirements.  42 C.F.R. § 488.408(d).

Petitioner did not offer evidence that challenges the duration of the denial of payment for new admissions.  It contends that, as of October 27, 2017, CMS accepted a plan of correction from Petitioner that addressed the noncompliance findings.  However, “acceptance” of a plan of correction does not equate to a determination that proposed corrections were accomplished.  It means only that CMS accepts a facility’s proposal to fix whatever problems CMS determines may exist.  Implementation of a plan of correction is a different story entirely.  Petitioner offered no evidence whatsoever to prove that it implemented necessary corrections prior to December 17, 2017.

Petitioner argues, however, that the timing of CMS’s notice to Petitioner, dated January 17, 2018, telling Petitioner that it had abated its noncompliance effective December 17, is unfair and that it worked an unreasonable hardship on Petitioner.  Petitioner’s Post-Hearing Brief at 8-9.  It states, without offering any proof, that “[t]his refusal to prepare a timely letter . . . cost . . . [Petitioner] over a million dollars in funds.”  Id. at 8.

I have no authority to decide whether CMS abused its discretion in sending a notice to Petitioner on a particular date.  I may only decide whether there is a basis for finding incorrect CMS’s determination of the duration of noncompliance.  Here, and as I have stated, Petitioner offered no evidence that refutes CMS’s duration determination.