Meadows Mennonite Home, DAB CR5167 (2018)

Department of Health and Human Services
Civil Remedies Division

Docket No. C-17-246
Decision No. CR5167


I sustain the determination of the Centers for Medicare & Medicaid Services (CMS) to impose civil money penalties of $1003 per day for each day of a period that began on August 19, 2016, and that continued through September 15, 2016.  As a consequence of the total penalty amounts (exceeding $10,314) Petitioner also loses the authority to conduct a nurse aide training and competency evaluation program (NATCEP) for a period of two years.

I.  Background

This case originally was assigned to another administrative law judge and then, reassigned to me.  CMS moved for summary judgment and Petitioner opposed the motion.  I denied the motion and held an in-person hearing on June 14, 2018.  At the hearing I received exhibits from CMS identified as CMS Exs. 1-37.  I received exhibits from Petitioner identified as P. Exs. 1-14.

The parties filed pre- and post-hearing briefs.  I cite to the parties’ briefs as follows:  CMS’s brief; CMS’s post-hearing brief; Petitioner’s brief; Petitioner’s post-hearing brief.

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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 proposed remedies are reasonable.

B. Findings of Fact and Conclusions of Law

The allegations of noncompliance in this case arise from surveys of Petitioner’s facility that transpired in August 2016.  I base all of my findings on regulations governing Petitioner’s Medicare participation that were in effect at the time of the surveys.

CMS alleges multiple failures by Petitioner to comply substantially with Medicare participation requirements.  CMS assigned low levels of scope and severity to these noncompliance allegations, with one exception.  That exception consists of Petitioner’s alleged failure to comply with the requirements of 42 C.F.R. § 483.25(c).  This regulation governs prevention and treatment of pressure sores.

I turn first to this allegation of noncompliance.

The regulation requires a facility to protect a resident against the development of pressure sores unless that resident’s clinical condition causes development of unavoidable sores.  It requires also that a resident with pressure sores receives necessary treatment and services to promote healing, prevent infection, and prevent new sores from developing.  42 C.F.R. § 483.25(c)(1), (2).

CMS’s noncompliance allegations relate to the care that Petitioner’s staff gave to a resident identified as R5.  This resident was in the final weeks of his life in July and August 2016.  During that period he developed wounds on his buttocks and coccyx area that ultimately became unstageable (so severe that Petitioner’s staff could not make assessments of the full extent of their severity).  CMS Ex. 20 at 1‑2.  These wounds, additionally, were very painful.  Id.

There is a dispute as to whether these wounds – or at least the most severe of them – were unavoidable.  On August 15, 2016, Petitioner’s staff assessed the largest of the wounds as a Kennedy Ulcer, a wound that is a sign of impending death in individuals who are in the final stages of their lives.  CMS Ex. 20 at 11.  Petitioner asserts that it should not be found noncompliant because this ulcer arguably would have occurred in any event.  I find it unnecessary to decide whether this wound or any of the wounds manifested by R5 were unavoidable.  I find that in July and August 2016, Petitioner failed to provide the treatments to R5 that its own internal policies and guidelines mandated.  These failures

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comprise a failure by Petitioner to provide necessary treatments and services to R5 in contravention of 42 C.F.R. § 483.25(c)(2).

Petitioner had policies that addressed both prevention and treatment of pressure sores (also called pressure ulcers).  CMS Exs. 26-27.  These policies provided generally that Petitioner would provide care to residents consistent with regulatory requirements.  They also contained specific instructions as to how Petitioner’s staff must assess and treat its residents in order to prevent and care for pressure sores.  The policies explicitly mandated the staff conduct comprehensive wound assessments that included:  location of any wound; its length, depth, and width; direction and length of tunneling of any wound; its appearance; whether there is drainage; and other characteristics including the wound’s color, consistency, and the presence or absence of odor.  CMS Ex. 27 at 1.

Petitioner also had physicians’ standing orders addressing pressure sores.  These orders required that a resident with a sore or sores of any stage be turned and repositioned frequently.  For those residents with pressure sores assessed at Stage II or worse (the generally accepted definition of a Stage II pressure sore is one that presents as a shallow open ulcer with a red or pink wound bed without slough), the orders mandated Petitioner’s staff:  apply hydrocolloid to the sores every three days or as needed; monitor measurements of any sore weekly in interdisciplinary and skin notes; and consult with a dietician upon discovery of any sore.  CMS Ex.  29 at 1-2.

Petitioner’s staff committed multiple violations of Petitioner’s policy and standing orders in providing care to R5.  These violations, individually and collectively, contravened the treatment requirements of 42 C.F.R. § 483.25(c)(2).

Petitioner’s staff observed an open wound on R5’s coccyx on July 8, 2016.  CMS Ex. 20 at 6.  Petitioner’s policy required the staff to measure the wound.  But, the staff did not do so until July 15, 2016, and did not measure it again until August 2, 2016.  CMS Ex. 20 at 1-2, 5.  This failure to measure was in plain violation of Petitioner’s policy for treatment of pressure sores.  CMS Ex. 27 at 2.  Petitioner’s staff further violated that policy in that the staff failed to consult with Petitioner’s dietician immediately upon discovery of the wound.  Id.  The staff did not consult until August 16, 2016, more than a month after staff had discovered the wound.  CMS Ex. 20 at 23-25.  The staff did not commence repositioning of the resident until August 10, 2016, at the earliest, an additional violation of Petitioner’s policy.  Id. at 11; CMS Ex. 33; see CMS Ex. 27 at 1-2.  Furthermore, staff observed no dressing on the resident’s wound on August 17, 2016, a contravention of a physician’s standing order.  CMS Ex. 16 at 6.

Petitioner’s primary defense to this evidence is that the resident’s pressure sores – principally, his Kennedy Ulcer – were unavoidable.  Petitioner’s brief at 5, 9-11.  On that theory, Petitioner argues that any treatment that it may not have provided as required by its policy would have been useless in any event.

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That is no defense.  A facility may not defend against failure to comply with regulatory requirements, as implemented by its own policies, by asserting that treatment would have been futile.  The regulations are explicit:  a facility must do everything within its capabilities to treat a resident’s pressure sores.  Failure to do so is never excused by a claim that in retrospect the withheld treatment would not have benefitted the resident.

Petitioner argues additionally that CMS intentionally confuses and intermingles three different skin conditions manifested by R5 in order to make it appear that Petitioner failed to treat the resident according to its policies.  Petitioner’s brief at 5.  Petitioner asserts, for example, that Petitioner’s staff documented different wounds on the resident’s buttocks on July 8 and July 15, 2016, and that the July 8 wound had healed by July 12.  Petitioner’s argument, apparently, is that CMS wrongly asserts the continued presence of a sore on the resident’s buttocks when, in fact, there was more than one sore.  From this, Petitioner asserts that CMS is wrong in contending that there was a failure by Petitioner to treat consistently the resident’s sores.  Id.

This argument fails for more than one reason.  First, Petitioner’s records are not at all clear as to whether the sore documented on July 15, 2016, is a different sore than the one documented on July 8 of that year.  See CMS Ex. 20 at 5, 6.  Petitioner is effectively arguing that the ambiguity of its own records justifies the manner in which its staff cared for the resident.  That is not a legitimate assertion.  Petitioner’s staff had the duty to document precisely whatever it was that R5 manifested.  Failure to do so is a deficiency in and of itself.  Moreover, it is no defense in any event to CMS’s findings of noncompliance.  Whether or not the sores manifested by the resident on July 8 and 15 were one or multiple sores, Petitioner failed to do what it was obligated to do in order to treat them.  It did not consult immediately with the facility dietician as is required by its policy.  It did not begin repositioning and turning the resident immediately upon discovery of these sores.  It did not immediately begin to measure the sores.

Petitioner argues also that the wound that its staff observed on July 8, 2016, was not a pressure sore, therefore relieving it from any obligation to treat the wound pursuant to regulatory requirements and Petitioner’s policy.  Petitioner’s brief at 6.  But, no one came to that conclusion – whether or not it is correct – until well after the fact.  There is absolutely no assessment of the wound that states or even suggests that the staff withheld implementing its pressure sore policy because it had determined that it was unnecessary to do so.  Hindsight is no excuse for failure by Petitioner to implement its policies when its staff first identified the wound. 

Petitioner insists that on July 15, 2016, its staff identified a “new wound” on R5’s left buttock measuring 1.0 cm by 0.4 cm.  Petitioner’s brief at 6.  But, and as I have stated, Petitioner’s records do not make it clear that this wound was “new.”  See CMS Ex. 20 at 5, 16-18.  In any event, and as I have explained, whether the wound was new or simply the same wound (albeit more advanced) than that which the staff observed on July 8 is

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irrelevant to my findings of noncompliance.  Petitioner’s policies called for immediate interventions as of the discovery of the July 8 wound and Petitioner did not implement them.

Petitioner asserts that although it did not document this wound at least weekly, it was not required to do so by the regulation.  Petitioner’s brief at 7.  But, Petitioner’s own policy required weekly monitoring and documentation of skin wounds for all residents.  CMS Ex. 26 at 1.  Petitioner’s policy was its considered approach to compliance with the regulations’ pressure sore treatment requirements.  The regulation may not specify exactly how a skilled nursing facility must treat a pressure sore, but once a facility decides on an approach it must implement it or explain why it does not.

Petitioner also contends that its staff documented the sore allegedly first discovered on July 15 to be unchanged in size on August 2 and 8, 2016.  Petitioner’s brief at 7.  From this, Petitioner apparently suggests that failure by the staff to document the wound’s size and appearance between July 15 and August 2 was no violation inasmuch as the wound didn’t change in size during that period.  This is a kind of “no harm, no foul” argument in which Petitioner asserts that its failure to comply with wound treatment requirements should be excused because, fortuitously, the resident suffered no adverse consequences during the period of noncompliance.  That argument is unpersuasive.  A facility may not excuse its noncompliance on the premise that the noncompliance failed to affect the outcome of a disease process.

Finally, Petitioner asserts that it provided prompt and vigorous care to R5’s Kennedy Ulcer upon its discovery on August 10, 2016.  Petitioner’s brief at 8-11.  However, whatever the amount and intensity of treatment that the staff may have provided beginning on August 10, that does not excuse its failure to treat the resident’s previously discovered wounds (whether or not those wounds were different from, or a stage in the development of, the resident’s Kennedy Ulcer) prior to August 10.

As I have discussed, CMS alleges several additional, albeit somewhat less severe, examples of Petitioner’s noncompliance with regulatory requirements.  CMS alleges that Petitioner contravened the requirements of 42 C.F.R. § 483.10(b)(11).  Among other things this regulation requires a skilled nursing facility to consult with a resident’s treating physician and notify the resident’s family of any significant change in a resident’s condition.  Petitioner’s policy is consistent with this regulatory requirement.  CMS Ex. 28.

CMS alleges that Petitioner failed to comply with this regulation because it failed to consult with R5’s treating physician about a significant change in the resident’s condition, namely, the development of a wound on the resident’s buttocks on July 8, 2016.

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Petitioner argues that the development of this wound was not a significant change in the resident’s condition.  Petitioner’s brief at 12.  It justifies its contention by asserting that the development of a pressure sore is not a life-threatening condition such as a heart attack or stroke, citing to the examples in the State Operations Manual.  However, those examples are just that – examples – and there is nothing in the State Operations Manual that suggests that these examples are limiting.

I take notice that pressure sores are potentially life-threatening conditions for helpless and greatly debilitated individuals such as R5.  Petitioner’s staff had no way of knowing what would be the progress of the wound that they identified on July 8, 2016, as of the time that they identified it.  That wound was a significant change in the resident’s condition and the staff was obligated to consult with the resident’s physician about it.

Petitioner further attempts to justify its failure to consult by asserting that the resident’s wound was merely a skin tear that healed within four days.  However, and as I have discussed, there is nothing in Petitioner’s records to suggest that Petitioner’s staff assessed the wound and concluded that it was not a pressure sore.

Next, CMS contends that Petitioner failed to comply substantially with the requirements of 42 C.F.R. § 483.13(c).  The regulation requires immediate reporting to relevant government officials of any possible episode of abuse, including injuries of an unknown source.  It also requires a facility to develop and implement written policies and procedures that prohibit neglect, mistreatment, or abuse of residents.

Petitioner’s anti-abuse policy requires that its administrator and director of nursing or their designee must immediately investigate any possible incident of resident abuse and must fax the findings of any investigation immediately to the state department of public health (the policy effectively defines “immediately” to mean not more than 24 hours from completion of the investigation).  CMS Ex. 25 at 3.

Petitioner plainly failed to follow this policy in the cases of R7 and R2, and its failure constitutes a violation of regulatory requirements.  On August 7, 2016, a member of Petitioner’s staff noticed a small bruise on the left side of R7’s forehead.  CMS Ex. 15 at 1, 4-5.  The staff documented the bruise but failed immediately to notify Petitioner’s administrator and director of nursing.  These individuals did not investigate the cause of the bruise, nor did they report the results of an investigation to the appropriate authorities.  CMS Ex. 14 at 2; CMS Ex. 15 at 5; CMS Ex. 17.

In the case of R2, Petitioner investigated her complaints of abuse (she alleged that Petitioner’s staff had treated her roughly and had banged her knee against a wall, and she complained additionally that she thought that the staff had hit her roommate).  However, Petitioner delayed sending a report of its investigation to appropriate authorities for two days.  CMS Ex. 18; CMS Ex. 14 at 5.

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Petitioner argues that it did not violate its anti-abuse policies in treating R7 because its staff ultimately determined that the resident sustained a bruise while being transferred.  Petitioner’s brief at 15.  It also argues that the bruise sustained by the resident was minimal in size and was “not in a suspicious location.”  Id. at 16.  These assertions are rationalizations.  There is literally nothing in Petitioner’s records suggesting that the staff investigated the resident’s bruise and determined that abuse was not implicated.  And, even had they done so, Petitioner was still obligated to file a report immediately, which it plainly did not.

With respect to R2, Petitioner contends that there is nothing in the applicable regulation that establishes a time frame within which results of an investigation must be reported to appropriate authorities.  Petitioner’s brief at 16-17.  But, the regulation requires immediate reporting of an investigation’s results and Petitioner’s own policy defines “immediate” to mean within 24 hours.  Petitioner plainly contravened its own policy and failed to report the results of its investigation immediately.

CMS alleges that Petitioner failed to comply substantially with the requirements of 42 C.F.R. § 483.13(a).  This regulation directs that every resident in a skilled nursing facility has the right to be free from a physical restraint that is imposed for purposes of discipline or convenience and not required to treat the resident’s medical symptoms.

There is no dispute about the facts relating to CMS’s allegations of noncompliance.  I find that these facts establish noncompliance with regulatory requirements.  On August 6, 2016, a certified nursing assistant found a resident, identified as R1, buckled into a wheelchair with a seatbelt.  The resident was incontinent.  CMS Ex. 14 at 11; CMS Ex.  19.  This resident is cognitively impaired, suffering from memory problems and disorganized thinking.  CMS Ex.  14 at 23, 25.  The resident had been placed in a wheelchair during a prior nursing shift.  During that shift another nursing assistant had buckled the resident’s seat belt.  The resident was unable to release himself from the belt due to his cognitive impairment.  He had to be coached in order to do so.  Id. at 32-33.

Petitioner argues that its staff had buckled the resident’s seat belt as a diversion – that the resident was bored and that buckling and unbuckling the seat belt was a form of play, rather than restraint for discipline or convenience.  Petitioner’s brief at 14.

That may be so, but Petitioner’s defense does not gainsay the fact that the resident was left unattended and buckled into the wheelchair.  When the nursing assistant who reported the incident encountered the resident on August 6, 2016, she found the resident buckled into the chair and incontinent.  There is no evidence to show that the resident was accompanied by Petitioner’s staff at that time and I infer that he was alone and buckled in when discovered, helpless to unbuckle himself.  That is a restraint by any definition of the term.  Moreover, leaving the resident unattended clearly became a matter of convenience in the sense that the nursing assistant who had been attending to the

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resident when she buckled him into the chair found it to be in her interest to leave the resident buckled in place, at least for a short period of time.

CMS also alleges that Petitioner failed to comply substantially with the requirements of 42 C.F.R. § 483.25(a)(3).  This regulation requires that a resident of a skilled nursing facility receives the necessary services to maintain good nutrition, grooming, and personal and oral hygiene.  CMS alleges that Petitioner failed to comply with this regulation because its staff failed to provide continence care to residents of Petitioner’s dementia unit.  Specifically, CMS contends that on the morning of August 5, 2016, a licensed practical nurse on Petitioner’s staff began her shift in the dementia unit and discovered that sixteen incontinent residents of the dementia unit were soaked in urine, so much so that each of them required a complete change of bed linen in addition to receiving incontinence care.  CMS Exs. 21, 23-24.  Petitioner’s records show four of these incontinent residents had not received incontinence care after midnight of the previous evening, and that other incontinent residents had received incontinence care only once.  CMS Ex.  22.

This evidence more than establishes a failure by Petitioner to provide its demented residents with sufficient incontinence care to protect them against lying in urine-soaked garments and bedding.  On its face, this lapse is a failure by Petitioner to comply with the quality of living requirements of 42 C.F.R. § 483.25(a)(3).

Petitioner argues, first, that incontinence care is but one of a panoply of services that its staff provides to residents.  It contends that its compliance should not be judged by its possible failure to provide one aspect of that care.  Petitioner’s brief at 18.  I disagree.  Incontinence care is a significant and necessary item of care that a skilled nursing facility provides to its residents.  There are health issues that arise from lying in one’s own urine aside from the obvious comfort issues.  I take notice that prolonged contact with urine can irritate and damage skin, and that damaged skin can be a portal for infection.

Petitioner also asserts that it had policies and protocols in place to protect residents against incontinence.  Petitioner’s brief at 18; P. Ex. 11.  I do not disagree with that, but in this instance it is evident that the policies and protocols failed to protect Petitioner’s residents.

Finally, Petitioner contends that it is unfair to find it noncompliant based solely on the staff’s performance during a five-hour time period on one evening.  It argues that, whatever may have happened on that evening, compliance should not be measured by such a small window of time.  That argument notwithstanding, the evidence proves that several of Petitioner’s demented residents were left lying in their own urine as a consequence of Petitioner’s staff failing to perform its duties.  That is an evident regulatory violation even if it is an isolated incident.

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CMS contends that Petitioner failed to comply substantially with the Life Safety Code of the National Fire Protection Association, NFPA 101 (2000), (Life Safety Code).  At the time of the survey this code was incorporated by reference into the conditions of participation governing skilled nursing facilities at then-applicable 42 C.F.R. § 483.70(a)(1)(i).  The specific provision of the Life Safety Code then applicable to Petitioner’s facility required that doors be provided with a means of keeping them closed that is acceptable to the enforcement authority.  Life Safety Code §

At the time of the survey several of Petitioner’s doors were equipped with manual flush bolts.  CMS Exs. 2, 35.  A manual flush bolt does not latch automatically but must be manually operated in order to securely close a door.  CMS Ex. 35.  CMS found these bolts to be unacceptable, because CMS requires automatic latching mechanisms on facility doors.

Petitioner argues that CMS incorrectly interprets and applies the provisions of the Life Safety Code in effect at the time of the survey.  Petitioner contends that the Life Safety Code does not require automatic latching mechanisms on doors but, rather, requires only that the doors resist a pressure of five pounds before opening.  Life Safety Code §  Petitioner asserts also that if it is CMS’s policy that doors be equipped with automatic latching mechanisms, that policy was never communicated to Petitioner, and it should not be bound by what Petitioner refers to as a “secret” policy.  Petitioner’s post‑hearing brief at 17.  Petitioner argues furthermore that CMS offered no objective evidence to prove that the doors in Petitioner’s facility would respond to pressure of less than five pounds.

I do not find that Petitioner failed to comply with the then-applicable provisions of the Life Safety Code.  As I noted at the hearing, whatever policy CMS may have had about door latching mechanisms is irrelevant if that policy is not communicated to the facilities that are subject to it.  Transcript at 64.  Moreover, CMS failed to offer objective proof that the doors in Petitioner’s facility would open when subjected to less than five pounds of pressure.

I sustain CMS’s imposition of civil money penalties of $1003 per day against Petitioner for each day of a period beginning on August 19, 2016, and continuing through September 15, 2016, and the concomitant loss of NATCEP.  The evidence in this case establishes that Petitioner failed to comply substantially with four Medicare conditions of participation during this period.  That noncompliance is sufficient to justify the penalties imposed even if the evidence fails to establish that Petitioner failed to comply substantially with a fifth requirement, the Life Safety Code requirement.  Indeed, Petitioner’s noncompliance with the requirements of 42 C.F.R. § 483.25(c)(1) and (2), governing the prevention and treatment of pressure sores, is in and of itself sufficient to justify the penalties that CMS determined to impose.

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I note that the penalties that CMS determined to impose are relatively modest, comprising only about 1/6 of the maximum penalty amount that, at the time of the survey, CMS was authorized to impose for non-immediate jeopardy level penalties.  42 C.F.R. § 488.408; 45 C.F.R. § 102.3.  These penalties are entirely reasonable when measured against the factors that govern permissible civil money penalty amounts.

Regulations governing imposition of non-immediate jeopardy level daily civil money penalties that CMS may impose establish criteria for evaluating the reasonableness of penalty amounts.  42 C.F.R. §§ 488.438(f)(1)-(4); 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.

In this case the seriousness of Petitioner’s noncompliance is sufficient to sustain the penalty amounts.  Failure by a facility to treat appropriately a resident’s pressure sores is serious noncompliance because such failure can lead to severe complications or death.  The seriousness of Petitioner’s failure to treat a resident’s sores is thus sufficient, even when considered in isolation, to justify the penalties that CMS determined to impose.  Moreover, and as CMS alleges, Petitioner is culpable for its noncompliance, both with the pressure sore requirements and in other instances, because its staff failed to comply with policies that the facility had in place.  I infer from these multiple compliance failures that Petitioner was indifferent to enforcement of those policies.  Finally, I note that Petitioner has a history of regulatory noncompliance.  CMS Ex. 4.  The noncompliance established here is a continuation of that history, meriting the substantial penalties CMS determined to impose.

Petitioner argues that these penalties are unreasonable because they are not imposed consistent with CMS’s internal protocol governing when, and in what amounts, civil money penalties ought to be imposed.  Petitioner’s brief at 21-22.  I do not have authority to evaluate penalties based on CMS’s internal guidelines for imposing them.  To the contrary, my authority is de novo.  I am charged with conducting an independent review of penalty amounts based on the regulatory criteria that I cite above.  I have done so in this case and find the penalties to be eminently reasonable.