Signature Healthcare of Norfolk, DAB CR5663 (2020)

DECISION

Signature Healthcare of Norfolk (Petitioner or “the facility”) challenges the determination by the Centers for Medicare & Medicaid Services (CMS) that it was not in compliance with 42 C.F.R. § 483.25(d)(1), (2) (Tag F323, relating to accident prevention and adequate supervision).  Petitioner also challenges CMS’s determination that this deficiency posed immediate jeopardy to resident health and safety, and the imposition of a per-day civil monetary penalty (CMP) of $7,437 for 190 days of immediate jeopardy.  For the reasons discussed below, I find that there is no dispute as to any material fact, and CMS is entitled to judgment as a matter of law because the facility was not in substantial compliance with Medicare program requirements, the deficiency resulted in immediate jeopardy to resident health and safety, and the CMP imposed is reasonable.

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I.  Background

The Social Security Act (Act) establishes requirements for skilled nursing facility (SNF) participation in the Medicare program and authorizes the Secretary of Health and Human Services (“the Secretary”) to promulgate regulations implementing those statutory provisions.  See 42 U.S.C. § 1395i-3; 42 C.F.R. pts. 483 and 488.  To participate in the Medicare program, an SNF must maintain substantial compliance with program participation requirements.  In order to be in substantial compliance, an SNF’s deficiencies may “pose no greater risk to resident health or safety than the potential for causing minimal harm.”  42 C.F.R. § 488.301.  “Noncompliance” means “any deficiency that causes a facility to not be in substantial compliance.”  Id.

The Secretary contracts with state agencies to conduct periodic surveys to determine whether SNFs are in substantial compliance with participation requirements.  42 U.S.C. § 1395aa(a); 42 C.F.R. §§ 488.10, 488.20.  The Act and its implementing regulations require that facilities be surveyed on average every twelve months, and more often if necessary, to ensure that identified deficiencies are corrected.  42 U.S.C. § 1395i-3(g)(2)(A); 42 C.F.R. §§ 488.20(a), 488.308.  CMS may impose a per-day CMP for the number of days an SNF is not in substantial compliance, or a per-instance CMP for each instance of the SNF’s noncompliance.  42 U.S.C. § 1395i-3(h)(2)(B)(ii); 42 C.F.R. § 488.430(a).1

If CMS imposes a remedy based on a noncompliance determination, then the facility may request a hearing before an administrative law judge (ALJ) to challenge the

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noncompliance finding and enforcement remedy.  42 U.S.C. §§ 1320a-7a(c)(2), 1395i‑3(h)(2)(B)(ii); 42 C.F.R. §§ 488.408(g), 488.434(a)(2)(viii), 498.3(b)(13).

Surveyors from the Virginia Department of Health’s Office of Licensure and Certification (state agency) completed an “unannounced Medicare/Medicaid standard survey” on January 31 through February 3, 2017, and an extended survey from February 1-3, 2017, and determined that Petitioner was not in substantial compliance with Medicare program participation requirements.  CMS Ex. 1 at 1-70.

In a letter dated May 1, 2017, CMS notified Petitioner that it was not in substantial compliance with Medicare program participation requirements.  CMS Ex. 41.  CMS determined that the “most serious health deficiency” was an immediate jeopardy2 deficiency at the “J” level of scope and severity,3 cited as Tag F323,4 42 C.F.R. § “483.25(d)(1)(2)(n)(1)-(3).”5  CMS Ex. 41 at 1.  CMS explained that “the immediate jeopardy situation was abated” on February 1, 2017.  CMS Ex. 41 at 2.  CMS imposed,

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inter alia, a per-day CMP of $7,437 for 190 days for the period from July 26, 2016, through January 31, 2017, for a combined CMP of $1,413,030.6  CMS Ex. 41 at 2.

Petitioner, through counsel, timely requested a hearing on June 27, 2017.  CMS filed a pre-hearing brief and 43 proposed exhibits (CMS Exs. 1-43), and Petitioner filed a brief (P. Br.) and seven proposed exhibits (P. Exs. 1-7).  Thereafter, CMS filed a motion for summary judgment (CMS Motion), and Petitioner filed a response in opposition (P. Response).

In the absence of any objections, I admit CMS Exs. 1-43 and P. Exs. 1-7 into the evidentiary record.  Because I am granting CMS’s motion for summary judgment, an oral hearing is unnecessary in this case to allow the parties an opportunity to cross-examine witnesses.7

II.  Issues

The issues presented are:

Whether summary judgment is appropriate;

Whether Petitioner was in substantial compliance with 42 C.F.R. § 483.25(d)(1),(2), and if not, whether the deficiency posed immediate jeopardy to resident health and safety;

Whether the cited duration of the noncompliance was appropriate; and

Whether a per-day CMP of $7,437 is reasonable.

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III.  Discussion8

A. Summary judgment is appropriate because material facts are not in dispute.

Summary judgment is appropriate when there is no genuine dispute as to any issue of material fact for adjudication and/or the moving party is entitled to judgment as a matter of law.  Senior Rehab. & Skilled Nursing Ctr.,DAB No. 2300 at 19-20 (2010), aff’d, Senior Rehab. & Skilled Nursing Ctr. v. Health & Human Servs.,405 F. App’x 820 (5th Cir. 2010); see Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248 (1986).  The moving party must show that there are no genuine disputes of material fact requiring an evidentiary hearing and that it is entitled to judgment as a matter of law.  Anderson,477 U.S. at 248.  If the moving party meets its initial burden, the non-moving party must “come forward with ‘specific facts showing that there is a genuine issue for trial.’”  Matsushita Elec. Indus. Co. v. Zenith Radio Corp., 475 U.S. 574, 587 (1986) (emphasis omitted).  “To defeat an adequately supported summary judgment motion, the non-moving party may not rely on the denials in its pleadings or briefs, but must furnish evidence of a dispute concerning a material fact -- a fact that, if proven, would affect the outcome of the case under governing law.”  Senior Rehab., DAB No. 2300 at 3.  In determining whether there are genuine issues of material fact for hearing, an ALJ must view the evidence in the light most favorable to the non-moving party, drawing all reasonable inferences in that party’s favor.  Id.

It is well established that an ALJ is empowered to decide a case on a motion for summary judgment, without an evidentiary hearing.  Shah v. Azar, 920 F.3d 987, 996 n.25 (5th Cir. 2019) (citing Cedar Lake Nursing Home v. U.S. Dep’t of Health & Human Servs., 619 F.3d 453, 457 (5th Cir. 2010)); see Fal-Meridian, Inc. v. U.S. Dep’t of Health & Human Servs., 604 F.3d 445, 449 (7th Cir. 2010) (“All it means for a decision to be based on a grant of summary judgment is that there are no issues that would benefit from being resolved in an evidentiary hearing.”) (emphasis added); Crestview Parke Care Ctr., 373 F.3d 743, 748-50 (6th Cir. 2004) (explaining that [t]he statute authorizing the imposition of penalties requires a hearing ‘on the record,’ and that the use of summary judgment is “valid” and “provides an alternative to in-person, oral hearings.”).

The material facts establishing Petitioner’s noncompliance with 42 C.F.R. § 483.25(d) are not disputed.  Although Petitioner generally disputes the finding of noncompliance, it does not present evidence to challenge the facts that underlie the finding of a deficiency under section 483.25(d) (i.e., that a resident sustained a significant coffee burn and that the facility developed, but did not implement, several policies to prevent avoidable injuries from hot liquid spills).  Further, Petitioner does not present evidence that it

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returned to compliance at a date earlier than February 1, 2017.  There is no genuine dispute as to any material fact that requires a hearing, and summary judgment in CMS’s favor is warranted.

Resident # 25

At the time of her admission in January 2015, Resident # 25 was a 60-year-old woman whose admitting and primary diagnosis was unspecified psychosis.  CMS Ex. 6 at 2.  Resident # 25 also had diagnoses that included major depressive disorder, anxiety disorder, insomnia, unspecified mood (affective) disorder, schizoaffective disorder, and bipolar II disorder.  CMS Ex. 6 at 2.  A Minimum Data Set assessment in January 2017 reported that Resident # 25 normally used a wheelchair for mobility, and had to be provided set-up assistance with transfers, locomotion on the unit, dressing, eating, and personal hygiene during the seven-day lookback period for the assessment.  CMS Ex. 6 at 17-18.  A Resident Mood Interview assessment indicated that Resident # 25 was “[f]eeling down, depressed, or hopeless” nearly every day over the two-week assessment period.  CMS Ex. 6 at 11.  Active diagnoses reported in the January 2017 Minimum Data Set included arthritis, muscle weakness (generalized), anxiety disorder, depression, manic depression, psychotic disorder, and schizophrenia.  CMS Ex. 6 at 24-25.

On July 26, 2016, Resident # 25 sustained a coffee burn.  A facility nurse reported the following description of the incident in a witness statement:

I was coming out of [the] kitchen and [Resident # 25] had just been served coffee and she kept moving up to table and back from table that she was sitting at.  Then she attempted to grab her coffee and knocked it over instead with her hand onto herself.  She then yelled I’m on fire and I told her to come with me so that she could be assessed by nurse.  I took her upstairs with me on elevator [and] made sure she got back to [the] 2nd floor and then I told nurse to assess her because she spilled coffee on herself.

CMS Ex. 5 at 6.  Another witness, a cook, completed a witness statement in which she recounted that Resident # 25 had been served coffee in a Styrofoam cup (CMS Ex. 5 at 9), and another witness reported that she had served Resident # 25 coffee in a plastic cup.9  CMS Ex. 5 at 10.  A July 28, 2016 statement submitted by a “skin integrity” registered nurse reported her observation that Resident # 25’s abdomen “showed redness

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[with] blisters noted” and “open areas [with] pink/yellow wound bed.”  CMS Ex. 5 at 8.  The nurse documented that “moderate sero-sanguinous drainage [was] noted.”  CMS Ex. 5 at 8.

The service temperature of the coffee that Petitioner served at the July 26, 2016 lunch meal is not documented, and likewise, the temperature of the cup of coffee that spilled on Resident # 25 is unknown.  In fact, Petitioner acknowledged that, at the time of the accident, “nurses and aides did not necessarily test the temperature of each cup of coffee before serving it.”  Request for Hearing at 3.  Petitioner also conceded that, prior to Resident # 25’s burn, its coffee service system, whereby it maintained heated coffee urns on each of its four floors, “turns out not to have been ideal, as it was difficult to maintain a consistent temperature in [coffee] urns.”  Request for Hearing at 3.

A nursing assessment performed at 12:15 pm on July 26, 2016, reported that Resident # 25 sustained a coffee burn in the dining room.  CMS Ex. 7 at 1.  The assessment explained that Resident # 25 “was attempting to drink a cup of coffee” and “accidently [sic] spilled the hot coffee on herself.”  CMS Ex. 7 at 1.  The assessment further explained that Resident # 25’s abdominal area was “red and blistering.”  CMS Ex. 7 at 1.

Progress notes from July 26, 2016, indicated that Resident # 25 had “several blister[s] to abdomen and left inner thigh.”  CMS Ex. 9 at 1.  The progress notes reported that blistering had been observed through July 30, 2016, and that the wound exhibited drainage through August 6, 2016.  CMS Ex. 9 at 7-8.  Resident # 25 intermittently reported pain and/or discomfort through August 7, 2016, and progress notes indicate that Petitioner’s staff administered Tylenol and Ultram (tramadol) for pain.  CMS Ex. 9 at 5-8.  Progress notes indicate that nursing staff applied bacitracin and Silvadene cream to the wound and performed dressing changes through at least August 8, 2016.  CMS Ex. 9 at 5-8.  Nursing notes indicate that while Resident # 25 was recovering from her injury, she spent much of her time in bed.  CMS Ex. 9 at 5-8.  On August 5, 2016, nursing staff reported that Resident # 25 “has decline[d] to participate [in] ongoing activity on unit and off unit [and] continue to be encourage [sic] but continue to decline.”  CMS Ex. 9 at 8.  That same day, nursing staff reported that Resident # 25 had “started with restorative nursing for transfers and self care,” but “has refused to participate.”  CMS Ex. 9 at 8.

Physician orders prescribed daily treatment of the wound with bacitracin, Silvadene cream, or Santyl, or a combination of more than one of those topical medications, through August 24, 2016.  CMS Ex. 10.   

On July 31, 2016, Resident # 25’s physician examined her, at which time he provided the following description of Resident # 25’s chief complaint:

I have been requested to see this patient due to pain management.  She spilled hot coffee on her abdomen

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approximately five days ago suffering second-degree burns.  She is lying in bed saying her pain is approximately 7/10.  She is noted [sic] her activity level has decreased due to the pain.  She is hesitant to start any pain medication, but we will try Ultram.

CMS Ex. 12 at 1.  The physician assessed “[s]econd-degree abdominal burns secondary to coffee,” and prescribed Silvadene cream twice per day and Ultram every six hours as needed for pain.  CMS Ex. 12 at 1; see CMS Ex. 10 at 2.

An incident report form completed on July 31, 2016, documents that Resident # 25 “was burned with hot coffee” on July 26, 2016.  CMS Ex. 8 at 1, 3.  The report documented that Resident # 25 had been admitted to the facility for long-term care, and that she had primary diagnoses of depression, anxiety, paranoia, and psychosis.  CMS Ex. 8 at 1.  The report discussed a new and painful burn to Resident # 25’s abdominal area, with a pain intensity level of 8 out of a scale of 1-10.  CMS Ex. 8 at 2.  Resident # 25’s abdominal area was observed as being “bright red and top layer of skin peeling.”  CMS Ex. 8 at 2.  The incident report documented that Petitioner notified Resident # 25’s physician that same day, and the physician ordered that Silvadene cream be applied twice per day and that Petitioner’s wound nurse assess and treat the wound.  CMS Ex. 8 at 3.

On July 28, 2016, Resident # 25’s physician ordered a wound care consultation.  CMS Ex. 10 at 1.  A wound care physician conducted an initial evaluation on August 11, 2016.  CMS Ex. 12 at 2-4.  The physician reported that Resident # 25 “present[ed] with a burn wound of the left abdomen” and that the wound had “moderate serous exudate.”  CMS Ex. 12 at 2.  The physician reported there was no indication of pain.  CMS Ex. 12 at 2.  At that time, the wound was measured to be 2 cm x 15 cm with no measurable depth, and consisted of 70 percent thick adherent black necrotic tissue and 30 percent skin.  CMS Ex. 12 at 3.  Resident # 25 refused debridement even though she was advised that the “risks of not removing necrosis include[ed] infection, sepsis, limb loss or death.”  CMS Ex. 12 at 3.  The physician summarized that Resident # 25 “was burned from hot coffee on the abdomen— now with large burn on her stomach— still with non-black eschar present,” and that the plan was to “soften up the eschar for possible debridement next week.”  CMS Ex. 12 at 4.  Five days later, on August 16, 2016, the wound care physician reported improvement, and reported that Resident # 25 again refused debridement despite being warned of the “risks of not removing necrosis.”  CMS Ex. 12 at 6.  On August 23, 2016, the wound care physician reported that the wound was “[e]pithelialized and [r]esolved.”  CMS Ex. 12 at 8.  A February 2017 skin evaluation reported that Resident # 25 had a 7 cm x 20 cm abdominal scar “from [a] previous documented burn.”  CMS Ex. 17 at 1.

Petitioner conducted a hot liquids safety evaluation of Resident # 25 on July 29, 2016, at which time it assessed the presence of two risk factors:  mood (varying over the course of

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the day or easily agitated) and behaviors (frequent impulsive acts/short tempered).  CMS Ex. 16.  Based on this assessment, Petitioner implemented interventions that included the use of lidded cups for hot beverages, making sure that the temperature of hot liquids would not “exceed 180 degrees,” and having staff assist Resident # 25 with all hot liquids.  CMS Ex. 16.

Petitioner’s hot liquid policy and corrective actions

A copy of Petitioner’s hot liquids policy pre-dating July 29, 2016, is not of record.  In its request for hearing, Petitioner referenced its former coffee service policy, explaining:

Petitioner will show that the Center is a four-story building, and so historically has made snacks and beverages available on all resident units so that residents do not have to go downstairs to the dining room for a snack or cup of coffee.  Until Resident #25’s accident, the Center had stationed heated coffee urns on each unit, located in a nutrition room behind the nursing station, so that hot coffee would be readily available.  In retrospect, this system turns out not to have been ideal, as it was difficult to maintain a consistent temperature in such urns, and nurses and aides did not necessarily test the temperature of each cup of coffee before serving it.

Request for Hearing at 3.

In July 2016, after Resident # 25 sustained a coffee burn, Petitioner’s Quality Assurance Committee identified a “problem area” and “deficiency” of an “[u]nsafe practice of using a sty[ro]foam 16 oz cup with coffee without protective lid.”10  CMS Ex. 18 at 4 (bold and capitalization omitted).  The committee determined that a number of corrective actions should be implemented, to include, but not limited to, conducting hot liquid assessments on each resident, updating care plans to reflect resident-specific interventions, serving coffee in rooms in lidded cups, ensuring that all hot liquids are served at no greater than 155 degrees, in-servicing the dietary manager on temperature logs and daily monitoring, and randomly testing the temperature of coffee served to residents.  CMS Ex. 18 at 4-7.  The committee reported that the corrective actions had been implemented on or before August 31, 2016.  CMS Ex. 18 at 4-7.

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On July 29, 2016, Petitioner established a new policy that had been developed by Crandall Corporate Dietitians, “Safe Holding and Serving Temperatures for Hot Beverages.”  CMS Ex. 19 at 2-3; see P. Exs. 3 at 3; 5 at 2; 6 at 2.  At the outset, the policy stated the following:  “The temperatures that hot beverages should be served at are governed by palatability and by the risk for a burn.”  CMS Ex. 9 at 2.  The policy included the following directives:

• Serve the hot beverages between 140 and 155 degrees.  Dietary should record hot beverage temperatures for every meal.
• Residents at high risk for spillage should be assisted as needed.  Recommend using an insulated mug with a lid for all hot beverages when needed.

CMS Ex. 19 at 2.  Additionally, the policy explained that “elderly who are immobilized in a wheelchair and confused residents are more susceptible” to hot liquid burns.  CMS Ex. 19 at 2.

The policy also directed that staff consider additional measures for residents with “behavioral or medical conditions that put them at risk for spills,” to include the following:

• Evaluate resident’s ability to independently manage hot beverages and provide appropriate assistance.
• Allow hot liquids to cool before serving.
• Utilize an insulated mug with a lid.

CMS Ex. 19 at 3. 

In its request for hearing, Petitioner explained changes that it made to its coffee service following Resident # 25’s coffee burn, stating:

First, the Center removed all coffee urns from the units.  Instead, kitchen staff poured coffee into carafes in the kitchen, monitored the temperature before the coffee left the kitchen (no coffee was released until it had cooled to 165 degrees), and then the coffee was taken to the units.

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The Center also made some changes to its coffee preparation procedures.  Petitioner will show that coffee manufacturers typically recommend that coffee be brewed at 195-205 degrees to allow the characteristic flavor aromatics to be released.  A safe consumption temperature is 150 degrees or so.  For a short time after Resident #25's accident, the Center actually brewed all coffee at 175 degrees, but many residents complained about its palatability, so the Center increased the brewing temperature and instituted specific monitoring of temperatures before delivering carafes to the units, and serving to residents – leave kitchen at no more than 175 degrees; maintain on unit at no more than 165 degrees, and serve at no more than 155 degrees.  (Petitioner will show that coffee hotter than 170 degrees or so is so hot that even a confused person would spit it out; conversely, most people, including residents, find coffee cooler than 140 degrees or so to be unpalatable, even though a hot beverage at 140 degrees could cause a burn on skin.)  Digital instant-read thermometers were provided on each unit and in the dining room, which dietary and nursing aides used to measure at least the first cup poured from each carafe (if the first cup was at an appropriate temperature, later cups presumably were as well).  Residents said that they preferred this system, and complaints about palatability ended.

The Center also ended the practice of serving hot beverages in (or allowing residents to serve themselves in) 16 ounce styrofoam cups.  Instead, residents were provided covered mugs, or, if they preferred, 8 ounce styrofoam cups with tight-fitting plastic lids.  The Center also removed coffee service that had been kept available for visitors, and limited the ability of residents to take hot beverages out of the dining room, and into their rooms.

Request for Hearing at 3-4.

On February 3, 2017, the facility placed an order for 96 “Turnbury 8 oz. Insulated Pedestal Base Mug[s].”  CMS Ex. 28; P. Br. at 12 (“The Center also purchased covered mugs during the survey.”); see CMS Ex. 19 at 2-3 (July 29, 2016 policy recommending that high risk residents use “an insulated mug with a lid for all hot beverages when needed,” and that staff consider whether at-risk residents should use “an insulated mug with a lid.”).

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The surveyors obtained copies of “Service Line Checklist” forms that list the recorded temperatures of food and beverages served in the dining room between July 1, 2016, and January 31, 2017.11  CMS Ex. 20; see P. Ex. 7 at 3 (dietary aide’s testimony that Service Line Checklist forms were used for dining room meal service).  Through July 26, 2016, the day Resident # 25 sustained a coffee burn, the temperature provided for “hot beverages” generally included both “tea and coffee” together, even though these items are brewed through separate processes.  CMS Ex. 20 at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, and 17.  Further, through July 26, 2016, a single “hot beverages” temperature is recorded to cover both breakfast and lunch.  CMS Ex. 20 at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, and 17. 

Petitioner’s new policy that required that hot liquid temperatures be recorded at every meal became effective on July 29, 2016.  CMS Ex. 19 at 2.  However, Service Line Checklist forms are available for only 41 days out of an approximately six-month period between July 29, 2016, and the start of the survey on January 31, 2017.  CMS Ex. 20 at 18-60.  Further, the pre-printed Service Line Checklist form continued to list a pre-printed reference temperature of 190 degrees for hot beverages, even though Petitioner’s new policy directed that coffee be served between 140 and 155 degrees.  CMS Ex. 20 at 18-60; see CMS Ex. 19 at 2.  Likewise, Petitioner often listed coffee, tea, and/or hot chocolate together with a single temperature, even though those beverages are not brewed through the same process (CMS Ex. 20 at 19, 20, 24, 37, 43, 49).  Further, Petitioner often recorded a single hot beverages temperature to cover both the breakfast and lunch meals (CMS Ex. 20 at 19, 20, 21, 22, 23, 24, 27, 28, 29, 31, 32, 33, 35, 36, 37, 38, 39, 40, 41, 43, 44, 45, 47, 49, 52, 56, 60).  No hot beverage temperatures are recorded on two of the checklists, even though meals had been served on those days.  CMS Ex. 20 at 26, 34.

In discussing these Service Line Checklist forms, CMS alleged that Petitioner failed to record hot beverage temperatures for every meal as required by its policy.  CMS Br. at 8 (“Temperature logs were only available for 54/214 (25.2%) days between July 1, 2016 and January 31, 2017.”); see CMS Ex. 19 at 2 (Petitioner’s policy requiring that it “record hot beverage temperatures for every meal.”).  Petitioner did not submit evidence to refute this allegation, nor did it argue otherwise.  Rather, Petitioner submitted evidence, in the form of “Coffee Temperature Log” forms, on which it recorded temperatures for coffee served on its 2nd, 3rd, and 4th floor units, between August 2016 and February 2017.  P. Ex. 2.

Petitioner’s coffee temperature logs12 contain fields for staff to record the temperature of

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coffee served on the floors as measured in both the kitchen and on the unit.13  P. Ex. 2.  Inspection of the logs reveals that the temperature of the coffee when it was brought to the floors was frequently well above the 165 degree maximum temperature listed on the forms; in fact, the recorded coffee temperature on the floors was sometimes higher than the coffee temperature taken in the kitchen.14  P. Ex. 2; see P. Ex. 3 at 3 (administrator’s testimony that he “directed that the dietary staff should measure the temperature of the coffee brewed in the kitchen, and not to take that coffee to the units until it was below 175 degrees”).  For example, the temperature of the coffee on the 2nd floor unit was measured to be 180 degrees or greater on September 10, 19, 21, 23, and 30, and in each of those instances, the coffee temperature on the floor was higher than the temperature of the coffee when it was measured in the kitchen.  P. Ex. 2 at 4.  Likewise, coffee on the second floor was recorded as being 185 degrees on October 7, 18, 25, and 27, and 180 degrees on October 6, 20, and 28.  P. Ex. 2 at 5.  Further, even though the coffee temperature was higher than the parameters set by Petitioner’s administrator and the pre-printed range provided on the coffee temperature log form, the forms lack any notations in the section provided for “Corrective Action Taken/Comments.”15  P. Ex. 2 at 4-5.  The coffee temperature log forms also contain incomplete data; for example, the 2nd floor log for November 2016 lacks data regarding the temperature of the coffee on the unit for half of the days that month (November 4, 5, 6, 7, 8, 9, 11, 12, 13, 19, 20, 21, 22, 23, and 29).  P. Ex. 2 at 7-8.

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B. Petitioner was not in substantial compliance with 42 C.F.R. § 483.25(d)(1),(2) because a resident sustained a serious coffee burn injury as a result of Petitioner’s admittedly unsafe coffee service practices, and Petitioner did not implement corrective actions it developed to mitigate the risk of harm from avoidable accidents involving hot liquid spills.

C. Petitioner has not raised a genuine dispute as to the facts demonstrating that the cited deficiency constituted immediate jeopardy.  

Subsection 483.25(d) is part of the quality of care regulation at 42 C.F.R. § 483.25, which states that “[q]uality of care is a fundamental principle that applies to all treatment and care provided to facility residents.”  Subsection 483.25(d) imposes specific obligations upon a facility related to accident hazards and accidents, as follows:  The facility must ensure that —

(1) The resident environment remains as free of accident hazards as is possible; and

(2) Each resident receives adequate supervision and assistance devices to prevent accidents.

42 C.F.R. § 483.25(d)(1),(2).

The Departmental Appeals Board (DAB) has held that subsection 483.25(d)(1)16 requires that a facility address foreseeable risks of harm from accidents “by identifying and removing hazards, where possible, or, where the hazard is unavoidable because of other resident needs, managing the hazard by reducing the risk of accident to the extent possible.”  Maine Veterans’ Home - Scarborough, DAB No. 1975 at 10 (2005) (explaining the inherent standard of care in section 483.25(h)(1)); see The Bridge at Rockwood, DAB No. 2954 at 10 (2019)(“The correct question is whether the facility did what it reasonably could to ensure that all residents received supervision needed to ‘mitigate foreseeable risks of harm’ based on what it knew about the residents, their care needs, and the conditions in the facility.”).  The provisions of section 483.25(d) “come into play when there are conditions in a facility that pose a known or foreseeable risk of accidental harm.”  Meridian Nursing Ctr., DAB No. 2265, at 10 (2009), aff’d sub nom. Fal-Meridian, Inc. v. U.S. Dep’t of Health & Human Servs., 604 F.3d 445 (7th Cir. 2010).  The DAB has held that subsection 483.25(d)(2) requires that a facility take “all reasonable steps to ensure that a resident receives supervision and assistance devices that

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meet his or her assessed needs and mitigate foreseeable risks of harm from accidents.”  Briarwood Nursing Ctr., DAB No. 2115 at 11 (2007), citing Woodstock Care Ctr. v. Thompson, 363 F.3d 583, 589 (6th Cir. 2003) (facility must take “all reasonable precautions against residents’ accidents”), aff’g Woodstock Care Ctr., DAB No. 1726 (2000).  Facilities are given “the flexibility to choose the methods” they use to provide supervision or assistive devices to prevent accidents, so long as the chosen methods constitute an “adequate” level of supervision for a particular resident’s needs.  Windsor Health Care Ctr., DAB No 1902 at 5 (2003), aff’d sub nom. Windsor Health Ctr. v. Leavitt, 127 F. App’x 843 (6th Cir. 2005). 

The State Operations Manual (SOM) (CMS Pub. 100-07), Appendix PP, provides guidance to state agency surveyors.17  See CMS Ex. 30.  With respect to Tag F323, the SOM explains that “[m]any residents in long-term care facilities have conditions that may put them at increased risk for burns caused by scalding.”  CMS Ex. 30 at 12.  The SOM discusses that these conditions include decreased agility (reduced reaction time), decreased cognition or dementia, decreased mobility, and decreased ability to communicate.  Id.  Resident # 25 used a wheelchair and had multiple psychiatric impairments (CMS Ex. 6 at 18, 25), and based on the aforementioned SOM guidance, she was at risk for burns.  CMS Ex. 30 at 12.  Additionally, Petitioner conducted its own assessment in July 2016 following Resident # 25’s coffee burn and determined that Resident # 25 was at risk for coffee burns.  CMS Ex. 16.

In the statement of deficiencies, CMS cited Petitioner for failing to ensure its environment remains as free of accident hazards as possible and that each resident receives adequate supervision and assistance devices to prevent accidents, in violation of 42 C.F.R. § 483.25(d).  CMS Ex. 1 at 31-32.  The statement of deficiencies stated the following, in pertinent part:

Based on a resident group interview, clinical record review, observations, staff interviews, and facility document review the facility staff failed to ensure safe coffee temperatures on 7/26/16 to prevent an avoidable accident for Resident #25 resulting in second degree abdominal burns after spilling hot coffee on herself, and on 2/1/17 during the survey the coffee served to Residents #26, #27, #28, #29, and #30 in the dining room at 5:45 p.m. was identified at temperatures sufficient to

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cause third degree burns resulting in the identification of Immediate Jeopardy.

CMS Ex. 1 at 32.  The statement of deficiencies further explained that the state agency became aware of Resident # 25’s July 2016 coffee burn when, in a group interview during the survey, “residents were asked about their coffee grievance in their resident council minutes” and the council president explained that “[c]offee has been a problem since that lady got burned.”  CMS Ex. 1 at 32-33; see CMS Ex. 5 at 2 (Resident Council Concern form), 4-5 (Resident Council minutes). 

Petitioner does not contest CMS’s basis for citing a deficiency regarding Resident # 25’s coffee burn on July 26, 2016.  P. Br. at 14 (“Petitioner is willing to assume, at least for purposes of the following discussion, that CMS could have cited an ‘actual harm’ deficiency relating to Resident #25’s accident.”).  Even though CMS argued that Petitioner “created an avoidable hazard by serving extremely hot coffee to Resident [#] 25 in a lidless Styrofoam cup” and that “facility staff served her ‘boiling’ hot coffee (in excess of 170 degrees) in a lidless Styrofoam cup and then walked away” (CMS Br. at 13), Petitioner did not offer any evidence to rebut CMS’s allegation.  See CMS Ex. 1 at 32, 53 (statement of deficiencies citing the July 26, 2016 coffee burn as a basis for immediate jeopardy); P. Ex. 2 (Petitioner’s submission of coffee temperature logs that post-date the July 26, 2016 incident); P. Exs. 3, 4, 5, 6, 7 (various witness statements that do not dispute that, on July 26, 2016, Resident # 25 was served coffee in excess of 170 degrees in an unlidded Styrofoam cup).  Rather, Petitioner argues that the statement of deficiencies and CMS, in its pre-hearing brief, did not allege that immediate jeopardy was based on Resident # 25’s coffee burn, and that CMS first associated immediate jeopardy with Resident # 25’s coffee burn in its motion for summary judgment.  P. Response at 2.  However, the statement of deficiencies unambiguously based the determination to call immediate jeopardy beginning on July 26, 2016, on Petitioner’s failure “to ensure safe coffee temperatures on 7/26/16 to prevent an avoidable accident for Resident # 25, resulting in second degree abdominal burns after spilling hot coffee on herself.”  CMS Ex. 1 at 32.  Further, Petitioner did not refute that Resident # 25’s coffee burn was a basis for immediate jeopardy, and to the contrary, it conceded that “hot beverage burns such as this sometimes are avoidable, and Petitioner most likely would not have contested an ‘actual harm’ or ‘past noncompliance’ citation focused on the circumstances of the accident.”  P. Br. at 9.  Additionally, Petitioner determined, through its own quality assurance review, that its practice of serving coffee in unlidded Styrofoam cups was an “[u]nsafe practice.”  CMS Ex. 18 at 4.  Petitioner further conceded that, prior to Resident # 25’s coffee burn, its “staff did not routinely test the temperature of coffee as it was served.”  Request for Hearing at 2.  Additionally, facility records indicate that the coffee served on July 26, 2016, was measured at 174 degrees in the kitchen prior to service in the dining room (CMS Ex. 20 at 17), and Petitioner has not offered any evidence that the coffee had actually cooled to a safe serving temperature or that it had a protocol in place at that time to ensure that coffee had sufficiently cooled prior to service.

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See CMS Ex. 19 at 2 (facility’s new policy stating that a safety precaution included serving coffee at between 140 and 155 degrees); P. Ex. 6 at 2 (testimony of a cook/dietary aide that “a safe serving temperature was less than 155 degrees.”); P. Response at 3 (“It is obvious that whatever the actual temperature of the coffee at the time of the spill, it was hot enough to injure the Resident.”).18  Thus, by lacking protocols that ensured that it served coffee at a safe temperature and in a safe manner (i.e., not in a lidless Styrofoam cup), Petitioner did not make adequate efforts to prevent a coffee burn such as the one Resident # 25 sustained on July 26, 2016. 

CMS asserts that Petitioner’s deficiency constituted immediate jeopardy to resident health and safety beginning on July 26, 2016, and continuing until Petitioner presented acceptable evidence of correction on February 1, 2017.  Petitioner has not specifically challenged the determination of immediate jeopardy on July 26, 2016; rather, Petitioner argues that neither the statement of deficiencies nor CMS’s brief made any such finding associating the finding of immediate jeopardy to Resident # 25’s coffee burn.  Petitioner is mistaken.  The statement of deficiencies unquestionably reported that “facility staff failed to ensure safe coffee temperatures on 7/26/16 to prevent an avoidable accident for Resident # 25, resulting in second degree abdominal burns after spilling hot coffee on herself.”  CMS Ex. 1 at 32.  Further, CMS addressed this issue at length in its brief.  See CMS Br. at 13-14 (Legal Analysis argument headings that “Signature Created a Foreseeable Risk of Harm by Serving Extremely Hot Coffee to Residents” and “The facility created an avoidable hazard by serving extremely hot coffee to Resident 25 in a lidless Styrofoam cup.”).

Immediate jeopardy exists if a facility’s noncompliance has caused, or is likely to cause, serious injury, harm, impairment, or death to a resident.  42 C.F.R. § 488.301.  I must uphold CMS’s determination as to the level of a facility’s substantial noncompliance (which includes an immediate jeopardy finding) unless it is “clearly erroneous.”  42 C.F.R. § 498.60(c).  The DAB directs that the “clearly erroneous” standard imposes on a facility a heavy burden to show no immediate jeopardy and has sustained determinations of immediate jeopardy where CMS presented evidence “from which ‘[o]ne could reasonably conclude’ that immediate jeopardy exists.”  See, e.g., Barbourville Nursing Home, DAB No. 1962 at 11 (2005) (citing Florence Park Care Ctr., DAB No. 1931 at 27-28 (2004)).

Here, CMS’s finding of immediate jeopardy is not “clearly erroneous.”  At the time Resident # 25 was injured, Petitioner served coffee in lidless Styrofoam cups; Petitioner recognized that this practice was unsafe.  CMS Ex. 18 at 4.  To remedy this problem,

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Petitioner determined that significant changes to its coffee service procedures were necessary.  CMS Ex. 18 at 4-8.  Among those changes, Petitioner determined a need to conduct hot liquids safety assessments of all of its residents (CMS Ex. 18 at 4-5), which revealed that Resident # 25 was at risk for hot liquid burns.  CMS Ex. 16.  Petitioner also determined that a safe coffee temperature is no higher than 155 degrees (CMS Ex. 18 at 6); yet, it offered no evidence that the coffee served to Resident # 25 on July 26, 2016, was served at such a safe temperature.  See P. Ex. 2 (coffee temperature logs submitted by Petitioner that post-date Resident # 25’s burn); P. Exs. 3-7 (Petitioner’s sworn witness testimony that lacks any discussion of whether the coffee served to Resident # 25 was a safe temperature).  In fact, Petitioner does not present any evidence to refute CMS’s claim that the coffee served to Resident # 25 was “in excess of 170 degrees.”  CMS Br. at 13.  Rather, Petitioner argued, without any factual support, that coffee “obviously cools over time between brewing and serving, and that it had presumably cooled from 174 degrees by the time of the accident” because it was Resident # 25’s second cup of coffee.  P. Br. at 8 n.4.

The DAB has considered circumstances akin to the ones presented here in Crawford Healthcare and Rehabilitation, DAB No. 2738 at 16 (2016), in which a resident sustained second-degree burns and had a course of treatment that was “extended and complicated.”  The DAB determined that “actual serious harm is not necessary to support an immediate jeopardy determination if CMS finds a likelihood that serious harm will occur from the cited conditions absent immediate correction.”  Crawford, DAB No. 2738 at 17.  In particular, the DAB determined that residents who had “suffered actual [burn] injuries were endangered by the facility’s failure to carry out interventions which its own assessments established to be appropriate to protect residents from hot liquid spills.”  Id.

Petitioner has not submitted any evidence to rebut CMS’s claims that Resident # 25 sustained a “large second degree burn, endured prolonged pain and treatment, and suffered a permanent scar” and that “[h]er injuries were clearly serious.”19  CMS Br. at 13, 20.  Petitioner also recognized that, at the time of Resident # 25’s accident, it served coffee in an unsafe manner in unlidded Styrofoam cups.  See CMS Ex. 18 at 4-8.  Based on these circumstances, and the severity of the burn which involved an extended and complicated course of treatment, along with pain and a permanent scar across Resident # 25’s abdomen, the accident resulted in serious harm for purposes of immediate jeopardy.  See CMS Ex. 12 at 1 (physician report of “second-degree burns covering the

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anterior aspect of the abdomen” with 7/10 pain and decreased activity level); 2-3 (wound care evaluation reporting necrosis and moderate serous exudate more than two weeks after the burn); P. Br. at 14 (conceding actual harm “for purposes of . . . discussion”).  Resident # 25 sustained a large and painful wound, and had an “extended and complicated” recovery; Resident # 25 sustained serious harm, as contemplated by 42 C.F.R. § 488.301.  See Crawford, DAB No. 2738 at 16-17.  

D. Immediate jeopardy continued through January 31, 2017, at which time Petitioner implemented all corrective actions to prevent avoidable hot liquid spill injuries.

Following Resident # 25’s coffee burn, Petitioner’s Quality Assurance Committee developed various corrective actions to address the self-identified deficiency of an “[u]nsafe practice of using a sty[ro]foam 16 oz cup with coffee without protective lid.”  CMS Ex. 18 at 4.  Among these corrective actions, Petitioner’s Quality Assurance Committee determined that staff will “[e]nsure all hot liquids are served no greater than 155 degrees.”  CMS Ex. 18 at 6.  Further, Petitioner implemented a new policy that identified various “safety precautions,” to include serving hot beverages “between 140 and 155 degrees.”  CMS Ex. 19 at 2.  To serve that end, the new policy directed that “[d]ietary should record hot beverage temperatures for every meal.”  CMS Ex. 19 at 2.  The policy recommended, for high risk residents, “using an insulated mug with a lid for all hot beverages when needed,” and also directed staff to consider, for residents with “behavioral or medical conditions that put them at risk for spills,” that “[i]f appropriate, utilize an insulated mug with a lid.”  CMS Ex. 19 at 2-3.

In furtherance of its new policy and corrective actions following Resident # 25’s burn injury, Petitioner provided witness testimony that it had trained and directed its staff to record coffee temperatures, to include recording the dining room coffee temperatures on Service Line Checklist forms.  CMS Ex. 20 (compilation of Service Line Checklist forms covering the period from July 1, 2016, through January 31, 2017); see P. Ex. 6 at 1-2 (testimony of Ms. Cassell, a cook/dietary aide, that her responsibilities included brewing coffee and serving coffee to residents in the dining room, and that she had been instructed by the dietary manager to “record [the coffee] temperature on the Service Line Checklist” after she brewed it); P. Ex. 7 at 3 (testimony of Ms. Lloyd, a dietary aide, that she logged the temperature of coffee served in the dining room on the Service Line Checklist “after it was brewed in the kitchen”); P. Ex. 4 at 3 (testimony of Ms. Lane, the dietary manager, that “we instructed our aides to record the temperature of the coffee and then move the coffee from the kitchen to the dining room,” and that the administrator had asked her to keep the temperature logs “so that he could review how we were implementing the new procedure.”).

CMS submitted copies of the Service Line Checklist forms covering the time period at issue.  CMS Ex. 20.  Even though Petitioner’s new hot liquids policy took effect on July

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29, 2016, and required staff to “record hot beverage temperatures for every meal,” the surveyors obtained Service Line Checklist forms covering only 40 days between July 29, 2016, and January 31, 2017.  CMS Ex. 20 at 18-60; see CMS Br. at 8 (discussing that a total of 54 Service Line Checklist forms had been completed for the 214-day period between July 1, 2016, and January 31, 2017).  Petitioner did not dispute CMS’s claim that it did not record the temperatures of coffee served in its dining room at every meal, as required by its policy.  See CMS Ex. 19 at 2.  Rather, Petitioner submitted copies of logs for coffee served on its floors, which similarly were incomplete.  P. Ex. 2; see P. Br. at 11 (acknowledging CMS’s argument that Service Line Checklist forms lacked  recorded temperatures for coffee served in its dining room on many days, but not refuting it).

Further, Petitioner’s July 2016 policy required that it serve coffee at a temperature of between 140 and 155 degrees.  CMS Ex. 19 at 2.  However, the coffee temperature logs and Service Line Checklist forms indicate that Petitioner’s staff did not record temperatures at all meals.  CMS Ex. 20; P. Ex. 2.  In fact, the temperature logs lacked dining room coffee temperatures for the majority of days, lacked dining room dinner meal temperatures for all days, lacked numerous entries in the floor unit logs, and documented numerous instances in which the coffee temperature on the floor was higher than the kitchen temperature and exceeded the prescribed maximum temperature.  P. Ex. 3 at 5; see CMS Exs. 19 at 2; 20 (Service Line Checklist (dining room) logs); P. Ex. 2 (floor unit logs).  Notably, although the administrator testified that he directed staff “not to take [the] coffee to the units until it was below 175 degrees” and pre-printed forms listed a maximum temperature of 165 degrees for coffee on the floors, coffee temperatures recorded on the floors were frequently in excess of 175 degrees, reaching over 180 degrees on a number of occasions.  See Request for Hearing (reporting coffee did not leave the kitchen until the temperature was no more than 175 degrees and it was maintained on the unit at no more than 165 degrees); P. Ex. 2 at 4-5 (reporting coffee temperatures of 180 degrees or higher on the 2nd floor unit on September 10, 19, 21, 23, and 30, and October 6, 7, 18, 20, 24, 25, 27, and 28).  And although the administrator reported that coffee was given a half hour to cool to a safe temperature, he premised this statement on the stated policy that coffee taken to the floors would be below 175 degrees, which is unsupported by the contemporaneous temperature logs.  P. Ex. 3 at 3; see P. Ex. 2 at 4-5.  In fact, the testimony of the dietary manager details a “test” she conducted in which she allowed 173 degree coffee to cool for a half hour, resulting in a temperature of 150 degrees.  P. Ex. 4 at 5.  Petitioner has not submitted evidence to dispute CMS’s claim it did not adhere to its own revised policy that required it to serve hot beverages between 140 and 155 degrees and to record temperatures for hot beverages at every meal.  CMS Ex. 19 at 2.

Additionally, CMS argued in its brief that, after Petitioner developed its new policy, “coffee continued to be served in Styrofoam cups, rather than in insulated mugs.”  CMS Br. at 9; see CMS Exs. 19 at 2-3 (recommending that high risk residents use “an insulated

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mug with a lid for all hot beverages when needed” and directing staff to consider using “an insulated mug with a lid” for at-risk residents); 28 (February 3, 2017 order for mugs).  Petitioner did not refute this allegation of noncompliance in its brief.  P. Br. at 12 (“The Center also purchased covered mugs during the survey.”).  CMS reiterated this allegation in its motion for summary judgment (CMS Motion at 9, 18), and Petitioner again did not refute it, much less submit evidence that it had in its possession the lidded and insulated mugs that are referenced in its July 29, 2016 policy prior to February 3, 2017.  See CMS Ex. 28.

Substantial compliance means not only that the facility corrected the specific cited instances of substantial noncompliance but also that it implemented a plan of correction designed to assure that no additional incidents would occur in the future.  Once a facility is found to be out of substantial compliance, it remains so until it affirmatively demonstrates that it has achieved substantial compliance once again.  Ridgecrest Healthcare Ctr.,DAB No. 2493 at 15 (2013) (citing Premier Living & Rehab. Ctr., DAB No. 2146 at 23 (2008) and Lake City Extended Care Ctr., DAB No. 1658 at 12-15 (1998)).  The burden is on the facility to prove that it is compliant with program requirements, and not on CMS to prove that deficiencies continued to exist after they were discovered.  Asbury Ctr. at Johnson City, DAB No. 1815 at 19-20 (2002).  Noncompliance found during a survey is “presumed to continue until the facility demonstrates that it has achieved substantial compliance.”  Taos Living Ctr.,DAB No 2293 at 20 (2009); see Pearsall Nursing & Rehab. Ctr. – North, DAB No. 2692 at 7 (2016) (affirming summary judgment where Petitioner “refer[red] broadly to ‘the evidence presented in [its] Response’” but “identifie[d] no specific evidence relevant to the material facts”).

CMS determined that immediate jeopardy existed on July 26, 2016, and continued until February 1, 2017, when Petitioner, inter alia, implemented corrective actions that it had not previously implemented.  CMS Ex. 1 at 53-54.  These corrective actions included, but were not limited to, the following, as relevant to the previous discussion:  the implementation of a protocol to ensure that coffee is served at no more than 155 degrees (by not allowing the coffee to leave the kitchen until it had cooled to 155 degrees); requiring Dietary to maintain daily temperature logs of hot liquids served in the dining room and on the floors that would be subject to monthly quality assurance review; and, requiring that coffee being served to residents in their rooms be provided in a proper cup with a lid.  CMS Ex. 27 at 1-5; see CMS Ex. 1 at 53-54; 28 (Petitioner’s February 3, 2017 order for 96 insulated and lidded mugs).  These corrective actions are consistent with the actions that Petitioner determined were necessary in July 2016, but it did not implement these actions until February 1, 2017.  CMS Ex. 27 at 1-5.  Petitioner has not demonstrated an earlier return to compliance, and therefore, I sustain CMS’s determination that immediate jeopardy was not abated until February 1, 2017.

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E. The CMP is reasonable.

If a facility is not in substantial compliance with program requirements, CMS has the authority to impose one or more of the enforcement remedies listed in 42 C.F.R. § 488.406, to include a CMP.  In determining whether the CMP imposed against Petitioner is reasonable, I apply the factors listed in 42 C.F.R. § 488.438(f):  1) the facility’s history of noncompliance; 2) the facility’s financial condition; 3) the factors specified in 42 C.F.R. § 488.404; and 4) the facility’s degree of culpability, which includes neglect, indifference, or disregard for resident care, comfort or safety.  The absence of culpability is not a mitigating factor.  The factors listed in 42 C.F.R. § 488.404 include: 1) the scope and severity of the deficiency; 2) the relationship of the deficiency to other deficiencies resulting in noncompliance; and 3) the facility’s prior history of noncompliance in general and specifically with reference to the cited deficiencies.  Unless a facility contends that a particular regulatory factor does not support the CMP amount that CMS proposed, an ALJ must sustain the CMP.  Coquina Ctr., DAB No. 1860 at 32 (2002).

The DAB has explained that “[i]t is settled law that ALJ review of the reasonableness of CMP amounts imposed by CMS is de novo.”  Fireside Lodge Retirement Ctr., Inc., DAB No. 2794 at 19 (2017).  I consider whether the evidence supports a finding that the amount of the CMP is at a level reasonably related to an effort to produce corrective action by a provider with the kind of deficiencies found, and in light of the above factors.  I am neither bound to defer to CMS’s factual assertions, nor free to make a wholly independent choice of remedies without regard for CMS’s discretion.  See, e.g., Barn Hill Care Ctr., DAB No. 1848 at 21 (2002).  The DAB has explained that “[t]he determination of whether a CMP amount is reasonable is a conclusion of law, not a finding of fact.”  Cedar Lake Nursing Home, DAB No. 2344 at 12 (2010), aff’d, Cedar Lake Nursing Home v. U.S. Dep’t of Health & Human Servs., 619 F.3d 453, 457 (5th Cir. 2010).

The regulations specify that a CMP that is imposed against a facility on a per-day basis will fall into one of two ranges.  42 C.F.R. §§ 488.408; 488.438.  The upper range of a CMP, $3,050 per day to $10,000 per day, as adjusted annually under 45 C.F.R. part 102, applies to deficiencies that pose immediate jeopardy to a facility’s residents.  42 C.F.R. § 488.438(a)(1)(i).  In assessing the reasonableness of a CMP, an ALJ looks at the per-day amount, rather than the total accrued CMP.  See Kenton Healthcare, LLC,DAB No. 2186 at 28 (2008).  Pursuant to 42 C.F.R. § 488.408(g)(2), a facility cannot appeal CMS’s choice of a remedy, and an appeal of a CMP is limited to review based on the regulatory factors set forth at 42 C.F.R. §§ 488.438(f) and 488.404(a)-(c).  See, e.g., Senior Rehab.,DAB No. 2300 at 19-20.

CMS imposed a per-day CMP of $7,437 for the period of immediate jeopardy noncompliance from July 26, 2016 through January 31, 2017, for a total CMP of

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$1,413,030.  CMS Ex. 41 at 2.  The per-day CMP of $7,437 is at the very low end of the $6,394 to $20,965 range for penalties imposed for deficiencies constituting immediate jeopardy.  42 C.F.R. §§ 488.408 (e)(1)(iii); 488.438(a)(1)(i); 45 C.F.R. § 102.3; see 82 Fed. Reg. 9174, 9182.  Petitioner has not argued that any of the enumerated regulatory factors warrant a reduction of the per-day CMP, and it does not cite any regulatory basis to challenge the reasonableness of the per-day CMP.  Rather, Petitioner’s arguments focus on the duration of its immediate jeopardy noncompliance, which I have addressed above. 

The per-day CMP of $7,437 is reasonable.  First, I note that Petitioner has considerable culpability and the deficiency was serious; the undisputed facts show that Resident # 25 sustained a large second degree burn that involved a prolonged period of recovery, during which she reported pain and exhibited decreased participation in activities.  See 42 C.F.R. § 488.438(f)(4).  Petitioner has acknowledged that its coffee service practices that were in effect at the time of Resident # 25’s injury were unsafe.  CMS Ex. 18 at 4.

I also note that Petitioner has a history of noncompliance, which it does not dispute.  See CMS Br. at 25 (“The facility also has an extensive history of non-compliance, including multiple G-level tags within the past three years.”); see CMS Ex. 42 (AEM Nursing Home Enforcement History).  In fact, the enforcement history reveals that Petitioner was cited for the same deficiency (Tag F323) at the actual harm level in early 2016.  CMS Ex. 42 at 1.

Petitioner broadly argues that the remedy imposed is a “huge CMP” and a “huge sanction.”  P. Br. at 1, 6, 16; P. Resp. at 4.  I do not disagree with Petitioner’s assessment that this CMP is “huge,” in that the combined CMP is in excess of $1.4 million.  A perusal of publicly posted decisions of the DAB and ALJs indicates that the total CMP imposed in this case is at the high end of a typical CMP for a nursing home enforcement case.  Further, a review of other decisions reveals that CMS has, at times, opted to impose a per-instance CMP, rather than a per-day CMP, in circumstances where a resident may have been exposed to a greater level of actual or potential harm based on circumstances such as death, abuse, or elopement, or where the facility may have been more culpable.  However, even though I agree with Petitioner that the CMP imposed is considerable, my subjective agreement is not premised on the legal standard I must employ when assessing the reasonableness of a CMP.  CMS has the discretion to select the remedy, and it selected a per-day CMP.  Therefore, my review is limited to whether the amount of the per-day CMP is reasonable.  The per-day CMP is at the very low end of the penalty range, despite the presence of factors that could have warranted a higher per-day CMP.  I conclude that a per-day CMP of $7,437 for the duration of Petitioner’s immediate jeopardy is reasonable pursuant to 42 C.F.R. § 488.438(f).

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IV.  Conclusion

For the reasons discussed above, I grant summary judgment in favor of CMS.  There is no genuine dispute of material facts, and I find that the facility was not in substantial compliance with the Medicare participation requirements.  A $7,437 per-day CMP for 190 days of immediate jeopardy is reasonable.

• 1. The cost-of-living adjustment was mandated pursuant to the Federal Civil Penalties Inflation Adjustment Improvements Act of 2015, 104 Pub. L. No.  114-74, § 701, which was enacted on November 2, 2015.  The Secretary determined that the new CMP amounts would apply to any CMP imposed on or after September 6, 2016, regardless of the date of the survey, so long as the noncompliant conduct occurred on or after November 2, 2015.  See S&C: 16-40-NH/HHA/CLIA (September 8, 2016), https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/Downloads/Survey-and-Cert-Letter-16-40.pdf, last visited July 8, 2020; 81 Fed. Reg. 61,538 (Sept. 6, 2016) (discussing that the law “provides a clear formula for adjustment of the civil monetary penalties, leaving agencies little room for discretion.”).  The inflation-adjusted CMPs are applicable, as the survey was completed on February 3, 2017, and the CMP was imposed on May 1, 2017.  The per-day CMP range applicable to this case is $6,394 to $20,965 for the immediate jeopardy-level deficiency. 82 Fed. Reg. 9174-75, 9182 (Feb. 3, 2017) (“The adjusted civil penalty amounts apply to civil penalties assessed on or after February 3, 2017, when the violation occurred after November 2, 2015.”); but see CMS Pre-hearing Brief (CMS Br.) at 24 (reporting an applicable CMP range of $6,291 to $20,628).
• 2. Immediate jeopardy exists when “the provider’s noncompliance with one or more requirements of participation has caused, or is likely to cause, serious injury, harm, impairment, or death to a resident.”  42 C.F.R. § 488.301.
• 3. Scope and severity levels are used by CMS and state survey agencies when selecting remedies.  The scope and severity level is designated by letters A through L.  Pub. 100-7, State Operations Manual (SOM), chap. 7, § 7400.5.1 (Factors That Must be Considered When Selecting Remedies), “Assessment Factors Used to Determine the Seriousness of Deficiencies Matrix” (table) (Rev. 63, effective Sept. 10, 2010 (applicable at the time of the survey at issue)); see SOM, chap. 7, § 7400.3.1 (Rev. 185, effective November 16, 2018) (current version)); see also 42 C.F.R. § 488.408.  As relevant here, a scope and severity level of “J” indicates an isolated instance of immediate jeopardy to resident health or safety.
• 4. Tag F323 pre-dated CMS’s redesignation of its F-Tags in November 2017.  See List of Revised F-Tags, https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/GuidanceforLawsAndRegulations/Downloads/List-of-Revised-FTags.pdf (last visited July 8, 2020).
• 5. The statement of deficiencies and CMS’s letter identified the regulatory participation requirement corresponding to Tag F323 as 42 C.F.R. § “483.25(d)(1)(2)(n)(1)-(3),” which presumably refers to two separate accident prevention provisions found in 42 C.F.R. § 483.25:  section 483.25(d)(1),(2), pertaining to accident prevention, supervision, and assistance devices, and section 483.25(n)(1)-(3), pertaining to the use of bed rails.  CMS Exs. 1 at 31; 41 at 1.  Because subsection 483.25(n)(1)-(3) is irrelevant to the deficiency at issue, I do not further address that provision.
• 6. Because Petitioner has not challenged the non-immediate jeopardy deficiencies, I do not address the per-day CMPs totaling $9,090 for the period from February 1 through March 2, 2017.  See CMS Ex. 41 at 2.  The total CMP imposed, including the CMP for the non-immediate jeopardy deficiencies, is $1,422,120.  CMS Ex. 41 at 2.
• 7. I neither rely on the testimony of CMS’s witnesses, nor cite to the statement of deficiencies to establish undisputed facts.  See CMS Exs. 1 (statement of deficiencies), 2 (surveyor testimony of Ms. Russell), 3 (surveyor testimony of Ms. Kelly), 4 (surveyor testimony of Ms. Hudnall).  Although I reference the testimony of Petitioner’s witnesses throughout this decision, CMS is not prejudiced by not having an opportunity to cross-examine Petitioner’s witnesses.
• 8. Findings of fact and conclusions of law are in bold and italics.
• 9. Petitioner reported that Resident # 25’s coffee had been served in a 16 ounce Styrofoam cup.  Request for Hearing at 2; see CMS Ex. 18 at 4-8 (Petitioner’s quality improvement plan addressing the past “[u]nsafe practice” of serving coffee in unlidded Styrofoam cups).
• 10. Petitioner raised the corrective actions developed through its quality review process in its request for hearing, explaining that its Quality Assurance Committee “responded immediately to Resident #25’s accident, determined its root cause, [and] implemented interventions to reduce the chance of injury from hot beverages.”  Request for Hearing at 3.
• 11. Temperatures for breakfast and lunch, but not dinner meals, are recorded on these forms.
• 12. The heading of “Germantown Home” is inexplicably listed on numerous pages of the coffee temperature logs.  P. Ex. 2 at 5-11, 16-22, 27-34.  CMS did not dispute the authenticity of these logs, and therefore, I accept, for purposes of summary judgment, that these logs were created and maintained by Petitioner.
• 13. Petitioner initially and sporadically recorded coffee temperatures at the lunch meals, but stopped recording lunchtime coffee temperatures by late September 2016.  P. Ex. 2 at 4, 14, 26.  Petitioner began using a new form in October 2016 that did not include fields to enter temperatures for the lunch meal.  See P. Ex. 2 at 5-6, 16-17, 27-28.  I note that Resident # 25 sustained her burn injury during a lunch meal, although she consumed that meal in the dining room and not in her room on a floor.  See CMS Ex. 5 at 7.
• 14. Although the forms consistently included fields to record the temperature of coffee in both the kitchen and on the floor, Petitioner’s dietary manager testified that staff did not begin to record both temperatures until late September, explaining that this was an “additional refinement of the procedure.”  P. Ex. 4 at 3; see P. Ex. 3 at 4-5 (administrator’s testimony that in September, Petitioner realized that it “really should have a second temperature recorded for the destination location.”).
• 15. I add that the pre-printed form directed that “IF ANY TEMPERATURE IS OUT OF RANGE AT ANY TIME, YOU MUST TELL YOUR SUPERVISOR IMMEDIATELY.”  P. Ex. 2 at 4-5 (capitalization in original).
• 16. The DAB referenced section 483.25(h)(1); that section was redesignated as section 483.25(d)(1) pursuant to regulatory revisions that became effective November 28, 2016.  81 Fed. Reg. 68,688 (Oct. 4, 2016).
• 17. Appendix PP of the SOM has been revised several times since the survey; the current version (Revision 173, dated November 22, 2017) can be found at https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/som107ap_pp_guidelines_ltcf.pdf.
• 18. The SOM explains that water at 155 degrees can cause a third degree burn in one second, whereas water at 140 degrees can cause a third degree burn in five seconds.  CMS Ex. 30 at 12.  While a resident may not be able to react quickly enough to clean a hot liquid spill off herself within a single second, she or a bystander may be able to do so if given a few more seconds, and thereby prevent or mitigate a potential burn.
• 19. Without citing any specific evidence, Petitioner argues that Resident # 25’s burn “resolved uneventfully within a few weeks” and “without any complications.”  P. Br. at 1, 9 n.5.  Petitioner also argues that Resident # 25 “was burned, albeit not seriously.”  P. Br. at 16.  Petitioner does not address, much less submit evidence to rebut, the wound care physician’s observations that, even three weeks after Resident # 25’s burn injury, evaluation of the wound revealed moderate serous exudate and necrotic tissue that warranted debridement.  CMS Ex. 12.