Park Valley Inn Health Center, DAB CR6077 (2022)

DECISION

I grant summary judgment in favor of the Centers for Medicare & Medicaid Services (CMS) sustaining the imposition of the following remedies against Petitioner, Park Valley Inn Health Care Center, a skilled nursing facility:

• A per-instance civil money penalty of $20,780;
• Civil money penalties of $12,950 for each day of a period that began on March 19, 2021, and that continued through March 21, 2021; and
• Civil money penalties of $1,350 for each day of a period that began on March 22, 2021, and that continued through March 30, 2021.

I.  Background

CMS filed a pre-hearing brief that included a motion for summary judgment and 76 proposed exhibits that it identified as CMS Ex. 1-CMS Ex. 76.  Petitioner filed a brief in opposition and six proposed exhibits that it identified as P. Ex. 1-P. Ex. 6.

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I do not receive the parties' exhibits' into evidence because I grant summary judgment based on undisputed material facts.  However, I note that neither party has objected to my receiving exhibits.  I cite to some of the 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 undisputed facts establish that Petitioner failed to comply substantially with Medicare participation requirements, whether there are facts from which I could infer that CMS's determinations of immediate jeopardy-level noncompliance are clearly erroneous, and whether CMS's remedy determinations are reasonable.

B. Findings of Fact and Conclusions of Law

CMS made determinations of noncompliance and to impose remedies based on the surveyors' findings at three surveys of Petitioner's facility, completed on January 8, 2021, January 25, 2021, and March 30, 2021.  Petitioner no longer challenges the noncompliance determination resulting from the January 8, 2021 survey and the $5,000 per-instance penalty that CMS imposed.  Petitioner's Pre-hearing Brief and Response to Respondent's Motion for Summary Judgment (Petitioner's brief) at 1-2.  Consequently, only the findings of noncompliance resulting from the January 25, 2021 and March 30, 2021 surveys and the remedies that CMS determined to impose based on those findings remain at issue.

1. January 25, 2021 Survey

1. Failure to Comply with the Requirements of 42 C.F.R. § 483.25(i)

The relevant regulation requires that a skilled nursing facility ensure that any resident needing respiratory care is provided with that care consistent with professional standards of practice, the resident's care plan, and the resident's goals and preferences.  CMS alleges that Petitioner's staff failed to implement an order from a nurse practitioner that a resident suffering from acute respiratory distress be administered oxygen.

The undisputed material facts support CMS's allegations.  The failure to administer oxygen to the resident, identified in the report of the January 25, 2021 survey as Resident 1, blatantly violated the requirements of 42 C.F.R. § 483.25(i).

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Resident 1 was 77 years old and had multiple illnesses.  CMS Ex. 31 at 3; CMS Ex. 34 at 1; CMS Ex. 35; CMS Ex. 38 at 10.  In early January 2021 she contracted Covid-19 (“Covid”).  I take notice that Covid is an extremely serious illness that can be lethal, especially with elderly and infirm individuals such as Resident 1.  Covid can infect an individual's lungs and cause severe or even fatal respiratory distress.

On January 5, 2021, a nurse practitioner examined Resident 1.  CMS Ex. 35 at 1.  The nurse practitioner found the resident to be experiencing a blood oxygen saturation deficiency, with oxygen saturation levels fluctuating between 88 and 90 percent.  The nurse practitioner verbally instructed a member of Petitioner's staff, a licensed vocational nurse, to provide Resident 1 with supplemental oxygen with the goal of attaining and maintaining a blood oxygen saturation level of 92 percent.  Id. at 1; CMS Ex. 69 at 2.  The nurse practitioner followed up the verbal order with a written order.  CMS Ex. 38 at 6, 51.

Petitioner's staff failed to carry out the order.  The nurse practitioner was not advised by the staff that there were any difficulties carrying out the order.  CMS Ex 35; CMS Ex. 69.  On the following day, January 6, 2021, the nurse practitioner found Resident 1 to be without supplemental oxygen and in acute respiratory distress with a blood oxygen saturation level of 70 percent.  Id.  At the nurse practitioner's direction, paramedics were summoned to transport Resident 1 to a hospital.  However, the resident was nonresponsive by the time the paramedics arrived at Petitioner's facility and was subsequently pronounced dead.  CMS Ex. 38 at 4; CMS Ex. 69 at 3.

The nurse practitioner demanded that Petitioner's staff explain why the order to provide Resident 1 with supplemental oxygen had not been carried out.  The licensed vocational nurse who had originally been ordered to administer oxygen averred that she had been unable to find an oxygen concentrator – a device used to deliver supplemental oxygen – and therefore, had not carried out the nurse practitioner's order.  CMS Ex. 35; CMS Ex. 69 at 3.  Petitioner admits that it had oxygen concentrators on hand, one of which could have been utilized to provide oxygen to Resident 1.  Petitioner's brief at 5.

As I have stated this failure to carry out the nurse practitioner's orders blatantly violated regulatory requirements.  I find Petitioner's assertion that it complied with regulatory requirements to be unavailing.

Petitioner asserts that its policy is that verbal orders by a physician or a nurse practitioner need not be carried out by staff absent the presence of an emergency.  Petitioner's brief at 4.  It contends that the licensed vocational nurse who received the nurse practitioner's order to administer supplemental oxygen to Resident 1 concluded that the resident's blood oxygen saturation level did not justify a finding of an emergency and therefore oxygen could be withheld pending receipt of a written order to administer oxygen signed by a physician.  Id.  Additionally, according to Petitioner, the licensed vocational nurse

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was at the end of a shift when the nurse practitioner issued the order to administer supplemental oxygen, so she appropriately handed off the responsibility to execute the order to an incoming staff member.  Id. 

These arguments make for no defense even if I assume – solely for purposes of deciding whether summary judgment is appropriate – that the facts as related by Petitioner are true.  If Petitioner's nurse exercised her own judgment to withhold oxygen from Resident 1, she did so in defiance of a direct order.  She had absolutely no authority to do so.  Moreover, the nurse's purported assessment of Resident 1's condition was wrong.

For an individual suffering from Covid, a blood oxygen saturation level of between 92 and 96 percent is medically appropriate.  A blood oxygen saturation level of below 92 percent in an individual suffering from Covid is life threatening.  Covid-19 Treatment Guidelines, Oxygenation and Ventilation, National Institute of Health (last updated Dec. 16, 2021), https://www.covid19treatmentguidelines.nih.gov/management/critical-care/oxygenation-and-ventilation/.

Petitioner concedes that Resident 1's blood oxygen saturation level was below 92 percent when the nurse practitioner ordered that the resident receive supplemental oxygen.  That clearly was an emergency, requiring immediate execution of the nurse practitioner's verbal order pursuant to Petitioner's own policy.

Moreover, although Petitioner focuses on the verbal order issued by the nurse practitioner, it does not deny that the nurse practitioner also entered the order into Petitioner's electronic system for recording orders.  CMS Ex. 38 at 6; CMS Ex. 69 at 2.  Thus, there was a written order to administer oxygen to Resident 1.

Petitioner contends that the failure by its nurse to carry out the nurse practitioner's order “was simply unforeseeable to facility leadership.”  Petitioner's brief at 4.  It contends that such an unforeseeable failure should not be imputed to Petitioner's management.  Id. at 5.

Petitioner's argument notwithstanding, it is settled law that a skilled nursing facility is responsible for the acts and omissions of its staff.  Life Care Center at Gwinnett, DAB No. 2240 at 12-13 (2009); Emerald Oaks, DAB No. 1800 at 7 n.3 (2001).  There are two reasons why this is so.  First, a skilled nursing facility owes a duty to its residents and to the Medicare program to assure that its staff members apply professional standards of care when they provide care to residents.  A facility's management must be diligent in assuring that staff perform up to standard.  Letting a facility off the hook for staff misfeasance would serve as a disincentive for management to police its staff's performance.

Second, virtually all interactions between a skilled nursing facility and its residents are performed by staff.  Excusing a facility for incompetent or other noncompliant

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performance by staff would render nearly all skilled nursing facility regulations meaningless.  It would also greatly heighten the risk that residents will receive shoddy or even dangerous care, be neglected, or abused.

2. Immediate Jeopardy

The presence of immediate jeopardy is not a prerequisite for imposing a per-instance civil money penalty, as CMS determined to impose for Petitioner's noncompliance established at the January 25, 2021 survey.  See 42 C.F.R. § 488.438(a)(2).  Whether or not a per-instance penalty is reasonable depends on facts relating to the criteria set forth 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)).  I could, therefore, address the issue of remedy for the January 25, 2021 noncompliance without ruling on the issue of immediate jeopardy.

However, one of the criteria for deciding on the amount of a per-instance penalty is the seriousness of a facility's noncompliance.  Immediate jeopardy is the most serious noncompliance and therefore, the presence of immediate jeopardy is, if nothing else, a persuasive basis for imposing a strong remedy.  For that reason, I am addressing the issue of whether immediate jeopardy existed as of the January 25, 2021 survey.

“Immediate jeopardy” is defined at 42 C.F.R. § 488.301 as noncompliance that causes or is likely to cause serious injury, harm, impairment, or death to one or more residents.  Where noncompliance is established – as is the case here – it is the facility's burden to prove that a finding of immediate jeopardy is clearly erroneous.  42 C.F.R. § 498.60(c)(2); Universal Healthcare – King, DAB No. 2382 at 16 (2011), aff'd, 499 Fed. App'x 299 (4^th Cir. 2012).

Given that I am considering the issue of immediate jeopardy in the context of a motion for summary judgment my task is to decide whether the facility offers any facts from which I could reasonably infer that the finding of immediate jeopardy is clearly erroneous.  I find no facts that would call CMS's immediate jeopardy finding into question. The undisputed facts clearly establish at least a likelihood that Petitioner's noncompliance put Resident 1 at risk for serious harm or death.

As I have explained, an individual suffering from Covid may die if his or her blood oxygen saturation level is below 92 percent.  Here, the nurse practitioner determined that supplemental oxygen was essential to maintaining Resident 1's blood oxygen saturation level at 92 percent.  The resident's blood oxygen saturation level was below 90 percent before the nurse ordered that supplemental oxygen be administered.  The only reasonable conclusion that I can draw from these undisputed facts is that the resident would likely continue to experience potentially lethal blood oxygen saturation levels if supplemental oxygen was not administered, causing a likelihood of harm or death to the resident.

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Petitioner challenges CMS's finding of immediate jeopardy level noncompliance by arguing, first, that there are material fact questions as to whether an adverse action was “caused” by Petitioner's noncompliance.  Petitioner's brief at 12.  It asserts that it cannot be determined that failure to provide supplemental oxygen to Resident 1 caused the resident's death or caused her to suffer serious harm or injury.  Id.

This argument misstates the definition of immediate jeopardy by leaving out an important element of that definition.  Noncompliance that causes serious harm, injury, or death certainly is immediate jeopardy level noncompliance.  But so is noncompliance that creates a likelihood of such adverse consequences.  42 C.F.R. § 488.301.  It is unnecessary that I find that the failure to provide supplemental oxygen to Resident 1 caused the resident's death.  In this case the undisputed facts show a likelihood that the resident would suffer harm or that she would die.  That is because undisputed facts establish that a blood oxygen saturation level of below 92 percent, manifested by Resident 1, put the resident in jeopardy of dying.

Second, Petitioner contends that there was no need that it undertake immediate corrective action to address staff's failure to carry out the nurse practitioner's order.  Petitioner's brief at 13.  Citing to the State Operations Manual, Petitioner contends that there cannot be immediate jeopardy absent a need for immediate corrective action to remedy a deficiency.  Petitioner's brief at 11, citing Appendix Q- Core Guidelines for Determining Immediate Jeopardy, State Operations Manual Pub. 100-07 State Operations (effective Sept. 6, 2019), https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/2019Downloads/R192SOMA.pdf.

This argument is wrong as a matter of law.  The State Operations Manual does not supersede regulatory language governing what constitutes immediate jeopardy.  Foxwood Springs Living Center, DAB No. 2294 at 7-9 (2009).  Indeed, the document on its face states that it consists of guidelines, not legal authority.  Regulations – which are legally binding – define what constitutes immediate jeopardy.  The regulatory definition of immediate jeopardy does not condition such noncompliance on the need for immediate remedial action.

However, there clearly was a need, and an immediate one, for Petitioner to do something about its staff's failure to comply with the nurse practitioner's order.  That failure called for immediate corrective action – at the least addressing the failure by the individual staff member to carry out the order – but, more broadly, to assess the level of training and preparedness of the entire staff.

Finally, Petitioner argues that its noncompliance involved only a single resident.  Petitioner's brief at 13.  Even so, that is enough to establish immediate jeopardy level noncompliance.  There is no “single resident” exception to the definition of immediate jeopardy level noncompliance.

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Moreover, even if only one resident was put into jeopardy, the noncompliance that caused the jeopardy was due to the misfeasance of a staff member who certainly interacted with many residents.  That staff member's failure to understand the need to carry out the nurse practitioner's order signified a fundamental misunderstanding by her of the scope and limits of her duties.  That was a problem that potentially could have affected many residents treated by this staff member.

3. Remedy

CMS determined to impose a per-instance civil money penalty of $20,780 to address Petitioner's noncompliance.  I find the penalty to be reasonable for two reasons.

First, the noncompliance was extremely serious.  As I have discussed, Resident 1 exhibited life-threatening blood oxygen saturation levels prior to the nurse practitioner ordering that the resident be administered supplemental oxygen.   The resident had a critical need for supplemental oxygen that Petitioner's staff failed to address despite being ordered to do so.  That misfeasance surely jeopardized Resident 1's life.

Second, Petitioner was culpable for the noncompliance.  The failure to administer oxygen to Resident 1 was not mere error on the staff's part.  The licensed vocational nurse who was ordered to administer oxygen to Resident 1 knew that she had been ordered to administer oxygen but chose not to do so.  That is deliberate noncompliance and not simple negligence.

Petitioner argues that it does not have a recent history of noncompliance.  It asserts that the deficiency established as of the January 25, 2021 survey was not a widespread deficiency in that it consisted of failure to provide ordered care only to one resident, Resident 1.  It asserts that the penalty should be mitigated for these reasons.  Petitioner's brief at 16.

I do not find these arguments to be persuasive.  As I have discussed, the noncompliance established here was serious to the point of putting Resident 1 in immediate jeopardy.  Petitioner is highly culpable for its noncompliance. That is enough to establish that the penalty amount is reasonable without regard to Petitioner's allegedly good compliance history and whether the noncompliance relates to the care provided to one resident.

Petitioner also denies that it is culpable for the noncompliance.  I disagree for the reasons that I have stated.

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2. March 30, 2021 Survey

1. Failure to Comply with the Requirements of 42 C.F.R. §§ 483.25 and 483.45

CMS contends that the findings of the March 30, 2021 survey establish that Petitioner failed to comply with two participation requirements.  Pursuant to 42 C.F.R. § 483.25, a facility must provide a resident with care that complies with the resident's comprehensive plan of care and that is in accordance with professional standards of practice.  Additionally, a facility must ensure that its residents are free from significant medication errors.  42 C.F.R. § 483.45.  CMS asserts that Petitioner failed to comply with these requirements in caring for a resident who is identified as Resident 1.1

The undisputed material facts sustain CMS's allegations.  Petitioner's staff failed to provide care to Resident 1 consistent with his plan of care and professional practice standards and erred grievously by failing to assure that the resident receive prescribed medication.  The staff failed to comply with a directive that it administer a form of insulin to the resident, failed to chart the resident's blood sugar levels consistently despite being directed to assure that those levels remain within a normal range, and failed to investigate the resident's sudden cognitive decline.  After just a few days in Petitioner's facility Resident 1 fell and suffered a severe head injury.  When admitted to a hospital the resident was discovered to have a potentially lethal blood sugar reading.

Petitioner admitted Resident 1 to its facility on March 19, 2021, after he was discharged from a hospital.  CMS Ex. 42 at 12.  The resident was then 77 years old and suffered from several illnesses, most notably Type 2 diabetes.  CMS Ex. 45 at 29.  The resident's physician described the resident as being a “brittle diabetic.”  Id. at 45.  I take notice that brittle diabetes is a form of that illness that is extremely difficult to manage.  It is characterized by wide swings in an individual's blood sugar level.  Extreme fluctuations in blood sugar can produce grave and very dangerous consequences including unconsciousness.  Rachel Reiff Ellis, What is Brittle Diabetes?, WebMD (medically reviewed on January 27, 2022), https://www.webmd.com/diabetes/brittle-diabetes-all-about.

The discharge orders from the hospital included an order that Resident 1 be administered Lisipro four times a day.  CMS Ex. 42 at 12; CMS Ex. 45 at 22-23, 24-26, 42.  Lisipro is a fast-acting insulin that is intended to protect individuals suffering from diabetes from experiencing episodes of hyperglycemia (blood sugar above normal levels) after they eat.  Hyperglycemia can pose extreme danger to a diabetic individual.  It may cause life-

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threatening consequences such as ketoacidosis (diabetic coma).  Diabetes & DKA (Ketoacidosis), American Diabetes Association (last visited May 11, 2022), https://www.diabetes.org/diabetes/dka-ketoacidosis-ketones.

Petitioner had an admission protocol policy that directed its nursing staff to ensure that medication orders were completed, verified, and forwarded to a pharmacy for fulfillment.  CMS Ex. 63 at 2; CMS Ex. 65.  However, Petitioner's staff failed to input Resident 1's prescription for Lisipro.  CMS Ex. 45 at 44-45; CMS Ex. 73 at 10.  The direct consequence of this failure was that staff did not administer this medication to Resident 1.  Between March 19, 2021, the date of the resident's admission and March 22, 2021, Petitioner's staff failed to administer 10 doses of Lisipro to Resident 1.  Members of Petitioner's staff did not consistently chart the resident's blood glucose levels during this period even though they were directed to maintain the resident's blood sugar within normal limits.  CMS Ex. 45 at 20, 43, 47-48.

During the three-day period, Resident 1, who suffered from dementia, evidenced cognitive decline.  On the evening of March 20, 2021, the resident became acutely agitated.  CMS Ex. 45 at 46.  There is nothing in the record to show that Petitioner's staff, despite orders that they monitor the resident's cognition, considered that Resident 1's decline might be related to his blood glucose levels.  CMS Ex. 45 at 20.

On March 22, 2021, Petitioner's staff found Resident 1 lying on his bathroom floor, suffering from a head injury.  CMS Ex. 46 at 2.  Petitioner transferred the resident to a hospital where he was diagnosed to be suffering from a subarachnoid hemorrhage (intracranial bleeding) and severe dehydration, a sign of acute hyperglycemia. The resident was diagnosed to be critically ill and on admission had a blood glucose level of 748 mg/dl, a potentially lethal level.  CMS Ex. 45 at 4, 16.

Petitioner does not dispute the facts that I recite nor does it provide a defense for its misfeasance.

Petitioner does not deny that its staff failed to administer Lisipro to Resident 1 as was ordered.  Rather, it contends that it has effective admission controls that designate the duties for each facility department including medication administration.  Petitioner's brief at 6.  It contends also that its staff received training that emphasized the importance of verifying admitting orders.  Id.  These assertions, accepting their truth for the purpose of deciding CMS's summary judgment motion, provide no defense for the misfeasance that occurred.  Whatever controls Petitioner may have implemented, they failed to protect Resident 1 as did the training that Petitioner may have given to its staff.  The failure to provide the resident with prescribed insulin was a gross and glaring error by Petitioner's staff, not compensated for by protocols or training.

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Petitioner also does not deny that members of its staff failed to consistently chart Resident 1's blood glucose levels or investigate his sudden cognitive decline.2

Petitioner argues also that CMS has not offered facts to prove that Resident 1 fell because he was hyperglycemic or due to the staff's failure to administer prescribed insulin to him.  Petitioner's brief at 8.  It is unnecessary that I find that Petitioner's failures caused the Resident to fall or sustain injuries.  What is apparent, and as I discuss in more detail below, is that the failure to provide prescribed insulin to Resident 1 created a likelihood that he would suffer from serious injury, harm, impairment or death.  That is sufficient to find noncompliance, and in this case, immediate jeopardy level noncompliance.

2. Immediate Jeopardy

Petitioner did not offer facts from which I might infer that CMS's determination that the noncompliance was at the immediate jeopardy level was clearly erroneous.  All of the facts of record point to only one conclusion:  that Petitioner's failures created a likelihood that Resident 1 would sustain serious injury, harm, impairment or death.

As I have discussed, Resident 1 was a brittle diabetic, subject to wide and difficult to control swings in his blood sugar levels.  Brittle diabetics are at risk for a range of adverse consequences from their illness including unconsciousness and even death.  It is certain that the resident's physician prescribed Lisipro as an effort to control the resident's fluctuating blood sugar.  Failure to provide the resident with this medication left him unprotected and vulnerable to the adverse effects of his illness.  The likelihood that Resident 1 would suffer from severe adverse effects in the absence of prescribed medication is high even without considering what happened to him on March 22, 2021.

Petitioner asserts that there is no proof that the failure to administer Lisipro to Resident 1 caused him to fall or to experience the extremely high blood sugar level that he manifested when he arrived at the hospital.  Petitioner's brief at 8.  I do not find causation in this case; it is unnecessary that I do so.  What matters is that Petitioner adduced no facts to show that CMS's determination of a likelihood of serious injury, impairment, harm, or death resulting from Petitioner's noncompliance is clearly erroneous.

3. Remedies

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CMS determined to impose two remedies to address the noncompliance found at the March 30, 2021 survey:  civil money penalties of $12,950 for each day of a period that began on March 19, 2021, and that continued through March 21, 2021; and civil money penalties of $1,350 for each day of a period that began on March 22, 2021, and that continued through March 30, 2021.  The larger penalty amount relates to Petitioner's immediate jeopardy level noncompliance.  The smaller penalty amount addresses continuing noncompliance at a level of less than immediate jeopardy.

Although Petitioner contends that it complied with participation requirements and therefore challenges the basis for imposition of remedies, it does not specifically challenge the duration of noncompliance found by CMS.  In other words, Petitioner does not argue that it implemented corrective actions sooner than CMS found to be the case.  Consequently, duration is not an issue here.

Per-diem civil money penalties are authorized by regulation as redress for a facility's noncompliance with participation requirements.  42 C.F.R. § 488.438(a).  The penalties that CMS imposed fall within the permissible ranges for per-diem penalties as adjusted.  42 C.F.R. § 488.438(a)(1)(i), (ii), 45 C.F.R. Part 102.

The penalty amounts not only fall well within the permissible ranges for immediate jeopardy and non-immediate jeopardy level penalties, but they are relatively modest, with the immediate jeopardy level per diem amount being only somewhat more than half the allowable maximum and the non-immediate jeopardy level per diem amount comprising less than one-quarter of the allowable maximum.  45 C.F.R. Part 102.

I find these penalty amounts to be amply supported by the seriousness of Petitioner's noncompliance.  Although I do not find that the noncompliance is the proximate cause of the injuries sustained by Resident 1, I find that the undisputed material facts plainly put this resident at a likelihood of sustaining serious injury, harm, or even death.  As I discuss above, this resident, a brittle diabetic, was highly susceptible to episodes of hyperglycemia that could have killed him.  Petitioner's failure to provide him with prescribed medication jeopardized his life.

Petitioner argues that it manifested no culpability for its noncompliance and that its compliance history does not justify the penalty amounts.  I find these arguments insufficient to counter the undisputed facts establishing that Petitioner put Resident 1 at great risk for harm or worse.  Consequently, Petitioner has not provided any basis for me to mitigate the penalty amounts.

1. The Resident 1 referred to here is not the same individual whose care is the basis for findings of noncompliance made at the January 25, 2021 survey.
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2. Petitioner offered evidence to show that it recorded Resident 1's blood sugar on March 22, 2021 as being 109 mg/dl.  P. Ex. 4.  I accept that Petitioner's staff may have charted the resident's blood sugar levels on occasion.  That does not derogate from my conclusion that staff members failed to systematically chart the resident's blood sugar levels, and Petitioner has not pointed to any evidence that it did so.
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