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                              Palm Gardens Center for Nursing and Rehabilitation, DAB CR5835 (2021)
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Palm Gardens Center for Nursing and Rehabilitation, DAB CR5835 (2021)








  
  
    

  
      
Department of Health and Human Services 
    DEPARTMENTAL APPEALS BOARD
          Civil Remedies Division





Palm Gardens Center for Nursing and Rehabilitation,
(CCN: 33-5328),
Petitioner,

v.

Centers for Medicare & Medicaid Services.
Docket No. C-18-1353Decision No. CR5835March 23, 2021

        
              
    

      DECISION

I grant summary judgment in favor of the Centers for Medicare & Medicaid Services (CMS), sustaining its determination that Petitioner, Palm Gardens Center for Nursing and Rehabilitation, a skilled nursing facility, failed to comply substantially with Medicare participation requirements.  I find that Petitioner’s deficiencies included an immediate-jeopardy-level failure to comply with a regulatory requirement.  I sustain CMS’s remedy determinations, including the imposition of a civil money penalty of $8,899 for each day of a period that began on June 14, 2018 and that ran through June 17, 2018.  I also sustain CMS’s determination to impose a non-immediate jeopardy level penalty of $105 per day, beginning June 18, 2018.  For reasons that I discuss below, I find that this penalty should run through July 30, 2018 rather than August 20, 2018, as was originally determined by CMS.

I. Background

I received this case very recently as a transfer from the docket of another administrative law judge.  I learned upon reviewing the record that CMS had filed, and that Petitioner had replied to, a motion for summary judgment.  In support of its motion CMS filed 19 proposed exhibits that it identified as CMS Ex. 1-CMS Ex. 19.  In replying, Petitioner filed 23 proposed exhibits that it identified as P. Ex. 1-P. Ex. 23.

Page 2

Petitioner filed objections to many of CMS’s proposed exhibits, objecting to these exhibits primarily on the ground that they contain hearsay.  It is unnecessary that I rule on these objections or to admit exhibits into evidence inasmuch as I base my decision in this case on undisputed material facts.  I cite to some exhibits in this decision, but only to illustrate facts that are undisputed.

II. Issues, Findings of Fact and Conclusions of Law

**A. Issues**

The issues are whether Petitioner failed to comply substantially with Medicare participation requirements, whether its noncompliance with any requirement was so egregious as to comprise immediate jeopardy for residents of Petitioner’s facility, and whether CMS’s remedy determinations are reasonable.

**B. Findings of Fact and Conclusions of Law**

In deciding a motion for summary judgment my task is to decide whether the moving party’s arguments are supported by undisputed material facts.  I do not resolve fact disputes.  I must deny the motion if a potentially outcome-determinative fact allegation is legitimately in dispute.

I find that there are core facts – outcome determinative – that are not in dispute in this case.  I predicate my decision exclusively on these undisputed facts.  However, in deciding the case I have also reviewed all of the fact allegations made by Petitioner in opposition to the motion for summary judgment.  I accept each of these allegations as true for purposes of deciding the motion.  As I explain below, those allegations do not derogate from my findings.

Petitioner also made arguments that are legal in nature.  I address each of these arguments in this decision.  I find them not to be meritorious.

CMS alleges that Petitioner failed to comply with two regulatory requirements.  First, it alleges that Petitioner did not comply with requirements stated at 42 C.F.R. § 483.25(i).  This section requires that a skilled nursing facility ensure that any resident requiring respiratory therapy is provided such care consistent with professional standards of practice, the resident’s plan of care, and the resident’s goals and preferences.  This regulation incorporates another regulation by reference, 42 C.F.R. § 483.65.  The latter regulation mandates, among other things, that a facility provide respiratory therapy to a resident if such therapy is required by the resident’s plan of care.

Second, CMS asserts that Petitioner failed to comply with the requirements of 42 C.F.R. § 483.12(c)(1), (4).  This regulation requires that a facility report to appropriate

Page 3

authorities, immediately, but no later than two hours, all allegations of abuse, neglect, exploitation or mistreatment that result in serious bodily injury to a resident or residents.

The heart of CMS’s case – including its allegation of immediate jeopardy level noncompliance – centers on Petitioner’s alleged noncompliance with 42 C.F.R. § 483.25(i).  I address this alleged noncompliance first, including CMS’s allegations and Petitioner’s defenses.  I address Petitioner’s alleged noncompliance with 42 C.F.R. § 483.12(c)(1), (4) subsequently.  Finally, I explain why I decide that CMS’s remedy determinations are reasonable.

**1. Noncompliance with 42 C.F.R. §** **483.25(i)**

I find the following material facts relating to Petitioner’s alleged noncompliance with the requirements of 42 C.F.R. § 483.25(i) to be undisputed:

Petitioner’s staff provided care to two residents of Petitioner’s facility identified as Resident # 1 and Resident # 2.  Resident # 1 was admitted to Petitioner’s facility on December 10, 2014, with diagnoses that included chronic obstructive pulmonary disease and acute respiratory failure.  CMS Ex. 4.  The resident required a ventilator to assist in breathing and was on full ventilator use.  CMS Ex. 5.
	Resident # 2 was admitted to Petitioner’s facility on May 13, 2014, with diagnoses that included acute and chronic respiratory failure.  CMS Ex. 12.  The resident was dependent on a ventilator for respiration.  CMS Ex. 13.
	Neither Resident # 1 nor Resident # 2 was capable of breathing for a prolonged period unassisted by a ventilator.
	I take notice that a ventilator is a machine that is powered by electricity and that physically assists an individual who suffers from respiratory failure to breathe.  At Petitioner’s facility ventilators were operated and maintained by respiratory therapists who received special training in the maintenance and use of these machines.
	Petitioner had a policy that directed that an “operational verification procedure” (OVP) be performed periodically on the ventilators that were in use at Petitioner’s facility.  OVP is a process intended to establish whether a ventilator is functioning properly after the machine is cleaned and reassembled.  CMS Ex. 11 at 1.  Pursuant to this policy a respiratory therapist would make rounds at Petitioner’s ventilator unit every eight hours to check the ventilators and to assure that the settings on the ventilators corresponded with the residents’ physicians’ orders.  P. Ex. 20 at ¶ 19.Page 4

Petitioner’s policy directed a respiratory therapist to perform a circuit check on a ventilator as part of OVP.  To accomplish this the therapist would briefly deactivate the ventilator.  The resident would not receive the assistance of the ventilator while the circuit check was being performed.  The policy gave specific instructions for performing the circuit check.  CMS Ex. 11 at 2.  Once the circuit check was accomplished, Petitioner’s policy directed the respiratory therapist to restart the ventilator by performing the following steps:  (1) activate ventilation (restart the ventilator); (2) check the resident for chest rise and bilateral breath sounds; (3) check for peak pressure rise and fall; and (4) do a final ventilator check in order to confirm a safe connection.  *Id.*
	Restarting the ventilator means more than simply turning the machine on.  A ventilator can be “on” and in “standby condition,” meaning that the machine is activated but that it is not performing its designed function of mechanically assisting a resident to breathe.  P. Ex. 20 at ¶ 30.  In the standby condition a ventilator is not ventilating – it is not cycling oxygen through the resident’s lungs.  *Id.*  Even when the ventilator is in the “on” condition, an operator must press a restart button in order that the ventilator cease being in standby condition and commence its designed function of cycling oxygen.
	The manufacturer’s instructions for maintenance of the ventilators in use at Petitioner’s facility included check lists designed to ensure that the ventilators were maintained properly.  CMS Ex. 11 at 3-4.  Petitioner did not incorporate these check lists into its own ventilator policy.  Petitioner did not use a check list to assure that ventilators were not only “on” but were actually ventilating after the respiratory therapist completed OVP.
	To an untrained observer, a ventilator that is “on” and in standby condition might appear to be functioning.  The ventilator’s screen would be illuminated, and the fields (effectively, gauges) would be populated with numbers and other information.  P. Ex. 20 at ¶ 38.
	Nurses and other professional staff at Petitioner’s facility who provided care to residents who were assisted by mechanical ventilators were not trained to distinguish between a ventilator that is “on” but in standby condition and a ventilator that is actually ventilating.  *See*P. Ex. 20 at ¶ 38.  When attending to a resident they would have seen an illuminated ventilator screen and might assume from that observation that the ventilator was ventilating even if the ventilator was in standby condition.  *See Id.*
	Shortly before 5 p.m. on June 4, 2018, a respiratory therapist performed OVP on the ventilator being utilized by Resident # 1.  CMS Ex. 7 at 1.  The respiratoryPage 5

therapist turned the ventilator back on after performing OVP but left the machine in standby condition.  P. Ex. 20 at ¶ 30.  Consequently, the ventilator was not ventilating Resident # 1 after completion of OVP.
	Shortly after 6 p.m. on June 4, Petitioner’s staff observed Resident # 1 to be “ashen gray” and unresponsive.  The respiratory therapist restarted the resident’s ventilator and attempts were made to resuscitate the resident.  CMS Ex. 8 at 9; P. Ex. 20 at ¶ 30.  These attempts failed and the resident was pronounced dead at about 7 p.m. on June 4.  CMS Ex. 8 at 11.
	At around 4:30 p.m. on June 4, 2018, the respiratory therapist performed OVP on the ventilator being utilized by Resident # 2.  As with Resident # 1, the therapist left the machine in standby condition.  P. Ex. 20 at ¶ 31.  The ventilator was not ventilating Resident # 2 after completion of OVP on June 4.
	At about 6:30 p.m. on June 4, Resident # 2 was observed to be without vital signs.  CMS Ex. 16 at 7.  The ventilator was restarted, and unsuccessful efforts were made to resuscitate Resident # 2.  The resident was pronounced dead at about 7:15 p.m. on June 4.  *Id.*
	A licensed practical nurse entered and left Resident # 1’s room twice during the period of time between the failure to restart Resident # 1’s ventilator on June 4, 2018 and when the resident was observed to be unresponsive.  CMS Ex. 18 at 1-2.  The nurse did not observe that the resident’s ventilator was in standby condition and not ventilating the resident.
	A licensed practical nurse entered and left Resident # 2’s room three times during the period of time between the failure to restart the resident’s ventilator on June 4, 2018 and when the resident was observed to be unresponsive.  CMS Ex. 18 at 2.  The nurse did not observe that Resident # 2’s ventilator was in standby condition and not ventilating the resident.These undisputed facts amply support CMS’s contention that Petitioner failed to provide its residents with vital respiratory services.

The only reasonable conclusion that I can draw from these facts is that on June 4, 2018, two of Petitioner’s residents – each dependent on ventilation for survival – were left without that support due to human error.  The failure to ventilate these residents caused the residents’ death.  But, even if that is not the case, the failure to ventilate violated the residents’ plans of care and their physicians’ orders and left the residents at great risk for dire consequences, including death.

Page 6

The failures that occurred on June 4 were not simply the failures by a respiratory therapist to restart two ventilators after performing OVP.  The undisputed facts unequivocally establish that there was a fundamental failure by Petitioner and its staff to ensure that residents who were dependent on ventilators not be put in harm’s way, either due to human error or to some mechanical failure by the ventilators.  These residents were dependent on the ventilators’ assistance for their survival.  They were at risk for grave consequences if they were not ventilated.  However, in the interval between the respiratory therapists’ rounds, no nurse on Petitioner’s staff was instructed to ascertain during their visits to residents’ rooms whether the ventilators were actually ventilating the residents.

Petitioner did not train its nurses to distinguish between a ventilator that was “on” and in standby condition and one that was actually ventilating a resident.  The consequence – as Petitioner acknowledges – is that a nurse could attend to a resident with a non-performing ventilator and never know that the ventilator was not functioning as prescribed.

The catastrophes experienced by Residents #s 1 and 2 might not have occurred, even accounting for the negligence of the respiratory therapist on June 4, 2018, had Petitioner’s nursing staff been trained to at least observe whether the residents’ ventilators were actually ventilating.  Nurses attended to each of these residents multiple times between the therapist’s failure to restart the ventilators and the first observations that the residents were nonresponsive.  The fact that Petitioner’s nurses were not trained is no basis for me to infer that they could not have been trained.  There are no facts to show that training a nurse to observe whether a ventilator was actually ventilating a resident would have been something beyond the nurse’s capabilities and level of skill.  Indeed, Petitioner provided its nurses with precisely this training after the events of June 4 had been discovered by state agency surveyors and Petitioner had been cited for noncompliance.  P. Exs. 11, 13.

There was also a defect in Petitioner’s written policy for performing OVP.  Petitioner failed to develop or implement a check list to assure that ventilators were actually operating and ventilating residents after respiratory therapists completed OVP.

The undisputed facts direct a finding that Petitioner’s noncompliance with 42 C.F.R. § 483.25(i) was so egregious as to comprise immediate jeopardy for Petitioner’s residents.1
  The term “immediate jeopardy” means noncompliance that causes, or is likely

Page 7

to cause, a resident or residents to suffer serious injury, impairment, harm, or death.  42 C.F.R. § 488.301.  Here, the undisputed facts strongly support a finding that deficient care led directly to the deaths of two of Petitioner’s residents.  However, even if that weren’t the case, these facts unequivocally support a finding that there was a likelihood that the deficient care would seriously injure these residents at the least.  These residents had been determined to be dependent on ventilation for survival.  Physicians ordered that these residents be ventilated because of their life-threatening respiratory problems.  The residents’ plans of care transmitted these orders to Petitioner’s staff.  Axiomatically, depriving these residents of ventilation created a likelihood of grave consequences.

Moreover, the jeopardy that existed at Petitioner’s facility was not confined to the consequences suffered by just two residents.  As I have discussed, there was a fundamental defect in Petitioner’s system of surveillance of ventilated residents.  Under Petitioner’s system residents receiving ventilation could go for hours without staff verifying that ventilators were actually ventilating them.

Petitioner does not dispute any of the facts that I have cited.  Indeed, I have drawn on facts offered by Petitioner to state the material facts of this case.  Petitioner’s central argument, resting on the undisputed facts, is that the events of June 4, 2018, were unforeseeable:

An “unknown unknown” is a risk that is impossible to imagine in advance, an unfathomable uncertainty.  Because it is unimaginable and unknown, it is impossible to manage it, to foresee it, or to prevent it.  This is the essence of unavoidability.  This is what happened here.

Petitioner’s Pre-hearing Brief in Support of Its Appeal and Opposition to CMS’s motion for summary judgment (Petitioner’s brief) at 1.  Petitioner elaborates on this assertion by contending that this case involves two “unknown unknowns”:  “the unlikely improbability ***not only*** that an experienced licensed respiratory therapist would conduct routine ventilator circuit checks without restarting the ventilation at the end, ***but also*** that the error would be undetectable to experienced nurses because the residents would continue to breathe spontaneously without exhibiting signs or symptoms.”  *Id.* at 1-2.  Petitioner characterizes this scenario that it portrays as “impossible to imagine.”  *Id.* at 2.

However, the fact that an event or a combination of events is unlikely doesn’t make that event or combination unforeseeable.  The undisputed facts do not provide support for a conclusion that Petitioner could not have envisioned the events that occurred on June 4, 2018, or other events, such as an unforeseen equipment failure, that would have resulted in loss of ventilation to residents, and protected its residents against those possibilities.

As I have discussed, the system employed by Petitioner did not require its respiratory therapists to complete a check list to assure that a ventilator, once serviced, would be

Page 8

restarted.  That was a flaw that may have contributed directly to what happened on June 4, 2018.  Furthermore, and as Petitioner acknowledges, the nurses on its staff were not trained to ascertain whether ventilators were actually ventilating residents.  Absent such training, residents were left entirely at the mercy of respiratory therapists to assure that the residents were actually being ventilated.  That left hours each day when residents were left at risk for equipment failure or for the events that occurred here, their ventilators turned off due to human error.

Petitioner discusses at length the policies and procedures that it employed to manage operation of ventilators.  Petitioner’s brief at 5-8.  It asserts that its nursing department had a system in place to monitor residents receiving ventilator care.  According to Petitioner, licensed nurses and respiratory therapists enter each resident’s room on an hourly basis to conduct visual rounds.  *Id.* at 7.  It contends that during the visual rounds, the nurse or respiratory therapist observes the resident’s color and breathing, identifies environmental needs, and observes the status of ventilator alarms, tracheostomy placement, and safety interventions.  *Id.* at 7-8.  Petitioner contends that this system assures that residents on ventilators are protected against unforeseen mishaps.

Granting that Petitioner’s policy provided for this protection, it clearly was not implemented for Residents #s 1 and 2 on June 4, 2018.  The residents were visited by nurses – twice, in the case of Resident # 1 and three times in the case of Resident # 2 – during the interval between the ventilators being placed on standby condition and the subsequent discovery of the residents in a non-responsive state.  The nurses did not observe that the ventilators were not ventilating the residents.  Indeed, Petitioner expressly acknowledges that.

Petitioner argues that its nurses were trained to observe residents’ vital signs and that the two residents whose care is at issue displayed no changes after the ventilators were put in standby condition that would have alerted the nurses to the possibility that the ventilators were not actually functioning.  Petitioner’s brief at 12.  I accept Petitioner’s representation as true for purposes of deciding CMS’s motion for summary judgment.2
  However, the fact that the residents may have looked ok to the nurses – i.e., they were breathing – does not justify the nurses’ failure to observe that the residents’ ventilators were not ventilating the residents.  As I have concluded, the nurses should have had at

Page 9

least the minimal training to be able to ascertain whether the ventilators were actually functioning.  The undisputed facts establish that they lacked that training.

Indeed, the fact that the residents appeared to the nurses to be stable for the two hours between their ventilators being put in standby condition and the residents being discovered unresponsive underscores the need for all of Petitioner’s professional staff – not just respiratory therapists – to be trained to be able to ascertain whether the ventilators were actually ventilating residents.  Because, if the residents’ physical appearance would furnish no clue as to their possibly deteriorating condition, then knowing whether their ventilators were functioning became critical.

Petitioner does not assert that it would have been impossible or even difficult to provide its nurses with the basic training necessary to ascertaining whether residents’ ventilators were ventilating residents.  Rather, Petitioner asserts that such training was not a necessary measure because the events of June 4, 2018 were unforeseeable.  Petitioner’s brief at 13-14.  As I have stated, I emphatically disagree with Petitioner’s characterization of the events as unforeseeable.  Human error is foreseeable, and Petitioner could have protected against that foreseeable possibility.

Petitioner cites Departmental Appeals Board (the Board) decisions that impose on facilities the duty to consider what accidents and hazards might be foreseeable and to protect its residents against them.  *E.g.*, *Woodstock Care Ctr.,*DAB No. 1726 at 25-35 (2000), *aff’d*, *Woodstock Care Ctr. v. Thompson*, 363 F.3d 583 (6th Cir. 2003).  In *Woodstock*and in many other cases the Board imposed a very stringent requirement on facilities to protect their residents against accidents and accident hazards.  It is true that the applicable standard does not impose strict liability on facilities.  However, *Woodstock*and related cases require facilities to consider all possibilities of accidents, to identify all foreseeable hazards, and to protect residents against them.

There are no facts to suggest that Petitioner could not have foreseen the errors that occurred on June 4, 2018.3
  More than that, Petitioner should have foreseen that problems can develop with ventilators in between maintenance by respiratory therapists.  Assuring that ventilators are actually functioning after completing OVP is a necessary element of the job description of a respiratory therapist and failure to do so constitutes a failure by the therapist to perform a basic – and from the resident’s perspective, absolutely vital – task.  And, while it would not be reasonable to require nurses to have the level of training and skill acquired by a respiratory therapist, it was necessary that the nurses at

Page 10

Petitioner’s facility should know, at a minimum, whether the ventilators were actually ventilating residents.

Petitioner argues that CMS disingenuously asserts that Petitioner should have trained its nurses to recognize whether a ventilator is on or off.  Petitioner’s brief at 15.  Petitioner contends that, in fact, its nurses *can* recognize when a ventilator is off, because when the ventilator is turned off, its panel lights are out.  That assertion – which I accept as true – begs the question.  It is obvious that the nurses needed to know more than whether a ventilator was “on.”  They needed to know whether the machine was actually ventilating a resident and not simply in standby condition.  As I have stated, there are no facts from which I might infer that the nurses could not have been trained to recognize the distinction between “standby” and ventilating.

In fact, and as Petitioner points out, nurses at Petitioner’s facility did receive some training about ventilator operation.  Nurses at Petitioner’s facility, for example, averred that they were competent to compare the settings on ventilator screens to what physicians had ordered.  Petitioner’s brief at 16.  The nurses were trained to be able to assess the information displayed on ventilators but not to manipulate ventilator settings.  *Id.*  The only reasonable inference that I can draw from these facts is that it would have not been a bridge too far for Petitioner to have trained its nurses to be able to distinguish between a functioning ventilator and one that was in standby condition.

Furthermore, and as I discuss above, Petitioner provided such training to its nurses after June 4, 2018.  Evidence offered by Petitioner shows that it developed lesson plans to teach its nurses precisely what the nurses should have known prior to June 4.  P. Exs. 11, 13.

Petitioner claims that there is a dispute as to whether its noncompliance, assuming that noncompliance existed, comprised immediate jeopardy.  Petitioner asserts that no immediate jeopardy exists because it “did what it was supposed to do:  hire qualified, well trained, experienced professionals; develop and implement reasonable and prudent policies to care for ventilator-dependent residents; and train its staff in the policies and procedures.”  Petitioner’s brief at 18.

I accept as true all of the facts offered by Petitioner concerning its staffing, its policies, and the training that it gave to its staff.  They do not address the jeopardy that existed here.  The flaws in Petitioner’s policy and the failure to train nurses to identify whether ventilators were in standby condition or were ventilating at the least put residents at risk of serious injury or death.  That is the essence of immediate jeopardy.

Petitioner also asserts that it was not “culpable” because it had “systems in place to care for ventilator residents.”  Petitioner’s brief at 18.  It asserts that these systems were all

Page 11

that were necessary to anticipate and protect residents against any problems or malfunctions that might occur.

This assertion notwithstanding, the undisputed facts establish that the incidents that occurred on June 4, 2018, were foreseeable.  I do not suggest that Petitioner’s failures to consider the possibility that human error might leave ventilator-dependent residents without ventilation or to provide backup training to its nurses to enable them to determine whether ventilators were actually ventilating were willful failures by Petitioner.  However, these failures were just as damaging to residents’ health and safety as if they had been willful.  There is nothing in the definition of immediate jeopardy to suggest that willfulness is a necessary element of such noncompliance.  *See*42 C.F.R. § 488.301.

**2. Noncompliance with 42 C.F.R. §** **483.12(c)(1), (4)**

CMS asserts that the deaths of Residents #s 1 and 2 on June 4, 2018, imposed on Petitioner’s management the duty to report immediately the deaths and their circumstances to appropriate authorities, because staff neglect of these residents was clearly an apparent cause of these deaths.  However, the deaths and surrounding circumstances were not reported to Petitioner’s administrator until June 6 and to Petitioner’s director of nursing until June 7.  CMS Ex. 18 at 8.  Appropriate state authorities were not notified until June 7, 2018.  Petitioner did not notify local law enforcement authorities of the deaths.  CMS Ex. 19 at ¶ 41.

Petitioner does not deny the facts relied on by CMS.  It concedes that its failure to report the events of June 4 immediately comprise a technical violation of regulatory requirements.  However, it contends that the facts do not support a conclusion that its failures to report had the potential for causing more than minimal harm to residents of its facility.

I disagree.  The purpose of the regulatory reporting requirement is to assure that independent and impartial entities may promptly investigate serious episodes of possible neglect, abuse, or mistreatment of residents.  Implicit in this requirement is recognition that facilities’ self-interest may interfere with or corrupt the thorough investigation of serious events.  That is precisely why facilities *must* immediately report such events.  There is no regulatory exception for a good faith failure to do so.  Potential harm follows necessarily from the failure to report timely.

**3. Reasonableness of Remedies**

CMS imposed civil money penalties of $8,899 for each day of the period running from June 14 through June 17, 2018.  CMS predicated these penalties on its finding of immediate-jeopardy-level noncompliance and its conclusion that Petitioner did not revise its OVP policy and train its nurses on recognition of ventilator status until June 18.  CMS

Page 12

additionally imposed civil money penalties of $105 for each day of the period running from June 18 through August 20, 2018, grounded on its conclusion that Petitioner did not fully rectify non-immediate-jeopardy-level noncompliance until August 20.

Regulations establish criteria for deciding whether civil money penalty amounts are reasonable.  Those criteria include the seriousness of noncompliance, a facility’s compliance history, its culpability for noncompliance, 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)).

CMS offered no evidence as to Petitioner’s performance history or its culpability and Petitioner has not offered evidence relating to its financial condition.  Petitioner argues that it has an excellent performance history and that it should not be found culpable for its noncompliance.  Consequently, according to Petitioner, the penalty amounts are excessive.  Additionally, Petitioner challenges the duration of both the immediate jeopardy level and the non-immediate jeopardy level penalties.

I find the immediate jeopardy level penalties imposed by CMS to be reasonable in amount and duration.  I base my conclusion solely on the seriousness of the noncompliance.  For purposes of summary judgment, I accept as true Petitioner’s assertions of its compliance history.  Furthermore, I agree that Petitioner was not willfully noncompliant.

The immediate-jeopardy-level noncompliance nonetheless was serious.  Two residents died or at the very least were put at extreme risk due to obvious flaws in Petitioner’s policy and its system for assuring that residents on ventilators received ventilation.  That level of seriousness merits serious penalties.  I note that the immediate jeopardy penalty amount is modest, comprising less than one-half of the maximum penalty amount that CMS might have imposed.  42 C.F.R. § 488.438(a)(1); 45 C.F.R. § 102.3 (2017) (providing an upper-level CMP range of $6,394 to $20,965 per day).

CMS based its duration findings for its immediate jeopardy level penalties on its conclusion that Petitioner did not complete in-service training of its nurses and revise its OVP policies prior to June 17, 2018.  Petitioner disputes that finding.  However, the undisputed facts relied on by Petitioner support CMS’s determination of duration of immediate jeopardy level noncompliance.  Petitioner did not prepare a lesson plan to teach its nurses about ventilator function until June 14, 2018.  P. Ex. 11.  It did not prepare a lesson plan to teach its nurses about the need to assess residents after “circuit change” (which, I infer, is maintenance of the ventilator by a respiratory therapist) until June 16, 2018.  P. Ex. 13.  Petitioner notified state agency authorities of completion of in-service training on June 18, 2018.  P. Ex. 21 at ¶ 23.

Page 13

I do not find that the undisputed facts support CMS’s assertion that non-immediate jeopardy level noncompliance persisted at Petitioner’s facility until August 20, 2018.  CMS imposed daily penalties of $105 based on that determination.  CMS offered no explanation of the August 20 end date.  By contrast, Petitioner provided undisputed facts to show that it attained compliance by July 31, 2018.  I accept this assertion as true in the absence of any countervailing facts.  Consequently, I sustain civil money penalties of $105 per day for each day of a period running from June 18 through July 30, 2018.


          /s/
        Steven T. Kessel

                      Administrative Law Judge
      1. If I were to hold an evidentiary hearing Petitioner’s burden would be to prove that a finding of immediate jeopardy level noncompliance is clearly erroneous.  Here, however, I decide the case based on undisputed facts.  From the facts presented by the parties there are no facts from which I could infer or conclude that Petitioner’s noncompliance with 42 C.F.R. § 483.25(i) was at a less egregious level than immediate-jeopardy-level noncompliance. back to note 1
                      2. That said, it strikes me as highly unlikely that the residents would have shown no significant changes in their vital signs during the approximately two-hour period between their ventilators being put in standby condition and the residents’ being observed to be nonresponsive.  For example, I find it hard to believe that the residents’ blood oxygenation levels would have remained acceptable and constant during this period, had the nurses checked them.  Petitioner offered no records to show that the nurses checked and recorded the residents’ blood oxygen levels. back to note 2
                      3. Petitioner argues that the therapist who committed the errors on February 4, 2018 had an unblemished employment record and furthermore, nothing like these errors had occurred previously.  I accept those assertions as true.  However, that history doesn’t excuse Petitioner’s staff from envisioning the possibility that simple human mistakes, such as those occurring here, could happen. back to note 3 Back to top
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