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                              Saint Anne Nursing and Rehabilitation Center, DAB CR6038 (2022)
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Saint Anne Nursing and Rehabilitation Center, DAB CR6038 (2022)








  
  
    

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





Saint Anne Nursing and Rehabilitation Center
(CCN: 50-5417),
Petitioner,

v.

Centers for Medicare & Medicaid Services,

Respondent.
Docket No. C-18-701Decision No. CR6038March 7, 2022

        
              
    

      DECISION

Respondent, the Centers for Medicare & Medicaid Services (CMS), determined that Petitioner, Saint Anne Nursing and Rehabilitation Center (Saint Anne), was not in substantial compliance with Medicare participation regulations and imposed a per-day civil money penalty (CMP) for the facility’s substantial noncompliance.

As explained below, I sustain the imposition of a $1,010 per-day CMP from October 23, 2017 through January 7, 2018, for a total CMP of $77,770.

I.   Background

Saint Anne is a skilled nursing facility (SNF) located in Seattle, Washington participating in the Medicare and Medicaid programs.  Following a survey completed on November 1, 2017, CMS determined that Saint Anne was not in substantial compliance with the following program requirements:

42 C.F.R. § 483.40(d) (Tag F250 – provision of medically related social services)Page 2

42 C.F.R. § 483.25(b)(1) (Tag F314 – treatment/services to prevent/heal pressure sores)CMS Exhibit (Ex.) 2 at 1.  These deficiencies were cited at a scope and severity level “G”, meaning isolated substantial noncompliance with actual harm that is not immediate jeopardy.  *Id.*CMS imposed a $1,010 per-day CMP for 77 days beginning October 23, 2017 and continuing through January 7, 2018, for a total CMP of $77,770.

Saint Anne timely filed a request for hearing on March 28, 2018.  I was designated to hear and decide this case and issued an Acknowledgment and Pre-hearing Order (Pre-hearing Order) that established a briefing schedule and directed the parties to file pre-hearing submissions that included written direct testimony for all proposed witnesses, proposed exhibits, and pre-hearing briefs.

CMS filed a pre-hearing brief (CMS Br.) and 32 proposed exhibits (CMS Exs. 1-32), which included written direct testimony for two witnesses.  Saint Anne filed a pre-hearing brief (P. Br.) and three exhibits (P. Exs. 1-3), which included the written direct testimony of two witnesses.  CMS requested to cross-examine Saint Anne’s witnesses.

II.   Hearing and Admission of Exhibits.

On May 16, 2019, I held a hearing by videoconference to allow CMS to cross‐examine Saint Anne’s witnesses.  At the outset of the hearing, CMS objected to Saint Anne’s Exhibit 1, the declaration of Tony Wilson, on the grounds that he had not appeared for cross-examination.  Hearing Transcript (Tr.) at 9.  Saint Anne confirmed that Mr. Wilson was an employee of the facility but claim he was not available the day of the hearing, despite receiving ample notice of the time and place.  I ruled that Saint Anne did not establish good cause for his absence from the hearing and therefore granted CMS’s objection, striking Saint Anne’s Exhibit 1.  Tr. at 10-11.

I entered CMS Exhibits 1 through 32 and Saint Anne’s Exhibits 2 through 3 into evidence.  Following the hearing, the parties filed post-hearing briefs (CMS Closing Br. and P. Closing Br.).

II.   Statement of issues

The issues presented are:

Whether Saint Anne was in substantial compliance with the Medicare program requirements at 42 C.F.R. §§ 483.25(b)(1) and 483.40(d), and if not;

Whether the $1,010 per-day CMP imposed by CMS is reasonable.

Page 3

III.   Jurisdiction

I have jurisdiction to hear and decide this case.  42 U.S.C. § 1395i-3(h)(2)(B)(ii); 42 C.F.R. §§ 488.408(g), 488.434(a)(2)(viii), 498.3(b)(13).

IV.   Burden of Proof

CMS must first make a prima facie showing that Saint Anne failed to comply substantially with federal participation requirements.  If this occurs, Saint Anne must prove substantial compliance by a preponderance of the evidence in order to rebut CMS’s showing and prevail.  *Hillman Rehab. Ctr.*, DAB No. 1611 at 8 (1997); *Batavia Nursing & Convalescent Ctr.*, DAB No. 1904 (2004); *Emerald Oaks*, DAB No. 1800 (2001); *Cross Creek Health Care Ctr.*, DAB No. 1665 (1998).

V.   Discussion

**A.  Applicable Legal Authority.**

The Social Security Act (Act) sets requirements for skilled nursing facilities to participate in the Medicare program.  The Act authorizes the Secretary of the United States Department of Health and Human Services (Secretary) to promulgate regulations implementing those statutory provisions.  Act § 1819 (42 U.S.C. § 1395i-3).  The Secretary’s regulations are found at 42 C.F.R. pts. 483 and 488.

A facility must maintain substantial compliance with program requirements in order to participate in the program.  To be in substantial compliance, a facility’s deficiencies may “pose no greater risk to resident health and safety than the potential for causing minimal harm.”  42 C.F.R. § 488.301.

The Secretary contracts with state agencies to conduct periodic surveys to determine whether skilled nursing facilities are in substantial compliance with the participation requirements.  Act § 1864(a) (42 U.S.C. § 1395aa(a)); 42 C.F.R. § 488.10.  The Act also authorizes the Secretary to impose enforcement remedies against skilled nursing facilities that do not comply with the participation requirements.  Act § 1819(h)(2) (42 U.S.C. § 1395i-3(h)(2)).  The regulations specify the enforcement remedies that CMS may impose if a facility is not in substantial compliance.  42 C.F.R. § 488.406.  Among other enforcement remedies and relevant here, CMS may impose a per-day civil money penalty for the number of days a facility is not in substantial compliance.  42 C.F.R. § 488.430(a).  A per-day civil money penalty may range from $50 to $3,000 per day (adjusted for inflation) for less serious noncompliance, or $3,050 to $10,000 per day (adjusted for inflation) for more serious noncompliance that poses immediate jeopardy to the health

Page 4

and safety of residents.  42 C.F.R. § 488.438(a)(1).1
  In 2017, the applicable range for less serious noncompliance adjusted for inflation was $105 to $6,289.  45 C.F.R. § 102.3.

A facility has a right to appeal a “certification of noncompliance leading to an enforcement remedy.”  42 C.F.R. § 488.408(g)(1); *see also* 42 C.F.R. §§ 488.330(e), 498.3(b)(13).  However, the facility may not appeal CMS’ choice of remedies.  42 C.F.R. § 488.408(g)(2).

**B.  Saint Anne failed to substantially comply with 42 C.F.R. § 483.40(d), Tag F250, when it failed to provide translation services to Resident 50 resulting in psychosocial harm to the resident.**

42 C.F.R. § 483.40(d) concerns the provision of medically related social services, one of the “behavioral health services” requirements.  The regulation states that behavioral health “encompasses a resident’s whole emotional and mental well-being.”  42 C.F.R. § 483.40.  The specific regulation provides:

(d) The facility must provide medically-related social services to attain or maintain the highest practicable physical, mental and psychosocial well-being of each resident.

42 C.F.R. at § 483.40(d).

The State Operations Manual (SOM) specifies that “‘[m]edically-related social services’ means services provided by the facility’s staff to assist residents in maintaining or improving their ability to manage their everyday physical, mental, and psychosocial needs.”  State Operations Manual (SOM) – Guidance to Surveyors for Long Term Care Facilities, CMS Pub. 100-07, App. PP at 102 (rev. 26, eff. Aug. 17, 2007), *available at* https://www.cms.gov/regulations-and-guidance/legislation/cfcsandcops/downloads/som107ap_pp_guidelines_ltcfpdf; CMS Ex. 31 at 2.  The SOM further provides a non-exhaustive list of examples of medically related social services.  These services might include:

assisting staff to inform resident and those they designate about the resident’s health status and health care choices and their ramifications;
	providing or arranging provision of needed counseling services;
	through the assessment and care planning process, identifying and seeking ways to support residents’ individual needs;Page 5

promoting actions by staff that maintain or enhance each resident’s dignity in full recognition of each resident’s individuality;
	assisting residents to determine how they would like to make decisions about their health care and whether they would like anyone else to be involved in those decisions;
	finding options that most meet the physical and emotional needs of each residentSOM App. PP at 102-103; CMS Ex. 31 at 2-3.

The SOM notes that the types of conditions to which a facility should respond with social services by staff or referral include behavioral symptoms, the presence of a chronic disabling medical or psychological condition, depression, chronic or acute pain, difficulty with personal interaction, and socialization skills.  *Id*. at 3-4.  The SOM explains “it is the responsibility of the facility to identify the medically-related social service needs of the resident and assure that the needs are met by the appropriate disciplines.”  *Id*. at 2.

CMS asserts Saint Anne did not substantially comply with the demands of 42 C.F.R. § 483.40(d) because it failed to meet the physical, mental, and psychosocial needs of Resident 50, a primarily Spanish-speaking resident, by failing to provide him with adequate translation services.2
  CMS Br. at 11.  Saint Anne contends it was not obliged to hire a translator under the regulations because its staff utilized “communication techniques” such as gesturing and otherwise relied on the resident’s family for translation when those techniques were insufficient.  P. Br. at 10-11.  Saint Anne also argues the record fails to establish evidence of actual physical, mental, or psychosocial harm to Resident 50.  *Id*. at 11-12.

I find Saint Anne’s claim that it provided adequate translation services to Resident 50 unpersuasive.  The facility recognized Resident 50, who was 92 years old at admission and spoke Spanish as his primary language, would have issues with communication.  CMS Ex. 8 at 1; *see also*CMS Ex. 9 at 2, 6, 7, 8, 11, 12, 16 (notes from facility staff indicating Resident 50 did not speak English).  The care plan Saint Anne fashioned for Resident 50 similarly documented “a communication problem [relating to] Language barrier,” and noted his “difficulty making [himself] understood and understanding others.”  CMS Ex. 10 at 2.

Page 6

As a result, Saint Anne identified several interventions to address Resident 50’s communication limitations, including:  use of “communication techniques which enhance interaction;” asking yes/no questions; using “simple, brief, consistent words/cues;” referring to “speech therapy for evaluation and treatment;” and providing a “translator as necessary to communicate with the resident.”  *Id*. at 2-3.

Despite recognizing that Resident 50 would require a translator “as necessary” for his communication needs, the facility did not actually ensure one would be available “as necessary.”  Instead, Saint Anne relied exclusively on Resident 50’s family to provide translation services in an ad hoc fashion.  When staff needed to interact with Resident 50 in the absence of his family, they used gestures or basic questions in Spanish.3
  CMS Ex. 7 at 16-17; CMS Ex. 9 at 2, 3, 7, 12, 16, 18.  But for any communication that exceeded the facility’s limited capacity, it relied on the resident’s sons, who visited regularly during visiting hours and translated for their father during these visits.  *Id.* at 16 (care conference notes indicating the resident’s sons “visit regularly and [are] available to provide translation.”); CMS Ex. 10 at 2 (care plan noting that “[o]ften family is at bedside and they all assist in interpreting); P. Ex. 2 at 2.

Saint Anne argues this approach was reasonable because Resident 50’s sons were present daily during visiting hours and were therefore generally available when he was likely to be awake and in need of translation assistance.  But relying exclusively on Resident 50’s family for translation meant that Resident 50 would be without translation services outside of visiting hours, including nights or any other times his sons were not present.  Tr. at 38.  Moreover, the resident’s sons were not ideal choices as translators because staff could not always understand what the facility’s Administrator described as their “heavily accented English.”  *Id.*at 49.  Finally, relying exclusively on Resident 50’s family members for translation would not be appropriate if Resident 50 wished to express health care choices or needs he did not want to make known to his family.

Saint Anne otherwise contends there was no need to procure dedicated translation services for Resident 50 because he knew enough English to make his needs known.  P. Br. at 11; P. Closing Br. at 9.  But the record before me does not demonstrate the resident had such capacity.  It instead memorializes numerous instances where facility staff could not adequately communicate with the resident, particularly at night when his sons were not present.  Facility progress notes indicate Resident 50 had several nocturnal episodes where he was sleepless, combative, and yelling at staff.  CMS Ex. 9 at 7-13, 16.  He was also found lying or sitting on the floor next to his bed or lying with bed controls wrapped around him.  *Id*.  On another night he tore his bed apart and threw a wet brief on the floor.  *Id*. at 9.  Staff noted on June 20, 2017 that Resident 50 was “often restless at night . . .

Page 7

[and] will not ask for help.”  *Id*. at 7.  Saint Anne’s Administrator testified that Resident 50 would express his anger by hollering, yelling, pounding the table, and waiving his urinal.  P. Closing Br. at 13, *citing* Tr. at 52.  These episodes all occurred overnight or during early morning hours when Resident 50’s sons were not available to provide translation services, belying the facility’s claim that relying on either the resident’s sons to translate when they were present or on the resident himself to make his needs known was adequate.4

Saint Anne’s staff inability to understand Resident 50 or respond to his needs was not limited to nights.  On one occasion, a surveyor observed a staff member moving Resident 50 down the hall in his wheelchair.  CMS Ex. 7 at 17; CMS Ex. 28 at 2.  The surveyor heard Resident 50 yelling in Spanish that he did not want to be moved.  *Id*.  However, the staff member did not understand Resident 50 and continued to move him down the hall despite his protestations.  *Id*.  The staff member did not attempt to find out what Resident 50 was saying or seek interpretation from his family located in the resident’s room.  *Id*.  Resident 50’s yelling grew progressively louder until his son came and brought him back.  *Id*.

On another occasion, a surveyor observed bingo activity in the facility dining room, which was conducted only in English.  CMS Ex. 7 at 16; CMS Ex. 28 at 2.  Resident 50, appearing agitated and shaking his wheelchair, motioned for the surveyor to come over and “loudly [stated] he wanted to return to his room.”  *Id*.  The Activities Assistant leading the activity did not know what Resident 50 was saying and the surveyor perceived no effort on her part to understand him.  *Id*.  Absent the coincidental presence of a surveyor who spoke Spanish and could advise the Activities Assistant of Resident 50’s stated wishes, it does not appear the facility had resources in place to adequately understand and accommodate the resident’s requests, even one as simple as asking to return to his room.  *Id*.

The record does not indicate Saint Anne found alternative ways to effectively communicate with Resident 50.  The facility placed a communication binder in his room, but only after the survey began.  CMS Ex. 10 at 4; Tr. at 35, 36.  Even Saint Anne’s Administrator did not believe a “picture book” the best way to communicate with Resident 50, Tr. 35, and the fact that the facility did not attempt to utilize one until months after his admission, during the survey, does not suggest a meaningful effort to establish effective means of communication with Resident 50.  Indeed, there is no evidence Saint Anne sought to initiate any of the interventions contemplated to meet that end in the resident’s care plan, such as communication techniques to enhance interaction

Page 8

or referrals to speech therapy for evaluation and treatment, or, most applicable here, on-demand translation services.

Saint Anne’s claim that its inadequate efforts to establish effective communication with Resident 50 was acceptable because it did not cause him psychosocial harm is without merit.  The facility documented numerous instances where Resident 50 exhibited restlessness, frustration, and yelling.  CMS attributes these behaviors to Resident 50’s frustration being in a facility where no one could understand him.  CMS Closing Br. at 16-17.  Saint Anne now insists Resident 50’s behaviors “had nothing to do with the ‘communications’ or translation” and instead attributes them to the discontinuation of melatonin, his overall frustration about being in a nursing home, difficulty hearing, and dementia.  P. Closing Br. at 13-15.  But its Activities Director admitted to a surveyor that “she felt the reason why the resident [] yells so much is because he feels like he is not being heard so he yells out loud to try and communicate what he wants to say.”  CMS Ex. 7 at 17.  Resident 50’s sons also thought their father’s behavioral issues resulted from frustration arising from communication difficulties.  CMS Ex. 7 at 16.

But it is ultimately irrelevant whether Resident 50 expressed frustration due to the inability to communicate effectively or for the other reasons speculated upon by Saint Anne because the facility did not establish effective communications with the resident in the first place.  Had it done so, there would be no confusion as to cause of Resident 50’s frustration and disruptive behavior.

Saint Anne’s Social Services Director reported she did not know what caused Resident 50 to yell in frustration and that she “[had] not looked into what might be causing the resident’s unrest.”  CMS Ex. 7 at 17.  Facility staff instead assumed Resident 50’s behavioral issues arose from dementia or difficulty in hearing, despite the absence of evidence in his medical records to support either conclusion.5
  *Id*.  At least one staff member simply dismissed the behavior as characteristic of Resident 50.  *Id*.

In short, the facility’s failure to communicate effectively with the resident meant that it never considered or provided additional social services or referral for more specialized treatment.  Even if Resident 50’s behavior could be attributed to any of the causes identified by Saint Anne, the facility still failed to meet its obligation under the regulations to communicate with him and assess his needs in order to provide him better care and support.  Saint Anne was obligated to assist Resident 50 in improving his physical, mental, and psychosocial needs that were made evident by his disruptive behavior.  It did not do so.  I conclude Saint Anne did not provide the social services Resident 50 needed so that he could attain the highest practicable physical, mental, and

Page 9

psychosocial well-being and therefore was not in substantial compliance with 42 C.F.R. § 483.40(d).

**C.  Saint Anne failed to substantially comply with 42 C.F.R. § 483.25(b)(1), Tag F314, by failing to take the necessary precautions to protect Resident 58 from developing preventable pressure ulcers.**

42 C.F.R. § 483.25(b)(1), the regulatory subsection concerning pressure ulcer prevention and treatment, is a “quality of care” requirement.  The quality of care regulation broadly demands that “the facility must ensure that residents receive treatment and care in accordance with professional standards of practice, the comprehensive person-centered care plan, and the resident’s choices...”  42 C.F.R. § 483.25.  The regulatory regime “imposes on facilities an affirmative duty designed to achieve favorable outcomes to the highest practicable degree.”  *Windsor Health Care Ctr.*, DAB No. 1902 at 16-17 (2003), *aff’d, Windsor Health Care Ctr. v. Leavitt*, 127 F. App’x 843 (6th Cir. 2005).  To that end, the facility must take “reasonable steps” and “practicable measures to achieve that regulatory end.”  *Clermont Nursing & Convalescent Ctr.*, DAB No. 1923 at 21 (2004), *aff’d, Clermont Nursing & Convalescent Ctr. v. Leavitt*, 142 F. App’x 900 (6th Cir. 2005).

The quality of care regulation applicable to pressure ulcers provides:

(b) *Skin integrity* – (1) Pressure ulcers.  Based on the comprehensive assessment of a resident, the facility must ensure that –
(i) A resident receives care, consistent with professional standards of practice, to prevent pressure ulcers and does not develop pressure ulcers unless the individual’s clinical condition demonstrates that they were *unavoidable*; and
(ii) A resident with pressure ulcers receives necessary treatment and services, consistent with professional standards of practice, to promote healing, prevent infection and prevent new ulcers from developing.

42 C.F.R. at § 483.25(b) (emphasis added).

This regulatory requirement does not impose strict liability on a facility whenever a resident develops a pressure ulcer.  Instead, in assessing the facility’s compliance with this requirement, the relevant question is:  did the facility “take all necessary precautions” to promote healing, prevent infection, and prevent new ulcers from developing?  In other words, was development of the pressure ulcer unavoidable?6
  If so, the fact that a resident

Page 10

develops ulcers does not demonstrate a deficiency.  But if the evidence establishes that the facility fell short of taking all necessary precautions, it has failed to meet the demands of the regulation.  *Senior Rehab. & Skilled Nursing Ctr.*, DAB No. 2300 at 13-14 (2010), *aff’d, Senior Rehab. & Skilled Nursing Ctr. v. Health & Human Servs.*, 405 F. App’x 820 (5th Cir. 2010); *Koester Pavilion*, DAB No. 1750 at 32 (2000).  In short, “a facility must provide all necessary care and services to prevent the development of pressure sores, rather than just provide prompt treatment after they develop, particularly where the residents involved were known to have a high risk of developing sores.”  *Koester Pavilion*, DAB No. 1750 at 33 (2000); *see also Clermont Nursing*, DAB No. 1923 at 9-10 (2004), *aff’d, Clermont Nursing*, 142 F. App’x 900.

Relevant here, Resident 58 was a 90-year-old woman on admission to Saint Anne on July 27, 2017.  CMS Ex. 18 at 1.  The facility assessed her with numerous ailments including dementia, anxiety, and resistance to eating.  CMS Ex. 20 at 4.  Saint Anne described her as “very debilitated and in the last days of her life.”  P. Br. at 7.  On the date of her admission, Resident 58 underwent a skin assessment and “no skin problems [were] noted.”  CMS Ex. 23 at 1.  Saint Anne completed a Minimum Data Set (MDS)7
 assessment on August 3, 2017 which noted Resident 58 had no pressure ulcers but was at risk for developing pressure ulcers.  CMS Ex. 25 at 29.  A second MDS assessment completed one week later again noted Resident 58 was at risk for developing pressure ulcers.  CMS Ex. 26 at 29.

Despite these conclusions, the record does not contain evidence that the facility took additional measures to assess or diminish Resident 58’s risk of developing pressure ulcers.  Resident 58’s care plan, implemented on July 30, 2017, did not identify her to be at risk for developing pressure ulcers or contain any interventions or services in order to prevent pressure ulcers from developing.  CMS Ex. 20; *see* CMS Ex. 27 at 2.  However, Saint Anne’s “Task List Report” indicated that skin observation was to occur as needed.  P. Ex. 2 at 10.  The resident’s treatment flow sheets also indicated the facility implemented a “weekly skin check.”  CMS Ex. 21 at 5,19, 35, 51.

On September 20, 2017, facility staff observed an unstageable8
 pressure ulcer on Resident

Page 11

58’s left heel measuring 2.5 cm by 2 cm with eschar present.  CMS Ex. 23 at 5; P. Ex. 2 at 14, 30.  However, the facility’s weekly skin assessment from September 21, 2017 indicated “no noted skin issues.”  CMS Ex. 24 at 1-2.  The facility again documented the presence of a left heel pressure ulcer on September 26, 2017.  CMS Ex. 23 at 5.9

Once the facility diagnosed the pressure ulcer, Resident 58’s progress notes indicated it was appropriate to include new interventions, namely changing the wound coverings every two days and wearing a “[s]age pillow heel protection boot at all times.”  CMS Ex. 23 at 5.  At this time, Resident 58 reported 10 out of 10 levels of pain.  *Id*.  Saint Anne updated Resident 58’s care plan to reflect “a left heel pressure ulcer [related to] decreased mobility and poor nutrition.”  CMS Ex. 20 at 6.  The update added interventions to help the pressure ulcer heal, including floating Resident 58’s heels, administrating treatments and medications, following facility policies, monitoring and reporting any skin changes, and educating Resident 58, her family, and caregivers about skin breakdown.  CMS Ex. 20 at 6-7.

On October 17, 2017, Resident 58’s pressure ulcer had grown to 6 cm by 3 cm, which was attributed to continued pressure on the area.  CMS Ex. 23 at 10.  At that time, Saint Anne updated Resident 58’s care plan again to focus on skin integrity.  CMS Ex. 20 at 1.

Based on these facts, CMS contends Saint Anne failed to render necessary treatment and services to Resident 58 to prevent the development of a pressure ulcer on her left heel approximately two months after her admission to the facility.  CMS. Br. at 12-13.  Saint Anne responds that Resident 58 had no need for specific pressure ulcer interventions until September 20, 2017, at which point the facility implemented comprehensive measures to address the pressure ulcer and thus provided appropriate wound care under the regulations.  P. Br. at 14-15; P. Closing Br. at 24-25.

I conclude Saint Anne did not substantially comply with 42 C.F.R. § 483.25(b) because it failed to deliver the necessary care and services to Resident 58 to prevent the development of pressure ulcers, despite recognizing the risk of their occurrence.  There is no dispute that Resident 58 was admitted to the facility in July 2017 with no pressure ulcers and then developed an unstageable ulcer on her left heel by September 20, 2017.  The question is whether the development of this pressure ulcer was unavoidable.  Generally, the failure of a facility to follow its own plan of care to prevent pressure sores from developing is evidence of noncompliance with section 483.25(b).  *See e.g., Lakeridge Villa Health Care Ctr.*, DAB No. 1988 at § 5 (2005), *aff’d, Lakeridge Villa*

Page 12

*Health Care Ctr. v. Leavitt*, 202 F. App’x. 903 (6th Cir. 2006) (facility failed to provide care consistent with its own plan of care to ensure avoidable pressure sores did not develop and to promote healing and prevent infection of existing pressure sores).
Here, Saint Anne recognized Resident 58 was at risk to develop pressure sores, memorialized that risk in the resident’s MDS, but included no specific interventions in her care plan to account for the risk.  CMS Ex. 29 at 1; CMS Ex. 27 at 3 (“a pressure ulcer prevention plan had not been developed prior to Resident 58 developing the pressure ulcer.”).  By its own admission, Saint Anne took no steps to prevent pressure ulcers from developing.  P. Br. at 15; P. Closing Br. at 26 (Resident 58 “did not have any pressure ulcer issues at [admission], and the plan was to deal with anything [that] developed as needed.”).

Saint Anne’s argument that it did not have to plan to deal with the risk of pressure ulcers in an extremely elderly resident until the appearance of an actual pressure ulcer turns the regulation on its head.  A plan to wait to “deal with anything” until it became an observable problem is not adequate under the regulation concerning pressure ulcers, which requires a facility provide care “to *prevent*pressure ulcers,” not merely treat them when they appear.  42 C.F.R. at § 483.25(b)(1) (emphasis added).   Nor does this approach satisfy the facility’s more general obligation to ensure Resident 58 received “treatment and care in accordance with professional standards of practice, the comprehensive person-centered care plan, and the resident’s choices . . .”  42 C.F.R. § 483.25.

Moreover, while not memorialized in Resident 58’s actual care plan, Saint Anne did acknowledge the need for interventions including skin observation to occur “as needed,” P. Ex. 2 at 10, and weekly skin checks.  CMS Ex. 21 at 5,19, 35, 51.  It does not appear the facility met even these minimal obligations.  Saint Anne asserts its staff gave Resident 58 “[a] daily skin assessment [from] head to toe” with specific attention to “bony prominences” that would have included her heels.  P. Closing Br. at 24, citing P. Ex. 2, App. D at 1.  But it is exceedingly unlikely that staff providing weekly skin checks and daily scrutiny of Resident 58’s skin would have missed the development of an unstageable pressure ulcer.10
  Had the facility provided these minimal measures, it is likely Resident 58 might have avoided the development of a pressure wound, or at least one of such severity.  The failure to provide these needed interventions that should have

Page 13

been incorporated into the resident’s care plan confirms the facility failed to meet its obligations under 42 C.F.R. at § 483.25(b).  *Lakeridge Villa*, DAB No. 1988 at § 5.

Saint Anne also seeks to establish unavoidability by blaming the resident and her family for her choice of shoes, speculating the pressure ulcer may have been caused by Resident 58 kicking off the shoes provided by her family, which the facility described as “beaten up.”  P. Br. at 8-9; P. Closing Br. at 20-21; Tr. at 82.  It is somewhat absurd to blame the resident’s pressure ulcers on her family’s choice of footwear.  But even if this was the cause (and there is no evidence to that effect), the facility is not absolved of the responsibility to provide needed care to prevent pressure ulcers.  42 C.F.R. at § 483.25(b)(1).  Furthermore, the notion that a resident’s particular footwear might cause an ulcer, particularly a pair the facility considered “beaten up,” is hardly unforeseeable or, therefore, unavoidable.  *Koester Pavilion*, DAB No. 1750 at 32 (“While it is understandable that a facility would wish to accommodate the preferences of a resident or his/her family members, the facility has an obligation under the regulations to take any necessary precautions to prevent pressure sores . . .  The facility should accommodate the family’s preferences as much as possible but must still take necessary measures to prevent the predictable consequence of pressure sores.”).

Saint Anne’s remaining arguments detail the actions the facility took once the pressure ulcer was discovered, asserting “the facility had resolved any deficiency with the care changes initiated on September 20 and September 26, and the care plan modification on October 16, 2017.”  P. Br. at 15-16; P. Closing Br. at 26.  But as I have explained, the regulation requires facilities to take measures to prevent the development of pressure ulcers, and not merely provide prompt treatment after they develop, particularly where the facility had concluded the resident in question had a risk of developing pressure ulcers.  Appropriate treatment of a pressure ulcer after it develops does not address the question of whether a facility took adequate measures to prevent development of a pressure ulcer in the first place.

Here, the record demonstrates that the only intervention Saint Anne utilized to prevent pressure ulcers from developing was weekly or “as needed” skin checks.  But the facility did not document how it conducted those skin checks, and as I have observed, there is sufficient reason here to suspect the thoroughness of those skin checks.  In sum, Saint Anne may have provided competent and adequate care for Resident 58 after she developed a pressure ulcer, but it still failed to substantially comply with the regulations because it did not impose or execute adequate interventions to prevent development of a pressure sore in the first place.  For these reasons, I find Saint Anne failed to substantially comply with 42 C.F.R. § 483.25(b)(1).

**D.  The per-day CMPs imposed by CMS are reasonable.**

My authority to review the reasonableness of a CMP is set forth at 42 C.F.R.

Page 14

§ 488.438(e).  In determining the reasonableness of the penalty amount imposed, I look to the factors set forth at 42 C.F.R. §§ 488.438(f) and 488.404 (incorporated by reference into 42 C.F.R. § 488.438(f)(3)).  These factors include the seriousness of the deficiency, the facility’s compliance history, its financial condition, and its degree of culpability.  *Id.*

Unless a facility contends that a particular regulatory factor does not support the CMP amount, I must sustain it.  *Coquina Ctr.*, DAB No. 1860 at 32 (2002).  My review of the reasonableness of the CMP is de novo and based upon the evidence in the record before me.  However, the Board has held that the CMP amount selected by CMS is presumptively reasonable based on the regulatory factors listed above, and that the burden is on the SNF “to demonstrate, through argument and the submission of evidence addressing the regulatory factors, that a reduction [in the penalty amount] is necessary to make the CMP amount reasonable.”  *Crawford Healthcare & Rehab.*, DAB No. 2738 at 19 (2016).  My role is therefore to determine whether the amount of a CMP is “within reasonable bounds” considering the purpose of the Act and regulations.  *Emerald Oaks*, DAB No. 1800 at 12 (2001).

In this case, CMS imposed a $1,010 per-day CMP for 77 days from October 23, 2017 through January 7, 2018 for a total CMP of $77,770.  This CMP is near the minimum per-day CMP that CMS may impose.  42 C.F.R. § 488.438(2); 45 C.F.R. § 102.3.11
  CMS summarily argues that the per-day CMP proposed is reasonable because Saint Anne has a history of noncompliance and the deficiencies were serious in nature and showed a degree of culpability.  CMS Closing Br. at 20.  Saint Anne objects to CMS’s selection of a per-day CMP rather than a per-instance CMP, citing guidance provided in CMS’s 2017 Survey & Certification Group (S&C) Memorandum addressing revisions to CMP policies and the CMP Analytic Tool.  P. Br. at 16 (citing CMS S&C Memorandum, 17-37-NH).12
  Saint Anne therefore argues that any CMP imposed should be “no more than $10,000.00.”  P. Br. at 17.

Page 15

Saint Anne’s argument is not without merit.  But CMS’s choice of remedies, including whether to impose a per-day or per-instance CMP, is not an initial determination subject to appeal and therefore not within my jurisdiction.  42 C.F.R. § 498.3(d)(11).  I do not have authority to evaluate penalties based on CMS’s internal guidelines for imposing them.  My review is limited to whether the penalty imposed is reasonable.  In assessing the overall reasonableness of a per-day CMP amount, I am required to consider the per-day amount itself is reasonable, rather than the total accrued CMP.  *See Kenton Healthcare, LLC*, DAB No. 2186 (2008).

Upon consideration of the regulatory factors, I find the $1,010 per-day CMP imposed by CMS to be reasonable.  In the first place, despite bearing the burden of demonstrating the unreasonableness of the penalty in question, *Crawford*, DAB No. 2738 at 19, Saint Anne fails to argue how to apply any of the factors I must consider.  P. Br. at 15-16; P. Closing Br. at 26-27.  The facility instead persists in arguing that only a per-instance CMP would be appropriate here.  Nevertheless, I have considered the regulatory factors.

Neither party argues that Saint Anne’s financial condition is a factor affecting the penalty amount.  Saint Anne has not proffered evidence of financial vulnerability that would warrant a reduction in the CMP amount.  I have given no consideration to this factor.

Concerning the facility’s history of noncompliance, CMS presented evidence that Saint Anne had a prior CMP imposed for a “G” level deficiency five months prior to the survey at issue in this case.  CMS Ex. 3 at 1.  Saint Anne has not contested the veracity of this document. I have taken the facility’s history of noncompliance into account.

I conclude that Saint Anne demonstrated a high level of culpability and that the deficiencies cited were serious in nature.  As I have discussed, Saint Anne provided deficient care to Residents 50 and 58 and caused actual harm to both residents.  With respect to Resident 50, Saint Anne failed to provide translation services to the resident, leaving no effective way to communicate when his family was not present thus harming his quality of life and psychosocial well-being as a resident of the facility.  With respect to Resident 58, Saint Anne failed to place any interventions in place to prevent pressure ulcers from developing despite assessing her to be at risk of developing pressure ulcers at admission.  Saint Anne is culpable for placing no interventions in place to prevent pressure ulcers from developing for Resident 58.  The development of an unstageable pressure ulcer caused Resident 58 great pain in the last days of her life and could have been avoided with better and more thorough interventions in place.  Accordingly, in light of the seriousness of the deficiencies and the facility’s culpability, I find the $1,010 per-day CMP for the non-immediate jeopardy deficiencies in this case to be reasonable.

Turning to duration of the per-day CMP, neither party discusses the reasonableness of the proposed duration of the CMP, which is 77 days.  Upon review, I conclude the evidence of record supports the duration of the CMP.  State agency surveyors determined

Page 16

Saint Anne was out of compliance on October 23, 2017.  CMS Ex. 1.  The state agency completed a revisit survey on January 8, 2018, finding that Saint Anne had returned to substantial compliance on that day.  CMS Ex. 2.  Saint Anne has failed to present evidence that it returned to substantial compliance earlier than January 8, 2018.  *Brier Oak Terrace Care Center*, DAB No. 1798 at 8-9 (2001) (providing the facility bears the burden of proving it achieved substantial compliance on a date earlier than that determined by CMS).  I therefore conclude that the duration of the CMP is reasonable.

VI.   Conclusion

Based on the foregoing, I conclude that Saint Anne was out of substantial compliance with Medicare participation requirements.  I sustain the imposition of a $1,010 per‐day CMP from October 23, 2017 through January 8, 2018, for a total CMP of $77,770.


          /s/
        Bill Thomas

                      Administrative Law Judge
      1. Civil money penalty amounts increased, effective February 3, 2017, for deficiencies occurring after November 2, 2015.  See 82 Fed. Reg. 9,174, 9,175 (Feb. 3, 2017).  The lower range for a per-day CMP in effect at the time of the survey at issue here was $105 to $6,289.  42 C.F.R. § 488.438(a)(2); 45 C.F.R. § 102.3; 82 Fed. Reg. at 9,175. back to note 1
                      2. Saint Anne does not dispute that providing translation is a medically related social service.  It would not be well placed to do so after it incorporated translation services as an intervention into Resident 50’s care plan.  CMS Ex. 10 at 2-3.  In any case, skilled nursing facilities could hardly provide services “to assist residents in maintaining or improving their ability to manage their everyday physical, mental and psychosocial needs,” CMS Ex. 31 at 2, if their staff did not at minimum establish effective means of communications with residents. back to note 2
                      3. It is not clear which members of staff could speak Spanish or how well; at least one staff member claimed to speak Spanish but was unable to demonstrate how to translate “I need to give you a shower.”  CMS Ex. 9 at 16; CMS Ex. 28 at 3. back to note 3
                      4. It does not appear Resident 50’s sons thought this approach was adequate.  The sons expressed concern and frustration with Saint Anne’s treatment of their father.  CMS Ex. 7 at 16; CMS Ex. 28 at 2.  One son indicated that the lack of communication with facility staff caused his father “to yell out loudly and get[] agitated and sometimes [cry].”  CMS Ex. 7 at 16. back to note 4
                      5. If true, it is equally concerning that members of the facility’s staff believed they recognized signs of dementia or of hearing loss yet did nothing to further evaluate Resident 50 for those issues and provide additional services if needed. back to note 5
                      6. In its guidance to surveyors, CMS provides “avoidable” pressure ulcers occur where “the resident developed a pressure ulcer and. . . the facility did not do one or more of the following: evaluate the resident’s clinical condition and pressure ulcer risk factors; define and implement interventions that are consistent with resident needs, resident goals, and recognized standards of practice; monitor and evaluate the impact of the interventions; or revise the interventions as appropriate.”  CMS Ex. 32 at 3. back to note 6
                      7. The MDS entails a comprehensive, standardized assessment of each resident’s functional capabilities and health needs.  See 42 C.F.R. § 483.20(b). back to note 7
                      8. “Unstageable” refers to full-thickness skin and tissue loss where the extent of damage cannot be assessed because of obscuration by dead tissue referred to as slough or eschar.  If the dead tissue were removed, a Stage 3 or 4 pressure injury would be revealed.  Nat’l Pressure Ulcer Advisory Panel, NPUAP Pressure Injury Stages at 1, available at https://cdn.ymaws.com/npiap.com/resource/resmgr/online_store/npiap_pressure_injury_stages.pdf (last visited Mar. 1, 2022). back to note 8
                      9. Despite this inconsistency in Saint Anne’s clinical notes, the parties agree the facility discovered the pressure ulcer on Resident 58’s left heel on September 20, 2017.  See CMS Closing Br. at 5; P. Closing Br. at 22. back to note 9
                      10. The only indication that weekly skin checks were implemented at all was contained in the Physician’s Order Form.  P. Ex. 2 at 13.  Saint Anne presented no evidence to establish how skin checks were performed or how they were documented.  It is noteworthy that Resident 58’s unstageable pressure ulcer was discovered on September 20, 2017, but not identified in the September 21, 2017 skin assessment. Compare P. Ex. 2 at 30, with CMS Ex. 24 at 1-2.  The only reasonable inference to draw is that the staff member who completed the skin assessment on September 21, 2017 either did not conduct the skin assessment at all or did not perform one thoroughly enough to notice an unstageable pressure ulcer on Resident 58’s left heel. back to note 10
                      11. As previously explained, the range for per-day CMPs in the lower range may be $105 to $6,289 per day. back to note 11
                      12. The CMP Analytic Tool is used by CMS Regional Offices to calculate the amount of a CMP imposed based on the type of noncompliance.  On July 7, 2017, CMS issued a revised CMP Analytic Tool to instruct “how to use Per Day and Per Instance CMPs depending on the timing of the noncompliance in relation to the survey, whether residents were harmed or abused, whether the facility has a good compliance history, and whether the noncompliance was an isolated event or persistent deficient practices were identified.”  CMS S&C Memorandum 17-37-NH.  The memorandum is available at https://ltcombudsman.org/uploads/files/library/cmp-analytic-tool-revision.pdf. (last visited Mar. 1, 2022).  CMS has since rescinded the guidance cited by Saint Anne, and now reserves the discretion as to whether to impose a per-day or per-instance penalty for prior noncompliance.  CMS Revision of Civil Money Penalty (CMP) Policies and CMP Analytic Tool 17-37-NH, available at https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/Policy-and-Memos-to-States-and-Regions-Items/Survey-and-Cert-Letter-17-37.  back to note 12 Back to top
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